CA2234581A1 - Fluid delivery device with bolus injection site & fill assembly - Google Patents

Abstract

This invention is an apparatus (10) for accurately infusing fluids into a patient at specific rates over an extended period of time. The apparatus (10) is of a low profile, laminate or layered construction having a stored energy source in the form of a distended membrane (28), which in cooperation with the base (12) of the apparatus (10), defines one or more fluid reservoirs (20), each having a fluid inlet (22) and a fluid outlet (32). The apparatus further includes a novel conformable ullage made of yielding materials which uniquely conform to the shape of the elastomeric membrane (28) as the membrane (28) returns to its less distended configuration. This arrangement will satisfy even the most stringent medicament delivery tolerance requirements, and will elegantly overcome the limitations of materials selection encountered in devices embodying solely a rigid ullage construction. Additionally, in one form of the invention, the apparatus includes a novel fill assembly (302) for controllably filling the reservoirs of the device in the field.

Description

CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 Fluid Deliver~ Device with Bolus Injection Site Background of The Invention This is a Continuation-ln-Part application of co-pending U.S. Serial No. 08/541.184. filed October 11. 1995.
Field of The In~ ention The present invention relates ~enerallv to fluid delivery devices. More particularly, the invention concerns an improved fluid delivery a~ualrlLLls for precise delivery over time of medicinal liquids to an ambulatory patient. the device includin~ a bolus injection site for bolus deliverv of medicinal liquids as from time toltime may be required.
Discussion of The Invention A number of different types of liquid dispensers for dispensin(~ medicaments to ambulator~ patients ha~e been sug~ested. Many of the devices seek either to improve or to replace the traditional hypodermic syringe which has been the standard for delivery of liquid medicaments such as insulin solution.
Those patients that require frequent injections of the same or different amounts of medicament. find the use of the hypodermic svrin~e both inconvenient and unpleasant. Further~
for each injection. it is necessary to first draw~l1e iniection dose into the syril1~e. then check the dose and. after makin~ certain that all air has been expelled from the syrin~Te finally. inject the dose. This cumbersome and tedious procedure~creates an unacceptable probabilih~ of debilitatin~
complications. particularlv for the elderly and the infirm.
One example of the ur~Jent need for an improved liquid delivery device for ambulatory patients can be found in the strinc~ent therapeutic re~Timens used hy insulin-dependent di:lbetics. The therapeutic objective for diabetics is to consistently maintain blood ~lucose levels ithin a norn1al ran~e much as the normall~ functionin~ pancreas would do h! secretin(T a very SL ~111 ~JTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13S44 PCT~US96116361 low level of e~;tremelv fast-acting insulin at a basal rate into the blood stream throu~hout the day and night.
Consider the normal individual who doesn't ha~e diabetes. A normal individual's cells require energy throughout the day just to m~int~in a basal metabolic rate. This energy is supplied to the cells by glucose that is transported from the bloodstream to the cells by insulin.
When food is consumed, the blood glucose level rises and the pancreas responds b~r releasing a surge of fast-acting insulin. To mimic this natural process with individual injections. the individual would have to ~fimini~iter minuscule amounts of fast-acting insulin every few minutes throuchout the day ,~nd ni~ht.
Conventional therapv usually involves injecting. separatel!. or in combination.
fast-acting and slower-acting insulin by syringe several times a day. often coinciding with meals.
The dose must be calculated based on glucose levels present in the blood. Slower-acting insulin is usually a-lminictered in the morning and evening to take advantage of longer periods of lower level glucose uptake. Fast-acting insulin is usually injected prior to meals. If the dosage of fast-acting insulin is off. the bolus ~lmini~tered mav lead to acute levels of either glucose or insulin resulting in complications. including unconsciousness or coma. Over time. high concentrations of glucose in the blood can also lead to a variety of chronic health problems. such as vision loss. kidney failure. heart disease. nerve damage. and amputations.
A recently completed study sponsored bv the National Institutes of Health (NIH) investigated the effects of different therapeutic re, imen~ on the healtll outcomes of insulin-dependent diabetics. This stud! revealed some distinct advantages in the adoption of certain therapeutic regilllens. Intensive therapy that involved intensive bloodglucose monitorin~
an(l more irequcnt administration of insulin by conventional means. for e~iample. syrin~Tes.
thro~lgllout the day saw dramatic decreases in the incidence of debilitatin~ complications.

Sl~ 111 ~JTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13S44 PCTrUS96/16361 The NIH study also raises the question of practicality and patient adherence to an intensive therapy reo~imen. A bona fide improvement in insulin therapy mana(!~ement must focus on the facilitation of patient comfort and convenience as well as dosace and ~(tminictration schemes. Basal rate delivery of insulin by means of a convenient and reliable delivery device over an extended period of time represents one means of improvin~ insulin mana~ement. Basal rate deliverv involves the delivery of very small volumes of fluid (for example. 0.3-3 mL.
dependinc~ on bod~ mass) over comparativel~ lonL periods of time (18-24) hours). As will be appreciated from the discussion which follo~s~ the apparatus of the present in~ention is uniquel!
suited to provide precise fluid deliverv manaL~ement at a low cost in those cases where a variety of precise dosa(~e schemes are of utmost importance.
An additional important feature of the apparatus of the present invention is the provision of a bolus injection site which permits. in addition to the basal rate. a bolus delivery of medication on an as-needed basis. For example. if the a~ dLIls is bein~ used for basal deliver~ of insulin over an extended period of time. should a bolus deliver! of medication be required to mana~e an anticipated increase in blood su~ar. such a bolus deliver! can be quickl~
and easil! accomplished usin~ the device's bolus injection site and eliminates the need for a direct subdermal injection at an alternate site on tlle individual's bod~.
~ 'ith re~ard to the prior art. one of the most versatile and unique fluid deli~er~
apparatus de~reloped in recent years is that de-reloped b!~ one of the present inventors and described in E'. .~. Patent 5.~05.8'70. The component of this novel fluid deliver~ apparatus ~enerall~ include: a base assembl!. an elastomeric membrane servin(~ as a stored enerC! means.
fluid flo~ challnels for filline and deliver!. flo~ control means. a cover. and an ulla_e ~hich cc)mprises a part of the base assembl!. Tlle ulla_e in these de~ices is provided in the form of a semi-ri(!~id su uct-lre ha~ hl~ flo~- channels leadin_ I'rolll the top of the struct~ll-e throu_h the base SlJts- - 1 1 1 UTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 to inlet or outlet ports of the device. Since the inventions described herein represent improvements over those described in Patent No. 5 205.8~0. this patent is hereby incorporated by reference as though fully set forth herein.
In the rigid ullage configuration described in Patent No. 5.~05.870~ the stored energ~ means of the device must be superimposed over the ullage to form the fluid-cont~inin,~
reservoir from which fluids are expelled at a controlled rate by the elastomeric membrane of the stored energy mealls tending to return to a less distended configuration in the direction toward the ullage. With these constructions, the stored energy membrane is typically used at higher extensions over a significantlv large portion of the pressure-deformation curve.
For gc)od performance. the elastomeric membrane materials selected for construction of the stored energy membrane must have good memor~ characteristics under conditions of extension; low stress relaxation; good resistance to chemical and radiological degradation: and ~I~,t).o~,l;ate gas permeation characteristics depending upon the end application to be made of the device. Once an elastomeric membrane material is chosen that will optimally meet the desired performance requirements. there still remain certain limitations to the level of refinement of the deli~ery tolerances that can be achieved usin~ the rigid ullage configuration.
These result primarily from the inability of the rigid ullage to conform to the ch~n~ing geometry of the elastomeric membrane near the end of the delivery period. This nonconformity can lead to extended deliver! rate tail-off and higher residual problems when extremely accurate deliver!
is required. For e:;ample. when larger volumes of fluid are to be delivered. the tail-off volume represents a smaller portion of the fluid amount delivered and therefore exhibits must less effect on tlle total fluid delivery profile. but in v ery small dosages. the tail-off volume becomes a larger portion of the total volume. This sometimes places severe ph!sical limits on the range of deliver! prol'iles that may easily be accommodated using the rigid ullage confi(Turation. An 5~1~111 ~JTE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 additional penalty inllerellt in ricid ullace construction is the high Z axis heigllt of the ulla~e that will be required to maintain acceptable flow tail off delivery requirements.
As will be better appreciated from the discussion which follows. the a~,~)a.dlu~ of the present inventioll provides a unique and novel improvement for a disposable dispenser of simple but highly reliable construction that may be adapted to many applications of use. A
particularly important aspect of the improved apparatus is the incorporation of conformable ullages made of y ieldable materials which uniquely conform to the continuously ch~n~ing geometl y of the stored energy membrane durinc the delivery cycle. This no~el construction will satisfy even the most strincent delivery tolerance requirements and elegantl! overcomes the limitation of materials selection.
Anotller useful liquid deliver~ device is that described in U. S. Patent No.
6.896 issued tc H~rris. This device comprises a multidose svringe having the same general appearance as a pen or mechanical pencil. the device is specifically adapted to provide for multiple measured injections of materials such as insulin or human growth hormones.
Still another type of liquid delivery device is disclosed in U. S. Patent No.
4.~9~.74~ issued to Rex et al. This device is. in principle. constructed as a llypodermic svringe~
but dif f'ers in that it enables dispensing of a predetermined portion from the available medicine and in that it dispenses very accurate doses.
The present invention seeks to significantl!~ improve over the prior art by providing a no~el fluid delivery device having one or more fluid res~rvoirs. whicll is low in profile. is compact is easy to use b! ambulator~ patients. and is eminently capable of meeting the most strhlgent of fluid deli~er! tolerance requirements. Additionally. the de~ ice pro~ ides novel means l'or accomplisllill~ immediate bolus deli~ery of medication on an as-needed basis.
~ ~iummar~ of The In~ention SUBSTITUTE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 It is an object of the present invention to provide an apparatus havin~ a self-contained stored energy membrane for expellin~ fluids at a preciselv controlled rate which is of a compact extremely low profile~ l~min:~t~ construction. More particularly. it is an object of the invelltion to provide such an appaldlus which is of very low profile so that it can conveniently be used for the precise deliverv of pharmaceutical fluids. such as insulin solution and the like. into an ambulatory patient at controlled rates over extended periods of time It is another object of the invention to provide an apparatus of the aforementioned character wllicll is hi~lllv reliable and easy-to-use bv lav persons in a non-hospital environment.
It is another object of the invention to provide an appd~ ls as described in the precedin~ para~raphs whicll. can be used for both basal and bolus deliver~ of fluids. In this re-~ard. the ap~-a.~LLIs includes a novel and unique bolus injection site which can be used to deliver bolus doses of medication as may be required.
Anotller object of the invention is to provide an apparatus which embodies a conformable mass which defines an ulla~e within the reservoir of the device whicb will closely conform to the shape of the stored enercy membrane thereby effectivelv avoidin~ extended flow delivery rate tail-off at the end of the fluid delivery period and thus preciselv controls the time of delivery A further object of the invention is to provide a low profile. fluid deliverv device of laminate construction which can meet even the most strin~ent basal fluid delivery tolerance re-quirements and at the same time permit bolus deliverv of medicaments to the patient as may be r equired Anothel- object of the invention is to provide an apparatus of the character described whicll. due to its unique construction. can be manufactured ine~;pensivel! in lar~e volullle hy autom~ted maChiner!~
Otllcr objects of the invention are set forth in 1~ S. Patent ~o 5.~05.8~() whicl SlJts:j 111 ~ITE SHEET ~RULE 26) -CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96116361 is incorporated herein b~ reference and still further objects will become apparent from the discus-sion which follows.
Brief Description of the D .~ .gs Ficure 1 is a generally perspective. exploded v iew of one embodiment of the liquid delivery device of the present invention showin~ an ancillary syringe type device usable for bolus deliverv of liquid medication via the bolus injection site of the device.
Ficure ~ is a top plan view of the invention shown in Figure I partly broken away to show intem I construction.
Ficure is a cross-sectional view taken alon ~ lines 3-3 Ficure ~.
Ficure 4 is an enlarged cross-secrional view taken alon~c lines 4-4 of Figure Ficure ~ is a greatly enlarged. cross-sectional view taken along lines ~-~ of Figure ~.
Ficure 6 is an enlarged. cross-sectional vie w taken along lines 6-6 of Figure ~.

