CN101522234B - Systems, devices and methods for fluid/drug delivery - Google Patents

Systems, devices and methods for fluid/drug delivery Download PDF

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Publication number
CN101522234B
CN101522234B CN2007800339432A CN200780033943A CN101522234B CN 101522234 B CN101522234 B CN 101522234B CN 2007800339432 A CN2007800339432 A CN 2007800339432A CN 200780033943 A CN200780033943 A CN 200780033943A CN 101522234 B CN101522234 B CN 101522234B
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China
Prior art keywords
delivery system
fluid delivery
tube
fluid
penetrates
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CN2007800339432A
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CN101522234A (en
Inventor
O·约迪法特
G·J·伊丹
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Medingo Ltd
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Medingo Ltd
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Priority claimed from PCT/IL2007/000932 external-priority patent/WO2008012817A1/en
Publication of CN101522234A publication Critical patent/CN101522234A/en
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Abstract

Fluid delivery systems, methods and devices for delivering a therapeutic fluid to the body of the patient are disclosed. A fluid delivery device (100) for delivering fluid to the body of the patient includes a housing having an upper wall (534) and a lower wall (536), wherein the upper wall includes an upper opening (116) and the lower wall includes a lower opening (540), a well-arrangement mechanism (510) configured to be disposed inside the housing and between the upper wall and the lower wall and including a tubular member (322) having a bore (326), wherein the bore is configured to be disposed between the upper opening and the lower opening, and a penetrating cartridge (662) for delivery of therapeutic fluid to the body of the patient, wherein the penetrating cartridge is configured toengage the bore following its insertion through the upper opening and the lower opening, wherein therapeutic fluid is configured to be delivered through the tubular member into the penetrating cartri dge into the body of the patient when the penetrating cartridge engages the bore.

Description

Be used for system, apparatus and method that fluid/medication is carried
The cross reference of related application
The U.S. Provisional Application No.60/833 that the application requires Yodfat to submit on July 24th, 2006; The 110 U.S. Provisional Application No.60/837 that submit on August 14th, 2006 with Yodfat; 877 priority, the whole contents of these applications is incorporated into this as quoting.
Technical field
The present invention relates to be used for system, the apparatus and method of treatment fluid to patient (patient) conveying more specifically, are related to portable infusion apparatus (for example pump).Some embodiments of the present invention relate to infusion set, and it can directly be adhered on patient's the skin.Some embodiments of the present invention are paid close attention to a kind of " well device (well-arrangement) ", and it links the liquid reservoir (container) from infusion set fluid delivery tube that stretches out and the intubate that is used for the subcutaneous insertion of patient body.
Background technology
The fluidic traditional subcutaneous delivery device of treatment that gets into patient body also is called as the portable infusion pump of revocable " similar pager ", and it mainly is used to successive insulin and carries.Typically, the pump of these similar pagers is attached to and is fixed on patient's belt on one's body.Then, long carrier pipe is connected with the liquid reservoir in the said device, also is connected with the subcutaneous intubate of infusion set.
In order to carry medicine continuously and to have developed traditional on-fixed infusion pump to the patient.These revocable infusion pump comprise liquid reservoir and the long tube that is used for carrying to the subcutaneous intubate of infusion set medicine usually.Said intubate is inserted into the sharp-pointed member that penetrates usually.The instance of such infusion pump is at United States Patent(USP) No. 6,423, is disclosed in 035 and No.6,872,200.
Be disclosed in other instances patent below of traditional fluid infusion apparatus.The United States Patent(USP) No. 6,830,562 of the United States Patent(USP) No. 6,093,172 of Funderburk etc. and Mogensen etc. discloses a kind of injection device that comprises the spring-loaded piston of the automatic subcutaneous placement that is used for infusion set.The United States Patent(USP) No. 6,699 of Flaherty etc., but 218 a kind of device of the skin adherence that is used for fluid is carried to the patient is disclosed, and it comprises the outer housing with fluid storage compartment.Said fluid storage compartment be used for fluid is communicated with by the allotter fluid that limited amount distributes to spout assembly from liquid reservoir, fluid medicine is discharged from said spout assembly, and the entering patient body.Device in the patent of Flaherty also can be realized automatic intubate insertion.Through using the greatly relative heavier and bigger parts of expanding unit size, such insertion can realize.
After inserting, do not consider the motion of patient body or the relative motion between pump outer housing and the intubate, intubate stably remains on its subcutaneous position.But this has caused all difficulties of the infusion set of skin adherence.
Another problem of present infusion set comprises that some patient is unwilling to stick a needle into themselves skin.Such patient uses automatic-inserting device to solve said problem usually.Other patient prefers manually inserting method.
To some shortcomings general introductions of traditional apparatus and method of patient's conveyance fluid as follows:
Long pipeline: in the insulin pump of common similar pager, long fluid delivery tube is easy to fold, knot, break and/or separate.In addition, such pipe is considered thoughtful and restriction patient's behavior.
Inflexible intubate connects: but in the pump of traditional skin adherence, intubate is connected with outer housing rigidly, and like this, the moving suddenly of patient body will cause the patient uncomfortable and intubate is separated with the patient and/or separate with the outer housing that installs.
Insert mechanism: some traditional insertion mechanisms are bonded in the device outer housing.Such device is heavier relatively and bigger, and (3-4 days usually) are carried by user during whole operation.
The intubate of single hop: the intubate of the preparatory installation in some present infusion sets only has a section of predetermined length.
The fixing angle of inserting: in the device of some traditional similar pagers, the patient can only insert infusion set with single predetermined angle of penetration, and said angle of penetration is generally 30 °, 45 ° or 90 °.
Therefore, expectation provides a kind of system, device and/or method, to solve the problem above-mentioned of traditional fluid delivery system.Especially, expectation provides a kind of subcutaneous intubate that can be implemented in the maximum flexibility ratio of selecting on intubation length, inserted mode and the angle of penetration of patient to insert.
Summary of the invention
Some embodiments of the present invention relate to portable fluid delivery system and the device and method that is used to deliver the fluid to the patient.Such system allows intubate to use the independence " insert " that after intubate is inserted, need not carry and passes through " well device " insertion.The present invention also allows user to select multiple intubation length and/or inserts angle.
