CN101500624A

CN101500624A - Disposable infusion device with medicament level indicator

Info

Publication number: CN101500624A
Application number: CNA2007800201386A
Authority: CN
Inventors: 约翰·M·亚当斯; 克利夫顿·A·阿尔费尼斯; 丹尼尔·霍金斯
Original assignee: Calibra Medical LLC
Current assignee: Calibra Medical LLC
Priority date: 2006-05-31
Filing date: 2007-05-25
Publication date: 2009-08-05
Also published as: CN101478957A; CN101478999A; CN101478999B

Abstract

A wearable infusion device delivers a liquid medicament, such as insulin, to a patient. The device comprises a base that contacts a patient's skin, a reservoir arranged to contain a liquid medicament to be delivered to beneath a patient's skin, a pump that causes the medicament to flow from the reservoir, and a level indicator that provides an indication of medicament level.

Description

Disposable infusion device with medicament level indicator

Priority request

This application requires the U.S. Provisional Application No.60/809 that submits on May 31st, 2006 be merged in by reference, 957 and the title submitted on May 10th, 2007 be the priority of the novel application of U.S. utility of " DISPOSABLE INFUSION DEVICE WITH MEDICAMENT LEVELINDICATOR ".

Background technology

Showed already that the strictness control for insulin administration in type i diabetes (being generally young hair style) and type ii diabetes (being generally the late hair style of adult) had improved these patients' quality of life and holistic health level.The administration of insulin is diet to be compensated with the basic needs that satisfy the patient and by short-acting insulin by the subcutaneous injection protamine zine insulin to implement.Recently, the development of electronic external insulin infusion pumps has allowed at the lasting transfusion of keeping the Semilente Insulin that the basis needs and at the compensation liquid level of diet.These transfusion systems have demonstrated the control that has improved blood sugar level, yet they but have the shortcoming of size, cost and complexity aspect, and these shortcomings have hindered a lot of patients to accept the hypodermoclysis of this technology with alternate standard.Basis and the pre-meal insulin with the supply aequum controlled and need be programmed to these pumps electronically.

Therefore, in this technical field, exist to be used for basis needs and need before the meal, the simple demand of Mechanical Driven infusion set, this infusion set directly is attached to health and and without any need for electronic device medicine-feeding rate is programmed.Be similar to prior art, preferably insulin be transported in the subcutaneous tissue by skin by little, sheet-metal duct (sleeve pipe).

In the use of this kind device, if the user can distinguish the liquid level (level) of liquid medicine, such as the remaining amount that will distribute, then this kind device will be desirable.But, consider that claimed apparatus is small-sized, and throwing aside of device also need economically feasible, making provides such indicator to be difficult to current techniques.The present invention is directly at these or other problem about such device.

Summary of the invention

The invention provides a kind of infusion set of wearing, it comprises: the base portion of contact patient skin; Reservoir, this reservoir are arranged to hold the liquid medicine that will be transported to below the patient skin; Pump, this pump make medicine flow along reservoir; And fluid level indicator, this fluid level indicator provides the indication of medicament level.

The indication of medicament level can make the amount of remaining medicine in the indication reservoir.Fluid level indicator can comprise display.Display can be a conformable display.Analog information can comprise the pop-up indicator such as display pointer.

Reservoir can be formed by flexible material, and changing shape in response to the amount of medicine, and fluid level indicator can be in response to the variation of reservoir shape with the indication medicament level.The STATEMENT OF FEDERALLY SPONSORED that this installs the follower of the variation that also comprises the shape of following reservoir and follower is attached to fluid level indicator.Fluid level indicator can comprise that pop-up indicator and STATEMENT OF FEDERALLY SPONSORED can be connected to pop-up indicator with follower.

This device also comprises the shell that covers base portion and closed reservoir and pump.This shell can comprise window, can check fluid level indicator by this window.Fluid level indicator can comprise display pointer.

