CA2112365C - Apparatus for patient-controlled infusion - Google Patents
Apparatus for patient-controlled infusion Download PDFInfo
- Publication number
- CA2112365C CA2112365C CA002112365A CA2112365A CA2112365C CA 2112365 C CA2112365 C CA 2112365C CA 002112365 A CA002112365 A CA 002112365A CA 2112365 A CA2112365 A CA 2112365A CA 2112365 C CA2112365 C CA 2112365C
- Authority
- CA
- Canada
- Prior art keywords
- conduit
- pump
- liquid
- reservoir
- patient
- 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 - Lifetime
Links
- 238000001802 infusion Methods 0.000 title claims description 9
- 239000007788 liquid Substances 0.000 claims abstract description 46
- 239000003814 drug Substances 0.000 claims abstract description 17
- 230000037452 priming Effects 0.000 claims description 14
- 238000002347 injection Methods 0.000 claims description 8
- 239000007924 injection Substances 0.000 claims description 8
- 238000000034 method Methods 0.000 claims description 6
- 230000000994 depressogenic effect Effects 0.000 claims description 4
- 238000006073 displacement reaction Methods 0.000 claims description 4
- 230000002441 reversible effect Effects 0.000 claims description 4
- 241000894006 Bacteria Species 0.000 claims description 3
- 238000013022 venting Methods 0.000 claims description 3
- 229940079593 drug Drugs 0.000 abstract description 2
- 230000036592 analgesia Effects 0.000 description 3
- 230000000202 analgesic effect Effects 0.000 description 3
- 239000012530 fluid Substances 0.000 description 2
- 230000036407 pain Effects 0.000 description 2
- 229920003023 plastic Polymers 0.000 description 2
- 229940035676 analgesics Drugs 0.000 description 1
- 239000000730 antalgic agent Substances 0.000 description 1
- 230000003474 anti-emetic effect Effects 0.000 description 1
- 229940125683 antiemetic agent Drugs 0.000 description 1
- 239000002111 antiemetic agent Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000010276 construction Methods 0.000 description 1
- 230000034994 death Effects 0.000 description 1
- 231100000517 death Toxicity 0.000 description 1
- 230000003028 elevating effect Effects 0.000 description 1
- 230000002706 hydrostatic effect Effects 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 238000001990 intravenous administration Methods 0.000 description 1
- 238000012423 maintenance Methods 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 230000000474 nursing effect Effects 0.000 description 1
- 229940005483 opioid analgesics Drugs 0.000 description 1
- 230000000737 periodic effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 230000002980 postoperative effect Effects 0.000 description 1
- 238000010926 purge Methods 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 229940125723 sedative agent Drugs 0.000 description 1
- 239000000932 sedative agent Substances 0.000 description 1
- 238000012549 training Methods 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14212—Pumping with an aspiration and an expulsion action
- A61M5/1424—Manually operated pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M2005/1401—Functional features
- A61M2005/1405—Patient controlled analgesia [PCA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/75—General characteristics of the apparatus with filters
- A61M2205/7527—General characteristics of the apparatus with filters liquophilic, hydrophilic
Abstract
A reservoir (3) is connected to a manually operable pump such as an aspirating syringe (1) via a flow control tube (4) which has a fine bore of accurately known size. Actuation of the syringe (1) by the patient discharges a fixed volume of drug via a non-return valve (5) to the patient. The syringe (1) is refilled by a return spring (2) drawing liquid from the reservoir (3) at a rate controlled by the bore of the flow control tube (4), thus silting a maximum dosage rate.
Description
1 Apparatus for Patient-Controlled Infusion 3 This invention relates to an improved apparatus for 4 effecting patient-controlled infusion of liquid medicaments and is particularly, but not exclusively, applicable to 6 patient-controlled analgesia (PCA).
8 It has been recognised for some time that PCA is desirable 9 in many situations of chronic or temporary (for example, post operative) pain. Before the advent of PCA, analgesia 11 relied on periodic injections of drugs such as synthetic 12 opioids by the physician or nurse, typically at 4-hour 13 intervals. This has the disadvantage that for most of the 14 time the patient's analgesic level is significantly above or below the optimum.
17 PCA improves on that prior art by enabling the infusion of 18 small quantities of analgesics at regular intervals as 19 perceived to be required by the patient. However, to date PCA has been effected by sophisticated electronic pump 21 systems which have a number of disadvantages:
22 a) They are expensive.
1 b) They are complex and require skilled maintenance.
3 c) They are capable of administering an overdose as a result of machine 4 failure or of operator error in setting up; a number of deaths from this cause have been report.
7 An object of the present invention is to provide an improved PCA apparatus which is 8 simple and inexpensive to manufacture and use, and which has a high level of inherent 9 safety.
