CN107592819A

CN107592819A - Device for targeted delivery therapeutic implant

Info

Publication number: CN107592819A
Application number: CN201580078547.6A
Authority: CN
Inventors: L·韦策尔; G·N·谢蒂; A·M·维尔; R·S·卢梭
Original assignee: Unl Holding Co
Current assignee: Unitract Syringe Pty Ltd; Unl Holding Co
Priority date: 2015-04-01
Filing date: 2015-04-01
Publication date: 2018-01-16
Also published as: WO2016160004A1; IL254625A0; ZA201706437B; BR112017021081A2; CA2980714A1; JP2018511405A; JP6574264B2; HK1243657A1; KR20180003541A; AU2015390076A1; RU2683394C1; EP3277347A1; MX2017012591A

Abstract

One kind is used for the cylinder adapter (220) of syringe (200), and the syringe has cylinder (218) and plunger (212).The adapter includes cylinder sophisticated (232) and needle retraction mechanisms (211), the needle retraction mechanisms have pin sub-component (221), actuator sub-component (210) and biasing member (240), and the pin sub-component has pin (201) and tube chamber.The pin sub-component is from the retracted position that injection position is moved in the cylinder tip.Retainer (224), the probe (254) being retained in probe disk (214) and the jaw (242) entered in the retainer that the actuator sub-component includes being connected on the cylinder tip.The probe slides in the needle lumen, and is spaced apart in the injection position with the needle tip.The biasing member makes the NOM be biased from the retainer.Lock arrangement compresses the biasing member when locked, and discharges the biasing member when by pressing the plunger to activated, and this makes the jaw be moved against the retainer.The biasing member makes the pin and probe be moved to the retracted position from the injection position in release.

Description

Device for targeted delivery therapeutic implant

Technical field

The present invention relates to the device for targeted delivery therapeutic implant.More precisely, embodiments of the invention relate to And a kind of delivery system that embedded drugs can be deposited on ad-hoc location, help to deliver embedded drugs, pearl The syringe of the regracting sleeve pipe of grain, pill or capsule, for manufacturing the method for such device and their application method.

Background technology

Nearest therapy changes treatment such as AMD, diabetic retinal revolutionaryly The mode of the diseases such as disease, diabetic macular edema.Aging population and diabetes prevalence, which increasingly increase, to be promoted to controlling Treat the demand of the treatment of eye disorders.In addition to those drugmakers with commercialized medicine, several pharmacy public affairs Department plays an active part in the new treatment for developing this field.

The most common medicine for being presently used for treating wet age related macular degeneration is angiogenesis inhibitors, these The glass body portion that angiogenesis inhibitors are typically injected into eyes (fills the saturating of eyes from posterior surface of lens to retina Gelatin-like material) in.Most of treatments need monthly to inject.In addition to patient's inconvenience, injection also with some infection risks, Such as entophthamia is related.In addition, clinician needs to treat increasing patient, whole medical health system is caused to bear Load.

Embedded drugs or medicine storing have potentiality and are kept for the active duration in target site to increase medicine.This drop Low patient needs to inject the frequency for the treatment of；Therefore this alleviates the burden of medical health system, and also reduce patient's Inject the possibility of relevant risk.

It is desirable that for dispose or deposit the device of this implant or storing should be easy to clinician using, cause most Small patient is uncomfortable, and should not change the drug delivery kinetics of embedded drugs or storing.For dispose/deposit implant Present apparatus typically need to train partial clinical doctor extensively, be painful for patient (except being probably Harmful), and cause the notable shearing force that may damage implant.The physical damage of implant may change medicine delivery and move Mechanics, and therefore change the clinical efficacy and/or regulatory compliance of medicine.Present apparatus do not allow typically yet implant or Storing is accurately positioned.

The content of the invention

According to an aspect of the invention, there is provided a kind of cylinder adapter for being used to deliver syringe, delivering injection Utensil has cylinder and is adapted for the plunger assembly moved in the cylinder.Cylinder adapter includes being configured to and cylinder Distal seal engagement cylinder tip.Cylinder adapter also includes needle retraction mechanisms, the needle retraction mechanisms include pin sub-component, Actuator sub-component and at least one biasing member.Pin sub-component, which includes the needle mould that covers that pin and the pin extend through, to be had.Needle set has Tube chamber, and pin sub-component is at least partially disposed in cylinder tip and is adapted for being moved to contracting from injection position Return is put, and pin is from the distal end extension at cylinder tip in the injection position, and pin is arranged on cylinder tip in the retracted position Or at least one of cylinder.Actuator sub-component include be connected on cylinder tip cover pin die holder, probe and Hold the probe disk of the near-end of the probe.Actuator sub-component also includes covering in pin die holder through probe disk and entrance At least one jaw.At least one jaw may be actuated in response to movement of the plunger assembly in cylinder.Probe can be axially Slide and be at least partially disposed in needle lumen, and when pin is in injection position, probe is proximally set simultaneously And it is spaced apart with the distal tip of pin.At least one biasing member, which is arranged on, covers needle mould tool and between covering pin die holder, It is biased away to make to cover needle mould tool and covers pin die holder.Cylinder adapter also includes activatable lock arrangement, the locking Arrangement is configured to that at least one biasing member is maintained at into energising position when lock arrangement is locked and works as lock arrangement Biasing member is discharged when being activated by actuator sub-component.Lock arrangement may be actuated by plunger depressed component, so that at least one Individual jaw moves against pin die holder is covered.At least one biasing member is configured to when biasing member discharges from energising position When, there is provided the relative motion of pin and probe from injection position to retracted position.

In another aspect of the present invention, there is provided a kind of implant delivering syringe of auto retractable.Delivering injection Device is included with cylinder proximally and distally, and is configured to the plunger assembly moved in the cylinder.Deliver syringe bag Include the cylinder tip engaged with the distal seal of cylinder, and needle retraction mechanisms.Needle retraction mechanisms include pin sub-component, actuator Sub-component and at least one biasing member.Pin sub-component, which includes the needle mould that covers that pin and the pin extend through, to be had.Needle set has tube chamber, and And pin sub-component is at least partially disposed in cylinder tip and is adapted for being moved to retracted position from injection position, Pin is from the distal end extension at cylinder tip in the injection position, and pin is arranged in cylinder tip or cylinder in the retracted position At least one in.Actuator sub-component includes being connected to covering pin die holder, probe and hold the spy on cylinder tip The probe disk of the near-end of pin.Actuator sub-component also include through probe disk and enter cover in pin die holder at least one Individual jaw.At least one jaw may be actuated in response to movement of the plunger assembly in cylinder.Probe can axially slide and Be at least partially disposed in needle lumen, and when pin is in injection position, probe proximally set and with pin Distal tip is spaced apart.At least one biasing member, which is arranged on, covers needle mould tool and between covering pin die holder, to make to cover Needle mould tool, which is biased away from, covers pin die holder.Delivering syringe includes activatable lock arrangement, and the lock arrangement is set At least one biasing member is maintained at energising position and when lock arrangement is by actuator into when lock arrangement is locked Component discharges biasing member when activating.Lock arrangement by plunger depressed component and actuatable so that at least one jaw against Cover the movement of pin die holder.At least one biasing member is configured to when biasing member discharges from energising position, there is provided pin With relative motion of the probe from injection position to retracted position.

In another aspect of the present invention, there is provided a kind of method for the delivering syringe for assembling auto retractable.The party Method includes setting plunger assembly to engage with the distal seal of the cylinder cylinder tip to be moved in cylinder, and by pin Component is arranged in the cylinder.Pin sub-component, which includes the needle mould that covers that pin and the pin extend through, to be had.Needle set has tube chamber, and pin Component is at least partially disposed in cylinder tip and is adapted for being moved to retracted position from injection position, in the note Penetrate pin in position from the distal end at cylinder tip to extend, pin is arranged in cylinder tip or cylinder at least in the retracted position In one.This method also includes actuator sub-component being arranged in cylinder.Actuator sub-component includes being connected to cylinder tip On cover pin die holder, probe and hold the probe near-end probe disk.Actuator sub-component is included through probe disk And enter at least one jaw covered in pin die holder.Shifting of at least one jaw in response to plunger assembly in cylinder Move and may be actuated.Probe axially can be slided and be at least partially disposed in needle lumen, and when pin is in injection position When middle, probe is proximally set and is spaced apart with the distal tip of pin.This method includes setting at least one biasing member Put and covering needle mould tool and between covering pin die holder, be biased away to make to cover needle mould tool and cover pin die holder.This method Also include to cover needle mould tool in lock arrangement and being actuatably locked to covering on pin die holder, to be locked when lock arrangement At least one biasing member is maintained at energising position and discharged when lock arrangement is activated by actuator sub-component inclined by timing Put component.Lock arrangement may be actuated by plunger depressed component, so that at least one jaw moves against pin die holder is covered It is dynamic.At least one biasing member is configured to when biasing member discharges from energising position, there is provided pin and probe are from injection position To the relative motion of retracted position.

In whole this specification, unless otherwise stated, " including (comprise) ", " including (comprises) " " including (comprising) " or such as " including (include) " or the relational language of " consist of " be included in and It is not to use in exclusive manner, so that it is whole that the integer or the group of integer stated may include that one or more other are not stated The group of number or integer.As described further below, embodiments of the invention may include can be considered as medical device industry In standarized component one or more additional components.These parts and embodiment including this base part are in the pre- of the present invention In phase, and it is interpreted as falling in the range and scope of the present invention.

Brief description of the drawings

The following non-limiting example of the present invention is described with reference to the following drawings herein, wherein：

Fig. 1 is the lateral elevational view according to the first embodiment of the delivering syringe for including delivery system of the present invention；

Fig. 2 is the exploded view along the longitudinal axis of the embodiment shown in Fig. 1；

Fig. 3 A show the side view of the amplification of cylinder adapter according to an embodiment of the invention；

Fig. 3 B show that side cross-sectional view of Fig. 3 A cylinder adapter along longitudinal axis (for the sake of clarity, eliminates Intersecting hachure)；

Fig. 3 C show the partial exploded side view of Fig. 3 A cylinder adapter, and the figure is by its of needle assemblies and cylinder adapter He separates part；

Fig. 4 shows the isometric view of locking mechanism according to an embodiment of the invention；

Fig. 5 shows the isometric view at cylinder tip according to an embodiment of the invention；

Fig. 6 shows that the equidistant of the activation mechanism including jaw pedestal, probe disk and probe according to embodiments of the present invention regards Figure；

Fig. 7 A- Fig. 7 D are shown, are contracted as syringe advances through pin injection, pin retraction activation, implant delivering and probe The stage returned, the lateral elevational view of the delivering syringe for including cylinder adapter according to embodiments of the present invention；

Fig. 8 A- Fig. 8 D are shown similarly as syringe advances through pin injection, pin retraction activation, implant delivers and spy The stage that pin is retracted, the partial section of the amplification of the embodiment shown in Fig. 7 A-7D (for the sake of clarity, eliminate intersection shadow Line).

