US20230090486A1 - Injector needle insertion retraction assembly - Google Patents

Abstract

A needle insertor for a medicament delivery device is presented having a driver having a first part movably arranged within the case and a second part connected to the base, a needle assembly movably held by the first part in the case, a rotator arranged in the case and configured to engage the first part for moving the driver, an energy accumulation member configured to interact with the rotator for applying a rotational force on the rotator, a movable stop arranged on the base and configured to interact with the rotator for preventing the rotator from rotating. The first part has a first position where the needle assembly is held inside the case, a second position where the needle portion is positioned outside the case after being moved to pass through the injection site end, and a third position where the needle portion is positioned inside the case.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
• The present application is a Divisional of U.S. Application No. 15/734,291, filed Dec. 2, 2020, which is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2019/074302 filed Sep. 12, 2019, which claims priority to U.S. Provisional Pat. Application No. 62/735,045 filed Sep. 22, 2018, and European Patent Application No. 18205273.8 filed Nov. 8, 2018. The entire disclosure contents of these applications are herewith incorporated by reference into the present application.
TECHNICAL AREA
• The present disclosure relates to a needle insertion and retraction assembly of a medicament delivery device and in particular to a needle insertion and retraction assembly in which the needle and catheter are inserted at an insertion site and the needle is subsequently withdrawn from the insertion site
BACKGROUND
• A large number of people suffering from diabetes use some form of insulin therapy to maintain close control of their glucose levels. Currently, there are two principal modes of daily insulin therapy. The first mode includes syringes and insulin pens. These devices are simple to use and are relatively low in cost, but they require a needle stick at each injection, typically three to four times per day. The second mode includes infusion pump therapy, which entails the purchase of an insulin pump that lasts for about three years. The initial cost of the pump can be significant, but from a user perspective, the overwhelming majority of patients who have used pumps prefer to remain with pumps for the rest of their lives. Infusion pumps, although more complex than syringes and pens, offer the advantages of continuous infusion of insulin, precision dosing and programmable delivery schedules. This results in closer blood glucose control and an improved feeling of wellness.
• The use of an infusion pump further requires the use of a disposable component, typically referred to as an infusion set or pump set, which conveys the insulin from a reservoir within the pump into the skin of the user. An infusion set typically consists of a pump connector, a length of tubing, and a hub or base from which an infusion needle or cannula extends. The hub or base has an adhesive that retains the base on the skin during use. The hub or base may be applied to the skin manually or with the aid of a manual or automatic insertion device. Often, the insertion device is a separate, stand-alone unit that the user is required to carry and provide.
• There are many available versions of infusion sets, including steel cannula infusion sets and soft (flexible) catheter sets. Soft catheter sets are typically inserted into a patient manually with the aid of a steel introducer needle, which is later removed from the patient leaving the soft catheter in place. In another type of infusion set, as noted above, a mechanized insertor is used to automatically insert the introducer needle and catheter, remove the introducer needle, or both. The introducer needle is completely removed from the infusion set before the soft catheter is connected to the insulin pump.
• One problem associated with manually inserting and retracting the introducer needle is variability in the insertion and retraction force, speed, smoothness and angle. This variability can lead to an increased rate of catheter insertion failure.
• Further, as noted above, the user typically must remove the introducer needle after inserting the cannula. This exposes the user to accidental needle sticks from handling the removed introducer needle.
• Accordingly, a need exists for an infusion set that facilitates insertion of the cannula, while reducing the number of components a user must carry and substantially preventing accidental needle sticks.
SUMMARY
• In the present disclosure, when the term “distal” is used, this refers to the direction pointing away from the dose delivery site. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal” is used, this refers to the direction pointing to the dose delivery site. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which under use of the medicament delivery device is/are located closest to the dose delivery site.
• Further, the term “longitudinal”, with or without “axis”, refers to a direction or an axis through the device or components thereof in the direction of the longest extension of the device or the component.
• The term “lateral”, with or without “axis”, refers to a direction or an axis through the device or components thereof in the direction of the broadest extension of the device or the component. “Lateral” may also refer to a position to the side of a “longitudinally” elongated body.
• In a similar manner, the terms “radial” or “transversal”, with or without “axis”, refers to a direction or an axis through the device or components thereof in a direction generally perpendicular to the longitudinal direction, e.g. “radially outward” would refer to a direction pointing away from the longitudinal axis.
• Also, if nothing else is stated, in the following description wherein the mechanical structure of the device and the mechanical interconnection of its components is described, the device is in an initial non-activated or non-operated state.
• These and other aspects of, and advantages with, the present disclosure will become apparent from the following detailed description of the present disclosure and from the accompanying drawings.