11 In accordance with an aspect of the present invention, ihere is provided an apparatus for 12 patient-controlled infusion of a liquid medicament, the apparatus comprising a reservoir 13 for the medicament, a positive displacement pump having a predetermined working 14 volume, a first conduit connecting the reservoir to the pump, a second conduit connected to and extending from the pump and having a distal end to be inserted in the patient, a 16 one-way valve positioned between the pump and the distal end of the second conduit 17 permitting liquid flow from the pump to the patient and preventing reverse flow, and a 18 dismountable connection means wherein the second conduit being connected to the pump 19 by said dismountable connection means for introducing a priming liquid into the second conduit without the priming liquid passing through the first conduit; the pump being 21 manually operable to displace liquid through the valve and comprising resilient restoring 22 means for returning the pump to its initial state while drawing liquid from the reservoir 23 through the first conduit; and in which the first conduit comprises a capillary tube and has 24 a length in the range 1 cm to 40 cm and a lumen diameter in the range of 0.025 mm to 0.20 mm whereby the flow rate of liquid medicament through the first conduit is 26 restricted to a rate chosen in conjunction with the working volume of the pump to define 27 a predetermined maximum dosage rate; and wherein the length and the lumen diameter of 28 the first conduit are chosen so as to define a small internal volume which does not affect 29 the operation of the system; and wherein said capillary tube is connected directly into said second conduit.
2a 1 In accordance with another aspect of the present invention, there is provided a method of 2 priming an apparatus for patient-controlled infusi<7n of a liquid medicament, the 3 apparatus comprising a reservoir for the medicament, a positive displacement pump 4 having a predetermined working volume, the pump laving a plunger, a first conduit connecting the reservoir to the pump, a second conduit connected to and extending from 6 the pump and having a distal end to be inserted in the patient, a one-way valve positioned 7 between the pump and the distal end of the second conduit permitting liquid flow from 8 tile pump to the patient and preventing reverse flow, and a dismountable connection 9 means wherein the second conduit being connected to the pump by said dismountable connection means for introducing a priming liquid into the second conduit without the 11 priming liquid passing through the first conduit; the plunge~w of the pump being manually 12 moveable within the pump from an initial position to a depressed position to displace 13 liquid through the valve and comprising resilient restoring means for returning the pump 14 to its initial position while drawing liquid from the reservoir through the first conduit; and in which the first conduit comprises a capillary tube and has a length in the range 1 em to 16 40 cm and a lumen diameter in t1e range of 0.025 mm to 0.20 mm whereby the flow rate 17 of liquid medicament through the first conduit is restricted to a rate chosen in conjunction 18 with the working volume of the pump to define a predetermined maximum dosage rate;
19 wherein the length and the lumen diameter of the first conduit are chosen so as to define a small internal volume which does not affect the operation of the system; and wherein said 21 capillary tube is connected directly into said second conduit; said method being 22 characterised by the steps of:
23 - disconnecting the pump from the second conduit;
24 - filling the second conduit with liquid; and - reconnecting the pump and the second conduit while holding the plunger in 26 its depressed position.
28 An important preferred feature of the invention resides in the provision of means for 29 introducing a priming liquid into the second conduit without the priming liquid passing through the first conduit, which means _ _ .... ..... .. ,. . .. ..u . .. ._ 1 may conveniently comprise a dismountable connection 2 between the pump and the second conduit whereby the pump 3 may be removed to allow the second conduit to be filled 4 with priming liquid through said connection.
6 Preferably the pump is a syringe having a plunger biased 7 outwardly by resilient means.
9 The second conduit preferably includes means for venting gas thereform, suitably in the form of a filter which is 11 also capable of removing bacteria.
13 In one form of the invention, means are provided for 14 introducing liquid into the reservoir while the apparatus is in use, preferably in the form of a third conduit 16 extending from the reservoir and terminating in an 17 injection port.
19 The third conduit preferably includes a one-way valve, and may include an air-trapping filter or alternatively a 21 branch for removing air.
23 For safety reasons, the injection port and/or the air 24 removing branch if present may be provided with lockable covers.
27 The reservoir may suitably comprise a piston and cylinder 28 or a flexible bag.
Embodiments of the invention will now be described, by way 31 of example only, with reference to the drawings in which:
32 Fig 1 is a schematic view of a PCA apparatus forming a 33 first embodiment of the invention;
1 Fig 2 is a schematic view of a second embodiment 2 containing additional features;
4 Fig 3 is a similar view of a third embodiment being a modified version of the embodiment of Fig 2;
7 Fig 4 is a similar view of a further modified 8 embodiment; and Fig 5 is a perspective view of a practical embodiment 11 suitable for ambulatory use.
13 Referring to Fig 1, the apparatus comprises a reservoir in 14 the form of syringe 3 which is in communication via a small a bore tube 4 with a metering device in the form of an 16 aspirating syringe 1 whose plunger la is biased upwardly by a 17 return spring 2. The aspirating syringe 1 is arranged to 18 discharge via a patient line comprising a one-way valve 5, 19 tubing 6 and male luer lock connection 9 to an intravenous catheter secured to the patient.
Interposed in the tubing 21 is a filter of known type for preventing passage of 22 bacteria and including a hydrophilic membrane 8 which 23 discharges to atmosphere any air which inadvertently enters 24 the system. The aspirating syringe 1 can be connected to and disconnected from the patient line by means of a connection 26 joint 10.
28 In use, the reservoir 3 is filled with a quantity of 29 analgesic suitable for pain control over a period, for example 4 hours. Once the system is primed with liquid and 31 connected to the patient, depression of the plunger la causes 32 a quantity of analgesic equal to the volume of the aspirating 33 syringe 1, typically about 0.5m1, to 1 be infused. When the plunger la is released, it returns 2 under the influence of the spring 2, but at a rate which is 3 determined by the rate of flow of liquid from the reservoir 3 4 through the small bore tube 4. The overall infusion rate is 5 thus controlled by suitable selection of the volume of the 6 aspirating syringe 1 and the flow-resistance of the tube 4 in 7 relation to a given liquid.
