CA2091568C

CA2091568C - Catheter attachment device

Info

Publication number: CA2091568C
Application number: CA002091568A
Authority: CA
Inventors: Thomas M. Young
Original assignee: Strato Medical Corp
Current assignee: Strato Infusaid Inc
Priority date: 1990-10-10
Filing date: 1991-09-13
Publication date: 1995-02-14
Anticipated expiration: 2011-09-13
Also published as: US5129891A; WO1992007215A1; DE69123752T2; DE9190145U1; AU8925291A; ATE146577T1; HK1008066A1; JPH05507342A; EP0553254A1; DE69123752D1; CA2091568A1; DK0553254T3; GR3022422T3; JPH0781662B2; US5312337A; ES2094826T3; EP0553254B1; AU655611B2

Abstract

A connector (10) for detachably sec-uring an end of a tube, such as a catheter (20), to a fluid port (37) of a fluid transfer assembly, such as an implantable device (30), the connector having a body part (50) which defines a coupler for coupling to a coupler receiver (43) of the transfer assem-bly. The connector includes a sleeve (40) which fits within the body part and defines an aperture (46) for compressively receiving an end of the tube which has been fitted over a fluid port (37) of the transfer assem-bly. The body part is rotatable about the sleeve to facilitate coupling of the coupler and coupler receiver. In one embodiment, the connector further includes bayonet pins (54a, 54b) for twist locking the coupler in the coupling receiver. A tie down (62) may be provided to prohibit the coupler from be-ing inadvertently detached from the coup-ling receiver. A tactile indicator (55, 155) may be included to indicate correct coupling of the coupler and the coupler receiver. The sleeve generates a compressive force to secure the tube to the fluid port. A compression insert (80) may be inserted between the sleeve and tube to provide a higher degree of compression of the tube upon the fluid port. In one embodiment, the tube is a cathe-ter (120) coupled to a patient and the fluid transfer assembly (130) is an implantable device, for subcutaneous delivery of fluid to a patient in which the catheter and device have been implanted.

Description

The present invention generally relates to the fleld of tube coupling devices, and more particularly, to a device for releasably attaching an end of a tube or catheter to a port of a fluid transport device.
Flexible tubes or catheters are often used with transport devices for fluid delivery systems. For example~
numerous surgical and non-surgical treatment procedures require that a catheter be placed in fluid communication wlth a patient's vascular system. A number of devices for this purpose are known.
Both implantable treatment reservoirs/ such as disclosed in U.S.
Patent No. 4,673,394, and traditional cannula devices, afford access to a patient's vascular system, using catheters attached to those devices.
Such devices may also be used for blood transfer, for example, in hemodialysis. U.S. Patent No. 5,041,098, assigned to the same assignee as the present application, discloses devices that are particularly adapted for this purpose. Flexible tubes are also used extra-corporeally to establish a desired fluid transport system. In the latter application~ the tubes are often fit with connectors to permlt flexibility ln the assernbly of a deslred system for standardlzed components.
Wlth regard to lmplantable vascular access devlces of the prior art, catheters are typically permanently afflxed to the implantable device prior to implantation. It is also known to use an implantable device which is adapted for attachment of a catheter to a chambered extension (i.e., a fluid exit or inlet port) of that device during the implantation procedure, but after the device is positioned within the patient. Typically, such la 64680-635 catheters are adapted to be slldingly placed over a tubular port, and to be frictionally held in place.
In view of the nature of the procedures by which implantable treatment devices are surgically implanted in patients, it is necessary that the connection between a catheter and the implantable device be easily accomplished. This enables a surgeon to concentrate on the proper placement of the implantable device. Nevertheless, the friction fit and placement of the catheter has proven to require some degree of skill and patience during implantation.
Known connectors, such as, for example, a mere collar circumscribing the catheter and which fits over a tubular port proiecting from the implantable device, often ~`
'','~

