• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    basal medicine manual bolus delivery device. the present invention relates to a fully manually operated infusion device that provides both a basal and bolus delivery of a liquid drug to a patient. in some embodiments, the device includes a main reservoir that supplies the liquid medication, an outlet port that releases the liquid medication to the patient, a basal dispenser that releases a substantially constant flow of the liquid medication into the outlet port and a pump manually triggered bolus that releases a bolus dose of liquid medication from the main reservoir to the outlet when triggered. the basal dispenser releases the substantially constant flow of liquid medication to the outlet port under the stored energy as a direct result of and only through the manual actuation of the bolus pump. also, in some modalities, the supply of basal medication releases a volume of liquid medication from the main reservoir to the basal dispenser in line with each activation of the bolus pump.
    公开号:BR112013021028B1
    申请号:R112013021028-1
    申请日:2012-01-30
    公开日:2021-03-23
    发明作者:Clifton Alferness；John Adams
    申请人:Calibra Medical, Inc.；
    IPC主号:
    专利说明:

    [0001] [0001] The present application claims the priority of US application No. 13 / 360,485 filed on January 27, 2012, which claims the benefit of copending US provisional patent application serial number 61 / 444,121, filed on 17 February 2011 that applications are incorporated into the present invention by references in their entirety. BACKGROUND OF THE INVENTION
    [0002] [0002] The present invention relates to infusion devices to be used close to the body and more particularly to such devices that allow liquid medications to be conveniently and safely self-administered by a patient. The present invention is more particularly directed to such a device to be used close to the body that provides both basal and bolus drug delivery and that is fully operable and manually operated. A liquid drug that is often self-administered by a patient is insulin and for ease of description, insulin administration is generally used in the present invention for exemplary purposes although the invention should not be limited by that exemplary use.
    [0003] [0003] Insulin administration has traditionally been performed using a syringe. Recently, devices similar to a pen containing a needle have also been employed for this purpose. Both forms of insulin administration require patients to insert themselves into themselves every time they inject insulin, often many times a day. In addition, a new clean needle needs to be fitted to the device every time it is used, and discarded after each use, creating the added problem of having the "needles" with them whenever the patient needs to administer insulin and needs to dispose of them with after each use. Thus, these traditional forms of insulin administration have been a major invasive intrusion into the lives and routines of patients who have had to adopt and employ them.
    [0004] [0004] More recently, insulin pumps attached by tubing to an infusion set mounted on the patient's skin have been developed as an alternative form of insulin delivery. Such pumps can be controlled by a programmable electronic remote system employing short-range radio communication between a control device and electronic components that control the pump. Although such devices may involve fewer syringes, they are expensive to manufacture. They are also complex to operate and impractical and awkward to use. In addition, the cost of such devices can often be the daily expense of using traditional injection means such as a syringe or insulin pen.
    [0005] [0005] The devices of the type mentioned above, also require a significant amount of training to control and thus the use of the devices. Great care in programming the devices is necessary because the pumps generally carry enough insulin to last for a few days. The improper programming or general operation of the pumps can result in the release of an excessive amount of insulin which can be very dangerous and even fatal.
    [0006] [0006] Many patients are also reluctant to use a pump device because they can be socially embarrassing. The devices are generally very noticeable and can be as large as a pager. Adding to its discomfort is its fixation on the outside of the patients' clothes and the need for a catheter as a set of tubing that passes from the device to the infusion set located on the patient's body. In addition to being obvious and perhaps embarrassing, using such a device can also be a serious impediment to many activities, such as swimming, bathing, athletic activities and many activities, such as sunbathing where portions of the patient's body are necessarily uncovered.
    [0007] [0007] In view of the above, a simple, lower cost device has been proposed whereby an injection system is discreetly attached directly to the patient's skin. An example of such a device is described in detail in US patent application No. 12 / 147,283 filed on June 26, 2008 and entitled DISPOSABLE INFUSION DEVICE WITH REDUNDANT SAFETY VALVE, which order is owned by the assignee of that order and is here incorporated in full, as a reference. Such a device can be attached to the patient under the patient's clothing to deliver insulin to the patient by manually pumping small doses of insulin from the distal end of a temporarily internal cannula that is part of the pump device. The device can be very small and when worn under clothing, completely unnoticeable in most social situations. You can also carry enough insulin to last the patient for several days. It can be colored to harmonize naturally with the patient's skin color, so as not to be noticeable when the patient's skin is exposed. As a result, insulin can be transported by the patient discreetly for several days and conveniently applied in small dosages after a single needle stick. For another description of the devices of this type, reference can also be made to the copending order of serial number 11 / 906.130, deposited on September 28, 2007 for DISPOSABLE INFUSION DEVICE WITH DOUBLE VALVE SYSTEM, which the order is owned by assignee of that request and is hereby incorporated in its entirety, by way of reference.
