CA1183749A - Medical infusor - Google Patents

Medical infusor

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Publication number
CA1183749A
CA1183749A CA000446676A CA446676A CA1183749A CA 1183749 A CA1183749 A CA 1183749A CA 000446676 A CA000446676 A CA 000446676A CA 446676 A CA446676 A CA 446676A CA 1183749 A CA1183749 A CA 1183749A
Authority
CA
Canada
Prior art keywords
bladder
posts
assembly
lumen
housing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000446676A
Other languages
French (fr)
Inventor
Peter F. Carpenter
John R. Peery
William K. Griesinger
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alza Corp
Original Assignee
Alza Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US06/113,224 external-priority patent/US4318400A/en
Application filed by Alza Corp filed Critical Alza Corp
Application granted granted Critical
Publication of CA1183749A publication Critical patent/CA1183749A/en
Expired legal-status Critical Current

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  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Abstract of the Disclosure A portable elastomeric bladder-powered infusor for dispensing drug in liquid form under pressure at a predetermined flow rate is disclosed.
The main elements of the infusor are a tubular housing, a plug/flow control assembly fixed in one end of the bladder, an axially slidable piston/filling port assembly within the housing, and a tubular bladder. The plug and piston assemblies each has an axial post about which the bladder ends are attached.
When the bladder is not charged with drug, the posts fill the bladder's lumen and their ends abut. Drug is charged to the infusor by inserting a drug-filled syringe into the open end of the housing with the syringe's needle entering an axial bore in the piston, penetrating a septum that blocks the bore, and extending into the axial post. The force exerted on the piston by the syringe is transmitted to the fixed plug assembly via the axial posts. Drug is plunged from the syringe causing the posts to separate and the bladder to expand axially and radially. Once the bladder is filled, the syringe is with-drawn, with the septum sealing itself. The drug is dispensed from the bladder via the plug/flow control assembly and a conduit that is connected to that assembly and extends to the infusion site.

Description

The invention relates to an infusor for dispensing drugs in liquid form to a patient.
The in-fusor of this invention was developed as an improvement of the infusor disclosed in commonly owned Uni-ted States Patents Nos. 3,8~5,631 4,140,117. The infusor of those patents involves two basic components: a replaceable cartridge assembly that is designed to hold the drug within an elastomer bladder; and a housing into which the cartridge is inserted. The housing is shaped to fit on an extremity of the patient and it contains an adjustable flow control subassembly. These patented infusors performed satis-ractorily. But, they are complex ill that they are composed of a great many parts. Accordingly, they cannot be easily manufactured in an automated manner and are thus costly relative to the conventional gravity-feed infusion appa-ratus used in health care.
SU~ARY OF THE INVENTION
The invention provides an elastomeric bladder assembly for dis-pensing a fluid under pressure comprising in combination:
(a) an elastomeric bladder having opposed ends;
~b) puncturable, resealable seplum means in fluid sealing relationship to one end of said bladder whereby fluid may be introduced into said bladder through said septum means and;
(c) lumen Eilling means disposed between said opposed ends, said lumen filling means comprising at least two posts received in and substantially filling the lumen of said elastomeric bladder when said elastomeric bladder is i.n a deflated condition, said posts in the deflated condition being axially aligned in end to end abutting relationship and being capable of resisting axial compressive loads between said opposed ends while offering substantially no resistance to axial expansion and contraction of said bladder; whereby said opposed ends may be maintained in spaced apart relationship while said bladder is deflated and said opposed ends are free to move axially apart during inflation and axially togetiler during deflation of said bladder.
The invention will further be described, by way of example only, with reference to the accompanying drawings, wherein:
Figure l is an exploded, perspective view of the preferred embodiment of the infusor;
Figure 2 is a perspective view of the infusor of Figure 1 with -the bladder of the infusor filled with liquid;
Figure 3 is an enlarged~ sectional view of the in-fusor of Figure l taken along line 3-3 of Figure 2; and Figure ~ is an enlarged sectional view of the infusor of Figure 1 showing the infusor bladder ready to be filled with liquid from a syringe;
and Figure 5 is an enlarged sectional view similar to Figure 4 of another embodi.ment of the infusor.
Figures 1 and 2 depict the basic elements of the preferred embodiment of the infusor, which is generally designated 11 in the drawings.
Those elements are: a tubular housing 12; a plug/flow control assembly 13; a piston/fil].ing port assembly 1~; an elastomeric bladder 15; a filling port cover 16; and a delivery conduit 17. Infusor 11 is symmetrical about the axis of housing 12. Its manufacture is thus simplified since no radial orientation of parts is required during its assembly.
Except for the delivery conduit 17, the elements of the infusor are contained within the lumen of cylindrical housing 12. Housing 12 may be made from various thermoplastic polymers. A graduated volume scale 18 is imprinted, scribed, or otherwise applied to the housing wall. As described below this volume scale indicates the quantity of liquid contained within 3'~