Ficure 7 is a greatly enlarged. fr~gm~nt~r v vie w of the liquid delivery port of the device and of the locking tabs for lockably interconnecting a quicl; connect delivery fitting with the base of the device.
Figure 8 is a generally perspecti e. exploded. view of the liquid delivery port of the device and o f all infusion set usable with the device.
Fi ~ure 9 is a cross-sectional vie ~ of the quick connect delivery fitting shown in Figure ~.
Fi ~ure 9A is an end v iew of the qu;ck connect fitting showll in Figure 9.

Fi ule 10 is a creatl~ enlarced~ross-sectional vie~ of the alea designated as I() ill Fig~ure ~

SL t~ JTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCT~US96/163~1 Figure IOA is a ~Tenerally perspective. illustrative view sllowiLl~ one manner of fillin~ the fluid reservoir of the device.
Fi~rure I OB is a ~enerally perspective. illustrative view showing the device of the inventioll attached to the patient and showing the patient engage in injectin~T a bolus dose of liquid medication.
Ficure 11 is a ~enerall~ perspective. exploded view of an alternate embodiment of the invention.
Fi~ure l ~ is a top view of the embodiment shown in Fi~ure I I partlv broken awav to sho~. internal construction.
Figure 13 is a side elevational. partly cross-sectional view taken alon~T lines 13-13 of Figure 1~.
Ficure 14 is a cross-sectional view taken alonc lines 14-14 of Fi~ure 13. F~e 1~ is a ~Treatl~ enlar~ed. fra~Tmentar~ . cross-sectional view of a portion of the base and cover of the device illustratin~T the manner in which the rlict~n~l~hle membrane and the barrier membrane of the device are sealably clamped between the base and cover.
Fi~rure 16 is a fra~mentary. cross-sectional view of the flow control assembly of the device which is positioned within the base.
Figure 17 is an enlarged, ~Tenerally perspective view of the flow control assembly shown in Fi(Ture 16.
Fi~Ture 18 is a front vie~A- of yet another form of the fluid deliverv device of the invention partly broken away to showll internal construction.
Fi~Ture 19 is a top v iew of the embodiment shown in Ficure 18 partl~ broken a~ay to sh(lw interllal construction.
Figure ~0 is a cross-sectional v ie~ taken along lines ~O-~() of~ Figure 19.

SlJt~ JTE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 Ficure 71 is a cross-sectional view taken alon~ lines 21-21 of Figure 19.
Fi~ure 21A is a fra~ment~ry. cross-sectional view taken alon' lines 21A-21~ of FiL~ure 21.
Figure 72 is a cross-sectional view taken along lines 22-2~ of Figure 19.
Figure 72A is a cross-sectional view similar to Figure '2 but showing the fluid being expelled from the fluid reservoir into the body subdermal tissue.
Fi~ure 73 is a cross-sectional. e~ploded view of this latest embodiment of the inventioll.
Figure 24 is an enlarged~ generally perspective. exploded ~iew of the bolus injection port of the device.
Figure 2~ is a generally schematic view illustrating the vario~ls modes of operation of the apparatus of the invention.
Figure 26 is a generally perspective. exploded vieu of an alternate embodiment of the liquid deliverv device of the present invention showing a dispensin(~ and a fill assembly usable f'or fillin~ the fluid reservoir of the dispensin~ assembly.
Fi~ure 77 is a generally perspective . exploded view of one form of the fill assemblv of the present invention.
Figure 78 is an enlarged cross-sectional view of the fill assembly illustrated in Figure 77 as it appears in the assembled configuration.
Fi(Ture 29 is an enlarged. cross-sectional view taken alons~ lines 29-29 of Ficrure ~8.
Fi(Ture 30 is a cross-sectional ~ ieu similar to Fi~ure '8 but showin(~ the appearance of tlle component parts of the fill assembly after the plun(~er of tllc container has been telesco} ically moved from a first to a second position.

SlJt~ JTE SHEET tRULE 26) CA 02234~X1 1998-04-09 Fi~ure 31 is a ~enerally perspective. exploded view of the apparatus of this latest form of the invelltioll showin~ both the dispensing assembly and the fill assembly in an exploded confi~uration.
Fi<~ure 3~ is a top plan view of the assembled apparatus of the invention shown in Fi~ure 76 partly broken away to show internal construction.
Fi(7ure 33 is a right-side view of the apparatus shown in Fi~ure 32.
Fi(~ure 34 is an enlar~ed. cross-sectional view taken alon~ lines 34-34 of Figure 3' Fi(7ure 3~ is an enlar~ed. cross-sectional view taken alono lines 35-3~ of Fi~ure 3~
Fi(~ure 36 is a view taken alon(7 lines 36-36 of Fi~ure 3~.
Ficure 37 is an enlar~ed. cross-sectional view taken alon(7 Ihles 37-37 of Figure 3~
Fi( ure 38 is an enlarged. cross-sectional vieu taken alonc lines 38-38 of Fi~ure 3~. Fi( ure 39 is a ~reatly enlar~ed. fra(Tmentary vie~ of the liquid delivery port of the device and of the quick connect delivery fittin~ whicll is interconnectable ~vitll the base of the device.
Fi(~ure 40 is a cross-sectional vieu taken alon~ lines 40-40 of Fi~ure 39.
Ficure 41 is an enlar~ed. ~ enerally perspective view of the quicl; connect delivery fittinc sho~in(~ the lockin~ tabs for lockably interconnectin~7 the fittin~ witll the base of the device.
I)escription of the In~ention Rel'errin(7 to the drauin.~s and particularly to Fi~Tures 1 throu(TI1 10. one form of the lo~- proiilc 11uid delivery device of the in~ ention is there shc)wn and l~enerally desi(~nated h~