In some embodiments of the invention; But through use have pump and be used to treat the conveyer device of the skin adherence of fluidic liquid reservoir, device that fluid between the carrier pipe of drawing from said liquid reservoir and the intubate that is used to the pipe is provided and insert the patient hypodermically is communicated with, can avoid the use of long tubing.In certain embodiments, the said device that is used to provide fluid to be communicated with is called as " well device ".
Some embodiments of the present invention provide greater flexibility through the required angle of penetration (for example spending about 90 degree (or bigger) from about 0) that realizes supplying the patient to select for the patient.The present invention can be set to through preventing separating and treating the interruption of fluid to patient's supply of infusion set and intubate, thereby does not limit patient movement, and offers the better safety of patient.
Some embodiments of the present invention can realize:
Well device delivery pipe and the fluid between the intubate by means of special use are communicated with;
The variation of angle of penetration (for example 0 to 90 degree (or bigger));
Automatic and the manual subcutaneous insertion of intubate;
Relatively moving between intubate and the pump is so that intubate mobile insensitive to the pump outer housing.
In certain embodiments, carrier pipe is communicated with the intubate fluid through Connection Element, and said Connection Element is called as the well device.Said device comes into question in common unsettled, total Israel patent application No.171813, and its disclosure is incorporated into this through its integral body is quoted.Said well device can be realized the insertion of needle assembly, and said assembly comprises and penetrates member (for example pin) and intubate.After in thrusting skin, then insert intubate and extract pin out, the fluid connection between carrier pipe, intubate and the subcutaneous tissue promptly is able to set up and keep.
In certain embodiments, said well device above that side can comprise and can be set to the openings/apertures that is used to load.The patient can fill liquid reservoir and carrier pipe.Through observing the drop in the openings/apertures, the patient can know does not have bubble to stay in the system.After in thrusting patient's skin, openings/apertures can be set to by rubber cap and seal.Said rubber cap can be attached on the intubate, to prevent the leakage in the device operating process.The downside of well can be set to by rubber septum and close.In thrusting the process of skin, the rubber septum of bottom is needled into, and rubber cap seals up upper opening/hole simultaneously.Use the well equipment mechanism, the present invention also can be set to fluid delivery tube is connected with intubate.
In certain embodiments, said well device can be set to unsteady arrangement form and be connected with the outer housing of fluid delivery system.Especially, use said arrangement form, relatively moving between intubate and the outer housing can be able to allow, thereby it is uncomfortable and/or eliminated the isolating probability of intubate to have reduced the patient who does not expect.
In certain embodiments, said well device comprises tubular element, and it can be provided with and be used for the cross walkway that intubate is inserted.Vertical sidepiece path that said cross walkway can be set to through being arranged in the said tubular element is communicated with the carrier pipe fluid.The zone of the said well of reception of outer housing can be set to and/or be provided with to be of a size of can realize the pressure rotation of tubular element along its longitudinal axis.Therefore by means of this set, anyone can change the inclination angle of cross walkway with respect to patient skin, and penetrates member and thrust the angle that skin and intubate be inserted into and can be changed.Penetrating assembly can be set to by means of special instrument (for example " insert ", a kind of such insert is described below) and manually or automatically be inserted in the tubular element.Tubular element can be above-described " floating " form.
In certain embodiments, be used for the fluid delivery system of treatment FLUID TRANSPORTATION to patient body is provided, and can be set to the module unit that comprises have single use portion (disposable portion) and reusable part.Single use portion can be set to and comprise the first wall that is arranged at said single use portion and the well device between second wall.First aperture can be arranged in the first wall, and second aperture can be arranged in second wall.The well device can comprise tubular element, and said tubular element has the side path between hole, the inlet that is communicated with the carrier pipe fluid and said inlet and the said hole.
In the above embodiments, tubular element can be set to rotatable, so that said hole can be positioned a plurality of positions.
Some embodiments of the present invention comprise the tube that penetrates that is used in the fluid delivery system.Penetrating tube can be set to and comprise main part, intubate and be suitable for thrusting the member that penetrates in patient's the skin.Main part comprises and is used to second chamber that receives fluidic first chamber and be communicated with the intubate and first chamber.
In yet another embodiment, be used for the fluid delivery system of treatment FLUID TRANSPORTATION to patient body can be set to and comprise that the fluid delivery system with module unit, said module unit comprise single use portion and reusable part.Single use portion comprise first wall, have second wall, the fluid delivery tube in second aperture and be arranged at first wall with first aperture and second wall between the well device.Said well device can comprise the tubular element of the inlet that has the hole, be communicated with the carrier pipe fluid and the side path between inlet and hole.Tubular element can be rotatable, so that said hole can be positioned a plurality of positions of first and/or second wall vertical (for example) of said relatively single use portion.Said system also can comprise the tube that penetrates in the hole that can be received in tubular element, and wherein, the said tube that penetrates can comprise intubate and be suitable for thrusting the member that penetrates in the patient skin.The main part that penetrates tube can comprise and is used to second chamber that receives fluidic first chamber and be communicated with intubate and said first chamber.
Can comprise " insert " instrument in the some embodiments of the present invention, with as being used for penetrating the device that assembly (" penetrating tube ") automatically inserts tubular element.Said insert instrument can penetrate tube by patient or maker preloaded before insertion.User can make the insert instrument align with cross walkway, and discharges the tube that penetrates of preloaded through the button that promotes actuator.
Tubular element and insert instrument can be provided with separately be pressed into groove and projection, thereby can realize insert instrument and tubular element make things convenient for interlock (joint), and penetrate aliging accurately of member and cross walkway.
In certain embodiments, insert has additional function.In case insert and tubular element be pressed into the groove interlock, user can be so that tubular element (comprising said well) rotates to required angle of penetration.In other words, insert not only is used for alignment, and it also can be used as the device that is used to adjust angle of penetration.