    [0008] [0008] As can be seen from the above, insulin delivery devices to be used close to the body exist in either mechanical or electronic configurations. The mechanical devices do not contain batteries and the necessary energy is supplied by the patient through compression buttons on the device fixed in a small syringe. The mechanical or manual devices currently available adequately deliver bolus or mealtime insulin. However, the patient must inject one or more doses of long-acting insulin daily to provide a basal supply of insulin. Therefore, there is a need to combine both basal release and bolus of insulin in a single manual insulin pump to simplify dosing, soothe pain and optimize compliance. The present invention addresses these and other issues. SUMMARY OF THE INVENTION
    [0009] [0009] The present invention provides a fully manually operated infusion device that provides both a basal and bolus delivery of a liquid medication to a patient. The device includes a main reservoir that supplies the liquid medication, an outlet port that supplies the liquid medication to a patient, and a basal dispenser that releases a substantially constant flow of the liquid medication to the outlet port. The device additionally includes a manually operated bolus pump that releases a bolus dose of liquid medicine from the main reservoir to the outlet when triggered and a supply of basal medicine that releases a volume of liquid medicine from the main reservoir to the basal dispenser in line with each activation of the bolus bomb.
    [0010] [00010] The device may also include a path for fluid overflow from the basal drug supply to the main reservoir to allow the basal dispenser to be maintained in a filled state.
    [0011] [00011] The bolus pump may include a piston pump, the basal drug supply may also include a piston pump, and the device may also include a common driver that manually drives the bolus piston pump together with the pump basal medicine supply piston.
    [0012] [00012] The bolus piston pump and the basal medicine supply piston pump can each have a return stroke and the basal medicine supply piston pump can be refilled with the liquid medicine from the main reservoir during the stroke courses. return.
    [0013] [00013] The bolus piston pump and the basal medicine supply piston pump can share a common piston and piston camera. The basal medicine supply can be refilled as the liquid medicine bolus is released to the outlet and the bolus pump can be refilled as the basal medicine supply releases the liquid medicine volume into the basal dispenser.
    [0014] [00014] The device can also include an alternating valve that, when in a first position, establishes the first concomitant flow paths to recharge the basal drug supply and to release the bolus for the exit and when in a second position , establishes the second concomitant flow paths to recharge the bolus pump and to release the volume of the liquid medication to the basal dispenser. The alternating valve can establish an additional flow path from the basal dispenser to the reservoir when in the second position to provide overflow for maintaining the basal dispenser in a full state.
    [0015] [00015] The basal dispenser can have a filling capacity and the basal drug supply can fill the basal dispenser up to its filling capacity with each activation of the bolus pump. In this modality, the supply of basal medication may include a path for fluids from the main reservoir to the basal dispenser. The fluid path can include a one-way valve.
    [0016] [00016] In another embodiment, the basal dispenser includes a reservoir and each activation of the bolus pump causes the liquid medicine from the main reservoir to drain into and fill the basal dispenser reservoir.
    [0017] [00017] In some embodiments, the basal dispenser includes a supply chamber that has sufficient volume to enable the dispenser to deliver the substantially constant flow of liquid medication to the outlet port for an extended period of time.
    [0018] [00018] The invention additionally provides a fully manually operated infusion device that provides both a basal and bolus delivery of a liquid medication to a patient. The device includes a main reservoir that supplies the liquid medication, an outlet port that releases the liquid medication to the patient, a basal dispenser that releases a substantially constant flow of the liquid medication into the outlet port, and a manually driven bolus pump that releases a bolus dose of liquid medication from the main reservoir to the outlet when triggered and the basal dispenser releases the substantially constant flow of liquid medication to the outlet port subject to stored energy as a direct result of and only due to the manual actuation of the bolus pump . BRIEF DESCRIPTION OF THE DRAWINGS
    [0019] [00019] The characteristics of the present invention, which are believed to be innovative, are presented with particularity in the attached embodiments. The invention, together with its additional features and advantages, can be better understood by referring to the description taken in conjunction with the accompanying drawings, in the various figures of which the same reference numbers identify identical elements, and in which:
    [0020] [00020] Figure 1 is a schematic representation of a basal bolus infusion device to be used close to the body in accordance with an embodiment of the present invention;