Brief Description Of Drawings

In claims, elaborated the novel characteristics that is considered to of the present invention.By combining with accompanying drawing following explanation is carried out with reference to understanding further feature and the advantage of the present invention together with it best, among several secondary figure in described accompanying drawing, same reference number identifies components identical, and wherein:

Fig. 1 is the perspective view that embodies infusion set of the present invention;

Fig. 2 is the perspective view of the device of Fig. 1, and wherein its top cover is removed and is in and prepares to utilize in the state of its reservoir of liquid medicine filling;

Fig. 3 is the perspective view of infusion set after its reservoir is filled by liquid medicine at Fig. 1, and wherein its top cover is removed;

Fig. 4 is Fig. 1 infusion set, the cut perspective view of some parts, illustrates the path of liquid medicine in this device;

Fig. 5 is the top view of Fig. 1 device, and wherein its reservoir is removed, and is used for signal and causes liquid medicine in the mobile mode of this device;

Fig. 6 is the perspective view of Fig. 1 infusion set, and wherein its reservoir is removed, and is used to illustrate its others of pump;

Fig. 7 is the perspective view of the cut Fig. 1 infusion set of some parts, is used for illustrating being in the safety check-valves of its open position;

Fig. 8 is the perspective view that is similar to Fig. 7, illustrates the safety closure of check ring;

Fig. 9 is the perspective view that can be used for the reservoir of Fig. 1 infusion set according to alternate embodiments;

Figure 10 is the cut perspective view of the some parts of Fig. 9 reservoir, is used to illustrate according to its others of the present invention;

The perspective view of another infusion set that Figure 11 is according to another embodiment of the present invention to be arranged;

Figure 12 is the cross-sectional perspective view of this device of Figure 11, is used to illustrate reservoir and STATEMENT OF FEDERALLY SPONSORED and display pointer when reservoir is cleared; And,

Figure 13 is the cross-sectional perspective view of this device of Figure 11, is used to illustrate reservoir and STATEMENT OF FEDERALLY SPONSORED and display pointer when reservoir is filled.

The specific embodiment

With reference now to Fig. 1,, its signal embodies infusion set 100 of the present invention.For example, when providing the big liquid level liquid medicine that will carry below patient skin such as insulin, infusion set 100 can be useful.

Device 100 generally includes base portion 110, top cover 120 and sleeve port 130.The base portion 110 that at first is applied to patient skin has first tab member 112 and second tab member 114.First tab member 112 when being removed, exposes sterilization material layer 116, and sterilization material for example is an ethanol, it can be in the zone of adhering apparatus 100 the wiping patient skin.In case antibacterial has been applied to patient skin, second fin 114 is removed, and to expose the adhesion layer on the base portion 110, this adhesion layer is used for device is adhered to patient skin then.In case this device is adhered to patient skin, by sleeve port 130, sleeve pipe be directed in this device and patient skin below.

As finding out in Fig. 2, device 100 also comprises a pair of actuator button 120 and is positioned to receive the reservoir 140 of liquid medicine.As seeing hereinafter, while depressed actuator button 120 causes the liquid medicine in the reservoir 140 to flow down flexible conduit 150 and finally flows to below the patient skin.The

related springs

122 and 124 of the starting position by button 120 being turned back to they is carried out spring to each button 120 and is loaded.

Reservoir 140 as shown in FIG. 2 is receiving fluids medicine not as yet.When reservoir 140 emptied, blocking mechanism 160 prevented that button 120 is depressed., will notice that tappet 162 is striden reservoir 140 extensions and ended at closed block 164 places for this reason.Block 166 is coupled to button 120 and engage latch parts 164 to prevent that actuator button 120 is pressed when reservoir empties.

With reference now to Fig. 3,, when anticipating as shown in FIG. 3 like that, when filling reservoir, tappet 162 moves along with the expansion of reservoir 140.For this reason, reservoir 140 preferably by flexible material for example plastics form, and when being filled, will expand.Tappet 162 moves with rising closed block 164 along with the filling of reservoir 140.When reservoir was filled, closed block 164 was raised to following degree, thereby made that promptly block 166 can be at it down through causing to patient's pumping liquid medicine to allow button 120 to be depressed.And

spring

122 and 124 assists button 122 is turned back to the starting position.

Reservoir 140 as noticing, comprises a plurality of raised portions 142 that form along its periphery in Fig. 3.This reservoir shape causes and form air pocket in reservoir, and this air pocket is caught with reservoir and exported 144 isolated air.Correspondingly, intention is when carried device 100, and its major axis 102 is levels.In this orientation, the air in reservoir 140 can be trapped in air pocket for example in the air pocket 146.

