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CN101983078A - Insertion device with horizontally moving part - Google Patents

Insertion device with horizontally moving part
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Publication number
CN101983078A
CN101983078ACN2009801096598ACN200980109659ACN101983078ACN 101983078 ACN101983078 ACN 101983078ACN 2009801096598 ACN2009801096598 ACN 2009801096598ACN 200980109659 ACN200980109659 ACN 200980109659ACN 101983078 ACN101983078 ACN 101983078A
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CN
China
Prior art keywords
insertion device
body portion
parts
shell
motion
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN2009801096598A
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Chinese (zh)
Inventor
S·吉尔恩
R·M·希克莫特
A·D·莫顿
H·耶普森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Unomedical AS
Original Assignee
Unomedical AS
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Unomedical ASfiledCriticalUnomedical AS
Priority claimed from PCT/EP2009/051974external-prioritypatent/WO2009103759A1/en
Publication of CN101983078ApublicationCriticalpatent/CN101983078A/en
Pendinglegal-statusCriticalCurrent

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Abstract

The invention relates to an insertion device comprising a penetrating member (50) connected to transformation means (52), a moving part (38) comprising guiding means (39) which guiding means (39) restrict the movement of the transformation means (52) and guide the penetrating member (50) from a first to a second position in a first direction, i.e. the direction of insertion, towards the injection site, and a stationary housing (30) comprising guiding means (32) which guiding means (32) restrict the movement of the moving part (38). The guiding means (32) guide the moving part (38) in a second direction which is linear and different from the first direction i.e. the direction of insertion.

Description

Insertion device with horizontal movement part
Technical field
The present invention relates to a kind of insertion device, this insertion device is used for the part insertion patient's of medical treatment device or medical treatment device subcutaneous or muscle region.
Background technology
Insert device (being also referred to as insert or syringe) in medical field, be used for usually with more or less automatically the skin of mode by patient insert medical treatment device such as infusion device and analog.
Usually, when using insert, the user, promptly patient or treatment supplier (for example, nurse, doctor, relatives or the like) must apply power so that the injection of medical treatment device (pin, sleeve pipe, pick off and analog) is provided towards the surface of patient's skin.This can cause physiology or mental anguish and/or discomfort, and can cause the inappropriate of medical treatment device to apply.Many people fear sharp-pointed object, such as the entry needle that is generally used for Medical Treatment and treatment and other penetrating device.Thisly fear it often is irrational, and it may hinder suitable Medical Treatment.For example, under the situation of self-medication, lack the required medical components give suitable dosage and can cause complication, this complication even may be life-threatening.When for example treating diabetes in teenager, the danger of existence is, owing to fear that to inserting the irrational of pin add the understanding and the consciousness that generally lack about the consequence that correctly applies of saving device and dosage, required insulin dose can not be given by the oneself.
About the other known problem of the insertion of medical treatment device be penetrate member apply preceding or applying during the danger of pollution.This can for example easily cause infectious disease is guided in the patient body by the insertion pin that pollutes.This pin exposes long more, and the risk of accidental pollution (for example, by with the finger contact pin, pin is contacted with uncleanly surface, perhaps pass through airborne pollutant, aerosol contaminants or the like) is big more.Depend on and the bonded pollutant of patient's the overall health character of (for example, comprising virus, antibacterial, fungus, yeast and/or Protein virus) that the infection that causes thus may change life-threatening situation rapidly into.
At last, what know is, especially in hospital environment, contact infection may be life-threatening with pin, and must minimize accidental exposure to with the risk of the contaminated materials of the form of inserting pin.
Document WO 2002/002165 discloses a kind of needle device, and this needle device has needle retraction mechanisms, this needle retraction mechanisms pin of withdrawing when removing this device from skin surface.This needle device comprises: what be connected to transform component (44) penetrates member N; Actuator (40), this actuator comprises guide member, this guide member limits the motion of transform component and will penetrate member N towards the insertion position along direction of insertion and is directed to the second position from primary importance.In addition, needle device comprises static housing (20), and this static housing is provided with the guide member of the motion of limiting actuator (40).Actuator (40) and attached pin N be along identical direction, i.e. direction of insertion motion.According to the present invention, penetrating component moves with respect to motion parts, and motion parts separates fully from penetrating component after inserting.This makes can push moving part along a direction by simple spring mechanism, penetrates member simultaneously and is directed into the injection site along direction of insertion.Separating this unit makes when the independent probability maximization of controlling each part when for example setting in motion is with acceleration of each part with this direction.
Therefore, significant need addresses the above problem in this field sane, reliable, accurate, safe, health and user-friendly insertion device.
Summary of the invention
The invention provides a kind of insertion device that penetrates member that is used for introducing hypodermically, wherein " penetrate member " and be understood that pin, sleeve pipe, pick off or analog.Penetrate member remain on before inserting and during inserting usually it to patient invisible and it before its actual insertion can not with the position of user or contact patients in.
Target of the present invention provides a kind of insertion device, and this insertion device comprises:
Be connected to the member that penetrates of transform component;
The motion parts that comprises guide member, the motion of this guide member restriction transform component and towards the injection site along first direction, promptly direction of insertion will penetrate member and be directed to the second position from primary importance; With
The static housing that comprises guide member, the motion of this guide member constrained motion part, this guide member is along second direction guided-moving part, and this second direction is linear and is different from first direction is direction of insertion.
According to an embodiment, second direction is perpendicular to first direction, but second direction can become any angle with respect to first direction, is generally to depart from 40-90 ° angle from first direction.
" static housing " means shell and do not move with respect to insertion portion during inserting.Usually, the guide member and the contact between the transform component of motion of restriction transform component is " slips ", and the contact between this expression guide member and the unit that will be directed is successive, and promptly it does not interrupt, but contacts with guide member in all positions maintenances.
According to an embodiment, to insert device and comprise guide member, the motion that this guide member will penetrate member is restricted to the linear movement along first direction.These guide members guarantee to penetrate member during inserting along entering patient skin with the linear direction of direction of insertion, the time period that limits " during inserting " be when the skin that will insert patient penetrate member that part of begin when being about on injection site transdermal surface and when to insert penetrate that part of being fully inserted into of member the time end time period.If guide member does not exist, then will be only the adjusting of speed by penetrating member guarantee linear movement, when use simply and not during expensive component, this is difficult especially.
According to the other embodiment that inserts device, first direction with penetrate member and will insert wherein surperficial angulation β, and 30 °≤β≤90 ° wherein.Angle beta is restricted to from lucky time before penetrating its surface mounted thereto of member contact and up to its final position that this member is in this lower face and penetrates the direction that member enters.This motion is linear.Penetrating member can insert with the angle that tilts, wherein β: 30 °≤β<85 ° or 95 °<β≤150 °; Usually, the angle of inclination will be about 45 °, i.e. 30 °≤β<60 ° or 120 °≤β<150 °; Perhaps 40 °≤β<50 ° or 130 °≤β<140 °; Wherein said angle of penetration β is restricted to and penetrates penetrating travel direction and penetrating angle between the member surface mounted thereto of member.
According to this embodiment that inserts device, angle beta can be substantially perpendicular to and insert device surface mounted thereto.The skin surface that penetration direction is substantially perpendicular to patient means angle of penetration β=90 °, usually from 90 ° little departing from, such as 85 °≤β<95 °, also will be considered to perpendicular to skin surface.
According to the other embodiment that inserts device, the direction of motion parts is linear and is arranged essentially parallel to and inserts device surface mounted thereto during inserting.The substantially parallel angle that means the direction of motion parts and install between the surface of this direction is about 0 ° on position.Can there be tilt angle alpha :-45 °<α<45 °; Wherein positive tilt angle alpha is represented towards the motion of skin surface inclination, and the motion that skin surface tilts is represented to leave in minus angle of inclination.Usually, between the direction of the surface of patient's skin and motion parts, will exist less than 10 ° depart from, promptly-10 °<α<10 °.The direction of motion of motion parts is that the linear motion parts that means moves to second point along straight line from first.
According to the other embodiment that inserts device, the other motion of motion parts can provide described holding member and/or insert the retraction movement of pin." motion in addition " means after first motion, be that linear movement is located to finish at second, travelling forward of motion parts can proceed to thirdly, thirdly locate at this, travelling forward of motion parts stops, perhaps alternatively, the linear movement of motion parts can be oppositely or along second direction.
According to the other embodiment that inserts device, insertion portion can be attached to body portion, and this body portion can be fastened to and penetrate the surface that member will insert, and will make and penetrate member and contact with body portion when inserting.
According to the other embodiment that inserts device, penetrate surface fixed body and telescopic retention feature that member comprises sleeve pipe, keeps described telescopic body and inserting.Sleeve pipe is kept by body in the mode that can not discharge, because sleeve pipe is very little and self is difficult to handle.
According to this embodiment that inserts device, retention feature can interact with the interaction parts on the body portion when inserting and the body that will penetrate member remains to body portion.