WO g2/07215 PCI~/US91/06484 .,. , ~

-2-20gl5~8 do not afford secure attachment. If the inner diameter of the collar does not properl~r conespond to the outer diameter of the catheter, either the collar will not fit over the catheter, or the collar will not generale a su"i: ~nt cG~"~r~ssive force to secure the catheter to the port. With known assemblies, therefore, it is necessA~y to keep on hand S a variety of connectors so that an appropriate connector can be s~lr 1ed and used which will specifically accG,.,n,odate the particular catheter being conne-,ted.U.S. Patent No. 4,673,394 discloses a particularly effective ~.~ngement for attaching a ~II.eter to an implanted access device. That a,-~-~ement includes a twist-lockr ' le (bayonet-type) coupler in which a pair of bayonet pins extend in opposite 10 directions from the generally cylindrical outer surface of the coupler. The pins, together with the geometry of the coupler, may be slidingly positiGned over the tubular port of the implant with a particular angular orientation, and then twisted so that the pins are captively held in place by pGiliGns of the Implant which define a void region used to capture the pins. - -Of course, care must be taken such that the action of twisting the bayonet-type coupler to lock the catheter to the implant does not cause the catheter to be d~ . .aged.
Even with such care, torquing of the cdtl,eter should be avoided, since a twisted Cdtl .eter may become partially t I ~: ' ;ed to fluid flow, or worse yet, especis~lly in multiple lumen c~U-~te.:" may beco,ne entirely blocked to fluid flow.
It is ll.erefore an object of the present invention to provide an improved connector tor securely attaching a flexible tube, such as a calh~ter~ to a chambered extension, such as a tubular fluid exit or inlet port, of a fluid t~ ansfer assembly, such a an i..",lantuble fluid delivery device.
It is ~nctl.er object of the invention to provide a ~tl.eter-to-device connector 25 which is easily installed, provides a frictional lock betvleen the catheter and device and enables twist~ockable action bêtwc en the connector and device without substc.rltially twisting the cdti.~ter.
It is yet another object of the invention to provide a cG,..pression sleeve for use with a catheter connector to provide greater co,..pressive interaction between the0 cdtl.~ter and a fluid exit or inlet port of an implantable device.
Summary Of The Invention These and other objects of the present invention are well met by the presently disclosed flexible tube connector. The connector provides easy and secure coupling ~ 209 1 568

3 64680-63 of a flexible tube, such as a catheter, to a chambered extenslon of a fluid transfer assembly, such as a fluid exit or inlet port of an lmplantable fluid dellvery devlce. The connector ls configured so as to enable desired connection of the connector and assembly without causing an obstruction of the fluld flow path or damage to the tube.
The invention provides connector apparatus for coupling an end of a resilient tube about the exterlor of a tubular extension of a fluid transfer assembly, said extension extending along a port axis and having an outer diameter d, said connector apparatus characterized by a rigid tubular sleeve extending along a reference axis, said sleeve having an inner diameter Ds, where Ds ls greater than d;
and a rigid body part disposed about said tubular sleeve and associated capture means for capturing said sleeve wlthln sald body part, whereby said sleeve is freely rotatable about said reference axls wlth respect to sald body part, wherein said body part furt~-ler includes twlst lock means responslve to coaxial alignment of said port axis and said reference axis and to subsequent rotatlon of said body part about said reference axls and sald port axis, for selectlvely engaglng said body part to said fluid trans~er assembly with said sleeve being coaxial wlth and positioned about sald tubular extenslon.
The invention also provides connector apparatus for coupling an end of a resillent tube about the exterior of a tubular extension of a fluid transfer assernbly, said extension extending along a port axis ar~d having an outer diameter d, said t~
r - `- 209 ~ 568 3a 64680-63 connector apparatus characterized by a rigid tubular sleeve extending along a reference axis, said sleeve having an inner diameter Ds, where Ds is greater than d;
a rigld body part disposed about said tubular sleeve and associated capture means for capturing said sleeve within said body part, whereby said sleeve is freely rotatable about said reference axis with respect to said body part; and a substantially annular compression insert, said lnsert having an external surface adapted for at least partial receipt within said sleeve, wherein said body part further includes twist lock means responsive to coaxial alignment of said port axis and said reference axis and to subsequent rotation of said body part about said reference axis and said port axis, for selectively engaging said body part to said fluid transfer assembly with said sleeve being coaxial with and positioned about said tubular extenslon, and wherein at least a portlon of sald insert is compressively held against the interior of said sleeve.
The connector is preferably provlded with a locking element on the connector body (such as a T-shaped flange) and a matlng receiver on the fluid transfer devlce (such as a generally T-shaped vold region defined by a peripheral flange).
The sleeve assures compresslve securing of the tube to the fluld port. In this aspect of the lnvention, when the sleeve is fitted over the ~oined tube and the fluid port, a compressive force is generated to secure the tube to the outer surface of the fluid port, while the slidable cooperation of the exterlor of the sleeve and the interior of the body part perrnits locking interaction of the body part's locking element and a mating t~;.' 3b 64680-635 receiver on an implantable access devlce wlthout detrimental twisting or torquing of the tube.
One aspect of the invention is adapted for use wlth an implantable device, such as that described in U.S. Patent No.