8 It has been recognised for some time that PCA is desirable 9 in many situations of chronic or temporary (for example, post operative) pain. Before the advent of PCA, analgesia 11 relied on periodic injections of drugs such as synthetic 12 opioids by the physician or nurse, typically at 4-hour 13 intervals. This has the disadvantage that for most of the 14 time the patient's analgesic level is significantly above or below the optimum.
17 PCA improves on that prior art by enabling the infusion of 18 small quantities of analgesics at regular intervals as 19 perceived to be required by the patient. However, to date PCA has been effected by sophisticated electronic pump 21 systems which have a number of disadvantages:
22 a) They are expensive.
1 b) They are complex and require skilled maintenance.
3 c) They are capable of administering an overdose as a result of machine 4 failure or of operator error in setting up; a number of deaths from this cause have been report.
7 An object of the present invention is to provide an improved PCA apparatus which is 8 simple and inexpensive to manufacture and use, and which has a high level of inherent 9 safety.
11 In accordance with an aspect of the present invention, ihere is provided an apparatus for 12 patient-controlled infusion of a liquid medicament, the apparatus comprising a reservoir 13 for the medicament, a positive displacement pump having a predetermined working 14 volume, a first conduit connecting the reservoir to the pump, a second conduit connected to and extending from the pump and having a distal end to be inserted in the patient, a 16 one-way valve positioned between the pump and the distal end of the second conduit 17 permitting liquid flow from the pump to the patient and preventing reverse flow, and a 18 dismountable connection means wherein the second conduit being connected to the pump 19 by said dismountable connection means for introducing a priming liquid into the second conduit without the priming liquid passing through the first conduit; the pump being 21 manually operable to displace liquid through the valve and comprising resilient restoring 22 means for returning the pump to its initial state while drawing liquid from the reservoir 23 through the first conduit; and in which the first conduit comprises a capillary tube and has 24 a length in the range 1 cm to 40 cm and a lumen diameter in the range of 0.025 mm to 0.20 mm whereby the flow rate of liquid medicament through the first conduit is 26 restricted to a rate chosen in conjunction with the working volume of the pump to define 27 a predetermined maximum dosage rate; and wherein the length and the lumen diameter of 28 the first conduit are chosen so as to define a small internal volume which does not affect 29 the operation of the system; and wherein said capillary tube is connected directly into said second conduit.
2a 1 In accordance with another aspect of the present invention, there is provided a method of 2 priming an apparatus for patient-controlled infusi<7n of a liquid medicament, the 3 apparatus comprising a reservoir for the medicament, a positive displacement pump 4 having a predetermined working volume, the pump laving a plunger, a first conduit connecting the reservoir to the pump, a second conduit connected to and extending from 6 the pump and having a distal end to be inserted in the patient, a one-way valve positioned 7 between the pump and the distal end of the second conduit permitting liquid flow from 8 tile pump to the patient and preventing reverse flow, and a dismountable connection 9 means wherein the second conduit being connected to the pump by said dismountable connection means for introducing a priming liquid into the second conduit without the 11 priming liquid passing through the first conduit; the plunge~w of the pump being manually 12 moveable within the pump from an initial position to a depressed position to displace 13 liquid through the valve and comprising resilient restoring means for returning the pump 14 to its initial position while drawing liquid from the reservoir through the first conduit; and in which the first conduit comprises a capillary tube and has a length in the range 1 em to 16 40 cm and a lumen diameter in t1e range of 0.025 mm to 0.20 mm whereby the flow rate 17 of liquid medicament through the first conduit is restricted to a rate chosen in conjunction 18 with the working volume of the pump to define a predetermined maximum dosage rate;
19 wherein the length and the lumen diameter of the first conduit are chosen so as to define a small internal volume which does not affect the operation of the system; and wherein said 21 capillary tube is connected directly into said second conduit; said method being 22 characterised by the steps of:
23 - disconnecting the pump from the second conduit;
24 - filling the second conduit with liquid; and - reconnecting the pump and the second conduit while holding the plunger in 26 its depressed position.
28 An important preferred feature of the invention resides in the provision of means for 29 introducing a priming liquid into the second conduit without the priming liquid passing through the first conduit, which means _ _ .... ..... .. ,. . .. ..u . .. ._ 1 may conveniently comprise a dismountable connection 2 between the pump and the second conduit whereby the pump 3 may be removed to allow the second conduit to be filled 4 with priming liquid through said connection.
6 Preferably the pump is a syringe having a plunger biased 7 outwardly by resilient means.
9 The second conduit preferably includes means for venting gas thereform, suitably in the form of a filter which is 11 also capable of removing bacteria.
13 In one form of the invention, means are provided for 14 introducing liquid into the reservoir while the apparatus is in use, preferably in the form of a third conduit 16 extending from the reservoir and terminating in an 17 injection port.
19 The third conduit preferably includes a one-way valve, and may include an air-trapping filter or alternatively a 21 branch for removing air.
