JPS61234874A - Reusable injection catheter - 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 Field of the Invention The present invention relates to a device for the delivery of drugs, and more particularly to a disposable reservoir for a drug solution delivered to a patient by a roller-type infusion pump. 15Q into a reusable infusion catheter to retain the cassette and drug as it flows from the reservoir cassette towards the patient.

DESCRIPTION OF THE PRIOR ART Many diseases of humans and animals are caused by subcutaneous injections of insulin in the affected person's daily regimen. This treatment method cannot completely normalize glucose metabolism,
Therefore, other metabolic and biochemical properties are likely to be affected. Today, the relatively rapid administration of insulin every few hours induces capillary, neurotic, and other complications that can be minimized or eliminated by more frequent, relatively small doses of insulin administered subcutaneously. It is recognized that there is a risk of

However, as the frequency of administration increases, Inuyama's syringe must be kept at all times, and he must also remember the exact time for insulin injections and find a private place to administer the injections. This raises questions regarding benefits for patients. Furthermore, the pain and tissue damage that results from frequent injections of small amounts of insulin make such an attempt impractical. It is more desirable to deliver insulin intermittently into the patient's body by placing an implanted needle within the patient's body via a subcutaneous procedure, or to deliver insulin continuously through an implantable intramuscular or intravenous catheter. However, for a certain period of time, for example, 24
Continuous or intermittent injections over time are impractical without a lightweight, compact administration device that can be attached to the patient's body or clothing without interfering with the patient's daily life.

Huller (U.S. Pat. No. 3,384,080) and Haxwe Il (U.S. Pat. No. 3,198,385)
Both patents teach devices capable of continuous injection of medical fluids into the human body. However, these instruments are large and bulky and cannot be easily and safely attached to the patient's body. The Huller patent requires a separate reservoir WI section which adds bulk to the pumping device. Also, large separate reservoirs create potentially life-threatening problems if the safety device fails and the pump injects the entire reservoir into the patient. Haxw
The eIl patent teaches a very complex device for high pressure injection in which the ampoule is removed via a pair of rollers, one of which is driven to squeeze the drug solution from the ampoule.

Xanthol) OLllO3 U.S. Patent (No. 4.18)
No. 7.057) teaches a disposable cassette for use in a spiral infusion pump,
US Pat. No. 4,256,43γ also relates to a screw-type infusion pump. Xan above
The thopou los pump is large and bulky and is not suitable for attachment to a patient's rest area. This is also intended to pump the intravenous drug solution from a separate reservoir. The XanthOpOLIIO3 patent moves the cassette into and out of an operating position in which the A-kump rollers engage and compress the tubular portion of the cassette by moving the entire cassette in a plane parallel to the plane of rotation of the rollers. Teach them how to do things. This type of construction is undesirable in that movement of the cassette in the plane of the rollers as a result of the relative movement between the tube of the cassette and the O-La causes the drug solution to be injected into the patient's body.

Albisser et al., U.S. Patent Application No. 267,364, May 22, 1981, assigned to the present applicant.
US Pat. No. 5,001,101 teaches a compact device for the controlled subcutaneous injection of dispersed amounts of a drug, such as insulin, at selected time intervals. The Albisser et al. patent application describes a compact roller-type pump configured to deliver drug fluids via flexible tubing coupled to an infusion needle in a subcutaneous location. Users of this invention, such as the AIbiSSer, place the tube needle assembly on the roller pump and then insert the needle into the insulin container. The pump is then used to draw insulin from the container into the tube. The needle is then removed from the container and placed on the patient. This method requires removing the needle from the patient each time the drug volume is exhausted.

Also at issue is U.S. Patent No. 4.2 of Tney et al.
No. 35,234, Ill., which teaches a hypodermic injection device with a positioning pad supporting a needle having a right-angled tube section. The portion of the needle in front of the right-angled tube lies in the plane of the locating pad, and the rear portion of the right-angled tube, including the tip, projects a predetermined distance in a generally perpendicular direction from the locating pad. Since the locating pad is in direct contact with the patient's skin, the needle penetration depth is reliably controlled.

US Pat. No. 2,847,995 to Adam S. shows a known spring resilient valve sheath used for sealing the end of a needle cannula. This configuration is commonly used with evacuated blood collection tubes that have rubber stoppers. Pressing the tube stopper toward the end of the cannula causes the cannula to pierce the sheath and past the stopper, thereby creating a flow condition between the inside of the evacuated blood collection tube and the cannula. secure. When the cannula passes through the rubber stop, the sheath is compressed into an accordion shape.

When the needle is withdrawn from this stop, the sheath returns to its original position and seals the cannula.

With the above-mentioned problems of the prior art in mind, the delivery needle can be inserted into and removed from the pump mechanism without removing it from the injection site, and the same catheter tube can be used with successive reservoirs. It would be desirable to provide a disposable reservoir cassette that allows for the use of a dispensing needle and a dispensing needle. It would also be desirable to provide a disposable storage cassette that can be purchased pre-filled by the user or filled by the user using simple and inexpensive filling equipment. Furthermore, it is easy to install and can be removed from the pump, does not force excess medication into the patient during installation and removal operations, and can be used with a spare reservoir cassette. It would be desirable to provide a disposable storage cassette that allows the user to defecate.

[Configuration of the Invention] The disposable storage cassette of the present invention comprises a compressible reservoir, a gas-permeable but liquid-impermeable element at one end of the reservoir, and a gas-permeable but liquid-impermeable element allowing access thereinto. and an access device at the other end of the reservoir. In order to transfer the medicinal solution from the reservoir, and to press the reservoir against the housing device and drive the medicinal solution held inside in the direction toward the access device, the reservoir is moved by an acting force applied from outside. A housing arrangement is provided which holds the reservoir accessible to said access device for contacting.