4,673,394. That irnplantable devlce includes a tubular exit port extending from its periphery. The port at one end ls surrounded by a generally T-shaped vold region defined by a peripheral flange, which mates with the generally T-shaped connector connecting element.
In use, the catheter is fitted over the tubular fluid port of the implant and the sleeve ls forced over this catheter/port conjunctlon to compress the resilient catheter against the port. The T-shaped coupling of the body part now is twlsted about the central axls to mate that element with the T-shaped vold reglon recelver of the lmplant devlce. Thls assures secure and leak-free coupllng of the catheter and access port.

.~'~

5~ CI /US91/06484 2091~68 4 The rot 'le coope.dtiGn of the body part and sleeve assures that the body part can be tumed about its central axis to effect twist-locking of the connector and implant device without torquing or twisting of the catheter. Such torquing or twisting may oU-e~ iss dangerously abuse the fluid flow path; or da,nage the catheter.
In a pr~f~,.ad embodiment, opposed wing~ike elements radially project from each side of the conne.~tor body part. The wing elements are pr~f~r~ly ad7~ptad to be tied down to the implant to permit the! cou rl~ connector to be secured to the implant so as to prevent inadvertent decoupling. A tactile indicator may be provided to indicate to the surgeon that correct coupling of the connector and device has been made.
The present invention may further include a cG",pression insert, pr~fefably tapered in cross-section, which, when inserted between the sleeve and cdtl,eter, affords further cGr"prassiGn of the catheter against the port. This provides a greater degree of assurance that the catheter and fluid port connection will be leak-free.
Brief DescriPtion of The Drawinqs These and other features and advantages of the present invention will be more fully understood by r~:ference to the f~ w:. -g datailed desc,i~tion in conjunction with the attached d~ .~..g in which like r~ference numerals refer to like ele...e.lb and in which:
FIG. 1 is a perape ~;.,c view of an embodiment of a conne~,tor e.,.bo-lying the 20 prese-lt invention;
FIG. 2 is a cross-sectional view of the conne-;tor of FIG. 1 coupled over a caU.ater fitted on a fluid port of an i-npl&nt~ble vascular access device;
FIG. 3 is a perspective view of the il"plar,t 'le vascular access device of FIG. 2, shoJr...g a call~ter/,~GIl conjunction but not including the connector of the present 25 invention; - - ~
.-t FIG. 4 is a bottom view of the i",plæn~ '-le device of FIG. 3 without attached U ,~t~l, -FIG. 5 is a perspective view of an altemative embodiment of the presentinvention adapted for coupling a dual lumen c~tl,eter to a dual lumen fluid llanalar 30 device;
FIG. 6 is a cross-sectional view of an altemative embodiment of the invention installed over a catheter fitted over a fluid access port, but before being mated with a cooperating twist-locking receiver of a fluid transfer device; and WO 92/0721~ - ~` PCI`/US91/06484 ~5~ 2a~156'8 FIG. 7 is a cross-s~tiGnal view of the connector embodiment of FIG. 6 and a partial view of a fluid l,an~f~r device after the connector is mated with the twist~ocking receiver of the fluid l-~s~er device.
Detailed Des-;,i,.tiGn of the Invention FIG. 1 is a perspective view of a connector 10, having a r~f~rence axis A, in acco~lance with the prese.lt invention, show ,g general cooperdtiGn of a cylindrical compression sleeve 40 (having an inner diam~ter D,) fitted v~/ithin a body part 50. Body part 50 is provided with extensions, such as pins or wing E' eme. lt~ or bayonet flanges 54a, 54b, and, along with sleeve 40, generally forms a general T-shaped coupler for coupling with a generally T-shaped coupler recGiver of a cooperdti"g fluid transfer device.
FIG. 2 is a top cross-sectional view of connector 10 about to secure the proximal end 29 of a flexible vascular catheter or tube 20 to a tubular extension or fluid port 37 (having an outer diameter d) extending from an ;"~plant ~le vascular access device 30 of the type generally shown in U.S. Patent No. 4,673,394. The distal end (not shown) of catl,~ter 20 is positioned at a desired posilion in the patierlt's vascular system. --ln one embodiment, a cooperali.,g fluid t~.,r,s~er device takes the form of an implantable vascular access device 30 as shown in the pe";~ecti~ c view of FIG. 3 and the bottom view of FIG. 4. Device 30 preferably includes a device housing 32 which defines an internal generally cup-shaped reservoir cavity 34, e.g., for holding treatment fluids or medicine. Device housing 32 has an open face which is closed off by a cover 36. Tubular fluid flow or fluid exit (or inlet) port 37 extends out radially from wall 35 of device housing 32 along port axis 37a. The interior of port 37 is coupled directly to 25 ~ cavity 34.
Cover 36 is formed of a seH-resealing polymer, which is pr~sfe~d~ly an elastol"er such as silicone, rubber or latex, and is ~dapted to permit access to the reservoir cavity 34 using a hypodermic needle. Hence, in use, a hy~.ode,."ic needle may be employed to puncture cover 36 to deliver a treatment fluid to reservoir cavity 34. The l,edt,.,ent 30 fluid is then delivered to catheter 20 coupled to the tubular port 37 (having outer diameter d, where d is less than D.) of device 30, whereby the fluid is provided to the vascular system of the patient. Device 30 may altematively be configured to permit out-flow of body fluids, for example, blood in conjunction with a hemodialysis WO 92/07215 ~- PCr/US9t/U6484 ~

