WO1980001459A1 - Self-contained injection system - Google Patents

Abstract

Method of and apparatus for injecting fluid into a patient from a chamber (148) carrying the fluid with an outlet (175) connecting the fluid to the patient and with a piston (146) in the chamber movable toward the outlet to force the fluid into the patient using a driving means (20) to move the piston only a prescribed distance toward the outlet each time the driving means is operated regardless of the length of time the driving means is operated by alternately operating and stopping the operation of the driving means to cause the fluid to be injected at the average prescribed rate over the sum of the times the driving means is operated and not operated so that, in the event of a malfunction which continuously operates the driving means, the piston will be moved only the prescribed distance toward the outlet to prevent overdosing the patient. Also disclosed is a subcutaneous injection needle assembly (610).

Description

SELF-CONTAINED INJECTION SYSTEM TECHNICAL FIELD

This invention relates generally to devices for dis¬ pensing or injecting a fluid at a controlled rate and more particularly to a device for use in the medical field to inject fluids into the body of a patient at a slow rate over a prolonged period of time. II. BACKGROUND ART

It is desirable in the medical profession to inject fluids such as liquid medicaments into the body of the patient, whether human or animal, at a relatively slow rate over a prolonged period of time. Several varieties of medical treatments such as chemotherapy, pre- and post- surgery treatments for the prevention of blood clotting, various nutrient treatments, various antibiotic treatments and treatment of certain other diseases generally require low rates of injection over a long period of time. Such injections are generally made intravenously or subcuta- neously into the patient. Some of these treatments gene- rally require that the fluid be introduced relatively continuously over an extended period of time at varying rates ranging from very slow rates, usually about lcc per 24-hour period, to relatively fast rates of more than about 5 cc per 24-hour period. Because a significant increase in the predetermined rate of injection during these continuous treatments must be accurately controlled to prevent serious injury to or fatality^" of the patient, the rate of injection must be frequently and closely monitored. There are a number of liquid dispensing or injection devices presently known which attempt to dispense or in¬ ject a liquid into a patient at a very slow continuous rate over an extended period of time. These prior art injection systems, however, suffer from a number of drawbacks.

O FI /,- IPO One problem frequently encountered with such prior art injection systems is that the system cannot reliably inject small quantities of fluid over a prolonged period of time. To compensate for this inadequacy, medical per- sonnel have had to dilute the liquid medicament with neu¬ tral fluids to- reduce the unit liquid medicament concen¬ tration of the fluid being injected so that a relatively large quantity of fluid could be injected without over¬ dosing the patient with the active liquid medicament and so that the undesired consequences due to variations in fluid injection rate were minimized. This, of course, increases the weight of the fluid being injected and also increases the power required to inject this larger quan¬ tity of fluid into the patient. The net result is that the overall weight of these systems due to the weight of the fluid to be injected and the weight of the necessary power supply is at a level that virtually precluded these injection systems being made sufficiently portable for the patient to carry on his usual daily activities. Another problem commonly found with the prior art in¬ jection systems is that a failure in some component of the system can cause the injection system to exceed the - desired injection rate. This not only has resulted "in the use of the diluted liquid medicament but has also required frequent monitoring of the injection system by medical personnel to compensate for this problem. To further com¬ pensate for this problem, the patient has usually been confined to a medical facility so that counteractive treatment is quickly available in the event of overdosage of the patient.

In addition to the problems associated with prior art injection devices themselves, another problem has been en¬ countered when attempts have been made to subcutaneously inject fluids into a patient. This problem resides in the fact that the injection needle used for the subcutaneous

-gtJREAl OMPI injection has been difficult to locate properly for the injection and difficult to maintain in the proper posi¬ tion for injection once the proper location was initially achieved. In subcutaneous injection, the fluid must be injected within the subcutaneous fat layer between the patient's skin and muscle. Inasmuch as it is desirable to inject the fluid as deep as possible into the subcu¬ taneous fat layer to isolate the point of injection of the fluid from any skin surface irritation created by the injection needle puncturing the skin, it has been diffi¬ cult for the medical personnel installing the injection needle to assure that the point of injection was always sufficiently deep in the subcutaneous fat layer to be isolated from skin irritation without sometimes penetra- ting the muscle. This is because the thickness of the subcutaneous fat layer varies widely and because no phy¬ sical limit is provided on prior art injection needles to limit the depth of penetration.

III. SUMMARY OF THE INVENTION

According to the invention, there is provided a method of injecting fluid into a patient at an average prescribed injection rate over a prolonged period of time from a chamber carrying the fluid with an outlet connecting the- fluid to the patient and with a piston in the chamber movable toward the outlet to force the fluid into the patient characterized by the steps of connecting the piston to a driving means constructed and arranged to move the piston only a prescribed distance toward the out¬ let each time the driving means is operated regardless of the length of time the driving means is operated to force a known volume of the fluid into the patient each time the piston is moved the prescribed distance at an injec- tion rate greater than the desired average prescribed rate where the known volume is much less than the total volume of fluid to be injected over the prolonged period of time; and alternately operating and stopping the opera¬ tion of the driving means to cause the fluid to be in- jected at the average prescribed rate over the sum of the times the driving means is operated and not operated so that, in the event of a malfunction which continuously operates the driving means, the piston will be moved only the prescribed distance toward the outlet to prevent over- dosing the patient.

The method of the invention may be further charac¬ terized by operating the driving means for^{^} a fixed period of time each time the driving means is operated and stop- ping the operation of the driving means for a selectively variable period of time so that the average prescribed injection rate can be changed. The method of the inven¬ tion may likewise be further characterized by selectively varying the prescribed distance the iston is moved each time the driving means is operated so as to vary the known

OMPI IPO _rf volume of fluid injected each time the driving means is operated while maintaining the period of time the dri¬ ving means is not operating constant to selectively change the average prescribed injection rate. The invention also includes the apparatus for car¬ rying out the above methods of injecting fluid into the patient. The driving means may include a solenoid, a stepping motor, or a piezoelectric device with an appro¬ priate control means. Further, according to the invention, there is provi¬ ded a method of subcutaneously injecting fluids from a fluid supply source into the subcutaneous fat layer of a patient using an injection needle and a locating surface characterized by the steps of positively locating an in- jection needle with a sharpened end thereon with respect to a locating surface so that the sharpened end of the needle projects from the locating surface a prescribed distance slightly less than the minimum distance between the skin surface and the interface between the subcuta- neous fat layer and the muscle tissue in the patient likely to be encountered at the position where subcutaneous in¬ jection is to take place, and so that the sharpened end of the needle is oriented generally normal to the loca¬ ting surface; inserting the sharpened end of the needle into the patient at that position where subcutaneous in¬ jection is to take place until the locating surface is in juxtaposition with the skin surface while maintaining the positive location between the needle and the locating sur¬ face to insure that the sharpened end of the needle is located within the subcutaneous fat layer; and attaching the needle and locating surface to tϊie patient to keep them in place.

The invention also includes apparatus for carrying out the method of subcutaneous injection characterized by an injection needle defining a fluid passage there- through, the injection needle having an inlet end con- nectible to the fluid supply source and a sharpened out¬ let end adapted to puncture the patient's skin and subcu¬ taneous fat layer; and locator means mounting the needle 5 thereon, the locator means defining a locating surface thereon adapted, to lie against the patient's skin and the sharpened end of the needle projecting from the locating surface generally normal thereto so that the sharpened end is located a prescribed distance from the locating

10 surface to positively control the depth of penetration of the sharpened end of the needle into the subcutaneous fat layer of the patient when the locating surface is in juxtaposition with the patient's skin.

In summary, the invention of this application over-

15 comes the problems and disadvantages associated with the prior art by providing an injection system which has the capability of injecting fluid slowly and precisely into a patient at a known, easily measurable and easily variable rate. The system is extremely fail-safe in that failure

20 of any part of the device will result in disabling the device to prevent a too rapid injection rate or any fur¬ ther injection of the fluid. Further, the system pro¬ vides a human receptive indication, visible and/or audi¬ ble, of whether the device is working which can be

25 easily and readily monitored by the patient and/or medi¬ cal personnel thereby greatly reducing the number and skill of medical personnel necessary to monitor the in¬ jection rate. Because the system of the invention is abl to precisely control the injection of the fluid, the vo-

30. lume and thus the weight of the fluid injected is minimiz because of its concentrated form ratϋer than diluted form Also, the power required to dispense this minimized volum of fluid is minimized to minimize the power pack weight. As a result, the system of the invention can be made

35 highly portable so that the patient is not hampered in hi

OMPI ambulatory capability thereby maximizing the amount of productive time available to the patient even during treatment. Because of these features, the system of the invention is ideally suited for out-patient use not pre¬ sently clinically available to prevent unnecessary hos- pitalization and expense.

These and other features and advantages ofthe in¬ vention disclosed herein become more apparent upon con¬ sideration of the following detailed description and accompanying drawings wherein like characters of refe- rence designate corresponding parts throughout the several views -and in which:

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a perspective view illustrating the in¬ vention; Fig. 2 is an exploded perspective view illustrating the injection apparatus of the invention;

Fig. 3 is an enlarged exploded perspective view illustrating a first embodiment of the apparatus seen in Fig. 2 with portions thereof broken away to show the construction thereof;

Fig. 4 is an elevational view partly shown in cross- section of that embodiment of the apparatus seen in Fig.

3;

Fig. 5 is an enlarged view of the ratchet mechanism of the apparatus taken along line 5-5 in Fig. 4;

Fig. 6 is enlarged view of the transmission in Fig.

4;

Fig. 7 is an enlarged view of that portion encircled by line 7 in Fig. 4 and shown partly in cross-section; Fig. 8 is an enlarged view of that portion encircled by line 8 in Fig. 4 and shown partly in cross-section;

Fig. 9 is an enlarged view taken along line 9-9 in Fig. 2 showing the ampule;

Fig. 10 is an enlarged cross-sectional view taken along line 10-10 in Fig. 1;

Fig. 11 is an enlarged cross-sectional view taken along line 11-11 in Fig. 1;

Fig. 12 is an electrical block diagram of the con¬ troller circuit of the invention seen in Figs. 1-3; Fig. 13 is a graphic illustration of the control

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/.. WIIPPOO - circuit of Fig. 12 ;

Fig. 14 is a view similar to Fig. 6 illustrating a modification of the invention;

Fig. 15 is an enlarged side view taken along line 15-15 in Fig. 14;

Fig. 16 is an enlarged exploded perspective view similar to Fig. 3 illustrating a second embodiment of the apparatus of the invention;

Fig. 17 is an enlarged view taken generally along line 17-17 in Fig. 16;

Fig. 18 is an electrical block diagram of the con¬ troller circuit of the invention seen in Fig. 16;

Fig. 19 is a graphic illustration of the control output of the controller circuit illustrated in Fig. 18; Fig. 20 is an enlarged partial perspective view illustrating a modified second embodiment of the power unit;

Fig. 21 is an enlarged view taken generally along line 21-21 in Fig. 20; Fig. 22 is a view illustrating a first alternate embodiment of the invention;

Fig. 23 is a view illustrating a second alternate embodiment of the invention;

Fig. 24 is a top right perspective view illustrating an embodiment of the subcutaneous injection needle assem¬ bly of the invention;

Fig. 25 is a bottom right exploded perspective view of the embodiment of the invention seen in Fig. 24;

Fig. 26 is an enlarged cross-sectional view taken generally along line 26-26 in Fig. 24 and showing the invention in use;

Fig. 27 is a perspective view illustrating a second embodiment of the subcutaneous injection needle assembly of the invention; Fig. 28 is a perspective view similar to Fig. 27 showing the cover removed;

Fig. 29 is an enlarged cross-sectional view taken generally along line 29-29 in Fig. 28;

Fig. 30 is a perspective view similar to Fig. 28 showing the invention unfolded ready for use;

Fig. 31 is an enlarged cross-sectional view taken generally along line 31-31 in Fig. 30;

Fig. 32 is a perspective view illustrating a third embodiment of the subcutaneous injection needle assembly of the invention; and

Fig. 33 is an enlarged cross-sectional view taken along line 33-33 in Fig. 32.