In certain embodiments, the present invention relates to a kind of fluid delivery system that is used to deliver the fluid to patient body.Said fluid delivery system comprises outer housing, the well equipment mechanism with upper wall and lower wall and penetrates tube; Wherein said upper wall comprises upper opening and said lower wall comprises lower openings; Said well equipment mechanism is set to and is arranged between outer housing inside and upper wall and the lower wall; And comprise the foraminous tubular element of tool; Wherein said hole is set to and is arranged between said upper opening and the said lower openings, and the said tube that penetrates is used to treat the conveying of fluid to patient body, wherein said penetrate tube be set to along with its through the insertion of upper opening and lower openings with the interlock of said hole.The treatment fluid is set to when penetrating tube with the interlock of said hole, delivers into through tubular element and penetrates tube, and get in the patient body.
In certain embodiments, the present invention relates to a kind ofly be used to use fluid delivery system to deliver the fluid to the method for patient body.Said fluid delivery system comprises outer housing, the well equipment mechanism with upper wall and lower wall and penetrates tube; Wherein said upper wall comprises upper opening and lower wall comprises lower openings; Said well equipment mechanism is set to and is arranged between outer housing inside and upper wall and the lower wall; And comprise the foraminous tubular element of tool; Wherein said hole is set to and is arranged between said upper opening and the said lower openings, and the said tube that penetrates is used for treating the conveying of fluid to patient body, wherein said penetrate tube be set to along with its through the insertion of upper opening and lower openings with the interlock of said hole.Said method comprising the steps of: will penetrate in the hole of fill-in well equipment mechanism up to said and penetrate tube and the interlock of said hole; And when said when penetrating tube, will treat FLUID TRANSPORTATION through said tubular element and get into and penetrate tin and get in the patient body with said hole interlock.
The structure of the more feature and advantage of the present invention and each embodiment of the present invention at length discloses with operating in reference to the accompanying drawings.
Description of drawings
Present invention is described with reference to accompanying drawing.In the accompanying drawings, identical Reference numeral is represented identical or intimate element.In addition, in most of the cases, leftmost one digit number or long number are represented the accompanying drawing that said Reference numeral occurs first in the Reference numeral.
Fig. 1 is the exploded view according to the exemplary fluid conveyer device of some embodiments of the present invention;
Fig. 2 is the assembly drawing of the exemplary fluid conveyer device shown in Fig. 1;
Fig. 3 is another exploded view of the exemplary fluid conveyer device shown in Fig. 1;
Fig. 4 shows another assembly drawing of other details of the fluid delivery system shown in Fig. 1;
Fig. 5 shows the example well equipment mechanism according to the fluid delivery system of some embodiments of the present invention;
Fig. 6 shows the exemplary tube that penetrates according to well equipment mechanism some embodiments of the present invention, shown in Fig. 5;
Fig. 7 a is another view that penetrates tube shown in Fig. 6;
Fig. 7 b is the cutaway view according to the exemplary tub of the well equipment mechanism of some embodiments of the present invention;
Fig. 7 c is the cutaway view that penetrates tube shown in Fig. 6;
Fig. 8 is the exploded view that penetrates tube shown in Fig. 6;
Fig. 9 is the exploded view that penetrates tube shown in the tub shown in Fig. 7 b and Fig. 6;
Figure 10 according to some embodiments of the present invention, be inserted into tub penetrate the tube cutaway view;
Figure 11 according to some embodiments of the present invention, be inserted in the tub and penetrate the cutaway view that penetrates tube that member shifts out from penetrate tube;
Figure 12 is inserted in the tub and penetrates another cutaway view that penetrates tube that member shifts out from penetrates tube;
Figure 13 is according to some embodiments of the present invention, the cutaway view that penetrates tube of inclination before in the tub of fill-in well equipment mechanism;
Figure 14 a-d is according to the cutaway view of the tub of some embodiments of the present invention, well equipment mechanism;
Figure 15 is another cutaway view of the tub shown in Figure 14 a-d;
Figure 16 shows according to exemplary fluid conveyer device some embodiments of the present invention, that be set to the pressure rotation that can realize tub;
Figure 17 is another illustration of the exemplary fluid conveyer device shown in Figure 16;
Figure 18 is another illustration of the exemplary fluid conveyer device shown in Figure 16;
Figure 19 show according to some embodiments of the present invention, be set to and allow to penetrate the exemplary fluid conveyer device in the tub of automatic fill-in well equipment mechanism;
Figure 20 is another illustration of the exemplary fluid conveyer device shown in Figure 19;
Figure 21 show according to some embodiments of the present invention, be set to allow to penetrate the tube with the exemplary fluid conveyer device in the tub of the automatic fill-in well equipment mechanism of required angle;
Figure 22 shows according to some embodiments of the present invention, shown in Figure 19 and be used for penetrating the exemplary fluid conveyer device that the device of the insertion of tube shifts out from the tub of well equipment mechanism;
Figure 23 show according to some embodiments of the present invention, penetrate the exemplary fluid conveyer device that member shifts out the tube from penetrating of well equipment mechanism.
The specific embodiment
Fig. 1 shows the exploded view according to the exemplary fluid conveyer device 100 of some embodiments of the present invention.Fluid delivery system 100 comprises and is set to module unit that can adhere on the patient body 110 and distant control unit (not shown in figure 1).Module unit 110 comprises single use portion 112, and it is connected with reusable part 114 separably.Some embodiment with said fluid delivery system of module unit are disclosed in total, common unsettled Israel patent application No.171813, and its whole contents is incorporated into this by reference.One of advantage of above-mentioned structure is in reusable part, to use the relatively costly parts of fluid delivery system, and in single use portion, uses not too expensive component.Simultaneously, said device cost in making, sell and using is lower.
Fig. 2 shows the assembly drawing according to the illustrated blocks unit 110 of the fluid delivery system 100 shown in Fig. 1 of some embodiments of the present invention.As shown in Figure 2, reusable part 114 is set to single use portion 112 and is connected.Single use portion 112 comprises aperture, top 116.The tubular element that aperture, top 116 is set to well equipment mechanism (not shown in Fig. 2) provides access.The well equipment mechanism is set to (not shown in Fig. 2, as still to combine Fig. 5 to discuss below) between the upper wall and lower wall that is arranged in single use portion 112.