Fig. 9 A show the lateral elevational view of delivering syringe according to another embodiment of the invention, the delivering syringe Including the cylinder adapter being connected with screw thread；

Fig. 9 B show according to another embodiment of the invention be included in needle cap (for clarity, being shown as transparent component) The lateral elevational view of cylinder adapter shown in interior Fig. 9 A, such as available for packing, transport and/or assemble；

Fig. 9 C are shown shown in Fig. 9 A in assembled configuration

Deliver the lateral elevational view of syringe and cylinder adapter；

Figure 10 A show the lateral elevational view of the amplification of the plunger assembly according at least one embodiment of the present invention；

Figure 10 B show the amplification of the probe assembly with probe and probe disk according at least one embodiment of the present invention Lateral elevational view；

Figure 10 C show the probe guiding piece and one or more protuberances or jaw according at least one embodiment of the present invention Amplification lateral elevational view；

Figure 11 A- Figure 11 C show the lateral elevational view of the plunger rod according at least one embodiment of the present invention, the plunger rod Rotated respectively with 90 degree of interval around axis A, as indicated by arrowr；

(for the sake of clarity, Figure 12 shows the partial section of the amplification of the embodiment of the delivering syringe shown in Fig. 9 A Eliminate intersecting hachure)；

Figure 13 A- Figure 13 D are shown as syringe advances through pin injection, pin retraction activation, implant delivering and probe contracting The stage returned, partial section's (for the sake of clarity, eliminating intersecting hachure) of the amplification of the embodiment shown in Fig. 9 A；

Figure 14 A and Figure 14 B show the section according to the delivering syringe of the present invention and another embodiment of delivery system Scheme (for the sake of clarity, eliminating intersecting hachure)；

Figure 15 A and Figure 15 B show the partial section of the amplification of the embodiment shown in Figure 14 A and Figure 14 B；And

Figure 16 A, Figure 16 B and Figure 16 C show the embodiment according to Figure 14 A and Figure 14 B cover needle mould tool (" NOM ") and The exploded view of NOM retainers.

Embodiment

Embodiments of the invention retract deposition implant using pin.Implant can be such as medicament elution or can To be radiation-emitting pearl.For the purpose of present disclosure, term " implant " will be used for collective or individually comprise storing, implantation Thing, bead, pill, capsule, tubercle, pharmacological eluting arrangement, drying or lyophilized medicine or therapeutic agent, or the implantation of other forms Thing etc..

Clinician is familiar with the targeting provided by conventional syringe and the ease for use of operation.By using such syringe Basic sides, and by integrating retraction mechanism, present inventors have developed a kind of wieldy delivery system, this is passed System is sent using retractible needle injection accurately and safely to deliver or dispose implant.Implant is deposited over pin and is located at At point in target position.This allows the accurate placement of implant, and causes the placement of pin than the existing apparatus for being implanted into more It can determine that delivery location.Existing apparatus for implantation is generally utilized for implant to be released for storing or implant delivering Sleeve pipe device.Such device is typically inaccurate, because user it is generally desirable to the tip of sleeve pipe being positioned at target position Put place.Once the tip of sleeve pipe is in target position, then implant release sleeve pipe is caused by the inaccurate of implant by conventional method True delivering.In order to compensate this inaccuracy, user may be selected to arrive the tip " position shifts to an earlier date " of sleeve pipe and target position phase Distance away from estimation, so that implant is promoted closer to target position.Embodiments of the invention using it is a kind of fundamentally not Same method, this method substantially increase the accuracy of targeted delivery, and easily operated for the user.By that will plant Enter thing to be positioned at the tip of syringe needle, syringe needle is inserted into desired target position, and then take out syringe needle Go out or retract deployment implant, the accuracy that implant is delivered to target position carries significantly compared with the conventional meanses for implantation It is high.Further, since the position of implant does not change in whole implantation process, it is thus eliminated that for being calculated or being estimated by user Any need of meter, embodiments of the invention are easily operated for the user.In addition, embodiments of the invention offer is made us Desired security feature, because syringe needle is retracted back into the cylinder of implant delivering syringe, so as to eliminate pricking wound Harmful risk.

In the first embodiment, the invention provides a kind of delivery system, the delivery system to include pin, probe, retraction machine Structure, activation mechanism and the implant for delivering.With the probe of pin substantially coaxial line be placed on pin tube chamber (for example, The hollow hole of pin) in.In one embodiment, probe can be partly overlapping from non-patient end (that is, near-end) with pin.Implant quilt In the tube chamber for the pin being placed between probe and the patient end (that is, distal end) of pin.The activation mechanism of such as plunger rod can be used for swashing Retraction mechanism living, so as to cause pin to be retracted.Initially, probe is fixed relative to pin, and is retracted pin by retraction mechanism Exposure is used to deliver in target region.Probe ensures that implant does not follow the pin when pin is retracted.Only in probe After the distal end of retraction pin, probe could be retracted with pin for distal end.The retraction order of probe and time are such that in pin retraction The retraction of probe is activated or triggers afterwards, although same retraction mechanism can be used come both parts of retracting.Close to retraction mechanism Probe disk can be used for ensuring desired retraction order.Retraction mechanism contracts with the distance between probe disk setting probe relative to pin The time returned.

Embodiments of the invention provide accurate implant deployment mechanism, the implant deployment mechanism using pin retract without Need the manufacturing process of complexity.The embodiment provides a kind of injector assembly of relative simplicity, the injector assembly Including less part, a kind of friendly and safe implant deployment syringe of user is thus provided, while will be manufactured into Originally minimize.The novel cylinder adapter of the present invention is particular enable to be adapted for the main ingredient with various configuration and material Thing cylinder, such as preferred straight tube glass or plastic cylinder, to provide the needle assemblies and retraction mechanism integrated to cylinder.Therefore, this hair The bright implant deployment that is adapted to can neatly be attached, fix, installing or being otherwise coupled to such as with needle retraction mechanisms The standard cylinder of straight glass cylinder.Cylinder adapter can be configured to cylinder coordinate in a number of different manners, however, excellent Select in embodiment, cylinder adapter is configured so that at least proximal connecting portion is shaped as the distal portions for being installed to cylinder Internal diameter and in the internal diameter.Therefore, cylinder adapter can be by least by the proximal part of adapter insertion and attached Connect, fix, installing or being otherwise coupled to the distal end of cylinder and being connected on standard straight barrel syringe.Cylinder adapter can For example, by interference engagement component, it is clasped component and/or screw thread matable assembly and is connected on cylinder.As this area is common What technical staff will be understood that, any one of these connection methods may also include lock-in feature, with for example during use or Notify user to have been carried out connecting afterwards and prevent cylinder adapter from being disconnected with delivering syringe.The present invention's In at least one embodiment, as explained further herein, cylinder adapter can be connected to cylinder via screw thread matable assembly On body.Therefore, novel cylinder adapter of the invention design eliminates the specific cylinder for needle assemblies are mounted thereto The needs of shape or configuration.This can significantly reduce manufacturing cost, the related system particularly to manufacturing the glass cylinder of custom-made Cause this.The novel cylinder adapter of the present invention can be mounted on for example straight glass or plastic cylinder, so as to simplify Manufacturing process and the cost related to manufacturing more complicated cylindrical shape.

The cylinder adapter of the present invention can be selectable when in use, or be pre-attached to cylinder in the fabrication process On body.In selectable option, design of the invention and construction allow user to select the pin with particular design or size And/or needle assemblies, and adapt it to the injector cartridge for medicine storing or implant delivering.For example, cylinder is adapted to Device and needle assemblies may be structured to provide multiple different pin length or thickness.Then, user can use the pin chi needed for them Very little selection cylinder adapter, and syringe is adapted it to deliver implant.In the embodiment shown in Fig. 1 and Fig. 2, cylinder Body adapter is directly mounted on cylinder.One or more additional components can be used for providing this self-adaptive features.For example, one Individual or multiple connection members can be used for the cylinder tip of cylinder adapter being connected on cylinder.In such embodiment In, a connection member (such as receiving part) can be fixedly mounted on the distal end of cylinder.Receiving part can be received directly simultaneously And cylinder tip of the engagement with the retraction mechanism integrated.Alternately, cylinder adapter may include to be used for engaging receiver part Additional connection members (such as component).It is described in further detail as described above and herein, at least the one of the present invention In individual embodiment, cylinder adapter can be connected on cylinder via screw thread matable assembly, both its middle cylinder body adapter and cylinder Male and female pitch portion or part corresponding to being respectively provided with.Other optional features known to persons of ordinary skill in the art, it is all As elastomeric seal can be required and be incorporated in the device in order to the connection between cylinder adapter and cylinder.Cylinder Although body adapter includes substantially the same part, but regardless of pin size how, can be customized in order to implant dispose And pin and probe are fully retracted in cylinder.For example, as one of ordinary skill will be understood like that, may Longer biasing member (for example, longer spring) must be selected or changed in order to the retraction of longer pin.Similarly, profit is worked as During with longer or thicker pin, longer or thicker probe is probably necessary.Such size can also be adjusted, for example, so as to In the delivering for being initially retained in the longer or shorter implant for being used for delivering in pin.

Embodiments of the invention are provided also using the construction for being readily used for material that medicine uses and part, many of which It is to be increasingly considered to be ready-made or standard part.Exactly, used material can have low carry Take the material of thing content.It reduce overall manufacturing cost, simplifies assembling process, and avoids generally non-standard with use The material unnecessary supervision problem related to part.In addition, the present invention, which provides aesthetically to be similar to, does not have pin retraction machine The conventional syringe of structure, there is ergonomics attraction to terminal user (such as medical practitioner and automedication patient) Part and device, and the integrated safe feature of high expectations is provided.Therefore, the offer of these embodiments is readily integrated into existing Novel and cost-effective part and device in manufacturing process.The aspects of the invention can provide high expectations function and Aesthetic features, and can be modified to produce a series of different constructions.

The syringe of the present invention can targeted delivery there are the embedded drugs of overall security because they prevent accident Exposed to pin, as common in the case of needle stick injury.It is described in detail as described above and in the accompanying drawings, user can utilize this The delivering syringe of invention come perform embedded drugs delivering stage, including：Pin injection, pin retraction activation, implant delivering Retracted with probe.Syringe reuse and/or pin are prevented or at least minimize by integrating one or more locking systems Evil is stabbed, embodiments of the invention provide ideal product, and these products are cost-effective for manufacture, and are easy to Used by medical practitioner and automedication patient.Such locking system may include such as needle retraction mechanisms and/or prevent what is retracted The arrangement that pin extends again from the end of syringe.The cylinder adapter of the present invention and the novel feature and function of syringe are to make User provides many benefit of safety.For example, locking mechanism may be structured to user provide drug dose completely delivering, Vision, the sense of hearing and/or the tactile that retraction mechanism has been activated, pin has been retracted and syringe can be used safely in dispose are anti- Feedback.

The part of the present invention can also be configured to the destruction increase for causing part and whole syringe at the end of use.This The safety of kind integration and destruction prevent the reusability of syringe and increase the security features of device.For example, optional Pin block may be structured to prevent pin from translating out from cylinder tip in the proximal direction after pin is retracted.In such configuration, Plunger depressed bar and in the proximal direction axial translation pin will cause when user's applying power hour hands become bended in cylinder.