23 For safety reasons, the injection port and/or the air 24 removing branch if present may be provided with lockable covers.
27 The reservoir may suitably comprise a piston and cylinder 28 or a flexible bag.
Embodiments of the invention will now be described, by way 31 of example only, with reference to the drawings in which:
32 Fig 1 is a schematic view of a PCA apparatus forming a 33 first embodiment of the invention;
1 Fig 2 is a schematic view of a second embodiment 2 containing additional features;
4 Fig 3 is a similar view of a third embodiment being a modified version of the embodiment of Fig 2;
7 Fig 4 is a similar view of a further modified 8 embodiment; and Fig 5 is a perspective view of a practical embodiment 11 suitable for ambulatory use.
13 Referring to Fig 1, the apparatus comprises a reservoir in 14 the form of syringe 3 which is in communication via a small a bore tube 4 with a metering device in the form of an 16 aspirating syringe 1 whose plunger la is biased upwardly by a 17 return spring 2. The aspirating syringe 1 is arranged to 18 discharge via a patient line comprising a one-way valve 5, 19 tubing 6 and male luer lock connection 9 to an intravenous catheter secured to the patient.
Interposed in the tubing 21 is a filter of known type for preventing passage of 22 bacteria and including a hydrophilic membrane 8 which 23 discharges to atmosphere any air which inadvertently enters 24 the system. The aspirating syringe 1 can be connected to and disconnected from the patient line by means of a connection 26 joint 10.
28 In use, the reservoir 3 is filled with a quantity of 29 analgesic suitable for pain control over a period, for example 4 hours. Once the system is primed with liquid and 31 connected to the patient, depression of the plunger la causes 32 a quantity of analgesic equal to the volume of the aspirating 33 syringe 1, typically about 0.5m1, to 1 be infused. When the plunger la is released, it returns 2 under the influence of the spring 2, but at a rate which is 3 determined by the rate of flow of liquid from the reservoir 3 4 through the small bore tube 4. The overall infusion rate is 5 thus controlled by suitable selection of the volume of the 6 aspirating syringe 1 and the flow-resistance of the tube 4 in 7 relation to a given liquid.
9 The tube 4 is preferably a plastics tube having a very narrow bore and a relatively thick wall, the latter ensuring that it 11 does not kink in use. Such a tube and the method of 12 producing it are described in published International Patent 13 Application No W088/02637. The tube 4 preferably has a 14 length in the range 1 to 40 cm and a lumen diameter in the range 0.001 inch (0.025 mm) to 0.008 inch (0.20 mm). In a 16 particularly preferred form, the lumen diameter is 0.070 mm 17 and the tube length 23 mm.
19 The use of fine bore tubing not only sets the refill time of the aspirating syringe 1, but also acts as a safety factor in 21 inhibiting siphoning of liquid from the reservoir 3 to the 22 patient. As an additional safety factor, the one-way valve 23 should have an opening pressure greater than the maximum 24 possible hydrostatic pressure which could be present by elevating the reservoir above the patient to the maximum 26 height permitted by the length of the tubing.
28 The embodiment of Fig 2 is similar to that of Fig 1 and like 29 parts are denoted by like reference numerals. In this embodiment, the reservoir 3 is provided with a fill line 20 31 terminating in an injection site 21 where the system can be 32 filled or emptied by means of a standard hypo dermic syringe.
1 The embodiment of Fig 3 is similar to that of Fig 2, but the 2 reservoir is in the form of a collapsible bag 30, and the 3 aspirating syringe is replaced by a balloon 31. The balloon 4 31 is a thick-walled rubber balloon with sufficient recovery force to draw liquid from the reservoir 30 through the small 6 bore tube 4.
8 Fig 4 shows optional features which may be added to the 9 systems of Figs 2 and 3. A gas-trapping filter 40 may be included in the fill line 20 to prevent any air inadvertently 11 introduced at the injection site 21 from reaching the 12 reservoir 3. Alternatively a branch 41 may be provided, 13 ending in a port 42 for removing from the system air either 14 introduced inadvertently or at the initial purging of the system. A one-way valve 45 may be included in the fill line 16 20 to prevent removal of liquid from the system.
18 A cover 43 may be placed over the port 42 and secured in 19 place by a padlock 44 to prevent accidental or unauthorised use. The cover 43 and padlock 44 may similarly be used to 21 bar unauthorised access to the injection site 21.
23 Fig 5 illustrates one presently preferred, practical 24 implementation of the invention. Again, like parts are denoted by like reference numerals. In Fig 5, the reservoir 26 syringe 3 is enclosed within a transparent plastics bag 50 27 for reasons of safety and hygiene. The return spring of the 28 aspirating syringe 1 is housed within a cylindrical casing 29 51, the plunger being actuated by a patient demand button 52 extending from the casing 51. The syringe 1 and the bag 50 31 are linked by a cord 53 which allows the apparatus to be hung 32 around the patient's neck for ambulatory use.
1 An important preferred feature is the ability to remove the 2 syringe 1 (or equivalent) to assist in priming the system.