Fig. 3 and 4 shows other details of the module unit 110 shown in Fig. 1 and 2, comprises the parts that are arranged in reusable part 114 and single use portion 112.Module unit 110 comprises the tubular element 322 that is full of the fluidic liquid reservoir of treatment 318, carrier pipe 320 and is provided with the well equipment mechanism in hole 326.Carrier pipe 320 is set to liquid reservoir 318 and is connected with tubular element 322, so that their mutual fluids are communicated with.Module unit 110 can be set to and comprise and be used for pump that the treatment fluid is distributed to intubate (not shown at Fig. 3, but combine Fig. 6 to discuss below) from liquid reservoir 318, and said intubate can be set to hypodermically and insert in the patient body.In certain embodiments; Intubate can be set to be inserted in the tubular element 322; And be set to through hole 326 with through the suitable aperture, bottom in the lower wall that is arranged in single use portion 112 (not shown in Fig. 3 and 4, but combine Fig. 5 to discuss below) and get into patient body hypodermically.
With reference to Fig. 4, carrier pipe 320 can be set between the roller of the swiveling wheel 424 that is placed on fixing head 428 and pump.Roller is invisible in Fig. 4.Pump can be peristaltic pump or other suitable pumping mechanisms arbitrarily.In certain embodiments, can operate, can use spring 430 that fixing head 428 is pushed to roller in order to make module unit 110.By this method, when the wheel rotation, roller to fixing head 428 extruding, pushes carrier pipe 320 with carrier pipe 320 thus, and this can be called as the positive-displacement motion.Therefore, the fluid quilt is pumping entering carrier pipe 320 from liquid reservoir 318 periodically, and the stepping of going forward side by side goes into to be inserted hypodermically the intubate of patient body (not shown in Fig. 4).In some embodiments of the invention, single use portion 112 is set to holds the well equipment mechanism, and this will further describe.The well equipment mechanism can be set between the outlet 432 and intubate of carrier pipe 320.Because said well equipment mechanism makes carrier pipe 320 to be communicated with the intubate fluid, and can realize treating fluid from the supply of liquid reservoir 318 to patient body.
Fig. 4 also shows and passes hatching A-A and the B-B that tubular element 322 is drawn.The corresponding cross section A-A of module unit 110 and the details of B-B are illustrated in respectively among Fig. 5 and the 7a-c.
Fig. 5 shows according to the example well equipment mechanism 510 shown in the mode of the cutaway view of module unit 110 some embodiments of the present invention, that cut open with A-A along the line.Well equipment mechanism 510 comprises the tubular element 322 in the space in the single use portion 112 that is contained between the upper wall 534 of single use portion 112 and lower wall 536.In certain embodiments, tubular element 322 can be set to the tub that is limited cylindrical peripheral wall and two opposite butt ends (butt end).Only for convenience, tubular element 322 will be called as tub 322.Tub 322 has the center X axle of portrait orientation.Hole 326 is Y axle and in tub 322, extend perpendicular to the X axle along the center, as shown in Figure 5.Hole 326 can be set to and can get into through the aperture in the upper wall 534 116.The lower wall 536 of single use portion 112 comprises and 116 corresponding apertures 540, aperture.Aperture 540 is positioned at the position opposite with aperture 116, and aperture 116 and 540 combination are set to the inlet that the tub 322 of passing in the well equipment mechanism 510 is provided and arrives patient skin.Aperture 116 and 540 size and dimension can be set to angle and/or position intubate that gets into patient body and the insertion that penetrates member (discussing below) that provides with any desired.
Well equipment mechanism 510 also comprises two annular grooves 544,546 and corresponding sealing ring 548,550, and said sealing ring 548,550 is set to and is placed on respectively in the said annular groove 544,546.The tub 322 of well equipment mechanism 510 also comprise be set to along the X axle from the hole 326 side paths 552 that extend to carrier pipe 320.Side path is provided with the inlet 554 at the junction point place that is disposed in carrier pipe 320 and tub 322.Side path 552 also is set to the fluid that hole 326 is provided and enters the mouth between 554 and is communicated with.Because carrier pipe 320 is connected with inlet 554, so the treatment fluid can be transported to patient body through hole 326 from liquid reservoir 318.Tub 322 comprises that also two are pressed into groove (indentation grooves) 556 and 558, and they can be disposed on the cylindrical peripheral wall (groove 556 and 558 will combine Figure 16-23 to be described in more detail below) of tub 322.
In certain embodiments, the size of tub 322 and the layout between upper wall 534 and lower wall 536 thereof can realize that tub 322 centers on rotatablely moving of its X axle, shown in direction arrow 560.When tub 322 during around the rotation of X axle, the orientation of Y axle changes, and therefore, hole 326 is along with tub 322 rotations, and with respect to patient's skin tilt (suppose that before rotation Y axle skin or any plane of reference with the patient basically is vertical).Those skilled in the art will appreciate that tub 322 can rotate to any required angle.This allows intubate to insert in patient's the skin with the angle of penetration of any desired through hole 326.
Tub 322 can be made by cheap material (for example plastics, polyethylene or other suitable material arbitrarily); Said material can be designed as and is applicable to insulin or other treatment fluid arbitrarily; And can be set to fluid delivery system 100 is each use after, be dropped with the single use portion 112 of module unit 110.
Fig. 6 shows to be set to and is inserted in the tub 332 and penetrates tube 662 in the patchhole 326 especially.Penetrate tube 662 and be set to disposablely, and can be dropped with single use portion 112.The said tube 662 that penetrates is set to along in the Y axle insertion tub 322, and said Y axle is shown in Fig. 5.
In certain embodiments, penetrate tube 662 comprise main part 664, the intubate 666 that is connected with main part 664 and have most advanced and sophisticated 686 penetrate member 668, tip 686 is suitable for thrusting patient's skin.Main part 664 can be set to and comprise long chamber 670 and short cavity 672.Long chamber 670 can be set to along main part 664 longitudinal extensions.Short cavity 672 can be set to and cross main part 664 horizontal expansions.Penetrate member 668 and can be inserted in the main part 664, and from main part 664, be moved out of through long chamber 670.