Another security feature realized by the present invention is the retraction speed that can control pin.Controlled pin is retracted and prevented The injury to caused by patient after drug dose has been delivered.This (such as can limit biasing member to exist by driving part The one or more friction members for the expansion rate retracted when activating) or (such as selection has relatively slow expansion by passive components Biasing member) promote.In the embodiment shown in Fig. 1 and Fig. 2, retract by plunger rod and the control of jaw pedestal.Contracted in pin When returning activation, user still contacts and to the near-end applying power of plunger rod.When causing biasing member to expand, the biasing structure Part applies axial force in the proximal direction so that pin and/or needle assemblies are retracted.This action transfers force to when retracting and needle stand The jaw pedestal and plunger rod of contact.The retraction of friction limitation needle assemblies as caused by needle stand and jaw pedestal against inner barrel Speed.When user reduces the power that they are applied on plunger rod, they can also control retraction speed.This controlled contracting It is that syringe user is highly desirable to return, because it adds security and reduces the sensation of pain of patient.

Embodiments of the invention are described in further detail in refer to the attached drawing herein.It should be appreciated that these are only non-limiting realities Example is applied, and in range and scope of other similar embodiments within the expection of the present invention and in present disclosure.

Such as it is used herein to describe any relative position of delivery system, syringe, cylinder, cylinder adapter or part of the present invention Put, term " axial direction " or " axially " typically refer to longitudinal axis " A ", syringe or cylinder are linear preferably about the longitudinal axis Into, although not necessarily symmetric around.Term " radial direction " is typically referred to perpendicular to axis A direction.Term " near-end ", " rear ", " backward ", " back of the body " or " backward " typically refer to away from there is the axial direction at the pin end for being administered to patient's body (total in Fig. 1 It is identified as on body " P ").Term " distal end ", " preceding ", " forward ", " pressure " " onwards " are typically referred to towards being administered to The axial direction (being generally designated as in Fig. 1 " D ") at the pin end of patient's body.It should be appreciated that term " spring " is used herein to It is proposed can be compressed and allow the biasing member expanded in given directions, such as the substantially coil of spiral winding.Although Using the spring for the arrangement discussed and utilized in all embodiments as detailed herein, but within the expection of the present invention, other The biasing member of type can be readily used for identical purpose, while be maintained in the range and scope of the present invention.For example, such as ability Domain ordinarily skilled artisan will understand that, can within the scope of the invention using such as compression spring, torque spring, constant force spring, Extension spring, the spring of leaf spring and the spring of identical or different type or the combination of other structures.10008 additionally or alternatively, Biasing member in addition to spring can also be used for similar purpose.The non-limiting examples of biasing member include being used to store and can release Spring, elastic tape or other devices of exoergic amount.However, at least one embodiment, biasing member is preferably spring, all Such as compression spring.

As used herein, term " glass " should be understood to include suitable for generally being applied the pharmaceutical grade for needing glass Other similar non-reactive materials.Term " plastics " may include both thermoplastic polymer and thermosetting polymer.Thermoplastic Property polymer can by heating soften into their reset condition again；Thermosetting polymer cannot.As used herein, art Language " plastics " refers mainly to mouldable thermal plasticity high polymer, such as polyethylene and polypropylene, or acrylic resin, and these are moldable Thermoplastic polymer generally also contain other compositions, such as curing agent, filler, reinforcing agent, colouring agent and/or plasticizer Deng, and can be formed or moulded under heat and pressure.As used herein, term " plastics " not include be approved for wherein it Glass or rubber elastomer in the application that is directly contacted with therapeutic fluid, these therapeutic fluids can be mutual with plastics Effect or the substituent degraded that otherwise can may be entered liquid from plastics.As used herein, term " elastomer ", " bullet Property body " or " elastomeric material " refer mainly to that pharmaceutical grade fluid is easier to deform but be approved for than plastics and be not easy to send out The thermoset rubber polymer of the crosslinking of raw leaching or gas transfer.As used herein, term " fluid " is primarily referred to as liquid, but The suspension of scattered solid in a liquid can also be included, and dissolve or be otherwise present in containing for syringe together The gas in liquid in fluid section.

Do not reacted substantially with medical fluid or medicine in addition, the device of the present invention utilizes, and be applied to pharmaceutical grade The material of application.The such innovative construction and delivering syringe of the present invention be implant and drug delivery device provide it is increased surely Qualitative and period parameters of guaranteeing the quality.Additionally, it is known that method and material can be used for store and transportation in embedded drugs are protected Hold in position.For example, the microdeposit (PLGA, CAHP etc.) of polymer can be used for this purpose.The property of used polymer Matter will depend on target site, such as select water-soluble polymer in water-based or aqueous position.Generally, the one of polymer is included Series of biologic degradation material can be used for injecting the distal end with pin is clogged before implant deployment in pin to keep implant.Can be Implant is placed in pin before or after clogging the distal tip of pin, this is probably necessary, in order to assemble and manufacture Cylinder adapter and delivering syringe.For example, when device assembly needs to insert from distal implant, implant can clog pin Distal tip before be put into pin.This is probably necessary, if for example, consolidated cylinder adapter before implant is inserted Determine onto cylinder.Alternately, implant can be put into pin after the distal tip of pin is clogged.This can be for example by cylinder Body adapter uses when implant is inserted in cylinder adapter before being assembled into the cylinder of delivering syringe.Similarly, can set Think the surface treatment of probe tip, to prevent the non-specific and specific adhesion of implant and probe, and can be on Any operation order of assembling and the manufacture of cylinder adapter and delivering syringe is surface-treated.For example, maximize probe The hydrophilic processing of tip end surface can be used for processing probe and/or coating probe tip.

One or more embodiments of the invention can also include some standarized components.For example, the cylinder adapter of the present invention Construction and injection device may include one or more O-rings.In at least one embodiment, using one or more O-rings The cylinder tip come in sealed cylinder and/or ensure gnotobasis and container integrity in the medicament lumen of cylinder.Additionally or Alternately, cylinder adapter may include one or more control members in order to control retraction speed.Similarly, cylinder is adapted to Device may include one or more pin blocks, clip, fin, flange etc., and the function of these pin blocks is to prevent pin and probe from contracting Return after mechanism has completed and translate or be projected into outside cylinder by the hole at cylinder tip.

In addition, delivering syringe may include for one or more parts attractive in appearance, easy to use or other purposes.Example Such as, as it will appreciated by a person of ordinary skill, one or more embodiments of the invention may include grip flange.Grip flange can It is pre-formed along cylinder or any part for delivering syringe, or can be attached to or be injected fixed to cylinder or delivering Separate part on device.In at least one embodiment, grip flange is the preform part in the proximal end of cylinder.Finger-like is convex Edge can be configured to allow user that their forefinger and middle finger are placed on flange, and when user is pressed with their thumb It can be provided when hydraulic plunger is to inject medicine and utilize interface.As the skilled person will readily understand, the position of this base part Put, shape, quantity and material alterable, to meet any amount of desired characteristic.

Similarly, although the part of cylinder adapter and delivering syringe is described as single part herein, at this Within the expection of invention, some groups of these parts single portions that can be combined to form the function of being able to carry out all parts Part.As described above, for example, at least one embodiment, if setting pin seal, needle stand and pin seal can be carried For a unified part of dual-use function.In addition, as one of ordinary skill in the art will appreciate, the part for delivering syringe can Integrally formed part is manufactured to, or as independent or single part.As described above, grip flange can be in manufacturing process Middle a part of preformed part as cylinder in itself.Therefore, at least one embodiment, grip flange can be cylinder The glass grip flange extension of body.In addition, although the part of cylinder adapter is described as single part herein, they It can be the unified part with multiple functions.For example, jaw pedestal can be a part for plunger or the portion separated with plunger Part.Similarly, protuberance or jaw can be the extension of jaw pedestal, or can be the parts separated with jaw pedestal, As described further on this.The construction of part and their component can be based on assembling process, device parameter and other expectations Characteristic and change.

Fig. 1 shows the isometric view of one embodiment of the delivering syringe 10 according to the present invention.Fig. 2 is shown shown in Fig. 1 Delivering syringe 10 and its part exploded view.According to the present invention, cylinder adapter 20 is provided for being attached to tool Have on the injector cartridge 18 of plunger assembly 12.The advantages of as embodiments of the invention, the cylinder tip of cylinder adapter 20 32 can be configured to coordinate by any appropriate method and any standard cylinder 18.Cylinder 18 can be plastic cylinder, glass Cylinder, or be made up of any other known material for medical treatment device.Cylinder 18 can be taper, it is non-cylindrical or It is substantially straight.In preferred embodiment for manufacturing purposes, cylinder 18 is straight tubular glass cylinder.In one or more In embodiment, cylinder 18 can be the ready-made part of such as standard, so as to provide valuable manufacture efficiency and running cost section About.Cylinder cover 16 can be set in addition, once delivering syringe 10 is assembled, the cylinder cover can suppress or prevent plunger assembly 12 and cylinder 18 separate.Cylinder 18 or cylinder cover 16 may include grip flange (as shown in the figure).

Embodiments of the invention can also realize significantly other advantages in the market of delivering syringe.For example, one or more Individual embodiment can use the standarized component of such as standard column stopper rod, cylinder, cylinder cover and rigid needle shield, so as to greatly reduce To custom-made or the needs of injection molding part.For example, in certain embodiments, delivering syringe 10 can utilize standard plunger piston Bar 14 and rigid needle shield (not shown) and other possible standarized components.If be provided, seal as used herein Can be rubber stopper/seal of ethylene tetrafluoroethylene (ETFE) coating, such as can be from Pennsylvania Lai Enweier The Xi Shi pharmacy service company (West Pharmaceutical Services, Inc.) of (Lionville, Pennsylvania) With trade name " FluroTec " or from Belgian Da Tehuaile (Datwyler Pharma Packaging) medical packaging The ethylene tetrafluoroethylene that (Datwyler Pharma Packaging) company is readily available with trade name " Omniflex " coats Rubber stopper/seal.Miscellaneous part can be similarly the ready-made part of standard, so as to provide the huge of embodiments of the invention Advantage.This advantage of embodiments of the invention provides valuable manufacture efficiency and running cost saving.

As it will appreciated by a person of ordinary skill, cylinder adapter 20 can be installed to note by any appropriate linkage arrangement On emitter cylinder 18.For example, cylinder adapter 20 can be by can separate with the part of cylinder adapter 20 and injector cartridge 18 Draw bail be connected on injector cartridge 18, it is or integral with cylinder adapter 20 and injector cartridge 18.In addition, cylinder Body adapter 20 can be connected on injector cartridge 18 before the use in syringe manufacturing process or just.Only as an example, Syringe adapter 20 can be coordinated in syringe manufacturing process by interference engagement, glue, be clasped component and/or screw thread Component etc. is connected on injector cartridge 18.Alternately, for example, injector cartridge 18 and cylinder adapter 20 may include to coordinate Screw thread or luer lock arrangement, so that cylinder adapter 20 just can be connected on injector cartridge 18 before the use. In at least one embodiment of the present invention, cylinder adapter can be connected on cylinder via screw thread matable assembly, and its middle cylinder body is fitted Orchestration and cylinder both of which have corresponding male and female pitch portion or part.In another embodiment, it is possible to provide one Individual or multiple draw bails are so that cylinder adapter 20 is connected on cylinder 18.One or more O-rings 36 can be provided to be used to set Put between cylinder adapter 20 and cylinder.