~91568 procedure. Device housing 32 is prefer~ly formed of a '~ ccompalible material, such as titanium or electro-F ~' s hed 316L stainless steel or other surgical grade steel or other hard material such as DuPont Delrin~'m' or Teflon~'m'.
A sul,slwltially planar, radially extending flange 38 circumscribes housing 32.

6 Flange 38 includes an array of holes 39 spaced about the perimeter of housing 32, for use in suturing device 30 to a layer of the pat;ent's tissue during the implaltdtiGn procedure. Exlension po.tions 41 of flange 38 extend on both sides of port 37.
Pl~ferably flange 38 and po,lions 41 define a generally T-shaped void region 24 ~isposed about port 37. More particularly, void region 24 cG".prises an axially 10 extending portion 44 and a circu"~fw~ltially extending portion 46. The axial portion 44 has a width D and the circu" If erential portion 46 has a width D' where D' is greater than D. Flange 38 and pol lions 41 and void region 24 thus form a T-shaped twist-locking receiver 43 whose function is further set forth below.
A leak-free and secure fit is required between the resilient catheter prcximal end 16 29 and the rigid tubular port 37. However, the difficulty of forcing catheter end 29 over tubular port 37, particularly in the restricted environment of a s~ ~hcuPrleous installation, requires such cooperalion that the catheter end 29 slides onto port 37 with some e~ase.
- As a result, this eased coupling may not be so tight as to be leak free, or worse, may permit inadvertent dls~onnection.
Furthermore, the ligllt"ess of ft b 4hJeen the cdtl.. 2ter and port in the past has been accGl"panied by a twisting of the catheter as it is forced over the port. This tw,~li. ,9 often dis~torted the catheter and partly obscured the p~ss~ge of fluid within the catheter. This problem is magnified when a multiple lumen cdU ,eter is e~l ", 'oyed: such ~ ter~ are more sensitive to correct alignment-with a coope~ti..g multiple lumen26 port, and the difficulty of obtaining correct alignment makes their secure _nd leak-free interconnection problematic. The prese.lt invention solves this pre t~ leh-.
By way of example, an altemative fluid l.~sfer device 130 and associated catheters 132 and 134 are shown in FIG. 5, tog~l.er with a connector 10 e!l"bodying the invention. Device 130 is Ad~ted to couple each of catheters 132 and 134, through 30 one of ports 175a and 175b to a respe~ e lumen 173a, 173b of a dual lumen odtl .eter 120 having a proximal end 129. Device 130 includes structure compar~ble to that set forth in FIG. 4, namely T-shaped void region 124, flanges 138, holes 139, e)~tension portions 141, twist-locking receiver 143 and axially extending portion 144 of void region WO 92/07215 PCr/US91/06484 -

