JPH05507007A - Disposable infusion device with peristaltic pump - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] References to applications related to disposable infusion devices with helical pumps This application was filed on May 4, 1990 for "Programmable Injection System" ( PROGRAM MABLE INFUS I ON SYSTEM)J No. 071,518,987.

Technical field This invention relates to medical devices and, more particularly, to administering intravenous drugs to a patient at a controlled rate. Related to improved disposable infusion devices and spiral pumps for delivery.

Background technology Giving a patient a pharmaceutically active solution intravenously at a controlled rate over an extended period of time is often necessary. This is preferably done while the patient is ambulatory. Delicious.

The prior art does not deliver the drops by gravity through an IV tube or other controller. It includes a device that uses a bag filled with a liquid drug to be dispensed. It is important for the patient Walking with a force-delivered infusion device is difficult and flow control is very limited. ing.

Another prior art injection device includes a liquid container mounted in an elongated cylindrical housing. It includes an elastic sac forming a sac, a flow control valve, and a tube for supplying fluid to the patient.

The elastic wall of the sac expands along the cylindrical/X-uzing wall when filled with fluid. and apply pressure to release the liquid. The sac is typically fitted with a syringe by hand. , which often requires excessive force. Another drawback is that when the sac is full, I ＼Using is forced to expand into an unnaturally elongated shape along the wall. child As a result of the unnatural shape of the sac, the pressure in the sac varies widely depending on the amount of fluid within it.

Therefore, in most cases this type of elastomeric injection device is It will not have stable pressure and flow rate. Most of these devices have a capacity and have a flow rate that decreases with pressure that decreases together or it is relaxed It has a flow rate that remains roughly constant until the end. complex and expensive flow control valves and Attempts have been made to control pressure and flow with devices. Other approaches have used exotic and expensive elastic materials to control pressure and flow.

Other types of infusion devices include electrically driven spiral or other positive displacement pumps. I am using it. Four different modes: continuous, intermittent, PCA (patient controlled) Fluid delivery rate parameters in TPN (total parenteral nutrition) and TPN (analgesic) modes. Programmable infusion pumps with meter-accurate cutting capabilities are provided. There is. These programmable infusion pumps were originally designed for large, ambulatory patients. It was not suitable for These require complicated and expensive replacement points to maintain sterility. A pump cartridge was used. More recently, disposable A small programmable infusion pump with a plastic force cartridge It is available. However, such cartridges are bulky and high-quality. This requires excessive drive power within the pump, which can quickly drain the battery. connected.

Therefore, improvements are needed to deliver intravenous drugs at controlled rates to ambulatory patients. It would be desirable to provide a disposable infusion device and pump.

Disclosure of invention Therefore, the primary objective of this invention is to administer intravenous drugs at controlled rates to ambulatory patients. An object of the present invention is to provide an improved disposable infusion device and pump for delivery.

According to this invention, the disposable infusion device is connected to an IV tube via a coupling. including the proximal, distal and intermediate portions of. The middle part is screwed during one reciprocating pump operation. having a length sufficient to operatively engage a pump member of a dynamic pump.

The middle section also has a maximum of 75 durometers on the Shore A scale. Pump part For each reciprocating motion, the material has multiple frames installed side by side in substantially parallel relationship. Including fingers. A cam driven by a motor has a middle part arranged on a line that is When squeezed by the tube, the intravenous fluid in the tube is pumped through it. Thus, each of the fingers is individually reciprocated in a predetermined, timed sequence. messenger The disposal device is further connected to the opposite end of the intermediate section and connects the intermediate section to the pump section. and a door that is releasably loadable when operatively engaged with the material.

Brief description of the drawing These and other objects and advantages of the present invention when read in conjunction with the accompanying drawings: It will become clearer from the detailed description that follows.

Figure 1 shows the programming in which the preferred embodiment of our disposable device is loaded. Possible injection systems are shown in phantom. Disposable items are the same as traditional IV tube parts. Connected to the IV bag, spike connector and leur attachment. It is shown. The IV tube part is designed to make this finger more compact. It has been cut at various positions.

Figure 2 shows a programmable infusion system with a disposable device installed therein. Figure 2 is an enlarged partial view of the pump, showing its relationship to our preferred embodiment of a spiral pump. There is.

FIG. 3 is yet another enlarged view of the screw pump and the disposable door. IV tube Parts are not shown in this drawing.

FIG. 4 is an enlarged view of the three tube sections forming part of the disposable article.

Figure 5 shows how one of the fingers of a spiral pump connects to the middle tube section of a disposable. It is an enlarged side view showing how to push and close.