OMPI IPO These figures and the following detailed descrip¬ tion disclose specific embodiments of the invention; however, it is to be understood that the inventive con¬ cept is not limited thereto since it may be embodied in other forms.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS Referring to Fig. 1, it will be seen that the fluid injection system 10 includes an injector 11, a carrier 12 for mounting the injector on the patient, and a connector assembly 14 for connecting the output of injector 10 to the patient, usually intravenously or subcutaneously. Fig. 2 illustrates the injector 11 in more detail. The injector 11 has a power unit 20 for selectively forcing a fluid from the ampule or container 21 carrying the fluid. The ampule 21 is positioned on the power unit 20 by an ampule holder 22. Thus, the fluid from the ampule 21 is forced into the patient by the power unit 20 via the connector assembly 14.

A first embodiment of the power unit 20 is seen in Figs. 2-5. The power unit 20 includes a housing 30 which removably mounts the ampule holder 22 thereon about an expelling axis A_E (Fig. 2) as will become more apparent. The housing 30 mounts a drive screw assembly 31 therein about the expelling axis A_p to expel fluid from the ampule 21 carried in holder 22 as will become more apparent. The drive screw assembly 31 is driven by a driving solenoid 32 through a transmission 34 (Fig. 3). A battery 35 is pro¬ vided to power solenoid 32 through a controller 36.

The housing 30 has a base 39 which mounts the various components thereon. A removable cover 38 is adapted to fit over base 39 to enclose the components mounted on the base. Locating pins 37 maintain cover 38 in alignment with base 39 and latch pin 33 keeps cover 38 in place as best seen in Fig. 3. The drive screw assembly 31 includes an externally

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^n °\* threaded drive screw 40 (Figs. 2-4) which forces the fluid from ampule 21. The drive screw 40 is positioned coaxi- ally along the expelling axis A- by an internally threaded split nut 41 (Figs. 2 and 4) mounted on the base 39 of housing 30 so.that nut 41 is axially fixed along axis A^. Nut 41 can be "opened as seen by dashed lines in Fig. 2 to release the drive screw 40 so that it can be manually move axially along axis A- and nut 41 re-engaged as will become more apparent. With nut 41 closed to engage drive screw 40, rotation of drive screw 40 shifts drive screw 40 axi¬ ally along the expelling axis A- . The outboard end of drive screw 40 projecting outside of housing 30 is provi¬ ded with a pointed driving projection 42 (Figs. 2 and 9) which engages the piston in the ampule 21 as will become more apparent.

The drive screw 40 is driven through a slip joint 44 (Figs. 3, 4 and 7). The slip joint 44 is provided through a driven member 45 (Fig. 7) affixed to the inboard end of the drive screw 40. The drive screw 40 defines an axially extending passage 46 therein opening onto its inboard end with the passage 46 being closed by driven member 45. The driven member 45 defines a noncircular driven passage 48 therethrough which is shown as being hexagonal in shape. The driven passage 48 is centered on the expelling ^"axis A_p. A drive shaft 49 with a driving section 47 having a cross-sectional shape complementary to the driven passage 48 in driven member 45 slidably extends therethrough so that rotation of drive shaft 49 rotates the drive screw 40. The driving section 47 on drive shaft 49 projecting through the driven member 45 is freely received in the passage 46 in drive screw 40. The passage 46 extends along the length of drive screw 40 terminating just in¬ board of the projecting end of the drive screw 40 as seen in Fig. 9 so that clearance for the driving section 47 on drive shaft 49 is provided when drive screw 40 is fully retracted into housing 30.

The drive shaft 49 is rotatably journalled in bearings mounted in support plates 50 of the trans¬ mission 34 as seen in Fig. 6 so that the central axis of the drive shaft 49 is coaxial with the expelling axis AT_J. The journalled connections between the drive shaft 49 and the support plates 50 prevent axial movement of the drive shaft 49 along the expelling axis A_p while allowing the drive shaft 49 to be rotated about the ex¬ pelling axis Ag. Thus, it will be seen that, as the drive shaft 49 is rotated clockwise as seen in Fig. 3 with the nut 41 closed about the drive screw 40, the drive screw 40 will be rotated to axially displace the drive screw 40 along the expelling axis A_E and move the pointed driving projection 42 on the projecting end of the drive screw 40 out of the housing 30.

To retract the drive screw 40 back into the housing 30, the split nut 41 is opened as shown by dashed lines in Fig. 2 and the drive screw 40 manually pushed back into the housing 30 with the driving section 47 on the drive shaft 49 sliding through the driven member 45. After the drive screw 40 has been retracted back into the housing 30, the split nut 41 is reclosed to reengage the drive screw 40 so that it can be driven back out of the housing 30 by rotating the drive shaft 49.

The transmission 34 (Figs. 3-6) is powered by sole¬ noid 32 to rotate the drive shaft 49. The drive shaft 49 serves as the output of the transmission 34 with an output spur gear 51 fixedly mounted on the drive shaft 49 between the support plates 50 so that rotation of the output spur gear 51 rotates the drive shaft 49. The out¬ put spur gear 51 is rotatably driven by an input ratchet assembly 52 driven by the driving solenoid 32.

The input ratchet assembly 52 (Figs. 3 and 5) in- eludes a spur drive pinion 54 mounted on a pinion shaft 55"

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Λ, WWIIPPOO < -t^ rotatably journalled between the support plates 50. The pinion shaft 55 also mounts thereon a ratchet mechanism 56 which includes a driven ratchet member 58 defining ratchet teeth 59 thereon about a positioning boss 60. The driven ratchet member 58 is fixed to the pinion shaft 55 so that rotation of the driven ratchet member 58 also rotates the pinion shaft 55 and thus the spur drive pinion 54. Driving ratchet member 61 is rotatably mounted about the positioning boss 60 for both rotational movement about the boss 60 and axial movement along the boss 60. The driving ratchet member 61 includes ratchet teeth 62 there¬ on which are complementary to the ratchet teeth 59 on the driven ratchet member 58. The ratchet teeth 62 face the ratchet teeth 59 so that, when the driven ratchet member 61 is forced toward the ratchet teeth 59 on the driven ratchet member 58, the ratchet teeth 62 on the driving ratchet member 61 engage the ratchet teeth 59 on the dri¬ ven ratchet member 58 whereby rotation of driving ratchet member 61 counterclockwise as seen in Fig. 3 rotates the driven ratchet member 58 therewith thus rotating the spur drive pinion 54. When the driving ratchet member 61 is rotated clockwise as seen in Fig. 3, the ratchet teeth 62 can slip over the ratchet teeth 59 so that the driven ratchet member 58 can be held stationary while the driving ratchet member 61 rotates with respect thereto. A ratchet spring 64 is positioned around the positioning boss 60 on that side of the driving ratchet member 61 opposite the ra chet teeth 59 on driven ratchet member 58 so that the ratchet spring 64 constantly forces the driving ratchet member 61 toward the teeth 59 on the driven ratchet member 58 to maintain the ratchet teeth 59 and 60 in driving engagement with each other, yet the ratchet teeth 62 on the driving ratchet member 61 can ratchet over the rat¬ chet teeth 59 on the driven ratchet member 58 when the driving ratchet member 61 is moved clockwise as seen in Fig . 3 .

A ratchet clutch assembly 70 (Figs. 3 and 5) is pro¬ vided in the input ratchet assembly 52 to prevent the dri¬ ven ratchet member 58 from being rotated in a clockwise direction as seen^" in Fig. 3^". The" ratchet clutch assembly 70 includes a -ratchet wheel 71 affixed to the pinion shaft 55 and provided with peripheral ratchet teeth 72 which are engaged by a resilient stop member 74 best seen in Fig. 3. The ratchet teeth 72 on the ratchet wheel 71 are oriented with respect to the resilient stop member 74 so that the ratchet wheel 71 can rotate with the pinion shaft 55 in a counterclockwise direction as seen in Fig. 3; however, the resilient stop member 74 engages the rat¬ chet teeth 72 when an attempt is made to rotate the pinion shaft 55 in the clockwise direction to prevent the ratchet wheel 71 and thus the pinion shaft 55 from being rotated in a clockwise direction. This serves to prevent the dri¬ ven ratchet member 58 and thus the spur drive pinion 54 from being rotated in a clockwise direction as seen in Fig. 3. Because the stop member 74 is resilient, it will be deflected over the ratchet teeth 72 as the pinion shaft 55 and ratchet wheel 71 are rotated in the counterclockwise direction. The ratchet wheel 71 also serves to captivate the ratchet spring 64 between it and the driving ratchet member 61 so that the driving ratchet member 61 is forced toward the ratchet teeth 59 on the driven ratchet member 58. The ratchet wheel 71 is provided with locating flange 75 thereon which extends over the ratchet spring 64 to prevent inadvertent dislodgement of the ratchet spring 64. The transmission 34 is also provided with a manually operated flush mechanism 80 (Figs. 3^* 5 and 6) which drives the output spur gear 51 through the input ratchet assembly 52 to allow the drive screw 40 to be manually rotated for flushing the injector as will become more appa- rent. The manually operated flush mechanism 80 includes a driven spur pinion 81 affixed to the pinion shaft 55 adjacent the ratchet wheel 71 opposite the ratchet mecha¬ nism 56. The driven spur pinion 81 meshes with a manu¬ ally driven spur gear 82 journalled between one of the support plates 50 on the transmission 34 and a subplate 84 as best seen in Figs. 3 and 6. The shaft 85 carrying the spur gear 82 extends through the support plate 50 and is provided with a drive slot 86 in the projecting end thereof outside of the support plate 50 so that the drive slot 86 can be engaged .through an appropriate opening by a manually operated tool such as a screwdriver SD partly seen in Fig. 3 to rotate the shaft 85 and spur gear 82. This rotates the driven spur pinion 81 to drive the pinion shaft 55. It will also be noted that the ratchet clutch assembly 70 permits the pinion shaft 55 only to be rotated in the counterclockwise direction as seen in Fig. 3. Thus, the shaft 85 carrying the spur gear 82 can be rotated only in the clockwise direction to extend drive screw 40. Because of the gear ratio of the spur gear 82 with re- spect to the spur pinion 81, the drive screw 40 can be relatively rapidly extended to flush the injector 11 as will become more apparent.

Alternatively, a flush mechanism may be provided by extending the projecting end of the drive shaft 49 through that support plate 50 most remote from its driving sec¬ tion 47 and making a slot similar to slot 86 in shaft 85 in the projecting end of drive shaft 49 to be engaged similarly to shaft 85 to manually rotate shaft 49 clock¬ wise. This would eliminate the flush mechanism 80 while still providing a flushing capability_^. The input rat¬ chet assembly 52 and ratchet clutch assembly 70 would permit flushing in the same manner as explained for flush mechanism 80.

The driving ratchet member 61 is provided with a driving projectiong 90 (Figs. 3, 5 and 6) which is used

OMPI /,, WIPO .« ^'to rotate the driving ratchet member 61. The movement of the driving projection 90 rotating the driving rat¬ chet member 61 is limited by upper and lower stops 91 extending above and below the driving projection 90 between the support plates 50 as seen in Fig. 3. The driving projectiong 90 is constantly urged in a clock¬ wise direction toward the lower stop 91 as seen in Fig. 3 by a leaf spring 92 as will become more apparent.

The driving projection 90 is pivoted in counter- clockwise direction as seen in Fig. 3 by a drive arm 95 pivoted on the base 39 of housing 30 at 96. The drive arm 95 has a projecting end 98 which extends through a slot 99 in one of the support plates 50 to engage the driving projection 90 in opposition to the leaf spring 92. The drive arm 95 also has a driving projection 100 thereon which is engaged by a driving solenoid 32 to pivot the drive arm 95 clockwise as seen in Fig. 3 when the driving solenoid 32 is energized. This causes the projecting end 98 on the drive arm 95 to pivot the dri- ving projection 90 counterclockwise as seen in Fig. 3 to rotate the driving ratchet member 61 counterclockwise thereby driving the drive pinion 54 counterclockwise and the output gear 51 clockwise to rotate the drive screw 40 clockwise as seen in Fig. 3 and incrementally move the pointed driving projection 42 on the end of the drive screw 40 out of the housing 30. When the driving sole¬ noid 32 is de-energized, the leaf spring 92 pivots the driving projection 90 clockwise as seen in Fig. 3 while pivoting the drive arm 95 counterclockwise as seen in Fig. 3 to reset the drive for another advancement of the drive screw 40.