Main part 664 also comprises upper area 674, lower area 676 and zone line 678.Upper area 674 can be set to lower area 676 has identical external diameter, and zone line 678 can be set to the little diameter of external diameter that has than zone, upper and lower 674,676.Short cavity 672 can be set to along zone line 678 and extend.Short cavity 672 can be set to vertical with long chamber 670, and can further be set to and grow chamber 670 fluids and be communicated with.In some embodiments of the invention, short cavity 672 can be set to parallel with the X axle of tub 322, and said X axle is shown in Fig. 5.
Upper area 674 can be set to when penetrating and hold the elastic packing plug 680 that can be used to seal long chamber 670 when member 668 is not inserted in the main part 664.Upper area 674 can be set to by lid 682 and close.Lid 682 can comprise the eyelet of the insertion that is used to penetrate member 668.In case penetrate member 668 when being inserted into through lid 682, penetrate member 668 and thrust in the plug 680, said plug 680 is the inside of sealed body part 664 flexibly.In certain embodiments, lower area 676 is set to the seal cartridge 684 that comprises said intubate 666 of sealing and long chamber 670.Penetrate member 668 and can be set to the sharp-pointed tip that is provided with the skin that is suitable for penetrating the patient or the pin of end 686.Said pin also can comprise the blunt end 688 of the head 690 with most advanced and sophisticated 686 opposition sides.Said head 690 is set to when penetrating that member 668 is inserted in the main part 664 or being caught by the patient when wherein being moved out of.
The external diameter in upper and lower zone 674,676 can be selected by this way, promptly when penetrating tube 662 when being inserted in the hole 326, sealing ring 548, the 550 sealed body parts 664 in the tub 322.In addition, the size of main part 664 can be thus set, and promptly in case penetrate tube 662 when being inserted in the tub 322, short cavity 672 can be set to the side path 552 of tub 322 and align.
Fig. 7 a and 7b are respectively the cutaway views that penetrates tube 662 and tub 322.Fig. 7 b is the cutaway view along the profile direction B-B intercepting shown in Fig. 4.Fig. 7 b also shows the tub 322 that is positioned at position of rotation, and tub is (not shown in Fig. 7 b, but shown in Fig. 5 around X axle rotation in said position; In Fig. 7 b, the X axle is vertical with the Z axle with the Y axle, and therefore, it is vertical with page place face).Fig. 7 b also shows the Y axle with upper wall 534 and lower wall 536 vertical tub.The inclination in case tub 322 rotations (no matter being to apply under the situation of power by the strong hand or not), hole 326 promptly become, shown in Fig. 7 b, therefore, Y direction changes.New Y direction is by dotted line Y 1-Y 1Illustrate.Line Y 1-Y 1Expression penetrates member 668 and is inserted into the angle in the said skin 742 near patient's skin and intubate 666.
Fig. 7 a also comprises the hatching C-C that crosses zone line 678 draftings that penetrate tube 662.Fig. 7 c is the cutaway view of the tube 662 of C-C intercepting along the line.As from can seeing Fig. 7 c, the zone line 678 that penetrates tube 662 also comprises auxiliary short cavity 792.Auxiliary short cavity 792 can be set to vertical with short cavity 672, and can also be set to long chamber 670 fluids and be communicated with.Therefore, short cavity 672 and auxiliary short cavity 792 respectively along X axle and Z spindle guide to, they are vertical with the Y axle shown in the 7b with Fig. 5.Those skilled in the art will appreciate that in order to set up to be communicated with that additional short cavity and/or auxiliary short cavity can be arranged at and penetrate in the tube 662 with the fluid in long chamber 670.
Fig. 8-11 shows a plurality of views of the parts of the fluid delivery system 100 that is in different phase.Fig. 8 shows the exploded view that penetrates tube 662 according to some embodiments of the present invention.As shown in Figure 8, penetrate member 668 and be moved out of (that is to say, do not insert intubate 666) from main part 664.Therefore, before being used, penetrate member 668 and be set to through the eyelet in the lid 682 and insert in the main part 664 that penetrates tube 662 by patient (or medical worker).Those skilled in the art will appreciate that penetrating member 668 can be set to by patient, doctor or other medical worker arbitrarily, or the maker that penetrates tube 662 inserts.In addition, penetrate tube 662 can by cheap materials such as plastics, polyethylene or arbitrarily other suitable materials process.Like this, penetrating tube 662 can be dropped after fluid delivery system 100 each uses.
Fig. 9 shows and penetrates tube 662 assembly drawing, its have in main part of being inserted into 664 and place outer aperture 116 tops penetrate member 668, said outer aperture 116 is used for making and penetrates tube 662 patchholes 326.As shown in Figure 9, the lower wall 536 of single use portion 112 is set to contiguous patient's skin 742 placements.Figure 10 show in the hole 326 that is inserted into tub 322 penetrate the tube 662.As shown in Figure 10, penetrating member 668 is inserted into along main part 664 in a downward direction.When penetrating member 668 when being inserted in the hole 326, intubate 666 is outstanding with the opening 540 that its sharp-pointed end 686 is set to from lower wall 536, and thrusts patient's skin 742.(as shown in Figure 10) in certain embodiments, the head 690 that penetrates member 668 is set to the top of the upper wall 534 that remains on single use portion 112, and therefore, can from patient body, shift out in order to penetrate member 668, and it can be caught by the patient.As further illustrating among Figure 10, penetrate member 668 and be set to vertical with patient's skin 742.Those skilled in the art will appreciate that the angle of penetration that then penetrates 668 pairs of skins 742 of member will correspondingly change if tub 322 is rotated (shown in Fig. 5) around the X axle.
Figure 11 show when intubate 666 keeps being inserted in the skin 742, penetrate in the tube 662 penetrate that member 668 is moved out of penetrate tube 662.In certain embodiments, penetrate member 668 in order from skin 742, to shift out, patient's (perhaps arbitrarily other medical worker) can catch head 690, and spurs it in the upward direction away from skin 742.Shift out penetrate member 668 after, penetrate tube 662 inside and continue immediately to keep and outside seal (and the influence that continues to keep not receiving outer member thus).This is owing to the existence of elastic packing plug 680.