In one preferred embodiment of this aspect of the invention, a disposable reservoir cassette for use with a roller pump mechanism in dispensing medication to a patient includes a highly flexible reservoir tube; It consists of an air permeable but liquid impermeable element at the first end of the tube and a discharge chamber coupled to the second end of the tube. The discharge chamber includes a cylinder, a pierceable partition at one end of the cylinder, and a sealing member at the other end of the cylinder. The partition, the cylinder, and the sealing member define a cavity for receiving and storing a portion of the medicinal solution initially held within the tube. The sealing member has a centrally located orifice in communication with the second end of the tube.

A venting device is provided between the inside of the discharge chamber and the outside of the discharge chamber in order to allow gas to escape from the discharge chamber when the chemical solution enters. A rigid cassette housing containing a reservoir tube is also provided. The housing includes an opening for receiving a roller located on the outside of the roller pump mechanism and a rigid, generally circular rear stop supporting the tube over its length. The housing has a transfer boat therein and a device for fixedly holding the tube adjacent the rear stop such that the second end of the tube is adjacent to the transfer boat. In cooperation with a roller pump, the housing is positioned and removably retained such that the rear stop is disposed generally adjacent the path of the rollers of the roller pump, thereby A fixation device is provided for the roller to press the tube sufficiently to drive the drug fluid held therein in a direction toward the second end of the tube.

In another aspect of the invention, a reusable injection catheter includes a flexible conduit associated with a first end of the conduit for supplying a medicinal solution to the pathway. and a cannula extending outwardly from the second end of the conduit such that its free end is furthest from the conduit.

A sealing device is associated with the cannula to prevent fluid flow at all times. The sealing device responds to an externally applied force or fluid pressure to cause the drug solution to flow into the cannula.

In a preferred embodiment of another aspect of the invention, a reusable injection catheter for use with an externally applied source of pressurized medical fluid includes a highly flexible tube and a A first cannula extends outwardly from the distal end of the tube for insertion, and a connector housing at the proximal end of the duplex. The housing has a front end, a rear end adjacent the tube, and a passage therethrough. The passageway is in fluid communication with the tube. A second cannula extends outwardly from the forward end of the housing and is in communication with the housing passageway. The free end of this second cannula is located furthest from the housing. A highly elastic sleeve is also provided to cover the free end of the second cannula to prevent the flow of the medical solution. The sleeve is pierced by the free end of the second cannula upon application of an external force to the sleeve in a direction along the second cannula toward the housing, thereby causing the second has a closed end to allow passage of the fluid into the cannula. The sleeve is further adapted to return to its original position upon removal of external forces. A mounting device associated with the housing removably holds the housing in a fixed position relative to an externally supplied source of pressurized medical fluid. In this way, the second cannula and the sleeve are held in a position where the closed end of the sleeve is punctured by the second cannula, so that the second cannula is free to receive the drug solution at its free end. .

Many advantages and objectives are achieved in accordance with the principles of the invention. First, the present invention combines a disposable reservoir cassette and a reusable injection catheter for use in a compact drug delivery device to inject continuous or incremental doses into a patient. supply. The present invention is particularly for use with programmable body-mountable roller pumps. The present invention provides a disposable reservoir cartridge that can be purchased prefilled by the user or filled by the user using simple and inexpensive filling equipment. The reservoir cassette is easy to install, easy to remove from the roller pump, and allows for convenient carrying and use by the user of a spare reservoir cassette. Additionally, this reservoir cassette can be inserted and removed from the roller pump without removing the delivery needle from the site of injection, and because of the evacuation chamber, the same catheter can be inserted into the reservoir for successive uses. Allows for use of tubing and feeding needles. In this regard, reusable injection catheters assist by providing a resilient sleeve or seal that prevents fluid from escaping the catheter during reservoir exchange. Furthermore, since the entire amount of chemical solution in the cassette is built-in,
This avoids the problems associated with dispensing chemical fluids from large adjacent reservoirs.

Embodiment In FIG. 1, a drug supply device 29 operable to supply a drug, such as insulin, to a user includes a disposable storage cassette 30 and a programmable electrically controlled roller. It includes a pump 200 and a reusable infusion catheter 100. This roller
The pump is attached to the human body and is attached to the human body.
Preferably, it is a reusable electromechanical compact roller pump similar to the pump described in the U.S. Patent Application No. R, et al. The working principle of the feeding device is based on a modified helical movement in order to feed the entire contents of the disposable storage cassette 30 in one pass over the rollers. As described below, the contents of the reservoir cassette are delivered into the patient's body via an infusion catheter.

The roller pump of the embodiment described herein includes a rigid, dust-tight, water-tight body housing 201 containing a drive mechanism, an electronics package, and a power source (not shown). Projecting outward from the housing 201 is O.
- roller drive arm 202 and pump roller 204;

The drive mechanism driving roller 204 through arm 202 is an internal spring (not shown) that is unwound each time the pump is loaded with a new reservoir cassette. This winding action is effected when the roller drive arm is manually rotated counterclockwise from the empty position 205 to the loaded position 206. An internal indexing mechanism (not shown) constrains the clockwise movement of the rollers in 1.5 degree increments and is biased by the electronics package.