The driving solenoid 32 is mounted on the base 39 as best seen in Fig. 3 about an axis A~ . The solenoid 32 has an open ended tubular cylindrical case 110 which mounts an actuator coil 111 therein. A circular actuator plate 112 is pivoted to one end of the case 110 by a hinge spring member 114 so that the actuator plate 112 is mag¬ netically responsive to the actuator coil 11. The actuator plate 112 is seen in its deactivated or open position in Fig. 3. Activation of the actuator coil 111 pivots the actuator plate 112 toward the open end of the cylindrical case 110 to its activated or closed position. The movement of the actuator plate 112 is stopped by the end of case 110. The actuator plate 112 has an L-shaped driving projection 115 thereon with a driving section 116 coplanar with the actuator plate 112 and a check section 118 which extends along the side of the case 110 gene¬ rally parallel to the solenoid axis A_ς. The check sec¬ tion 118 is provided with a check slot 119 therein which is engaged by a check member 120 adjustably mounted on the case 110 by a locking screw 121. The check member 120 has a check projection 122 which extends through the check slot 119 in the driving projection 115 to limit the amount of movement of the driving projection 115 as the actuator plate 112 moves away from the open end of case 110 to its deactivated position. The actuator plate 112 is constantly urged toward its deactivated position by the resiliency of hinge spring member 114 as well as the leaf spring 92 in the transmission 34. Since the movement of the actuator plate 112 toward the open end of case 110 when coil 111 is energized is ar¬ rested by the end of case 110 and since the movement of the actuator plate 112 away from the open end of case 110 when coil 11 is de-energized is arrested by the check projection 122, the amount of movement of the driving section 116 on the driving projection 115 can thus b~e adjusted with the locking screw 121 holding the check member 120 on the case 110. Thus, the driving section 116 on the driving projec¬ tion 115 is moved the adjustable distance dg seen in Fig. 3 as the actuator plate 112 is moved from its deactuated position to its actuated position. The arcuate driving projection 100 on the drive arm 95 extends behind the driving section 116 on the driving projection 115 as seen in Fig. 3 so that the closure of actuator plate 112 when coil 110_. is energized serves to pivot the drive arm 95 clockwise as seen in Fig. 3. This in turn causes the projecting end 98 on the drive arm 95 to pivot the dri¬ ving projection 90 connected to the driving ratchet mem¬ ber 61 to rotate the drive- pinion 54 counterclockwise and the drive shaft 49 clockwise through output spur gear 51 to screw the drive screw 40 in the split nut 41 and move the pointed driving projection 42 out of the housing 30 as will become more apparent.

O PI /,, WIPO - It will also be appreciated that the input ratchet assembly and the ratchet clutch assembly may be used to connect the output spur gear 51 to the drive shaft 49 rather than connecting pinion shaft 55 to input drive pinion 54. This is illustrated in Figs. 14 and 15. Fig. 14 corresponds- generally to Fig. 6 and Fig. 15^* is taken along line 15-15 in Fig. 14 to show the connection be¬ tween the output spur gear 51 and drive shaft 49. The input ratchet assembly has been designated 52' and the check clutch assembly has been designated 70' in Figs. 14 and 15.

From Fig. 14, it will be seen that the driving pro¬ jection 90 is connected directly to the pinion shaft 55 and input drive pinion 54. The pivoting movement of pro- jection 90 is still limited by the stops 91, driven in a counterclockwise direction by the driving projection 98 on drive arm 95, and urged in a clockwise direction by the leaf spring 92 in the manner described above.

As seen in Fig. 15, however, the output spur gear 51 is rotatably journalled about the drive shaft 49 rather than being affixed thereto so that gear 51 is free to ro¬ tate about shaft 49. The input ratchet assembly 52' serves to connect gear 51 to drive shaft 49 so that rota¬ tion of gear 51 clockwise, when viewed in the same direc- tion as that seen in Fig. 3, will rotate shaft 49 but allows gear 51 to rotate in the opposite direction without rotating drive shaft 49 as will become more apparent.

Driving ratchet member 58' is affixed to the spur gear 51 so that it rotates therewith. An internally splined driven ratchet member 61' is mounted on the drive shaft 49 between support plates 50 vfa an externally splined connector 60' affixed to shaft 49. Connector 60' permits driven ratchet member 61' to slide axially along shaft 49 but rotation of driven ratchet member.-61' posi- tively rotates the drive shaft 49. The ends of ratchet

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WIP members 58' and 61' facing each other are respectively provided with meshing ratchet teeth 59' and .62'. Teeth 59' and 62' are constructed so that the driving ratchet teeth 59' rotate the driven ratchet member 61' and drive shaft 49 through driven ratchet teeth 62' when spur gear 51 is rotated -clockwise when viewed as in Fig. 3; how¬ ever, the driving teeth 59' can slip over teeth 62' when gear 51 is rotated counterclockwise so that drive shaft 49 will not be rotated counterclockwise. Ratchet spring 64' urges teeth 59' and 62' together to maintain them in mesh.

The ratchet clutch assembly 70' (Fig. 15) is provided in the input ratchet assembly 52' to prevent the drive rat¬ chet member 61' and thus drive shaft 49 from being rotated in a counterclockwise direction when viewed in Fig. 3.

The ratchet clutch assembly 70' includes ratchet wheel 71' affixed to the drive shaft 49 and is provided with peri¬ pheral ratchet teeth 72* which are engaged by a resilient stop member 74'. The ratchet teeth 72' on the ratchet wheel 71' are oriented with respect to the resilient stop member 74' so that the ratchet wheel 71' can rotate with the drive shaft 49 in a clockwise direction when viewed as in Fig. 3; however, the resilient stop member -74' engages the ratchet teeth 72' when an attempt is made to rotate the drive shaft 49 in the counterclockwise direc¬ tion to prevent the ratchet wheel 71' and thus the drive shaft 49 from being rotated in a counterclockwise direc¬ tion. Because the stop member 74' is resilient, it will be deflected over the ratchet teeth 72' as the drive shaft 49 and ratchet wheel 71' are rotated in the clock- wise direction. The ratchet wheel 71' also serves to captivate the ratchet spring 64 between it and the driven ratchet member 61' so that the driven ratchet member 61' is forced toward the ratchet teeth 59' on the driving ratchet member 58'. The ratchet wheel 71' may be

OMPI /,, IPO - ^{' • '■}• ^■' - 2 2 -

provided with locating flange 75' to prevent inadver¬ tent dislodgement of the ratchet spring 64'.

The flushing function is provided by flush mecha¬ nism 80' best seen in Fig. 15. The drive shaft 49 pro- jects through_. the support plate 50 opposite the driving section 47 on shaft 49 and is provided with a driving slot 86'. Engaging slot 86' with a tool such as the screwdriver mentioned -for use with slot 86 in flush mecha¬ nism 80 permits the drive shaft 49 to be directly rota- ted clockwise as viewed in Fig. 3. The driven ratchet member 61' can ratchet over ratchet member 59' so that gear 51 need not be rotated. The ratchet clutch mecha¬ nism 70' prevents rotation of shaft 49 counterclockwise.

OMPI The ampule holder 22 serves to locate the fluid ampule 21 coaxially about the expelling axis A- best seen in Figs. 2, 4 and 8 with the ampule 21 operatively associated with the pointed driving projection 42 on the drive screw 40 as will become more apparent. The ampule holder -22 has a tubular side wall 130 defining an ampule receiving chamber 131 therein closed at its outboard end by end wall 132 and open at its inboard end. The chamber 131 is sized so that the ampule 21 will just slidably fit in chamber 131 as will become more apparent. The holder 22 is removably attached to housing 30 by a bayonet type connector 135. Blades 136 of connector 135 are mounted on the side wall 130 of holder 22 adjacent its inboard end which cooperate with spaced apart locking pins 138 on the base 39 of housing 30 on diametrically opposite sides of the split nut 41 to lock the holder 22 on housing 30 with the holder coaxial with the expelling

The holder 22 also serves to maintain the split nut 41 closed about drive screw 40 as seen in Fig. 4 to in¬ sure positive threaded engagement between screw 40 and nut 41. The inside diameter of the side wall 130 is substan¬ tially equal to the outside diameter of nut 41 in its closed position so that, when the inboard end of side wall 130 is placed around nut 41, it is positively held closed and maintained in its closed position until the ampule holder 22 is removed.

The ampule 21 is illustrated in Figs. 2, 4, 8 and 9 and serves to carry the liquid medicament which is to be injected into the patient. Ampule 21 has a tubular side wall 140 with central passage 142 closed at its outboard end by a penetrable rubber plug 141 and open at its inboard end. The side wall 140 is of constant outside and inside diameter with an outside diameter such that it is just slidably received in chamber 131 in holder 22. The length L. of ampule 21 is such that ampule 21 just fits in chamber 131 between the annular arresting shoulder 139 (Fig. 8) in holder 22 adjacent its outboard end the split nut 41 when holder 22 is locked in position as seen in Fig. 4-.

The side wall 140 of ampule 21 has an inwardly di¬ rected lip 144 at its outboard end seen in Fig. 9 that engages an annular groove 145 around plug 141 to hold it in place. A resilient expelling piston 146 is sli¬ dably received in the central passage 142 through its open inboard end and in sealing engagement with side wall 140 to form a liquid chamber 148 between piston 146 and plug 141. The liquid medicament, usually in concen- trated form, fills the liquid chamber 148. When an opening is made in the rubber plug 141 as will become more apparent, the liquid medicament in the fluid chamber 148 can be expelled by moving the piston 146 toward the plug 141. Because the ampule side wall 140 is coaxial with the expelling axis A_p when positioned by the holder 22, the piston 146 will also be positioned for movement coaxially along the axis A_£. This aligns the piston 146 with the drive screw 40 as will become more apparent. As best seen in Fig. 9, the expelling piston 146 defines a driving cavity 150 therein facing the driving projection 42 on the projecting end of the drive screw 40. The piston 146 has annular sealing rings 151 there- around to form a sliding seal with the ampule side wall 140. The driving cavity 150 opens onto the inboard end of piston 146 with its outboard end closed by a conical, forwardly tapering driven surface 152 whose apex is cen¬ tered on the expelling axis A_p. The surface 152 tapers uniformly about the axis A_p so that the driving projec¬ tion 42 on the drive screw 40 is aligned with the apex of surface 152.

OMPI A conical driving plate 154 is carried in the dri¬ ving cavity 150 to transfer the motion of screw 40 to piston 146. The conical driving plate 154 has a conical, forwardly tapering .driving surface 155 complementary to the driven surface 152 in cavity 150 on its outboard side so that the plate 154 bears against the driven surface 152. The conical driving plate 154 also has a like conical, forwardly tapering transfer surface 156 on its inboard side facing the driving projection 42. The transfer sur- face 156 is aligned with the driving surface 155 so that the apex 158 of the transfer surface 156 is in alignment with the pointed driving projection 42 on drive screw 40. Thus, the pointed projection on drive screw 40 bears against the apex 158 of transfer surface 156 to drive piston 146. The driving surface 155 on driving plate 154 insures that the piston 146 will be smoothly moved along ampule 21 without canting to expel the liquid in the cham¬ ber 148.

The driving plate 154 is maintained in cavity 150 in piston 146 by an inwardly directed annular resilient lip 159 as best seen in Fig. 9. Because the lip 159 and piston 146 are resilient, the driving plate 154 can be forced into cavity 150 past -the lip. After the driving plate 154 is forced into cavity 150, the lip 159 reassumes the shape shown in Fig. 9 to keep plate 154 in place.