    [0021] [00021] Figure 2 is a detailed sectional view of a piston pump that can be used to both deliver bolus doses and to supply the basal medicine dispenser according to an embodiment of the invention;
    [0022] [00022] Figure 3 is a detailed, sectional view of the basal drug supply in Figure. 1;
    [0023] [00023] Figure 4 shows an alternative modality of a basal drug supply;
    [0024] [00024] Figure 4A is a plan view of the Belleville spring used in the embodiment of Figure 4;
    [0025] [00025] Figure 5 is a schematic representation of a basal bolus infusion device to be used close to the body according to another embodiment of the present invention;
    [0026] [00026] Figure 6 illustrates the device in Figure 5 with an alternating valve in it in a first position establishing the first trajectories of concomitant flows for refilling the supply of basal medication and for the release of boluses for the outlet;
    [0027] [00027] Figure 7 illustrates the device of Figure 5 with the alternating valve in it in a second position establishing the second trajectories of concurrent flows for refilling the bolus pump and for releasing the volume of liquid medication to the basal dispenser;
    [0028] [00028] Figure 8 is a schematic representation of a basal bolus infusion device to be used close to the body according to another embodiment of the present invention in which an additional valve is provided to allow the basal medicine dispenser to be quickly filled with the medication;
    [0029] [00029] Figure 9 illustrates the device in Figure 8 in which the basal medicine dispenser is being filled;
    [0030] [00030] Figure 10 illustrates a device similar to the device of Figures 5 to 7 in which the basal medicine dispenser is being filled and in which the device additionally includes overfill protection;
    [0031] [00031] Figure 11 illustrates another device similar to the device in Figures 5 to 7 with overfill protection;
    [0032] [00032] Figure 12 is a side view, in section, of another device according to an embodiment of the invention in which the basal dispenser is filled quickly; and
    [0033] [00033] Figure 13 is a schematic representation of another device according to an embodiment of the invention in which the basal dispenser is filled quickly. DETAILED DESCRIPTION OF THE INVENTION
    [0034] [00034] Now with reference to Figure 1, it is a schematic representation of a basal bolus infusion device to be used close to the body 10 according to an embodiment of the present invention. Device 10 generally includes a main reservoir 12, an outlet port 14, a bolus pump 16, a basal dispenser 18 and a supply of basal medication 20. The outlet port 14 is fluidly coupled to a cannula 22 which extends below of a patient's skin 24 to deliver medication, such as insulin, to the patient. While device 10 and other devices according to an embodiment of the invention can be illustrated here, the device can be physically constructed using the techniques and structures described in application US 12 / 147.283 mentioned above, filed on June 26, 2008 and entitled DISPOSABLE INFUSION DEVICE WITH REDUNDANT SAFETY VALVE, which order is owned by the assignee of that order and is incorporated here in full, by way of reference.
    [0035] [00035] The bolus pump 16 is a piston pump that includes a chamber 30 and a piston 32 that forces the medicine from the chamber 30, through a one-way valve 34 and to the outlet 14 to provide a medicine bolus to the patient. As the piston 32 is returned to its initial position by the spring 36, the chamber 30 is refilled with medicine extracted from the reservoir, 12 through a one-way valve 38.
    [0036] [00036] The basal medicine supply 20 is also a piston pump, and includes a chamber 40 and a piston 42. Piston 42 forces the medicine from chamber 40 into the basal dispenser 18 via a one-way valve 44. As per piston 42 it is returned to its initial position by the spring 46, the chamber 40 is refilled with medicine extracted from the reservoir 12 through a one-way valve 48.
    [0037] [00037] The basal medicine supply 20 and the bolus pump 16 share a common actuator 50. Therefore, whenever a bolus of medicine is released to the patient by the depression of the actuator 50, a volume of medicine is also transferred to the basal dispenser 18.
    [0038] [00038] Basal dispenser 18, also shown in Figure 3 in greater detail, is also a piston pump and has a chamber 60 and a piston 62. The basal dispenser also includes a spring 64 that forces piston 62 into the chamber 60 at a substantially constant speed to provide baseline therapy to the patient through a hydraulic restrictor 66.
    [0039] [00039] The bolus-dose piston pump 16 can be adjusted, for example, to supply 2 or 3 units of medicine. The basal medicine supply piston pump 20, which operates simultaneously with the piston pump 16 when the patient pushes the actuator button 50, may contain a smaller fixed volume, for example, of medicine determined by the relative diameters of each of the chambers 30 and 40. The pressure generated by the small piston 42 can be very high and easily exceeds the spring tension of the spring 64 when the dispenser chamber 60 receives the medication. The basal insulin dose is stored in chamber 60 for delivery to the patient over a long period of time, that is, a few hours.