The electronics package times and energizes the indexing mechanism, from 1 unit every 88.2 minutes to 1 unit every 15 minutes.
Adjustable to produce automatic roller movement up to a unit. The speed of advance movement of the rollers is proportional to the underlying flow rate, which is the rate at which insulin is delivered from the delivery device. For example, 100 units of insulin is 0.34 units per hour.
Adjustments are possible in the underlying flow rate to be delivered from 2.00 units per hour to 2.00 units per hour. This basic flow M is
It is adjusted up and down by activating buttons 207-209 on the housing and by observing the flow rate on liquid crystal display 210. A round button 211 is provided to allow manual control of the advance movement of the rollers and to allow positive insulin delivery greater than the basal flow rate. This feature allows the user to receive an extra dose of insulin as needed, for example before a meal. An on-off switch 214 is provided for use as a control for starting and stopping advance motion of the pump rollers by controlling the appropriate portions of the electronics package that power the internal indexing mechanism.

2-4, the disposable reservoir includes an air permeable but liquid impermeable element 35 and a discharge chamber 36 located at the second end 58 of the reservoir tube. The reservoir tube can be shaped along its entire length into a circular ring configuration. A rigid cassette housing 37 houses the reservoir tube, evacuation chamber and the elements.

The housing includes a rigid, generally circular rear stop 41 supporting the reservoir along the length of the tube, an opening 42 for receiving the rollers of a roller pump, and a transfer boat 72 adjacent to the discharge chamber. Contains. cassette·
Housing 37 includes an upper housing portion 39 and a lower housing portion 40.

As shown in FIGS. 5-7, the lower housing has a discharge chamber shoulder 4γ at the end of the discharge chamber recess 44 opposite the shoulder 46. The lower housing portion 40 also includes a circular transfer boat recess 69 and one or two connector housing locking grooves 70 . A sleeve locking wall surface 75 and a circular cannula conduit recess 74 are included. When the evacuation chamber and reservoir tube with attached elements are placed in the lower housing portion 40 as shown in FIG. 6, the evacuation chamber 36 is received within the recess 44 between shoulders 46 and 47. Similarly, element 35 at the opposite end of the reservoir tube is received within element recess 49 in the lower housing portion. The upper housing part 39 has similar recesses, grooves and n-sections so that the evacuation chamber and elements are sealed internally when the upper and lower housings are joined.

Such a structure limits the movement of the reservoir tube in one direction of the ring. This reduces dosage inaccuracies that may result from movement of the reservoir tube along the rear stop as the rollers move. by using an adhesive to attach the reservoir tube along the entire length of the back stop, or by providing cooperating structures along the tube and the back stop to maintain the relative position of the tube to the back stop. A similar result can be achieved by providing. It will be apparent to those skilled in the art that many configurations can be used to incorporate the reservoir tube within the housing portion, and that the configurations described above are illustrative of many such possibilities. The joining of the upper and lower housing parts is also done by transfer boat 7.
2, and forming a circular cannula conduit including the fourth section 74 of the cannula conduit and a similar recess in the housing portion 39. This cannula conduit connects the recess of the discharge chamber and the transfer boat.

In a preferred embodiment of the invention, said housing parts include cooperating structures on said housing parts;
Made from thermoplastic materials that can be joined together using fasteners, adhesives or compatible welding techniques. A preferred disposable storage cassette has a width of about 50.8 mm.
(2,0 inches), height approximately 50.8 m (2,Q inches), thickness approximately 7.6. It has a compact vertical structure with dimensions of (0.3 inches).

It is also within the scope of the invention to include housing parts that are removably attached to each other so that each part of the housing is reusable, but that the discharge chamber and the storage duplex with attached elements are disposable after a single use. It is in. The housing parts can be removably attached to each other by using threaded fasteners, snap fasteners or other suitable reusable coupling means to hold the housing parts together.

1 and 8, the disposable reservoir cassette 30 must be held in a removably fixed relationship to the roller pump 200, and in particular the pump roller 204. In FIGS. As the pump roller moves along a circular path while compressing the highly flexible reservoir tube 34, the action of the pump roller delivers the drug solution to the patient, so that the reservoir cassette is moved by the roller pump. It is important to be restrained so that no rotational movement occurs.

If the cassette rotates in the direction of the roller's motion, less drug is delivered than required, but if the cassette rotates in a direction opposite to the roller's motion, more drug is delivered than required. It turns out. Also, as is clear, the storage cassette must be removed and installed using rollers to ensure that no chemical solution is supplied and no air enters the device during the operation.
It is important that installation and removal occur without rotational movements relative to the pump.

Roller pump 200 with disposable reservoir cassette 30
A positioning surface 77 is provided on the cassette housing 37 to prevent rotational movement relative to the cassette housing 37. These locating surfaces are adjacent to locating blocks 215 that are attached to the roller pump housing by set screws 216. The positioning block 215 can be adjusted to approach the positioning surface 77 of the cassette/housing and then fixed in this position by tightening the screw 21G. It will be appreciated that rotational movement of the disposable storage cassette relative to the roller pump can be substantially restrained by such a structure. It should be noted that strict control of the dimensional tolerances of the various locating surfaces must allow the locating block to be formed as an integral part of the roller pump housing without adjustment screws. The above-mentioned cooperating aspects are also
A disposable reservoir for the roller pump such that the disposable reservoir cassette must be moved in a direction approximately perpendicular to the path of the pump roller during installation and removal of the pump roller with respect to the roller pump. This restricts movement of the cassette, thereby minimizing the possibility of the machine accidentally delivering drug solution or drawing air into the device.