The volume of liquid medicament carried by ampule 21 is, of course, determined by the internal diameter of the side wall 140 as well as the length L. of the ampule. The size is usually selected so that some convenient volume of liquid medicament is carried in the liquid chamber 48. The side wall 140 of the ampule 21 is usually graduated to indicate the volume therein and is illustrated as con¬ taining about 5cc of liquid medicament. Usually, the am¬ pule 21 is designed to carry that volume of liquid which is to be dispensed over a 24-hour period. Because

O ?I different treatments require widely different volumes, it would be desirable and within the scope of the in¬ vention that different volumes of liquid medicament be carried in the ampule 21, depending on the particular treatment requirements.

The exposed surface of the penetrable rubber plug 141 enclosing the end of the ampule may be covered by a tear-off cover member 160 as seen in Fig. 9 to insure the sterility of this surface. Because the liquid cham- ber 148 is completely enclosed by the rubber plug 141, the ampule side wall 140 and the piston 146, the steri¬ lity of the liquid medicament carried in the ampule is maintained prior to its being used.

The outlet through the penetrable rubber plug 141 in the end of the ampule 21 is provided by a piercing cap assembly 165 best seen in Figs. 2 and 8 mounted in the outboard end of the ampule holder 22. The piercing cap assembly 165 is attached to a boss. 166 on the out¬ board side of the end wall 132 on holder 22 so that the piercing cap assembly 165 is oriented coaxially with respect to the expelling axis A- . The piercing cap assembly 165 includes an externally threaded mount 168 that can be screwed into the internal threads provided in the hole through the boss 166. The externally threaded mount 168 has a piercing needle 169 extending therethrough with a pointed end 170 projecting from the mount 168 into the outboard end of the ampule receiving chamber 131 along the expelling axis A_p. The pointed end 170 of needle 169 extends sufficiently far into the ampule receiving chamber 131 to insure that the pointed end 170 pierces the penetrable rubber plug 141 in the outboard end of the ampule 21 when the ampule 21 is pushed into place. A penetrable needle cover 171 may be provi¬ ded over the pointed end 170 of needle 169 so that, when the penetrable rubber plug 141 in the outboard end of the

OMPI /,. WIPO a pule 21 is forced toward the pointed end of the pier¬ cing needle 169, the penetrable needle cover 171 will be penetrated by the pointed end 170 of the piercing needle 169 prior to the pointed end 170 piercing the penetrable rubber plug 141 in the ampule 21. This is best illus¬ trated in Fig.- 8.

An appropriate connector 172 connects the delivery tubing 174 in connector assembly 14 to the passage 175 through the piercing needle 169. Passage 175 serves as the outlet from the liquid chamber 148 of the ampule 21. Thus, it will be seen that,, as the piston 146 is forced toward the penetrable rubber plug 141, the liquid medica¬ ment in the ampule 21 will be forced out through the passage 175 in the piercing needle 169 and into the deli- very tubing 174.

The delivery tubing 174 may be connected directly to the patient or may be connected to the patient via con¬ nector assembly as seen in Fig. 1. The connector assem¬ bly 14 as seen in Fig. 1 includes a manifold block 180 illustrated in more detail in Figs. 10 and 11. The mani¬ fold block 180 may be permanently or removably attached to the carrier 12. Block 180 has a common delivery tube 181 therefrom to which is connected a common intravenous injection needle assembly 182 or subcutaneous injection needle assembly 610 for connection to the patient. Both types of needles 182 and 610 are illustrated in Fig. 1.

The common delivery tube 181 is in communication with a common delivery chamber 184 in block 180 through a quick disconnect 185 seen in Figs. 10 and 1^*1. The male coupling 186 on the delivery tubing 174 from the injector 11 is connected to a continuous injection transfer chamber 188 through a check valve 189. Chamber 188 is connected to the common delivery chamber 184 so that the fluid flows through

OMPI

/,. W WIIPPOO Λ the transfer chamber 188 into delivery chamber 184 and then into the patient via tube 181.

A second transfer chamber 190 may be provided in manifold block 180 to afford an additional connection point. Chamber 190 also communicates with the common delivery chamber 184 like chamber 188. The inlet to the second transfer chamber 190 is also equipped with a check valve 191 to permit liquid to only enter chamber 190 for discharge out the delivery chamber 184. Chara- ber 190 allows a second injector of the type shown herein or of other types to be used simultaneously with injector 11. A porous plug type metering assembly PPM from an alternate injector system is shown in Fig. 10 by way of illustration. It is also frequently desirable to provide short injections of medication to the patient with needle de¬ vices such as the hypodermic syringe HS partly^' seen in Fig. 11. To accommodate these injections, the manifold block 180 is provided with cross chambers 194 best seen in Fig. 11. The cross chambers 194 intersect one of the transfer chambers 188 or 190 and each are provided with a penetrable plug 195 such as rubber so that the needle HN on the syringe HS can be inserted through plug ,195 into one of the cross chambers 194. The syringe HS can then be used to inject unmetered fluid into the patient via the common delivery tube 181. Because the block 180 is made of a strong material, the needle HN will not pene¬ trate same to prevent injection from the hypodermic syringe and also isolates the needle HS from the delivery tube 181.

The carrier 12 is designed for convenient attachment to the patient's body. It is illustrated in Fig. 1 for attachment to the patient's arm. The carrier 12 includes a wide elastic band 196 which comfortably fits over the patient's arm without significantly affecting the patient's

- TJREΛ

O PI /,, WIPO . blood circulation. A support pouch 198 is mounted there¬ on which defines a continuous injector pocket therein to receive the injector 11 therein. The continuous pocket is closed by a flap 199 with an appropriate mechanism to hold the flap closed. A cutout 200 is provided in pouch 198 to allow the holder 22 on injector 11 to pass therethrough. The manifold block 180 is illustrated as attached to band 196.

- REAtT OMPI The controller 36 serves to alternatively connect and disconnect the battery 35 to solenoid 32 at a rate such that the desired average fluid injection rate is maintained. The controller 36 is schematically illustra- ted in Fig. 12. Basically, the controller 36 includes a timing pulse^" generator 210 whose pulse output operates a switching network 211 to cause the switching network 211 to alternatively connect the solenoid 32 to and dis¬ connect solenoid 32 from battery 35. The pulse output rate from the timing pulse generator 210 can be manually adjusted through the pulse time control 212. The pulse timer control 212 is illustrated in Figs. 2 and 3 as three manually adjustable potentiometers although . diffe¬ rent timer control arrangements may be used. The pulse generator output is schematically illus¬ trated in Fig. 13. While the output is illustrated as a square wave, it is not intended to be limiting since a variety of wave shapes may be used that functionally operate the switching network 211 in the manner described. Basically, the output from generator 210 has a duty cy¬ cle where the output goes to state A with time interval t-_j and then to state B with time interval t- during each duty cycle. State A causes the switching network 211 to connect the battery 35 to solenoid 32 to activate it and state B causes the switching network 211 to disconnect battery 35 from solenoid 32 to deactivate it. The phy¬ sical characteristics of solenoid 32 are such that it takes a prescribed maximum time interval t as seen in Fig. 13 after output from generator 210 goes to state A for the actuator plate 112 on solenoid 32 to move to its activated or closed position. Thus, the time interval t, that the output from generator 210 remains in state A is selected to be slightly longer than the maximum solenoid actuation time interval to insure full operation of actuator plate 112, On the other hand, since continued activation of solenoid 32 has no further effect on the movement of plate 112 after it reaches its activated or closed position, the time interval t, is selected to be as short as possible to conserve the energy of battery 35 and thus extend battery life. Since the solenoid 32 injects a fixed amount of liquid medicament each time it is activated and since the pulse generator output goes to state A once each duty cycle, varying the time period t--. (Fig. 13) of each duty cycle changes the injection rate. Because of the fixed actuation time ts of solenoid

32, the time interval t, can be maintained constant re¬ gardless of the pulse rate of the output generator 210. Thus, since about the same fixed amount of liquid medi¬ cament is expelled from ampule 21 each time solenoid 32 is activated, the overall injection rate can be controlled by varying the time interval t~. This is done by adjusting the pulse timer control 212.

Fig. 13 graphically illustrates two pulse rates, a faster rate shown by solid lines and a slower rate shown by dashed lines. The time interval t, is the same for both rates while time interval t« is varied. This, of course, varies the duty cycle time period --._c.

An indicator mechanism 213 such as lamp L seen in Figs. 1 and 2 or an audible sound generator may be used to provide an indication that the injector is operating. The indicator mechanism may be activated when the output from generator 210 is in state A or state B. Since state A is usually shorter than state B, however, it would usually be activated in response to state A to extend battery life.

By appropriately selecting the components of con¬ troller 36, the gear ratios of the various mechanical components of power unit 20 and the size of ampule 21, the setting of the pulse time control 212 can be made to correspond to the injection rate delivered. For instance, with the three potentiometers illustrated in the control 212, the setting could correspond to the injection rate to two decimal places. As an example, the setting illus¬ trated in Fig. 3 would correspond to an injection rate of 1.95 cc per 24-hour period. This facilitates adjust¬ ment of injection rate.

It will be appreciated that the overall gear ratio of transmission 34 and the drive screw assembly 31 will be determined by the size of the ampule 21, the stroke of the projecting end 98 of the drive arm 95 when sole¬ noid 32 is energized, and the desired incremental volume of liquid medicament to be injected each time the sole¬ noid 32 is energized. Simply for ease of monitoring, one set of parameters used was one energized time each minute for solenoid 32 when an injection rate of about 1 cc per 24-hour period was selected. Under these requirements and with the construction illustrated in Figs. 1-9, an overall gear ratio of about 229:1 was satisfactory where the drive screw 40 has 32 threads per inch. Thus, each time solenoid 32 is energized, about 0.0007 cc of liquid medicament is dispensed.

Any conventional battery 35 may be used provided it has a sufficient voltage output to power controller 36 and solenoid 32. The particular battery 35 illustrated is a 9 volt transistor type alkaline battery.

To protect against the controller 36 overdosing the patient through failure of one or more of the components, the battery 35 may be connected to the switching network 211 through a disabling monitor network 214 shown by phantom lines in Fig. 12. The disabling monitor network 214 is provided with a feedback circuit from the timing pulse generator 210 and the output of the pulse generator 210 so that malfunction of the timing pulse generator 210 causes the feedback circuit to activate the disabling monitor network 214 to cause the disabling monitor network

-^ORE OMPI ^P 214 to disconnect the battery 35 from the switching network 211 and thus disable the solenoid 32. A motion sensor may be operatively associated with the mechani¬ cal output of the solenoid 32 to provide another input to the disabling monitor network 214 so that, if the timing pulse generator 210 generates a signal in its output which should cause the switching network 211 to activate the solenoid 32 and no motion is sensed in the mechanical output of the solenoid 32, the disabling moni- tor network 214 disconnects the battery 35 from the switching network 211 to disable the solenoid 32. Thus, the disabling monitor network 214 serves to disable the solenoid 32 upon malfunction of the timing pulse gene¬ rator or the failure to obtain a mechanical output from the solenoid 32 when such output should be present.

SECOND EMBODIMENT A second embodiment of the power unit which has been designated by the numeral 220 is seen in Figs. 16 and 17. The power unit 220 is used in the same manner as power unit 20 for mounting the ampule 21 in the am¬ pule holder 22- to inject fluid from the ampule into the patient via the connector assembly 14. Attention is invited to the disclosure of these components herein- above and will not be redescribed. Those components of. the power unit 220 which are common with the power unit 20 have the same reference numerals applied thereto. From Fig. 16, it will be seen that the power unit 220 includes housing 230 which removably mounts the ampule holder 22 thereon about the expelling axis A_E as with the first embodiment of the power unit. The housing 230 mounts drive screw assembly 31 therein about the expel¬ ling axis A- to expel fluid from the ampule 21 carried in holder 22. The drive screw assembly 31 is driven by a drive motor 232 through transmission 234 and battery 35 is provided to power motor 232 through a controller 236.