bladder 15. It is graduated in mi:Llil.iters from 1 to 60 ml, the capacity of bladder 15 being 60 ml.
As shown in Figures 3 and 4, plug/flow control assembly 13 is fixed in one end of housing 12. The fixation may be effected by adhesion, fusion, or other appropriate means. Assembly 13 includes a main body 19 and an axial post 22 that is integrally connected to the inner side 23 of body 14.
The body has a peripheral shoulder 24 against which the end of housing 12 is seated. An axial bore 25 of varying diameter extends through body 19 and post 22. Bore 25 serves as an ou-tlet port for transmitting liquid from bladder 15 to delivery conduit 17. Within bore 25 are a cup-shaped particle filter 26 and a capillary flow control element 27. ~ilter 26 and element 27 are com-pression sealed within bore 25 through the use of 0-rings 28 and 29. 0-ring 28 is seated between a shoulder 32 at a diameter transition in bore 25 and the inner end of filter 26. 0-ring 29 is seated between the outer end of element 27 and the enlarg0d diameter inner end 33 of delivery conduit 17. A third 0-ring 34 forms a seal about the perimeter of the interface between filter 26 and capillary element 27. End 33 of conduit 17 is fusion sealed in an enlarg-ed diameter segment 35 of bore 25. End 33 (and in turn element 27 and filter 26~ is held under compression by a disc-shaped plug 36 that is fixed by ad-hesion, fusion, or other fixation means within a recess 37 in the outer side 38 of body 19. Plug 36 has an axial opening through which delivery conduit 17 extends.
Piston/filling port assembly 14 is slidably housed within the lumen of housing 12. It includes a head 42, a base 43 and an axial post 44 extending from the inner side of base 43 toward the axial post 22 of plug/flow control assembly 13. Head 42 has an end wall 45 that traverses the lumen of housing 12 and a cylindrical side wall 46 that extends ].aterally along the inside of housing 12. An axial bore 47 extends through end wall 45, base 43, ~'B;~

and axial post 44. Base 43 is affixed to head 42 by adhesion, fusion, or other affixation means. A septum 48 is contained withi.n a recess 49 in the outer side of base 43. Septum 48 is sealingly compressed at its perimeter. It traverses and closes bore 47. It is made from a material, such as an elastomer, that is capable of being punctured and resealing itself after the puncturing instrument is withdrawn. The outer side of end wall 45 has an axial projection 52 with a conical recess 53 that opens into axial bore 47. As described in detail below recess 53 acts as a guide for the instrument that is used to charge bladder 15 with liquid.
As shown in Figure 4, when bladder 15 is deflated (not filled) it :Eits about axial posts 22 and 44 in sleeve-like fashion. A pair of spring clamps 56 and 57 around the ends of the bladder effect fluid tight joinder between the posts and the bladder ends. The axial posts 22 and 44 substantially fill the lumen of bladder 15 and their free ends abut each other when the bladder is deflated. As discussed below, these features contribute to the com-plete discharge of liquid from the bladder and the ease with which the bladder may be charged with liquid.
Figure 4 shows the inEusor ready to be charged with a drug in liquid form, designated 58 in Figures 3 and 4. As shown, a syringe 59 contain-ing liquid 58 has been inserted into the lumen of housing 12 with the needle 62 of the syringe puncturing septum 48 and extending into the axial bore 47 of assembly 14. In this insertion procedure recess 53 guides the end of needle into the opening of bore 47 and the force applied to assembly 14 to puncture septum 48 is transmitted to fixed plug/flow control assembly 13 via the abut-ting posts 22, 44. Piston/filling port assembly 14 is thus supported during this initial step in the filling operation. Further, post 44 guides needle 62 after the septum is punctured and shields the bladder from being punctured.