Cylinder adapter 20 helps pin 28 being installed on injector cartridge 18 (referring to Fig. 2).Cylinder adapter 20 wraps Include cylinder tip 32, needle assemblies 42, and needle retraction mechanisms 21.Cylinder tip 32 can be connected to injection by any appropriate method On device cylinder 18, as explained above with respect to the attachment of cylinder adapter 20 and injector cartridge 18.When with syringe When cylinder 18 couples, needle tip 32 typically exhibits out the distal end of safety injector 10, and pin 28 extends through pin in injection process The distal end at tip 32 is to deliver implant.Cylinder tip 32 can also include form a part for needle retraction mechanisms 21 one or more Individual structure, as explained further on.

Needle assemblies 42 generally may include pin 28 and needle stand 24.O-ring 36 can be set around needle stand 24, in order to needle assemblies 42 Disposal.Pin 28 is configured to through needle retraction mechanisms 21 and cylinder tip 32, so that one end of pin 28 in cylinder, and And the other end of pin 28 passes through the hole 33 in cylinder tip 32 (referring to Fig. 3 B).A variety of needle retraction mechanisms can be used for promoting the present invention In pin retract.For example, needle retraction mechanisms can be similar to be disclosed as the A1 of WO 2013126118 International Patent Application PCT/ The needle retraction mechanisms disclosed in US2012/067793 and U.S. Patent Application Serial Number 13/693,915, these patents are for institute Purposefully combined herein with entire contents by quoting.In at least one embodiment, needle retraction mechanisms 21 include biasing structure Part 30 and actuating lock arrangement 31, biasing member 30 is maintained at energising position by the actuating lock arrangement, until needle assemblies 42 Untill when pin 28 is retracted into cylinder adapter 20.Although lock arrangement 31 can be that biasing member 30 is maintained at into energising position Any suitable design untill when pin 28 is retracted, but in the embodiment shown, lock arrangement 31 includes locking mechanism 22 With lock face 32a, these lock faces coordinate with the relative position on the surface for keeping being maintained at biasing member 30 in energising position, As will be explained in greater.When lock arrangement 31 activates, biasing member 30 makes pin 28 be retracted into cylinder tip 32.

In such embodiment of lock arrangement 31, biasing member 30 is compression spring.The end of spring 30 is adjacent The surface 23 and surface 35 of nearly locking mechanism 22 are arranged in cylinder tip 32.Surface 23, the relative position on surface 35 are being injected Biasing member 30 is maintained in the energising position of compression before, or allows spring 30 to be moved to position of deenergizing with injection Retraction back stitching 28.In order to which spring 30 is maintained in energising position, locking mechanism 22 and cylinder tip 32 include can the company of being disconnected Knot is to allow spring 30 to be moved to deenergize the fit structure of position.Hereafter will be discussed in more detail needle retraction mechanisms 21 structure and Operation.

Embodiment shown in Fig. 1-5 includes the construction that wherein locking mechanism 22 separates with cylinder tip 32.However, locking machine Structure 22 can be configured to be the part at cylinder tip 32 or be attached on the cylinder tip.As discussed above, machine is locked Structure 22 can be single part or double duty part, the locking mechanism 22 and pin block of such as double duty.In other words, lock Determining mechanism 22 may include or activate to prevent pin 28 after retraction mechanism has been activated and pin 28 has been retracted in far end party The feature axially upwardly translated.Alternately, using the single part of pin block 34 as shown in Fig. 2, Fig. 3 B and Fig. 3 C.

Fig. 3 B show the sectional view at the cylinder tip 32 shown in Fig. 3 A.However, for the sake of clarity, eliminate different parts Intersecting hachure.As that can observe in figure 3b, biasing member 30 is at least partially situated in cylinder tip 32.When in pressure During contracting state, biasing member 30 is located in cylinder tip 32 in far-end and is located in proximal end in locking mechanism 22.Cylinder The part of adapter 20 is shown with exploded view in fig. 3 c.Needle assemblies 42 including needle stand 24 and pin 28 can be with cylinder adapter 20 Miscellaneous part be assembled apart or assemble together.For example, as shown in Figure 3A, all parts can be pre-assembled to complete cylinder and fit Orchestration 20, for being coupled in the cylinder of all cylinders 18 as depicted in figs. 1 and 2.Alternately, the part of needle assemblies 42 can be with The remaining part of cylinder adapter 20 is assembled apart.In this second construction, needle assemblies 42 can in an assembling process proximally It is installed in cylinder, rather than the far-end in cylinder adapter 20.

Needle retraction mechanisms 21 can be activated by any appropriate trigger.For example, in the embodiment shown, needle retraction mechanisms 21 are activated by locking mechanism 22 towards the movement of the distal end of delivering syringe 10.In such configuration, needle stand 24 can be forced Contact and/or be pressed against on locking mechanism 22.The contact can be disengaged locking mechanism 22, so as to allow the base of biasing member 30 Expanded in the proximal direction along the longitudinal axis of cylinder 18 in sheet, so that the part of locking mechanism 22 and needle assemblies 42 (including pin 28) is retracted into cylinder 18.Needle stand 24 can be used for pin 28 being maintained at substantially fixed position, and cylinder is adapted to Device 20, delivery system and delivering syringe 10 are in the first stage for being generally configured for pin injection and implant delivering.Separately Other places or alternately, locking mechanism 22 can be used for for pin to be maintained at substantially during this of drug injection first stage Fixed position.

As will be explained in greater, when locking mechanism 22 is disengaged and activates retraction mechanism, it is allowed to bias Component or spring 30 expand, so that needle assemblies 42 are retracted in the proximal direction substantially along the longitudinal axis of cylinder. In some embodiments of the present invention, whole needle assemblies 42 are made to retract, and in other embodiments, only cause its some parts (including pin 28) retracts when the release of locking mechanism 22 and biasing member 30 expand.Similarly, in some embodiments of the present invention In so that locking mechanism 22 is retracted together with needle assemblies 42, and in other embodiments, locking mechanism 22 keeps substantially solid It is fixed, but the part of needle assemblies 42 or it is moved.

In certain embodiments, after the retraction of pin 28, cylinder adapter 20, which may be provided with, prevents or suppresses pin 28 remote Translated on extreme direction and remove the block at cylinder tip 32.Fig. 3 C show the embodiment of pin block 34, and the pin block can be located at cylinder point In the distal end at end 32.Shown pin block 34 is included with the flange 60 for being used for the centre bore that pin 28 passes through.A pair of arms 62 are from flange 60 extensions, the distal end of arm 62 support a pair of clips 64.When pin block 34 is arranged in cylinder tip 32, arm 62 makes the direction of clip 64 Offset with respect to each.In this embodiment, when pin 28 extends through the hole of flange 60, when pin 28 is in injection and retraction stage When, the clip 64 of the far-end of pin block 34 expands and allows pin 28 to be arranged between clip 64.However, when pin 28 is in near-end side When being withdrawn past clip 64 upwards, clip 64 is biased to closed position by arm 62, and does not allow pin 28 to wear in a distal direction Cross.Although component can be constructed additionally, in this embodiment, the distal end of biasing member 30 or spring 30 can be in assembling process Middle adjacent flange 60 is set.It should be appreciated that shown pin block 34 discloses only as example, and the block can be the structure substituted Make and structure.

According to another aspect of the present invention, syringe 10 and/or cylinder adapter 20 and the knot of injector cartridge 18 are delivered Close and can be used for delivering implant 49.As ordinarily skilled artisan will understand that, implant 49 can collective or be individually storing, implantation Thing, bead, pill, capsule, tubercle, pharmacological eluting arrangement, drying or the implantation of lyophilized medicine or therapeutic agent or other forms Thing etc., and may include the dispersion liquid or any combination of them of medicine, powder, suspension etc..In order to allow implant 49 Place or deployment, cylinder adapter 20 also include the probe 54 being arranged in the tube chamber 29 of pin 28, and preferably, have multistage Retraction mechanism.

With reference to figure 3B, pin 28 includes central lumen 29.Needle stand 24 has at its center (for example, substantially in these portions On the longitudinal axis of part and cylinder) serve as the hole 25 of path.The hole 25 can have the diameter of the external diameter equal to pin 28, having or In the case of needle stand 24, so that pin 28 is maintained at the appropriate position in needle stand 24 during initial injection phase Put, and allow the axial translation in the proximal direction when activating retraction mechanism.When pin 28 is arranged in hole 25 through needle stand 24 When, the near-end of pin 28 shows central lumen 29.Referring to figs. 2 and 6 in operation, probe 54 is arranged on the center of pin 28 In tube chamber 29, and there is implant 49 to be implanted to be included in the distal end of probe 54 in the tube chamber 29 of pin 28.Therefore, pin is worked as During 28 entrance target (not shown), pin 28 can be axially retracted on probe 54.By this way, probe 54 prevent implant 49 with Pin 28 is retracted together, so that implant 49 is maintained at the appropriate location in target.If probe 54 extends beyond cylinder tip 32, Then probe 54 can similarly from target retract, retracted after the positioning of implant 49 with together with pin 28, once or pin 28 contracted Return and just separately retracted with pin 28.Therefore, according to aspects of the present invention, at least pin 28 is retracted to provide the note of implant 49 Penetrate.According on the other hand, in certain embodiments, after implant 49 is delivered, probe 54 is equally retracted.

Be turning initially to the retraction of pin 28, although settable any appropriate actuatable lock arrangement 31, Fig. 3 B, Fig. 3 C, One embodiment of actuatable lock arrangement 31 is shown, Fig. 4 shows locking mechanism 22, and Fig. 5 shows cylinder in Fig. 4 and Fig. 5 Tip 32.Cylinder tip 32 has lock face 32a, and these lock faces can engage with locking mechanism 22.In this embodiment, cylinder Body tip 32 has the two lock face 32a engaged with the reception structure in locking mechanism 22.It will be appreciated, however, that cylinder is sharp End 32 can have one or more lock face 32a.

As shown in figure 4, the reception structure of locking mechanism 22 can be in the form of for example entrance 46 be locked.In shown implementation In example, locking entrance 46 is the otch of " L " shape, although it is contemplated that the shape substituted and arrangement.In the internal diameter of locking mechanism 22 One or more passages 47 allow lock face 32a to slide into locking entrance 46, and when locking mechanism 22 rotate, standing In the seat 22a of the locking entrance 46 of locking mechanism 22.By this way, when the biasing member 30 of this embodiment is by locking mechanism When 22 and the biasing of cylinder tip 32 separate, the relative position at locking mechanism 22 and cylinder tip 32 is kept.Although illustrated embodiment Locking mechanism 22 and cylinder tip 32 include locking entrance 46 and lock face 32a respectively, it is to be understood that, the He of locking mechanism 22 Cylinder tip 32 can alternatively include lock face and locking entrance or some other combinations respectively, as long as engagement offer is operable With engageable/releasedly couple the arrangement of associated part.It is also understood that locking mechanism 22 can completely be replaced For structure, as long as the arrangement provides pin 28, the regracting in syringe is set, preferably due to using delivering syringe 10 Inject implant 49 and may be actuated.