SlJ~ JTE SHEET (RUl E 26) CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 the nwneral 1(). The device comprises a base 1~. havin~ an upper surface 14 includin~ a central convex portion ] 4a and a peripheral portion 1 4b circumscribin~ central portion 1 4a. As best seen in Fi~ures I and 4. base 1'' is also provided witll a lower surface 16 to which a patient interconneCtiOII means or adhesive pad assembly 1~ is connected. In a manner presentlv to be described. pad assembly 18 functions to releasably interconnect the device to the patient so as to hold it securely in place during the li~uid deliverv step.
A stored energy means cooperates with the upper surface 14 of base 12 to form a reservoir 20 havin~ an inlet port 22 whicll is in communication with a flow passa_eway 24 wllicll. in turn. communicates with a fillin~ means shown here as a septwn assembly 26 (Fi~ures 2. 3 and 4). The stored enerev means is here provided in the form of at least one distendable membrane 28 wllicl1 is superimposed over base 1 '. Membrane 28 is distendable as a result of pressure imparted on the membrane by fluids "F" introduced into reservoir ''0 throu~h inlet port 22 (Fi~ures 2 and 3). As membrane 28 is distended in the manner shown in Fi~ure 3. internal stresses will be established. which stresses tend to move the membrane toward a less distended confi~uratioll and in a direction toward base 1~. Membrane 28 can be constructed from a sin~le membrane or from multiple membranes to form a l~min~te construction of the character shown in Fi(~ure 39 of Patent No. ~. 279.558. which patent is incorporated herein by reference. Mem-brane 39 can be formed from a variety of elastomers of the character discussed in detail in Patent No. 5.279.558 (see columns 9 and l0 of the patent).
Provided w ithin the reservoir portion of the device. which includes fluid reservoir ~0 and the conve:; central portion of the base. is ulla~Te definin(~ means for providin<l ulla~e ithin the reservoil and for en~ a(lement with membrane 28 as the membrane moves toward its less distended startin~ confi~uration in the manner shown in Fi~ure ~. The ulla~ e definin-r means in the embodiment of the invention shown in Fi~ures I throu(~l1 1 () comprises the conve~; central Sl~ts~ 111 UTE SHEET (RULE 26) CA 02234~X1 1998-04-09 W O 97/13544 PCTrUS96/16361 portion 14a of base 1~ and defines an enga~ement surface ~or en~acement b!~ the ~lict~n~l~kle membrane as the membrane returns to its less distended configuration. As the membrane returns toward this less distended confi~uration. fluid contained within the reservoir ~0 will flow through a fluid passa7eway ~la formed in the convex central portion 21. the base. and thence uniformly outuardly of the reservoir through an outlet port 3~. The fluid will then flow into a fluid outlet passa ~ewa~ 34 via flow control means. the character of ~vhich will presently be described.
Superimposed over base 1~ is a cover 40 which functions to sealablv enclose membrane ~8 A medicament and use label 41 is affixed to cover 40 in tlle manner shown in Fi_ure I Base 1~ and cover 40 can be constructed from a number of different materials of the character described in Patent No. 5.279.558 (see columns 9 and 11).
Referrin~ particularlv to Fi~ures I . 6. 8. and 9 in the present form of the invention.
tlle infusion means for infusin~ medicinal fluids from reservoir ~0 into the patient comprises a tapered outlet cavity 46 formed in base 1 ) (Fi~ure 6) which sealably receives a quick connect deliver~ fittin~ 48 that comprises a part of the infusion means of the invention. Fitting 48 in-cludes a tapered inboard end portion 48a and a hexa~onally shaped body portion 48b. A central bore 50 e~tends through portions 48a and 48b and communicates at its outboard end with a cannula 54 uhicll also forms a part of the infusion nneans of the invention for infusin_ liquids into the patient. The inboard end of bore 50 communicates with fluid passa~eway 34 when fittin~ 48 is seated ~~ithin cavitv 46 in the manner shown in Fi~ure 1.
In order to releasablv lock quic~ connect deliverv fittin~ 48 in the fluid deliver pOsitioll uithil- ca ity 46 and in fluid communication u-ith passa~eway 34. locl;in_ means shoun here as resilientl! deformable lockin~ tabs ~5 are pro ided on base 1~ (Fi~ure 7). Upon pushin l inualdl! on fitthl - 48. tabs 55 uill separate so that tapered portion 48a ofthe fittin_ can be intro-duced into cavit! 46 As the fittin ~ 48a seats u -ithin portion 46. the resilientl~ deformable SUts~ 1 l l ~ITE SHEET (RULE 26) CA 02234~X1 1998-04-09 W O 97/13544 PCTrUS96/16361 locl;in~r tabs ~ ill close about portion 48b and will en~a~e shoulder 48c in the manner to lockabl~
interconnect the infusion means with the base, Fillin~ reservoir 20 is accomplished b,v introducin~ fluid into the reservoir under pressure via fill means ~hich here comprises a septum assembl~ 26 mounted in base 12 (Figure 4). SeptUm assembl!~ 26 is of a similar construction to the bolus injection site of the invention.
the nature of which will presently be described. More particularly. the septum assemblv includes a pierceable septum 26a which is mounted within a tapered cavity l 9 formed in base 1~, Surroundin~T septum 26a is a ~enerallv circularl~ shaped ~uide channel 26b. Usinc a conven-tional s! rince assembl! . fluid can be introduced into passa~ewa~ ~4 via a pierceable septum 26a ~~']liCh comprises a part of septum assembly 26. Durin~ this fillin<T step. distendable membrane ~8 is distended outwardl! in the manner shown in Fi~ures 3 and ]0 and internal stresses are thereb~ formed in the membrane which tend to ur~e it toward its less ~lictencled startin~

conficuration.
In a manner presently to be described. a mechanical injection pen can also be used to fill the fluid reservoir.
Durin~ the fluid dispensinc step. the distendable membrane ~ ill provide a constant fluid expellin~r pressure on the fluid contained within the reservoir throuchout the fluid deliver cvcle. thereb~ pro~idinc precise deliver!~ of liquid medicament over the prescribed deliver~
period. In the manner discussed in Patent No. j.~79.558~ distendable membrane ~8 can be tailored to pro~ ide the desired fluid flo~ characteristics. (See for example Column 17 of the patent.) Durin~r the liquid deliverv step. fluid v~ill flo-~ from reservoir ~0, throu~rh outlet port 3~ thro-l(rh the pre~iousl! identified flo~ control means and then into outlet passa~re~av 3~
(l~isrure I()). The ~ control means. ~hicll further controls the fl~lid ~lo~ cllaracteristics ofthe de~ ice hele coll1pl-ises an assembla~e ~G ~hic!~ Is recei~ed in a ca~ it~ 6] t~OI Illed in base 1~ and SlJ~ 111 IJTE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13544 PCT~US96/16361 which is pref'erablv constructed from a plurality of stac~;ed members 36a. 36b. and 36c. Member 36a is a porous member: member 36b is a rate control element. and member 36c is a porous supporting substrate. Member 36a is preferably constructed from a material comprising polysulfone sold by Gelman Sciences under the name and style of "SUPOR". Member 36c is preferably constructed from a porous polycarbonate material available f'rom Cornin~ Costar Corporation or f'rom a material sold by DuPont under the name and style KAPTON which has been laser drilled or m~hined to provide a~ iate flow orifices. Member 36c can be constructed from a porous polypropylene. After flowing~ throu~h the flo~ control means. the liquid medicament will flow outwardly of the device v ia passa~eway 34 and tlle infusion means in the manner best seen in Fi~ure 8. An important f'eature of the dpp~d~lS of the present invention comprises the previously mentioned bolus injection means V. hiCIl here comprises a bolus injection site mounted in cover 40 and base 1~ and generally cle~i!n~t~cl by the numeral 6~. Referring particularly to Fi~ures 1 and 5. this novel bolus injection means includes a tapered cavitv 67 provided in base 12 within which a pierceable septum 70 is mounted A peripheral ~roove. or guide channel. 72 is provided in cover 40 ~uld surrounds septum 70 Septum 70 is accessible v ia an opening provided in cover 40 and channel 72 is speciallv desi~ned to ~uidably receive a first sl;irt portion 74a of a novel adapter means or adapter assembly 74 which also comprises a part of the bolus injection means of the invention. Adapter assembly 74 includes a central body portion 74b which supports a double-endcd hollow needle 76. For purposes presently tc- be described. needle 76 has a pierceable point 76a at one end and a pierceable point 76b at tlle other end. A second internally threaded sliirt portion 74c extends from central body portioll 74h and surrounds end 76a of needle 76.
T~lrnin~ to Fi~ure 1. it is to be noted that second sl;irt portioll 74c is speciall~-desiglled lo he thleadabl~ interconnected witll tlle threaded barrel portioll "B" ol a syringe sho~-n I ~