The housing 230 has base 39 common with power unit 20 which mounts the various components thereon. A re¬ moval cover 238 is adapted to fit over base 39 to enclose components mounted on the base and has a construction the same as the cover 38 for the power unit 20 except that the cutout for the controller 236 is slightly larger in the cover 238. Like housing 30 for power unit 20, locating pins 37 maintain cover 238 in alignment with base 39, and latch pin 33 keeps cover 238 in place.

The drive screw assembly 31 includes the externally threaded drive screw 40 the same as with power unit 20 which is maintained coaxially along the expelling axis A_E by the internally threaded split nut 41 (not seen in Fig. 14), the same as with the power unit 20. Thus, the drive screw 40 is axially moved along the expelling axis A- simply by rotating the drive screw 40 with respect to the split nut 41.

The drive screw assembly 231 also is driven through slip joint 44 with drive shaft 249 having a driving sec¬ tion 47 thereon the same as with the drive shaft 49 in the power unit 20. The drive shaft 249 is rotatably jour¬ nalled in bearings mounted in the support plates 250 of transmission 234 as best seen in Fig. 16 so that the drive shaft 249 is maintained coaxial with the expelling axis

A_p. Similarly to drive shaft 49 of the power unit 20, the journal connections between the drive shaft 249 and sup¬ port plates 250 prevent axial movement of the drive shaft 249 on the expelling axis Ap while allowing the drive shaft 249 to be rotated about that axis. The drive screw 40 is retracted in the same manner as the drive screw 40 in the power unit 20.

The transmission 234 is powered by the motor 232 to rotate the drive shaft 249 as will become apparent. The drive shaft 249 serves as the output of the transmission 234 with the output spur gear 51 fixedly mounted on the drive shaft 249 between the support plates 250 so that ro¬ tation of the output spur gear 51 rotates drive shaft..2-49 similarly to that described with the first embodiment of the power unit. The output spur gear 51 is rotatably driven by an input pinion 254 mounted on an input shaft 255 journalled between the support plates 250 of the trans¬ mission 234. The input shaft 255 is driven by the motor 232 as will become more apparent so that rotation of the input shaft 255 by motor 232 rotates the output spur gear 51 and thus the drive screw 40 to extend it.

The transmission 234 is provided with a manually ope¬ rated flush mechanism 280 as seen in Figs. 16 and 17 which allows the drive shaft 249 to be manually rotated for flushing the injector as will become more apparent.

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OMPI _ /,, IPO . It will be seen that the drive shaft 249^"rotatably ex¬ tends through the support plate 250 opposite the drive screw 40 and is provided with a drive slot 286 in the projected end thereof outside the outboard support plate 5 250 so that the drive slot 286 can be engaged through an appropriate opening in the cover 238 by a manually ope¬ rated tool such as a screw driver illustrated in Fig. 3 so that the drive shaft 249 can be manually rotated. This allows drive shaft 249 and thus drive screw 40 to be 0 manually rotated for flushing. It will also be noted that the flush mechanism 280 can be substituted for the flush mechanism 80 in power unit 20.

To insure that the drive motor 232 must rotate the output spur gear 51 in a clockwise direction to always 5 extend the drive screw 40, the ratchet clutch assembly 270 seen in Fig. 17 is provided on the drive shaft 249 between the support plates 250. The ratchet clutch assembly 270 includes a ratchet wheel 271 affixed to the c drive shaft 249 and is provided with peripheral ratchet 0 teeth 272 which are engaged by a resilient stop member 274. The ratchet teeth 272 on the ratchet wheel 271 are oriented with respect to the resilient stop member 274 so that the ratchet wheel 271 can rotate with the drive shaft in a clockwise direction as seen in Fig. 16; 5 however, the resilient stop member 274 engages the rat¬ chet teeth 272 when an attempt is made to rotate the drive shaft 249 in the counterclockwise direction to pre¬ vent the ratchet wheel 271 and thus the drive shaft 249 from being rotated in a counterclockwise direction. Be- 0 cause the stop member 274 is resilient, it can be deflec¬ ted over the ratchet teeth 272 as the drive shaft 249 and ratchet wheel 271 are rotated in a clockwise direc¬ tion. Thus, the drive shaft 249 can only be rotated in the clockwise direction both by the drive motor 232 and 5 when it is being manually rotated through the slot 286 when flushing.

-^ORE ^-

OMPI /., WIPO ,

^ Rϊim The drive motor 232 is mounted on the base 39 as best seen in Fig. 16 coaxially about the axis A of the input shaft 255 to transmission 234. The output shaft 260 of the motor 232 is connected directly to the input shaft 255 of transmission 234 so that rotation of output shaft 260 counterclockwise as seen in Fig. 16 rotates the output spur gear 51 clockwise thus rotating the drive screw 40 in the desired clockwise direction as seen in Fig. 16. Preferably, the motor 232 is a stepping motor which rotates its output shaft 260 through a prescribed angular displacement A _M as seen in Fig. 16 each time the motor 232 is activated. Thus, by selecting the appro¬ priate gear ratio between output spur gear 51 and the drive pinion 254, the amount of extension of drive screw 40 each time the drive motor 232 is stepped can be se¬ lected. The stepping motor 232 will only step through the angle A_nM each time it is activated regardless of the length of time it remains activated. Therefore, if the controller 236 fails while keeping motor 232 activated, it will only step one increment to prevent overinjection. The controller 236 serves to alternatively connect and disconnect the battery 35 to drive motor 232 so that the liquid medicament from ampule 21 -is injected into the patient at the desired rate. The controller 236 is sche- atically illustrated in Fig. 18. The controller 236 is selectively programmable to deliver the desired injection rate via manually operated input switch network 300. The switch network 300 includes a rate increase control switch 301 operated by rate increase input button 302, a rate decrease control switch 304 operated by rate decrease in¬ put button 305, and a mode selector switch 306 operated by actuator 308. Switches 301 and 302 respectively con¬ trol outputs Oττ and 0_D to an encoding network 310 while switch 306 allowiT'the controller 236 to be programmed while in a program mode and operate the motor 232 while in an operating mode as will become more apparent. Buttons 302 and 305 as well as actuator 308 can also be seen in Fig. 16.

The encoding network 310 generates an encoding out- put Op selectively adjustable through outputs Oτ_j and 0_D from switches -301 and 304 which is representative of the volume of liquid medicament to be dispensed over a se¬ lected time period as will become more apparent. The output O_p is connected to one of the inputs of mode se- lector switch 306 and also to the input of a dosage rate logic network 311.

The dosage rate logic network 311 calculates the pulse rate required to dispense the selected volume of liquid medicament represented by output O_p in equal incre- ments over the manually selected time period through manual adjustment of selector actuator 312 on time period selector 314. Actuator 312 is seen in Fig. 16 also. After calculating the required pulse rate, the regulating output 0_R from logic network 311 adjusts the timing pulse output 0_Tp of the timing pulse generator 315. Output 0_Tp controls switching network 316 to connect and disconnect the motor 232 to battery 35. Because controller 236 is equally applicable to the other embodiments of the power unit, the motor is illustrated as an electro-mechanical driving device. The operation of the timing pulse gene¬ rator 315 and switching network 316 may correspond to that already described for generator 210 and switching network 211.

The mode selector switch 306 has a first position which allows the controller 236 to be programmed and a second position which allows the injection rate to be monitored. In the first position, the switch 306 connects the output O_p from the encoding network 310 to a liquid crystal display 318 so that the amount of liquid medica- ent to be dispensed is visually indicated by the liquid crystal readout 319. In the first position, selector switch 306 also -enables the rate increase and decrease control switches 301 and 304 while disabling the timing pulse generator 315 to prevent injection during program- ing. The personnel programming the injection rate ope¬ rates switches- 301 and 304 to establish the desired amount of liquid medicament to be injected. Depressing input button 302 on rate increase switch 301 operates encoding network 310 to increase the displayed output O_p in the liquid crystal readout 319, while depressing input button 305 on the rate decrease switch 304 operates en¬ coding network 310 to decrease the displayed output Op in the liquid crystal readout 319.

Preferably, the encoding network 310 is constructed so that, the longer the button 302 or 305 is depressed, the faster the displayed output O_p is increased or de¬ creased as the case may be. This allows the personnel to rapidly run encoding network 310 until the displayed output O_p reaches the vicinity of the desired amount to be injected, release the button 302 or 305, and then press the appropriate button 302 or 305 to finally adjust the displayed output O_p.

After the desired amount of liquid medicament is dis¬ played in readout 319, the mode selector switch 306 is transferred to the operation mode via actuator 308. The particular mode of switch 306 may be indicated by indi¬ cator lights 313 seen in Fig. 16. The actuator 312 on . time period selector 314 has usually already been set at the desired time period over which the amount of liquid medicament is to be injected. The time periods available may be appropriately changed. However, since the injec-^' tion rates are usually based on increments of a twenty-four hour period, it will probably be convenient to have a twenty-four hour period and several other shorter periods. When the mode selector switch 306 is in the operation

- EACΓ

O PI mode, the control switches 301 and 304 are disabled to prevent changing output O_p from encoding network 310 to the dosage rate logic network 311. The dosage rate logic network 311, based on the output 0_E and the set- ting of the time period selector 314, calculates the pulse rate requirements to inject the liquid medicament into the patient and then adjusts its regulating output O_n to the timing pulse generator 315 to cause the timing pulse generator 315 to generate the appropriate timing pulse output O_τp to switching network 316 to operate motor 232 at the required stepping rate to inject the liquid medicament at the desired rate.

To provide a visual indication of the actual injec¬ tion rate, a monitor network 320 is connected to the output 0_Tp from the pulse generator 315 and generates a monitored output 0 to the liquid crystal display 318 via mode selector switch 306 when it is in the operation mode. The monitor network 320 may also be connected to the time period selector 314 so that the monitored rate is adjusted for different time periods.

To protect against the controller 236 overdosing the patient, the battery 35 is connected to the switching network 316 through a disabling monitor network 321. The disabling monitor network 321 is provided with a feedback circuit from the timing pulse generator 315 and the out¬ put Orp of generator 315 so that, malfunction of the ti¬ ming pulse generator 315 causes the feedback circuit to activate the disabling monitor network 321 to cause the disabling monitor network 321 to disconnect the battery 35 from the switching network 316 and thus disable the motor 232. A motion sensor 322 is operatively associated with the mechanical output of the electro-mechanical dri¬ ving device to provide another input to the disabling monitor network 321 so that, if the timing pulse gene- rator 315 generates a signal in its output 0~-

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OMPI

^Lwι* which should cause the switching network 316 to activate the electro-mechanical driving device and no motion is sensed in the mechanical output of the electro-mechanical driving device by the motion sensor 22, the disabling monitor net-work 321 disconnects-the battery 35 from the switching network 316 to disable the electro-mechanical driving device. Thus, the disabling monitor network 321 serves to disable the electro-mechanical driving device upon malfunction of the timing pulse generator or the failure to obtain a mechanical output from the electro¬ mechanical driving device when such output should be present. An alarm device 324 may be provided to the dis¬ abling monitor network 321 to provide an alarm that the system is malfunctioning to warn the patient and/or the personnel who is monitoring the injection of the liquid medicament into the patient.

It will be seen that the output 0_Tp from the timing pulse generator 315 and the operation of the switching circuit 316 may be the same as that described for the first embodiment of the invention. That is, the electro¬ mechanical driving device may be activated for a fixed period of time and deactivated for a variable period of time to change the injection rate. Thus, one duty cy¬ cle of the timing pulse generator consists of the fixed "on" time plus the variable "off" time. On the other hand, the duty cycle of the timing pulse generator may be changed so that it has a multiple pulse duty cycle. This type of output is illustrated in Fig. 19 and has been identified as output 0_Tp' . Curve (a) in Fig. 19 illustrates one injection rate for the electro-mechanical driving device while Curve (b) illustrates a greater injection rate.