A retaining spring 217 applies pressure against outwardly extending longitudinal ribs 79 of the cassette housing to retain the reservoir cassette against the roller pump housing. This retaining spring can be deflected out of path by forced movement of the reservoir cassette in a direction perpendicular to the motion of the roller pump, thereby retaining the reservoir cassette in a removably fixed relationship with the roller pump. Provides a resilient fitting device. The retaining spring 217 is attached to the retaining screw 21
It is held in place by 6.

shows an element 35 which is impermeable to liquids. The plug has a flange portion 54 whose diameter is larger than the outer diameter of the reservoir tube and a body portion 55 that is inserted into the reservoir tube. The plug is retained within the reservoir tube by an interference fit or by the use of an adhesive or the like, with the outer diameter of the body 55 being slightly larger than the inner diameter of the tube. aisle 5
A gap that allows air to pass through but not liquid so that 2 is covered! I56 is attached to the plug. Due to this structure, gas at the plug end of the reservoir tube must pass through this diaphragm, but the liquid drug held within the reservoir cannot pass through it. In some cases, as shown below, it is desirable to use a porous diaphragm with a maximum pore size of about 0.5 microns to filter microorganism-containing particles from gases entering the reservoir tube. The diaphragm can be attached to the plug 51 using adhesive or heat sealing. It is also within the scope of the invention to include plugs made of completely air permeable but liquid impermeable materials, thereby eliminating the need for passageways and separate septa.

11 and 12, the cylinder 57, the pierceable septum and the sealing member disposed at one end of the cylinder can be made of a highly rigid material or a highly elastic elastomeric material; The latter is preferable. The pierceable septum 59 is preferably made of a highly elastic elastomeric material with a centrally located slit 63 which is always open. The slit 63 is forced open by components described in more detail below when liquid medicine is inserted or withdrawn with respect to the reservoir tube. In addition to this slit, it is within the scope of the invention to include other self-sealing structures such as solid resilient septum, duckbill or reed valves, etc. as part of the pierceable septum, and many slit structures may be used. This is an example of a possible modification of . A puncturable septum 59 is attached to the cylinder 51 using adhesive.

The sealing member includes a centrally located orifice 61 in communication with the second end 58 of the reservoir tube 34. The small diameter part 62 of the sealing member is connected to the second part of the storage tube.
Insert it into the end of the These parts are joined using an interference fit in which the outer diameter of the small diameter section 62 is larger than the inner diameter of the reservoir tube. Adhesives or other suitable means may also be used to join the discharge chamber and reservoir tube.

The boat 13 in the discharge chamber communicates between the inside of the discharge chamber and its outside so that when the chemical solution enters the discharge chamber, any gas that may be held in the discharge chamber can be released. It has a filter 64 that does not. Filter 6
4 takes the form of an element or a sheet material mounted within the boat γ3 in the cylinder 57 so as to cover the boat 73 in the cylinder 51.

13-17, a preferred reusable infusion catheter 100 includes a flexible conduit 101 having a lumen 102 therethrough and a flexible conduit 101 in communication with the conduit. and a first cannula 104 at the distal end 103 of the conduit. This first cannula has a sharp bevel point 10 to facilitate insertion into the patient.
It has 6. Preferably, adhesive is used to hold the first cannula in the flexible conduit. This first cannula preferably has a bend 117 in a region adjacent to the distal end of the flexible conduit. This bend must cause the free end of the first cannula to project outwardly from the flexible conduit 101 at an obtuse angle relative to its longitudinal axis and its interior. This obtuse angle is approximately 120 to 1
Although it is desirable that the angle be within a range of 60°, it is not an essential condition. The length of the flexible conduit depends on the distance between the roller pump and the injection site. The inner diameter of the flexible conduit 101 is preferably about 0.01 finch.

A connector housing 101 having a passageway 109 therethrough is provided at a proximal end 113 of conduit 101 . As shown in Figures 13 to 15, this connector
The housing 107 is removably held in a fixed position with respect to the conduit 101 by attachment means threadably engaged on its outer periphery. The connector housing is preferably made from a thermoplastic material and attached to the flexible conduit using adhesive or other suitable means. Connector housing protrusion 108 extends radially outward from connector housing 107 and is sized and positioned to engage connector housing locking groove γO of cassette housing 31. A second cannula 105 extends outwardly from the connector housing;
It is in fluid communication with passageway 109 . This second cannula may be an integral part of the connector housing or a separate cannula attached to the housing. As will become clear below, it is not necessary for the second cannula to have a tip. The elastic sleeve 110 is
The free end 111 of the second cannula is covered to prevent the flow of medical fluid therein. The sleeve is made of an elastic material with a normally closed slit 112 at its closed end. As will be explained in more detail below, applying an external force F (FIG. 17) to the resilient sleeve 110 in the direction of the connector housing 107 causes the sleeve to accordion-like folding and release the second cannula. is passed through slit 112, thereby allowing the medical fluid to flow into the second cannula. Removal of this external force causes the resilient sleeve to return to its original position, in which it prevents the flow of drug fluid within the second cannula and thus prevents any fluid that may be present within the flexible conduit. This prevents the chemical solution from exiting the second cannula.

In addition, the flexible conduit is opened by an acting force in the direction inside the second cannula, that is, the pressure of the medicinal solution, allowing the medicinal solution to flow, but the medicinal solution does not exit from the elastic conduit through the second cannula. It is also within the scope of the invention to provide a one-way valve arrangement within the connector housing that prevents.