According to the other embodiment that inserts device, the guide member of motion parts comprises groove, and the transform component that penetrates member can slide in this groove.This groove can be for being defined for the V basically or the U-shaped of starting point, intermediate point and terminal point that penetrates member or penetrate a plurality of at least parts of member.In addition, the inclination of groove from the starting point to the intermediate point limits the speed of insertion with the proal speed of motion parts.Limit the inclination of groove with respect to a coordinate system, in this coordinate system, the x axis horizontal is placed, the i.e. direction of the line that forms along surface that body portion is placed on it and along the travelling forward of motion parts (motion parts moves along the x axis towards-∞), the y axis is placed to perpendicular to this surface.In this coordinate system, groove will have minus inclination between intermediate point and starting point, and the big young pathbreaker of nominal who tilts influences the speed that penetrates member during inserting, and it is steep more to tilt, and inserts fast more.Maybe the tangent line of this inclination (if groove is crooked, promptly not being straight line) usually will be between-1 and-2 in this inclination.In addition, the inclination of groove from the intermediate point to the terminal point limits the speed of withdrawal with the proal speed of motion parts (38).Groove will have positive inclination between intermediate point and terminal point, and the big young pathbreaker of nominal who tilts at isolating insertion pin or during penetrating the withdrawal of other parts of member influence penetrate the speed of member, it is steep more to tilt, it is fast more to withdraw.The tangent line of this inclination or inclination usually will be between 1 and 2.
According to the other embodiment that inserts device, motion parts can be used as the result of direct or indirect user's input and moves.That means that the user provides direct power to this device, and promptly the user pushes away or the moving part of roping, and perhaps the user triggers spring or analog, and this spring or analog are with pusher or the moving part of roping.
According to this embodiment, the insertion device of motion parts motion can be started by triggering triggering part, and triggering part contacts with energy storage means and influence the state of energy storage means when triggering.In addition, energy storage means can be a spring, and described spring is in state bias voltage or that twist be in the state that loosens or part is loosened and the actuating at triggering part before triggering after.
According to this embodiment that inserts device, energy storage means provides and is used for making motion parts to move to the required energy of stop position from the starting position.
According to an embodiment who inserts device, shell can comprise motion parts is remained on retention feature in the starting position, motion parts is included in the starting position and the interactional Lock Part of holding member, and triggering part is included in when triggering and the interactional interaction parts of Lock Part.Lock Part can be by triggering part the interaction of interaction parts be released from latched position.In addition, Lock Part can have the form of hook, and this hook is provided with the inclined surface that points to along the direction opposite with travelling forward of triggering part, and retention feature can be from the outstanding part of shell, and the hook that this part can locked parts forms is caught.
According to these embodiment, interaction parts by triggering part and be used for contact between the retention feature of motion parts stop to travel forward of triggering part.
According to one embodiment of present invention, groove is provided with flex section (39A) between starting point (22a) and intermediate point (22b), and this flex section (39A) can move along the direction opposite with direction of insertion.Flex section (39A) but can have the form of outstanding pivoting portions (39A), but outstanding pivoting portions (39A) has:
Contact surface, this contact surface during movement contact with the transform component (51) of sleeve portion (7) and push sleeve portion (7) to injection site; With
The noncontact surface relative with contact surface, this noncontact surface is moveable to and does not contact other parts in the open spaces.
According to this embodiment, contact surface can have two straight lines being connected with angle n or the form of flat surfaces near the point (D) of the sealing contact of sleeve portion (7) and surface plate (1) (see Figure 18 a), common 10 degree<n<45 are spent.
According to the other embodiment that inserts device, motion parts can be surrounded by shell.
According to the other embodiment that inserts device, body portion can be fastened to the surface to be installed and to insert device and can be included in to provide before inserting and insert device the non-fastening parts of insertion device to body portion are provided to the fastening of body portion and when telescopic the insertion.
According to this embodiment that inserts device, provide the parts that insert the fastening of device and body portion and discharge to comprise: the shell that secure component, this secure component releasably will insert device locks onto body portion; And releasing parts, this releasing parts discharges shell from body portion after the insertion that penetrates member.Releasing parts can comprise the elastic component that is in bias voltage or twisted state, and this elastic component will insert device when the release of secure component shell pushes away body portion.Elastic component can have the form that is arranged in body portion and inserts the sheet spring between the device; When the insertion device is locked into body portion, the sheet spring will be twisted.
According to these embodiment that insert device, the secure component that releasably shell is locked onto body portion can have the form of hook of hard material of the integral part that is shell, and this hook is caught the counterpart of body portion.This hook is the part that the integral part of shell means its formation shell, and promptly it locks onto shell and for example be configured to for example part of the wall of shell in the mode that can not discharge.
According to these embodiment that insert device, secure component has the form of one or more ledge, and this ledge is assembled in the corresponding opening in the body portion.One or more ledge can remove by the corresponding opening that rotatablely moves from body portion, and inserts device and penetrate member and insert wherein surperficial certain distance and be installed to body portion and make this apart from allowing to insert rotatablely moving of device to leave.By inserting device construction the inclination proximal end face is arranged, obtain to leave and penetrate this distance that member inserts surface wherein, this proximal end face makes and rotatablely moves and penetrate member and inserted wherein surperficial parallel.
According to these embodiment that insert device, secure component can be connected to static housing flexibly.Motion parts can be provided with one or more ledge, and this ledge contacts with the secure component of flexible connection when the motion of motion parts, and discharges the insertion device by this contact from body portion.
According to the other embodiment that inserts device, insert the parts that are used for carrying out following operation when device is included in the actuating of triggering part:
(a) loading of spring;
(b) motion of motion parts from the starting position to the stop position; With
(c) the described conversion that moves to the back followed by the insertion campaign that penetrates member of the retraction movement of the holding member that penetrates member of motion parts.
This embodiment also can comprise the parts that can realize following function:
(d) when the insertion that penetrates member, discharge shell from substrate.
According to these embodiment that insert device, shell can be connected to substrate by link.Link can comprise at least one hinge and at least one locking component.
According to these embodiment that insert device, the interaction of the part of the sidewall by release component and shell can discharge shell from substrate.The described part of the sidewall of shell can be flexible, and can be twisted (pivot) with respect to the residue shell.
According to the other embodiment that inserts device, penetrate member and have primary importance (i) with respect to static housing and the second position (ii), wherein penetrate member withdrawal and not giving prominence to fully in primary importance (i) from the shell that inserts device; And the second position (ii) in, give prominence to from shell (30) such as a sleeve pipe and/or a part that penetrates member of inserting pin the biglyyest.First retracted position is that the position and the second maximum extrusion position that penetrate member before inserting are to penetrate the position that penetrates member when member has inserted fully just.Penetrate member and can have the 3rd other position (iii), in the 3rd position, sleeve pipe is given prominence to from shell the biglyyest, and holding member and/or insert pin and be withdrawn in the shell and no longer contact with keeping telescopic body.
According to these embodiment that insert device, the second position (ii) in and in the 3rd position the body that penetrates member in (iii) is held by the described retention feature of body and the interaction of the interaction parts on the body portion.
According to the other embodiment that inserts device, motion parts can have the primary importance (i with respect to shell*), the second position (ii*) and optional the 3rd position (iii*), and at primary importance (i*) and optional the 3rd position (iii*) in, guide member remains on holding member from the position that patient's skin is withdrawn by transform component, and at the second position (ii*) in guide member holding member is remained in the position that comes close to or in contact with patient.
According to this embodiment that inserts device, motion parts is by being fastened to the retention feature of shell in the mode that can not discharge, be fastened to the Lock Part of motion parts and be maintained at primary importance (i with the interaction parts that the mode that can not discharge is fastened to triggering part in the mode that can not discharge*) in.
According to the other embodiment that inserts device, this tool set also comprises: body portion, inserted device at least and be fastened to this body portion before inserting; With send part, this is sent part and can be fastened to body portion and be formed into by inserting the fluid path that penetrates member that device inserts.
Definition
As here using, " parallel " or " substantially parallel " refers to along with respect to first or second the moving of reference plane or the direction direction, plane, project or the analog that limit, and these reference plane or direction have the direction as angle [alpha]=0 ° qualification; And second plane or direction ° depart from maximum ± 10; Usually leave first or reference direction α be no more than ± 5 °.
Under the application's situation, " level " or " substantial horizontal " mean along the moving an of direction, direction, plane, project or analog such as above definition ground parallel or be arranged essentially parallel to the surface of patient's skin.For example, inserting device, to be fastened to body portion on it can be level or substantially horizontally to mean parallel or be arranged essentially parallel to skin.
As here using, " vertically " or " perpendicular " refers to along moving with respect to second of direction, plane, project or the analog of reference plane or direction qualification, and these reference plane or direction have the position or the direction of angle beta=0 °; And second plane or direction depart between 80-100 °; Usually leave first with reference to β between 85-95 °.
Under the application's situation, " laterally " or " substantial lateral " can with as vertical or perpendicular defined above use interchangeably.
" parts ": as here using, this expression means and can comprise one or more parts.Irrespective is that if with regard to grammer, odd number or plural number represented in the verb that relates to described parts.
Description of drawings
To make the detailed description of embodiments of the invention with reference to the accompanying drawings, wherein like reference numerals is indicated counterpart in different figure.
Figure 1A-C illustrates the cross section of first embodiment of the insertion device according to the invention that is in three states: A: before triggering; B: just after inserting; C: after the withdrawal of inserting pin.