7 2091568 124. Catheter 120 includes an intemal divider 173 which creates the two lumens 1 73a, 173b intemal to the catheter. The tubular extension or fluid port 176 of device 130 cG""~.~ises two ports 175a and 175b which are separated by a gap 175c, each portbeing adapted to receive one of the lumens 173a, 173b of ~tl,.ater 120 for ll~nspo,l 5 of mu~tiple fluids from/to a multiple lumen l~clnspGll device 130. Gap 175c is so configured as to receive catheter divider 173 as the catheter is fitted over the ports.
The need for proper alignment and coupling of the respective cdtl ,eter lumen and ports 1 75a and 1 75b is ll ,er~l - re sslf ovidant. (It will be further appreciated, hov~ever, that the present invention applies equally well in use with a single, multiple lumen catheter and 10 like single multiple lumen port.) Toward these ends, for ex~"rle with respect to the devices of FIGS. 2 a~d 5, connector device 10 of the present invention provides CGI, ,pression sleeve 40 to assure a leak-free and secure fit of the catheter end 29 over port 37 (FIG. 2) or end 129 over ports 1 75a and 1 75b (FIG. 5). The compression sleeve is suL.~t~ntially rigid relative to 15 the suL.~lar,lially flexible catheter. Hence, the resilient ~ll ,~ter can be reasonably sized for tight but comfG,lable placement over port 37 (or ports 175a and 175b). The cGnne~tor device 10 is first positioned so that sleeve 40 e~tends about end 29 (or 129) of the c~tl.~ter 20 (or 120) and then this entire ~Isselllbly is slidingly placed over port 37 (or ports 175a and 175b). Altematively, the cdtl,~ter can first be slidingly placed 20 over port 37 (or ports 175a and 175b) without, or with minimal, twisting, und then CGIl ,pression sleeve 40 is slidingly placed over the catheter/port conjunction. The rigid sleeve s~FFli~s a higher degree of cGmpressiol1 between the joined tube und port to assure a leak-free conne~,~tion that will not easily or inadvertently disconnect.
- Body part 50 defines a generally arcuate sm~otl, inner glide surface 51 of 25 cylindrical central aperture 56. The outer surface of cG-"pression sleeve 40 defines a - generally arcuate slllG~tll glide surface, i.e., an exterior generally cylindrical outer contour 48 configured to cooper~te with glide surface 51 of the body part central aperture 56. Sleeve 40 further defines a generally ucuate sr"ootl, w~" s i orifice, i.e., a generally cylindrical central aperture 46 for cGI"pressive receipt of catheter 20.
30 Aperture 46 is of u~ intemal diameter which causes col"pression of the catheter as the sleeve is slid over the surface of the catheter up to und over the catheter/portconjunction 47, as enabled by the r~ s !i_. ,l character of the catheter material (typically a plastic or elastomer).