• According to a main aspect of the disclosure it is characterized by a needle insertor for a medicament delivery device, comprising, a case having a base and an injection site end, a driver having a first part movably arranged within the case and a second part connected to the base, a needle assembly movably held by the first part of the driver in the case, a rotator arranged in the case and configured to interact with the first part of the driver for moving the driver, an energy accumulation member configured to interact with the rotator for applying a rotational force on the rotator, a movable stop arranged on the base and configured to interact with the rotator for preventing the rotator from rotating. The needle assembly includes a needle portion positioned substantially perpendicular to the injection site end.
• Further, the first part has a first position where the needle assembly is held inside the case, a second position where the needle portion is positioned outside the case after being moved to pass through the injection site end and pierce an injection site, and a third position where the needle portion is positioned inside the case. In addition, a movable stop is further configured to interact with the rotator for releasing the rotator and allow the rotational force from the energy accumulation member to rotate the rotator to further allow the first part to move between said positions.
• In one embodiment, the needle insertor may further comprise a cannula assembly configured to interact with the needle assembly, wherein the cannula assembly remains within the case when the first part is in the first position. The cannula assembly is moved by the needle assembly to enter the injection site when the first part is in the second position.
• Further, the cannula assembly includes a cannula base portion and a cannula portion substantially perpendicular to the injection site end. The cannula portion is coupled with the cannula base portion and configured to enter the injection site when the first part is in the second position. The cannula portion is positioned in the injection site when the first part is in the second position.
• The cannula base portion includes a medicament input opening, wherein the cannula portion and cannula base portion are hollow so that a medicament can pass through the medicament input opening, the cannula base portion, and exits through the cannula portion.
• Further, the needle portion is positioned within the cannula portion when the first part is in the first and second positions, the needle portion is not positioned within the cannula portion when the first part is in the third position.
• The cannula base portion is positioned between the needle assembly and the injection site end, wherein the needle assembly interacts with the cannula base portion to move the cannula assembly toward the injection site end when the first part moves from the first position to the second position.
• Further, the base includes at least one locking member configured to engage and fix the cannula assembly on the base when the first part reaches the second position.
• The base includes a container port for accommodating a medicament container, a piercer coupled with the container port for piercing the medicament container, a medicament path assembly coupled with the base. The medicament tube assembly having a first end connected to the piercer and a second end connected to the cannula assembly, wherein a medicament can flow from the medicament container through the piercer and the medicament tube assembly to enter the cannula assembly.
• The needle assembly can further include a needle base portion coupled with the needle portion and configured to be movably held by the first part, wherein the first part of the driver drives the needle base portion to move the needle portion outside the case when moving from the first position to the second position. The first part of driver drives the needle base portion to move the needle portion back inside the case when moving from the second position to the third position.
• The rotator further includes an engagement member configured to interact with the first part, wherein the engagement member of the rotator is rotated by the energy accumulation member interacts with the first part to move the first part between said positions.
• In one embodiment, the second part of the driver is pivotably fixed on the case. However, in another embodiment, the driver can have a flexible elastic structure, wherein elasticity of the driver allows the second part of the driver to move the first part of the driver to the third position when the engagement member no longer interacts with the first part.
• The base includes a first rest configured to accommodate the energy accumulation member and a second rest configured to engage the rotator and keep the rotator rotatably connected to the base. The injection site end of the case includes a first injection site opening configured for the needle assembly to pass through and pierce the injection site. The base includes a second injection site opening corresponding to the first injection site opening, the needle assembly passes through both the first and second injection site openings to pierce the injection site. The base includes a guiding structure forming a channel extending perpendicularly to the injection site end, wherein the needle assembly is at least partially accommodated in the channel while held movably by the first part of the driver.
• The needle insertor can further include a sleeve configured to accommodate the rotator and the energy accumulation member, wherein the base includes a sleeve port configured to accommodate the sleeve.
BRIEF DESCRIPTION OF DRAWINGS
• In the following detailed description of the present disclosure, reference will be made to the accompanying drawings, of which
• FIG.1 shows an exploded view of an example needle insertor according to a first embodiment of the present disclosure.
• FIG.2 shows an exploded view of the insert assembly according to the first embodiment of the present disclosure.
• FIG.3 shows an exploded view of cannula assembly and medicament path assembly according to the first embodiment of the present disclosure.
• FIGS.4A,4B and4C show perspective views and exploded views of the needle assembly, cannula assembly, and medicament path assembly as well as a perspective view of said components assembled.