Output 0_Tp' has an "on" pulse burst PB followed by an "off" time OT. The pulse burst PB has one or more "on" pulse P_N with short "off" pulses p therebetween so that the electro-mechanical driving device can cycle.^" Curve (a) illustrates output 0_τp' with two "on" pulses P„ and one "off" pulse P_p in pulse burst PB. Thus, it will be seen that the electro-mechanical driving device will be operated two times during the pulse burst PB and then deactivated during the "off" time OT. The injection rate, then, is determined by the duty cycle time t of the output 0_Tp' which is the pulse burst time period t plus" the "off" period time t_p. Curve (b) illustrates output 0_Tp' with three "on" pulses P„ and two "off" pulses Pp in pulse burst PB. Thus, it will be seen that the electro-mechanical driving device will be operated three times during the pulse burst PB and then deactivated during the "off" time OT. The injection rate,

2 then, is determined by the duty cycle time t^ of the output 0_Tp which is the pulse burst time period t plus the "off" period time t_p and the injection rate for Curve (b) is greater than that for Curve (a) . One simply in¬ creases the injection rate by increasing the number of "on" and "off" pulses P_N and P_p in pulse burst PB. The off time period t_p between the pulse burst PB from the timing pulse generator 315 can remain fixed. For in¬ stance, where stepping motor 232 is used, the stepping motor 232 would step only two times between each "off" time OT in the output 0_τp' shown in Curve (a) while the stepping motor 232 would step three times between each "off" time OT in the output 0_Tp' shown in Curve (b) in Fig. 19.

While the liquid crystal readout 319 on the liquid crystal display 318 may be changed as is appropriate, the liquid crystal readout 319 is arranged to indicate the volume of liquid medicament to be injected over the se¬ lected time period to two decimal places with the deci¬ mal point 325 being shown in Figs. 16 and 18 on the li- quid crystal readout 319. The liquid crystal readout

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O PI WIPO

^RUll 319 as shown in Figs. 16 and 18 has four integers so that up to 99.99 cc of medicament can be programmed for -dis¬ pensing into the patient.

O PI As seen in Figs. 20 and 21, it will be seen that a conventional electric motor 232' may be substituted for the stepping motor 232 shown in Figs. 16 and 17. To insure that the conventional motor 232' can only drive the output spur gear 51 a set amount, the input shaft 255 connected to the driving motor 232' may be provided with a mechanical stop projection 256' seen in Fig. 20 which extends between upper and lower stops 258' carried on support plates 250 so that the stop projection 256' can only rotate with input shaft 255 back and forth between the upper and lower stops 258'. A return spring 259' is connected between the input shaft 255 and the support plates 250 so that the input shaft 255 is constantly urged in a clockwise direction in Fig. 20. Thus, when motor 232' is not activated, the return spring 259' urges the input shaft 255 and the mechanical stop projection 256' until the stop projection 256' engages the lower stop 258' between the support plates 250. When the motor 232' is energized, it drives the input shaft 255 and the me- chanical stop projection 256' in the counterclockwise direction in Fig. 20 until the stop projection 256' engages the upper stop 258' to prevent further rotation of the input shaft 255. When the drive motor 232' is de-energized, the return spring 259' rotates the input shaft 255 back to its initial position with the stop projection 256' engaging the lower stop 258'.

As best seen in Fig. 21, input ratchet assembly 52' already described is used on drive shaft 249 together with ratchet clutch assembly 270 so that the output spur gear 51 drives shaft 249 when it is rotated clockwise but can rotate back counterclockwise"with input drive pinion 254 without rotating drive shaft 249. The input ratchet assembly 52' function is already described and will not be repeated here. The function of the ratchet assembly 270' has already been described and will not be repeated here. It will thus be seen that the return spring 259' rotates both the input drive pinion 254 and the output spur gear 51 back with the input shaft 255 so that the drive motor 232' always starts from the same rotational position and is able^•to-rotate the input shaft and thus the output spur gear 51 only for a prescribed angular displacement in order that only a known fixed amount of the liquid medicament will be injected each time the drive motor 232' is energized. Alternatively, it will also be appreicated that the conventional type drive motor 232' without the projection 256', assembly 70' and ratchet assembly 52' may be used where the amount of rotation of the drive motor 232' can be accurately controlled such as with a brake (not shown) so that, each time the controller 236 is activated, the drive motor 232' will rotate through a known angle or rotation. If such a drive motor is used, it will be appreciated that the controller 236 may be adjusted so that the pulse burst PB may be a single "on" pulse P-^ whose time period t_v is varied.

FIRST ALTERNATE INJECTOR An alternate injector which has been designated by the numeral 411 is seen in Fig. 22. The injector 41 may be mounted in the carrier 12 and connected to the connec- tor assembly 14 for injection of liquid medicament into the patient. -The injector 411 includes an expelling unit 420 and an ampule 421 which is connected to the expelling unit 420 to expel the liquid medicament carried in the ampule 421 into the patient via the connector assembly 14 (not shown in Fig. 22) . The expelling unit 420 includes an expelling piston assembly 431 which is driven by a battery 435 through a.controller 436. The battery 435 is the same as the battery described hereinbefore and the controller 436 corresponds to the controllers described hereinabove.

The expelling piston assembly 431 includes a housing

440 which defines an elongate cylindrical piston chamber

441 therein about an expelling axis A_p. The piston cham¬ ber 441 has a length L_p as will become more apparent. The piston chamber 441 slidably mounts a magnetically responsive piston 442 therein for sliding movement back and forth along the expelling axis A_E within the piston chamber 441. It will also be noted that the magnetically responsive piston 442 is in s^tealing engagement with the piston chamber 441 and has a length L_p which is slightly less than one-half the length L_pf, of the piston chamber 441 as will become more apparent. Thus, it will be seen that the magnetically responsive piston 442 can be sli¬ dably moved from one end of the piston chamber 441 to the other. An inlet port 444 is provided through the housing 440 into the piston chamber 441 and is centered along the length of the piston chamber 441. The length L_p of the piston 442 is selected so that, when the piston 442 is in either of the opposite ends of piston chamber 441, the in- let port is in communication with that end of the piston chamber 441 in which the piston 442 is not located. Thus, it will be seen that when the piston 442 is in the end of the piston chamber 441, fluid can be introduced into the opposite end of the piston chamber 441 via the "inlet port 444. A pair of solenoid coils 44^~5 are wound around the housing 440 at opposite ends of the piston chamber 441 so that when either of the solenoid coils 445 is energized, a magnetic force will be generated which urges the magnetically responsive piston 442 toward that end of the piston chamber 441 around which the solenoid coil 445 extends. Thus, it will be seen that the piston 442 can be moved to one end of the piston chamber 441 by energizing one of the solenoid coils 445 while the piston 442 can be moved to the other end of the piston chamber 441 by energizing the other solenoid coil 445.

Each of the opposite ends of the piston chamber 441 communicates with a discharge port 446 so that, as the piston 442 moves toward each end of the piston chamber 441, any liquid between the moving piston 442 and the dis- charge port 446 associated with the opposite end of the piston chamber 441 will be discharged through the discharge port 446. A check valve 448 is associated with each of the discharge ports 446 so that the check valves 448 -per¬ mit liquid to flow only from the piston chamber 441 out through the discharge port 446 associated therewith and not in the reverse direction. It will also be noted that the check valves 448 require sufficient pressure to open them that liquid flowing into the piston chamber 441 through the inlet port 444 will not leak out through the discharge port 446 in communication therewith until the piston 442 is forced toward the discharge port 446 to expel the liquid. The discharge ports 446 from opposite ends of the piston chamber 441 are connected to a common outlet port 449 which is'connected to the connector as- sembly 14 (not shown) so that the liquid discharged out of the discharge ports 446 by the piston 442 will be injected into the patient.

To insure that the piston 442 is held in the ends of the piston chamber 441, permanent magnets 450 may be provided in the housing 440 at opposite ends of the piston chamber 441 so that, once the solenoid coil 445 has moved the piston into the end of the piston chamber 441, the permanent magnet 450 at that end of the piston chamber 441 keeps the piston 442 in that end of the piston chamber. 441 until the solenoid coil 445 asso¬ ciated with the other end of the piston chamber 441 is energized to drive the piston 442 back toward the other end of the piston chamber 441.

It will also be seen that an inlet check valve 451 may be provided in the inlet port 444 to prevent fluid from being forced from within the piston chamber 441 out through inlet port 444. While the piston 442 is moving from one end of the chamber 441 to the other, it will be seen that the piston 442 covers the inlet port 444 so that liquid will not flow into the piston chamber 441. The ampule 421 is different than the ampule 21 in that the ampule 421 is flexible so it can be prefilled with a known volume of liquid medicament to be injected into the patient. The movement of the piston 442 in the piston chamber 441 creates a partial vacuum behind the piston 442 so that, when the piston 442 uncovers the inlet port 444, liquid medicament from the ampule 421 having its outlet connected to the inlet port 444 can flow into the piston chamber 441 to be expelled when the piston 442 moves back toward that end of the piston cham¬ ber 441. It would likewise be noted that a permanent container may be provided in lieu of the ampule 441 which can be filled before the injector 411 is used.

The controller 436, as already explained, would be about the same as the controllers described hereinbefore

OMPI WIPO except that the switching network associated with the controller would alternatively connect the "on" pulse output from the timing pulse generator to one of the solenoid coils 445 and then the other of the solenoid coils 445 to o-scillate the piston 442 back and forth within the piston chamber 441. Like the other embodi¬ ments of the invention, it will be seen that the move¬ ment of the piston 442 in either direction within the piston chamber 441 can only inject a prescribed volume of fluid so that prevention of overdosage to the patient is insured.

SECOND ALTERNATE INJECTOR An alternate injector which has been designated by the numeral 511 is seen in Fig. 23. The injector 511 may be mounted in the carrier 12 and connected to the connector assembly 14 for injection of liquid medicament into the patient. The injector 511 includes an expelling unit 520 and an ampule 521 which is connected to the ex¬ pelling unit 520 to expel the liquid medicament carried in the ampule 521 into the patient via the connector assembly 14 (not shown in Fig. 23). The expelling unit 520 includes an expelling piston assembly 531 which is driven by a battery 535 through a controller 536. The battery 535 is the same as the battery described herein¬ before and the controller 536 corresponds to the control- lers described hereinabove.

The expelling piston assembly 531 includes a housing 540 which defines a cylindrical piston chamber 541 there¬ in about an expelling axis A_p. The piston chamber 541 slidably mounts an expelling piston 542 therein for sli- ding movement back and forth along the expelling axis

Ap within the piston chamber 541. Thus, it will be seen that the piston 542 can be slidably moved from its re¬ tracted position seen in Fig. 23 toward and away from the discharge end 552 of the piston chamber 541. An in- let port 544 is provided through the housing 540 into the piston chamber 541 between piston 542 and discharge end 552 of chamber 541 so that, when piston 542 is in its retracted position, the chamber 541 between piston 542 and discharge end 552 can be filled with liquid medicament via port 544.

The discharge end 552 of the pis^*ton chamber 541 communicates with a discharge port 546 so that, as the piston 542 moves toward the discharge end 552 of the piston chamber 541, liquid between the moving piston 542 and the discharge port 546 will be discharged through the discharge port 546. A check valve 548 is associated with discharge port 546 to permit liquid to flow only from the piston chamber 541 out through the discharge port 546 and not in the reverse direction. It will also be noted that the check valve 548 requires sufficient pressure to open it that liquid flowing into the piston chamber 541 through the inlet port 544 will not leak out through the discharge port 546 until piston 542 is forced toward the discharge port 546 to expel the li- quid. The discharge port 546 is connected to the con¬ nector assembly 14 (not shown) so that the liquid dis¬ charged out of the discharge port 546 by the piston 542 will be injected into the patient.

It will also be seen that an inlet check valve 551 may be provided in the inlet port 544 to prevent fluid from being forced from within the piston chamber 541 out through inlet port 544. While the piston 542 is moving toward and returning from the discharge end 552 of cham¬ ber 541, it will be seen that the piston 542 covers the inlet port 544 so that liquid will not flow into the piston chamber 541.