Fig. 2 A-F illustrates the cross section of second embodiment of six kinds of insertion devices in the state.A: before triggering; B: after triggering, C: just after inserting, D: after the withdrawal of inserting pin, E: after the release of insert shell, and F: remove from body portion insert device after.
Fig. 3 illustrates first embodiment of the assembly that comprises insertion device according to the invention.
Fig. 4 illustrates second embodiment of the assembly that comprises insertion device according to the invention.
Fig. 5 A and 5B illustrate second embodiment of assembly, in Fig. 5 A, insert device and are installed on the body portion, and in Fig. 5 B, remove the insertion device from body portion.
Fig. 6 illustrates and does not insert device and have and isolating second embodiment that sends assembly partly of body portion A: from beneath; B: observe from the top; C: the coupling part of observing and illustrate body portion from the top; And D: the body portion of observing from the top only is shown.
Fig. 7 illustrates vertical cutting of passing the assembly shown in Fig. 3-6, and this cutting is positioned at one position of the secure component that is used to insert device.
Fig. 8 illustrates the insertion device that is not attached to body portion.
Fig. 9 is illustrated in the 3rd embodiment of the insert that the state before the insertion of sleeve portion will use with this assembly down.
Figure 10 is illustrated in the embodiment of the insertion insert identical with Fig. 9 afterwards of sleeve portion.
Figure 11 A-C illustrates how from the embodiment according to the insert shown in the bodyportion separation graph 9 and 10 of assembly of the present invention.
Figure 12 A and 12B illustrate the embodiment of the motion parts that will use with the assembly shown in Fig. 9-11.
Figure 13 A and 13B are illustrated in the 4th embodiment of the insert that the state after the insertion of sleeve portion will use with this assembly down.
Figure 14 A and 14B illustrate the interior section of insert shell of the 4th embodiment of insert.
Figure 15 A and 15B illustrate the embodiment of the motion parts that will use with the assembly shown in Figure 13-14.
Figure 16 illustrates an embodiment who penetrates member that can use with this assembly.
Figure 17 illustrates the cutaway view of second embodiment that penetrates member that can use with this assembly.
Figure 18 a illustrates the embodiment of the motion parts of the tolerance with increase.
Figure 18 b is illustrated in how to observemotion parts 38 among Figure 18 a.
Figure 19 illustrates driving mechanism, and this driving mechanism is included in the leaf spring that can be used for driving forwards motion parts among any embodiment that illustrates of insert.
The specific embodiment
Figure 1A-1C illustrates an embodiment who is used for inserting theinsertion device 1 that penetratesmember 50 according to of the present invention.
Insertingdevice 1 comprisesshell 30,body portion 100,motion parts 38 and penetrates member 50.For the sake of clarity,motion parts 38 is drawn in translucent mode.Figure 1A, 1B and 1C are illustrated in respect to penetratingmember 50 in three diverse locations ofmotion parts 38.
Penetratemember 50 and comprise that maintenance penetrates the holdingmember 52 ofmember 50, thetransform component 51 that is attached to the holdingmember 52 that penetratesmember 50,body 24,sleeve pipe 22 and inserts pin 53.According to this embodiment,sleeve pipe 22 is the soft tubes that need be inserted under the help of insertingpin 53, and this insertion pin is attached to a part of inserting device and is not attached in the mode that can not discharge and penetrates member50.Sleeve pipe 22 is attached tobody 24 in the mode that can not discharge.In addition,body 24 comprisesretention feature 23, and whensleeve pipe 22 inserted fully, this retention feature was used forsleeve pipe 22 is fastened to body portion 100.According to this embodiment, retention feature 23 forms mechanical hook, and this mechanical hook inwardly can be forced to, promptly towards the center of arranging sleeve pipe 22.Be forced to after the center, when mechanical hook is fastened tobody 24 in flexible mode, hook will turn back to their initial position, and this is flexible normally because the character that is used to produce body, hook and is formed on the material of the connection between them.
In another embodiment of the present invention, penetratemember 50 and comprise pick off or pick off and sleeve pipe.In other embodiment of the present invention, penetratemember 50 and comprise more than asleeve pipe 22 for example a plurality of sleeve pipes and/or a plurality of pick off.
Shell 30 comprisesguide member 32 that is used formotion parts 38 and theguide member 33 that is used to penetrate member 50.Comprise that according to the guide member that is used formotion parts 38 32 of thisembodiment motion parts 38 can be along the surface of the inwall of theshell 30 of its slip, and theguide member 33 that is used to penetratemember 50 comprises upright tubular form.Motion parts 38 is provided with the transform component with the form of V-arrangement opening, and thetransform component 51 that this transform component formed and penetratedmember 50 closelycooperates.Shell 30 is releasably connected tobody portion 100, and can separate frombody portion 100 after having inserted penetrating member 50.When connecting,shell 30 andbody portion 100 surround and penetratemember 50,motion parts 38 and be respectively applied formotion parts 38 and penetrate theguide member 32,33 ofmember 50, thereby a unit is provided.
Body portion 100 comprises opening 101, and this opening is arranged to appropriate size to allow to penetrate passing or entering ofmember 50 or its at least a portion (such assleeve pipe 22,entry needle 53 and retention feature 23).
Base portion part 100 andshell 30 be discrete component normally, and this element can separate in reversible or irreversible mode.According to present embodiment, opening 101 comprises theretention feature 23interactional interaction parts 102 that are suitable for and penetrate the body of member 50.Opening 101 can be closed and/or protection by sealingmember 121, and sealingpart 121 is dismountable or can be penetratedmember 50 andpenetrate.Sealing member 121 can cover the big zone ofbody portion 100, and ifbody portion 100 partly constitute by installation pad with tacky surfaces, then sealingmember 121 can be a releasing layer of protecting tacky surfaces before use.
Theguide member 32 that is used formotion parts 38 provides the directionally controlled motion of the motion parts inshell 30 38 basically.In the embodiment that describes,motion parts 38 can be with respect tobody portion 100 substantially parallel ground, i.e. essentially horizontally motion under situation about being guided by guide member 32.This motion can be characterized by sliding motion.
The motion thatmotion parts 38 is carried out is lengthwise movement, promptly with respect to the linear movement of shell 30.The means that are used to start and keep the motion ofmotion parts 38 can directly be provided by the user, and promptly the user pushes away or the movingpart 38 of roping, and perhaps it can be by only must being provided by the machinery such as spring that the user triggers.
Be that the part ofmotion parts 38 or theguide member 33 that is used to penetratemember 50 that is connected tomotion parts 38 provide and penetratemember 50 moving along the direction of the direction of motion that is different from motion parts 38.This feature has at least two advantages: 1. user's the unlikely influence of action penetrates the actual insertion ofmember 50 when triggering or pushing movingpart 38; Can construct in less and compacter mode with 2. insertion devices.
According to the embodiment of Fig. 1, the direction of motion that penetrates member 50 is substantially perpendicular to the direction of motion of motion parts 38.The guide member 33 that is used to penetrate member can comprise provides the strict track that limits or one or more part of pipe together, penetrating member can or slide in this track or pipe along this track or pipe, for example guide member 33 can comprise the hollow cylindrical element that is fastened to shell 30, penetrating member 50 can move in circle tube element along the longitudinal axis of described circle tube element, is equivalent to the motion of piston in cylinder.Because the inner surface of circle tube element and the contact that penetrates between the outer surface of member 50 provide guiding, this motion can be described to sliding motion.Alternatively, the guide member 33 that penetrates member 50 can comprise that domination penetrates one or more bar of the direction of motion of member 50.As seeing among Fig. 1, according to this embodiment, the guide member 33 that is used to penetrate member 50 extends to body portion 100 from the inner roof wall of shell.The guide member 33 that penetrates member 50 needn't be attached to body portion 100.Guide member 33 is for example stopped and/or contact body portion 100 and/or be connected with body portion 100 usually.In the embodiment that describes, penetrate the guide member 33 of member 50 and be connected to shell 30 in the inboard of upper surface (" roof ") and at one or more sidepiece (" wall ") of shell 30.
Theguide member 39 ofmotion parts 38 or transform component are that thetransform component 51 that penetratesmember 50 limits track.This track extends tointermediate point 22b and ends atterminal point 22c from starting point 22a.As seeing among Fig. 1, this track is a V-arrangement, perhaps V-arrangement basically.In the embodiment that describes, theguide member 39 ofmotion parts 38 is set to the continuous groove in themotion parts 38 or runs throughopening.Intermediate point 22b is than the moreclose body portion 100 ofstarting point 22a, and also than the moreclose body portion 100 ofterminal point 22c, andstarting point 22a is than the moreclose body portion 100 ofterminal point 22c.
Howstarting point 22a andterminal point 22c change relative to each other is unessential,, can haveterminal point 22c has same distance than the embodiment of the moreclose body portion 100 ofstarting point 22a orstarting point 22a andterminal point 22c tobody portion 100 embodiment that is.Yet, should guarantee thatstarting point 22a is positioned to leave body portion a distance that this distance is enough far away from before insertion the end ofsleeve pipe 22 and the end of isolatinginsertion pin 53 are remained in theshell 30.