7~

Once the syringe has been positioned as shown in Figure 4, the plunger (no-t shown) of the syringe is depressed to eject liquid 58 into bladder 15 via needle 62~ and bore 47. It should be noted that there is no seal between the free ends of posts 22, 44 so that the liquid is free to flow from bore 47 into the bladder. It should also be noted that the conduit 17 must be capped, valved or otherwise closed off at this point in time to prevent the premature dispensing of the liquid from the infusor. As liquid is ejected from the syringe into the bladder, the bladder expands axially and radially until it assumes the expanded (filled) state depicted in Figure 3. The volume of liquid in the bladder may be determined by observing the location of an indicator line 63 in wall 46 relative to volume scale 18. Housing 12 is transparent in the area of sca.le 18 so that indicator line 63 may be so observed. Piston assembly 14 slides axially within the housing to accommodate the axial expansion of the bladder. As it does so, line 63 movss along scale 18. When the bladder is fully filled, line 63 will register with the 60 ml mark on scale 18. When filled the bladder wall is spaced from posts 22, 44 except at the clamped ends and a. radial air vent 64 traversing post 44 is exposed and un-obstructed. The bladder wall is also preferably spaced from housing 12, except that gravi.ty may cause a portion of the blaclder wall to touch the housing.
Such spacing prevents the housing from constricting the bladder.
Once bladder 15 is filled with liquid 58 the infusor is tipped into a vertical position with the piston-filling port uppermost. This causes any air that may have been trapped in the bladder to rise to the piston-filling port end of the bladder. The syringe is then withdrawn partly so that the tip of the needle resides in the segment of bore 47 between septum 48 and air vent 64 and any air trapped in the bladder is sucked therefrom into the syringe via air vent 64. The syringe is then withdrawn completely from the infusor, with septum 4S sealing itself and closing bore 47 to liquicl flow. Filling port cover 16 is then inserted flush into the open end of housing 12 to prevent patients from tampering with the contents of the housing. Infusor 11 is then ready for use.
For use on ambulatory patients, infusor 11 will normally be attached directly to an extremity with a strap accessory or to the body or clothing with an appropriate holster, pouch, beltl or similar attachment means.
A cannula is then inserted at the infusion site. The end of delivery conduit 17 is then attached to the cannula. Liquid 58 will then commence to be infused into the patient from the bladder through bore 25, filter 26, the capillary of element 27, conduit 17 and the cannula. The flow rate of liquid to the patient will depend upon the dimension of the capillary of element 27, the pressure exerted on the liquid by the bladder, and the viscosity of the liquid.
At a fixed capillary dimension and pressure, flow rate may be correlated solely to viscosity and thus may be predetermined accurately.
When infusor 11 is exhausted, bladder 15 will appear as in Figure 4. The infusor is capable o dispensing essentially all of its liquid charge because posts 22, 44 occupy the deflated volume of the lumen of bladder 15 leaving no room for residual liquid.
Figure 5 illustrates an alternate, less preferred infusor, gener-ally designated 65. It is similar to in-fusor 11 except as regards the attach-ment of the bladder ends, the bladder lumen filling means, and the location of the liquid flow control regulator. Since infusor 65 is similar to infusor 11 in other respects, only the above mentioned differences are described in detail hereinafter.
The basic elements of infusor 65 are: a tubular housing 66; a plug/flow control assembly 67; a piston/filling port assembly 68; and elastomeric 7f-~bladder 69; a filling port cover ~not shown); and a delivery conduit 72.
Piston/filling port assembly 68 includes an integral axial post 73 that extends nearly the entire length o:f deflated bladder 69 and abuts against the inner side of assembly 67 when bladder 69 is deflated. Post 73 is an alternate bladder lumen filling means to posts 22, ~4 of infusor 11. Bladder 69 fits about post 73 in sleeve-like fashion. Barbs 7~ on the piston end of post 73 anchor enlarged diameter end 75 of the bladder to the post. The other end of the bladder is sealingly seated within assembly 67. Post 73, as posts 22 and 4~ of infusor 119 functions as a filling needle guide and provides support for assembly 68 lluring the filling operation. A filter and flow control subassem-bly, generally designated 76, is contained wholly within the body of assembly 67 rather than partly within an axial post and partly within the main body of the assembly as in infusor 11.
Modifications of the embodiments shown in the drawings and des-cribed above that are obvious to those of skill in the medical device and/or mechanical arts are intended to be within the scope of the following claims.
Such modifications include, without limitation, other axial post arrangements such as a pair of axial posts similar to bul shorter than posts 22, ~ with a "floating" post segment therebetween, other means for attaching the bladder ends to the posts such as by correlating tlle respective dimensions of the posts and bladder such that sufficient hoop stress is maintained on the bladder ends to provide a fluid tight seal between the ends and the posts, alter-natives to septum ~8 such as a one-way, self sealing valve, and other flow regulators such as porous plugs, fiber bundles, porous films or known adjust-able flow regulators.