As best shown in FIGS. 17 and 18, another embodiment of a reusable infusion catheter includes a connector housing 119 and a retainer for the connector housing 119. connector housing protrusion 120 sized and positioned to engage l570. A second cannula 121 extends outwardly from the connector housing. The shield member 122 is removably engaged to the connector housing by an interference fit between the inner diameter 124 of the shield member and the engagement surface 125 of the shield member on the housing. The shielding member 122 is a connector/
It is provided to protect the second cannula 121 from damage and contamination when the housing 119 is not engaged with the disposable reservoir cassette. A vertical member 126 is also provided to vent air trapped within the shield while the shield is engaged with the connector housing. Without the vertical member 126, this engagement between the shield member and the connector housing could force air through the second cannula 121 and into the flexible conduit. This is undesirable because air within the flexible conduit may be injected into the patient. If initially sterile, the second cannula 121 constructs the venting member 126 with a filter material that prevents bacterial flux so that it does not become contaminated during subsequent handling before the shielding member is removed. This is desirable. Those skilled in the art will appreciate that there are many ways to design the cover member to engage the housing, such as screwing and snap-fitting, and that there are many ways to provide ventilation within the cover member; It will be appreciated that the form is an example of many of these possible forms.

Next, in FIGS. 20 to 24, after the first cannula 104 is inserted into the subcutaneous fat layer Q below the patient's skin S, a hanging member is used to fix the cannula 104 to the patient P. 114 are provided. The suspension member has a first side 115 covered with a contact adhesive.
It may be a circular flexible pad with a After the first cannula is positioned through the central opening 116, the member 11
4 is folded onto itself on an axis transverse to flexible conduit 101.

The contact adhesive causes member 114 to maintain this folded condition as best shown in FIG. Member 114
can then be folded again along an axis substantially parallel to the flexible conduit 101. In this position, as shown in FIG. 23, the patient can grasp the suspension member and use it as a handle to assist in subcutaneously placing the first cannula. After the cannula is properly placed, the patient releases member 114 and resizes it to the shape shown in FIG. 22 so that it can be taped to the patient's body. 1st canyule 1
The bend at 04 facilitates subcutaneous placement of this cannula. As best shown in Figure 24, the bend also ensures that the needle remains elevated above the skin when removed, and movement is restrained by the suspension member while it is attached to the patient. request that it be done. Preferably, the thought-facing surface 118 is coated with an adhesive that removably adheres to the skin, and a paper backing (not shown) is also used to cover the adhesive. - Once the needle is properly placed, the patient can remove this paper backing and press the surface 118 against the skin S, keeping the suspension member removably attached to the skin.

and a suspension member without an opening for receiving the first cannula, wherein the distal end of the flexible conduit is attached to the suspension member instead of being held between the layers. It is within the scope of this invention.

In FIG. 25, the programmable O-La pump 200 can be secured to the patient's body by a flexible waist band 212. The illustrated waist attachment is an example of a wide range of possible roller pump positions, as there is a wide range of possible roller pump positions within each region of the patient or adjacent clothing. Once a location for the programmable roller pump has been selected, the injection site can be any convenient location on the patient's body proximate to the pump and the suspension member 114 can be used to connect the first cannula 104 of the infusion catheter. The site may have sufficient fat to ensure proper subcutaneous placement of the tissue.

In FIG. 26, to fill the desired disposable storage cassette (if not pre-filled),
The user first transfers the drug solution from a standard drug container with a cap (not shown) into which a needle can be inserted into a hypodermic injection voice 65 equipped with a needle blade nub 66 . This needle cannula is then pushed through the pierceable septum 59 and into the sealing member 60 of the discharge chamber. At this time, the drug solution is forced out of the syringe into the reservoir tube. The gas in the reservoir tube that is discharged by the chemical liquid exits through the element 35, but the chemical liquid cannot pass through this. If air bubbles become trapped in the drug solution in the reservoir tube, they can be removed by drawing a volume of the drug solution back into the syringe with the bubbles so that the drug solution can be returned to the reservoir tube without the bubbles. can. It has been found that air entrained within the reservoir tube can retain bacteria. This is not a problem if the drug solution contains a bacteriostatic agent. However, if this element is made of a material with a maximum pore size of about 0.5μ, so that the element can filter microorganisms from the gases that enter the reservoir tube, Transmission can be prevented.

Note that the cannula 66 prevents medical fluid from entering the interior portion 67 of the discharge chamber.

In use, as best shown in FIGS. 27, 28, and 29 in conjunction with FIGS. Rotating counterclockwise toward the load position, the reservoir cassette is placed between the locating blocks 215 of the roller pump housing and pressed directly against the roller pump to release the retaining spring 217 in the pump housing. A disposable reservoir cassette filled with a drug solution is inserted into the roller pump by engaging the external ribs of the reservoir cassette housing. Reusable infusion catheter 100
At this time, the connector housing 107 is inserted into the transfer boat 72 in the cassette housing such that the connector housing protrusion 108 is aligned with the connector housing retaining groove 70 in the cassette housing.
It is coupled to the reservoir cassette by inserting it into the reservoir cassette. The retaining groove in the connector housing only allows the connector housing to enter the transfer boat to a depth that places the second cannula 105 in communication with the reservoir tube 34 filled with medical fluid. At this time, twisting the connector housing fixes it to the storage cassette like a bayonet. During insertion, sleeve shoulder 71 on cassette housing 37 forces resilient sleeve 110 against the connector housing to pierce slit 112 in the resilient sleeve, thereby opening a second cannula to receive drug solution from the reservoir cassette. You will find that it does. Additionally, during insertion, the exposed free end 111 of the second cannula 105 cuts through the slit in the puncturable septum 59 so that the second cannula is now in communication with the highly flexible reservoir tube 34. Puncture and enter the orifice 61 of the sealing member 60.