In certain embodiments, because the diameter of zone line 678 is set to the diameter less than upper area 674 and lower area 676, so annular space 1194 can and penetrate between the zone line 678 of tube 662 in tub 322.Said annular space 1194 can be set to by sealing ring 548,550 sealings.Annular space 1194 also is set to and is full of the treatment fluid, and said treatment fluid is set to through side path 552 and gets in the annular space 1194.Pump can be set to and make the treatment fluid be full of annular space 1194.Annular space 1194 can be manually, automatically, periodically or with any required time be filled at interval.As shown in Figure 11, annular space 1194 is set to long chamber 670 fluids and is communicated with.Such fluid is communicated with through short cavity 672,792 (not shown in Figure 11) to be realized.Therefore, the treatment fluid gets into the intubate 666 through flow into long chamber 670 from annular space 1194.
Figure 12 is another cutaway view that penetrates tube 662 along B-B (shown in Fig. 4 of front) intercepting.Penetrating tube 662 is shown as after it inserts in tub 322.Annular space 1194 is shown as through short cavity 792 and is communicated with long chamber 670 fluids.
Figure 13 be near the opening 116 that is placed in the upper wall 534 of single use portion 112, be used for another view that penetrates tube 662 with angle [alpha] patchhole 326.Angle [alpha] centers on the X axle rotation of said tub by tub 322 and forms, and is the angular displacement of Y axle, and said Y axle passes hole 326 longitudinal extensions with respect to the surface of patient's skin 742.In order to penetrate in tube 662 patchholes 326, the said tube 662 that penetrates also tilts with identical angle [alpha], to align with hole 326.The rotation of tub 322 and the instance that penetrates tube 662 inclination are discussed with reference to Figure 16-18 below.
Figure 14-15 shows " float " exemplary embodiment of characteristic of well equipment mechanism.In some embodiments of the invention, term " floats " and means that the upper wall 534 that tub 322 can be set to respect to single use portion 112 can relatively move with lower wall 536.In certain embodiments, tub 322 and and the vertical wall of the contiguous single use portion 112 of tub between be provided with the gap.
Figure 14 a-d shows the cutaway view of tub 322.Especially, Figure 14 b is the cutaway view in the tub 322 of the line B-B place's intercepting shown in Figure 14 a.Figure 14 c is the cutaway view in the tub 322 of the line C-C place's intercepting shown in Figure 14 a.Figure 14 d is the cutaway view in the tub 322 of the line X-X place's intercepting shown in Figure 14 a.Figure 15 is the cutaway view in the tub 322 of the line D-D place's intercepting shown in Figure 14 a.
Shown in Figure 14 a-d, tub 322 at one end has recess 1496, has circular projection 1498 at the other end.Single use portion 112 also comprises vertical wall 1402.Axle 1400 is set as and is placed between tub 322 and the vertical wall 1402.One end of axle 1400 can be contained in the recess 1404 that is formed in the vertical wall 1402, and the other end of axle 1400 can be contained in the recess 1496. Recess 1404,1496 can be set to the form fit with axle 1400 respective end portions, thereby can realize the rotation of tub 322 around its vertical X axle.In certain embodiments, the end of axle and corresponding recess 1404, can have little gap between 1496.Said gap is set to realize that tub 322 moves with respect to the linearity of its outer housing along X axle and Z axle.
With reference to Figure 14 a-b and 15, tub 322 is set to and comprises vertical partitions 1410.Separator 1410 can be set between the upper wall 534 and lower wall 536 of single use portion 112.Separator 1410 can also be set to vertical with vertical X axle of tub 322.In certain embodiments, separator 1410 has the width greater than the diameter of tub 322.The width that those skilled in the art will appreciate that other also is feasible.Separator 1410 comprises opposite end 1412,1414. End 1412,1414 is set to by the corresponding alcove 1416,1418 that is arranged in the single use portion 112 and holds, shown in Figure 14 d.End 1412,1414 is set to and is engaged in the alcove 1416,1418, so that corresponding gap 1420,1422 is in the end 1412,1414 and corresponding alcove 1416, form between 1418.Said gap 1420,1422 is set to can realize separator 1410 moving relative to linear with respect to single use portion 112.
With reference to Figure 14 a-b, single use portion 112 also comprises the projection 1498 that is set in the opening that is received in the separator 1410.Said opening can be set to and said projection 1498 frictional fit, can realize that simultaneously the linearity of tub 322 around the rotation of its vertical X axle and separator 1410 along the Z axle moves.In certain embodiments, little gap 1424 can be arranged between tub 322 and the separator 1410, thereby can realize tub 322 and separator 1410 moving relative to linear along the X axle.
In certain embodiments, the combination of axle 1410 and projection 1498 can be set to the effect of playing sliding bearing, thereby can realize the rotation of tub 322 around its vertical X axle.This also allows patient's (or doctor or other medical worker) arbitrarily adjustment to penetrate member 668 (not shown in Figure 14 a-15) to thrust in the skin and can be inserted into the angle in the patient body hypodermically with intubate 666.
In certain embodiments, gap 1506,1508,1420,1422 and 1424 can be set to and can realize tub moving relative to vertical in horizontal plane.This can compensate and make that when the patient is worn over module unit on the his or her health inevitably moving of 666 pairs of outer housings of intubate is insensitive.In certain embodiments, fluid delivery system 100 can comprise and is set to the sealing ring 1426 that the sealing between carrier pipe 320 and the single use portion 112 is provided.
Figure 16-18 shows the exemplary embodiment that is set to the fluid delivery system of the pressure rotation that can realize tub 322 according to of the present invention.In certain embodiments, in order to make tub 322 rotations, use special-purpose the Shear tool 1628.Instrument 1628 is set to and tub 322 interlocks, as shown in Figure 16.Shown in figure 16, special-purpose the Shear tool 1628 can be set to handle, and can be through aperture, top 116 (shown in Figure 17) and tub interlock.In such embodiment, instrument 1628 can be caught by patient (or doctor or other medical worker) arbitrarily, and rotates to required angle along arrow 1630 by the strong hand.Required angle has determined to penetrate the angle that tube 662 will thrust patient's skin.