• FIGS.5A and5B show perspective views and exploded views of the torsion spring, rotator, and sleeve as well as a perspective view of said components assembled.
• FIG.6 shows an exploded view of the base, piercer, cannula assembly, driver, needle assembly, and medicament path assembly.
• FIG.7 shows a perspective view of the base, piercer, driver, needle assembly, cannula assembly, and medicament path assembly assembled.
• FIG.8 shows a perspective view of a movable stop to be assembled with the base.
• FIG.9 shows a perspective view of a torsion spring, rotator, and sleeve to be assembled with the base.
• FIG.10 shows a cross-section view of the needle insertor before the rotator is released.
• FIG.11 shows a cross-section view of the needle insertor when the rotator is rotated by an associated torsion spring.
• FIG.12 shows a cross-section view of the needle insertor when the rotator retracts the needle portion back inside the case and is prevented from further rotating.
• FIG.13 shows an exploded view of an example needle insertor according to a second embodiment of the present disclosure.
• FIG.14 shows a perspective view of the needle insertor according to a second embodiment of the present disclosure.
• FIG.15 shows another perspective view of the needle insertor according to a second embodiment of the present disclosure.
DETAILED DESCRIPTION
• FIG.1 shows an exploded view of aneedle insertor100 according to the first embodiment of the present disclosure. The needle insertor100 includes acase200, acover300, a plurality of fixingelements310, an O-ring320, afirst seal331, asecond seal332, and athird seal333. The needle insertor100 further includes aninsertor assembly500 positioned within the enclosure of thecase200 andcover300. The structure ofinsertor assembly500 will be further explained in details below.
• Thecase200 includes afirst opening211, asecond opening212, and athird opening213 on aninjection site end240, wherein theinjection site end240 faces the injection site when a medicament delivery device having theneedle insertor100 is placed on the injection site. The first, second, andthird seals331,332,333 are configured to attach to thecase200 to cover the first, second, andthird openings211,212,213.
• Theinsertor assembly500 includes acontainer port501 configured with apiercer502 for piercing a medicament container. Theinsertor assembly500 further includes a movable stop530 (illustrated inFIG.2) configured to be moved to activate the needle insertion sequence of theinsertor assembly500. Theinsertor assembly500 includes a fourth opening214 (illustrated inFIG.1) corresponding to thethird opening213, wherein a needle within theinsertor assembly500 will pass through the third andfourth openings213,214 to penetrate the injection site. When theinsertor assembly500 is positioned inside thecase200, thepiercer502 and stop530 will be respectively exposed through the first andsecond openings211,212 of thecase200. However, the first andsecond seals331,332 cover the twoopenings211,212 to ensure that external objects will not interact with thepiercer520 and stop530 before theneedle insertor100 is ready for use. Similarly, thethird seal333 covers the third andfourth openings213,214 to ensure that no external objects interact with the needle within theinsertor assembly500 before theneedle insertor100 is ready for use.
• Thecover300 is configured to couple with thecase200 and covers the opening through which theinsertor assembly500 is inserted into thecase200. Thecover300 includes an O-ring portion301 surrounded by the O-ring320. This arrangement allows the O-ring portion301 and O-ring320 to create a seal with the inner surface ofcase200 when inserted into thecase200. In this embodiment, the fixingelements310 are screws configured to pass through the corresponding screws openings on thecase200 and cover300 to secure the twocomponents200,300 together. Together,case200,cover300, and the first, second,third seals331,332,333 ensure that external objects will not make contact withinsertor assembly500 before theneedle insertor100 is ready for use. Also, other suitable fixing elements known to a skilled person such as bolts can be used to secure thecase200 and cover300 together.
• FIG.2 shows an exploded view of theinsertor assembly500 according to the first embodiment of the present disclosure. Theinsertor assembly500 includes abase510, apiercer502, acannula assembly520, amovable stop530, adriver540, aneedle assembly550, amedicament path assembly570, anenergy accumulation member580, arotator590, and asleeve600. The function of each component mentioned above and its relationship with the base510 will be explained in more details below.
• FIG.3 shows an exploded view of thecannula assembly520 andmedicament path assembly570. Thecannula assembly520 includes acannula portion521 and acannula base portion522. Thecannula portion521 andcannula base portion522 are both hollow inside. Thecannula base portion522 has ahose opening523 and acannula mount524 that has an opening to accommodate thecannula portion521. Thehollow cannula portion521 is mounted on thecannula mount524 to gain access to the inner space of thecannula base portion522. Thus, once thecannula portion521 is coupled with thecannula mount524, liquid entering thehose opening523 will be able to pass through the inner space ofcannula base portion522 and then exit through thecannula portion521.
• In the present embodiment, themedicament path assembly570 includes anattachment pin571, afirst crimp572, asecond crimp573, and ahose574. Theattachment pin571 has a thicker portion configured to be fitted in thehose opening523 to gain access to the inner space ofcannula base portion522. Theattachment pin571 also has a thinner portion configured to be coupled with one end of thehose574, wherein thefirst crimp572 surrounds the portion ofhose574 coupled with theattachment pin571 to ensure that the two components are fastened. Thesecond crimp573 is configured to surround the portion ofhose574 coupled with thepiercer502 which will be explained with figure later.
• In the present embodiment, themedicament path assembly570 includes four components assembled together. In other embodiments, themedicament path assembly570 can instead include only one tube or other number of components suitable to be assembled with thecannula assembly520.