SU~;~ JTE SHEFT (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 here as a dose indicatin~ injection pen "IP" of the character disclosed in U. S. Patent 5. 226.896 issued to Harris. While any type of conventional svrin~e assembly havin~T an injection needle can be used to provide the bolus dose via septum 70 the ~laL~Is of the present form of the inventiOIl is speciallv well suited for use with the Harris injection pen. For this reason. the Harris patent No. 5.226 896 is llereby incorporated by reference as throu~h fully set forth herein.
In accomplishing the bolus delivery usin~ the Harris device. internallv threaded second sl;irt 76c of the adapter assembly is first threadabl~ connected to barrel "B" of the Harris device Durin~T this step. end 76a of the needle will pierce the septum o~ a medicament vial disposed withill tlle device IP. Next. the adapter assemblv is mated with cover 40 by inserting first sl;irt 74a illtO ~Troove.72 and then pressin(~ in~ardly on the pen to cause needle end 76b to pierce septum 70 Tllis places the bore of the hollo~ needle in communication ~ith the passa~e-way 34 formed in base 12 and also in communication ~A~ith bore 50 of fittino 48 of the infusion means. Operation of the injection pen "IP" in the manner described in U. S Pa~tent 5= _26,896 will then cause a bolus dose to enter the infusion means for deliver~r to the patient.
Witll this hi~hly novel construction. the patient can receive from liquid reservoir 20 a selected basal dose of insulin of. b~ wav of example. one-half milliliter over a ~4 hour period. Should the patient determine that the blood su(Tar level is undulv hi_h. a bolus injection of a predetermined volume can quickly and easilv be accomplished throu~h use of the bolus injectioll means of the invention therebv ~ ol..iately supplementin~T the basal dose bein~
delivered from the fluid reservoir 20 More particularl~. by usin~ either a conventional syrin(Te or b! usin(T the injection pell IP. a bolus dose can be introduced illtO fluid passa~e~ay 34 ~ ia septum 7Q. Because of the reSistallCe tO Llpstream flo~ offered by the rate control me~ns. the bolus dose ~ill flo~ throu(~ll passa~e .~ to~ard the central bore 50 of quicl'; connect fittin~ 4~ and thellce illtO delivery line SlJts:~ 111 tJTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 54 lnterconnected with line ~4 is a soft cannula assembly 80 (Figure 8). the operation of which is w-ell understood h~ those skilled in the art. Once the soft cannula 80a llas been introduced into the patient s subdermal tissue "ST" in the manner shown in Figure 8. the cannula insertion assembly 8~. whicll includes a trocar 82a can be removed. Ieaving the soft cannula 80a in position witllin the patient. Needle cannula interconnect 84a of the connector assembly 84 of the infusion set can then be inserted into assembly 80 and interconnect therewith using~ the con~entional latch mechanism 8~. Connector assembl~ 84 which also forms a part of the infusion means. wllell connected to assembly 80, places soft cannula 80a in fluid communication with reservoir 2() The infusion set of this form of the invention. which comprises line 54.
connector assembly 84. and soft c~-lnul~ assemblv 80. is of a character well known in the art and is readily a~ailable from several commercial sources including Pharma-Plast International A/S
of L~nge. Denmarl;.
Turning to Fi~ure 10B. it is to be noted that the injection pen IP can effectively be used to provide the bolus dose delivery when the device of the invention is affixed to the patient s body as. for example. a location proximate the patient s waist. Due to the novel design of the sl;irt portion 74a of the adapter assembly 74. the injection pen can be easily mated with de~ ice 10 hy simpl! inserting the skirt portion into the circular g~uide channel or groove 7~.
As illustrated in Fi~ure 10A. the injection pen IP can also be convenientl!~ used to fill the fluid reser~ oir of the device via filling septum ~6a while being held in the user s hand.
In tllis case. sl;irt portion 74a is guidably recei~ed ~,ithin ~uide channel ~6b formed as a part of septulll assembl! ~6 (see also Fi_ure 4).
Referrin,g next to Fis~ures 11 throu_ll 17 still another f'orm of Ille fluid deli~er~
dc~ ice o~ the in~ entic)ll is there shown and g~enerall! designated k!- the numeral 90. As best seen h~ referrin_ to Fi_ures 11 and 1". this latest embodiment of the inventioll is similar in some SUBSTITUTE SHEET (RULE 26) CA 02234~8l l99X-04-09 W O 97/13544 PCTrUS96/16361 respects to that sllown in Fi~ures 1 through 10. Accordingl)~. like numbers are used to describe like components However~ this latest embodiment of the invention is unique in that it includes dual reservoirs ~-hicll communicate with the infusion means of this latest embodiment of the invention.
As best seen in Figures 12 and 13. the embodiment of the invention there shown comprises a base 92 havin~ an upper surface 94 including a central portion 94a and a peripheral portion 94b circumscribing central portion 94a. Base 9~ is also provided witll a lower surface 96. Fomled within base 92 is a fluid passagewa~ 100 (Fi~ure 12). whicll communicates with a tapered ~all. cavit~ 102 provided in base 9 '. which cavit~ sealablv receives portion 104a of a 4uicli connect deliver~ fitting assembl~ 104 which is somewhat similar to fittin~T 48 as previousl~
described.
As before. the ~:lldlUS shown in Fi~ures 11 through 17 includes stored energv means for forming. in conjunction with the base 92. a pair of reservoirs 106 and 108 having outlets I 10 and I I 2 respectively (Figure 13) As best seen in Figure 1~. outlet I 10 is in communication witll a first inlet passa~ewa~ 114 leadint to passagewa~ 100. while outlet 11~
is in communication with a second inlet passa~eway 1 16 leadin~ to passa~Tewav 100. Filling of central or inner reservoir 106 is accomplished via fill means here comprisint~ a first septum assembl~ 1 18 while filling of outer or toroidal reservoir 108 is accomplislled via a second fill means or second septum assembl~ 120. Both septum assemblies include a pierceable septum 119 (Fi~ure 14) ~llich is pierceable bv a needle of a conventional svrin~e As before. the stored energ~r means is provided in the fonn of at least one distendable membrane 1-'2 which is superimposed over base 92. An ulla~e definin-l means is disposed witl~ a central chamber 1~4 formed in a covel- 1 6 for formin~l ulla~e witl-ill tlle cllalllbel- Similarl~ an ullage definin~ means is disposed witllin a toroidal ~:hamber 130 formed S~ ITE SHEET (RULE 26) CA 02234j81 l998-04-os 4 PCT/USg6/16361 in cover 1 ~6 each of the central chambers for formin(g ulla_e within the toroidal chamber. The ullage means interact with membrane 1 ~2 which. after bein~ ctenclerl will tend to return to its less distended confi~uration The ullage defining means of this latest embodiment of the invention comprises conformable masses 134 and 136 which uniquel~ conform to the continuousl~ chang~ing shape of the rlictt ntl~ble membrane as the membrane tends to return to its less distended confi,=uration The first conformable mass 134 is disposed ~vithin chamber 124.
while the second conformable mass 136 is disposed within chamber 130 The ulla~e defining means. or flowable masses 134 and 136 are preferablv constructed from materials such as ~els.
foams. fluids and soft elastomers. More particularl~. materials particularl! well suited for constructin~ the conformable masses include oil. ~aseous materials. v arious polvmers and various ViSCous liquids. Additionall~ those masses can be formed from sodium palmitate . sodium sterate and meth~ I cellulose Where. as is here the case. the conformable ullag~e comprises a ~el.
a !~ieldable encapsulation barrier means or membrane 140 is used to encapsulate the conformable masses 134 and 136 between the distendable membrane and the barrier membrane. With this construction. the conformable ullages are located between the barrier membrane 140 and the distendable membrane 1~ Barrier membrane 140 can be constructed from various materials includin(~ pol~urethane. pol-propvlene. polvethvlene and fluorosilicon.
As indicated in Figure 15. the peripheral portion of the cover 1 ~6 is provided with a capture ~roove 14~ and an adjacent tongue 144. Similarl!. base 9~ is provided with tongue ]46 ~hich mates witll g~roove 14~ as the cover moves into enga(g~emellt witll base 9~ Base 9 ~ is fLIrtller pl ovided w ith an upst~n~ling membrane cutting means. or protuberance 147 whicll ~;lnctions to cleanl~ cut the stored ener_! means and barrier membrane 14() LlpOII cover 1~6 bein,g hroug~llt into pressural enga,g~ement witll base 9~ ith this constructioll. follo~ing cutting of the SIJ~ ~ ITE SHEET (RULE 26) CA 02234~Xl l998-04-09 W O 97/13544 PCT~US96/16361 membrane the cover can be sonically u-elded to tlle base in a manner well understood bv those s~;illed in the art In usin~ the apparatus of this latest form of the invention. central reservoir can be filled via septum assemblv 118 and passageway 118a usin~ a conventional fluid c~"~
svrin~e assembly havinc needle adapted to penetrate septum 119 of septum assembly 118.
Similarl~. toroidal reservoir 108 can be filled via septum assemblv 1~0 and passagewa~ 120a usin~ a second svrin~e assembly cont~inin,r a second fluid either the same as or different from the first fluid used to fill chamber 106 Fluids flowinL~ into the reservoirs are filtered by filter means shown in Fi~ ure 14 as filter elements 157. With the chambers filled. and the quicl;
connect deliver! fittin~ assembly 104 colmected to base 9~. the device is in condition for the liquid delivery step As seen in Fi~ure 1~. the quicl; connect delivery f'ittin(~ assembly is of sli~htl!~ different construction. as is the outlet port assembly of the device More particularl~. the outlet port housin~ 154. within which tapered portion 10~ is formed. extends outwardly from the base and is provided with a circumferentially e~tendin~ locking ~roove 156 whicll forms a part of the infusion set lockin(~ means of this form of the invention. Fittin~ assembly 104 also includes a pair of spaced-apart lockin,~ arms 158 uhich terminate at their inboard ends in hool;-lilie extremities 158a which are receivable within ~roove 156 By pressin~ inwardly on the rearuardl! extendin(T portions 158b of arms 158. extremities 158a will pivot about a collar 158c carried by the fittin<~ and will resiliently spread apart to permit their release from normal biased en~a~ement uith ~roove 156 As before~ the base of the device is provided with a suitable adhesive to enable the device to be removabl~ affixed to the patient's body such as to the arm or le(~ of the patient.
Once the device is interconnected ~ith the patient. it uill be appreciated that the ~ fluids contained uitllill first or central chamber 106 and withill toroidal chamber 108 uill be SlJ~S ~ JTE SHEET (RULE 26) CA 02234~81 l998-04-09 W O 97/13544 PCTrUS96/16361 ur~ed to flow throu~ fluid passa~7ewav 100 as the stored energy means. or distendable membrane 1''~ tends to return to its less ~ tended confic~uration. As before~ the conformable ullages contained within the reservoirs will closelv conform to the ch~n~~in, ~eometry of the stored energy means as the stored enercy means moves toward base 9~.
The flow control means here comprises a pair of assemblies each being of the character shown in Figure 17. Each assembly is receivable within a cavity provided in the base.
More particularly. assemblace 160 is mounted within a cavity 162 provided in the central portion of the base while assembly 164 is mounted within a cavitv 166 provided in the peripheral portion of the base. As shown in Fi~ure 17. each assemblace 160 and 164 is of a l~lmill~tP construction comprisin(7 filterinc means for filterin~ the fluid flowin~ outwardlv of the reservoirs and rate con-trol means for controllin~ the rate of fluid flow from the reservoirs into passa~eway 100.
Referrin~ to Fi~ure 17. it can be seen that the filter means comprises disl;-lil;e filter element 1 60a while the rate control element comprises a disl;-lil;e rate control element 1 60b. A porous disk-like support substrate 160c provides support to elements 160a and 160b. The assemblage comprisin(7 filter element 160a. rate control element 160b and porous substrate 160c is supported in base 9~ in the manner shown in Fi~ure 16. Filter element 160a can be constructed from a wide v ariety of materials. However. a material comprisin.7 polvsulfone sold hy Gelman Sciences under the name and stvle of SUPOR has proven satisfactory. Rate control element 160b is preferabl~ constructed from a polycarbonate material havin~ extremely small flow apertures ablatively drilled by an excimer laser ablation process. Both the orifice size and unit distribution can be closel~ controlled b this process. However. a number of other methods can also be used to construct this element. Porous substrate 1 60c can similarlv be constructed from various materials such as a porous polypropvlene available from Gelman Sciences.
The latest embodiment of the invention also includes bolus injection means 2r SUt~ ITE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 comprisin~ a bolus injection site 6~ which is identical in construction and operation to that previouslv described. As before. the bolus injection means includes a pierceable septum 70 which is accessible throu~h the cover of the device and also includes a ~uide channel 72 which permits easy matin~ of the previously described adapter assemblv 74. As best seen in Fi~ure 13?
liquids introduced via septum 70 will flow into a passa~ewa~ IOOa which communicates with outlet passa~ewa~ 100. thereby permittin~ delively to the patient of bolus doses of medication via the infusion means of the device.
Ref'errint to Fi~ures 18 througll ~4. yet another form of the fluid deliverv device of tlle invention is there sho~n and L~enerallv d~si~n~t d bv the numeral 170. This latest form of the in~ention is similar in manv respects to that shown in Ficures I throu~TIl 10. but in this latest embodiment the infusion means is specially desi~ned for subdermal infusion of selected medicaments. The device here comprises a base 17~. having an upper surface 174 including a central portion 1 74a and a peripheral portion ] 74b circumscribin~T central portion 1 74a. As best seen in Fitures 18 and ~. base 17~ is also provided with a lower surface 176 to which a patient intercolmection means or adhesive pad assembl! 178 is connected. As before. pad assembl~ 178 functions to releasabl~ interconnect the device to the patient so as to hold it securely in place durin~r the deliverv step.
As was the case with the earlier described embodiments of the invention. a stored ener(~! means cooperates with the upper surface 174 of base 17 ~ to form a reservoir 180 havin~r all inlet port 18~ WlliCIl iS in communication~witll a flow passa~ewa~ 18 i which. in turn commullicates v~itl1 a fillinc means shown hereas a septum assembl~ 186 (Fi~ures 18. 19. and 70). Tl~e stored ener~ means is here provideSin the fonn of at least one distendable membrane 188 wllicll is superimposed over base 17~. Meulbrane 188 is distendable as a result of pressure imparted on the membrane h~ fluids "F" intraduced into reservoir 180 tl1rou<rll inlet port 18 SU~S 111 ~JTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 (Figure 20) As membrane 188 is distended in the manner shown in Figure 20. internal stresses will be established. which stresses tend to move the membrane toward a less distended con-figTuration and in a direction toward base 172. Membrane 188 is substantiallv identical to membranc 28 (Figure 3) and can be constructed from a single membrane or from multiple membranes to form a l~min~te construction.
Provided within the reservoir of the device. which is defined by the upper surface 174 of the base and a concave surface of a cover means for covering the distendable membrane.
is ullage defining means for providing ullage within the reservoir and for engagement with membrane 188 as the membrane moves toward its less ~ t~ncled startin~ configuration. The ulla~e defining means provided in this latest embodiment of the invention comprises a conformable mass 19() which is enga~eable by the distendable membrane as the membrane returns to its less distended configuration Conformable mass 190 is of a character similar to the conformable masses that make up the ullage defining means of the form of the invention shown in Fi~ures 11 through 17. As before~ when the ~ ten~l~hle membrane returns toward its distend-ed confiruration. fluid contained within the reservoir 180 will flo~ uniforml~ outwardly of the reservoir througll an outlet port 192 and into a fluid outlet passagewa~ ]94 via flow control means generally designated by the numeral 196 (Figure 2 7A).
Superimposed over base 172 is the cover means. shown here as a rigid cover 200.
WlliCIl functions. through the use of novel sealing means. to sealably enclose membrane 188. The sealing means here comprises a circular ~roove 175 formed in peripheral surface 174b of base 172 and a circular rim lil;e protuberance 200a formed on the lower surface of cover 200 I'rotuberance 20()a is receivable within groove 17~ and functions to sealabl! clamp distendable melllbrane 18Pj between the co~er and the base in the manner shown hl Fi_ures 20 and 22. If desired. a medicament and use label 41 can be affi~;ed to cover 200 hl tll~ manner previousl~