Pump roller 204 is now advanced to the starting position as best shown in FIG. 1 by pressing and holding round button 211. By advancing the pump roller to the starting position, the roller compresses the flexible reservoir tube 34 and forces a portion of the drug contained therein into the infusion catheter, while at the same time displacing the drug into the infusion catheter. Fill and expel all air from fluid path. The first cannula 104 can then be inserted into the patient's body at a subcutaneous location and attached to the vital body using the suspension member 114, as described above. At this time, the roller pump timing mechanism is activated by switching the on-off switch 214 to the on position. The roller is then advanced intermittently to administer controlled doses to the patient over a drug delivery time ranging from approximately several hours to 48 hours, depending on the type of insulin used by the patient and the dosage required by the patient. Inject a certain amount of drug solution. As the roller pump moves forward, the chemical liquid in front of the roller passes through the second cannula 105 from the highly flexible reservoir tube 34 into the flexible conduit 101 and then into the first cannula 104. from the patient. Note that the second cannula 105 prevents medical fluid from flowing into the interior 67 of the discharge chamber. The interior of the flexible storage duplex behind the rollers, which is no longer medicinal, is filled with air that has entered via an air-permeable but liquid-impermeable element 35. If the first end of the flexible reservoir tube were sealed instead of having element 35, the part of the flexible reservoir tube no longer free of drug solution would be behind the advancing roller. It has a tendency to expand and create a negative pressure within the reservoir tube in which it is located, thus requiring more force to advance the roller. This tendency is eliminated by the presence of element 35. At the end of the drug supply period, the roller
The pump timing mechanism is deenergized by switching the on-off switch 214 to the off position. The infusion catheter is then disconnected from the reservoir cassette while the first cannula 104 remains attached to the patient in a subcutaneous position. The roller drive arm 202 is now rotated counterclockwise to the loaded position 206 and the reservoir cassette is at 0-
It is removed from La Pump and discarded. A new disposable reservoir cassette 34 filled with chemical solution is attached to the roller pump. Because the reusable infusion catheter is filled with drug while the first cannula is attached to the patient, there is no need to provide an initial amount of drug to the catheter.

It will be appreciated that when the infusion catheter is not attached to the reservoir cassette, the resilient sleeve 110 prevents the liquid drug contained within the catheter from exiting the second cannula. Before attaching the infusion catheter to the reservoir cassette, the rollers are again advanced to the starting position.

Medicinal liquid ejected by this roller movement, which is not necessary to fill an empty infusion catheter, flows against the interior 67 of the evacuation chamber as shown in FIG. Any gas that may be present in the interior 67 is forced out of the exhaust chamber through the filter 64. The infusion catheter is now coupled to the reservoir cassette and the roller pump timing mechanism is energized to begin another drug delivery period. This second
At the end of the drug delivery period, it may be desirable to discard the original catheter and begin the delivery period with a new infusion catheter and a new injection site, but this step is not required.

Cassette housing 37 is preferably made from plastics such as polystyrene, polypropylene and polyethylene. Additionally, the upper housing portion 39 is constructed from a transparent plastic such as polystyrene so that the patient can easily observe the condition and location of the disposable reservoir cassette and roller pump components in the upper housing portion. This is desirable. Also,
It is also desirable to construct the entire housing from a transparent material so that the internal components can be easily viewed.

The flexible reservoir tube 34 is made from a material that is compatible with the drug fluid contained therein and sufficiently flexible so as not to require large amounts of energy from a roller pump to compress the tube. must be configured. Thermoplastic materials such as polyvinyl chloride, thermoplastic elastomers and natural rubber can be used. However, the material making up the inner part of the tube is selected to have a small water vapor permeability and compatibility with the chemical solution, while the material making up the outer part is flexible and consumes less energy when subjected to pressure. Coextruded materials are preferred because they are selected as such. If insulin, such as regular 100 units, is the drug solution used, a composite material using polyolefins such as polyvinyl chloride and polyvinylidene chloride is preferred, where the polyolefin is placed in the inner portion of the reservoir tube to contact the insulin. Acts as a liner.

Plug 5 of element 35 that allows air to pass through but not liquid
1 can be made from plastic such as polyethylene or polypropylene. The diaphragm 56, which is permeable to air but not permeable to liquid, has a length of approximately 0.08 to 0.25 m (
It can be made from a non-woven fabric of a polymer selected from polytetrafluoroethylene, polyester, polyvinyl chloride, polypropylene, polyethylene, etc., preferably with a thickness in the range of 0.003 to 0.0000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000--2000- able fabric possible. Materials such as those just described are manufactured by W. L. Gore & As5ocia, Elkton, Maryland, USA.
It is available from TES Corporation and is commercially available as the GORE-D EX-A product. A desirable element is approximately 0.2m
(0,008 inches) thick. Diaphragm 5G can be attached to plug 51 using adhesive or heat sealing. This plug is also from G.
Prex Di by lasrock Products
It can be made only from materials that are permeable to air but impermeable to liquids, such as the microporous polypropylene manufactured by Vision. Another example of a reusable infusion catheter is that the air-permeable but liquid-impermeable filter 64 and venting member 126 of the ms-like evacuation chamber 36 are similar to the above-mentioned separation WA.
It can be made from the same material as 56.

Cylinder 51 and sealing member 60 can be constructed from a wide range of stiff or flexible materials using elastic materials such as rubber and preferably thermoplastic elastomers. The cylinder 57 and the sealing member 60 can be made, for example, in one piece or as separate components joined together by adhesive. The pierceable septum 59 can be constructed from a wide variety of elastic materials, including:
Rubbers and thermoplastic elastomers are preferred.

Highly flexible conduit 1 of a reusable infusion catheter
01 is preferably made from extruded polymer tubing, preferably polyolefin or polyvinyl chloride. A preferred material for first cannula 104 is stainless steel. Connector housing 1
07 can be made from a wide variety of rigid materials, preferably using thermoplastic materials such as polypropylene and polyethylene. The second cannula 105 can be made from stainless steel or thermoplastic materials such as polypropylene and polyethylene, or can be molded as an integral part of the connector housing 107. Elastic sleeve 110 is preferably made from self-sealing resilient materials such as rubber and thermoplastic elastomers. Suspension member 114 is preferably made from a water vapor permeable and bacteria barrier material. A wide range of medical grade adhesive coatings are available to achieve adhesive properties for hanging members. The preferred material for the adhesive-attached hanging member is
HinneSOta Min as TegadermJ
There is a skin batch system manufactured by Ing & Manufacturing.