    [0040] [00040] While the dose in the piston pump 20 is stored in the reservoir 60 during the compressive stroke of the actuator 50, the bolus dose in the piston pump 16 is sent to the outlet 14 and the cannula 22 through the check valve 34 directly to inside the patient. The time period for the release of the basal dose is controlled by the pressure inside the chamber 60 above ambient pressure and the hydraulic restrictor 66 between the basal drug supply chamber 60 and the cannula 22. Therefore, each time the patient releases a bolus dose of insulin, a fixed volume of insulin is refilled into the basal drug supply chamber 60. Since patients have a normal ratio between basal requirement and bolus, diameters or pistons 42 and 32 can be selected from a variety of sizes available to release the proper ratio between basal insulin and bolus insulin. The diameter and length of the hydraulic restrictor 66 together with the compaction force of the spring 64 will determine the time course of the basal release. Such restrictors 66 are known in the art formed with perforation of microlaser or porous metals.
    [0041] [00041] The advantage of this embodiment of the invention is that a single insulin reservoir 12 (usually fast-acting) can be used to deliver both doses of basal and bolus insulin to the patient with the same manipulation of the actuator button on the device. No additional injection of slow-acting insulin is needed while bolus dosing is being practiced. Also, no basal flow electronic device is needed. If a greater stroke volume is required for baseline needs, the two piston pumps 16 and 20 can be reversed and the larger one used to charge the basal reservoir.
    [0042] [00042] Figure 2 shows an alternative piston pump 70 that can be used to both deliver bolus doses and to supply the basal drug dispenser according to another embodiment of the invention. The piston pump 70 displaces less volume in the device.
    [0043] [00043] The piston pump 70 includes a piston cylinder 72 and a piston 74. A bolus of medication is delivered as piston 74 is moved into the cylinder. The stroke of the piston 74 times the area defined by the diameter 33 determines the bolus dose per stroke of the piston 74 when the patient pushes the actuator button 76. The basal dose per stroke is determined by the return stroke (equal to the pressure stroke) times the area defined by diameter 33 minus the area defined by diameter 21. The return stroke is performed by the energy recovered in spring 78. When this alternative version is used, the return pressure in the basal chamber determined by spring 78 needs to be greater than the pressure required to overcome the spring force 64 of the basal medicine dispenser chamber 60. Sealing ring 80 provides a seal between piston 74 and the inner wall of piston cylinder 72. One or more sealing rings can be used in any sealing point for redundancy in this or any other described embodiment of the present invention.
    [0044] [00044] An alternative supply of basal medication is shown in Figures 4 and 4A. Here, insulin is stored between a hard surface 92 and a flexible membrane 94 of a basal medicine dispenser reservoir 96. A Belleville spring 98, also seen in Figure 4A, is used to provide more constant pressure within reservoir 96. This provides a more constant flow rate of the basal insulin dose.
    [0045] [00045] Now with reference to Figure 5, it shows a bolus basal infusion device to be used close to the body according to another embodiment of the present invention. This embodiment 100 employs an alternating valve 102 to establish the flow paths within the device. Device 100 generally includes alternator valve 102, a main reservoir 104, basal dispenser 106, a hand-operated piston pump 108 and a supply of basal drug 110. The alternator valve carries seal rings 112 that form a plurality of valves 114, 116, and 118.
    [0046] [00046] Basal dispenser 106 is like basal dispenser 18 in Figure 1. At its end there is a chamber 120 and a piston 122. Basal dispenser 106 also includes a spring 124 that forces piston 122 into chamber 120 in one substantially constant speed to deliver baseline therapy to the patient through a hydraulic restrictor 126.
    [0047] [00047] The piston pump 108 includes a piston 130. Chamber 132 is used to deliver bolus doses. Chamber 134, which forms part of the basal drug supply 110, supplies basal dispenser 106 with insulin during the return stroke of piston 130.
    [0048] [00048] Figure 6 illustrates the device in Figure 5 with the alternating valve 102 in a first position establishing the first concomitant flow paths for refilling the basal drug supply 110 and for the bolus release to outlet 140. The alternating valve 102 includes an actuator button 142 that has been pressed to a first position as shown in Figure 6. With the actuator button 142 pressed, the actuator piston 136 can be pressed against the force of the spring 138. The depression of the actuator 136 moves the piston 130 to inside the chamber 132 forcing the medicine there along a path indicated by the arrows 146 through the valve 116 and towards the exit 140. This movement of the piston also causes the medicine to be extracted from the reservoir 104 into the chamber 134 of the supply of basal medicine 110 along a path indicated by arrows 148 through valve 114.
    [0049] [00049] Figure 7 illustrates the device 100 of Figure 5 with the alternating valve 102 there in a second position establishing the second flow paths concomitant for refilling the bolus pump 108 and for releasing the volume of the liquid medication from the basal drug supply. 110 for the basal dispenser 106. Here, alternator actuator 142 and valve 102 have been returned to a second or starting position by spring 143. When piston 130 in this way returns to its initial position under the force of spring 138, the drug it will be extracted from the reservoir 104 along a path indicated by the arrows 150, through the valve 116 and into the chamber 132 of the bolus piston pump 108. At the same time inside the chamber 134 the supply of basal medicine 110 is forced by the piston 130 along a trajectory indicated by arrows 152 through valve 118 and into chamber 120 of basal dispenser 106. When this is completed, the medicine is free to flow u basal speed of dispenser 106, through hydraulic restrictor 126 and to outlet 140.