3 The tube 4 has such an extremely fine bore that it is 4 difficult to force liquid through it from the reservoir 3 to prime the system, and such a procedure would take an 6 extremely long time. Accordingly, to prime the system the 7 aspiration syringe 1 is removed from the connector 10 and 8 the patient line is filled with liquid, which may be done 9 by connecting a relatively large syringe at the connector 10 and injecting from this to overcome the resistance of 11 the one-way valve 5. In the case of the embodiments of 12 Figs 2 to 5, the reservoir fill line is also primed with 13 liquid at this stage.
19 The use of fine bore tubing not only sets the refill time of the aspirating syringe 1, but also acts as a safety factor in 21 inhibiting siphoning of liquid from the reservoir 3 to the 22 patient. As an additional safety factor, the one-way valve 23 should have an opening pressure greater than the maximum 24 possible hydrostatic pressure which could be present by elevating the reservoir above the patient to the maximum 26 height permitted by the length of the tubing.
28 The embodiment of Fig 2 is similar to that of Fig 1 and like 29 parts are denoted by like reference numerals. In this embodiment, the reservoir 3 is provided with a fill line 20 31 terminating in an injection site 21 where the system can be 32 filled or emptied by means of a standard hypo dermic syringe.
1 The embodiment of Fig 3 is similar to that of Fig 2, but the 2 reservoir is in the form of a collapsible bag 30, and the 3 aspirating syringe is replaced by a balloon 31. The balloon 4 31 is a thick-walled rubber balloon with sufficient recovery force to draw liquid from the reservoir 30 through the small 6 bore tube 4.
8 Fig 4 shows optional features which may be added to the 9 systems of Figs 2 and 3. A gas-trapping filter 40 may be included in the fill line 20 to prevent any air inadvertently 11 introduced at the injection site 21 from reaching the 12 reservoir 3. Alternatively a branch 41 may be provided, 13 ending in a port 42 for removing from the system air either 14 introduced inadvertently or at the initial purging of the system. A one-way valve 45 may be included in the fill line 16 20 to prevent removal of liquid from the system.
18 A cover 43 may be placed over the port 42 and secured in 19 place by a padlock 44 to prevent accidental or unauthorised use. The cover 43 and padlock 44 may similarly be used to 21 bar unauthorised access to the injection site 21.
23 Fig 5 illustrates one presently preferred, practical 24 implementation of the invention. Again, like parts are denoted by like reference numerals. In Fig 5, the reservoir 26 syringe 3 is enclosed within a transparent plastics bag 50 27 for reasons of safety and hygiene. The return spring of the 28 aspirating syringe 1 is housed within a cylindrical casing 29 51, the plunger being actuated by a patient demand button 52 extending from the casing 51. The syringe 1 and the bag 50 31 are linked by a cord 53 which allows the apparatus to be hung 32 around the patient's neck for ambulatory use.
1 An important preferred feature is the ability to remove the 2 syringe 1 (or equivalent) to assist in priming the system.
3 The tube 4 has such an extremely fine bore that it is 4 difficult to force liquid through it from the reservoir 3 to prime the system, and such a procedure would take an 6 extremely long time. Accordingly, to prime the system the 7 aspiration syringe 1 is removed from the connector 10 and 8 the patient line is filled with liquid, which may be done 9 by connecting a relatively large syringe at the connector 10 and injecting from this to overcome the resistance of 11 the one-way valve 5. In the case of the embodiments of 12 Figs 2 to 5, the reservoir fill line is also primed with 13 liquid at this stage.
The aspirating syringe 1 is then re-applied to the 16 connector 10 with its plunger la held down. On release of 17 the plunger la, fluid is drawn through the fine bore tube 18 4. This fluid is initially air which becomes trapped in 19 the syringe 1, but the volume of air involved (equal to the internal volume of the tube 4) is so small that it does not 21 affect the operation of the system.
23 The invention thus provides a patient-controlled apparatus 24 which is of simple and inexpensive construction and has a high level of inherent safety. The apparatus is extremely 26 simple to operate. Owing to its simplicity and cheapness 27 it can be used as a disposable item. The apparatus can be 28 manufactured for use with a particular medicament by 29 suitable choice of aspirating syringe and bore of the flow control tube; on-site adjustment is then not required, and 31 the apparatus can be used by nursing staff without 32 specialist training who simply have to recharge the 1 reservoir from time to time, suitably by injecting a single 2 standard 4-hour bolus into the reservoir.
4 Although described with particular reference to patient-s controlled analgesia, the invention can be applied to 6 patient-controlled infusion of other medicaments such as 7 sedatives and antiemetics.
23 The invention thus provides a patient-controlled apparatus 24 which is of simple and inexpensive construction and has a high level of inherent safety. The apparatus is extremely 26 simple to operate. Owing to its simplicity and cheapness 27 it can be used as a disposable item. The apparatus can be 28 manufactured for use with a particular medicament by 29 suitable choice of aspirating syringe and bore of the flow control tube; on-site adjustment is then not required, and 31 the apparatus can be used by nursing staff without 32 specialist training who simply have to recharge the 1 reservoir from time to time, suitably by injecting a single 2 standard 4-hour bolus into the reservoir.
4 Although described with particular reference to patient-s controlled analgesia, the invention can be applied to 6 patient-controlled infusion of other medicaments such as 7 sedatives and antiemetics.