With reference to Figure 17, the Shear tool 1628 comprises can be set to the lower end 1732 that comprises projection 1734 (shown in Figure 17) and 1836 (shown in Figure 18).Projection 1734 and 1836 is set to away from the bottom surface of lower end 1732 extends.Projection 1734 and 1836 is set to provides the reliable interlock of the Shear tool 1628 with tub 322.In certain embodiments, the shape that is set to the end face of tub 322 of the bottom surface of lower end 1732 is complementary.Projection 1734,1836 is set to and is engaged in (before shown in Fig. 5) in the groove 556,558 respectively.Therefore; In order to adjust the angle of tub 322; Patient (or doctor or other medical worker) is through aperture 116 insertion instruments 1628; And projection 1734,1836 and corresponding grooves 556,558 are closely cooperated, in case instrument 1628 and tub 322 interlocks, patient (doctor or other medical worker) just makes tub rotate to required angle.After tub 322 was adjusted to required angle of penetration, instrument 1628 was moved out of, and penetrate tube 662 be inserted into (as top discuss with reference to Fig. 1-13).It will be appreciated by those skilled in the art that; The insertion of instrument 1628, rotate and shift out and penetrate tube 662 insertion and shift out and can manually or automatically accomplish, and its can also by patient, doctor, other the medical worker or arbitrarily other titular individuals carry out.
Figure 19-23 shows according to pressure rotation of the present invention, as can to realize tub 322 and penetrates the exemplary embodiment that tube 662 gets into the fluid delivery system of the automatic insertion in the tub 322.Shown in Figure 19-23, can be set to pressure rotation that tub 322 is provided and the automatic insertion that penetrates tube 662 with penetrating tube 662 wherein " insert " instrument 1915 of being included in.In certain embodiments, insert instrument 1915 be set to with the mode and tub 322 interlocks of the top similar content of being discussed with reference to Figure 16-18.
Insert instrument 1915 comprises jacket tube 1938.Patient's (or doctor or other titular individuals) arbitrarily can catch jacket tube with tub 322 interlocks in order to make insert instrument 1915.The inside of jacket tube 1938 can be set to comprise and penetrate tube 662, and allows to penetrate tube 662 slip in jacket tube 1938.In certain embodiments, jacket tube 1938 also can comprise actuation spring 1940 and flip-over type actuator 1942.Flip-over type actuator 1942 is set to the top that is positioned at jacket tube 1938.In case discharge flip-over type actuator 1942, spring 1940 be set to make penetrate tube 662 along the length of jacket tube 1938 advance and retracted position between move.Progressive position is limited in the tube 662 that penetrates that is discharged into from jacket tube 1938 tub 322 (going out as shown in Figure 20).Retracted position is limited in the tube 662 that penetrates that is fixed in the jacket tube 1938 (going out as shown in Figure 19).Those skilled in the art will appreciate that spring 1940 can be wind spring, helical spring or other can be with penetrating the device that tube 662 is discharged in the tub 322 arbitrarily.
As stated, Figure 19 show when insert 1915 in its outer housing 1938 by preloaded to penetrate tube 662 and actuation spring 1940 biased so that penetrate the situation of tube 662 when being positioned at its retracted position above the tub 322.In certain embodiments, to the patient, module unit 110 is adhered on patient's the skin 742 in the treatment FLUID TRANSPORTATION, and the lower end 1943 of " insert " instrument 1915 is (similar with the method for discussion among Figure 16-18 with tub 322 interlocks.Those skilled in the art will appreciate that it also is feasible making other modes of said instrument and tub 322 interlocks).As shown in Figure 19, insert instrument 1915 does not tilt as yet, and likewise, tub 322 is not also rotated through instrument 1915 by the strong hand.In certain embodiments, the initial angle (before the rotation) of instrument 1915 and tub 322 interlocks approximately is 90 degree with respect to the top surface of module unit 110 (or skin 742, or other surface) arbitrarily.Those skilled in the art will appreciate that it is feasible making instrument 1915 and other angles of tub 322 interlocks.Insert instrument 1915 also can comprise being set to make and penetrates tube 662 and remain on the safe locking mechanism 1944 in the inner retracted position of the outer housing 1938 of instrument 1915.In case actuator 1942 is released and safe locking mechanism 1944 is separated, penetrates tube and 662 promptly be released and be advanced in the tub 322, and utilize and penetrate member 668 and thrust in patient's the skin 742 (as shown in Figure 20) by spring 1940.
Figure 21 shows insert instrument 1915 and is tilted (similar with the method for being discussed among Figure 16-18) situation to required angle.In case insert instrument 1915 is tilted, penetrate tube 662 promptly to be released with similar mode shown in Figure 19-20.
Figure 22-23 shows the insert instrument 1915 that from tub 322 and module unit 110, is moved out of (or separation).In certain embodiments; In case instrument 1915 can be set to and penetrate tube and 662 be inserted in the tub 322, penetrate member 668 and thrust in patient's the skin 742 and intubate 666 has been inserted in the patient body (as shown in Figure 22), said instrument 1915 promptly is moved out of.In case said instrument 1915 is moved out of, penetrates member 668 and promptly can under the situation that does not shift out intubate 666, from penetrate tube 662, shift out (as shown in Figure 23).Those skilled in the art will appreciate that the angle that intubate 666 can be set to any desired is inserted into.Treat fluid then and be supplied to patient body hypodermically through intubate 666, said intubate 666 is communicated with carrier pipe 320 fluids through tub 322.
Those skilled in the art will appreciate that insert instrument 1915, penetrate tube 662, penetrate member 668 and can be set to and manually or automatically shifted out.In certain embodiments, spring can be set, thus can implementation tool 1915 and the separating of tub 322.
The exemplary embodiment of method of the present invention and parts here is described.Mention like other places, these exemplary embodiments are only described for illustrative purposes, and unrestriction.Other embodiment is feasible, and is covered by the present invention.Be based on the instruction that this comprises, such embodiment is conspicuous for those skilled in the relevant art.Therefore, range of the present invention and scope should be by above-mentioned exemplary embodiment restrictions arbitrarily, and should be only limit according to following claim book and the description that is equal to thereof.