    [0050] [00050] As can be understood from the above, device 100 is fully operated, activated and manually activated. Depending on each basal release, a volume of medication is also supplied to the basal dispenser 106 to support baseline therapy. The pressure in the chamber of the reservoir 120 releases a basal rate rate for the patient through hydraulic resistance 126, the outlet 140 and the cannula 22. In this way, the bolus dosage recharges the basal reservoir and because of the relative and fixed volumes of the chambers 132 and 134, provides the correct ratio between basal insulin and bolus insulin.
    [0051] [00051] At night, when no pre-meal boluses are provided, sufficient basal insulin will be needed for the duration of sleep and until the next bolus (usually a breakfast dose). This can be accommodated in different ways. For example, Figure 8 is a schematic representation of a bolus basal infusion device to be used close to the body 160 according to another embodiment of the present invention that satisfies this need in which an additional alternating valve 168 is provided to allow the basal medicine dispenser is quickly filled with the medicine. Figure 9 illustrates the device 160 of Figure 8 in which the basal medicine dispenser is being filled. Since the device 160 is identical to the device 100 of Figures 5 to 7 (except where otherwise indicated in the present invention), the previous description of Figures 5 to 7 is repeated here and equal reference numbers for like elements are also repeated here.
    [0052] [00052] In the normal position shown in Figure 8, alternating valve 168 directs an insulin bolus to outlet 140 and cannula 22 along a route indicated by arrows 164. In Figure 9, alternating valve 168 was pressed and held . Now when the actuator 136 is pressed, the medicine inside the chamber 132 is forced along a trajectory indicated by the arrows 166 of the chamber 132, through the valve 116 of the alternating valve 102, through the alternating valve 168 and into the chamber 120 of the basal dispenser 106. This allows you to load enough medicine to last an extended period of time, such as eight to ten hours, or for an overnight supply, in the basal dispenser chamber 120. This can be done before bedtime or for charging the chamber of the basal dispenser 120 when the device is first attached to the patient.
    [0053] [00053] An alternative means of providing a sufficient supply of basal insulin is to keep the basal reservoir fully charged with fewer button activations that are typically required for bolus delivery. This is done with each bolus dose episode with the basal loading dose much higher than the bolus dose. Figure 10 illustrates a device 180 similar to the device 100 of Figures 5 to 7 in which the basal medicine dispenser is being filled and in which the device additionally includes overfill protection. Since device 180 is identical to device 100 of Figures 5 to 7, (except where otherwise indicated in the present invention) the previous description of Figures 5 to 7 is repeated here and equal reference numbers for like elements are also repeated here.
    [0054] [00054] Figure 10 shows how a flow path, indicated by arrows 182, can be formed from the chamber of the basal dispenser 120 to the reservoir through a bypass channel 184. Flow path 184 can provide a return path for the reservoir 104 whenever the chamber 120 of the basal dispenser 106 is full. This provides an installation to control the maximum volume of insulin stored in the basal reservoir and ensures a sufficient constant basal supply, at all times, simply by routine bolus dosing. In that mode the volume of the piston chamber 134 can be increased to change the ratio between the relative volumes of chambers 132 and 134.
    [0055] [00055] Figure 11 illustrates another device 200 similar to the device 100 of Figures 5 to 7 with overfill protection. Again, since device 200 is identical to device 100 of Figures 5 to 7 (except where otherwise indicated in the present invention) the previous description of Figures 5 to 7 is repeated in the present invention and equal reference numbers for like elements are also repeated here. Here, unlike the device 100 of Figures 5 to 7, the device 200 includes a shutoff valve of the peak pressure 202. The pressure in the chamber 120, when it is filled and the medication is being forced from the chamber 134 by the piston 130 to fill chamber 120, will increase and open pressure relief valve 202. Excess medication will return to storage reservoir 104 via a flow path indicated by arrows 204 through relief valve 202. This will also ensure storage of enough medicine in chamber 120 of basal dispensation 106 to last for an extended period of time for basal release, such as, for example, eight to ten hours or overnight.