• FIGS.4B &4C shows an exploded view of the needle assembly550 (seeFIG.4A), cannula assembly520 (seeFIG.4B), andmedicament path assembly570 as well as a perspective view of the assembly of said components. Thecannula assembly520 andmedicament path assembly570 are assembled as described above. On the other hand, theneedle assembly550 includes aneedle base portion551 andneedle portion552 coupled together. Thecannula base portion522 includes aneedle opening525 for allowing access to the inner space ofcannula base portion522. Thus, theneedle portion552 can pass through theneedle opening525 and pass through thecannula portion521 as illustrated on the right side ofFIG.4A.
• In the present embodiment, thecannula base portion522 includes abase coupling key526 having aprotrusion527. On the other hand, theneedle base portion551 has acoupling trough553 configured to couple with theprotrusion527. Said structure ensures that theneedle base portion551 andcannula base portion522 are coupled together in such as a way that external forces will not cause vibration of theneedle base portion551 that may cause damage to theneedle portion552 within thecannula portion521. The configuration also serves to make sure that thecannula base portion522 is coupled with a correspondingneedle base portion551. Also, in other embodiments, theprotrusion527 can be disposed on theneedle base portion551 while the correspondingcoupling trough553 is disposed on thebase coupling key526. Other suitable configuration can also be used to couple theneedle base portion551 with thecannula base portion522.
• FIG.5B shows an exploded view of the energy accumulation member580 (seeFIG.5A),rotator590, andsleeve600 as well as a perspective view of the assembly of said components. Therotator590 has adriver end591 and acoupling end592 for passing through theenergy accumulation member580 and coupling with thesleeve600. Thedrive end591 is configured to interact with the driver540 (illustrated inFIG.2) when therotator590 is released to be rotated by theenergy accumulation member580. Thesleeve600 is hollow in order to accommodate both theenergy accumulation member580 and therotator590. Thesleeve600 has arotator coupling opening601 configured to allow thecoupling end592 to pass through and couple with thesleeve600. Each of the two coupling ends592 has afin593 extending and slanting radially outward. When thecoupling end592 is pressed against the inner surface ofsleeve600, the inner surface ofsleeve600 forces the slanting surface offin593 andcoupling end592 as a whole to flex radially inward. In this way, both the coupling ends592 together become thin enough to pass through therotator coupling opening601. Afterward, the coupling ends592 flex radially outward and thefins593 engage the outer surface ofsleeve600 surrounding theopening601 to prevent therotator590 from being pulled away. This coupling allows therotator590 to be rotatable relative to thesleeve600 and prevents therotator590 to move longitudinally relative to thesleeve600. On the other hand, theenergy accumulation member580 has two ends, one positioned between the two coupling ends592 ofrotator590 and the other positioned in anotch602 on thesleeve600.
• In the present embodiment, theenergy accumulation member580 is a torsion spring. However, in other embodiments, theenergy accumulation member580 can be other forms of force generating component capable of accumulating energy and release the energy when released.
• FIG.6 shows an exploded view of thebase510,piercer502,cannula assembly520,driver540,needle assembly550, andmedicament path assembly570.FIGS.7 and8 show perspective views of the assembly ofpiercer502,base510,cannula assembly520,driver540,needle assembly550, andmedicament path assembly570. Thebase510 has acontainer port511 for accommodating a medicament container and apiercer opening512 for accommodating thepiercer502. In the present embodiment, the end ofhose574 surrounded by thesecond crimp573 is positioned on one end of thepiercer opening512 while thepiercer512 passes through the other end ofpiercer opening512 to be coupled with both thebase510 andhose574. Thus, a medicament container can have its seal pierced to have the medicament within flowing through thepiercer502,hose574,cannula base portion522, and finally exit through thecannula portion521.
• In the present embodiment, thebase510 has a guidingstructure513 configured to accommodate and guide the insertion of theneedle assembly550 andcannula assembly520. The guidingstructure513 creates a space with size and shape corresponding to those of theneedle assembly550 andcannula assembly520. As illustrated inFIG.8, thebase510 has thefourth opening214 configured for thecannula portion521 andneedle portion552 to pass through and reach the injection site.
• As illustrated inFIGS.6 and7, thebase510 also has adriver rest514 configured to couple with thedriver540. In the present embodiment, thedriver540 has afirst part541 configured to couple with theneedle base portion551, asecond part542, and athird part543 configured to couple with thedriver rest514. As illustrated, thethird part543 ofdriver540 has a circular opening with size corresponding to that of thedriver rest514. Thus, thebase510 anddriver540 can be coupled by putting thethird part543 on thedriver rest514 as illustrated inFIG.7.
• Further, as illustrated inFIG.6, theneedle base portion551 has adriver opening554 configured for thefirst part541 ofdriver540 to pass through to couple thedriver540 with theneedle assembly550. When thefirst part541 is under no external forces it maintain the position of theneedle assembly550 on one end of guidingstructure513 away from theinjection site opening514, as illustrated inFIGS.7 and8. On the other hand, external forces may also be exerted on thefirst part541 to move theneedle assembly550 toward the injection site opening514 as will be explained later.
• Here please refer toFIG.8 for the explanation on installation of themovable stop530. In the present embodiment, thebase510 has astop rest515 configured to accommodate themovable stop530. Thestop530 has amain portion531 and afirst obstruction portion532. On the other hand, thestop rest515 is tubular and has atunnel516 for themain portion531 to pass through and agap517 for thefirst obstruction portion532 to pass through. One end of thetunnel516 is disposed withstop openings518 so that an external object can move thestop530 by interacting with themain portion531 through thestop openings518.