FIG. 6 is a side view of one of the cam wheels of the spiral pump. cam wheel movement is shown in phantom.

Figures 7-9 detail the disposable door, tube clamp and IV tube coupling. It shows.

Best mode for making inventions Referring to FIG. 1, a programmable infusion system 10 is shown in our disposable infusion device. The pump is shown adapted for use with a stationary and screw pump. It is small and portable. It includes a rectangular case 12 that is portable. As an example, this case is injection molded approximately 3.5 inches long and approximately finch long. 1 inch wide (on the right side of Figure 1) and approximately 1 inch thick (on the right side of Figure 1). .

The preferred embodiment of our disposable IV tubing device 14 (FIG. 2) has a long releasably loaded or seated in receptacle 16 (FIG. 2) on the lateral edge. It's okay.

The proximal end disposable IV tube device 14 is connected to a conventional spike 20 (FIG. 1). There is. The patient administers the spike to a conventional package of intravenous fluids in which the desired drug substance is dissolved. Insert it into the tag 22. The distal end of the disposable IV tubing device 14 has a conventional male luer. - (leur) fitting 26, which connects to a conventional IV catheter (not shown) is connected to. Disposable IV fluid delivery is a requirement in infusion systems. Yes, because it ensures sterility. It is also a new IV When drug administration begins, the amount of drug remaining from one dose of IV drug is transferred in the opposite direction. prevent it from being carried away.

Referring to FIG. 2, a preferred embodiment of our helical pump 30 has a beam septacle 16. It is installed in the case 12 adjacent to the. The pump member 32 of the pump is not used. Engages the in-line intermediate portion 34 of the disposable IV tubing device 14.

Pump member 32 has nine members that slide back and forth relative to and from intermediate IV tubing section 34. Contains 32g of separate fingers.

Finger 32a is moved by a corresponding cam wheel 36 (FIG. 6). flexible A sexual boot 33 (FIG. 2) surrounds the finger and connects the finger and the intermediate portion 3 of the IV tube. 4. An interface is formed between the two. The peripheral edge of this boot is inside the case. Sealed into the wall to protect the pump from dirt. Each cam wheel 36 (FIG. 5) has a It has a slotted mounting hole 37 that is offset from the center of the wheel. There is.

Each finger 32a consists of a rectangular block with an annular hole in which the finger One of the corresponding wheels 36 rotates. The hole rotates inside the hole and the wheel rotates inside the hole. slightly larger than the outside diameter of the wheel so that the fingers are pulled forward and backward by It has a large diameter. The movement of one cam wheel is represented by a phantom line in Figure 6. ing.

Cam wheel 36 individually moves each finger 32a in a predetermined, timed sequence. Mounted on grooved shaft 38 in forward offset alignment for backward movement. I get kicked.

Portion 34 located in line with the IV tubing allows intravenous fluids within the tubing to be pumped through it. It is forwardly squeezed by fingers 32a so as to be fed by the pump.

Intermediate IV tubing section 34 is preferably formed of vinyl or silicone; It has a maximum durometer of 75 as measured on the Shirawa A scale. This type of high By using a flexible tube section that is highly flexible, not stiff, and resilient, the screw The individual fingers 32a of the pump 30 engage the tube portion during one cycle of each cam wheel thereof. It is possible to squeeze out a minute and close completely. This squeezing is shown in Figure 6 . This ensures a correct positive displacement of the pump, where the groove is A predetermined amount of liquid is delivered to the disposable IV tubing device 1 by one rotation of the shaft 38. It will be sent through 4. Such a non-rigid disposable IV tube device 1 4 also allows the grooved shaft 38 to take less torque to rotate. to ensure that the spiral pump is as described below. Reduces overall energy consumption when powered electrically by battery power This results in

Finger 32a preferably has a small teet 32b projecting from its end (Fig. 6). These teats engage the intermediate IV tubing section 34 and squeeze it. do. These teats are completely squeezed by tube section 34 during each cycle of each finger. It has been decided to ensure that

The intermediate tube section 34 must have a minimum of stiffness and elasticity, or open and close in such a manner as to permit it to function as a helical pump. It is important to understand that Preferably, the tube section 34 is shore It has a minimum durometer of 35 measured on the A scale.