    [0056] [00056] Figure 12 is a side view, in section, of another device 220 of an embodiment of the invention in which the basal dispenser is quickly filled. Rapid filling is accomplished by lifting the 222 chamber either manually as shown or in conjunction with bolus activation. When this occurs, the shoulder-shaped part 224 lifts the diaphragm 230 creating negative pressure within the basal reservoir 232. This causes the check valve 233 to open quickly filling the reservoir. When the chamber 222 is released, the force of the spring 231 compresses the chamber 222 with a force above that of the spring 215. This then pressurizes the reservoir 232 to a pressure determined by the force of the spring 215 and the surface area of the diaphragm 230 causing flow substantially constant through resistor 211.
    [0057] [00057] Figure 13 is a schematic representation of another device 240 of an embodiment of the invention in which the basal dispenser is filled quickly. As can be seen in Figure 13, device 240 includes a reservoir 252, a bolus piston pump 254, a basal medicine dispenser 290, an outlet 280 and a cannula 260. The device additionally includes an alternating valve 251 including piston 271 and formation of a first valve 262 defined by the O-rings 263 and 265 and a second valve 264 defined by the O-rings 267 and 269. A fluid channel 282 defined by the O-rings 265 and 267 is between the valves 262 and 264. Although O-rings are used in the present invention to form seals, other types of valve construction can better employ sealing forms other than O-rings without departing from the invention. The fluid conduit 270 extends between valves 262 and 264. A fluid conduit 272 provides a fluid connection between the reservoir, 252 and the alternating valve 251 and the fluid conduit 274 provides a fluid connection between the alternating valve 251 and the pump 254. A conduit 276 provides a fluid connection between the alternating valve 261 and the outlet of the device 280. The outlet 280 is arranged to communicate with the cannula 260.
    [0058] [00058] It can also be seen that the actuator buttons 246 and 248 are actuated by the springs 266 and 268. The springs are provided to return the actuator buttons to their positions after a dosage is administered.
    [0059] [00059] The pump 254 of the device 240 comprises a piston pump. Pump 254 includes a pump piston 256 and a pump chamber 258. The actuator control button 248 is directly coupled to and is an extension of the pump piston 256.
    [0060] [00060] The basal dispenser 290 is a piston pump and includes a piston 292, a piston chamber 294 and a spring 296. The piston chamber 294 forms the reservoir for the basal dispenser 290. It is fluidly coupled to outlet 280 by a conduit 300 and flow restrictor 330. It is also coupled to the alternating valve 251 via conduits 302 and 304 and a one-way check valve 306.
    [0061] [00061] Piston 292 has an extension 310 that includes a slot 312. A connection 320 rotates around pivot point 322 and is connected to actuator button 248 at one end 324 and to extension 310 of piston 292 when captured in the slot 312 at the other end 326. However, end 326 is free to slide into slot 312.
    [0062] [00062] In operation, with the alternating valve 251 in the position shown in Figure 13, spring 268 is returning actuator button 248 and piston 256 to their starting positions. This causes the drug to be extracted from reservoir 252 into chamber 258 to prepare device 240 for the next bolus release.
    [0063] [00063] During the next bolus release, alternator valve 251 is first pressed causing channel 282 to communicate with piston chamber 258 with conduit 276 and outlet 280. It also causes reservoir 252 to be isolated from the channel 282, conduit 276 and outlet 280 and the reservoir is in fluid communication with conduit 304 through valve 262.
    [0064] [00064] Now, the depression of the actuator button 248 causes the piston 256 to force the medication in chamber 258 through conduit 274, channel 282, conduit 276 and to outlet 280 for release in the cannula 260. The depression of the actuator button stops releasing the bolus also causes connection 320 to rotate around pivot point 322. And this causes end 326 of coupling 320 to pull piston 292 against spring 296. This, on the other hand, causes chamber 294 expand by pulling the medicine from reservoir 252 and into chamber 294 through conduits 272, 304 and 302, valve 262 of alternating valve 251 and one-way valve 306. Therefore, each time a bolus is released by the depression of actuator 248, the chamber 294 of the basal dispenser is filled to its full capacity. Preferably, the capacity of chamber 294 is sufficient to sustain ten continuous hours of basal release by the basal dispenser 290.
    [0065] [00065] Basal release is accomplished by moving piston 292 through spring 296 at a substantially constant rate. This causes the medication inside chamber 294 to flow at a substantially constant rate through conduit 300, through flow restrictor 330 and to outlet 280 and cannula 260. Slit 312 within piston extension 310 allows spring 296 push piston 292 into chamber 294.