Ampule 521 is illustrated as the same as ampule 421 although different configurations can be used. The"-τe- turn movement of the piston 542 in the piston chamber 541 from discharge end 552 to its retracted position creates a partial vacuum between piston 542 and discharge end 552 so that, when the piston 542 uncovers the inlet port 544 in its retracted position, liquid medicament from the ampule 521 having its outlet connected to the inlet port 544 can flow into the piston chamber 541 to be expelled when the piston 442 moves back toward the discharge end 552 of the piston chamber 541.

To drive piston 542 back and forth within piston chamber 541, a driving member 554 such as quartz or the like exhibiting a piezoelectric effect is anchored to housing 540 and connected to piston 542 through an appropriate linkage 555. Because member 554 exhibits a piezoelectric effect, a voltage imposed thereon from controller 536 causes a change of volume of member 554. This change of volume is transmitted to piston 542 via linkage 555 to cause piston 542 to be moved toward the discharge end of chamber 541 to expel the liquid. When the voltage is removed, member 554 moves piston 542 back to its retracted position for chamber 541 to refill from ampule 421. Like the other embodiments of the invention, it will be seen that the movement of the piston 542 toward discharge end 552 can only inject a prescribed volume of fluid so that prevention of overdosage to the patient is insured.

Figs. 24-33 disclose injection needle assemblies designed to inject fluids into the subcutaneous fat layer of a patient by injecting the fluid to a known depth below the patient's skin to eliminate the trial and error technique required by the prior art. Figs. 24-26 illustrate a first embodiment of the subcutaneous needle injection assembly of the invention designated 610; Figs. 27-31 illustrate a second embodimentdesignated 710; and Figs. 32 and 33 illustrate a third embodiment designated 810.

As seen in Figs. 24-26, the subcutaneous needle injection assembly 610 includes generally an injection needle 611 and a locator pad 612. The needle 611 de¬ fines a fluid passage 615 therethrough from its inlet end 616 to its sharpened outlet end 618. The sharpened outlet end 618 punctures the patient's skin to allow the needle 611 to be inserted into the subcutaneous fat layer as will become more apparent. The injection needle 611 has a right angle bend 619 in it to form a locating sec- tion 620 about axis AT _ς adjacent the inlet end and a penetrating section 621 about axis A_p adjacent the shar¬ pened outlet end 618 with the penetrating section 621 oriented about normal to the locating section 62O. The inlet end 616 of needle 611 is connected to an appro- priate fluid supply source FSS schematically seen in Fig. 26 such as an injection device via tubing T.

The locator pad 612 may have a variety of configura¬ tions and is illustrated as having a generally recti¬ linear base 625 defining a generally flat locating sur- face 626 on the underside thereof. The pad 612 is usu¬ ally made of a resilient material such as plastic so that it will be comfortable to wear. The locating surface 626 will be in juxtaposition with the patient's skin when in¬ stalled as illustrated in Fig. 26. An integral needle mount 628 is formed on the top of base 625 to hold needle 611 in place .

Needle 611 is positioned on pad 612 so that the lo¬ cating section 620 extends through mount 628 with its axis A_τ generally parallel to the locating surface 626. The penetrating section 621 extends through base 625 so that it projects outwardly from surface 626 generally normal thereto. The base 625, then, keeps the penetrating section 621 on needle 611 normal to the surface 626. The length of the penetrating section 621 on needle 611 is selected so that the sharpened outlet end 618 projects from surface 626 a prescribed distance d 3. seen in Fig. 26.

The distance d is selected to be slightly less than the distance d„_N the subcutaneous fat layer/muscle interface is located below the skin surface at the likely encoun- tered minimum thickness of the subcutaneous fat layer in the patient. While this minimum thickness may vary be¬ tween different parts of the patient's body, this mini¬ mum thickness is about the same between corresponding parts of different patients' bodies. Thus, different dis- tances d may be provided for subcutaneous injection into different parts of the body but would normally not have to be different for different patients even though the thick¬ ness of the patients' subcutaneous^' fat layers may vary widely above this minimum thickness. This insures that the point of fluid injection will always be located sufficiently far from the puncture in the skin to iso¬ late the point of injection from any skin surface irrita¬ tion while, at the same time, preventing injection of the fluid into the muscle tissue of the patient. As seen in Fig. 25, a separable needle cover 630 may be provided to fit over the projecting penetrating section 621 of needle 611 to keep it sterile prior to use. The cover 630 would, of course, be removed prior to use. To reduce the likelihood of infection and irritation of the point where the skin is punctured, an antimicrobal substance M such as Betadine Jelly may be provided around the penetrating section 621 of needle 611 as seen in Figs.

25 and 26. Preferably, the antimicrobal substance M is in a preformed annulus 632 around the penetrating section 621 of needle 611 at its juncture with the locating surface 626 on pad 612- as seen in Fig. 25 so that the substance M is always in place for use and seals the puncture P in the skin around the needle 611. An enlarged section 631 may be formed in the needle cover 630 as seen in Fig. 25 to accommodate the preformed antimicrobal substance M. Once the penetrating section 621 of needle 611 is exposed, the assembly 610 is installed by simply pressing it into place keeping the locating surface 626 generally . parallel to the skin surface. After the assembly 610 has been pressed in place, a piece of tape 634 seen in Fig.

26 is usually applied to keep the assembly 610 in place. This insures that the penetrating section 621 of needle 611 is normal to the skin surface while minimizing the relative movement between the skin and needle 611 at punc- ture P to reduce irritation.

As seen in Figs. 27-31, the subcutaneous needle in¬ jection assembly 710 includes generally an injection needle 711 and a locator pad 712. The needle 711 is like needle 611 with inlet end 716 and sharpened outlet end 718. The injection needle 711 has a right angle bend in it to form the locating section adjacent the inlet end and the penetrating section 721 adjacent the sharpened outlet end 718 with the penetrating section 721 oriented about normal to the locating section. The inlet end 716 of needle 711 is connected to an appropriate fluid sup¬ ply source via tubing T. "

The locator pad 712 has a base 725 with a needle mount 728 to hold needle 711 in place. Unlike pad 612, however,-*the base 725 on pa"d 712 can be folded down around the penetrating section 721 on needle 711 to cover it. When unfolded, as seen in Figs. 30 arid 31, the base 725 corresponds in shape to base 625 and defines the flat locating surface 726 about the penetrating sec¬ tion 721 of needle 711. The base 725 is hinged gene- 5 rally along lines 735 on opposite sides of the needle mount 728 as s-een in Fig. 28 so that the base 725 has an effective fold axis A in registration under the axis of the locating section of the needle 711. While different hinging constructions may be used, the con-

10 struction illustrated has grooves 736 formed in the top side of the base 725. Because base 725 is made of a resilient material such as plastic, this forms a living hinge section 738 along the bottom of each of the grooves 736 as best seen in Fig. 29 so that the out-

15 board sections 739 on base 725 on opposite sides of the fold axis A_p can be folded down over the penetrating end 721 of needle 711 as seen in Fig. 29. The outer edges of sections 739 are in juxtaposition so as to seal the penetrating end 721 of needle 711 therebetween as

20 seen in Figs. 28 and 29 to keep it sterile prior to use. Tabs 740 may be provided on sections 739 to facilitate unfolding them prior to use.

The microbal substance M is prepackaged around the penetrating end 721 of needle 711 as seen in Fig. 29.

25 When the sections 739 are unfolded as seen -in Fig. 31, the substance M is exposed for use as already explained. Appropriate packaging 741 (Fig. 27) may be provided to maintain the sections 739 folded. The packaging 741 is stripped away prior to use.using grip strips 742 also

-30 seen in Fig. 27.

The installation of the injection assembly 710 after it is unfolded is the same as that discussed for assembly 610. Thus, the depth of injection is positively con¬ trolled.

35 As seen in Figs. 32 and 33, the subcutaneous needle injection assembly 810 also includes generally an injec¬ tion needle 811 and a locator pad 812. Additionally, a penetration adjustment mechanism 814 is provided to control the amount of exposure of needle 811 as will be- come more apparent. The needle 811, like needle 611, defines a fluid passage therethrough from its inlet end 816 to its sharpened outlet end 818. The injection needle 811 also has a right angle bend 819 in it to form locating section 820 adjacent the inlet end and penetra- ting section 821 adjacent the sharpened outlet end 818 with the penetrating section 821 oriented about normal to the locating section 820. The inlet end 816 of needle 811 is also connected to an appropriate fluid supply source via tubing T. The locator pad 812 corresponds generally to pad 612 with a generally rectilinear base 825 defining a gene¬ rally flat locating surface 826 on the underside thereof which will be in juxtaposition with the patient's skin when installed. An integral needle mount 828 is formed on the top of base 825 to hold needle 811 in place; however, needle mount 828 is short as compared with mount 628 and engages the locating section 820 of needle 811 adjacent its inlet end 816. Tjtiis g.l.lρws„$h.e bend 819 and penetra¬ ting section 821 of needle 811 to be raised or lowered with respect to the locating surface 826 on pad 812. The hole 850 in pad 812 through which penetrating section 821 passes keeps section 821 normal to surface 826.

The penetration adjustment mechanism 814 engages the locating section 820 of needle 811 adjacent bend 819 to positively control the distance d the sharpened outlet end 818 projects from surface 826. Mechanism 814 includes a stepped adjustment member 851 which slides on the top of base 825. The steps on member 851 may be grooved as seen at 852 to keep the member 851 in-place. Each groove 852 is located at a different height from the top of base 825 so that the penetration distance d can be changed by shifting the needle 811 to different grooves 852 in member 851. Guides 854 may be provided to keep member 851 in place axially of section 820 on needle 811.

This allows the injection assembly 810 to be adjusted for use at different body positions. After adjustment is completed, the injection assembly 810 would be installed like injection assembly 610.

^■ U EAl

OMPI

/,, WIFO

Claims

- b 9 -CLAIMS

1. A method of injecting fluid into a patient at an average prescribed injection rate over a prolonged pe¬ riod of time from a chamber carrying the fluid with an

5 outlet connecting the fluid to the patient and with a piston in the. chamber movable toward the outlet to force the fluid into the patient CHARACTERIZED BY the steps of: connecting the piston to a driving means con-

10. structed and arranged to move the piston only a pre¬ scribed distance toward the outlet each time the dri¬ ving means is operated regardless of the length of time the driving means is operated to force a known volume of the fluid into the patient each time the piston is moved

15 the prescribed distance at an injection rate greater than the desired average prescribed rate where the known volume of fluid is much less than the total volume of fluid to be injected over the prolonged period of time; and

20 alternately operating and stopping the opera¬ tion of the driving means to cause the fluid to be in¬ jected at the average prescribed rate over the sume of the times the driving means is -operated and not operated so that, in the event of a malfunction which continu-

25 ously operates the driving means, the piston will be moved only the prescribed distance toward the outlet to prevent overdosing the patient.

2. The method of Claim 1 where the step of alter¬ nately operating and stopping the operation of the driving means is further CHARACTERIZED BY the substeps of: ^~

5 alternately operating the driving means for a first prescribed short period of time of fixed duration much less than the prolonged-period of time;

- EXCΓ

OMPI /., WIPO ^ . alternatively stopping the operation of the driving means for a second prescribed short period of time less than the prolonged period of time so that the fluid is injected into the patient at the desired ave¬ rage prescribed rate over the sum of the first and se¬ cond prescribed short periods of time; and selectively varying the duration of only the second prescribed short period of time without varying the duration of the first prescribed short period of time to selectively vary the selected prescribed ave¬ rage rate at which the fluid is injected into the pa¬ tient.

3. The method of Claim 1 wherein the driving means includes an electro-mechanical device which is elec¬ trically operated to produce a mechanical output, and check means for limiting the mechanical output of the electro-mechanical device, and wherein the step of con¬ necting the piston to the driving means is further CHARACTERIZED BY the stubsteps of: connecting the mechanical output of the electro-mechanical device to the piston to move the piston; causing the check means to limit the mecha¬ nical output of the electro-mechanical device to a prescribed amount each time the electo-mechanical de¬ vice is operated regardless of the length of time the electro-mechanical device is operated so that the piston is moved only the prescribed distance toward the outlet each time the electro-mechanical device is operated; and resetting the check means"each time the opera- tion of the electro-mechanical device is stopped to permit the electro-mechanical device to again move the piston the prescribed distance toward the outlet the next time the electro-mechanical device is operated.