With reference now to Fig. 4,, its signal is when in response to depressed actuator button 120 during the pumping liquid medicine, the fluid flow path of liquid medicine.With dashed lines in Fig. 4 (dashed line) illustrates fluid flow path.As can be noted, the fluid flow from reservoir 140 starts from outlet 144 along flexible conduit 148.Utilize pump, the linear peristaltic pump 170 that for example will be described below comes the propulsive fluid medicine.It at first flows through valve 180, and valve 180 can be configured to when pump 170 pumping fluid medicines pump 170 be isolated from reservoir 140.Valve 180 is alternatively in some cases, for example when as will be hereinafter fully as described in, when using the linear peristaltic pump of described type here.

Thereby fluid continues along flexible conduit 148 mobile sleeve pipe 200 places that finally arrive.It is fed to the patient below patient skin then.

Fig. 5 and 6 illustrates the peristaltic pump of device 100 in further detail.Here, as can be seen, this peristaltic pump comprises a pair of press member 172 and 174.Press member 172 and 174 is placed on the opposite side of flexible conduit 148.Utilization is being indicated fluidic flow direction away from the arrow on the direction of reservoir (not shown) 149.Press member 172 and 174 is spaced, thereby on the updrift side with respect to fluid flow, they become more close gradually.Therefore, when press member 172 and 174 acted on the flexible conduit 148, they will be used at first clamping flexible conduit made its closure, and then, when applying other pressure, the extrusion conduit is upwards to oppress liquid medicine in downstream side.

As previously mentioned, valve 180 is alternatively.If the pump that is utilized is not that then valve 180 can be coupled to actuator button 120, thereby is utilizing pump before exerting pressure on the flexible conduit 148, valve 180 closure catheter for closing 148 as the pump of the at first closure catheter for closing of here illustrating.For this reason, valve 180 comprises first valve part 182 and the second fixed valve parts 184.When depressed actuator button 120, valve part 182 pivots around pivotal point 186 and makes its closure to clamp flexible conduit near fixed part 184.

In Fig. 6, can be clear that more, each press member 172 with 174 all with actuator button 120 in relevant one form.More specifically, each press member part that all can form as one with its actuator button 120.Because it is disposable needing device 100, actuator button and therefore press member 172 and 174 can form by plastics.

In case actuator button 120 is depressed and peristaltic pump 170 causes liquid medicine to flow downward along flexible conduit 148, actuator button 120 is turned back to their starting position by their

springs

122 and 124 separately.At this moment, flexible conduit 148 is fluid-filled to cause fluid medicine to leave sleeve pipe 190, anticipates as shown in FIG. 4.In order to resist the back pressure in sleeve pipe 190 and the flexible conduit, otherwise this will reduce the amount of the liquid medicine that is received by the patient, and check-valves 190 is provided.Check-valves 190 is positioned at the downstream of pump 170 and carries out two kinds of functions at least.At first, check-valves 190 prevents when cutting out that medicine from refluxing and guarantees that from the check-valves to the sleeve pipe medicine in 200 the flexible conduit finally spreads in patient's body.It prevents that also the liquid medicine accident is leaked in patient's body between the actuating of button 120.

Especially with reference to figure 7 and 8, in Fig. 7, can notice, utilize the shut-off block 192 that is coupled to actuator button 120 at attachment point 194 places to form valve 190.When actuator button 120 was side by side depressed, shut-off block 192 slided into the position of indicating among Fig. 7 and arrives open position, to allow fluid flow by flexible conduit 148.As can in Fig. 8, seeing, when actuator button 120 is released, cause shut-off block 192 on the direction of flexible conduit 148, moving, and finally between shut-off block 192 and fixation wall 196, clamp flexible conduit 148 and make its closure.In case valve 190 is closed as shown in Figure 8, will allow liquid medicine unexpectedly to drip, flow through conduit, and be transported to the patient from reservoir.

With reference now to Fig. 9 and 10,, they illustrate the alternative flexible reservoir that can be used to according in the infusion pump of the present invention.Flexible reservoir 240 is formed by flexible sheet material, comprises sheet 242 and sheet 244.

Sheet material

242 and 244 sealed along peripheral seal line 246.Notice that as can in Fig. 9 and 10, knowing reservoir 240 is shaped as and is forming formation raised portion 250 on raised portion 248 and the opposite side at reservoir on reservoir one side.Raised

portion

248 and 250 can be the tip shape zone with concave sidewalls.For example, pointed regions 248 has concave sidewalls 249 and pointed regions 250 has concave sidewalls 251.