    [0066] [00066] Therefore, it can be seen from the aforementioned that the modalities of the present invention provide an insulin delivery device that provides rapid actuation of insulin to provide both basal and bolus needs to a patient and which is triggered only by the mechanical action of the actuators. of the bolus pump. Over a 24-hour period of time, patients tend to use basal insulin at an approximately fixed ratio to the amount of bolus needed for pre-meals. As a result, a specific basal flow rate device can be selected from a variety of "sizes". In the embodiments described here, a substantially constant flow of insulin is released to supply the baseline demand. In the modalities described here, the devices are completely manual and do not require an external power supply. All the pumping of energy comes from the patient's fingers. During the day or active time, the devices have a piston pump that delivers the bolus quantities and simultaneously pumps a basal quantity (at a predetermined rate for the bolus) into a spring-loaded reservoir. The pumping pressures generated by the small cylinders of some modalities are very high, so that the basal quantity is easily loaded against the force of the spring-loaded reservoir basal dispenser. The amount of bolus medication is delivered directly to the cannula, but the basal medication is stored by a release measured over time through that same cannula. The basal spring force releases the basal quantity through a flow restrictor (high hydraulic resistance) to the cannula. The resistance of the flow restrictor is chosen to provide a substantially constant basal flow rate. Each bolus recharges the spring-loaded basal pump. Special springs, known as Belleville springs, can be used for the basal reservoir to maintain a substantially constant force and resulting flow rate.
    [0067] [00067] Since there are no bolus doses while the patient sleeps, in some modalities, means are provided to charge the basal spring-driven pump (reservoir) with a volume sufficient to last all night. In some embodiments, this is accomplished by attaching a third button to the device that directs the bolus piston to also pump into the basal reservoir. In this way, a quick loading of the basal quantity can be done before bedtime or at any time. In other embodiments, a larger basal amount is supplied to the spring-loaded reservoir with each bolus stroke so that each bolus dose refills the basal reservoir. With such modalities, the device always has a sufficient basal supply overnight from one day to the next.
    [0068] [00068] Although specific modalities of the present invention have been shown and described, modifications can be made and, therefore, with the attached embodiments it is intended to cover all such changes and modifications that are within the true spirit and scope of the invention as defined by those achievements.
    权利要求:
    Claims (13)
    [0001]
    Fully manually operated infusion device (10, 100, 160, 180, 200, 220, 240) that provides both basal and bolus delivery of a liquid medication to a patient, characterized by the fact that it comprises: a main reservoir (12, 104, 252) that supplies the liquid medication; an outlet port (14, 140, 280) that releases the liquid medication to a patient; a basal dispenser (18, 106, 290) that delivers a constant flow of liquid medication to the outlet port (14, 140, 280); a manually operated bolus pump (16, 108, 254) comprising a piston pump that releases a bolus dose of liquid medication from the main reservoir (12, 104, 252) to the outlet when activated; and a basal medicine supply (20, 110) comprising a piston pump that releases a volume of liquid medicine from the main reservoir (12, 104, 252) to the basal dispenser (18, 106, 290) according to each actuation the bolus pump (16, 108, 254); wherein each of the bolus piston pump (16, 108, 254) and the basal medicine supply piston pump (20, 110) has a return stroke; a common actuator (50, 136) that manually updates the bolus piston pump (16, 108, 254) and the basal medicine supply piston pump (20, 110) together; where the bolus piston pump (16, 108, 254) and the basal medicine supply piston pump (20, 110) are refilled with the liquid medicine from the main reservoir (12, 104, 252) during the strokes return.
    [0002]
    Fully manually operated infusion device (10, 100, 160, 180, 200, 220, 240) that provides both basal and bolus delivery of a liquid medication to a patient, characterized by the fact that it comprises: a main reservoir (12, 104, 252) that supplies the liquid medication; an outlet port (14, 140, 280) that releases the liquid medication to a patient; a basal dispenser (18, 106, 290) that delivers a constant flow of liquid medication to the outlet port (14, 140, 280); a manually operated bolus pump (16, 108, 254) comprising a piston pump that releases a bolus dose of liquid medication from the main reservoir (12, 104, 252) to the outlet (14, 140, 280) when activated ; a basal medicine supply (20, 110) comprising a piston pump that releases a volume of liquid medicine from the main reservoir (12, 104, 252) to the basal dispenser (18, 106, 290) according to each actuation the bolus pump (16, 108, 254), where each of the bolus piston pump (16, 108, 254) and the basal medicine supply piston pump (20, 110) has a return stroke; a common actuator (50, 136) that manually updates the bolus piston pump (16, 108, 254) and the basal medicine supply piston pump (20, 110) together; where the bolus piston pump (16, 108, 254) and the basal medicine supply piston pump (20, 110) share a piston (74, 130) and a piston chamber (72, 134) in common , in which the basal drug supply (20, 110) is refilled as at the same time as a bolus of liquid medication is released to the outlet (14, 140, 280), and in which the bolus pump (16, 108, 254 ) is refilled at the same time as the basal drug supply (20, 110) releases the volume of liquid medication to the basal dispenser (18, 106, 290).