4. Apparatus for carrying out the method of Claim 1 CHARACTERIZED BY: a container defining a fluid chamber therein carrying the fluid to be dispensed and an outlet from said fluid chamber connected to the patient; a piston slidably mounted in said fluid cham¬ ber for forcing fluid from said outlet as said piston is moved toward said outlet; an electrical power supply; electrically operated driving means for moving said piston toward said outlet when said electrically operated driving means is connected to said power sup¬ ply, said electrically operated driving means constructed and arranged to move said piston only a prescribed dis- tance toward said outlet each time said electrical power supply is connected to said electrically operated dri¬ ving means regardless of the length of time said elec¬ trical power supply is connected to said electrically operated driving means, said piston forcing a volume of the fluid from said outlet much less than the total vo¬ lume of fluid to be injected over the prolonged period of time each time said piston is moved said prescribed distance; and control means for selectively connecting said electrical power supply to and disconnecting said elec¬ trical power supply from said electrically operated driving means at a rate such that fluid is injected into the patient at the desired average rate over the prolonged period of time so that, if said control means fails so as to continuously connect said electrical power to said electrically operated'driving means, said piston will be moved only said incremental prescribed distance toward said outlet to prevent overdosing the patient.

5. The apparatus of Claim 4 further CHARACTER¬ IZED BY said electrically operated driving means being a solenoid.

6. The apparatus of Claim 4 further CHARACTER¬ IZED BY said electrically operated driving means being a stepping motor.

7. The apparatus of Claim 4 further CHARACTER¬ IZED BY said electrically operated driving means in¬ cluding resettable stop means for physically limiting the amount of movement transmitted from said electri- cally operated driving means to said piston each time said electrically operated driving means is connected to said electrical power supply, said resettable stop means resetting itself while said electrically ope¬ rated driving means is disconnected from said power supply to permit further movement to be transmitted to said piston when said electrically operated driving means is reconnected to said power supply.

8. The apparatus of Claim 4 further CHARAC¬ TERIZED BY manually operated flushing means opera¬ tively connected to said piston for selectively moving said piston independently of said electrically operated driving means.

9. The apparatus of Claim 5 further CHARACTER¬ IZED BY said driving means including ratchet means operatively connecting said solenoid to said piston so that the reciprocating motion output of said solenoid moves said piston in a first direction toward said outlet.

10. The apparatus of Claim 9 further CHARACTER¬ IZED BY said driving means including" clutch means operatively connected to said piston for permitting said solenoid to move said piston only in said first direction.

11. The apparatus of Claim 10 further CHARACTER¬ IZED BY said driving means including: a first threaded member carried by said hou¬ sing; a second threaded member threadedly engaging said first threaded member so that relative rotation between said threaded members causes said second threaded member to be axially moved to selectively engage and move said piston is said first direction toward the fluid outlet to force the fluid out of the fluid outlet in said container into the patient, said ratchet means ope¬ ratively connecting said solenoid to said second threaded member to effect relative rotation between said first and second threaded member.

12. The appratus of Claim 11 wherein said driving means is further CHARACTERIZED BY: a drive member mounted in said housing co- axially with said second threaded member, said drive member axially fixed with respect to said first threaded member and rotatable about its axis; and a slip joint interconnecting that end of said second threaded member opposite said piston with said drive member so that said second threaded member is axially movable with respect to said drive member while remaining rotationally fixed with respect to said drive member whereby rotation of said drive member rotates said second threaded member, said ratchet means opera¬ tively connecting said solenoid to said drive member to rotate said drive member.

13. The apparatus of Claim 4 wherein said control means is further CHARACTERIZED BY: switching means for selectively connecting said electrical, power supply to said electrically ope- rated driving means; timing pulse generator means for operating said switching means; and programming means for selectively control¬ ling the timing pulse rate output of said timing pulse generator.

14. The -apparatus of Claim 13 wherein said con¬ trol means is further CHARACTERIZED BY mode selector means for selectively activating said programming means to permit adjustment said programming means to change the timing pulse rate output of said timing pulse gene¬ rator means and for selectively causing said timing pulse generator means to generate the timing pulse rate output selected by said programming means while pre¬ venting adjustment of said programming means.

15. The apparatus of Claim 13 wherein said control means is further CHARACTERIZED BY: display means for providing a visual output; and monitoring means operatively connecting said timing pulse generator means to said display means to cause said visual output of said display means to be indicative of the average prescribed injection rate.

16. The apparatus of Claim 13 wherein said control means is further CHARACTERIZED BY disabling means ope¬ ratively connected to said timing pulse generator means and said switching means to cause said switching means to disconnect said driving means from said electrical power supply upon malfunction of said timing pulse gene¬ rator means.

17. A method of injecting a fluid into a patient at an average prescribed rate over a prolonged period of time CHARACTERIZED BY the steps of: alternatively injecting the fluid into the pa- tient at a first prescribed rate greater than the de¬ sired average prescribed rate for a first prescribed short period of time of fixed duration much less than the prolonged period of time; alternatively stopping the injection of the fluid into the patient for a second prescribed short period of time less- than the prolonged period of time so that the fluid is injected into the patient at the desired average prescribed rate over the sum of the first and second prescribed short periods of time; and selectively varying the duration of only the second prescribed short period of time without varying the duration of the first prescribed short period of time to selectively vary the selected prescribed average rate at which the .fluid is injected into the patient.

18. Apparatus for carrying out the method of Claim 17 CHARACTERIZED BY: container means defining a fluid chamber therein for containing the fluid to be dispensed and defining a fluid outlet therefrom through which the fluid is to be dispensed into the patient; expelling means operatively associated with the fluid in said container means to expel the liquid from said container means, said expelling means including a piston member slidably mounted in said fluid chamber for positively forcing the fluid from said -fluid outlet as said piston member moves toward said fluid outlet, said piston member moved toward said fluid outlet when said expelling means is driven; electrically operated driving means for se¬ lectively driving said expelling means to force said piston member toward said fluid outlet; an electrical power supply^*; and control means for selectively and successively connecting said electrically operated driving means to said electrical power supply to cause said piston member to successively and incrementally force the fluid from

-STO EXCΓ

OMPI A, WIPO v, said fluid outlet in said container means into the pa¬ tient at a selected prescribed average rate over a pro- longed period of time, said control means alternatively connecting said driving means to said electrical power supply for a first prescribed short period of time of fixed duration so that said driving means causes said expelling means to force fluid from said fluid outlet in said container means at a first prescribed rate greater than the selected prescribed average rate and said control means alternatively disconnecting said driving means from said electrical power supply for a second prescribed short period of time to stop the fluid flow from said fluid outlet so that the fluid is forced from said fluid outlet in said container at the selec¬ ted prescribed average rate over the sum of said first and second periods of time, said control means including adjustment means for selectively varying the duration of only said second presc^'irbed short period of time without varying the duration of said first prescribed period of time to selectively vary the selected pre¬ scribed average rate at which the fluid is forced from said fluid outlet of said container into the patient.

19. The apparatus of Claim 18 further CHARACTER¬ IZED BY connection means connecting said fluid outlet on said container means to the patient so that the fluid is injected into the patient at the average pre- scribed rate over the sum of said first and second short periods of time during the prolonged period of time.

20. The apparatus of Claim 19 further CHARACTER¬ IZED BY indicator means for providing a human recep¬ tive indication of each occurrence of said first pre¬ scribed short time period during which said driving means is connected to said power supply.

"fcϋ EA

O PI

/to WIPO

21. The apparatus of Claim 18 wherein said con¬ tainer means is further CHARACTERIZED BY an.ampule assembly comprising a seamless tubular side wall defi¬ ning a passage therethrough opening onto opposite ends of said side wall, and a penetrable member closing one end of said passage at one end of said side wall, said piston member slidably received in said passage from that end of said tubular side wall opposite said pene¬ trable member and in sealing engagement with said tubu- lar side wall, said tubular side wall, said piston member and said penetrable member defining the closed fluid chamber filled with the fluid; and said container means -further including a piercing assembly defining said fluid outlet therethrough for selectively penetra- ting said penetrable member to place said fluid out¬ let in communication with the fluid in the fluid cham¬ ber so that, as said piston member is forced toward said penetrable member, the fluid will be expelled through said fluid outlet.

22. The apparatus of Claim 21 wherein said pier¬ cing assembly is further CHARACTERIZED BY a piercing member defining said fluid outlet therethrough and having a sharpened piercing point thereon for penetra- ting said penetrable member on said ampule assembly; and a cover assembly for enhancing the sterility of said piercing member, said cover assembly comprising a pene¬ trable cover member capable of being penetrated by the piercing point on said piercing member, positioning means for selectively positioning said penetrable cover member in alignment with the piercing point of said piercing member so that said penetrable cover member is movable axially of said piercing member from a non-use position in which the piercing point of said piercing member is enclosed by said positioning means and said penetrable cover member to a use position in which the piercing point of said piercing member is exposed by penetrating the penetrable cover member, and urging means for urging said penetrable cover member toward its non-use position.

23. A method of subcutaneously injecting fluids from a fluid supply source into the subcutaneous fat layer of a patient using an injection needle with a sharpened end thereon and a locating surface CHARAC- TERIZED BY the steps of: positively locating the injection needle with respect to a locating surface so that the sharpened end of the needle projects from the locating surface a prescribed distance slightly less than the minimum dis- tance between the skin surface and the interface between the subcutaneous fat layer and the muscle tissue in the patient likely to be encountered at the position where subcutaneous injection is to take place, and so that the sharpened end of the needle is oriented generally normal to the locating surface;

ins.-rting the sharpened end of the needle into the patient at that position where subcutaneous injec¬ tion is to take place until the locating surface is in juxtaposition with the skin surface while maintaining the positive location to insure that the sharpened end of the needle is located within the subcutaneous fat layer; and attaching the needle and locating surface to the patient to keep them in place.

24. Apparatus for carrying out the method of Claim 23 CHARACTERIZED BY: an injection needle defining a fluid passage therethrough, said injection needle having an inlet end connectible to the fluid supply source and a sharp¬ ened outlet end adapted to puncture the patient's skin and subcutaneous fat layer;

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/to i^po locator means mounting said needle thereon, said locating means defining a locating surface thereon adapted to lie against the patient's skin and said sharpened end of said needle projecting from said locating surface generally normal thereto so that said sharpened end is located a prescribed distance from said surface to positively control the depth of pene- tration of said sharpened end of said needle into the subcutaneous fat layer of the patient when said loca¬ ting surface is in juxtaposition with the patient's skin.

25. The apparatus of Claim 24 wherein said in¬ jection needle is further CHARACTERIZED BY a locating section thereon adjacent said inlet end, and a pene¬ trating section thereon adjacent said sharpened outlet end integral with said locating section and oriented generally normal to said locating section, said loca¬ ting section mounted on said locator means so that said locating section is generally parallel to said locating surface and so that said penetrating section projects from said locating surface generally normal thereto.

26. The apparatus of Claim 25 further CHARACTER¬ IZED BY penetration adjustment means for selectively changing said prescribed distance that said sharpened end of said needle projects from said locating surface.

27. The apparatus of Claim 25 further CHARAC¬ TERIZED BY an antimicrobal substance around said needle penetrating section of said needle so that said anti¬ microbal substance is placed in operative cooperation with the puncture in the patient's skin made by said needle.

28. The apparatus of Claim 25 further CHARACTER¬ IZED BY said locator means constructed and arranged so that said locator means is foldable about a fold axis generally coaxial with said locating section of said needle whereby those portions of said locator means on opposite sides of said fold axis can be folded over said penetrating section of said needle to cover same and alternately unfolded from around said penetrating section of said needle to expose same for use.

OMP