In an illustrated embodiment, needle retraction mechanisms 21 are activated by the axial force for being applied to locking mechanism 22.Although axially Power can apply as the result of alternative structure, but in this embodiment, the contact and axial movement of needle stand 24 cause locking mechanism 22 corresponding movement in the axial direction.In actuating, when locking mechanism 22 such as by the contact of needle stand 24 in distal direction During upper translation, locking mechanism 22 is allowed to be disengaged with one or more corresponding lock face 32a at cylinder tip 32, so as to Permission spring 30 expands and retraction mechanism is activated.Locking mechanism 22 can be by locking mechanism with being disengaged for lock face 32a 22 axial translation causes.10008 additionally or alternatively, locking mechanism 22 can be by locking mechanism with being disengaged for lock face 32a 22 rotation (rotation such as in axial translation) causes.Rotation is combined in itself or with axial translation enables locking mechanism 22 Enough engagements departed from lock face 32a.In at least one embodiment, this rotation can pass through torsionally bias compression spring 30 And cause, in compression, the compression spring makes locking mechanism 22 be rotated in one direction around axis.In another embodiment In, rotation the construction of itself can be caused by locking mechanism 22, with by lock face 32a shaping or pass through lock face 32a with lock Determine the interface for promoting this movement and allowing part to be engaged and disengaged between mechanism 22 to realize this function, such as Profile in terms of the inclination of locking mechanism 22.

By what user applied activatable locking peace is activated for being equally applicable to the power of the axial translation of plunger rod 14 Row 31, so that locking mechanism 22 is disengaged with cylinder tip 32 and makes pin 28 retract.Therefore, the plunger rod of plunger assembly 12 14 parts are configured to the transmission for allowing pin retraction actuating power, and probe 54 is in and is used to inject the position with implant delivering. In order to allow pin retraction actuating power to be delivered to needle stand 24 from plunger assembly 12, and it is eventually transferred to locking mechanism 22, at least one Individual actuating jaw 51, which is provided in when plunger assembly 12 moves, longitudinally to advance, and probe 54 is kept in injector cartridge 18 It is substantially fixed.

It can such as observe in figure 6, at least one embodiment of the present invention, probe assembly 53 includes probe 54, should Probe extends so that probe 54 substantially is maintained at into suitable from the supporting construction of the form of probe disk 52 in injector cartridge 18 Work as position.Probe disk 52 can be maintained at the appropriate location in injector cartridge 18 by one or more O-rings.In order to allow to come From the transmission of the power of plunger assembly 12, there is provided it is configured to be longitudinally travelled at least one actuating jaw 51 through cylinder, and Probe disk 52 includes extending longitudinally through at least one path 53 of probe disk 52 and is configured to receive at least one actuating Jaw 51.Although illustrated embodiment includes two such jaws 51 and path 53, more quantity can be provided.In addition, though At least one path 53 that illustrated embodiment offer is spaced apart with the periphery of probe disk 52, but it will be understood by those skilled in the art that At least one path 53 alternatively or additionally can be set along the periphery of probe disk 52, so that injector cartridge 18 Inwall can equally be formed Longitudinal extending path 53 a part.It is also understood that the quantity of path 53 and jaw 51 need not It is identical.For example, single path 53 can allow the path 53 of more than one jaw 51.

Jaw 51 extends from pedestal 50, and the jaw is configured to move up in axle in injector cartridge 18.Jaw Pedestal 50 can be maintained at the appropriate location in injector cartridge 18 by one or more O-rings.Although pedestal 50 is shown as With disc-shape, it is to be understood that, it can have alternative form, as long as pedestal 50 keeps support jaw 51 and contributes to it Movement in cylinder 18.In operation, the axial movement of plunger assembly 12 causes pedestal 50 and associated jaw 51 It is mobile, so that jaw 51 contacts needle stand 24.Therefore, in an illustrated embodiment, jaw 51 can be made into contacting needle stand 24, So the power being applied to by user on plunger rod 14 is applied on pedestal 50, and is delivered to needle stand at least in part On 24.By this transmission, the surface or its similar aspect that can make needle stand 24 promote or otherwise started locking mechanism 22 releases connected from the engagement of the lock face 32a with cylinder tip 32.Pass through the lock by locking mechanism 22 from cylinder tip 32 Determine face 32a releases, it is allowed to which biasing member 30 (for example, spring) is swollen in the proximal direction substantially along the longitudinal axis of cylinder 18 Swollen and retraction includes the needle assemblies 42 of pin 28.In such embodiment of the present invention, make pin 28, needle stand 24 and locking mechanism 22 Retracted when the release of locking mechanism 22 and biasing member 30 expand.

It should be appreciated that jaw 51, pedestal 50 and plunger assembly 12 can be separately fabricated, or their one or more The unit that individual aspect is formed as independently forming and assembled later, or remain and assembling or using the delivering mistake of syringe 10 The single unit being engaged with each other in journey.In the embodiment shown in fig. 6,14 integral landform of jaw 51, pedestal 50 and plunger rod Into when plunger assembly 12 is depressed, jaw 51, pedestal 50 and plunger rod 14 move axially as individual unit.It is real substituting Apply in example, for example, pedestal 50 and jaw 51 may be integrally formed, so that when plunger rod 14 in injector cartridge 18 forward During promotion, the engaged with base 50 of plunger rod 14 is with mobile foundation 50 and associated jaw 51.

In assembling, it is placed on the probe 54 of the almost coaxial of pin 28 in the tube chamber 29 of pin 28.In embodiment, probe 54 can be partly overlapping from non-patient end (that is, near-end P) with pin 28.Implant 49 is placed on the patient end of probe 54 and pin 28 In the tube chamber 29 of pin 28 between (that is, distal end D).

In use, the activation mechanism of such as plunger rod 14 can be used for activation needle retraction mechanisms 21, so as to cause pin 28 to contract Return.Initially, probe 54 is fixed relative to pin 28；Implant 49 is exposed to by pin 28 by the retraction of needle retraction mechanisms 21 It is used to deliver in target region.Probe 54 ensures that implant 49 does not follow the pin when pin 28 is retracted.

According to aspects of the present invention, in order to ensure the accurate delivery of implant 49, probe 54 only pass through in the distal end of probe 54 Retract afterwards the distal end for crossing retraction pin 28.In an illustrated embodiment, the retraction order of probe 54 and time are such that in pin 28 Distal end be withdrawn past the mechanism for activating or triggering after the distal end of probe 54 for probe 54 of retracting, although same contracting can be used Mechanism is gone back to come both parts of retracting.It can be used for ensuring desired retraction order close to the probe disk 52 of needle retraction mechanisms 21.Pin The time that the distance between retraction mechanism 21 and probe disk 52 setting probe 54 are retracted relative to pin 28.In shown embodiment In, probe retraction mechanism is the engagement of needle stand 24 and probe disk 52.

Fig. 7 A-7D are shown as syringe 10 was advanced through with the next stage：Pin injection, pin retraction activation, implant delivering Retracted with probe, passing including cylinder adapter 20, retraction mechanism 21 and delivery system according to an embodiment of the invention Send syringe 10.Fig. 7 A show to be provided with the cylinder adapter 20 of cylinder 18.In packaging, cylinder adapter 20 may include rigidity Needle shield (RNS), the rigid needle shield are removedly engaged with cylinder tip 32 to protect a user from pin 28.Fig. 7 A are shown Removed RNS syringe, and pin 28 is exposed to be expelled to patient's body.Pin 28 between probe 54 and needle tip Tube chamber 29 contains the embedded drugs 49 for injecting.Fig. 7 B show the syringe after retraction mechanism 21 has been activated, its Middle plunger rod 14 is axially depressed in a distal direction, and jaw pedestal 50 contacts with needle stand 24.In the Min. of plunger rod 14 Further pressure in the case of, retraction mechanism 21 is activated, and locking mechanism 22 is allowed through such as biasing member 30 Torsion biasing and axial-rotation.As described above, when 22 axial-rotation of locking mechanism, locking mechanism 22 is allowed to and cylinder point The lock face 32a at end 32 is disengaged.

As seen in figure 7 c, biasing member 30 is allowed to axial expansion in the proximal direction.The near-end of biasing member 30 is near End side promotes locking mechanism 22, and this promotes needle stand 24 and pin 28, so that pin 28 is retracted into cylinder 18.This action, with The not mobile phase of pin 28 and probe 54 combines, and is used in targeted delivery and is exposed to the implant 49 of patient.It is complete in implant 49 After full exposure and delivering, probe 54 is set to be retracted together with pin 28.This action be contacted by probe disk 52 with needle stand 24 and Caused by two parts are retracted together.As mentioned above, these sizes are controlled to ensure the retraction of probe 54 only in implant 49 be delivered after just occur.Fig. 7 D show the syringe after pin 28 and the retraction of probe 54 has been completed.Fig. 8 A-8D show Go out the sectional view of the amplification of the embodiment shown in Fig. 7 A-7D, it shows to advance through with the next stage in syringe：Pin injection, pin The relation of part when retraction activation, implant delivering and probe are retracted.

In another embodiment, the invention provides one kind to deliver syringe, and the delivering syringe has can be via Screw thread mating connection is installed to the cylinder adapter on cylinder.As that will further describe herein, it is this construction can help to by The automatic implant insertion process that implant is loaded in the pin of cylinder adapter.Fig. 9 A are shown according to of the invention one so Embodiment delivering syringe 100 lateral elevational view, the delivering syringe include with screw thread be connected cylinder fit Orchestration 120.It is such delivering syringe (can for the sake of clarity be shown in figures 9 b and 9 as transparent component) by the use of needle cap 170, with Help to be attached to the cylinder adapter 120 including implant on the cylinder 118 of delivering syringe 100.Cylinder adapter 120 Can be fully located in needle cap 170, such as in the gnotobasis closed by removable membrane removal 171, for packing, transport and/or Assembling.Cylinder adapter 120 can for example be transported to filling or drugmaker in sterile needle cap 170, for insertion into implantation Thing and final assembling deliver the cylinder 118 of syringe 100.In at least one embodiment, cylinder adapter 120 will contained Sterile needle cap 170 is transported to before filling or drugmaker, and manufacturer is all by the distal tip of the pin 128 of cylinder adapter 120 Such as clogged by biodegradable polymer.In the needle cap that reception separates with the miscellaneous part of cylinder 118 and delivering syringe 100 When 170, load or drugmaker is peelable or otherwise removes removable membrane removal 171, and pass through cylinder adapter 120 Near-end inserts implant.Then it can be in or be not in the help of needle cap 170 and cylinder adapter 120 is attached or mounted to delivering note On the cylinder 118 of emitter 100.Delivering syringe is configured so that only when probe 154 and pin 128 axially align and pass through pin The hole of seat 124 is when inserting the near-end of the pin, and the assembling of cylinder adapter 120 to cylinder 118 is only possible.Fig. 9 C show Fig. 9 A Lateral elevational view of shown the delivering syringe and cylinder adapter in this assembled configuration.