All components of the disposable reservoir cassette and reusable infusion catheter that come into contact with medication or the patient during subcutaneous placement must be sterile. Therefore,
Materials should also be selected to be compatible with the aseptic process used.

Thus, the present invention allows for insertion and removal with respect to a roller pump without removing the infusion cannula from the injection site, thus allowing the use of the same infusion catheter for successive reservoirs. A disposable storage cassette is provided. The disposable storage cassette can be purchased by the user pre-filled or can be easily filled by the user using inexpensive filling equipment.

Since the reservoir cassette holds all the drug solution to be delivered to the user, a separate mounted reservoir is unnecessary. The present invention also includes an elastic sleeve or sealing member at one end of the reservoir cassette 1- to prevent loss of drug solution during exchange, and a suspension on the prong end to secure the syringe needle placed in the subcutaneous position. A reusable infusion catheter with a lowering member is provided.

[Brief explanation of drawings]

FIG. 1 is a plan view showing a preferred reusable injection catheter attached to a reservoir cassette and a preferred disposable reservoir cassette attached to a programmable roller pump; FIG. FIG. 3 is an exploded perspective view of the preferred disposable reservoir cassette and FIG. 4 shows the evacuation chamber as part of the reservoir cassette. FIG. 5 is an enlarged plan view showing the lower housing portion of the storage cassette; FIG. 6 is an enlarged plan view showing the lower housing portion of the storage cassette; FIG. FIG. 7 is an enlarged cross-sectional view of the disposable storage cassette taken along line 7--7 of FIG. 1; FIG. FIG. 9 is an enlarged cross-sectional view of the preferred storage cassette and roller pump taken along line 8--8 of FIG. 1; FIG. , FIG. 10 is a cross-sectional view showing elements taken along line 10--10 of FIG. 9, FIG. 11 is an enlarged side view showing the evacuation chamber of a preferred disposable storage cassette, and FIG. 12 is a cross-sectional view of elements taken from FIG. 13 is a perspective view of the preferred reusable infusion catheter; FIG. 14 is a cross-sectional view of the evacuation chamber of FIG. 15 is an enlarged side view of the connector housing with the resilient sleeve of the desired reusable infusion catheter; FIG. 16 is taken along line 1 of FIG. 15;
6-16 is a cross-sectional view showing the connector housing;
FIG. 17 is a cross-sectional view of the connector housing of FIG. 16 further showing the second cannula projecting through the slit in the resilient sleeve; FIG. 18 is a cross-sectional view of the connector housing of FIG. An enlarged side view showing the connector housing and cover member, FIG.
8 is a cross-sectional view of the connector housing and cover member taken along line 19-19 of FIG. Figure 21 is a perspective view of the first cannula end of the preferred infusion catheter with the first cannula inserted relative to the suspension member; Figure 22 is a perspective view of the first cannula end at right angles to the flexible conduit; FIG. 21 is a perspective view showing the assembled condition with the hanging member folded on the axis forming the axis; FIG. 23 shows the hanging member folded in position for insertion of the cannula into the patient. Second
Figure 24 is an enlarged side view of the distal end of the preferred infusion catheter in use; Figure 25 depicts the drug delivery device attached to the desired location on the patient's body; 26 is an enlarged cross-sectional view showing the syringe in use for filling the preferred disposable reservoir cassette; FIG. 27 shows the interaction with the preferred reusable infusion catheter and roller pump. FIG. 28 is an enlarged plan view partially broken away to illustrate the preferred disposable reservoir cassette; FIG. FIG. 29 is a partially enlarged cross-sectional view of a preferred disposable storage cassette showing the drug solution entering the discharge chamber. 29... Chemical supply device 30... Disposable storage cassettes 1-34... Storage tube 35... Air permeable liquid impermeable element 36... Discharge chamber 37 Cassette housing 39... Upper housing part 40... Lower housing part 41... Rear stop part 42... Opening 44... Discharge chamber recess 45... Storage tube recess 46... Shoulder part 47... Discharge to shoulder Part 49...Concave part 51...Plug 5
2... Passage 54... Flange portion 55
...Body part 56...Air permeable liquid impermeable diaphragm 5γ...Cylinder 59...Punctureable partition 6
0... Sealing member 61... Orifice 62.
... Small diameter part 63 ... Slit 64 ... Air permeable liquid impermeable filter 65 ... Hypodermic syringe 66
・Needle cannula 74 ・Concave part 77 ・・
・Positioning surface 79... Lip 100... Injection catheter 101... Conduit 102...
-Inner cavity 104...First cannula 105...Second cannula 106...Sharp bevel point 107...Connector housing 108...Protrusion 109...Passway 110...
Sleeve 111... Free end portion 112... Slit 114... Suspension member 116... Opening 117... Bent portion 126... Ventilation member
200...Roller pump 201...Housing 202...Roller drive arm 204...Pump middle roller 205...Empty position 206...Load position 20
7 to 209... Button 210... Liquid crystal display 211... Button 212... Waist band 214... On/off switch 215... Positioning block

Claims (1)