WO 92/07215 PCI`~US91~06484 ~
`_ . 7 20-9lg~i8` -8-As seen in FlGs.1, 2, and 5, body part 50 at its central aperture 56 is ftted over cGmpression sleeve 40 in a closely cooperdti"g -,anner, thus capturing sleeve 40.
I lowcvcr, since sleeve 40 compressively secures the proximal end 29 of ~ll ,etar 20 to port 37, the sleeve essentially is fixed in the axial direction relative to the catheter.
6 Therefore, body part 50 at its central aperture 56 must slidingly er,ya9e the outer surface 48 of sleeve 40 so that it can be twisted into locking cooperation at recei~er 43 of device 30 without causing the sleeve and catheter to be twisted. Hence, it isi.ltended that body part 50, as so mounted on sleeve 40, may be freely rotated about the relatively fxed sleeve.
In a pr~er.ed embodiment, body part 50 includes inset grooves 58a, 58b, and sleeve 40 includes raised flanges 48a, 48b, whereby, when connector 10 is locked into device 30, sleeve 40 is prevented from slippage away from its location over sleeve 40 bec~use flanges 48a, 48b are held within grooves 58a, 58b, while body part 50 can still be rotated about sleeve 40 during coupling of connector 10 and device 30. This 15 groove/flange cor..~!n~lion permit body part 50 to be forced over sleeve 40 after the latter has been fitted into its desired col"pressiGn loc~lion over the catheter/port conjunction 47. In an altemative embodiment of cGnne~,1Or 10, an ex~)~rle of which is shown in FIG. 6, only a single groove 91a and single flange 91b are provided for interlocking of body part 50 and sleeve 40. The locd~ions of the nanS~es on sleeve 40 20 and grooves on port 50 could be reversed in yet other embodiments. Still other validtions by which the sleeve 40 is captively held by body part 50 are also within the scope of the present invention.
In any event, it now will be apprec;dted that the relatively non-torqueable i. ner~liGn of sleeve 40 and Cdtl .~ter/pol l conjunction 47 is u. a~fe~,ted when body part 25 50 is torqued to lock bayonet flanges 54a, 54b into the COOperdtil 19 r~ceiver 43 (143) of device 30 (130). Thus connector 10 can tightly secure catheter 20 (120) to port 37 (or ports 175a and 175b) of device 30 (130) against unwanted leakage or d;sconnection, and the entire conne~tion is secured against unwanted ~iisconneulion by means of the T-shaped lock mechanism, without unwanted twisting or torquing of 30 the catheter.
It should be understood, I owevcr, that in the context of the invention, ~T-shaped~ refers to any reasonable shape having a width on the perimeter of the flange 38 which is smaller than the width at the end of the void region 24 which is distal to the WO 92/07215 PCI`/US91/06484 -flange perimeter. An alternate exas.,~le of such an opening would be adovetail-shaped opening. FIJ~ U .ermGre, it will now be appl ~C aled that while other h i~t;onal or U reLded coupling of connector 10 and device 30 is also within the scope of the pr~se,lt invention, a prefe,.ed T-shaped i"t~rcom-e-,tion is shown and desaiLed herein.
An optiGnal feature of the invention, as shown in FIG. 2 or S, includes a confirmation mechanisrn for indication of correct coupling of connector 10 and the fluid delivery device. The r"echanisrn may include a cGilta~,t spot or protrusion 55 on cor,ne~,tor body part 50 and a cooperating contact spot or lip 155 on the flange of the fluid delivery device. In this m&nner, a ~tactile- or click~-type indication of correct placement can be felt by the surgeon as the body part wing elements 54a, 54b areproperly seated in the .~ceiv~r of the fluid delivery device. Hence it will be 6p~r~aled that cGn~.,ct devices 55,155 are designed to interact only when the T-shaped connector is properly locked in secure and mating cooperation in the T-shaped recehrcr of the delivery device.
In ad-litiGn to the for~oL.g, a securing device 62 is provided on connector 10 to prevent inadvertent detachment of the connector from the delivery device. Securing device 62 may include a flange 62a which is an axt~sion of body part 50. Flange 62a - intemally defines a tie down hole 62b. Tie down hole 62b permits suturing the body part pe~h&ps to one of the plurality of holes 39 in flange 38 of device 30, for example, 20 after connector 10 is pr~pe.ly connected to device 30.
It will now be apprecidted that proper installation of sleeve 40 over cd~l .eter/port conjunction 47 requires s ele tian of a sleeve with an inner diameter greater than the outer diameter of the port and less than the outer d;~neter of the ~1het~r aner the call,~ter is installed on !ube 37. This normally assures ~de~u~te cG,.,pression of the 25 catheter.
Notwithstanding the fores o . ,9, further assurance of leak-free sealing at odl,~:ter/l,oll conjunction 47 may be desired. Hence, as shown in FIG. 6, an insert 80 provides for tight coupling of the ~tl.eter/port conjunction 47. In one embodiment, insert 80 is a generally cylindrical sleeve, which in cross-section, as shown in FIG. 6, 30 is generally wedge-shaped, and is formed from a m~te.ial which is cG",pressible bet~e~n device 30 and conne~;tor 10. The insert defines an outer surFace 81, an abutment surface 82, an inner surFace 83, and an insertion end 89. In this embodiment, sleeve 40 is preferably provided with an inclined edge 97 which defines a tapered WO 92/07215 PCr/US91/06484 .....