It is worth noting that, embodiments of the invention are shown in which that one or more jaws 151 are and jaw base The construction of 150 separate parts of seat.In such embodiment, one or more jaws are performed with being retouched above by reference to Fig. 1 The jaw identical correlation function utilized in the delivering syringe stated.However, in the embodiment shown in Fig. 9 C, jaw is in near-end Extend on direction from probe guiding piece 155, rather than extend in a distal direction from jaw pedestal as shown in Figure 1.No matter construction How, jaw 151 is configured to permit the axial translation on jaw 151 of probe disk 152, to advance through behaviour in delivering syringe Make the position of stage time control manufacturing probe 154.In the embodiment shown in Fig. 1 or the embodiment shown in Fig. 9 C, jaw 151 also can use In by the way that the power being applied to by user on plunger rod 114 is delivered on locking mechanism 122 to activate needle retraction mechanisms.Figure 10B and Figure 10 C show the spy to be interacted in the operating process of delivering syringe 100 with probe guiding piece 155 and jaw 151 The zoomed-in view of dials 152 and probe 154.

As described above, embodiments of the invention can simplify assembling, manufacture and the operation of implant delivering syringe.Such as figure Shown in 10A, these processes can be promoted by using optional plunger guide component 112.In one embodiment, plunger guide Component 112 includes cylinder cover 116 and the plunger rod 114 with pedestal 150.Cylinder cover 116 can have port 116A, guide finger 117 can be positioned in the port.Guide finger 117 can interact with plunger rod 114, passage, path such as with plunger rod 114 Interacted with stopper element for example to guide the assembling of delivery apparatus, manufacture and operation.Figure 11 A-11C are shown according to the present invention The lateral elevational view of the plunger rod 114 of at least one embodiment, the plunger rod is respectively with 90 degree of interval relative to guide finger 117 Rotated around axis A, as indicated by arrowr.Figure 11 A show to connect with stopper element 114D, path 114A, passage 114E and pedestal Connect aspect 114C plunger rod 114.As shown in figure 12,114C can be used for plunger rod 114 being connected to pedestal in terms of pedestal connection On 150.In such configuration, sell guiding piece 117 can be located in passage 114E and allow the axial translation of plunger rod 114 until Sell guiding piece 117 and contact stopper element 114D.

Shown in Figure 11 A construction can be used for for example from manufacturer to filler or drugmaker initial assembling and transport. In such configuration, stopper element 114D prevents the axial translation in a distal direction of plunger rod.Optionally, cylinder cover 116 It can be interacted with plunger rod 114 and for preventing the axial translation on the proximal direction of the plunger rod.Figure 11 B show post Stopper rod 114 have rotated 90 degree around axis A in a direction as indicated by arrowr, so that guide finger 117 is allowed to logical Road 114E, move by path 114A, between passage 114F.In such configuration, the translatable post of filler or drugmaker Stopper rod 114 is used to finally assemble with positioning probe disk 152 and probe 154 and operation.As described above, from the construction shown in Figure 11 A Transformation to the construction shown in Figure 11 B be able to will be implanted into for example before cylinder adapter is attached on the cylinder of delivering syringe Thing is placed into cylinder adapter.Delivering syringe can be shipped for user with the construction shown in Figure 11 B.Before the use, make Plunger rod 114 can be rotated another 90 degree by user around axis A in a direction as indicated by arrowr.The rotation can allow to be oriented to Pin 117 in passage 114F, by moving (as shown in Figure 11 C) between path 114B to passage 114G.In the construction shown in Figure 11 C In, plunger rod 114 is allowed in proximally and distally axially free translation on direction, with contribute to the deployment of implant and pin and The retraction of probe.Figure 12 shows the sectional view (for the sake of clarity, eliminating intersecting hachure) of the amplification of delivering syringe 100, Interaction wherein between guide finger 117 and plunger rod 114 is visible by cylinder cover 116.

Figure 13 A-13D are shown as syringe 100 advances through pin injection, pin retraction activation, implant delivering and probe The sectional view (for the sake of clarity, eliminating intersecting hachure) of the amplification in the stage of retraction.It can such as observe in figure 13a, In at least one embodiment of the present invention, probe assembly includes probe 154, and the probe is from the spy in injector cartridge 118 The supporting construction of the form of dials 152 extends so that probe 154 substantially is maintained at into initial position.Probe disk 152 can pass through one Or multiple O-rings are maintained at the appropriate location in injector cartridge 118.It is worth noting that, probe disk 152 and probe 154 exist Fixed position is remained essentially in by O-ring or by equivalent manners during the starting stage of operation, implant 129 is protected Hold proximally to retract until pin 128 in fixed position and be used to dispose to expose implant.This initial position quilt of probe assembly Maintained until probe disk 152 contacts when needle stand 124 and pin 128 are retracted with probe guiding piece 154.As shown in Figure 13 A-13D, pin 128 retract when needle retraction mechanisms activate, and are used to dispose by probe 154 to expose implant 129, subsequent probe 154 is retracted Into cylinder 118.When using connector 127 implant 129 initially is maintained at into the appropriate location of the distal tip of pin 128, In addition to the deployment of implant 129, connector 127 is also optionally disposed.

As shown in FIG. 13A, it can draw probe by the power being applied to by plunger rod 114 and/or pedestal 150 on jaw 151 Guiding element 155 contacts with needle stand 124.In an illustrated embodiment, probe guiding piece 155 can be made into contacting needle stand 24, so make Obtain the power being applied on plunger rod 114 by user to be applied on pedestal 150, and be delivered to needle stand 124 at least in part On.By this transmission, the surface or its similar aspect that can make needle stand 124 promote or otherwise started locking mechanism 122 releases connected from the engagement of the lock face with cylinder tip 132.Pass through the lock by locking mechanism 122 from cylinder tip 132 Determine face release, it is allowed to which biasing member 130 (for example, spring) is swollen in the proximal direction substantially along the longitudinal axis of cylinder 118 Swollen and retraction includes the needle assemblies of pin 128.In such embodiment of the present invention, make pin 128, needle stand 124 and locking mechanism 122 retract when the release of locking mechanism 122 and biasing member 130 expand.Initially, probe 154 is fixed relative to pin 128 's；Implant 129 is exposed in target region by pin 128 by the retraction of needle retraction mechanisms to be used to deliver.Probe 154 ensures to be implanted into Thing 129 does not follow the pin when pin 128 is retracted.In order to ensure the accurate delivery of implant 129, probe 154 is only in probe 154 Retracted after the distal end of retraction pin 128 distal end.In an illustrated embodiment, the retraction order of probe 154 and time are to make The mechanism for activating or triggering after the distal end of probe 154 for probe 154 of retracting is withdrawn past in the distal end of pin 128, although Same retraction mechanism can be used come both parts of retracting.Similar to the embodiment described above with reference to Fig. 1, probe disk 152 leans on Nearly needle retraction mechanisms, and can be used for ensuring desired retraction order.The distance between needle retraction mechanisms and probe disk 152 are available In the time that setting probe 154 is retracted relative to pin 128.

When needle retraction mechanisms activate, pin 128 is retracted into the cylinder 118 of delivering syringe 100, so that implant 129 expose for being deployed to target position.The retraction of needle assemblies (including needle stand 124 and pin 128) causes needle stand 124 to contact and retracted Probe guiding piece 155.As shown in Figure 13 B, probe disk 152 and probe 154 are maintained at the position of substantial constant, with pin 128 are kept in a relatively fixed position implant 129 when being retracted around it.When implant 129 is exposed for portion from pin 128 During administration, as shown in fig. 13 c, probe guiding piece 155 contacts and retraction probe disk 152, and thus contact and retraction probe 154. Significantly, since the retraction of needle assemblies and probe guiding piece 155 causes the axial direction of jaw 151 in the proximal direction to be put down Move, so also causing plunger rod 114 and/or pedestal 150 axial translation in the proximal direction.This allow user by keep with Plunger rod 114 is contacted to control the deployment of the retraction of needle assemblies and implant.As illustrated in figure 13d, terminate in implant deployment When, pin 128 and probe 154 are fully retracted and are safely accommodated in the cylinder 118 of delivering syringe 100.As described above, appoint The guide finger 117 of choosing can be used for the function of controlling delivering syringe 100 together with plunger rod 114.Therefore, embodiments of the invention Allow embedded drugs being delivered to target position exactly, while keep easy to use and prevent needle stick injury.

Embodiments of the invention also provide the commercially available part allowed using standard, so as to reduce overall manufacturing cost, essence Simple assembling process and the construction for avoiding supervision problem often associated with non-standard material and part.For example, cylinder can be by Some plastics, glass are generally used for any other material of medical grade product and are made.One or more parts of the present invention are also It can be made up of some plastics, such as by the primary radical innovations Plastics Company (SABIC of sand of Massachusetts pittsfield Innovative Plastics of Pittsfield, Massachusetts) with the makrolon of trade name " LEXAN " sale Plastics.Similarly, using some elastomer polymers or rubber, such as by New Jersey Peng Suojin Datwyler medicine bag U s company (Datwyler Pharma Packaging USAInc.of Pennsauken, New Jersey) is filled with trade name " HELVOET " sell rubber product, for such as pin seal (provided that) and jaw pedestal 50 part.As commonly What technical staff will be understood that, different medical level metal (such as stainless steel) can be used for pin.These parts, cylinder adapter and delivering Syringe can be shaped with a variety of different constructions or determine size to meet desired parameter.These parts, cylinder adapter and Syringe can be assembled by a variety of methods known in the art and/or filling implant.For example, well known glue or weldering can be used Method (such as ultrasonic bonding) is connect to assemble the part of the present invention.

The delivering syringe of the present invention can be configured to use in a manner of similar to conventional syringe.The method bag used Include following steps：Plunger depressed component 12 is to promote the delivering of the activation of retraction mechanism 21 and implant 49 from pin 28；Triggering lock Mechanism 22 is determined to make biasing member 30 be discharged from its energised state by the contact between biasing member 30 and needle assemblies 42, from And needle assemblies 42 are retracted into cylinder；Implant 49 is delivered to target position；Also, after implant 49 is delivered, it will visit Pin 54 is retracted into the cylinder of syringe.As discussed above with respect to the embodiment of syringe, existing makes locking mechanism 22, pin Seat 24 and miscellaneous part may be configured for the multitude of different ways for enabling biasing member 30 to engage and discharge.For example, In syringe 10, locking mechanism 22 may include the interface on the cylinder tip 32 of engaging locking mechanisms 22.Activated by user When, needle stand 24 can be used for starting release of the locking mechanism 22 from the engagement at it and cylinder tip 32.In another reality of syringe Apply in example, lock face 32a can be the part separated with cylinder tip 32, but be risen in a manner of similar to the part of syringe 10 Effect.The function of delivering syringe 100 is substantially similar to herein on delivering the function described by syringe 10.

Regardless of specific part, the application method for the delivering syringe of the present invention is relatively similar.Pass through Locking mechanism 22 is discharged from its engagement state, it is allowed to biasing member 30 expands so that needle assemblies 42 substantially along The longitudinal axis of cylinder 18 is retracted in a proximal direction.In some embodiments of the invention, whole needle assemblies 42 are made to retract, and In other embodiments, only its its some parts (including pin 28) are discharged and biasing member 30 in locking mechanism 22 Retracted during activation.Similarly, in some embodiments of the invention so that locking mechanism 22 is retracted together with needle assemblies 42, and In other embodiments, locking mechanism 22 keeps substantially fixed, but the part of needle assemblies 42 or it is moved.Optionally Ground, application method may include to prevent the axle in a distal direction of pin 28 with pin block after needle assemblies 42 are had been retracted into cylinder 18 To the step of translation.