According to the present invention and as shown in Figure 1A-1C, insertdevice 1 and be suitable for providing:
(i) first state (Figure 1A) wherein penetratesmember 50 and is in startingposition 22a, and it is withdrawn fully and be outstanding from theshell 30 that insertsdevice 1, andmotion parts 38 is in the starting position in the right side ofshell 30;
(ii) second state (Figure 1B), wherein penetratemember 50 22b that mediates, the a plurality of parts that penetratemember 50 that are inserted into, such assleeve pipe 22 and/orinsertion pin 53, protrude inshell 30 fully by the opening in thebody portion 100 101, andmotion parts 38 has moved forward to the centre position with respect to shell 30.Thestatic guide member 33 that penetratesmember 50 prevents to penetratemember 50 and moves and only allow to penetrate " vertically " motion ofmember 50 along the direction identical withmotion parts 38, that is, vertically here be appreciated that perpendicular to " level "; With
(iii) the 3rd position (Fig. 1 C), a plurality of parts that penetratemember 50 that wherein will be inserted into still protrude inshell 30, but with thetransform component 51 of holdingmember 52 withinsert pin 53 and be interminal point 22c and insert pin and withdraw from the injection site.Motion parts 38 has reached the end of its stroke to the left side in static housing.The second position (ii) in and the 3rd position (iii) in, the interaction between theretention feature 23 of thebody 24 of thebody 24 that penetratesmember 50 by penetratingmember 50 and theinteraction parts 102 ofbody portion 100 is held.
As shown, the level ofmotion parts 38 travels forward and is transformed to the insertion campaign that penetratemember 50 of back followed by the retraction movement of one or more part that penetrates member 50.Thisguide member 39 bymotion parts 38 is realized with the interaction that penetrates thetransform component 51 ofmember 50.
In primary importance (i), thetransform component 51 that penetratesmember 50 is in thestarting point 22a of track/guide member 39.Whenmotion parts 38, is penetratedmember 50 to move downward during horizontal movement by 32 guiding of its guide member, promptly " vertically " move towards body portion 100.The inclination of the movement velocity ofmotion parts 38 and guidemember 39 limits the movement velocity that penetratesmember 50, therefore limit insertion speed, the inclination that isguide member 39 is precipitous more, be used for penetrate the starting position ofmember 50 from withdrawal be directed to time of on position will be short more.
The second position (ii) in, thetransform component 51 that penetratesmember 50 has reached theintermediate point 22b of guide member 39.On this aspect, the incline direction ofguide member 39 changes to upwards (promptly leaving body portion 100) from downward (promptly towardsbody portion 100).Therefore, the orientation definition of the inclination ofguide member 39 penetrates the direction of motion of member 50.In addition, the horizontal movement forward ofmotion parts 38 produces holdingmember 52 that penetratesmember 50 and the retraction movement of inserting pin 53.Ifsleeve pipe 22 is hard self-gating sleeve pipes, then will not need isolatinginsertion pin 53 and also will not need to carry out the last withdrawal part of this motion, the last route and theintermediate point 22b that promptly can save the V in thetrack 39 will be equal toterminal point 22c.
The 3rd position (iii) in, thetransform component 51 that penetratesmember 50 has reached theterminal point 22c ofguide member 39, and penetrates the holdingmember 52 ofmember 50 and insertpin 53 and withdraw fully.
As seeing among Fig. 1,motion parts 38 does not protrude in shell 30.The direction of motion of the arrowindication motion parts 38 of figure top.
Fig. 2 A-2F illustrates the attachment component with automatic releasefunction.Inserting device 1 comprisesshell 30,body portion 100,motion parts 38, triggeringpart 11 and penetrates member 50.Penetrating an embodiment ofmember 50 shown in these figure, but also can use be similar among Figure 16-17 describe penetrate member penetrate member 50.For illustrative purposes,motion parts 38 is drawn in translucent mode.
Shell 30 comprises: be used for theguide member 32 ofmotion parts 38, thisguide member 32 allowsmotion parts 38 to move between at least two positions; Be used to penetrate theguide member 33 ofmember 50, thisguide member 33 allows to penetratemember 50 and moves between at least two positions; With theguide member 34 that is used for triggeringpart 11, thisguide member 34 allows triggering part to move between at least two positions.Shell 30 is attached to body portion 100.According to this embodiment, this is attached to be releasable.A plurality of parts of a plurality of parts of theshell 30 by comprisinghinge 35 andsecure component 14 andbody portion 100 interact and provide this attached, soshell 30 andbody portion 100 releasably are connected.Hinge 35 comprises the surface to the small part rounding of the wall ofshell 30, and when it was placed in the groove in thebody portion 100, it can pivot with respect to body portion 100.Thesecure component 14 ofshell 30 interacts with the Lock Part ofbody portion 100 108.
The height of theshell 30 ofdevice 1 is inserted in letter among Fig. 2 C " b " expression.Highly " b " will be advantageously in the scope of 5-100mm, and usually in the scope of 10-50mm, perhaps more particularly in the scope of 20-30mm.The embodiment that illustrates is 25mm.Do not remove among the embodiment of insert after inserting, insert should extend fartherly unlike sendingpart 8 from patient skin low as far as possible and usually.
Shell 30 also comprises retention feature 31.Retention feature 31 remains onmotion parts 38 in the starting position by engaging withLock Part 28 on the motion parts 38.According to this embodiment, retention feature also provides retainer for the motion of triggeringpart 11.
Theguide member 32 that is used formotion parts 38 provides the directionally controlled motion with respect to themotion parts 38 of shell 30.Guide member 32 is attached to or is connected to the integral part of the inner surface of the inner surface ofshell 30 orshell 30, and will have the shape corresponding to the long rails on the surface on themotion parts 38 usually, so that make themotion parts 38 can be along this slide.In the embodiment that describes,motion parts 38 can be under by the situation ofguide member 32 guiding withbody portion 100 abreast, promptly withbody portion 100 horizontal ground motions, this motion will be that i.e. this motion is lengthwise movement or linear movement along the sliding motion of the direction on the surface that is parallel tobody portion 100 usually.
Be the part of shell 30 or be connected to shell 30 or make that with guide member 33 that whole being used to of 30 one-tenth on shell penetrate member 50 penetrating members 50 only can move along the direction that strictness limits that this direction is different from the direction of moving link 38.In an embodiment, the direction of motion that penetrates member 50 is substantially perpendicular to the direction of motion of motion parts 38.The guide member 33 that is used to penetrate member 50 will be formed by the inner surface of shell 30 usually, for example, guide member 33 can comprise the inner surface of hollow cylindrical element, wherein penetrating member 50 can move forward and between the retracted position at least along the longitudinal axis of described circle tube element, is equivalent to the motion of piston in cylinder.Have rectangular cross section if penetrate member 50, then " cylindrical shape " element should be suitable for fitting closely to the cross section that penetrates member 50 of actual use natch.Because the inner surface of circle tube element and the Continuous Contact that penetrates between the outer surface of member 50 provide guiding, this motion will be a sliding motion.Alternatively, the guide member 33 that penetrates member 50 can comprise that domination penetrates one or more bar of the direction of motion of member 50.As seeing among the figure, according to this embodiment, the guide member 33 that is used to penetrate member 50 can extend to base section 100 from the inner roof wall of shell.The guide member 33 that penetrates member 50 is not attached to body portion 100 but can stretches downwards and contact it, perhaps for example provides support for body portion 100.
Theguide member 34 of triggeringpart 11 provides the directionally controlled motion with respect to the triggeringpart 11 of shell 30.Guide member 34 is attached to shell 30 or whole with 30 one-tenth on shell.In the embodiment that describes, triggeringpart 11 under the situation of guidedmember 34 guiding withbody portion 100 abreast, promptly withbody portion 100 horizontal ground motions, thisguide member 34 is set to a plurality of parts of the inner surface of shell according to thisembodiment.Guide member 34 can form along the long rails of the strict directionboot trigger part 11 that limits or only be the inner surface of the wall of shell 30.Becauseguide member 34 and trigger unit Continuous Contact when moving relative to each other, this motion is generally sliding motion.This motion will be linear movement usually.According to this embodiment, the direction of motion of triggeringpart 11 is identical with the direction of motion ofmotion parts 38, therefore theguide member 34 of triggeringpart 11 can be identical with theguide member 32 ofmotion parts 38, and promptly one group ofguide member 32,34 provides that the strictness ofmotion parts 38 and triggeringpart 11 limits and to small part motion simultaneously.
Motion parts 38 is provided withtransform component 39, this transform component with the motion (according to this embodiment, this motion is a level) ofmotion parts 38 be transformed to the back followed by the insertion pin that penetratesmember 50 at least along retracted orientation move penetratemember 50 moving along direction of insertion.According to this embodiment, this transform component is with following form: corresponding to the outstandingcylindrical shape part 51 on themember 50 of penetrating of the unlimited v-shapedtrack 39 in the motion parts 38.V-shapedtrack 39 be designed to appropriate size to closely cooperate with theledge 51 that penetratesmember 50 so that the strict motion path that limits is provided.