Referring again to FIG. 2, programmable infusion system 10 includes an intermediate IV tubing section. 34 includes means for releasably mounting adjacent pump member 32. middle The tube section 34 has a hook-shaped member 40a (FIG. 3) at one end and a compressed member 40a at the other end. It is mounted on a door 40 with a possible catch 40b. door hook type part The material 40a is placed at one end of the septacle 16 within the case 12 by the patient. shoulder 16a (FIG. 2). The other end of the door is then turned inside. The catch 40b is then snapped closed into the other end of the receptacle 16. During ~ The intervening IV tubing section 34 is supported by individual fingers 32a and the inside of the door 40. compressible and elastic pad 42 (FIGS. 3 and 6). Ru. This pad may be made of polyurethane foam.

An axle 38 (FIG. 3) supporting the cam wheel 36 is mounted on a jar at the opposite end of the ball bearing 44. I'm being bullied. The gear 46 fixedly installed on one end of the shaft 38 is 141 : fixed on the other shaft 50 of the DC motor module 51 with internal gear reduction of 1 It meshes with another gear 48 (FIG. 2) which is mounted in a fixed position. That is, DC motor When the armature rotates 141 times, the shaft 50 rotates once, and the camshaft 38 rotates once. also rotates once.

Referring to FIG. 4, disposable IV tubing device 14 is centered by couplings 56 and 58. proximal tube section 52 and distal tube section 54 connected to opposite ends of IV tube section 34 between and has.

These couplings are attached to the underside of the door 40, which will be described later in conjunction with FIG. There is.

Referring to FIG. 4, intermediate IV tubing section 34 preferably has a diameter within approximately 0.125 inches. It has a diameter. Commercially available silicone and vinyl tubing with the desired hardness can be used by hand. It is possible to put it in. Proximal portion 52 and distal portion 54 each have an outer diameter of approximately Clear polychloride with 0.140 inch and inner diameter approximately, 088 inch Preferably, it is formed from vinyl (PVC). This transparent PVC tube is part 52 and 54 to spike 20 and male fitting 26, respectively. and 55b (FIG. 1) in both the inner and outer diameters.

In our preferred embodiment, which is actually standard, the maximum scheduled delivery rate is That's about 300 milliliters per hour. The minimum scheduled delivery rate is approximately 0 per hour. ．． It is 1 milliliter. Sending resolution is 01 to 99.9 milliliters per hour. Approximately 0.00 liters per hour. 1 milliliter and approximately 10 per hour Approximately 1 ml per hour for 0 to 300 ml. as standard The maximum planned injection jl (VTB I) is 1000 milliliters, and the minimum injection volume (VTBI) is approximately 0.1 milliliter. Scheduled “ Vein open hold (ke pve im open)' (KVO) rate is 1 Approximately 1 ml per hour for a rate of 1 to 300 ml per hour Tutle, 0.00 per hour. 1 for speeds from 1 to 0.99 milliliters Approximately 0.1 to 0.99 milliliters per hour.

Referring to FIG. 7, the door 40 has a rectangular shape adjacent to the hook-shaped member 40a. It has an aperture 90. A resilient metal tube squeezer 92 is inserted into the opening in the door 40. It has an upper end portion 92a that is securely received by the chamfer 90. The compressor 92 has a wrapping part. It has a pair of downwardly parallel extending arms terminating at minute 92b. Refer to Figure 8. Then, when the disposable device is assembled, the intermediate section 34 is squeezed and the wrap is at section 9. Close between 2b. A door 40 is installed within the receptacle 16 of the case 12. When the hook-shaped member 40a engages the shoulder 16a (FIG. 2). clasp 40b The other end of the door having the door rotates toward the case. When this happens, The wrapped portion 92b of the tube squeezer 92 has an overhang 94 that stands upright within the receptacle. (Fig. 8). These overhanging portions are wrapped around the outside from the intermediate tube portion 34. spaced apart so as to be displaced and unclamped. This is shown in Figure 8. is represented by a virtual line. The press performs a very important function. In other words, use When the disposable IV tubing device 14 is inadvertently removed from the case 12, it Squeeze section 34 to prevent intravenous fluid from flowing freely due to the action of gravity. ingredient.

Referring to FIG. 3, the catch 40b is comprised of a V-shaped element. door 40 is preferably made of injection molded plastic, and the V-shaped stopper 40b is a stopper. is compressible as it rotates into the septacle 16 within the case.

This releases the wedge-shaped bulge 96 on the catch 40b behind the L-latch 98. allows it to be snapped into engagement.