Claims (14)
1. Apparatus for patient-controlled infusion of a liquid medicament, the apparatus comprising a reservoir for the medicament, a positive displacement pump having a predetermined working volume, a first conduit connecting the reservoir to the pump, a second conduit connected to and extending from the pump and having a distal end to be inserted in the patient, a one-way valve positioned between the pump and the distal end of the second conduit permitting liquid flow from the pump to the patient and preventing reverse flow and a dismountable connection means wherein the second conduit being connected to the pump by said dismountable connection means for introducing a priming liquid into the second conduit without the priming liquid passing through the first conduit; the pump being manually operable to displace liquid through the valve and comprising resilient restoring means for returning the pump to its initial state while drawing liquid from the reservoir through the first conduit; and in which the first conduit comprises a capillary tube and has a length in the range 1 cm to 40 cm and a lumen, diameter in the range of 0.025 mm to 0.20 mm whereby the flow rate of liquid medicament through the first conduit is restricted to a rate chosen in conjunction with the working volume of the pump to define a predetermined maximum dosage rate: and wherein the length and the lumen diameter of the first conduit are chosen so as to define a small internal volume which does not affect the operation of the system; and wherein said capillary tube is connected directly into said second conduit.
2. Apparatus according to claim 1, in which the pump is a syringe having a plunger biased outwardly by resilient means.
3. Apparatus according to either of claims 1 or 2, in which the second conduit includes means for venting gas from the second conduit.
4. Apparatus according to claim 3, in which the venting means comprises a filter which is also capable of removing bacteria.
5. Apparatus according to any of claims 1 to 4, further including means for introducing liquid into the reservoir while the apparatus is in use.
6. Apparatus according to claim 5, in which said introducing means comprises a third conduit extending from the reservoir and terminating in an injection port.
7. Apparatus according to claim 6, in which the third conduit includes a one-way valve.
8. Apparatus according to claim 6 or claim 7, in which the third conduit includes an air trapping filter.
9. Apparatus according to claim 6 or claim 7, in which the third conduit is provided with a branch for removing air.
10. Apparatus according to any of claims 1 to 9, in which the reservoir comprises a piston and cylinder.
11. Apparatus according to any of claims 1 to 9, in which the reservoir comprises a flexible bag.
12. Apparatus according to any of claims 6 to 9, in which the injection port is provided with a lockable cover.
13. Apparatus according to claim 1, wherein said dismountable connection is adapted to be terminated and re-established repeatedly.
14. A method of priming an apparatus for patient-controlled infusion of a liquid medicament, the apparatus comprising a reservoir for the medicament, a positive displacement pump having a predetermined working volume, the pump having a plunger, a first conduit connecting the reservoir to the pump, a second conduit connected to and extending from the pump and having a distal end to be inserted in the patient, a one-way valve positioned between the pump and the distal end of the second conduit permitting liquid flow from the pump to the patient and preventing reverse flow, and a dismountable connection means wherein the second conduit being connected to the pump by said dismountable connection means far introducing a priming liquid into the second conduit without the priming liquid passing through the first conduit; the plunger of the pump being manually moveable within the pump from an initial position to a depressed position to displace liquid through the valve and comprising resilient restoring means for returning the pump to its initial position while drawing liquid from the reservoir through the first conduit; and in which the first conduit comprises a capillary tube and has a length in the range 1 cm to 40 cm and a lumen diameter in the range of 0.025 mm to 0.20 mm whereby the flow rate of liquid medicament through the first conduit is restricted to a rate chosen in conjunction with the working volume of the: pump to define a predetermined maximum dosage rate; wherein the length and the lumen diameter of the first conduit are chosen so as to define a small internal volume which does not affect the operation of the system; and wherein said capillary tube is connected directly into said second conduit; said method being characterised by the steps of:
- disconnecting the pump from the second conduit;
- filling the second conduit with liquid; and - reconnecting the pump and the second conduit while holding the plunger in its depressed position.