Motion parts 38 comprisesrelease component 29, and this release component provides the separation of at least a portion ofshell 30 orshell 30 frombody portion 100 by thesecure component 14 that theLock Part 108 frombody portion 100 discharges shell.Described release is provided by the interaction ofrelease component 29 with the part ofshell 30, according to this embodiment, this part is the inwall of theshell 30 relative withtrigger unit 11, wherein, if the linear movement oftrigger unit 11 proceeds to this inwall ofshell 30 then will stop.
Shell compriseselastic component 36, and this elastic component startsshell 30 removing frombody portion 100 when the release of thesecure component 14 of shell.According to the embodiment shown in Fig. 2,elastic component 36 is integral parts ofshell 30, and promptly it is fastened to shell 30 in the mode that can not discharge.Elastic component 36 is to be fastened to shell 30 an end in the mode that can not discharge and to be pressed in sheet spring on thebody portion 100 in relative end.The flexible physical size by its material of structure and this material ofspring member 36 limits, according to the present invention, elastic component by with the shell identical materials, be rigid plastics structure and molding duringshell 30 molded usually, but it also can be by the metal construction that is fastened to shell 30 after shell molded in the mode that can not discharge.
Use the triggering that is inserted through triggeringpart 11 that penetratesmember 50 of insertion device according to theinvention 1 and started.By triggering part being pushed to shell 30, trigger triggering part 11.Triggeringpart 11 comprises interaction parts 41.Interaction parts 41 interact with theretention feature 31 ofshell 30, therefore stop travelling forward of triggering part 11.As seeing among Fig. 2 A, triggeringpart 11 protrudes inshell 30 under the not triggering state of describing.Letter " a "expression triggering part 11 is with respect to the outstanding length of shell 30.Usually will be in the scope of 1-100mm or 5-50mm or 10-25mm or 15-20mm at the protuberance before the triggering of triggering part 11.In the illustrated embodiment, this outstanding be 17mm.In another embodiment of the present invention, triggeringpart 11 does not protrude inshell 30, perhaps only protrudes inshell 30 on the limit.
Inserteddevice 1 before using, such as being in the state of triggering in transportation or memory period.
According to this embodiment,spring 45 is arranged betweenmotion parts 38 and the triggering part 11.Usually,spring 45 will be in relaxation state at memory period, this be since this will prolong product usually can the stored time when still fully function being arranged, ifspring 45 is in bias state at memory period, the danger that then exists the performance of product to reduce rapidly.Shown in Fig. 2 A-F,spring 45 can be a helical spring, comprises two ends:first end 46, thisfirst end 46 are attached tomotion parts 38 or are arranged to and be connected withmotion parts 38; With thesecond end 47, thissecond end 47 is attached to triggeringpart 11 or is arranged to and is connected with triggeringpart 11.Spring 45 arranges that along the direction of motion that is used for triggeringpart 11 this direction of motion is parallel to the upper surface ofbody portion 100.
The function ofspring 45 be for penetratemember 50 and/or penetrate member 50 a plurality of parts penetrate and/or retraction movement provides energy.If this energy be can't help spring 45 and is provided, then it must be by the user of this device this user by triggeringpart 11 being pushed to shell 30 horizontal movement of triggeringpart 11 is provided and directly providing when therefore the horizontal movement ofmotion parts 38 is provided.
The spring 45 of the embodiment that illustrates is stored the energy from the actuating movement of triggering part 11 when spring 45 is biased by this first motion.Between the period of energization of triggering part 11, motion parts 38 is immobilized.When the interaction parts 41 of triggering part 11 entered with the contacting of Lock Part 28, motion parts 38 was released and moves along the direction that guide member 32 limits from resting position.Travelling forward of triggering part 11 stops when the retention feature 31 of interaction parts 41 contact shells 30.According to the embodiment of Fig. 2, the direction of motion parts 38 and triggering part 11 forwards to identical.When the inner surface of the motion parts that promoted by spring 45 38 collision shells 30, spring 45 is thought that by bias voltage sufficiently the release of the releasable connection between the Lock Part 108 of the secure component 14 of shell 30 and body portion 100 provides energy.This provides by following: make flexible this wall that makes of at least a portion of the wall of shell 30 or this wall can be outwardly-bent and discharge secure components 14 from the Lock Part 108 of body portion 100.When locking connects when being released, elastic component 36 is pushed shell 30 open and the user will not need to draw back the insertion device from body portion 100 from body portion 100.
Fig. 3 illustrates first embodiment according to the assembly of insert of the present invention that comprises with drug unit 8.Because the entire upper surface ofbody portion 100 is covered bydrug unit 8, therefore only the sidepiece ofbody portion 100 can be insight.Drug unit 8 will comprise usually such as the reservoir of the medicine of insulin and with the form of pumping parts send part and for example dosage parts, these dosage parts can notice that patient has the medicine of prescribed dose.
Fig. 4,5A and B illustrate and comprise according to insert 10 of the present invention, send second embodiment of the assembly ofpart 8 and body portion.Body portion comprises thesurface plate 1 that is attached to contact surface.In this embodiment,surface plate 1 is made of molded plastic material and contact surface is the proximal lateral thatpad 2 is installed, and during the manufacturing of this device, thisinstallation pad 2 is fastened to surfaceplate 1 in the mode that can not discharge." near-end " means when pad being installed being attached to patient the most close patient's sidepiece or surface, and " far-end " means when this device is in the use location end or the surface away from patient.
Fig. 4 illustrates from the embodiment of the assembly of sidepiece observation and Fig. 5 the identical embodiment that observes from the top is shown.The member that penetrates of this embodiment is included in thesleeve portion 7, and this sleeve portion is inserted among theopening 12A ofconnector part 3 of body portion, and thisferrule openings 12A provide the opening that vertically passes bodyportion.Sleeve portion 7 is provided with the member that penetrates with the form ofsleeve pipe 22, this penetrate member during inserting, will penetrate patient skin the surface and arranged hypodermically or percutaneously.
Insert 10 maintainance settube portion 7 and this before inserting are inserted through push handle 11 and are started.Necessary push handle 11 is shown Fig. 5 so that the direction of the insertion of starting sleeve portion 7.After inserting, unshowned insertion pin can be withdrawn into the inside ofinsert 10, after this can remove insert 10 from body portion, stays the sleeve pipe that has inserted 22 that is fastened to surface plate 1.If thesleeve pipe 22 ofsleeve portion 7 is hard self-gating sleeve pipes, then will there be isolating insertion pin and therefore need withdrawal to insert pin.
Connector part 3 remains on the appropriate location by surface plate 1.According to an embodiment, during the manufacturing of this device, surface plate 1 and at least the outer covering piece of connector part 3 only be molded as monomer spare.Connector part 3 is at the reservoir 6 of for example medicine or be used for forming fluid path between the reservoir of the liquid collected from patient and the sleeve portion 7.Therefore, connector part 3 is provided with at least two openings, in each end of fluid path an opening is arranged, wherein first opening 13 is to receive fluid or delivery of fluids inlet or the exit opening to reservoir 6, and second opening 12 is reception fluid or delivery of fluids inlet or exit openings (seeing Fig. 6 C-D) to sleeve portion 7.Coupling part 3 can be provided with extra opening, for example, is used for second medicine or nutraceutical injection or is used for making the fluid of fluid path to contact with pick off.In order to guarantee the exit opening 12 in the coupling part 3 and the connection of the fluid-tight between the sleeve portion 7, the exit opening 12 of coupling part 3 is provided with elastic sealing element 18 around exit opening 12.When sleeve portion 7 inserts, it will be press fit in the ferrule openings 12, and elastic sealing element 18 will provide the liner of perfect fluid sealing around corresponding opening 12 and 20.To be press-fitted the fluid-tight that merges between the outlet that therefore improves sleeve portion 7 and fluid path and to connect in order to improve, ferrule openings 12A can be provided with the cross section that successively decreases in be parallel to sleeve pipe 22 and the plane perpendicular to the surface of the outlet of layout fluid path when inserting.Sleeve portion 7 will have the corresponding cross section that successively decreases.
Below,first opening 13 will be called " inlet " andsecond opening 12 will be called " outlet ", though inessential to the present invention by the mobile direction of fluid path.
Couplingpart 3 also is provided withferrule openings 12A, this ferrule openings accurately be engaged insleeve portion 7 around, promptly ferruleopenings 12A has the shape identical withsleeve portion 7 or profile and just in time enough big so thatsleeve portion 7 passes and is coupled to subsequently in this opening.Whensleeve portion 7 is inserted among body portion and the patient fully, upper surface then, promptly the distal surface ofsleeve portion 7 flushes with the outer surface of thecoupling part 3 that surroundsferrule openings 12A usually or is in than on the low level of this outer surface.Whensleeve portion 7 had been inserted in thecoupling part 3 fully, then theopening 20 in the side surface of the body ofsleeve portion 7 can flow to another part from a part corresponding to theopening 12 and the fluid of the fluid path ofcoupling part 3.