Further details of the disposable IV tubing device 14 can be seen in FIG. The coupling 56 is in a bracket 102 extending from the underside of the outside wall of door 40 near catch 40b. You can receive it in the slot. The coupling 56 is a solvent and is fused to the bracket 102. connected or combined. Coupling 58 is similarly formed within hook-shaped member 40a. It can be received in other hollows. The coupling 58 is also joined to the member 40a. It is a solvent. A magnet 106 (FIG. 9) is attached to the bracket 102 and attached to the receptacle. 16 (FIG. 3). hole The effect switch is connected to the microcontroller described below and its output is used. Indicates whether the disposable instrument has been correctly loaded into the case 12. Spiral pump 3 0 is a single channel straight screw with nine reciprocating fingers 321 It is a dynamic pump. The intermediate IV tubing section 34 is highly flexible as previously indicated. Ru. In the preferred embodiment of disposable device 14, intermediate IV tubing section 34 is It consists of a cone and has an inside diameter of approximately 0.125 inches. Approximately 0.12mm Every time the pump shaft 38 rotates, the liquid for intravenous injection of Lilittle is applied to the intermediate IV tube. Input via minute 34. Combined motor and gear reduction module 51 also preferably includes a built-in motor encoder. one suitable unit is MICRO-MO model 1624006S. This is a Teflon (trademark) film. Use a fixotropic lubricant. Traditional Robert clamp 23 (Figure 1) is used to isolate conventional IV It may also be provided on a section of tube 55b.

Advantages of our improved disposable infusion device and spiral pump for use with it Although preferred embodiments have been described, improvements and applications thereof may occur to those skilled in the art. must be understood. Therefore, the protection afforded to our invention is: It must be limited only according to the scope of the claims.

FIG.9 Disposable infusion device summary with spiral pump Disposable injection device! (10) is a coupling (20).

(26) including the proximal, distal and intermediate portions of the IV tube (14) connected via . The intermediate portion (34) is connected to the pump member (32) of the helical pump during one pump operation. ) of sufficient length to operatively engage the. Middle part (34) further shore It has a maximum durometer of 75 on A scale.

The pump members (32) are arranged side by side and in substantially parallel relationship for individual reciprocating motion. It includes a plurality of mounted fingers (32a). The motor drive cam (36) , the middle part (34) arranged on the line is squeezed by the finger (32a). When the intravenous fluid in the tube is pumped through it, a scheduled schedule is set. Each one of the fingers is individually reciprocated with the can. Disposable devices (10 ) is further connected to the opposite end of the intermediate section (34) and connects the intermediate section to the pump member. releasably loadable into the case (12) for positioning in operative engagement; a door (40).

Copy and translation of amendment) Submission form (Article 184-8 of the Patent Law) Having a spiral pump Disposable injection device 5, date of submission of amendment May 29, 1992 Scope of claims 2 1. Used with a spiral pump that is installed in a case and has a pump member. A disposable infusion device for use in a patient, the device comprising a housing beam septacle and a receptor. an opening from the tube to the housing adjacent to the pump member; a proximal end; a distal end of the IV tube; and the middle section of the IV tube with a maximum durometer of 75 on the Shore A scale. , the intermediate portion holds the pumping member of the vibrating pump and is operative during one pumping operation thereof. has sufficient length to engage the releasably mounted in a substantially fully recessed position within the receptacle; affixed to the first and second ends of the intermediate section of the tube, opening and pumping the intermediate section; releasably installed adjacent to the material, and a spiral pump installed within the receptacle. When positioning the intermediate portion of the IV tubing to engage the pump member of the helical pump means including a door for closing; a first cut connecting the first end of the proximal portion of the IV tube to the first end of the intermediate portion of the IV tube; Pulling and a second cut connecting the first end of the distal portion of the IV tube to the second end of the intermediate portion of the 1V tube; A disposable injection device, including a pulling ring.

2. The middle part of the IV tube is selected from the group consisting of vinyl and silicone. 2. The disposable injection device of claim 1, wherein the disposable injection device is made of a disposable material.

3. The middle section of the IV tube has a minimum decolometer of 35 on the Shore A scale. A disposable injection device according to claim 1.

4. The use of claim 1, wherein the proximal portion of the IV tube is formed from polyvinyl chloride. Disposable injection device.

5. The use of claim 1, wherein the distal portion of the IV tube is formed from polyvinyl chloride. Disposable injection device.

6. the door defines a receptacle on the first end thereof; engaging a portion of the case so that the second end of the door means extends toward and away from the case. The use according to claim 1, having hinge means for allowing rotation apart. Disposable injection device.

7. The door is at the second end, the second end of the door is connected to the receptacle at the second end thereof. Claims having all means for releasably connecting to the parts of the case specified in The disposable injection device according to item 6.

8. The spiral pump is multiple fingers; Installing the fingers in side-by-side substantially parallel relationship for individual reciprocating motions means for squeezing the line-arranged portion of the IV tube with the finger; When the intravenous fluid in the tube is pumped through it, a predetermined schedule is set. cam means for individually reciprocating each one of the fingers in the housing; and motor means for driving the cam means. Device.