- disconnecting the pump from the second conduit;
- filling the second conduit with liquid; and - reconnecting the pump and the second conduit while holding the plunger in its depressed position.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| AUPK6940 | 1991-07-01 | ||
| AUPK694091 | 1991-07-01 | ||
| AUPL2573 | 1992-05-25 | ||
| AUPL257392 | 1992-05-25 | ||
| PCT/GB1992/001184 WO1993000944A1 (en) | 1991-07-01 | 1992-06-30 | Apparatus for patient-controlled infusion |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CA2112365A1 CA2112365A1 (en) | 1993-01-21 |
| CA2112365C true CA2112365C (en) | 2004-08-31 |
Family
ID=25644065
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA002112365A Expired - Lifetime CA2112365C (en) | 1991-07-01 | 1992-06-30 | Apparatus for patient-controlled infusion |
Country Status (13)
| Country | Link |
|---|---|
| US (1) | US6056727A (en) |
| EP (1) | EP0592483B2 (en) |
| JP (1) | JPH07503378A (en) |
| AT (1) | ATE148635T1 (en) |
| AU (1) | AU665355B2 (en) |
| CA (1) | CA2112365C (en) |
| DE (1) | DE69217368T3 (en) |
| DK (1) | DK0592483T4 (en) |
| ES (1) | ES2099266T5 (en) |
| GR (1) | GR3023333T3 (en) |
| HK (1) | HK1000203A1 (en) |
| SG (1) | SG46575A1 (en) |
| WO (1) | WO1993000944A1 (en) |
Families Citing this family (27)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5267964A (en) * | 1992-03-23 | 1993-12-07 | Clintec Nutrition Co. | Fluid control device including automatic valve |
| AU674722B2 (en) * | 1992-12-21 | 1997-01-09 | John Elvin Teasdale | Improved pulsed infusion system |
| WO1994014487A1 (en) * | 1992-12-21 | 1994-07-07 | John Elvin Teasdale | Improved pulsed infusion system |
| AUPM564694A0 (en) * | 1994-05-17 | 1994-06-09 | O'Neil, Alexander George Brian Dr. | Spring driven infusion pumps with minimal risk of infection |
| JP3147346B2 (en) * | 1995-05-24 | 2001-03-19 | 株式会社ニッショー | Chemical self-injection tool |
| GB9524880D0 (en) * | 1995-12-05 | 1996-02-07 | Smiths Industries Plc | Fluid administration apparatus |
| GB2307953B (en) * | 1995-12-05 | 1999-07-07 | Smiths Industries Plc | Fluid administration apparatus |
| WO1997033637A1 (en) * | 1996-03-14 | 1997-09-18 | O'neil, Christine | Patient controllable drug delivery system flow regulating means |
| US6360784B1 (en) * | 1999-12-22 | 2002-03-26 | Medtronic, Inc. | Valved connector and method of use |
| US6520937B2 (en) | 2000-12-18 | 2003-02-18 | Scimed Life Systems, Inc. | Fluid injection device |
| US7867194B2 (en) | 2004-01-29 | 2011-01-11 | The Charles Stark Draper Laboratory, Inc. | Drug delivery apparatus |
| KR101013538B1 (en) * | 2004-11-19 | 2011-02-14 | 쿨린 메디컬, 인코포레이티드 | Controlled-volume infusion device |
| WO2008094672A2 (en) | 2007-01-31 | 2008-08-07 | Charles Stark Draper Laboratory, Inc. | Membrane-based fluid control in microfluidic devices |
| DE102007060131A1 (en) * | 2007-12-13 | 2009-06-25 | Technische Universität Dresden | Explanted organ's vessel connection filling method for medical field, involves continuously emptying dosage device and simultaneously withdrawing hose from vessel connection as long as vessel connection is completely filled |
| US8276589B2 (en) * | 2007-12-21 | 2012-10-02 | Massachusetts Eye & Ear Infirmary | Cricothyrotomy device |
| US20100100038A1 (en) * | 2008-10-15 | 2010-04-22 | Symbios Medical Products, Llc | Electronic flow control |
| US20110130714A1 (en) * | 2009-12-02 | 2011-06-02 | Wells John F | Multifunctional Device And Methods For Tissue Surgery |
| WO2011068507A1 (en) * | 2009-12-02 | 2011-06-09 | Wells John F | Multifunctional device and methods for tissue surgery |
| WO2011066865A1 (en) | 2009-12-03 | 2011-06-09 | Jean-Pierre Peters | Fluid interconnection set with particle filter |
| US20110196309A1 (en) * | 2010-02-10 | 2011-08-11 | Wells John F | Multifunctional Device And Methods For Tissue Surgery |
| US20110301539A1 (en) * | 2010-06-08 | 2011-12-08 | Rickard Matthew J A | Fill and purge system for a drug reservoir |
| US8814829B2 (en) | 2010-08-12 | 2014-08-26 | Baxter International Inc. | Drug delivery device for fluid restricted patients |
| DE202010011663U1 (en) * | 2010-08-21 | 2010-10-21 | Medizintechnik Promedt Gmbh | Refill kit for implantable infusion pumps |
| US8876795B2 (en) | 2011-02-02 | 2014-11-04 | The Charles Stark Draper Laboratory, Inc. | Drug delivery apparatus |
| US9616167B2 (en) * | 2011-05-24 | 2017-04-11 | Boston Scientific Scimed, Inc. | Anesthetic delivery device |
| US9572931B2 (en) | 2012-06-26 | 2017-02-21 | Ambu A/S | Device, system and method for self-administration of a treatment fluid |