• Here please refer to bothFIGS.9 and10 for the installation of theenergy accumulation member580,rotator590, andsleeve600 as well as the interaction between thestop530 androtator590. In the present embodiment, thebase510 has asleeve port517 configured to accommodate the assembly of theenergy accumulation member580,rotator590, andsleeve600. Thesleeve port517 includes asecond obstruction portion519 disposed on the inner surface of thesleeve port517. As illustrated inFIGS.2 and10, therotator590 includes a drivingmember591 configured to interact with thefirst part541 ofdriver540 after therotator590 is released. Also as illustrated inFIG.10, therotator590 also has anengagement member592 configured to interact thefirst obstruction portion532 ofstop530 before therotator590 is released. Theengagement member592 is also configured to interact with thesecond obstruction portion519 after therotator590 is released. The interaction between components mentioned above will be explained in more details below.
• When the assembly of theenergy accumulation member580,rotator590, andsleeve600 is inserted in thesleeve port517 ofbase510, theengagement member592 ofrotator590 will be positioned between the gap/space between theobstruction portion518 ofsleeve port517 and thefirst obstruction portion532 ofstop530. SeeFIG.10. In the present embodiment illustrated inFIG.10, theenergy accumulation member580 constantly applies a rotational force on therotator590 in a clockwise direction. However, thefirst obstruction portion532 prevents such clockwise rotation of therotator590 by engaging theengagement member592. Unless thestop530 is moved in order for thefirst obstruction portion532 to disengage theengagement member592, theenergy accumulation member580 will not be able to rotate therotator590 in a clockwise direction.
• FIG.11 shows a cross-section view of theneedle insertor100 after thestop530 disengaged therotator590. An external object can be used to push thestop530 exposed through thestop openings518 ofbase510. SeeFIG.12. The result of the stop’s530 movement is that itsfirst obstruction portion532 is no longer in engagement with theengagement member592 ofrotator590. Thus, therotator590 is promptly rotated under the rotational force of theenergy accumulation member580 in a clockwise direction. During such rotation, the drivingmember591 interacts with thefirst part541 ofdriver540 and pushes thefirst part541 downward toward theinjection site end240. As mentioned above, thefirst part541 is coupled with theneedle base portion551 ofneedle assembly550. Also, theneedle base portion551 is positioned above thecannula base portion522 ofcannula assembly520. Thus, as thefirst part541 is pushed downward, thefirst part541 will also push both thecannula assembly520 andneedle assembly550 downward. This downward movement results in both theneedle portion552 passing through thethird opening213 ofcase200 andfourth opening214 on the base510 to pierce the injection site to create an opening. Similarly, thecannula portion521 also passes through theinjection site opening514 and enters the injection site through the opening created by theneedle portion552. The needle penetration and cannula insertion procedures are complete.
• FIG.12 shows a cross-section view of theneedle insertor100 after therotator590 is prevented from further rotating by thesecond obstruction portion519 ofsleeve port517. As mentioned above, theenergy accumulation member580 constantly applies rotational forces on therotator590, even after the needle penetration and cannula insertion procedures have been accomplished. Therotator590 eventually rotates to the point where itsengagement member592 engages thesecond obstruction member519 and theenergy accumulation member580 can no longer rotate therotator590. SeeFIG.12. At this moment, the drivingmember591 is no longer in engagement with thefirst part541. Thus, the resilient nature of thedriver540 allows thefirst part541 to move upward. Since thefirst part541 is coupled with theneedle base portion551, this movement also brings theneedle assembly550 as a whole upward.
• On the other hand, thebase510 has a pair of lockingmembers610 disposed on its inner surface next to theinjection site opening514. In the present embodiment, the lockingmembers610 each have the shape of a hook. When thecannula assembly520 is pushed toward theinjection site opening514, itscannula base portion522 will push the lockingmembers610 radially outward in order to reach the inner surface ofbase510. As thecannula base portion522 reaches the inner surface ofbase510, the locking members flex radially inward and then engage the cut-outs on the outer surface ofcannula base portion522. The hook shape of lockingmembers610 ensures that thecannula assembly520 will not be brought back up together with theneedle base portion551 by thefirst part541. Accordingly, thecannula assembly520 andneedle assembly550 will separate when thefirst part541 returns to its initial position. The needle retraction and cannula locking procedures are complete.
• Now that the needle retraction and cannula locking procedures are complete, theneedle portion552 no longer occupies the space in thecannula portion521. Thus, after a medicament container is inserted in thecontainer port501 to have its seal pierced by thepiercer502, the medicament within can flow through thepiercer502,hose574,cannula base portion522,cannula portion521, and eventually enter the injection site.
• FIG.13 shows an exploded view of anexample needle insertor10 according to a second embodiment of the present disclosure. Theneedle insertor10 includes acase20, adriver arm30, aneedle assembly40, acannula assembly50, arotator60, atorsion spring70, astop member80, and aconnection member90, wherein therotator60 includes afirst rotator61 and asecond rotator62. Thesecond rotator62 is made transparent to facilitate illustration.