Fig. 5 B illustrates the embodiment of Fig. 5 A that removes insert.Fig. 5 B illustrated this device from the end that is inserted into part 10 coverings before removing insert.Can see the part of secure component 14 from this end, this secure component guarantees that insert 10 was attached to body portion before inserting.According to this embodiment, secure component 14 comprises two opening 14L and the 14R in the connector part 3.These openings are corresponding to from the sidepiece of insert shell outstanding two ledge 14PL and 14PR (seeing Fig. 7 and 8), and these two ledges are towards body portion with corresponding opening and connector part 3.When the corresponding secure component 14PL on the secure component 14L on the body portion and 14R and the insert 10 and 14PR engage, prevent on direction that at least insert 10 from moving with respect to body portion perpendicular to surface plate 1.After the insertion that penetrates member (penetrating member is inserted in the body portion fully), can remove or separate insert 10 from body portion.When from body portion separation insert 10, insert 10 is along becoming the direction of level to move with patient skin, and promptly body portion is not subjected to the power perpendicular to patient skin, is about to the power that body portion draws back from patient.Alternatively, can be for example insert is adhered to sends part 8 inserting forward position insert 10 and send abutment surface between the part 8, the skin that this surface should be substantially perpendicular to patient produces along the pulling force that is parallel to the direction of patient skin when removing insert 10 with box lunch from sending part 8.
Fig. 6 A-D illustrates the body portion that is in isolating position and sends part from different angles.In Fig. 6 A, this two parts are shown from the below.This view illustratesopening 12B, penetratesmember 7 and can pass that body portion inserts andsleeve pipe 22 extends through thisopening 12B by this opening.From this view as can be seenreservoir 6 how can be arranged in send thepart 8 and as can be seen the release handle 9 of two positioned opposite how to be arranged on the edge of sending part 8.In addition, can see long rails corresponding to the vertical protuberance guide member 4 on the body portion.
Two release handle 9 form S shape band, one of them end hinge shape is fastened to the shell and first bending in the S shape of sendingpart 8 and extends to the outer surface of sending shell partly slightly, and second bending is freely, promptly be not attached to the shell of sendingpart 8, and be provided with hook-like shapes, this hook-like shapes may be folded on around theoutstanding part 15 in the surface far away of body portion.When sending part when locking onto body portion, two release handle 9 all be folded inledge 15 around, when removing when sendingpart 8 from body portion, two relative release handle 9 are pushed together, the unci of release handle 9 is discharged by theledge 15 from body portion thus, and sending part can be backward, promptly moves and is removed from body portion along this direction along the direction of leavingsleeve portion 7.
In Fig. 6 B, this two parts are shown from the top.This view illustrates sendingpart 8 and how can sendingpart 8 and be connected to body portion by pushing away towards guide member 4 of this embodiment downwards, and this guide member is the platform with vertical protuberance of the clad lining 5 that for example is fastened to top surface in this case.Sendpart 8 and be provided with corresponding components, this corresponding components for example comprises the track corresponding to the platform 4 of protuberance.Sending the corresponding components ofpart 8 can be in a longitudinal direction slide along the clad lining 5 of raised platform 4.When sendingpart 8 its operating positions of arrival, two release handle 9 engage respectively with from twooutstanding ledges 15 of the upper surface of surface plate 1.When sendingpart 8 when being in its operating position, it is released handle 9 lockings along all horizontal directions.This locking mechanism makes can be fastening frequently as required and from body portion release delivery parts, and promptly the body portion that uses of single can divide combination with nonexpondable delivery portion.
In Fig. 6 C, this two parts are shown from the end relative with the position of fastening insert before the insertion that penetrates member.Can see inlet opening 13coupling part 3 from this sidepiece, for example the medicine fromreservoir 6 can enter by this opening that enters the mouth, and protects this inlet opening 13 to prevent to pollute microorganism to be arranged with thin film.According to an embodiment, couplingpart 3 is provided with connector pin (because it is placed on bubble-shaped thin film back, therefore not shown) and the self-enclosedthin film 17 of bubble-shaped, andreservoir 6 can be provided with the self-enclosed thin film of bubble-shaped.Thus, set up fluid path, this fluid path provides 3 the transmission from the reservoir to the connector part of insulin for example or nutraceutical medicine.Because two parts all are provided with self-enclosed thin film, therefore can make these two unit separated from one another and connect them more afterwards and do not pollutecoupling part 3 and therefore do not pollute patient.
Fig. 7 illustrates vertical cutting of passing the assembly shown in Fig. 4-6.Can see from this view how theconnector part 3 of body portion and the secure component separately 14 ofinsert 10 link together.
Fig. 8 illustrates theinsert 10 that is removed from the remainder of assembly.Can see the secure component 14PR and the 14PL of insert from this sidepiece.
Fig. 9-11 illustrates the 3rd embodiment of insert, and in Fig. 9 and 10, insert is shown as with all the other of assembly and separates.As first and second embodiment of insert, insert 10 comprisesactuator handle 11, and this actuator handle is shown as in Fig. 9 and is in pre-insertion state and is shown as the back state that inserts that is in Figure 10.The 3rd embodiment of insert is provided withmotion parts 38 as shown in Figure 12, and this motion parts is provided with protrudingmember 38A, and this protruding member is the integral part of motion parts 38.Motion parts 38 shown in two different views among Figure 12 A and the 12B.It is that " integral part " means it and motion parts and move simultaneously and be arranged to static with respect to motion parts.Usually, it will be molded together and have same material with motion parts, but it also can make and be attached tomotion parts 38 by different materials after producingmotion parts 38.
Ledge 38A on themotion parts 38 is provided with the slope.This slope is that the front outline ofledge 38A that makes on front side portion that is positioned atledge 38A forms the inclined surface of arrow.
The secure component of this embodiment compriseshinge portion 14, in this embodiment, this hinge portion is fastened to the shell ofinsert 10, and this hinge portion alternately is fastened to the interior section of insert, for example is fastened to identical part on it with ledge 14PL and 14PR.In the illustrated embodiment, owing to producehinge portion 14 by in the full-height of shell, making two cuttings, so infact hinge portion 14 is fabricated to the part of shell.Shell is usually by making such as polyacrylic hard molded plastics, and the long relatively shape ofhinge portion 14 makes it very flexible, behinge portion 14 very flexible and easily from release position to the extrapolation it, inwardly motion owing to be used to penetrate member the existence ofguide member 33 and blocked, this penetrating parts issleeve portion 7 in thisembodiment.Hinge portion 14 also can be made by the material (for example metal) of the material of the shell that is different from insert, and it rotatably is attached to shell subsequently.
Hinge portion 14 is provided with two inside hooks (" inwardly " means the inside that hook points to shell) at the following and close end ofhinge portion 14, and these two hooks lock onto body portion by the immobilizedledge 14B that catches body portion with shell.Since two hooks inwardly towards, therefore push away them and with their latched position release from them by outwards (promptly leaving the center of shell).Hinge portion 14 also is provided with thecontact member 14A of form of the plate with rounding of rigid material, and this contact member is arranged in around theguide member 33 that is used forsleeve portion 7 inside from hinge portion 14.Whenmotion parts 38 when its starting position moves to its final position, the protrudingmember 38A that is arranged on the trailing edge ofmotion parts 38 will collidecontact member 14A with ramped surfaces, and will be toextrapolation contact member 14A, and becausecontact member 14A is in the mode that can not discharge and be attached to hingeportion 14 rigidly, therefore also will be toextrapolation hinge portion 14.
The shell of insert also comprises two ledges of the form of hook 14PL with rounding and 14PR on the inner surface of the wall relative with the inside hook of hinge portion 14.These ledges 14PL and 14PR are coupled among thecorresponding opening 14L and 14R near the body portion of connector part 3.Opening in body portion shown in Figure 16 A.When the corresponding secure component with the form of the hook 14PL of rounding and 14PR with on the secure component of the form ofopening 14L and 14R and theinsert 10 on the body portion engages, be parallel on the direction longitudinally of body portion (since ledge be rounding and form in around openings hold) and on direction (because ledge is inserted in the opening), prevent that insert 10 from moving with respect to body portion perpendicular to surface plate 1.After insertion penetrates member fully (Figure 10), insert 10 can be removed from body portion or be separated.
In order to separateinsert 10 from body portion, insert 10 winds the axis of arranging along the upper surface ofopening 14L and 14R and pivots.(far-end) surperficial hook 14PL and the 14PR for rounding that go up ofopening 14L and 14R provides contact surface, wheninsert shell 30 stood to rotatablely move, therefore the hook 14PL of rounding and the downward contact surface of 14PR can and be forced to leaveopening 14L and 14R along this contact surface slip.After inserting, comprisesurface plate 1 and the body portion of thepart 7 inserted to have inserted wherein surface with respect to sleeve pipe or pick off complete static and rotatablely move and only provided byinsert 10.
Following or the proximal end face place of the shell of the insert that tilts at theupper surface 1 with respect to body portion makes to rotatablely move and becomes possibility, and be the displacement retaining space ofshell 30 therefore, in the ending that rotatablely moves, following (near-end) inclined surface of insert shell will rest on the patient skin usually.
Figure 11 A illustrates the insert that is in the position before inserting.In this state, inclined lower surface is moved away from patient's skin.The inside hook lock ofhinge portion 14 fixes on around the ledge 11B on the body portion.
Figure 11 B illustrates and inserts sleeve portion insert afterwards.In this state, inclined lower surface is parallel to patient's skin and the inside hook ofhinge portion 14 is released from latched position.