Claims (8)

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. An elastomeric bladder assembly for dispensing a fluid under pressure comprising in combination:
(a) an elastomeric bladder having opposed ends;
(b) puncturable, resealable septum means in fluid sealing relationship to one end of said bladder whereby fluid may be introduced into said bladder through said septum means and;
(c) lumen filling means disposed between said opposed ends, said lumen filling means comprising at least two posts received in and substantially filling the lumen of said elastomeric bladder when said elastomeric bladder is in a deflated condition, said posts in the deflated condition being axially aligned in end to end abutting relationship and being capable of resisting axial compressive loads between said opposed ends while offering substantially no resistance to axial expansion and contraction of said bladder; whereby said opposed ends may be maintained in spaced apart relationship while said bladder is deflated in said opposed ends are free to move axially apart during in-flation and axially together during deflation of said bladder.
2. The elastomeric bladder assembly of claim 1 wherein the post adjacent with said septum is provided with a port in alignment with said septum and of a length sufficient to receive the length of a needle used to inflate said bladder to substantially shield said elastomeric bladder from said needle when said bladder is in a deflated condition.
3. The elastomeric bladder of claim 1 wherein said axially aligned posts are connected to said opposed ends of said bladder.
4. The elastomeric bladder assembly of claim 1 wherein means are provided for maintaining the axial alignment of said posts when said bladder returns to a deflated condition after discharge of its fluid contents; whereby said lumen filling means will substantially fill the lumen of said deflated bladder and provide for substantially complete discharge of said fluid.
5. The elastomeric bladder of claim 4 wherein said bladder is received within a tubular housing and said means for maintaining the axial alignment of said posts comprises plug means engaging said housing proximate one end thereof and carrying one of said posts and piston means slidably engaged with the interior of said housing and carrying another of said posts.
6. The elastomeric bladder of claim 3 wherein means are provided for maintaining the axial alignment of said posts when said bladder returns to a deflated condition after discharge of its fluid contents whereby said lumen filling means will substantially fill the lumen of said deflated bladder and provide for substantially complete discharge of said fluid.
7. The elastomeric bladder assembly of claim 6 wherein said bladder is received within a tubular housing and said means for maintaining the axial alignment of said posts comprises plug means engaging said housing proximate one end thereof and carrying one of said posts and piston means slidably engaged with the interior of said housing and carrying another of said posts.
8. The elastomeric bladder assembly of claim 7 further comprising a flow control means for controlling the release of fluid from said bladder assembly to fluid communication with the lumen of said bladder.
CA000446676A 1980-01-18 1984-02-02 Medical infusor Expired CA1183749A (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US06/113,224 US4318400A (en) 1980-01-18 1980-01-18 Medical infusor
US113,224 1980-01-18
CA000368327A CA1165199A (en) 1980-01-18 1981-01-12 Medical infusor

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CA000368327A Division CA1165199A (en) 1980-01-18 1981-01-12 Medical infusor

Publications (1)

Publication Number Publication Date
CA1183749A true CA1183749A (en) 1985-03-12

Family

ID=25669223

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000446676A Expired CA1183749A (en) 1980-01-18 1984-02-02 Medical infusor

Country Status (1)

Country Link
CA (1) CA1183749A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6068011A (en) * 1993-10-13 2000-05-30 Paradis; Joseph R. Control of fluid flow

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6068011A (en) * 1993-10-13 2000-05-30 Paradis; Joseph R. Control of fluid flow

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