• On the other hand,FIG.14 shows a perspective view of theneedle insertor10 according to the second embodiment of the present disclosure. Thecase20 is made transparent to facilitate the illustration. Thecase20 includes a base21 to accommodate the rest of theneedle insertor10, adriver arm portion22 for coupling with one end of thedriver arm30, aguide structure23 for accommodating theneedle assembly40 and thecannula assembly50 and guiding the movement thereof, afirst rotator stand24 for accommodating thefirst rotator61, a second rotator stand25 for accommodating thesecond rotator62, and a stop member stand26 for accommodating thestop member80. Thebase21 includes aneedle opening27 for theneedle assembly40 andcannula assembly50 to pass through and exits outside thecase20. The base21 also includes a lockingmember28 for later fixing thecannula assembly50 on thebase21. Thecase20 also includes an activation member opening29 configured for an activation member (not illustrated) to pass through and interact with thestop member80 and then release therotator60. The interaction between the elements on thecase20 with the rest of theneedle insertor10 will be further explained later.
• In the present embodiment, thetorsion spring70 is accommodated in the space (illustrated inFIG.13) carved out of thefirst rotator61 and constantly exerts a rotational force on thefirst rotator61. Thefirst rotator61 andtorsion spring70 are both placed on thefirst rotator stand24.
• As illustrated inFIG.13, thestop member80 has afirst protrusion81 configured to be inserted into the opening of the stop member stand26 (illustrated inFIG.14) in order to couple thestop member80 with thebase21. However, thefirst protrusion81 is not fixed within the stop member stand26 and thestop member80 is rotatable with respect to the axis of thestop member stand26. Thestop member80 has asecond protrusion82 configured to couple with thefirst rotator61 in order to prevent therotator60 as a whole from being rotated by thetorsion spring70. As illustrated inFIG.13, thefirst rotator61 includes astop groove63 configured to accommodate thesecond protrusion82. As described above, thetorsion spring70 constantly applies rotational force on thefirst rotator60. Thesecond protrusion82 can absorb the rotational force and prevent thefirst rotator60 from rotating. Thestop member80 also has athird protrusion83 configured to be pushed in order to rotate thesecond protrusion82 in either a clockwise or anticlockwise direction. The purpose of thethird protrusion83 is to be rotated by user to subsequently rotate thesecond protrusion82 out of thestop groove63 in order to release thefirst rotator61. As described above, thecase20 also includes an activation member opening29 configured for an activation member (not illustrated) to pass through. The activation member can push thethird protrusion83 to rotate thesecond protrusion82 out of thestop groove63 so that therotator60 can be released and then rotated by thetorsion spring70.
• Thecase20 includes acontainer port91 with apiercer opening92 can be fitted with a piercer similar to thepiercer502 in the first embodiment. A medicament container can be inserted in thecontainer port91 to have its seal pierced so that the medicament within can flow through the piercer to reach the interior of case.
• Thefirst rotator61 andsecond rotator62 are meant to be coupled together so that the rotational force of thetorsion spring70 can rotate bothrotators61,62 simultaneously. Thefirst rotator61 has arotator opening66 and thesecond rotator62 has acorresponding rotator protrusion67 configured to be fitted into therotator opening66. The shape of both therotator opening66 androtator protrusion67 are not circular so that the rotational force from thetorsion spring70 can be transferred from thefirst rotator61 to the rotator protrusion64 and then thesecond rotator62 as a whole.
• In the present embodiment, onefirst portion31 of thedriver arm30 is rotatably coupled with thedriver arm portion22 of thecase20. Thefirst portion31 has an opening configured to be aligned with the two openings of thedriver arm portion22. Theconnection member90 is then fitted in the space of the three openings in order to couple thedriver arm30 with thedriver arm portion22. Also, theconnection member90, opening of thefirst portion31, and opening of the correspondingdriver arm portion22 preferably have circular shapes or other suitable shape in order for thefirst portion31 to be rotatably coupled with thedriver arm portion22.
• Thedriver arm30 further includes acam opening32 and thesecond rotator62 includes acam65 configured to be fitted within thecam opening32. As described above, the rotational force from thetorsion spring70 rotates both thefirst rotator61 andsecond rotator62. Thecam65 fitted inside theopening32 allows thesecond rotator62 to directly interact with thedriver arm30. In this way, the rotational force can be transferred from thecam65 to thedriver arm30. However, since thefirst portion31 is coupled with thebase21 of thecase20, the rotational force from thecam65 allows thecam65 to travel within thecam opening32 and will only pivot thedriver arm30 upward and downward. Thus, as long as thetorsion spring70 keeps therotator60 rotating, thedriver arm30 will continuously be pivoted upward and downward.
• Theintroducer needle40 includes aneedle portion41 and aneedle base portion42 located at one end of theneedle portion41. On the other hand, thedriver arm30 has asecond portion33 configured to grip thebase portion42. As thedriver arm30 is pivoted downward by the rotational force from therotator60, thesecond portion33 will drive thebase portion42 as well asneedle assembly40 as a whole downward toward the base20 so that theneedle portion41 can pass through theneedle opening27 on the base21 to initiate needle penetration.
• Thecannula50 includes acannula portion51 and acannula base portion52 located at one end of thecannula portion51. Thecannula base portion52 has afirst opening53 that allows theneedle portion41 of theintroducer needle40 to pass through. Thecannula portion51 is hollow inside and the space inside thecannula portion51 is connected to thefirst opening53 of thecannula base portion52. Also, theneedle portion41 is longer than thecannula portion51. Thus, theneedle portion41 of theneedle assembly40 can go all the way through thecannula portion51 so that its sharp end can emerge outside thecannula portion51. SeeFIG.15. As theneedle portion41 pass through thecannula portion51, thebase portion42 of theneedle assembly40 will abut thecannula base portion52 of thecannula50. Afterwards, the force moving theneedle assembly40 will be transferred to thecannula assembly50 and move theneedle assembly40 andcannula assembly50 together downward toward thebase21. Also, as illustrated inFIG.14, theguide structure23 is configured to accommodate the shape of thebase portion52 of thecannula50. Theguide structure23 has gaps corresponding to the three protrusions on thecannula base portion52. Thus, each of the protrusions is only allowed to move with the corresponding gap. The shape of the central passage of theguide structure23 also corresponds in shape to that of thecannula base portion52. The reason for theguide structure23 to have shapes corresponding to those of thebase portion52 is to ensure that theneedle assembly40 andcannula assembly50 remain at least substantially perpendicular to the base21 at all times. Also, thecannula base portion52 includes a second opening (not illustrated) configured to be connected with a medicament tube for medicament to pass through. The second opening is connected to thecannula portion51. Thus, the medicament passing through the second opening can enter thecannula base portion52, thecannula portion51, and eventually the injector site.