Figure 11 C illustrates the insert after body portion removes insert.
Figure 12 A and 12B illustrate themotion parts 38 of the 3rd embodiment of the insert shown in Fig. 9-11.Figure 12 A illustrates " dorsal part ", promptly deviates from the sidepiece that penetrates member, and Figure 12 B illustrates " front side ", promptly towards the sidepiece that penetrates member.This illustrates and has angled sides (promptly along the direction of motion forward towards the slope) theledge 38A of the trailing edge that is placed onmotion parts 38, and this illustrates thetransform component 39 with the shape of the longitudinal opening that forms V, and wherein the starting position final position that is in the upper end of first route among the V and is used for penetrating member is in the upper end of second route of V.
Figure 13 and 14 illustrates the 4th embodiment of insert, and this embodiment is different from the 3rd embodiment part and is,secure component 14 is fixed to body portion withinsert.Insert 10 is shown as in Figure 13 and 14 and is in the back state that inserts, and inserts in the state of back at this, removes insert from body portion.The 4th embodiment has and discharges the independently parts of secure component of the function in groups support each other.
As the 3rd embodiment, the 4th embodiment of insert is provided with the motion parts 38 (seeing Figure 15 A and 15B) with protrudingmember 38A, and this protruding member is the integral part of motion parts 38.Themotion parts 38 of the 4th embodiment also is provided with second integral part that is called positioning element 27.Thesepositioning elements 27 are attached to the following trailing edge ofmotion parts 38.
As the 3rd embodiment of insert, the secure component of this embodiment compriseshinge portion 14, and this hinge portion is fastened to the shell ofinsert 10 and thishinge portion 14 to move with the identical mode that the 3rd embodiment that is Fig. 9 and 10 describes.Thehinge portion 14 of the 4th embodiment also is provided with two inside hooks at the following or near-end of hinge portion 14.These two hooks are locked in shell on the body portion by the immobilizedledge 14B that catches the body portion with downward or near-end contact surface.Since two hooks inwardly towards, therefore push away them and discharge them by outside (promptly leaving the inside of shell).
Hinge portion 14 also is provided with along thecontact member 14A towards the form with plate of the direction at the center of insert (promptly around theguide member 33 that is used forsleeve portion 7 fromhinge portion 14 " inwardly ") setting.Whenmotion parts 38 when its starting position moves to its final position, the protrudingmember 38A that is arranged on the trailing edge ofmotion parts 38 will be with the ramped surfacescollision contact member 14A of protrudingmember 38A, and will apply outside power to contactmember 14A, and becausecontact member 14A in the mode that can not discharge and be attached to hingeportion 14 rigidly, therefore also will apply outside power to hingeportion 14.
According to the 4th embodiment, protruding member 14PL and 14PR are arranged on the flexure member 114.Protruding member 14PL and 14PR according to this embodiment have rectangular profile, but also can have for example circle or triangular-shaped profile.Protruding member 14PL and 14PR are coupled among theopening 14P and 14L near the body portion of connector part 3.These openings are corresponding to rectangle protruding member 14PL and 14PR.When the corresponding secure component with the form of protruding member 14PL and 14PR with on the secure component of the form ofopening 14L and 14R and theinsert 10 on the body portion engages, prevent thatinsert 10 is on perpendicular to the direction ofsurface plate 1 and be parallel on any direction ofsurface plate 1 and move with respect to body portion.
Flexure member 114 is attached to shell or makes flexure member to move between the two positions with respect to shell 30 immobilized parts, and these two positions are that insert locks onto the primary importance of body portion and insert from the d/d second position of body portion.Figure 13 A and 13B illustrate theflexure member 114 that is in the latched position of loosening and the arrow among Figure 13 B and represent that it moves inward so that reach the direction of second off-position.According to the embodiment that illustrates,flexure member 114 is fabricated to the integral part of theguide member 32 that is used for motion parts, and promptly flexuremember 114 constitutesmotion parts 38 along the surface of its slip or the part of wall.Flexuremember 114 is provided withcontact portion 115, and according to this embodiment, this contact portion has triangular-shaped profile, and this triangular-shaped profile has during inserting along the edge that comes to a point that the direction of motion is pointed toforward.Contact portion 115 is formed with the slope shape surface, and this slope shape surface is pointed to along the direction opposite with the direction of motion ofmotion parts 38 during inserting.
Enter second off-position forflexure member 114 is loosened with latched position from first, this flexure member must be subjected to a power, and this power is enough big so that can makeflexure member 114 move to the second position.
Figure 14 A and 14B illustrate the interior section ofinsert shell 30, and this interior section provides leader and invisible when shell on every side is in the appropriate location for motion parts.Figure 14 A and 14B illustrate the identical section that passes these inner shell parts, but in Figure 14 A,motion parts 38 be removed in case thecontact portion 115 that makes interior section asseen.Contact portion 115 is made up of outstanding inclined surface, and whenmotion parts 38 was in its termination or final position, this outstanding inclined surface was with thepositioning element 27 ofcontact movement part 38.
Figure 15 A and 15B illustrate themotion parts 38 of the 4th embodiment of the insert shown in Figure 13-14.Figure 15 A illustrates " dorsal part ", promptly deviates from the sidepiece that penetrates member, and Figure 15 B illustrates " front side ", promptly towards the sidepiece that penetrates member.This illustrates and has angled sides (promptly along the direction of motion forward towards the slope) theledge 38A of the trailing edge that is positioned atmotion parts 38, and this illustrates thetransform component 39 of the shape that is the longitudinal opening that forms V, wherein the starting position is in the upper end of first route among the V, and the final position that is used for penetrating member is in the upper end of second route of V.Final position is arranged to be lower than the starting position.Lower edge atmotion parts 38 illustratespositioning element 27, when theguide member 32 that provides along the peripheral part by the insert shell when motion parts slides, this positioning element guarantees the location ofmotion parts 38 with respect to the shell of insert, but the major function of this positioning element is whenmotion parts 38 and theflexure member 114 of thepositioning element 27 that becomes integral body through out-of-date " backward " compressing shell.
When thepositioning element 27contact flexure members 114 ofmotion parts 38,flexure member 114 is pushed away thecoupling part 3 of body portion, and is drawn out correspondingopening 14L and 14R in the body portion with the secure component of the form of ledge 14PL and 14PR.Whenmotion parts 38 is in its final position, becomewhole part 38A and 27 will be inhinge portion 14 and flexure member, this means whenmotion parts 38 is in its final position and can remove insert from body portion all by the position with latched position of loosening that pushes away them.
Figure 16 illustrates the enlarged drawing of the sleeve portion 7 that the embodiment with Fig. 1-2 uses.This embodiment comprises body 24, and this body is provided with sleeve pipe 22 and is provided with outstanding front portion 25, and this outstanding front portion has the flat surfaces that is provided with opening 20.Outstanding anterior 25 of sleeve portion 7 needs not be smooth; In fact it can have any desirable shape, as long as it can produce the corresponding surface on the coupling part 3 of sleeve portion 7.In one embodiment, anterior 25 tilt to make the cross section that cross section that the upper end (being far-end) of sleeve portion 7 locates is located greater than forward near-end (promptly after insertion the most close patient's end).Outstanding anterior 25 opening 20 is inlet or outlets that liquid could enter or leave sleeve portion 7 by it.Body 24 also is provided with top opening 21, and this top opening can be coated with self-enclosed thin film.Because opening 21 is towards the outer surface that contacts with environment, so opening 21 needs the protection that enters of some kinds.If sleeve pipe 22 is soft tubes, then when inserting sleeve portion 7, mainly use top opening 21.Sleeve pipe 22 is soft to mean that it is made by the soft relatively material that can not self penetrate patient skin, in this case, when inserting sleeve pipe, be necessary to use the insertion pin of the point of hard relatively material, and this sharp pin can insert by top opening 21, the overall length that passes the internal cavities in the body 24 of sleeve portion and pass sleeve pipe 22, makes the end of the point that inserts pin stretch out the open end of hollow bushing 22.After inserting, promptly after sleeve pipe 22 was placed among the patient hypodermically or percutaneously, then withdrawal insertion pin and sleeve pipe 22 were stayed in the patient.Sleeve portion 7 also is provided with secure component 23, and this secure component has the form of a series of outside hooks 23 in this embodiment, and these a series of outside hooks 23 are fastened to body 24 flexibly makes hook inwardly to pivot towards the center of sleeve portion 7.When sleeve portion 7 is pressed to body portion, hook 23 is through the edge, to center is pushed them at hook during through the edge in this edge, and when hook during through the edge, hook turns back to their initial position, and since one or more hook to upper surface contact this edge to lower surface, sleeve portion 7 is locked on this edge in the mode that can not discharge.