Claims (21)

1. one kind is used for the fluid delivery system of treating FLUID TRANSPORTATION to patient body is comprised:
At least hold be equipped with the treatment fluidic liquid reservoir outer housing and
Be set to from liquid reservoir and push the fluidic pumping mechanism of treatment towards patient body; And
Be set to the Connection Element that is arranged in said outer housing inside and comprises the hole, said Connection Element makes carrier pipe be communicated with the intubate fluid;
Wherein, in case through said hole intubate is inserted in the patient body, the fluid connection between said hole and the said intubate promptly is able to set up, so that the treatment fluid can be transported in the patient body.
2. fluid delivery system as claimed in claim 1 is characterized in that, said outer housing has the first wall and second wall, and said first wall has first aperture, and said second wall has second aperture, and said first aperture is positioned at the position opposite with second aperture;
Said Connection Element is arranged between said first wall and said second wall, and wherein said Connection Element comprises tubular element, said hole extend through said tubular element and
Said fluid delivery system also comprises the tube that penetrates of the conveying that is used to treat fluid to patient body, and wherein, the said tube that penetrates can insert in the said hole through said first aperture.
3. fluid delivery system as claimed in claim 2 is characterized in that, comprising:
At least the single use portion that comprises said liquid reservoir and said Connection Element; With
At least the reusable part that comprises the motor of pumping mechanism,
Wherein, said single use portion is connected with said reusable part separably.
4. fluid delivery system as claimed in claim 2 is characterized in that said tubular element comprises side path, and the treatment fluid can be transported to said hole through said side path.
5. fluid delivery system as claimed in claim 2 is characterized in that, said tubular element can tilt with respect at least one axle.
6. fluid delivery system as claimed in claim 2 is characterized in that, the said tube that penetrates also comprises:
Main part, it has:
Long chamber along said main part longitudinal extension;
At least one crosses the short cavity of said main part horizontal expansion, and said at least one short cavity is set to said long chamber fluid and is communicated with;
Wherein, said long chamber and said at least one short cavity also are set to when the said tube that penetrates and are communicated with said orifice flow body when being inserted in the said hole;
Be set to the said intubate that is connected with said main part;
Be set to the member that penetrates that inserts in said long chamber and the said intubate, wherein, the said member that penetrates is set to and thrusts in the patient skin.
7. fluid delivery system as claimed in claim 6 is characterized in that, the said member that penetrates can shift out from said main part.
8. fluid delivery system as claimed in claim 6 is characterized in that, said long chamber is set to vertical each other with said at least one short cavity.
9. fluid delivery system as claimed in claim 6 is characterized in that said main part cooperates with sealing-plug, and said sealing-plug is set to the said long chamber of sealing.
10. fluid delivery system as claimed in claim 2 is characterized in that, the said tube that penetrates can certain angle insert said hole.
11. fluid delivery system as claimed in claim 10 is characterized in that, said intubate can be inserted in the patient body by said angle.
12. fluid delivery system as claimed in claim 2 is characterized in that, also comprises being set to the Shear tool that said tubular element is tilted.
13. fluid delivery system as claimed in claim 2; It is characterized in that; Also comprise having to be set to and a said insert instrument that penetrates the outer housing that is fixed therein of tube, wherein said insert instrument are set at the said tube that penetrates said tubular element is tilted before inserting in the said hole; And in case make said tubular element tilt to required angle, said insert instrument is set to the said tube that penetrates is inserted in the said hole.
14. fluid delivery system as claimed in claim 13 is characterized in that, said insert instrument is set to manually the said tube that penetrates is inserted in the said hole.
15. fluid delivery system as claimed in claim 13 is characterized in that, said insert instrument is set to automatically the said tube that penetrates is inserted in the said hole.
16. fluid delivery system as claimed in claim 1 is characterized in that, said treatment fluid is an insulin.
17. fluid delivery system as claimed in claim 12 is characterized in that, said tubular element is provided with at least one recess, and said the Shear tool is provided with at least one and is used for the projection with said at least one recess interlock.
18. fluid delivery system as claimed in claim 13 is characterized in that, said tubular element is provided with at least one recess, and said insert instrument is provided with at least one and is used for the projection with said at least one recess interlock.
19. fluid delivery system as claimed in claim 2 is characterized in that, said Connection Element is provided with at least one sealing device that is used to seal said hole.
20. fluid delivery system as claimed in claim 2 is characterized in that, said tubular element can relatively move with respect to said first wall and said second wall.
21. fluid delivery system as claimed in claim 5 is characterized in that, comprises that at least one is used to the axle that said tubular element is tilted with respect to said outer housing.
CN2007800339432A 2006-07-24 2007-07-24 Systems, devices and methods for fluid/drug delivery Expired - Fee Related CN101522234B (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US83311006P 2006-07-24 2006-07-24
US60/833,110 2006-07-24
US83787706P 2006-08-14 2006-08-14
US60/837,877 2006-08-14
PCT/IL2007/000932 WO2008012817A1 (en) 2006-07-24 2007-07-24 Systems, devices and methods for fluid/drug delivery

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Publication number Priority date Publication date Assignee Title
JP2013070715A (en) * 2011-09-26 2013-04-22 Terumo Corp Liquid-drug administration device
CA2891227C (en) * 2012-11-26 2021-01-19 Kci Licensing, Inc. Combined solution pump and storage system for use with a reduced-pressure treatment system

Citations (2)

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Publication number Priority date Publication date Assignee Title
US4886499A (en) * 1986-12-18 1989-12-12 Hoffmann-La Roche Inc. Portable injection appliance
US6074369A (en) * 1998-02-20 2000-06-13 Becton, Dickinson And Company Low-profile automatic injection device with self-emptying reservoir

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Publication number Priority date Publication date Assignee Title
US4886499A (en) * 1986-12-18 1989-12-12 Hoffmann-La Roche Inc. Portable injection appliance
US6074369A (en) * 1998-02-20 2000-06-13 Becton, Dickinson And Company Low-profile automatic injection device with self-emptying reservoir

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