Figure 14 A to Figure 16 C show to deliver another embodiment of syringe 200.With the embodiment of above-mentioned delivering syringe Equally, delivering syringe 200 is configured to deposit to implant in target tissue.However, as will be described in more detail, Deliver syringe 200 and use the needle retraction mechanisms different from the embodiment described in Fig. 1-13.

As shown in figs. 14 a and 14b, delivering syringe 200 includes being used to be attached to the syringe with plunger assembly 212 Cylinder adapter 220 in cylinder 218.It is contemplated that the cylinder tip 232 of cylinder adapter 220 can be configured to pass through Any appropriate method coordinates with any standard cylinder.As above-mentioned cylinder 18, cylinder 218 can be taper, non-cylindrical It is shape or substantially straight and formed by any appropriate material.In preferred embodiment for manufacturing purposes, cylinder 218 It is straight tubular glass cylinder.In one or more embodiments, cylinder 218 can be the ready-made part of such as standard, so as to Valuable manufacture efficiency and running cost saving are provided.Cylinder cover 208 can be set in addition, once the delivering quilt of syringe 200 Assembling, the cylinder cover can suppress or prevent separating for plunger assembly 212 and cylinder 218.Cylinder 218 or cylinder cover 208 are (as schemed It is shown) it may include grip flange.Plunger assembly 212 can include plunger rod 213 and plunger 215.Plunger 215 can such as pass through It is threadedly engaged integral or be connected on the distal end of plunger rod 213 with the distal end of plunger rod 213.Plunger 215 can be relative to cylinder Body is activated to follow plunger rod 213 about 218.

As it will appreciated by a person of ordinary skill, cylinder adapter 220 can be installed to by any appropriate linkage arrangement On injector cartridge 218.For example, cylinder adapter 220 can be by can be with the portion of cylinder adapter 220 and injector cartridge 218 The separated draw bail of part is connected on injector cartridge 218, or with cylinder adapter 220 and injector cartridge 218 into one Body.In addition, cylinder adapter 220 can be connected on injector cartridge 218 before the use in syringe manufacturing process or just. Only as an example, syringe adapter 220 can in syringe manufacturing process by interference engagement, glue, be clasped component And/or screw thread matable assembly etc. is connected on injector cartridge 218.Alternately, for example, injector cartridge 218 and cylinder are fitted Orchestration 220 may include matching thread or luer lock arrangement, so that cylinder adapter 220 just can be connected to before the use On injector cartridge 218.In at least one embodiment of the present invention, cylinder adapter can be connected to via screw thread matable assembly On cylinder, its middle cylinder body adapter and cylinder both of which have corresponding male and female pitch portion or part.At another In embodiment, it is possible to provide one or more draw bails of such as adapter collar 233 by cylinder adapter 220 to be connected to cylinder On body 218.One or more O-rings 236 can be provided to be used to be arranged between cylinder adapter 220 and cylinder.

Cylinder adapter 220 helps pin 201 being installed on injector cartridge 218.Cylinder adapter 220 includes cylinder Tip 232 and needle retraction mechanisms 211.Needle retraction mechanisms 211 (show including actuator sub-component 210 in Figure 15 A and Figure 15 B Go out), pin sub-component 221, interior biasing component 240 and outer biasing member 241, and be configured to protect biasing member 240,241 Hold the actuatable lock arrangement in energising position.When coupling with injector cartridge 218, needle tip 232 typically exhibits out injection The distal end of device 200, pin 201 extend through the distal end of needle tip 232 in medical injection procedure.Cylinder tip 232 can also include The structure of a part for needle retraction mechanisms 211 is formed, such as sleeve 250, this will be explained in more detail below.

As shown in fig. 15 a and fig. 15b, pin sub-component 221 includes covering needle mould tool (" NOM ") 222, pin 201 and needle stand 216. As shown in fig. 15, the near-end 229 of pin 201 is arranged in the center of needle stand 216, and needle stand closes on NOM 222 near-end 223 are set, so that moving up for NOM will cause needle stand moving up relative to cylinder 218.In some embodiments In, NOM 222 near-end 223 may be coupled on needle stand 216.NOM 222 can be molded on pin 201, pass through a variety of sides Method combination, common mode system or attachment, it is mounted or affixed on pin.Alternately, such as the those of ordinary skill of field of mechanical technique It will readily appreciate that, NOM 222 can be the molding face of pin 201.

Cylinder adapter 220 also includes activatable lock arrangement, and the lock arrangement is configured to interior biasing component 240 Energising position is maintained at outer biasing member 241, until being activated by actuator sub-component 210 so that pin 201 is retracted.It is activatable Lock arrangement partly includes releasable between NOM 222 and NOM retainers 224 and coupled.As such as Figure 15 A and Figure 15 B institutes When showing assembling, centers of the NOM 222 essentially through NOM retainers 224 and the center cooperation through cylinder tip 232. In embodiment shown in Figure 15 A, NOM retainers 224 can such as barrier arm 250A with by connecing by NOM retainers 224 Close the sleeve 250 that the joint between the composition surface 224A that aperture 225 is formed removedly engages cylinder tip 232.Sleeve Arm 250A can include cammed surfaces, and the cammed surfaces allow sleeve 250 to be inserted into the end of NOM retainers 224, and And barrier arm 250A is allowed to be caught in appropriate location by engaging aperture 225.

NOM 222 and NOM retainers 224 are shown with the decomposed form in Figure 16 A, Figure 16 B and Figure 16 C.It should be appreciated that pin 201 itself do not show in Figure 16 A- Figure 16 C.In an illustrated embodiment, interior biasing component 240 and outer biasing member 241 (for Omitted for the sake of clear in Figure 16 A-C) it is sandwiched between retainer edge 230 and NOM edges 231.It should be appreciated that although Embodiment in Figure 14 and Figure 15 includes interior biasing component and outer biasing member, but in certain embodiments, it is contemplated that can To use single biasing member or additional bias component.NOM 222 is configured to receive in the center of NOM retainers 224, this Sample causes at least one retaining arm 234 to be caught in be engaged with the NOM shelves 235 included on NOM 222 in appropriate location, so as to shape Into the releasable connection of lock arrangement.Retaining arm 234 generally can be biased inwardly, to keep connecing with NOM shelves 235 Close.Contact between NOM shelves 235 and retaining arm 234 prevents NOM 222 from moving up, so that biasing member 240,241 is protected Hold in energising position.With reference to figure 15B, when NOM 222 is in appropriate location and is shown in energising position, cylinder point The sleeve 250 at end 232 engages with NOM otch 238, to prevent NOM and pin 201 relative to cylinder tip 232 further to moving down It is dynamic.As will be described further, lock arrangement may remain in energising position until being activated.

Turning now to Figure 15 A- Figure 15 B, actuator sub-component 210 is configured to activate activatable lock arrangement, to permit Perhaps biasing member 240,241 deenergizes, so that pin 201 is retracted.In an illustrated embodiment, actuator sub-component 210 includes visiting Dials 214, probe 254, at least one jaw 242, and NOM retainers 224.Shown embodiment includes prolonging from plunger 215 A pair of the jaws 242 stretched.By this way, plunger 215 serves as jaw retainer, and jaw 242 axially moves together with plunger 215 It is dynamic.It will be appreciated, however, that jaw 242 can from engaged with plunger 215 or fixed on plunger 215 unique base extension, as long as Jaw 242 is provided in the case that plunger 215 is depressed and vertically moved in a distal direction.

Jaw 242 is mounted slidably relative to needle stand 216, and the actuation ends 243 of these jaws extend to NOM holdings In the center of device 224, engaged with the interior section with retaining arm 234.The actuation ends 243 of jaw 242 can be formed cam shape with Just the interior section of retaining arm 234 is smoothly engaged.

Similar to the embodiment described above with respect to Fig. 3, syringe 200 and cylinder adapter 220 shown in Figure 14-Figure 16 It can be used for delivering implant.As shown in fig. 15b, needle stand 216 have it center (for example, substantially in these parts and On the longitudinal axis of cylinder) serve as the hole 227 of path.The hole 227 can have the diameter of the external diameter equal to pin 201, having or In the case of needle stand 216, so that pin 201 is maintained at appropriate in needle stand 216 during initial injection phase Position, and allow the axial translation in the proximal direction when activating retraction mechanism.When pin 201 is arranged on hole through needle stand 216 When in 227, the near-end 229 of pin 201 shows central lumen.In operation, probe 254 is arranged on the central lumen of pin 201 It is interior, and have implant to be implanted can be in the tube chamber that the distal end of probe 254 is included in pin 201.Therefore, when pin 201 enters During target (not shown), pin 201 can be axially retracted on probe 254.By this way, probe 254 prevents implant and pin 201 Retract together, so that implant is maintained at the appropriate location in target.If probe 254 extends beyond cylinder tip 232, visit Pin 254 similarly can retract from target, be retracted after implant positioning together with pin 201, or once pin has been retracted and pin 201 separately retract.Therefore, according to aspects of the present invention, at least pin 201 is retracted to provide the injection of implant.According to another On one side, in certain embodiments, after implant is delivered, probe 254 is equally retracted.

With reference now to Figure 14 A, when the distal end of probe is arranged in pin 201, probe disk 214 holds the near of probe 254 End 237.Probe 254 is retained in probe disk 214, so that when by probe disk relative to 218 axial translation of cylinder, Probe 254 will comply with this axial translation.Similarly, the near-end 239 of jaw 242 is retained in plunger 215, so that During 215 axial translation of plunger, jaw 242 will be towards distally moving down, i.e. as shown in figs. 14 a and 14b relative to cylinder 218 and actuator sub-component 210 move.Consequently, because retaining arm of the actuation ends 243 of jaw 242 against NOM retainers 224 234 interior section engagement, so the activation of actuator sub-component 210 be due to as to plunger assembly 212 axially downwards The plunger 215 of mobile reaction is moved and occurred axially downwards.When actuator sub-component 210 activates, the cause of jaw 242 Moved end 243 makes retaining arm 234 be displaced outwardly relative to NOM 222.Once retaining arm 234 is displaced outwardly and removes NOM shelves 235, retaining arm does not just rejoin NOM shelves, and NOM retainers 224 no longer prevent NOM 222 via interior biasing component 240 Moved up with the power of outer biasing member 241.When biasing member 240,241 pushes up NOM relative to NOM retainers 224 When 222, pin 201 is retracted into the distal end at cylinder tip 232 together with NOM.

Similar to the embodiment described above with respect to Figure 13 A- Figure 13 D, connector 127 (as shown in Figure 13 A- Figure 13 D) can be with For the appropriate location for the far-end that implant is initially maintained to pin 201.In addition to the deployment of implant, also optionally Dispose connector.In certain embodiments, as shown in Figure 14 A, probe disk 214 is set close to plunger 215, so that works as plunger rod 213 towards cylinder 218 activated when, plunger 215 pushes probe disk 214, so as to cause probe disk and probe 254 relative to cylinder 218 translations downwards.In such embodiment, just before the activation of actuator sub-component 210, probe 254 it is this it is slight to Lower axial movement causes probe to be translated downwards relative to pin 201.Probe 254 it is slight move down can be enough only to make connector from The distal end release of pin 201, but it is insufficient to allow implant to be discharged from pin.Once actuator sub-component 210 is activated, so that NOM 222 and needle stand 216 are axially retracted into cylinder 218, and pin 201 is just retracted around probe 254, so that probe forces Implant leaves pin.Once implant is deposited from pin 201, and biasing member 240,241 is by needle stand 216 It is pressed against on probe disk 214, probe 254 just can also retract relative to cylinder 218 and cylinder tip 232.