209~68 annular entryway for receipt of coope,ali~ely tapered surface 81 of insert 80. In this m~nel, as connector 10 is locked into the twist~ocking receiver 43 of device 30 the inclined edge 97 of the sleeve annular entryway cG",~resses the insert and forces the abutment surface 82 of the insert against wall 35 of device 30, as well as around and 5 into catheter 20, as shown in FIG. 7. Hence, insert 80 provides an extra degree of leak-free cGi"pressivc sealing b~ t~r~een catheter 20 and device 30.
In use of insert 80, prt~f~r~ly connector 10 is first placed over catheter 20 tooverlie the catheter end 29. Then the cGmpr~s~ ' le insert 80 is placed over end 29 of catheter 20. Now insert 80 and catheter 20 together with conr.e~,1Or 10 (sleeve 40 and 10 body part 50) are slid over port 37, with the cdU..ater end 29 extending up toward wall 36 of device 30. The body part 50 of connector 10 is then twist-lock coupled with device30. The action of forcing connector10 into locked interconne,_~ion with device 30 forces co",pression surfaces 81, 83 between sleeve 40 and catheter 20 and forces a portion of insert 80 b ~hv_en wall 35 and faces 50' of body part 50 and 40' of 15 sleeve 40 to further seal the catheter's connection to device 30.
In an altemative embodiment, insert 80 may be formed as a split ring of a material similar to that of sleeve 40, having an inner di~)-eter greater than the cdU.~ter inner diameter and less than the catheter outer J;ah ,eter.
~ ec~use device 30 is int~nded to be sutured directly to the patient, a high 20 degree of maneuverability of device 30 and ~ccessibility of suture holes 39 is desired to facilitate the surgical pr~cess of implantation. Additionally, be~se device 30 conne~ directly, via catheter 20, to the pali~ vascular system, the integrity of the connection bet~een the c~U,eter and the device must be assured. Moreover, in order to reduce risk of harm to the patient, it is pr~fer.ed that the catheter be moved 25 minimally during and after placement of the catheter distal end within the V?.SCUI--system.
It is therefore desirable, in pra_tice of the invention, to first posilion and affix device 30 to the patient, then insert the distal end of the catheter to the desired patient localiGn~ then ske the length of the catheter 20 by cutting its proximal end 29, and then 30 hiutiGr.ally couple the call,~ter proAi",al end 29 over tubular port 37 of device 30.
Sleeve 40 is forced over the edtl,~tertport conjunction 47, and then catheter 20 is secured to device 30 by a T-shaped coupler, formed by body part 50 mounted on sleeve 40, and T-shaped receiver 43 of device 30. The tactile aid of the confirmation WO 92/07215 PCI~US91/06484 -11- 2~91568 mechanisn, (devices 55 and 155) signals correct and complete connection of connector 10 and device 30. P~ ràbly~ connector 10 is secured in its coupled cooperation with device 30 by suturing the body part securing device 62 (at securing hole 62b) to a hole 39 of flange 38.
The sleeve and body part need not be formed from bioco" ",alible r"ate, ial if not to be implanted. They may be formed of DuPont Delrin'tm~ (acetal resin), the-l,lopl-ctic~
metal (such as tHanium), DuPont Teflon Itml (polytetrafluoroethylene), or a mixture of nylon and polyethylene, as their use may dictate. The compression seal, for ex~"ple, may be a split ring formed of the above ~llalelials or, as a soft coi"pressil)le ring, of silicone, polyurethane, butyl rubber, or ethylene propylene.
It will be u"der~lood that the above description pe"ain5 to only several embodiments of the present invention. That is, the description is provided by way of illustration and not by way of IilllHalion. For example, while the pOn and catheter are described and shown having particular diameters, connoting a circular cross-section, an oval or other non-circular cross-section is equally within the scope and teaching of the present invention. Therefol e, for ease of description, the term diameter used in this document will also be under~toGd to cGnnote an analogous cross-se~lional dimension of non-circular cross-section parts. Neve, U ,ele-cs, the scope of the invention is to be defined according to the fell~JJ.I9 claims.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. Connector apparatus for coupling an end of a resilient tube about the exterior of a tubular extension of a fluid transfer assembly, said extension extending along a port axis and having an outer diameter d, said connector apparatus characterized by a rigid tubular sleeve extending along a reference axis, said sleeve having an inner diameter Ds, where Ds is greater than d;
and a rigid body part disposed about said tubular sleeve and associated capture means for capturing said sleeve within said body part, whereby said sleeve is freely rotatable about said reference axis with respect to said body part, wherein said body part further includes twist lock means responsive to coaxial alignment of said port axis and said reference axis and to subsequent rotation of said body part about said reference axis and said port axis, for selectively engaging said body part to said fluid transfer assembly with said sleeve being coaxial with and positioned about said tubular extension.

2. The connector apparatus of claim 1 wherein said tube has a nominal inner diameter which is less than d, and said tube has a nominal outer diameter which is greater than Ds when said tube is extended to have an inner diameter equal to d, and wherein said sleeve is adapted to captively hold said tube end to said tubular extension when said body part is engaged to said fluid transfer assembly.

3. The connector apparatus of claim 1 wherein said body part comprises a connector mating means for mating with a cooperating transfer assembly such that said connector apparatus is adapted for interlocking coupling to said cooperating transfer assembly.

4. The connector apparatus of claim 3 wherein said connector mating means comprises a pair of flanges and said transfer assembly comprises flange receiver, whereby said pair of flanges is cooperable with said receivers to selectively interlockingly couple said connector apparatus and said transfer assembly.

5. The connector apparatus of claim 4 wherein said connector mating means includes a T-shaped portion of said body part and said cooperating transfer assembly includes a receiver defining a T-shaped void region formed on the periphery of said fluid transfer assembly.

6. The connector apparatus of claim 3 wherein said body part comprises at least one wing element which extends out from said body part to form said connector mating means.

7. The connector apparatus of claim 6 wherein at least one of said wing elements comprises a tie down means for enabling tying down said body part to prevent disconnection of said connector apparatus for a fluid transfer assembly to which it has been connected.