[Scope of Claims] 1. A flexible conduit having a fluid passage therethrough, in fluid communication with the conduit, extending outwardly from a distal end of the conduit, and further extending toward the patient. a first cannula adapted to be inserted into the conduit; a first cannula disposed at a proximal end of the conduit and in fluid communication with the conduit through a forward end and a rear end adjacent the conduit; a second cannula extending outwardly from the forward end of the housing and in fluid communication with the passageway, the second cannula having a free end furthest from the housing; A reusable infusion catheter comprising: 2. Covering the free end of the second cannula to prevent the passage of a medical solution therein, and applying an external force to the sleeve in a direction along the second cannula to the housing; An elastic sleeve having a closed end for allowing passage of the medical solution in the second cannula by being punctured into the free end is provided, and the sleeve is free of external action and simultaneously returns to its original state. 2. A reusable injection catheter according to claim 1, wherein said catheter is adapted to be returned to said position. 3. The reusable infusion catheter of claim 1 further comprising a shielding means removably engaged with said connector housing to cover said second cannula. 4. A reusable infusion catheter according to claim 3, wherein said shielding means includes a venting means for allowing air trapped therein to escape therefrom. 5. The reusable injection catheter according to claim 1, wherein the conduit is a long tube. 6. The invention further comprises attachment means for removably retaining said second cannula in a relatively fixed position in cooperation with an externally applied source of pressurized medical fluid. A reusable infusion catheter according to paragraph 1. 7. The reusable infusion catheter of claim 1, wherein said connector housing further includes a circular outer surface extending from said forward end to said rearward end. 8. said outer surface has a protrusion extending radially outwardly from said surface, said protrusion engaging an externally applied source of drug solution during introduction of drug solution into said second cannula; 8. A reusable infusion catheter according to claim 7, wherein said housing is removably retainable. 9. The first cannula further has a bend along its entire length in a region adjacent to the distal end of the conduit, the bend extending the first cannula in the longitudinal direction of the conduit. The reusable infusion catheter of claim 1, wherein the reusable infusion catheter extends outwardly from the end of the conduit at an obtuse angle to the axis. 10. The reusable infusion catheter of claim 9, wherein said obtuse angle is within a range of about 120 to 160 degrees. 11. The sleeve further includes a slit in the closed end for passing the free end of the second cannula, the slit being further adapted to close upon removal of the second cannula. A reusable injection catheter according to claim 2, characterized in that: 12. The reusable injection catheter according to claim 1, further comprising a fixing means for fixing the first cannula to the patient after the first cannula is inserted into the patient. . 13. The securing means includes a flexible hanging member at the distal end of the conduit in a plane substantially parallel to the longitudinal axis of the conduit, one side of the hanging member being A reusable infusion catheter (14) according to claim 12, characterized in that the reusable infusion catheter (14) is adapted to be removably secured to the skin of a patient. Claims further comprising an adhesive layer on the sides of the suspension member, the adhesive being adapted to removably adhere to the patient's skin when placed under pressure. 14. A reusable infusion catheter according to paragraph 13. 15. The reusable infusion catheter of claim 1, wherein said conduit is made of thermoplastic material. 16. The reusable infusion catheter of claim 15, wherein said thermoplastic material is selected from the group consisting of polyolefins and polyvinyl chloride. 17. The reusable infusion catheter of claim 1, wherein said first cannula is made from stainless steel. 18. The reusable infusion catheter of claim 1, wherein said second cannula is made from a material selected from the group of stainless steel and thermoplastic materials. 19. The reusable infusion catheter of claim 2, wherein said sleeve is made of a material selected from the group consisting of rubber and thermoplastic elastomer. 20. Claim 4 includes a filter having a maximum porosity rated at about 0.5 microns to act as a substantial barrier to particles larger than about 0.5 microns. reusable infusion catheter. 21. a flexible conduit having a fluid passage therethrough; and an injection means disposed at a first end of the conduit and in fluid communication with the conduit for supplying a medicament to a patient. a cannula in fluid communication with the conduit and extending outwardly from the second end of the conduit such that the free end is disposed furthest away from the conduit; a sealing means associated with the cannula which normally prevents the passage of internal fluid therein and is adapted to permit passage of fluid within said cannula in response to an externally applied force; Possible infusion catheter. 22, associated with the second end of the conduit for removably retaining the cannula and the sealing means in a fixed relationship with each other in cooperation with a source of externally applied force; 22. The reusable infusion catheter of claim 21 further comprising attachment means. 23, a reusable infusion catheter for use with an externally applied source of pressurized fluid, comprising a flexible tube having an internal fluid passageway and an external tube in fluid communication therefrom from a distal end of the tube. a first cannula extending toward the patient and inserted into the patient; a first cannula disposed at a proximal end of the tube; a front end adjacent to the tube; a second cannula extending outwardly from a forward end of the housing in fluid communication with the passageway and having a free end disposed furthest from the housing; a resilient sleeve covering the free end of the second cannula to prevent passage of fluid therein, the sleeve being applied against the sleeve along the second cannula in the direction of the housing; the second cannula having a closed end adapted to be punctured by the free end upon application of an external force, and adapted to permit passage of fluid within the second cannula; a resilient sleeve adapted to return to its original position when the acting force from the connector housing is removed; attachment means for removably retaining said second cannula and said sleeve in a fixed position, said closed end being punctured by said second cannula; and attachment means allowing the second cannula to receive fluid through said free end. 24. The reusable infusion catheter of claim 23, further comprising securing means for securing the first cannula to the patient after insertion thereof into the patient. 25. The first cannula further includes a bend along its length in a region adjacent the distal end of the tube, the bend forming an obtuse angle with respect to the longitudinal axis of the tube. from the end of the tube outwardly from the first
24. A reusable infusion catheter according to claim 23, characterized in that a cannula protrudes from the reusable infusion catheter.