S~S 111 ~JTE SHEET (RULE 26) -CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 described and as shown in Fi~ure 1. Once again~ base 17~ and cover 200 can be constructed from a v ariet v of materials of the character described in Patent No. 5. 79.558.
Ref'errin ~ particularly to Figures 19 and 24. the infusion means of this latest form of the invention for subdermal infusion of me~lic~nnent~ into the patient is of a lli~hly novel ~ construction. More particularl~ the infusion means here comprises a circuitous shaped hollow cannula 206 which is carried within a circuitous channel 208. formed in the intermediate body portion 1 72i of base 17 . Cannula 206 includes a body portion 206a which is mounted within channel 08 and also includes an outlet end 206b. here provided in the form of a needle-like se(Tment. whicll extends ~enerall~ perpendicularlv downward from the lower surface of base 172.
The circuitous bod! portion 206a. of the cannula. when mounted within channel 208. provides an extre1nel stron T and ri~id structure that effectively prevents bendin~ or breakage of the small diameter cannula. So that outlet end 206b can easil~ penetrate the patient s skin and tissue ST
f'or subdermal penetration (see Fi~ure 72A). end 206b is provided with a sharp. pointed extremit~
206c (Fif~ures 22 and ~2A).
To protect se~ments 206b and 206c of the cannula from damace. a protective cover assembl~ 210 surrounds these portions of the ç~nnnl~ At time of use. the skirt portion 210a of the protecti e co er 210 can be readil~ separated from the base b breakin-T it awa~ alon~ a serration line 1 I formed between the skirt portion 21 Oa and a disk like base portion 21 Ob. Skirt portion 210a is confi Tured to receive a plu ~lOp which provides a sterile barrier and prevents premature fluid flo~ from end 206c of the c~nnnl:l Base portion 210b is provided Aith an upstandin(T circumferelltiall extendin( rim 21 Oc which is receivable within a c~ lindricall! shaped ca it~ plo ided in base 172 ~see Fi(Ture -T). Disl;-lil;e base portion ~1()1 is also receivable ithill an aperture 178a pro ided in pad assembl! 178 (Fi Ture 23).
Fillhl T of reser oir 180 is accomplished h introducinc fl-lid into the reservoir SU~ ~ JTE SHEET (RULE 26) CA 02234~8l l998-04-09 under pressure via a septum assembly 186 which is mounted in base 17 7 (Fiéure 18). Usin~ an a~ o~liate svrin,~e assembly havinc a needle "N". fluid can be introduced into passa~eway 184 via a pierceable septum l 86a which comprises a part of septum assembly 186. During this filling step. a barrier means or barrier membrane 217 is ~ tencled outwardly a~ainst the conformable mass 190 controllablv moving it alon<~ with a c~i~t~ nr~hle membrane 188 toward cover 200. As the ullaée defininë means moves toward cover 200~ distendable membrane 188 will engage surface 219 formed in cover ~00. and the ulla~e definin~ means will uniquel~ conform to surface 219 as well as to the varyin~ shape of distendable membrane 188. As the distendable membrane moves to~ard surface 219 any ~ases contained within the reservoir will be vented to atmosphere v ia vellt means. ShO~ll here as a vent plu,~ '221. Barrier membrane 217 can be constructed from the various materials previously described.
When the fluid is dispensed from the device. the conformable ullace ~ill permit the distendable membrane to provide a constant fluid expelling ~les~u-e on the fluid contained within the reservoir throuéhout the fluid delivery cvcle. thereby avoiding undesirable delivery rate tail off at the end of the delivery period. This novel substantiall~ linear performance permits the device to meet even the most strin~ent of deliver~ protocols. Durin~ the deliverv step. fluid will flo~ from reservoir 180. throuéh outlet port 192. throu_h the flo~ control means. and then. in a manner presentl~ to be described. into cannula 206. The flow control means of this latest form of the inventioll comprises an assembla~e '724 which is received in a cavit~ 72~ formed in the hi~ll novel fusioll means of the present invention. the character of whicll ~ill presentl~ be described. Assembla~e 224 comprises a first wafer 224a which functions as a filter means of the character previousl~ described. ~afer 224b is preferabl~ constructed from a h~dro(Tel rate control Illedi-llll ~hiCIl. UpOIl imbibin,~ fluid. s~ells into a ca~ it~ provided in the filtel-. Upon s~-ellin~
in~O a l;nowll confit uratiom wafer ~4b will function to provide a specific permeabilit~ thereb~

Sl.l~ JTE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 precisel~ controllhI~ the rate of fluid flow from the reservoir 180. Wafer 224c functions as a support substrate for the assemblage.
TurnilIc particularly to Fi~ure 24. the novel infusion means of the present invention is there illustrated. This infusion means includes the previously identified circuitous shaped camIula 206~ the inlet end 206i of which is connected to a hollow housing 226 that is mounted in base 172 in the manner best seen in Fi~ure 21. Inlet end 206i of the cannula communicates with a chamber 226a formed in housin( 226 as does the outlet end 230a of a hollc)w tube 230. The inlet end 230b of tube 230 is connected to a second llollow housing 232 wlIicll is mounted in base 172 and within which the previously identified cavit! 2 25 is formed.
~ itll this constructiom tube ~30 places the outlet 1 80a of reservoir 180 in fluid communication w ith chamber 226a of housinc '226 and also in fluid communication with cannula 206 via an inlet port 234 whicll is disposed within chamber 226a. Accordingl). fluid can flo~ from reservoir 180 into chamber '2~ via the flow control means. then into tube 230 and finally into cannula 206 for subdermal deliverv to the patient.
As before. an important feature of this latest form of the invention is the a bolus injectioll means ~~hich here forms a part of the infusion means of the invention and includes a bolus injection site which is accessible throuL~h cover 200. Referrinc particularly to Fi~ures ~1 and 24. it can be seen that this novel bolus injection means is similar to that previously described but includes the earlier identified hollow housin~7 226 within which a pierceable septum 236 is mounted hl the manner shown in Fi~ure 21. Septum 236 is held in place ~vithin cover 200 by a retainer cap 237. A peripheral ~roove 2~8 surrounds retainer cap 237 and is specifically desi(med to receH-e the first skirt portion 74a of the previouslv described adapter means Ol adapter assembl!- 7~. Adapter assembly 7~ is of identical construction and operation to that described in conllectioll witll the embodiment of the invention show n in Fi~ res I throu(TII ] O and S~JtsS 111 ~)TE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13S44 PCT~US96/16361 serves to deliver a bol~1s dose of medicinal fluid into chamber ~26a of llollou; housinc 226 and thence into camlula ~06 via inlet ~34. As before adapter assembly 74 is speciallv ~lecignec7 to be threadably interconnected with the dose indicating injection pen "IP" of tlle character disclosed in U. S. Patent 5 ~6 896 issued to Harris.
With the highly novel construction of the device as described in the preceding para~Traphs. the patient can continually receive a selected basal dose of liquid medication. such as insulin from reservoir 180. However. should the patient at any time determine that his or her blood su~ar level is unduly hi~h. a bolus injection of a predetermined volume can quicklv and easil~ be administered through use of the novel bolus injection means of the invention and in this ua~ appropriately supplement the basal dose being delivered from reservoir 180.
Turl1ing finally to Fi~ure ~5. several fluid deliver!r regimens are there illustrated.
For example. at the upper portion of Figure ~5. a verv simple regimen is illustrated. Here a fluid delivery device ~50. having a fluid reservoir 25~ witll a volume V-l is used to accomplish deliverv of a liquid medicament such as insulin. The medicament is delivered to the patient througll an appropriate infusion means which includes a delivery line ~53 and a flow rate control means designated as R-l. Reservoir ~5~ can be filled using a filling means here shown as a septum assembly S-l. Using this basic arrangement. medicinal liquids can be delivered to the patient at a fixed rate over time with the rate of deliver!~ being governed by the character of the flow rate control means R-l.
Referring next to the arrangement illustrated in the central por~ion of Figure ~5.
a tluid deliver! device ~4 having~ a fluid reservoir ~5~ witll a volume V-] is there shou-n. As uac the case uitl1 the previously described arrang~ement. fluid can he delivered to the patient at a basal rate via a deliver! line ~55 and a flou rate control means deci~rn~t~d as R-l. Reservoir ~5~ can. once again. be filled h! a fill means shou n here is a septum assembl~ S-l. Houever.

SUBSTITUTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCT~US96/16361 formin~ an important part of this second deliverv system is a bolus dose deliver~ means ~enerall~
desi~nated as S-2. This bolus dose delivery means. which can be of the character illustrated and described in connection with the embodiment of the invention shown in Fi~ures 1 through 10 ~miquely enables the patient to ~ mini.~ter a pre-determined bolus dose of liquid insulin as ma~
be required. Device 254 exemplifies the types of sin~le reservoir devices of the invention illustrated in Fi~ures I through 10 and in FiL~ures 18 through 24 of the drawings.
Turnin~ to the last arran~ement schem~tically illustrated in Fi -ure 75. a deliver~
device 256 is there provided. Unlike deliver~ devices 750 and 754. device 756 includes dual fluid reservoirs 752 and 758. As before. reservoir 757 has a volume V-l. while second reservoir 758 has a volume V-2. Reservoir 752 can be filled by septum assembly S-l while reservoir 258 can be filled usin(T a septum assembly S-2. Reservoir 757 communicates with the patient via a deliverv line 257 and a first flow rate control means R-l. while reservoir ~58 communicates with the patient via a delivery line 259 and a second flow rate control means desi~nated as R-2. For reasons presently to be described. this arranL~ement is ideally for deliverin~ liquid medicaments such as insulin. For e:~ample. durin T the day when a lar~er basal rate is required. insulin can be delivered to the patient via deliverv line 261 with insulin flowinT simultaneousl~ from both reservoirs 757 and 258. The amount of fluid beinc delivered from each of the reservoirs is. of course. determined hv the character of the flow rate control device which is interconnected with that reservoir. B~ makin T the resistance offered to fluid flow from reservoir 758 ~Treater than the resistance to fluid flow from reservoir 757. it is a~palellL that reservoir 257 w ill emph faster than will reservoir 758. Accordin~Tlv. h~ correctly selectin T the flow rate control means R-l and R-7.
reservoir 752 will h~ empty at the end of the da~. However. because of the ~Treater resistance of'l'ered h! flo~ rate control means I~-7. durill(T the ni Thl insulin will colltillue to flow to the ~ l~atiellt irom resel-~oir 2~8 but at a lesser rate than the d~ytime basal deliver! rate. Once a Tain.

SUts~ 1 l l UTE SHEET (RULE 26) CA 02234~8l l998-04-09 W O 97/13544 PCTrUS96/16361 b~ properlv selecthl~ the flow rate control means R-~. insulin can be delivered to the patient at a prescribed basal delivery rate from reservoir 258 throu~hout the entire ni~httime hours. Thus a sin~le dual reservoir fluid deliverv device can be used to provide a precise basal delivery of insulin to the patient over an entire ~4-hour period.
An important additional feature of this last arran~ement. is tlle provision of a bolus dose deli~ery means desi~nated as S-3. This important bolus delivery means permits the patient to introduce into delivery line 261 ~ia S-3 a bolus dose of insulin at any time the patient discovers that his or her blood su~ar level is too hiL~h. As is apparent. this latest arran~ement as sho~n in Fi~ure '~. is exemplified b~ the dual reservoir embodiment of the invention ~hich is strated in Fi~ures I I throu~h 17 of the drawints.
In summary. it is clear from a studv of Fi~ure ~5 that each of the fluid deliver-re~imens illustrated in Fi~ure ~ and described in the preceding paragraphs can be accomplished usint a selected one of the various embodiments of the invention disclosed hl Fi~ures 1 through ~4 of the drawin~s. Referring next to Fi~ures 26 throu~h 41, yet another form of the ~ydldLuS
of the present invention is there illustrated. The apparatus here comprises t~o main assemblies.
namely a fluid deliverv assembly 300 (Fi~ures 26 and 31) and a fill assembly 30~ (Fi~ure '~7 throu~h 30) ~hich can be operabl~ mated with the fluid delivery assembly in a manner presently to be described. Fluid delivery assembly 300. the details of construction of which ~ill presently be described. is similar in some respects to the fluid deliverv devices previously described herein and includes a base 304 havin~ an upper suri'ace 306 includin( a central portion 306a and a peripheral portion 306b (Fi~Ture 31).
As hest seen by referrin~ to Fi~ures ~7 throu~h 30 the fill assembly portion 30~
of the apparatus comprises a container subassembl! 308. an adapter subassembl! .10. and a cover subassembl! 3 ] ~. the character of ~hich ~ill presently be described. Container subassembl~ 308 SUBSTITUTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 incJudes a bod!~ portioll 314. havin~ a fluid chamber 316 for cont~inin.~ an hljectable fluid "F"
which is provided witll first and second open ends 318 and 320 (Fi~ures ~8 and 30). First open end 320 is sealabl! closed bv closure means here provided in the form of a pierceable septurn assembl~ 3~. Septum assembly 3~2 is held securelv in position bv clampinë rin~ 324.
As best seen in Fi~ures 28 and 30. a plun~er 326 is telescopicall! movable within chamber 316 of container s~b~c~ bly 308 from a first location shown in Fi~!ure 28 where it is proximate open end 318 to a second position shown in Fi~ure 30 where it is pro~imate open end 3'~0. The vial portion of the container subassemblv can be constructed of various materials in-cludin(~ ~lass and plastic.
Referrin~ particularlv to Fi~ures ~7 and ~8. it can be seen that the adapter subassembl! 31() comprises a hollow housin(l 330 havin(~ a first open end 33~ and a second closed end 334 (Fieure 30). Container subassembl~ 308 is telescopicall~ recei~able within open end 332 of housinc 330 in the manner shown in Figure ~8 so that the housin~ can be moved from the first extended position shown in Fi~ure 28 to the vial encapsulation position shown in Fi(~ure 30. Formin~ an important part of the adapter subassembl~ is pusher means shown here as an elon~ated pusher rod 336 which functions to move plun~er 3~6 within fluid chamber 316 from the first position shown in Fi~ure 28 to the second position shown in Fi(~ure 30. In the form of the in~ention shown in the drawin~s~ pusher rod 336 has a first end 336a interconnected w ith a closure wall 334 of housin(~ 330 and an opposite end 336b which en~a(~es plun~er 326 and causes telescopic movement of the plun(~er within chamber 316 of container subassembl! 308 as housin~ 330 is moved from the e~ctended position into the vial encapsulathl(~ position shown in Fi(~ure 30.
As best seen b! rei'errin~ to Fi~ures 27 and 29. the interior wall 330a of IIOUS;II(~
33() is provided witll circumf'erentiall! spaced-apart protuberances 34() whicll en(~a~e and center SU~ 111 UTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCT~US96/16361 container subassembly 308 within housin~ 330. Due to tlle small surface area presented bv protuberances 340. there is little frictional resistance to tlle slidinL~ movemellt of container subassembly 308 relative to housin~ 330 as the housin~r is moved from the extended position shown in Fi~ure 28 into the vial enc~r.s~ ting position shown in Fi~ure 30.
Referrinc particularly to Figure 27. it is to be noted that cover subassembly 312 of the fill assembly of the present form of the invention includes a spiral wound. fran~ible portion 342 havin~ a first open end 342a for telescopicall~ receivin~r bod~ portion 314 of container subassembly 308 (Fi~ure 28) and a second closed end 342b. Portion 342 initially circumscribes a major portion of container sllb~ernhly 308 in the manner best seen in Fi~ure 28. An inte~rral pull tab 344 is provided to permit the spiral wound. fran~ible portion to be pulled from container cu~c~t mhly 308 so as to expose a substantial portion of body 314. As best seen in Fi~ures 27 and 28. a medicament label 346 circumscribes spiral ~ound portion 342 and serves to prevent accidental unwinding of the spiral portion from the container subassembly 308. However. upon pulling tab 344. the spiral portion will unwind and. in so doin~ will tear medicament label 346 so that the spiral portion 34~ of the covering as well as the cylindrical portion 348 which. also comprises a part of the cover assembly. can be slipped from the container subassembly 308 so as to expose to view septum assembly i22 (Fi~ure 30).
As shown in Fi~ures 27 and 28. end 34~b of cylindrical portion 348 of subassembly 31~ is provided with ventin~r apertures 3~0 which are covered by a porous vent patch 3~2 whicll can be constructed from an~ suitable porous material that will permit air entrapped within the interior of cover subassembl~ 312 to be expelled to atmosphere as the subassembl! is placed over container subassembly 308.
Turllillc particularly to Fi~rures 26 and 31 throu(rll 38. the ~1uid deli~ery assembl!
3()() of the apparatus of the invention can be seen to include the pre~iousl! identifed base 3W

SU~ ITE SHEET (RULE 26) -CA 02234~8l l998-04-09 W O 97/13S44 PCT~US96/16361 ~A'hiCIl defines upper surface 306.
As was the case with the earlier described embodiments of the invention, a flexible barrier means. shown here as a barrier membrane 354, cooperates with the upper surface 306 of the base to form a reservoir 356 havin~ an inlet/outlet port 358 which is in communication with flow passa~ewa~s 360 and 362 the latter of which. in turn communicates with a cannula 364~ the purpose of which will presently be described. (See Fi~ures 31 and 35). A stored energy means is here provided in the form of at least one tlicf~n~1~ble membrane 366 which is superimposed over barrier membrane 354 and base 304. Disposed between barrier membrane 354 and distendable membra11e 366 is an ulla~e defininc means. shown here as a conf'ormable mass 388 (Fi~ure 3,) Conformable mass 388 is of a character similar to the conformable masses that make up the ulla~e definin~ means of the form of the in~ ention shown in Fi~ures 1 I throu~h 17 and can comprise a cel or other deformable material. Membrane 354 is distendable as a result of pressure imparted on the membrane by fluids "F" introduced into reservoir 356 through port 358 As membrane 354 is ~ t~n~1etl in the manner shown in Fi~ure 35 it will act on the conformable ullaLe. which will, in turn, act upon distendable membrane 366 causinC internal stresses to be established. which stresses tend to mo~e the membrane toward a less distended con-fi~uration and in a direction toward surface 306a of base 304. As before. membrane 354 can be constructed from a sincle membrane or from multiple membranes to form a l:lmin~te When the distended membrane returns toward its less distended confi~uration~ fluid contained within the reser~,oir 356 will f1O~ uniforml~ outwardl~ of the reser~oir throu~h passa,l~ewa~ 360 and then intO a fluid outlet chamber 390 (Fi~ure 35) ~ia flow control means ~enerall~- desi~nated b~, the nul11eral 391, ~ uperimposed o~er the central portion 306a of the base is sealin(~ means. ShOWIl l1ere as a sealin(~ rin,~ 396 ~hich functions to sealabl~ interconl1ect membrane 366 with base 30 SU~ ~ JTE SHEET (RULE 26) CA 02234~81 l99X-04-09 WO 97/13544 PCTrUS96/16361 Ring 396 includes a circular ~roove 396a within which is received a circular rim like protuberance 400 formed on the upper surface of base 304 (Fi~,ure 35). Protuberance 400 is closely received witllin groove 396a and functions to sealably clamp distendable membrane 366 between the clampin_ rings and the base in the manner shown in Fi~ures 35 and 38. As shown in these figures. the periphery 354a of barrier membrane 354 is sealably affixed to the base by an! suitable means. such as adhesive or thermal bonding. Once ag~ain~ base 304 and clamping ring 396 can be constructed from a variety of materials of the character described in Patent No.