9. Interface surrounding the finger and between the finger and the portion of the IV tube. 9. The helical pump of claim 8, further comprising a flexible boot forming a .

10. Each finger protrudes therefrom and engages a portion of the IV tubing and its complete 10. A helical pump according to claim 9, having a teat ensuring a smooth squeeze.

11. When connected to the door and engaged with the case to open the middle part of the IV tube , usually a tube squeezer for closing or operatively squeezing the middle section of an IV tube. The disposable injection device of claim 1, further comprising a stage.

12. The cam means includes a slotted shaft and a plurality of identical cam wheels, each cam The wheel passes through a grooved installation offset from the center of the wheel. having a hole, the wheel is individually connected to each one of the fingers in a predetermined timed sequence. Mounts on grooved shaft with forward offset alignment for engaging and reciprocating motion. 9. The helical pump of claim 8, wherein the pump is attached.

international search report ME 604/153; 128/DIG, 12:-117/u74. →75 ．． 360

Claims (15)

[Claims] 1. A disposable infusion device for use with a peristaltic pump, the device comprising: a proximal end of the IV tube; a distal end of the IV tube; and the middle section of the IV tube with a maximum durometer of 75 on the Shore A scale. , the intermediate portion holds the pumping member of the peristaltic pump and is operative during a single pumping operation thereof. has sufficient length to engage the a first cup connecting a first end of the proximal portion of the IV tube to a first end of the intermediate portion of the IV tube; Pulling and a second cup connecting the first end of the distal portion of the IV tube to the second end of the intermediate portion of the IV tube; A disposable injection device, including a pulling ring. 2. The middle section of the IV tube is selected from the group consisting of vinyl and silicone. 2. The disposable injection device of claim 1, wherein the disposable injection device is made of a disposable material. 3. The middle section of the IV tube has a minimum durometer of 35 on the Shore A scale; A disposable injection device according to claim 1. 4. The use of claim 1, wherein the proximal portion of the IV tube is formed from polyvinyl chloride. Disposable injection device. 5. The use of claim 1, wherein the distal portion of the IV tube is formed from polyvinyl chloride. Disposable injection device. 6. further comprising means for releasably mounting the intermediate portion adjacent the pump member; The disposable injection device of claim 1, comprising: 7. The device for releasably mounting the intermediate portion adjacent the pump member is IV a case secured to the first and second ends of the intermediate section of the tube and defining a receptacle; releasably engageable with the portion of the peristaltic pump adjacent to the receptacle. to engage the pump member of a peristaltic pump when installed in a case that 7. The disposable of claim 6, including a door for positioning the intermediate portion of the IV tube. Injection device. 8. the door defines a receptacle on a first end thereof; engaging a portion of the case so that the second end of the door means extends toward and away from the case. 8. The use according to claim 7, comprising hinge means for allowing rotation apart. Disposable injection device. 9. The door is at the second end, the second end of the door is connected to the receptacle at the second end. Claims having clasp means for releasably connecting to parts of the case as specified in The disposable injection device according to item 8. 10. 9. A disposable injection device according to claim 8, wherein the hinge means includes a hook-shaped member. 11. When connected to the door and engaged with the case to open the middle section of the IV tube , usually a tube squeezer for closing or operatively squeezing the middle section of an IV tube. 9. The disposable injection device of claim 8, further comprising a stage. 12. A peristaltic pump for pumping intravenous fluids through a section of IV tubing. There it is, multiple fingers; Installing the fingers in side-by-side substantially parallel relationship for individual reciprocating motions means for squeezing the line-arranged portion of the IV tube with the finger; When the intravenous fluid in the tube is pumped through it, a predetermined schedule is set. cam means for individually reciprocating each one of the fingers in the housing; and motor means for driving the cam means. 13. The interface between the finger and the portion of the IV tube surrounds the finger. 13. The peristaltic pump of claim 12, further comprising a flexible boot forming a space. 14. Each finger protrudes therefrom to engage a portion of the IV tubing and completely 13. A peristaltic pump according to claim 12, having a dead that ensures a smooth squeeze. 15. The cam means includes a slotted shaft and a plurality of identical cam wheels, each cam The wheel passes through a grooved installation offset from the center of the wheel. having a hole, the wheel is individually connected to each one of the fingers in a predetermined timed sequence. Mounts on grooved shaft with forward offset alignment for engaging and reciprocating motion. 13. The peristaltic pump of claim 12, wherein the peristaltic pump is attached.