    [0003]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 1 or 2, characterized by the fact that it still comprises a path of overflow liquid from the supply of basal medication (20, 110 ) to the main reservoir (12, 104, 252) to allow the basal dispenser (18, 106, 290) to be kept in a full state.
    [0004]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 1 or 2, characterized by the fact that it still comprises an alternating valve (102) that, when in a first position, establishes first trajectories concurrent flow rates (304) to recharge the basal drug supply (20, 110) and to release the bolus to the outlet, and when in a second position, establish concomitant second flow paths (304) to recharge the bolus pump (16 , 108, 254) and to release the volume of the liquid medication to the basal dispenser (18, 106, 290).
    [0005]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 4, characterized by the fact that the alternating valve (102) establishes an additional flow path (184) from the basal dispenser ( 18, 106, 290) to the reservoir (12, 104, 252) when in the second position to provide overflow to keep the basal dispenser (18, 106, 290) in a full state.
    [0006]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 1 or 2, characterized by the fact that the basal dispenser (18, 106, 290) has a filling capacity and in which the basal drug supply (20, 110) fills the basal dispenser (18, 106, 290) to its filling capacity with each bolus pump trigger (16, 108, 254).
    [0007]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 6, characterized by the fact that the supply of basal medication (20, 110) comprises a fluid path (304) from the main reservoir (12, 104, 252) for the basal dispenser (18, 106, 290).
    [0008]
    Device (10, 100, 160, 180, 200, 220, 240) according to claim 7, characterized by the fact that the fluid path (304) includes a one-way valve (306).
    [0009]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 7, characterized by the fact that the basal dispenser (18, 106, 290) comprises a reservoir (294) and in which the actuation the bolus pump (16, 108, 254) causes the liquid medication from the main reservoir (12, 104, 252) to drain into and fill the reservoir (294) of the basal dispenser (18, 106, 290).
    [0010]
    Device (10, 100, 160, 180, 200, 220, 240) according to claim 1 or 2, characterized in that the basal dispenser (18, 106, 290) includes a supply chamber (60) having a volume sufficient to allow the dispenser (18, 106, 290) to release the constant flow of liquid medication to the outlet port (14, 140, 280) for an extended period of time.
    [0011]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 4 or 5, characterized by the fact that the dispenser (18, 106, 290) releases the constant flow of liquid medication to the port outlet (14, 140, 280) under stored energy as a direct result and exclusively due to the manual actuation of the bolus pump (16, 108, 254).
    [0012]
    Device (10, 100, 160, 180, 200, 220, 240) according to claim 1, characterized by the fact that the bolus piston pump (16, 108, 254) and the medicine supply piston pump basal (20, 110) share a piston and piston chamber (72, 134) in common, in which the basal medicine supply (20, 110) is refilled at the same time as a bolus of liquid medicine is released to the outlet (14, 140, 280), and in which the bolus pump (16, 108, 254) is refilled at the same time as the basal drug supply (20, 110) releases the volume of liquid medication to the basal dispenser (18, 106, 290).
    [0013]
    Device (10, 100, 160, 180, 200, 220, 240), according to claim 1 or 2, characterized by the fact that the volume of liquid medication released to the basal dispenser (18, 106, 290) is greater than the bolus dose of liquid medicine.
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    同族专利:
    公开号 | 公开日
    EP2675499A2|2013-12-25|
    BR112013021028A2|2016-10-11|
    AU2012218137A1|2013-09-05|
    AU2012218137B2|2016-08-25|
    KR20140005281A|2014-01-14|
    WO2012112289A3|2012-12-06|
    CA2827712C|2019-04-09|
    RU2013142257A|2015-03-27|
    US20120215175A1|2012-08-23|
    WO2012112289A2|2012-08-23|
    KR101906786B1|2018-10-12|
    RU2608622C2|2017-01-23|
    CN103702696B|2016-04-06|
    EP2675499A4|2017-08-30|
    JP5972909B2|2016-08-17|
    CN103702696A|2014-04-02|
    JP2014508005A|2014-04-03|
    US8753315B2|2014-06-17|
    CA2827712A1|2012-08-23|
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    法律状态:
    2018-12-18| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-09-15| B06A| Notification to applicant to reply to the report for non-patentability or inadequacy of the application [chapter 6.1 patent gazette]|
    2021-01-19| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2021-03-23| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 30/01/2012, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201161444121P| true| 2011-02-17|2011-02-17|
    US61/444,121|2011-02-17|
    US13/360,485|2012-01-27|
    US13/360,485|US8753315B2|2011-02-17|2012-01-27|Manual basal bolus drug delivery device|
    PCT/US2012/023145|WO2012112289A2|2011-02-17|2012-01-30|Manual basal bolus drug delivery device|
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