8. The connector apparatus of claim 3 wherein said body part further comprises first retention assembly and said sleeve comprises second retention assembly, such that when said body part is fitted over said sleeve, said first and said second retention assembly cooperate to retain said body part over said sleeve while enabling said body part to rotate about its central axis over said sleeve.

9. The connector apparatus of claim 8 wherein one of said first retention assembly and said second retention assembly comprises at least one groove and the other of said first retention assembly and said second retention assembly comprises at least one flange for fitting in said groove.

10. The connector apparatus of claim 1 wherein said body part has an inner diameter which is smaller at least in part than said outer diameter of said sleeve at least in part, such that said sleeve can be captured within said body part.

11. The connector apparatus of claim 3 wherein said fluid transfer assembly is an implantable fluid transfer device, said tubular extension is a fluid port of said implantable fluid transfer device, and said tube is a catheter.

12. The connector apparatus of claim 1 wherein said body part comprises a generally cylindrical body extending along a reference axis, and wherein the interior of said body part defines a substantially cylindrical central aperture extending along said reference axis for receiving said sleeve.

13. The connector apparatus of claim 12 wherein said sleeve exterior surface slidably engages said body part interior central aperture.

14. The connector apparatus of claim 13 wherein said sleeve defines a substantially cylindrical central aperture extending along said reference axis for compressive receiving of a flexible tube which is positioned about a chambered extension of a fluid transfer assembly.

15. The connector apparatus of claim 14 wherein said fluid transfer assembly is an implantable fluid transfer device, said extension is a fluid port of the implantable fluid transfer device, and said tube is a catheter.

16. The connector apparatus of claim 11 wherein said catheter has a plurality of lumens and said fluid port has a plurality of lumens within a discrete tube, whereby respective ones of said catheter lumens are adapted for coupling to respective ones of said fluid port lumens.

17. The connector apparatus of claim l further comprising a compression insert, said insert having an internal receiver means for receipt of said tube.

18. The connector apparatus of claim 17 wherein said insert is more resilient than said sleeve.

19. The connector apparatus of claim 18 wherein said insert is a split ring.

20. The connector apparatus of claim 18 wherein said insert is generally cylindrical and has a maximum outer diameter which tapers to a lesser outer diameter at one of the ends of said insert, wherein said insert presents an arcuate surface to said sleeve, wherein said surface is inclined with respect to the central axis of said insert at a predetermined angle.

21. The connector apparatus of claim 20 wherein one end of said insert comprises an abutment member for abutting against said fluid transfer assembly.

22. The connector apparatus of claim 21 wherein said sleeve further comprises a tapered annular insert receiver, for receipt of said insert, wherein said tapered receiver presents a conical surface generally inclined at said predetermined angle from its central axis.

23. The connector apparatus of claim 3 further comprising confirmation means for confirmation of correct mating of said connector mating means and said cooperating transfer assembly.

24. The connector apparatus of claim 23 wherein said confirmation means comprises a respective contact part on each of said connector mating means and said cooperating transfer assembly, such that as said connector mating means and said cooperating transfer assembly are correctly mated, said respective contact parts contact and cause a tactile mating indication.

25. Connector apparatus for coupling an end of a resilient tube about the exterior of a tubular extension of a fluid transfer assembly, said extension extending along a port axis and having an outer diameter d, said connector apparatus characterized by a rigid tubular sleeve extending along a reference axis, said sleeve having an inner diameter Ds, where Ds is greater than d;
a rigid body part disposed about said tubular sleeve and associated capture means for capturing said sleeve within said body part, whereby said sleeve is freely rotatable about said reference axis with respect to said body part; and a substantially annular compression insert, said insert having an external surface adapted for at least partial receipt within said sleeve, wherein said body part further includes twist lock means responsive to coaxial alignment of said port axis and said reference axis and to subsequent rotation of said body part about said reference axis and said port axis, for selectively engaging said body part to said fluid transfer assembly with said sleeve being coaxial with and positioned about said tubular extension, and wherein at least a portion of said insert is compressively held against the interior of said sleeve.

26. The connector apparatus of claim 25 wherein said compression insert is tapered from a first of its ends toward a second of its ends.

27. The connector apparatus of claim 25 wherein said fluid transfer assembly is an implantable fluid delivery device, said extension is a fluid port of said implantable fluid delivery device, and said tube is a catheter.

28. The connector apparatus of claim 25, wherein said tube has a nominal inner diameter which is less than d, and said tube has a nominal outer diameter which is greater than Ds when said tube is extended to have an inner diameter equal to d; and wherein said sleeve is adapted to captively hold said tube end to said tubular extension when said body part is engaged to said fluid transfer assembly.