5.'79 558.
A unique feature of the base assembly of this latest form of the invention comprises. along one side of base 304. an elongated receivin~,- chamber 4()4 wllich is adapted to receive a portion of the fill assemblv of the invention. Receiving chamber 404 is formed within a generall! c~lindrically shaped housing 406 which is integrally formed witll one of marginal portions 306b of the base. As best seen in Figures 31. 3~. and 34. the previously identified piercing camlula 364 extends into the inboard portion of receiving chamber 404 and functions to provide a fluid flow path between the fill assembly and the fluid reservoir 356.
Turning particularly to Figures 31 and 35. the fluid deliver! assembly 300 further includes a housing 407 llavinc an internal chamber 409 within which the base assembly. including chamber 404. is received. An apertured end wall 407a substantiallv encapsulates the base assemhly, withi-l chamber 409. End wall 407a includes an aperture 409a wllich is indexible with recei~ing chamber 404 when the base assembl! is positioned within housin_ 407 in the manner Sh()~ll ill Figure ~. Housing 407 is also pro~ided with an aperture 41() wllicll alic~ns with an important featul-e of the invention. namel~ a bolus injection means. the cllaracter of whicll will presentl! I e described.
In using the apparatus of this latest form of the invention w ith the fill assembl~-SIJ~S 111 ~JTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13S44 PCTrUS96/16361 in the filled confi~uration shown in Fi~ure 28. the cover subassembly is first removed from the container subassembly b~ pullin~ on pull-tab 344. This will cause the spiral portion 342 of the cover subassembly to tear awav from the container subassembly so that it can be separated from the forwardly disposed portion 348 Once the spiral wound portion 342 is removed. cylindrical portion 348 can also be removed and discarded. Removal of the cover subassembly to expose the forward portion of the container subassembly and septum 372 readies the adapter subassembly for intercolmection with the fluid deliverv assembly.
Prior to matin~ the adapter subassembly with the fluid deliverv assembly. a closure plun 41~ hich forms a part of the cover s~lb~csembly must be removed in the manner illustrated in Fi~ure 26 This done. the container subassemblv 308 can be telescopically inserted into receivin~
chamber 404 and pushed forwardly in the direction indicated by the arrow 31~ in Figure 34. A
force e.Yerted in the direction of the arrow will cause the adapter subassembl~ to move to the ri~ht as ~iewed in Fi~ure 34 and will cause the piercinë cannula 364 to pierce septum 322. Once a fluid flow patll between fluid chamber 316 of the container subassembly 308 and the fluid reservoir 3~6 of the fluid delivery assembly is thus created. a continued movement of the adapter subassemblv will cause pusher rod 336 to move plun~er 326 forwardly of chamber 316 to a pOSitiOII showll in Fi(sure 34 As plun~er 326 is moved inwardlv of chamber 316. the fluid "F"
contained w-itllin the chamber will flow throu~h open end 320. into passa~ewav 364a of the piercin(~ cannula. into passa~ewav 362 of base 304 and then into fluid reservoir 356 via passa(~eway 360. As the fluid under pressure flo~s into reservoir 3~6. barrier member 3~4 will ~e distended out~ardiv in the mamler showll in Fi_ure 3~ and will deform the conformable ulla~e 3~8 and at the same time distend the distendable membrallf 366 until it reaclles the position sho~n in Fi~ure 3~ Gases contained in the volullle between the cover and the distendable membrane will be vented to atmosphere via aperture 409a in end wall 4()7.1 Rin~ 396 ~hicl S~J~S 111 ~JTE SHEET (RULE 26) -CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 is in clampin~ engagement with base 304, functions to capture and seal the distendable membrane relative to the base. In a similar marmer~ the peripherv of the barrier member 354 is sealabl~
affixed to the base as by adhesive or thermal bonding. so as to prevent leaka~e of fluid around the perimeter of the member.
Referring partlcularly to Figure 35. it is to be noted that inlet means shown here as an inlet 417 formed in base 304 is provided to enable the introduction of gel which forms the conformable ullage 388 of this embodiment of the invention, Inlet 417 communicates with a fluid passa~ewa~, 419 which in turn communicates with the volume defined between the under surface of membrane 366 and the upper surface of barrier member 354 via an inlet port 419a.
Inlet 417 is sealabl! closed b~ a bonded plug 4~1.
With the construction described in the preceding paragraphs and as shown in Figures 3~ and 38 the conformable mass 388 which comprises the ullage defining means of the invention is in direct enga~ement with distendable membrane 366 which after being ~listen(1e-1, will tend to return to its less distended configuration, It is to be noted that the shape of the conformable ullage v~ill continuously vary as the distendable membrane distends outwardlv from the base during reservoir filling and then tends to return to its less ~lict~n-led configuration during fluid deliver~, While the conformable ullage. or mass 388 is here constructed from a flowable ~el.
the conformable ullage can also be constructed from a number of materials such as various types of foams. fluids and soft elastomers, ln some instances. the conformable ullage mav comprise an integral conforming mass In other instances. such as when a gel or fluid is used as the ulla~e medium. an encapsulation barrier member such as member 354 must be used to encapsulate the ~el or fluid and lo provide an a~ , iate interface to the fluid contained in the reservoir, Alternativel! a separate pliable fihn can be used to encapsulate the ~el or other fluid medium Sl.3~ JTE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 Once reservoir 356 is filled with fluid from the container subassembly of the fill assembly. the fluid will remain in the reservoir until such time as an outlet flow path of the fluid delivery assembly is opened. Once this path is opened in a manner presently to be described, distendable membrane 366 will tend to return to its less ~ t~nc~ed confi~uration and will act upon the conformable ulla(~e 388 and the barrier member 354 in a manner to cause fluid to flow from reservoir 356 outwardly throucll flow passa~eways 360 and 362 and then into chamber 390 via the flow control means 392 (Figure 35) Referrinc once again to Figures 31 and 34. it is to be noted that base portion 406 and adapter member 330 include lockin~ means for locking the adapter member 330 within receivin~ chamher 4(W after the fill subassembly has been mated with the fluid deliverv device.
These iocl;in~ means are here provided in the form of a series of forwardl~ and rearwardl~
disposed lockin_ teeth 4~0 and 4~ respectively formed on adapter 330 and a locking tab 4~4 formed on base portion 406. As indicated in Figure 34~ these lockinc teeth are constructed so that thev wil] slide under the flexible locking tab 4~4. which is provided proximate the entrance of receivinë chamber 404. as the adapter subassembl~ is ur~ed inwardl~ of receivin~ chamber 404. However. once the adapter subassembly has reached the fully inserted position shown in Fi~ure 34 wherein the fluid is transferred to reservoir 356 lockinc tab 4~4 will effectivel~
prevent removal of the adapter subassembly from passa~reway 404. With this novel construction.
once reservoir 356 has been filled with the fluid contained in the container subassembly. the adapter subassembl! calmot be removed from the fluid deliver~ device and. tllerefore. cannot be reused therehy preventin_ svstem adulteration.
Also f'ormin~ an important aspect of the present inventioll is the provision of viewill_ means fol- viewin~ the volume of fluid contained witllill chamber 316 of the fluid container subassembl! 30~. In the form of the invention shown in the drawin(~s. this viewin SUBSTITUTE SHEET (RULE 26) CA 02234~81 l998-04-09 W O 97/13544 PCTrUS96/16361 means takes the form of an elon~ated viewin g window 4~8 which is provided in housing 330 (Figure ~7). As indicated in Figure ~7. the body portion 308 of the container sllb~cc(~mhly is provided with a plurality of longitudinally spaced-apart index lines~ or marl;s 430~ which can be v iewed througl1 w indow 4~8. Index lines 430 provide reference points for observing the volume of fluid rem~irling ~vithin the container s--hz~cc~ mhl~. A protuberance 330a formed on housing 330 in cooperation with channel 406a ~Figures 31 and 38) functions to provide polarized orienta-tion of the sllb~cc~mhly as it is introduced into receiving chamber 404.
Ref'erring particularly to Figures 31. 40~ and 41~ in the present form of the invention the deliver!~ means for deliverin~ medicinal fluids from reservoir 3~6 outwardlv of the device comprises a tapered outlet cavity 433 which is formed in base 304 and defines outlet chamber 390. Cavity 433 is adapted to receive a quicl; connect deliver~
fitting 435 that comprises a part of the deliverv means of the invention. Fitting 435 includes a tapered inboard end portion 43~a and a body portion 435b. A central bore 437 extends throu~h portions 43-7a and 435b and communicates at its outboard end with a cannula 450 which also forms a part of the deliver~ means of the invention for delivering fluids from the device. When fitting 435 is seated within chamber 390~ the inboard end of bore 437 communicates with the chamber and with a stub passagewa~ 45 ~ which houses a portion of the flow control means 39~.