• As mentioned above, thecontainer port91 with a piercer allows a medicament container to be inserted to have its seal pierced so that the medicament within can flow through the piercer to reach the inside of case. A tube can be used to connect with the piercer and the second opening ofcannula base portion52. In this way, medicament within the container can flow through the piercer, tube,cannula base portion52, andcannula portion51 to eventually enter the injection site.
• Initially, thesecond protrusion82 of thestop member80 is located in thestop groove63 of thefirst rotator61 to absorbs the torsion spring’s forces and prevent therotator60 from rotating. Until thesecond protrusion82 moves out of thestop groove63, nothing will happen.
• Then, an activation member passes through theactivation opening29 of thecase20 to push thethird protrusion83 and rotate thesecond protrusion82 out of thestop groove63. The moment thesecond protrusion82 leaves thestop groove63, the forces of thetorsion spring70 will force thefirst rotator61 and thesecond rotator62 to start rotating. As thesecond rotator62 rotates,cam65 of thesecond rotator62 located inside thecam opening32 will transfer the forces to thedriver arm30 to press thedriver arm30 downward toward thebase21. Also, since thefirst portion31 of thedriver arm30 is fixed on thedriver arm portion22 of thecase20, thedriver arm30 as a whole will be pivoted relative to thedriver arm portion22. The forces on thesecond portion33 are transferred tobase portion42 of theneedle assembly40 and subsequently thecannula base portion52 of thecannula assembly50. The forces moves both theneedle assembly40 andcannula50 downward toward thebase21 and the two components are maintained perpendicular to thebase20 due the guidance of theguide structure23 surrounding the two components.
• Theneedle portion41 of theneedle assembly40 will pass through theneedle opening27 on the base21 to create an opening by piercing an injector site which is typically the user’s skin. Thecannula portion51 then follows theneedle portion41 and enters the injection site. Further, when thecannula base portion52 of thecannula50 reaches its lower position, it will substantially make contact with thebase21. The lockingmember28 on thebase21 will couple with thecannula base portion52 to fix thecannula base portion52 on thebase21 and thecannula portion51 at least partly within the injector site.
• The lockingmember28 of the present embodiment is similar to the lockingmember610 in the previous embodiment and has the shape of a hook. When thecannula assembly50 is pushed toward thebase21, itscannula base portion52 will push thelocking members28 outward in order to reach thebase21. As thecannula base portion52 reaches thebase21, the lockingmembers28 returns to their initial positions and respectively engages thecannula base portion52. The hook shape of lockingmembers28 ensures that thecannula assembly50 will not be brought back up later with theneedle assembly40 by thedriver arm30. In other words, thecannula assembly50 andneedle assembly40 will separate whendriver arm30 returns to its initial position.
• After theneedle portion41 passes through theneedle opening27 on thebase21, thetorsion spring70 continues to rotate therotator60 and thecam65 of thesecond rotator62 can continue to pivot thedriver arm30. Afterward, the forces from thetorsion spring70 will force thecam65 within thecam opening32 to pivot thedriver arm30 upward and away from thebase21. Since thesecond portion33 of thedriver arm30 is coupled with thebase portion42 of theneedle assembly40, thedriver arm30 will retract theneedle assembly40 back into thecase20.
• During this movement, theneedle portion41 is pulled out of the injection site and passes through the space within thecannula50 to create a clear passage from the second opening of thebase portion52 to the opening of thecannula portion51. In this way, the medicament can then flow through the second opening 55 and exit thecannula portion51 in order to enter the injection site for medicament injection. At this stage, theneedle insertor10 has accomplished its purpose of creating an opening on the injection site using theneedle assembly40, inserting thecannula50 into the injection site, and retracting theneedle assembly40 back into thecase20 in order to create a passage for medicament to flow through thecannula50 and enter the injection site.
• In the Figures, various engagement features for are shown for providing an engagement between one or more components of the drug delivery device. The engagement features may be any suitable connecting mechanism such as a snap lock, a snap fit, form fit, a bayonet, lure lock, threads or combination of these designs. Other designs are possible as well.
• It should be understood that the illustrated components are intended as an example only. In other example embodiments, fewer components, additional components, and/or alternative components are possible as well. Further, it should be understood that the above described and shown embodiments of the present disclosure are to be regarded as non-limiting examples and that they can be modified within the scope of the claims.
• While various aspects and embodiments have been disclosed herein, other aspects and embodiments will be apparent to those skilled in the art. The various aspects and embodiments disclosed herein are for purposes of illustration and are not intended to be limiting, with the true scope being indicated by the following claims, along with the full scope of equivalents to which such claims are entitled. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting.