When reservoir 240 is placed in infusion set for example in the infusion set 100 of Fig. 1 the time, it can be put to making

raises zone

250 and 248 along the limit with basic stay (pane).Put the zone 250 that becomes to make to raise at reservoir 240 and be positioned under the situation about raising above regional 248, will form air pocket in reservoir 240, for example air pocket 253.Air pocket 253 is isolated to guarantee in the liquid medicine that just is transported to the patient without any air with outlet 256.

With reference now to Figure 11,, it illustrates embodies another infusion set 300 of the present invention.As infusion set 100, infusion set 300 can be useful at the liquid medicine such as insulin with big liquid level aspect providing to patient's skin.

Device 300 generally includes base portion 310, top cover or shell 320, and sleeve port 330.Show the base portion 310 of preparing to be adhered to patient skin.Before being applied to patient skin, this device can have foregoing with the device 100 first and second tab member 114 that are connected.In case this device is adhered to patient skin, by sleeve port 130, the sleeve pipe (not shown) be directed in this device and patient skin below.

Device 300 also comprises a pair of actuator button 325 and is positioned to receive the reservoir 340 (Fig. 2) of liquid medicine.In embodiment in front, simultaneously depressed actuator button 325 causes the liquid medicine in the reservoir 340 to flow and finally flow to below the patient skin along the flexible conduit (not shown).For this reason, infusion set 300 can comprise the pump (not shown) of type as previously described.In the preferred spring load button 325 each is to turn back to button 325 their starting position.。

Reservoir 340 as shown in Figure 12 is receiving fluids medicine not as yet.On fluid level indicator 360, accurately indicated this point.Fluid level indicator comprises the mechanical display pointer 362 of pivotally installing and can passing through window 364 observations of shell 320.By STATEMENT OF FEDERALLY SPONSORED 366 display pointer 362 is attached to reservoir 340.Reservoir comprises the flexible tab parts 342 that change shape when filling and emptying reservoir.When filling reservoir 340 as shown in figure 13, reservoir 340 expansions in the accompanying drawings and flexible flap parts 342 upward deflect.Thereby this causes STATEMENT OF FEDERALLY SPONSORED 366 to promote display pointer 362 its indication reservoir around the pivot (not shown) is full.In this identical mode, but on opposite direction, when the reservoir contraction promptly was cleared, fluid level indicator will be indicated the liquid level of remaining liq medicine.

Therefore, as finding out from aforementioned, the invention provides a kind of simple, Mechanical Driven infusion set, this infusion set provides big liquid level liquid medicine such as insulin, and can directly be attached to patient body.This device is also carried or to carrying programming without any need for electronic device.As known in the art, can liquid medicine such as insulin be transported in patient's the subcutaneous tissue by small casing.The present invention further comprises the fluid level indicator of indicating medicament level.This fluid level indicator provides the accurate indication of medicament level and increases seldom installation cost to keep its disposable property.

Though illustrated and described specific embodiments of the invention, can modify, and therefore in claims expectation contain and fall into as by the true spirit of the present invention that those claim limited and all this change and the modification of scope.

Claims

1. can wear infusion set for one kind, comprise:

The base portion of contact patient skin;

Reservoir, described reservoir is positioned to receive the liquid medicine that will carry below patient skin;

The pump that causes medicine to flow down along reservoir; With

The fluid level indicator of the indication of medicament level is provided.

2. device according to claim 1, the indication of wherein said medicament level are the amounts of remaining medicine in the described reservoir of indication.

3. device according to claim 1, wherein said fluid level indicator comprises display.

4. device according to claim 3, wherein said display is a conformable display.

5. device according to claim 4, wherein said conformable display comprises pop-up indicator.

6. device according to claim 5, wherein said pop-up indicator comprises display pointer.

7. device according to claim 1, wherein said reservoir is to be formed by flexible material, wherein said reservoir changes shape in response to the amount of wherein medicine, and wherein said fluid level indicator is indicated medicament level in response to the change of described reservoir shape.

8. device according to claim 7, further comprise the shape of following reservoir variation follower and described follower is attached to the STATEMENT OF FEDERALLY SPONSORED of described fluid level indicator.

9. device according to claim 8, wherein said fluid level indicator comprise that pop-up indicator and wherein said STATEMENT OF FEDERALLY SPONSORED are attached to described pop-up indicator with described follower.

10. device according to claim 1 further comprises the shell that covers described base portion, described reservoir of described shell seal and described pump, and wherein said shell comprises window, can observe described fluid level indicator by described window.

11. device according to claim 10, wherein said fluid level indicator comprises display pointer.