In order to lock ~uick connect deliver~ fitting 433 in the fluid deliver~ position.
loc~;in T means sho~n here as resilientl~ deformable locking tabs 454 are provided on the bod~
portion of fitting 43~. Tabs 454 lockabl~ engage a lockin g surface 4~5 provided on cover 407 (Ficule 40). Iil70l- pushin g inwardl! on fittin g 43~. tabs 4~4 will !ieldabl! deform inwardl~ so that tapered portion 43~a of the fittin T can be introduced into chamber 39(). As the fittin g seats witllil1 the chamber. the resilientl! deformable locl;ing tabs will sprin - outwardl! and encTage SlJ~ JTE SHEET (RULE 26~

CA 02234~81 1998-04-09 W O 97113544 PCTrUS96tl6361 lockinc surface 455 in a manner to lockably interconnect the delivery means with the cover 407.
During this fluid step. fluid will flow from reservoir 356 throu~Th passageway 360 throu~h the previouslv identified flow control means and then into outlet cannula 450 (Figure 35).
~ The flow control means. which further controls the fluid flow characteristics of the device. here comprises an assembla~e 39~ which is preferably constructed from a pluralit~ of components 39'a. 392b. and 39~c. Member 392a is a porous member: member 39'b is a rate control element: and member 392c is a porous supportin~ substrate. Member 39~a is preferably constructed from a material comprising polysulfone sold by Gelman Sciences under the name and stvle of "SUPOR". Member 39~b is preferably constructed from a porous polycarbonate material available from Cornin~ Costar Corporation or from a material sold b~ DuPont under the name and style KAPTON which has been laser drilled or machined to provide ~ op. iate flow orifices.
Member 39~c can be constructed from a porous polypropylene. After flowin~r throu~h the flow control means. the liquid medicament will flow outwardly of the device via delivery cannula 450.

An e~;tremely important feature of the apparatus of this latest form of the present invelltion comprises the previouslv mentioned bolus injection means which here comprises a bolus injection site mounted in base 304 and accessible throu~h aperture 410 provided in cover 407.
Referrin~ particularly to Fi~ures 31. 3~. and 37. this novel bolus injection means includes a cavity 460 provided in base 304 within which a pierceable septum assembl~ 46~ is mounted.
Assembly 46~ includes a pierceable septum 464 and a retainine rin~ 466. Septum 464 is accessible via openin~ 410 provided in cover 407 and is specially desi~rned to accept a needle "~"' of a conventional syrin~e (see Fi~ure 37).
Throu~ll use of a conventional syrin~e. a bolus dose call be convenientl~
introduced into a il~lid passa re~ay 467 formed in base 3û4 via septum 464. Tlle bolus dose will SlJ~ ~ TE SHEET (RULE 26) CA 02234~81 1998-04-09 W O 97/13544 PCTrUS96/16361 then flow through passage 452 and toward the central bore 437 of quick connect fitting via the flow control means After passing through the flow control means. the bolus dose will flow into deliver- cannula 450.
With the highlv novel construction of the device as described in the preceding paragraphs. the patient can continually receive a selected basal dose of liquid medication. such as insulin from reservoir 356. However~ should the patiellt at any time determine that his or her blood sugar level is unduly high. a bolus injection of a predetermined volume can quickly and easily be ~lmillictt-red through use of the novel bolus injection means of the invention and in this wa! appropriately supplement the basal does being delivered from reservoir 356.
Having now described the invention in detail in accordance witl1 the requirements of the patent statutes. those skilled in this art will have no difficulty in making chan~es and modifications in the individual parts or their relative assembly in order to meet specific requirements or conditions. Such changes and modifications may be made without departing from the scope and spirit of the invention. as set forth in the followin~ claims 3~

SU ts~ 11 1 ~JTE SHEET (RULE 26)

Claims (20)

WE CLAIM

1. A fluid delivery apparatus comprising:
(a) a fluid delivery assembly having an outlet for delivering fluid from the apparatus, said fluid delivery assembly including:
(i) a base having a fluid passageway in communication with said outlet;
(ii) a stored energy means comprising at least one distendable membrane cooperating with said base to define a fluid reservoir in communication with said fluid passageway of said base; and (iii) a cover assembly connected to said base, one of said cover assembly and said base having a receiving chamber interconnected with said fluid passageway; and (b) a fill assembly interconnected with said fluid delivery assembly for filling said reservoir, said fill assembly comprising:
(i) a container assembly including:
a. a container having a body portion, a fluid chamber, and first and second open ends:
b. closure means for sealably closing said first end of said container; and c. a plunger telescopically movable within said container from a first location proximate said open end to a second spaced apart location; and (ii) an adapter assembly receivable within said receiving chamber, said adapter assembly comprising a hollow housing having a first open end for telescopically receiving a part of said body portion of said container of said container assembly and including a second end:
(c) delivery means for delivering fluid from said reservoir outwardly of the device; and (d) bolus injection means in communication with said delivery means for providing a bolus volume of fluid to said delivery means.

2. A device as defined in Claim 1 in which said cover assembly includes a cover connected to said base, said bolus injection means comprising an injection site formed in said base and accessible through said cover assembly.

3. A device as defined in Claim 1, including ullage defining means.

4. A device as defined in Claim 1 further including a barrier member disposed between said base and said ullage defining means.

5. A device as defined in Claim 1 further including flow control means for controlling fluid flow toward said delivery means.

6. A device as defined in Claim 5 in which said flow control means comprises a rate control element for controlling the rate of fluid flow outwardly of said device.

7. A device as defined in Claim 6 in which said delivery means further comprises a quick connect fitting for interconnection with said cover assembly.

8. A fluid delivery apparatus comprising:
(a) a fluid delivery assembly having an outlet for delivering fluid from the apparatus, said fluid delivery assembly including:
(i) a base having a fluid passageway in communication with said outlet of the apparatus:
(ii) a conformable mass overlaying said base for forming in conjunction therewith a reservoir having a fluid port in communication with said fluid passageway:
(iii) a cover connected to said base, said base having a receiving chamber interconnected with said fluid passageway;
(iv) a stored energy means for exerting forces on said means defining a conformable ullage, said stored energy means comprising at least one distendable membrane superimposed over said means defining a conformable ullage, said membrane being distendable by forces imparted thereon by said means defining a conformable ullage in response to fluids introduced into said reservoir, said forces establishing internal stresses within said distendable membrane, said stresses tending to return said distendable membrane toward a less distended configuration; and (v) bolus injection means comprising an injection site formed in said base and accessible through said cover for delivering a bolus dose of medication into said outlet;
(b) a fill assembly interconnected with said fluid delivery assembly for filling said reservoir, said fill assembly comprising:
(i) a container assembly including:
a. a container having a body portion, a fluid chamber, and first and second open ends;
b. closure means for sealably closing said first end of said container; and c. a plunger telescopically movable within said container from a first location proximate said open end to a second spaced apart location; and (ii) an adapter assembly receivable within said receiving chamber, said adapter assembly comprising a hollow housing having a first open end for telescopically receiving a part of said body portion of said container of said container assembly and including a second end; and (c) delivery means connected to said outlet of said fluid delivery assembly for delivering fluid from said reservoir outwardly of the device.

9. A device as defined in Claim 8 further including a barrier member disposed between said conformable mass and said base.

10. A device as defined in Claim 8 in which said conformable mass comprises a gel that is substantially conformable to the continually changing geometry of said distendable membrane as said membrane tends to move toward a less distended configuration.

11. A device as defined in Claim 8 in which said delivery means comprises a fluid delivery administration line and a quick connect fitting for interconnecting said administration line with said cover assembly.

12. A device as defined in Claim 8 including locking means for locking said adapter assembly within said receiving chamber.

13. A device as defined in Claim 8 in which said injection site comprises a pierceable septum mounted within a chamber formed in said base, said chamber being in communication with said fluid passageway.

14. A device as defined in Claim 8 further including flow control means for controlling fluid flow toward said delivery means.

15. A device as defined in Claim 13 in which said flow control means comprises a rate control element for controlling the rate of fluid flow outwardly of said device.

16. A fluid delivery apparatus comprising:
(a) a fluid delivery assembly having an outlet for delivering fluid from the apparatus, said fluid delivery assembly including:
(i) a base having an upper surface, a lower surface, and a fluid passageway formed in said base intermediate said upper and lower surfaces, said fluid passageway being in communication with said outlet of the apparatus and having first and second ends:
(ii) a conformable gel overlaying said base for forming in conjunction therewith a reservoir having a fluid port in communication with said second end of said passageway formed in said base:
(iii) a cover connected to said base, said base having a receiving chamber interconnected with said first end of said fluid passageway formed in said base:

(iv) an elastomeric membrane for exerting forces on said gel, said elastomeric membrane being superimposed over said gel, said membrane being distendable by forces imparted thereon by said gel in response to fluids introduced into said reservoir, said forces establishing internal stresses within said elastomeric membrane, said stresses tending to return said elastomeric membrane toward a less distended configuration;
(v) bolus injection means comprising an injection site formed in said base and accessibly brought said cover for delivering a bolus dose of medication into said outlet;
and (vi) flow control means for controlling fluid flow toward said outlet:
(b) a fill assembly interconnected with said fluid delivery assembly for filling said reservoir, said fill assembly comprising:
(i) a container assembly including:
a. a container having a body portion, a fluid chamber, and first and second open ends;
b. closure means for scalably closing said first end of said container; and c. a plunger telescopically movable within said container from a first location proximate said open end to a second spaced apart location; and (ii) an adapter assembly receivable within said receiving chamber, said adapter assembly comprising a hollow housing having a first open end for telescopically receiving a part of said body portion of said container of said container assembly and including a second end; and (c) delivery means for delivering fluid from said reservoir outwardly of the device.

17. A device as defined in Claim 16 in which said injection site is mounted within a chamber formed in said base, said chamber being in communication with said fluid passageway formed in said base.

18. A device as defined in Claim 16 further including a barrier member disposed between said base and said gel.

19. A device as defined in Claim 16 in which said flow control means comprises a rate control element for controlling the rate of fluid flow toward said outlet of said fluid delivery system.

20. A device as defined in Claim 16 further including locking means for locking said adapter assembly within said receiving chamber.