Figure 17 illustrates the enlarged drawing of second embodiment of sleeve portion 7.This embodiment also comprises body 24, this body is provided with sleeve pipe 22 and is provided with outstanding anterior 25, should have the flat surfaces that is provided with opening 20 in outstanding front portion, but according to this embodiment, outstanding anterior 25 tilt so that reduce to insert the required power of sleeve portion and so that reduce the distortion of sealing member 18.Anterior 25 inclination is limited by the centrage c of sleeve pipe 22 and the angle d that is parallel between the line on the surface around the opening 20.Angle d will be greater than 0 ° and less than 90 °, usually, according to the diameter of sealing member 18, d ∈ [0 °, 30 °], perhaps d ∈ [60 °, 90 °].Between the center c of far-end on the surface of ledge 25 (promptly after inserting away from the end of patient's sleeve portion 7) and sleeve portion 7 apart from d1Between the surface of the ledge of locating greater than near-end (after promptly inserting the most close patient end) 25 and the center c of sleeve portion 7 apart from d2Usually, apart from d2To such an extent as to like this little outstanding near-end of anterior 25 sealing member 18 of contact-and-connection portion 3 not during inserting.
In an embodiment (not shown), angle d is near 90 °, and promptly d=90 °, this embodiment will seem to have theupward opening 12 to thecoupling part 3 of under shed 20 that is coupled tosleeve portion 7 in the figure corresponding to Figure 11.This meanspush sleeve portion 7 power of sealingmember 18 to will be near will during sealingmember 18 slides the insertion that prevents to be sealed insleeve portion 7, twisting bysleeve portion 7 perpendicular to the contact surface of sealingmember 18 and this.In another embodiment (shown in Figure 16), becauseoutstanding front portion 25 is parallel with centrage c, d=0 °.According to this embodiment,sleeve portion 7 will with outstanding sealingmember 18 sliding-contacts, this can cause the sealing be twisted.
As the embodiment according to Figure 16,outstanding anterior 25 ofsleeve portion 7 needs not be smooth; In fact it can have any desirable shape, as long as it can produce the corresponding surface on thecoupling part 3 of sleeve portion 7.And, depending on the purpose ofsleeve portion 7,outstanding anterior 25opening 20 can be inlet or opening.How to be coated with self-enclosedthin film 21A attop opening 21 forbody 24 shown in Figure 17 of cutaway view.As embodiment according to Figure 10, ifsleeve pipe 22 is soft tubes, then when insertingsleeve portion 7, mainly usetop opening 21, buttop opening 21 also can be used for injecting medicine or nutrient except main medicine, this main medicine can be an insulin for example, and patient receives these insulins by opening 20.
This embodiment ofsleeve portion 7 also is provided withsecure component 23, andsecure component 23 has the form of theledge 23 on thesleeve portion 7 in this embodiment, and thisledge 23 is corresponding to theflex section 23A on the immobilized body portion.At theledge 23 on thesleeve portion 7 during the insertion ofsleeve portion 7 through out-of-date, as at Figure 17 by the arrow indication, can be to extrapolation flex section 23A.After inserting, theledge 23 ofsleeve portion 7 will be to upper surface by the downward surface lock of theflex section 23A of body portion and can not be from body portion separationsleeve tube portion 7.
Figure 18 a illustrates another embodiment of motion parts 18, and this motion parts has the tolerance of the increase that is used to depart from the standard insertion depth.Figure 18 a illustrates " dorsal part ", promptly deviates from the sidepiece that penetrates member, and in being placed on insert the time, motion parts will be from the right motion to a left side, the member that penetrates of insert is stayed in the stationary water mean place simultaneously, and in this position, it moves upward at first downwards and subsequently.This illustrates the ledge 38A at the trailing edge place that is arranged on motion parts 38 and is arranged on the guide member that is used for transform component 39 in the border of motion parts.According to this embodiment, guide member 39 is limited by the otch that has around the outer boundary of open spaces, and the transform component 51 that penetrates member can move in this open spaces.But guide member 39 also comprises pivoting portions 39A, but this part distaff pivot, be fastened to the body of movable part 38 by this bar.Movable part 38 according to Figure 18 a from the right motion to a left side, can pivoting portions 39A along with transform component through and when upwards swinging, but pivoting portions 39A provides the flexible boundary that goes up.But when pivoting portions 39A when having penetrated the transform component 51 of member, its swing is got back in its resting position.
Transform component 51 has the starting position with respect tomovable part 38 at position A place.Whenmovable part 38 moved to the left side, thetransform component 51 that penetrates member was by along the upper surface slide ofguide member 39 and in-position B at position B, penetrates theinsertion pin 53 contact patients' of member skin.
At position C, be connected to or surround thesleeve pipe 22 contact patients' that insertpin 53 skin.
At position D, the sealing beginning, promptly betweensleeve portion 7 andsurface plate 1, form contact, and the maintenance click can be listened and informs that user'ssleeve pipe 22 is in the information thatretention feature 23 on its tram and the static body portion has locked ontosleeve portion 7 body portion.
At thetransform component 51 that penetrates member during from position A to position D, but it slides along the following contact surface of pivoting portions 39A.This contact surface penetrates member to pressing down, and therefore importantly, this surface is slick and as far as possible little frictional resistance is provided.
At position E, penetrating member should insert fully.But pivotingportions 39A deflection and allow the insertion depth varied slightly is promptly in the scope of ± 0.5mm.
At position G, insert the self-enclosedthin film 21A thatpin 53 does not have thetop opening 21 of possibility overlappingcasing tube part 7, and, insert pin and be in home at position H, promptly insert the shell withdrawal ofpin 53 with respect to insert.Usually, it will be with respect to the shell 1mm at least that withdraws.
During from position E to position H, it slides along the upwards contact surface of the afterbody of theguide member 39 that formsmotion parts 38 at thetransform component 51 that penetrates member.This contact surface is raised and is penetrated member, and it should be slick and as far as possible little frictional resistance is provided.
Figure 18 b illustrates from the view of themotion parts 38 of sidepiece observation.Be labeled as the sidepiece shown in the arrow indicator diagram 18a of A.
Figure 19 A, B and C are illustrated in the embodiment of the leaf spring that can be used for driving forwards motion parts among any embodiment that illustrates of insert.According to this embodiment,spring 45 is arranged betweenmotion parts 38 and the triggering part 11.Usually,spring 45 will be in relaxation state at memory period, this be since this will prolong product usually can the stored time when still fully function being arranged, ifspring 45 is in bias state at memory period, the danger that then exists the performance of product to reduce rapidly.In this embodiment,spring 45 is the leaf springs that for example are made of plastics, and this leaf spring comprises two ends:first end 46, thisfirst end 46 are attached tomotion parts 38 or are arranged to and be connected withmotion parts 38; With thesecond end 47, thissecond end 47 is attached to triggeringpart 11 or is arranged to and is connected with triggering part 11.The second end ofspring 45 leans against on theblock 47a.
Thespring 45 of the embodiment that illustrates is stored the energy from the actuating of triggeringpart 11 whenspring 45 is biased by this first motion.The characteristic feature of leaf spring is, when this spring was biased, it was along curved, the existence ofblock 47a and the form of block, and promptly the length ofblock 47a guarantees that spring 45 only can be along a direction bending when it is biased.The unshowned shell of insert comprises retention feature 31.Retention feature 31 can have the form of pivotal arm, and this pivotal arm remains onmotion parts 38 in the starting position by engaging withLock Part 28 on the motion parts 38.The form that has the ledge of triangle for example or circular contour according to theLock Part 28 of the embodiment shown in Figure 19 A-C.
The distortion of thespring 45 that causes owing to bias voltage can be used for the starting position ofmotion parts 38 from locking discharged.
Figure 19 A illustrates the embodiment in the starting position.Spring loosens, i.e. bias voltage not, and theretention feature 31 of shell is in the latched position.In order to begin to insert, the user is necessary to push awayactuator 11, and by so doing, it is biased that spring will become.Between the period of energization of triggeringpart 11,motion parts 38 is immobilized.
Figure 19 B illustrates the embodiment in theloading position.Spring 45 is by bias voltage fully and bend to a degree at this complete bias state medi-spring 45 and make theretention feature 31 of its contact shell and they are pushed away theLock Part 28 ofmotion parts 38, therefore from shell releasedmovement part 38.
Figure 19 C illustrates the embodiment in the state thatmotion parts 38 moved to its final position.Actuator handle 11 is in identical position in the complete stress state with Figure 19 B, and theretention feature 31 of shell is in unlocked position.In this state, the member that penetrates that be inserted into will be inserted hypodermically, and user's next step will be to remove the insert shell from the insertion section displacement.

Claims (30)

CN2009801096598A2008-02-202009-02-19Insertion device with horizontally moving partPendingCN101983078A (en)

Applications Claiming Priority (7)

Application NumberPriority DateFiling DateTitle
US3002208P2008-02-202008-02-20
US61/030,0222008-02-20
DKPA2008002402008-02-21
DKPA2008002402008-02-21
US9537908P2008-09-092008-09-09
US61/095,3792008-09-09
PCT/EP2009/051974WO2009103759A1 (en)2008-02-202009-02-19Insertion device with horizontally moving part

Publications (1)

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JP (1)JP2011512886A (en)
KR (1)KR20100134599A (en)
CN (1)CN101983078A (en)
BR (1)BRPI0907828A2 (en)
NZ (1)NZ587469A (en)
RU (1)RU2010138626A (en)

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KR20100134599A (en)2010-12-23
RU2010138626A (en)2012-03-27
JP2011512886A (en)2011-04-28
NZ587469A (en)2012-04-27
BRPI0907828A2 (en)2017-04-11

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