| KR101798429B1 (en) * | 2015-07-08 | 2017-12-12 | 주식회사 더블유앤지 | A device for injecting drugs |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US1517849A (en) * | 1922-06-08 | 1924-12-02 | Mclellan Daniel | Blood-transfusion apparatus |
| GB348454A (en) * | 1930-07-10 | 1931-05-14 | Mor Kuensztler | Improvements in apparatus for intravenous injection |
| US2156023A (en) * | 1936-12-07 | 1939-04-25 | Mckay Angus Conrad | Hypodermic and other syringes |
| US2645224A (en) * | 1950-03-18 | 1953-07-14 | Ward L Beebe | Hypodermic syringe |
| US2923293A (en) * | 1955-08-15 | 1960-02-02 | Baxter Laboratories Inc | Dispensing closure |
| US3952919A (en) * | 1975-07-03 | 1976-04-27 | Joseph M. Magrath | Reservoir adapter for liquid dispenser |
| US4147280A (en) * | 1975-07-21 | 1979-04-03 | Spatz Corporation | Pump device for dispensing fluids |
| US4210173A (en) * | 1976-12-06 | 1980-07-01 | American Hospital Supply Corporation | Syringe pumping system with valves |
| US4187847A (en) * | 1977-07-11 | 1980-02-12 | Loeser Edward A | Airless intravenous fluid system |
| US4298000A (en) * | 1978-11-08 | 1981-11-03 | Minnesota Mining And Manufacturing Company | Fluid dispensing device |
| JPS5756066A (en) * | 1980-09-22 | 1982-04-03 | Yoshino Kogyosho Co Ltd | Spray |
| US4424056A (en) * | 1981-11-27 | 1984-01-03 | Alza Corporation | Parenteral administration |
| EP0392566A1 (en) * | 1984-10-01 | 1990-10-17 | Cook Incorporated | Implantable insulin administration device |
| JPS63501195A (en) * | 1985-08-06 | 1988-05-12 | バクスター、インターナショナル、インコーポレイテッド | Device for patient-controlled release of beneficial drugs |
| FR2588757B1 (en) * | 1985-10-21 | 1989-12-08 | Perouse Sa Laboratoires | DEVICE PLACED UNDER THE SKIN FOR DELIVERY OF A MEDICINAL SUBSTANCE |
| DE3715299A1 (en) * | 1987-05-08 | 1988-11-24 | Pfeiffer Erich Gmbh & Co Kg | DISCHARGE DEVICE FOR MEDIA |
| US4838855A (en) * | 1987-07-31 | 1989-06-13 | Lynn Lawrence A | Blood aspiration assembly and method |
| US4828551A (en) † | 1987-10-13 | 1989-05-09 | Gertler Robert A | Patient controlled analgesia apparatus |
| FR2631564B1 (en) * | 1988-05-18 | 1990-08-17 | Step Soc Tech Pulverisation | IMPROVED DOSING PUMP FOR SPRAYERS |
| US4904243A (en) * | 1988-07-11 | 1990-02-27 | Eduardo Bruera | Device for self-administration of drugs or the like |
| DE69032057T2 (en) * | 1989-12-05 | 1998-08-27 | Mckinley Inc | SELF-CONTROLLED PUMPING DEVICE |
| SG45171A1 (en) * | 1990-03-21 | 1998-01-16 | Boehringer Ingelheim Int | Atomising devices and methods |
| US5059173A (en) * | 1990-04-04 | 1991-10-22 | Sacco John J | IV apparatus |
| US5135491A (en) * | 1990-11-02 | 1992-08-04 | Baldwin Brian E | Patient controlled infusion apparatus and method |
| US5207661A (en) * | 1991-06-07 | 1993-05-04 | Smiths Industries Public Limited Company | Body fluid drainage assembly |
-
1992
- 1992-06-30 ES ES92912949T patent/ES2099266T5/en not_active Expired - Lifetime
- 1992-06-30 AT AT92912949T patent/ATE148635T1/en not_active IP Right Cessation
- 1992-06-30 AU AU21663/92A patent/AU665355B2/en not_active Ceased
- 1992-06-30 DK DK92912949T patent/DK0592483T4/en active
- 1992-06-30 SG SG1996006094A patent/SG46575A1/en unknown
- 1992-06-30 CA CA002112365A patent/CA2112365C/en not_active Expired - Lifetime
- 1992-06-30 DE DE69217368T patent/DE69217368T3/en not_active Expired - Fee Related
- 1992-06-30 EP EP92912949A patent/EP0592483B2/en not_active Expired - Lifetime
- 1992-06-30 JP JP5502061A patent/JPH07503378A/en active Pending
- 1992-06-30 WO PCT/GB1992/001184 patent/WO1993000944A1/en active IP Right Grant
-
1996
- 1996-03-07 US US08/610,803 patent/US6056727A/en not_active Expired - Lifetime
-
1997
- 1997-05-05 GR GR970400990T patent/GR3023333T3/en unknown
- 1997-09-09 HK HK97101746A patent/HK1000203A1/en not_active IP Right Cessation
Also Published As
| Publication number | Publication date |
|---|---|
| DK0592483T3 (en) | 1997-08-11 |
| DE69217368T2 (en) | 1997-07-10 |
| ES2099266T5 (en) | 2004-01-01 |
| SG46575A1 (en) | 1998-02-20 |
| AU2166392A (en) | 1993-02-11 |
| EP0592483A1 (en) | 1994-04-20 |
| DE69217368D1 (en) | 1997-03-20 |
| HK1000203A1 (en) | 1998-02-06 |
| GR3023333T3 (en) | 1997-08-29 |
| EP0592483B1 (en) | 1997-02-05 |
| ATE148635T1 (en) | 1997-02-15 |
| DE69217368T3 (en) | 2004-02-12 |
| EP0592483B2 (en) | 2003-06-25 |
| JPH07503378A (en) | 1995-04-13 |
| US6056727A (en) | 2000-05-02 |
| WO1993000944A1 (en) | 1993-01-21 |
| AU665355B2 (en) | 1996-01-04 |
| ES2099266T3 (en) | 1997-05-16 |
| CA2112365A1 (en) | 1993-01-21 |
| DK0592483T4 (en) | 2003-10-06 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| EEER | Examination request | ||
| MKLA | Lapsed | ||
| MKEC | Expiry (correction) |
Effective date: 20121202 |