Therefore, in one aspect of the invention, delivery system by user relative to the axially plunger depressed bar of cylinder 218 213 activate.The pressure of plunger rod 213 causes plunger 215 and probe disk 214 axial translation slightly downwards.Probe disk 214 to Lower movement causes the axial translation in pin 201 of probe 254, so as to force connector to be discharged from the distal end of pin, without by implant Released from pin.When plunger 215 continues to translate downwards, the plunger pushes down on jaw 242 relative to NOM retainers 224.Jaw 242 actuation ends 243 push out the retaining arm 234 of NOM retainers 224, so that NOM 222 discharges from holding position. Once NOM 222 has been released, then biasing member 240,241 can be moved to position of deenergizing from energising position, so as to force NOM 222 relative to NOM retainers 224 and cylinder tip 232 axially upwards.The bulldozing needle bases 216 of NOM 222, so as to drive upwards Move needle stand and the distal end of pin 201 is retracted into cylinder tip 232.When pin 201 is retracted, probe 254 is maintained at appropriate position Put, so as to force implant to leave the distal end of pin.Once the contact probe disk 214 of needle stand 216, then probe disk 214 can be upward Promote, so that probe 254 is also retracted into cylinder tip 232.

Embodiments of the invention also provide the commercially available part allowed using standard, so as to reduce overall manufacturing cost, essence Simple assembling process and the construction for avoiding supervision problem often associated with non-standard material and part.For example, cylinder can be by Some plastics, glass are generally used for any other material of medical grade product and are made.One or more parts of the present invention are also It can be made up of some plastics, such as by the primary radical innovations Plastics Company (SABIC of sand of Massachusetts pittsfield Innovative Plastics of Pittsfield, Massachusetts) with the makrolon of trade name " LEXAN " sale Plastics.Similarly, using some elastomer polymers or rubber, such as by New Jersey Peng Suojin Datwyler medicine bag U s company (Datwyler Pharma Packaging USA Inc.of Pennsauken, New Jersey) is filled with commodity The rubber product that name " HELVOET " is sold, for such as pin seal (provided that), and the part of plunger 215.As commonly What technical staff will be understood that, different medical level metal (such as stainless steel) can be used for pin.These parts, cylinder adapter and delivering Syringe can be shaped with a variety of different constructions or determine size to meet desired parameter.These parts, cylinder adapter and Syringe can be assembled by a variety of methods known in the art and/or filling implant.For example, well known glue or weldering can be used Method (such as ultrasonic bonding) is connect to assemble the part of the present invention.

The invention provides provide pin retract element (such as cylinder adapter, delivery system and retraction mechanism), Integrate delivering syringe, the method and their application method of the such delivering syringe of manufacture of such release mechanism.Such as with Upper to be stated, cylinder adapter, delivery system, retraction mechanism and delivering syringe can be utilized with a variety of different constructions. For example, as stated above, novel cylinder adapter of the invention is configured to coordinate, in cylinder or with it with cylinder He is connected on cylinder mode, but it may be desirable that any part of cylinder adapter is preforming on cylinder.It is such Modification is desired by embodiments of the invention and is covered by embodiments of the invention.Such as the institute in embodiment discussed above Description, part can be single part, unified part or multifunction component.Additionally, there are using novel pin described here Many different configurations of retraction mechanism, these, which are constructed, can utilize pin 28,201, probe 54,254, needle stand 24,216, probe disk 52, 214 and the interaction of jaw pedestal 50 and associated components.Therefore, similar to examples given above, cylinder of the invention Adapter and delivering syringe can be constructed, change and for starting embedded drugs delivering and being swashed with any amount of construction Pin living is retracted, while is maintained in the range and scope of the present invention.Accordingly, it is intended to the present invention covers the modification and change of the present invention More, as long as these modifications and changes are in the range of following claims and their equivalent.

It should be appreciated that above description provided the example of disclosed system and technology.It is contemplated, however, that other of present disclosure Implementation may be different in detail from examples detailed above.The all references of present disclosure or its example is intended to refer in the point The instantiation of discussion, it is no intended to more fully imply any restrictions to the scope of present disclosure.Difference on some features It is not intended to refer to lack the preference to these features with all language belittled, but is not to exclude these features completely originally draping over one's shoulders Outside the scope of dew, unless otherwise directed.

Substantially contradict unless otherwise indicated herein or with context, otherwise in the description of the invention in the context (especially In the context of claims below) using term "/kind (a/an) " and "the" with it is " at least one " and similar Denotion is understood to include both odd number and plural number.Substantially contradict, otherwise use unless otherwise indicated herein or with context The list of term " at least one " followed by one or more projects (such as " at least one in A and B ") should be interpreted to anticipate Refer to the project selected from the project (A or B) listed or any group of two or more projects listed (A and B) Close.

Unless otherwise indicated herein, the narration for the scope being otherwise respectively worth herein is intended only to be used as individually reference and belongs to the scope The stenography method of interior each independent values, and each independent values are as it is normally bonded in this specification in this independent narration.Can So that all methods described herein is performed in any suitable order, unless otherwise indicate that herein or in addition significantly with it is upper Hereafter contradiction.

Therefore, present disclosure be included in the theme described in the claim that the applicable law enclosed allows all modifications and Equivalent.In addition, unless indicated otherwise or otherwise clearly contradicted herein, otherwise it is possible to upper in version at it Any combinations for stating key element all cover in present disclosure.

Claims

1. one kind is used to delivering the cylinder adapter (220) of syringe (200), the delivering syringe have cylinder (218) and by The plunger assembly (212) for being moved in the cylinder is adapted to, the cylinder adapter includes：

The cylinder for being configured to engage with the distal seal of the cylinder is sophisticated (232)；

Needle retraction mechanisms (211), the needle retraction mechanisms include：

Pin sub-component (221), the pin sub-component include the needle mould that covers that pin (201) and the pin extend through and have (222), and the needle set has Tube chamber, wherein the pin sub-component are at least partially disposed in cylinder tip and are adapted for moving from injection position To retracted position, the pin is from the distal end extension at cylinder tip in the injection position, and the pin is set in the retracted position In at least one of cylinder tip or the cylinder,

Actuator sub-component (210), the actuator sub-component include being connected on the cylinder tip covering pin die holder (224), probe (254), hold the probe near-end probe disk (214), through the probe disk and entrance, this covers needle mould tool At least one jaw (242) of retainer, at least one jaw in response to movement of the plunger assembly in the cylinder and can Actuating, wherein the probe can axially be slided and is at least partially disposed in the needle lumen, and when the pin is in the note When penetrating in position, the probe is proximally set and is spaced apart with the distal tip of the pin, and

At least one biasing member (240,241), at least one biasing member, which is arranged on this and covers needle mould tool, with this covers needle mould Between having retainer, it is biased away from this to make this cover needle mould tool and covers pin die holder；And

Activatable lock arrangement, the activatable lock arrangement be configured to when the lock arrangement is locked by this at least one Individual biasing member is maintained at energising position and discharges the biasing member when being activated by the actuator sub-component, locking peace Row may be actuated by pressing the plunger assembly, so that at least one jaw covers the movement of pin die holder against this, this is extremely A few biasing member is configured to provide the pin and relative motion of the probe from the injection position to the retracted position.

2. cylinder adapter as claimed in claim 1, the wherein lock arrangement cover needle mould tool including this and cover needle mould tool guarantor with this Releasable connection between holder.

3. cylinder adapter as claimed in claim 2, the wherein releasable connection are formed on this and cover pin die holder At least one retaining arm (234) and this cover the covering between needle mould tool shelf (235) of needle mould tool.

4. the actuation ends (243) of cylinder adapter as claimed in claim 3, wherein at least one jaw are configured to make this At least one retaining arm removes the engagement that needle mould tool shelf is covered with this, to activate the lock in response to the pressing of the plunger assembly Arrange Dingan County.

5. cylinder adapter as claimed in claim 4, in addition to two jaws and two retaining arms.

6. near-end (237) quilt of cylinder adapter according to any one of the preceding claims, wherein at least one jaw It is arranged in the plunger assembly.

7. cylinder adapter according to any one of the preceding claims, wherein the probe disk are set adjacent to the plunger assembly, So so that the pressing of the plunger assembly causes before the pressing of the plunger causes the actuating of the lock arrangement, the probe exists Initial axial movement in the needle lumen.

8. cylinder adapter as claimed in claim 7, the wherein needle lumen are configured to receive implant (129) and in the plant Enter the connector (127) that the distal end of thing is set, and wherein the probe disk is configured such that the initial axial movement of the probe The connector is forced to leave the pin without forcing the implant to leave the pin.

9. cylinder adapter according to any one of the preceding claims, wherein the pin sub-component, which also include neighbouring this, covers needle mould Has the needle stand (216) set, and wherein the needle stand is configured to engage the probe disk when the pin is retracted.

10. cylinder adapter as claimed in claim 1, wherein when the pin is arranged in the retracted position, the pin is set Put at least one of cylinder tip or the cylinder.

A kind of 11. delivering syringe of the auto retractable of the cylinder adapter including as any one of claim 1-10 (200), the delivering syringe includes cylinder (218) and is configured to the plunger assembly (212) moved in the cylinder.

12. a kind of method for the delivering syringe for assembling auto retractable as claimed in claim 13,

This method comprises the following steps：

At least one biasing member is arranged on into this to cover between pin die holder and the pin sub-component,

With this cover pin die holder actuatably lock this cover needle mould tool to form activatable lock arrangement, the lock arrangement At least one biasing member is maintained at the energising position so that this covers the biasing of needle mould tool far when the lock arrangement is locked Pin die holder is covered from this and the biasing member is discharged when the lock arrangement is activated,

At least a portion of the pin sub-component is arranged in the cylinder tip, the distal end of the wherein pin extends through cylinder point End,

The probe extended from the probe disk is arranged in the near-end of the pin, at least one jaw is set and passes through the probe The distal end of at least one opening in disk, the wherein jaw may be actuated lock arrangement close to this and set,

The plunger assembly is set to be moved in the cylinder,

At least one jaw is arranged on to be moved axially together with the plunger in the cylinder, and

The probe disk and the activatable lock arrangement are arranged in the cylinder, and the cylinder is sophisticated remote with the cylinder End is sealingly engaged.

13. method as claimed in claim 12, the wherein needle lumen are configured to receive implant and in implant distal end The connector of setting, and wherein this method also includes setting the probe disk adjacent to the plunger assembly, so that the plunger assembly Pressing result in before the pressing of the plunger causes the actuating of the lock arrangement, the probe is initial in the needle lumen Axial movement, the initial axial movement force the connector to leave the pin without forcing the implant to leave the pin.