Claims (20)

1. A needle insertor assembly for a medicament delivery device, comprising:

a case having a base comprising a needle opening and a driver arm portion;

a driver having a first part rotatably coupled to the driver arm portion, a cam opening and a second part extending outward from the cam opening;

a needle assembly comprising a base portion and a needle portion positioned substantially perpendicular to the needle opening;

a rotator having an axis of rotation arranged in the case and configured to interact with the first part of the driver for moving the driver;

an energy accumulation member configured to interact with the rotator for applying a rotational force on the rotator; and

a movable stop that engages with the rotator to prevent the rotator from rotating;

wherein the second part of the driver is engaged with the base portion of the needle assembly in a first position prior to rotation of the rotavator such that the needle assembly is held inside the case

wherein rotation of the rotator causes the second part to move to a second position where the needle portion is positioned outside the case after being moved to pass through the needle opening to pierce an injection site

wherein further rotation of the rotator moves the second part to a third position where the needle portion is retracted to position inside the case, and

wherein a rotational movement of the movable stop relative to the base and along an axial path that is perpendicular to the axis of rotation of the rotator disengages the movable stop from the rotator to allow the rotational force from the energy accumulation member to rotate the rotator along the axis of rotation causing the second part to move from the first position to the second position and to the third positions.

2. The needle insertor assembly ofclaim 1 further comprising a cannula assembly operatively associated with a guide structure position on the base.

3. The needle insertor assembly ofclaim 2, wherein the cannula assembly comprises:

a cannula base portion; and

a cannula portion substantially perpendicular to the needle opening and configured to enter the injection site as the second part moves from the first position to the second position such that the cannula portion is positioned in the injection site before the second part moves to the third position.

4. The needle insertor assembly ofclaim 3, wherein the cannula base portion includes a medicament input opening, the cannula portion and cannula base portion are hollow so that a medicament can pass through the medicament input opening, the cannula base portion, and exits through the cannula portion.

5. The needle insertor assembly ofclaim 3, wherein the cannula base portion is positioned between the base portion of the needle assembly and the needle opening such that the needle assembly interacts with the cannula base portion to move the cannula assembly toward the needle opening when the second part moves from the first position to the second position.

6. The needle insertor assembly ofclaim 1, wherein the movable stop comprises a first protrusion rotatably positioned on the base and a second protrusion configured to movably disengage from the rotator.

7. The needle insertor assembly ofclaim 1, wherein the movable stop comprises a third protrusion that when rotated relative to the base will cause a second protrusion configured to movably disengage from the rotator.

8. The needle insertor assembly ofclaim 1, wherein the movable stop comprises a protrusion rotatably movable from a first position engaged with the rotator to prevent rotation of the rotator to a second position disengaged from rotator to cause rotation of the rotator and movement of the second part of the driver from the first position to the second position.

9. The needle insertor assembly ofclaim 1, wherein the case further comprises an activation opening that provides access to the moveable stop.

10. The needle insertor assembly ofclaim 1, wherein the rotator comprises a first rotator and a second rotator.

11. The needle insertor assembly ofclaim 10, wherein the energy accumulation member rotates both the first rotator and the second rotator when the movable stop disengages from the rotator.

12. The needle insertor assembly ofclaim 10, wherein the second rotator has a cam.

13. The needle insertor assembly ofclaim 12, wherein the cam is engaged with the cam opening such that rotation of the rotator cause the driver to pivotally move relative to the driver arm portion.

14. The needle insertor ofclaim 10, wherein the base further comprises:

a first rotator stand configured to accommodate the energy accumulation member and the first rotator; and

a second rotator stand configured to configured to accommodate the second rotator.

15. The needle insertor assembly ofclaim 2 further comprising a locking member that fixes the cannula assembly to the base structure before the second part of the driver moves to the third position.

16. The needle insertor assembly ofclaim 1, wherein the needle portion is positioned within the cannula portion when the second part is in the first and second positions and the needle portion is not positioned within the cannula portion when the second part is in the third position.

17. The needle insertor assembly ofclaim 3, wherein the cannula base portion is positioned between the needle assembly and the injection site end, the needle assembly interacts with the cannula base portion to move the cannula assembly toward the injection site end when the first part moves from the first position to the second position.

18. The needle insertor ofclaim 1, wherein the base further comprises:

a container port for accommodating a medicament container;

a piercer coupled with the container port for piercing the medicament container;

a medicament path assembly coupled with the base, the medicament path assembly having a first end connected to the piercer and a second end connected to the cannula assembly;

wherein a medicament can flow from the medicament container through the piercer and the medicament tube assembly to enter the cannula assembly.

19. A medicament delivery device comprising:

the needle insertor assembly as claimed inclaim 1; and

a container port comprising a piercer positioned perpendicular to the needle portion.

20. A needle insertor assembly for a medicament delivery device, comprising:

a case having a base comprising a needle opening and a driver arm portion;

a driver having a first part pivotally coupled to the driver arm portion, a cam opening and a second part extending outward from the cam opening;

a needle assembly comprising a base portion engaged with the second part and a needle portion positioned substantially perpendicular to the needle opening;

a first rotator operatively and a second rotator and sharing a common axis of rotation, where the second rotator comprises a cam slidably engaged in the cam opening such that rotation of the first and second rotators causes movement of the driver;

an energy accumulation member configured to interact with the first rotator for applying a rotational force to both the first and the second rotators; and

a rotatable stop comprising a first protrusion, a second protrusion and a third protrusion, where the second protrusion engages with the first rotator to prevent the rotators from rotating;

wherein the second part of the driver comprises a slot that is slidably engaged with the base portion of the needle assembly in a first position prior to rotation of the rotavator such that the needle assembly is held inside the case

wherein rotation of the first rotator causes the second part to move to a second position where the needle portion is positioned outside the case after being moved to pass through the needle opening to pierce an injection site

wherein further rotation of the first rotator moves the second part to a third position where the needle portion is retracted to position inside the case, and

wherein a rotational movement of the third protrusion of the movable stop about the first protrusion relative to the base disengages the second protrusion from the first rotator to allow the rotational force from the energy accumulation member to rotate the rotators along the axis of rotation causing the second part to move from the first to the second positions.

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