Patent Publication Number: US-2016228635-A1

Title: Disposable inserter for use with a medical device

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     The present application is a continuation application of U.S. patent application Ser. No. 14/562,881, filed on Dec. 8, 2014, which is a continuation application of PCT patent application no. PCT/EP2013/001685, which has an international filing date of Jun. 8, 2013 and claims priority to U.S. Provisional Patent Application No. 61/657771, filed on Jun. 9, 2012. The present application incorporates herein by reference the disclosure of each of the above-referenced applications in their entirety. 
    
    
     TECHNICAL FIELD 
     The present invention relates to inserters, and more particularly to systems and methods for use with a medical device. 
     BACKGROUND 
     Medical treatment of several illnesses/conditions requires drug infusion into various body compartments, for example, through subcutaneous and/or intra-venous injections. Patients suffering from Diabetes Mellitus (DM), for example, require the administration of varying amounts of therapeutic fluid, e.g., insulin, throughout the day to control their blood glucose levels. In recent years, ambulatory portable insulin infusion pumps have emerged as an alternative to multiple daily syringe injections of insulin for Type 1 diabetes patients (see, for example, Diabetes Medicine 2006; 23(2) 141-7) and subsequently for Type 2 diabetes patients (see, for example, Diabetes Metab 2007 Apr. 30 and Diabetes Obes Metab 2007 Jun. 26). Such pumps, which deliver insulin at a continuous and/or periodic basal rate as well as in bolus volumes, were developed to liberate patients from having to perform repeated self-administered injections, and to enable them to maintain a near-normal daily routine. Both basal and bolus volumes/doses have to be delivered in substantially precise doses, according to individual prescription, because an overdose or under dose of insulin could prove fatal. 
     SUMMARY 
     According to at least one embodiment of the present disclosure, a disposable inserter and method of use are disclosed. The disposable inserter in at least one embodiment is configured to be received by a skin adherable cradle for supporting an insulin pump. The exemplary disposable inserter comprises a housing comprising a cannula assembly and an insertion mechanism, two buttons concomitantly actionable for actuation of the insertion mechanism, wherein the insertion mechanism is configured to place a cannula assembly in a well disposed on the cradle; and a first part and second part, whereby the first part includes a handle and the second part comprises the entire insertion mechanism, whereby the first and second part are connected via an indentation. 
     In at least one embodiment of the inserter, the insertion mechanism comprises insertion and retraction springs, the springs being maintained in the housing by two latches aligned with holes disposed in the housing. 
     In at least one embodiment of the inserter, the inserter further comprises a protective ring which is put on the cylindrical portion of the inserter, the protective ring configured to cover the entire surface area of the two buttons. The two buttons, in at least one embodiment, are designed as torsion snap fit, whereby the torsion bar is a part of the housing. Upon actuation of the two buttons, in at least one embodiment, the buttons are tilted and the insertion spring is allowed to expand and pushes the entire mechanism assembly downwards to insert the cannula into the skin and the cannula assembly into the cradle well. 
     In at least one embodiment of the inserter, the springs are preloaded. 
     In at least one embodiment of the inserter, the inserter comprises feedback elements indicating the status of the inserter whereby a visible green protective ring indicates the inserter is unused and a visible red slider or parts of it indicate the inserter is used. 
     In at least one embodiment of the present disclosure, a method of inserting a cannula into a body is disclosed. The method, in at least one embodiment, comprises: placing an inserter base of an inserter on a skin adherable cradle adapted to receive a micropump, the inserter comprising a cannula assembly comprising a cannula; removing a protective ring preventing unintentional pressing of buttons on the inserter, the buttons configured to trigger an insertion mechanism; triggering the insertion mechanism by pressing concomitantly the buttons, the buttons being located on the two sides of the cylindrical portion of the inserter, the insertion mechanism inserting the cannula assembly into a well located in the cradle and further inserting the cannula of the cannula assembly into the body; and disconnecting the inserter from the cradle after insertion of the cannula 
     In at least one embodiment of the method, the method further comprises connecting a pump to the cradle, the connecting step comprising pricking a septum of the cannula assembly with a connecting lumen provided with the micropump. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the present disclosure may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of embodiments of the present disclosure, and together with the description serve to explain the principles of the present disclosure; it being understood, however, that this invention is not limited to the precise arrangements shown. 
         FIG. 1 a    illustrates the placing of the inserter and cradle on the user&#39;s skin in a chosen insertion site (e.g., lower abdomen, lower back, thigh or upper arm), according to at least one embodiment of the present disclosure. 
         FIG. 1 b    illustrates the removal of a protective ring before insertion, according to at least one embodiment of the present disclosure. 
         FIG. 1 c    illustrates the initiation of the insertion of a cannula via pressing on two buttons, according to at least one embodiment of the present disclosure. 
         FIG. 1 d    illustrates the disconnection of the inserter from the cradle after cannula insertion, according to at least one embodiment of the present disclosure. 
         FIG. 1 e    illustrates disposal of the inserter after cannula insertion is completed, according to at least one embodiment of the present disclosure. 
         FIG. 2  illustrates an exploded view of the inserter, according to at least one embodiment of the present disclosure. 
         FIG. 3 a    illustrates a perspective view of the mechanism assembly, according to at least one embodiment of the present disclosure. 
         FIG. 3 b    illustrates an exploded view of the mechanism assembly, according to at least one embodiment of the present disclosure. 
         FIGS. 4 a  and 4 b    illustrate perspective views of a slider part, including its various features/elements, according to at least one embodiment of the present disclosure. 
         FIG. 5 a    illustrate a cross section view of the inserter in a loaded position (e.g., upon initiation of insertion), according to at least one embodiment of the present disclosure. 
         FIG. 5 b    illustrates an enlarged view of the pressing of the buttons and showing the support and release of the slider, according to at least one embodiment of the present disclosure. 
         FIG. 5 c    illustrates the inserter when the cannula is inserted and the slider latches are fixed/engaged in the housing holes/grooves, according to at least one embodiment of the present disclosure. 
         FIG. 5 d    illustrates the retraction of the needle assembly, while the slider is fixed/in place, according to at least one embodiment of the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Usage of an infusion device (e.g., insulin pump, insulin micropump) may require the adherence of a cradle to the user&#39;s skin and the insertion of a cannula into the body. The insertion of the cannula is performed by inserting a cannula assembly into a well which is located in the cradle. The cradle can be adhered to the skin via an adhesive layer which is attached to the bottom surface of the cradle. In order to insert the cannula assembly to the skin and to snap it into the well, an insertion device may be required.  FIGS. 1 a -1 e    illustrates exemplary steps (e.g., five steps) of insertion that a pump user may perform in order to prepare the infusion system for pump connection, and drug (e.g., insulin) delivery. 
       FIG. 1 a    illustrates a step in which the disposable inserter  300  is placed at the user&#39;s skin, when the protective ring  390 , which prevents unintentional pressing of the buttons (not shown) and undesirable insertion of the cannula, is still placed on the inserter, as safety means. The adherence of the inserter is done, while the cradle  20  is firmly fixed to the inserter  300 . The user holds the entire assembly, that is, the disposable inserter and cradle by the handle  302 , protruding from the cradle. The inserter is pre-loaded, therefore the user does not have to load the cannula or to insert a cannula into the inserter  300 . 
       FIG. 1 b    shows the stage of preparing the inserter for insertion stage. This stage can be performed either when the inserter is already adhered to the user skin or prior to adherence. However, placing the device with the protective ring  390  is recommended to avoid insertion due to an unintentional press. The figure shows the user pulling the protective ring  390  upwards sliding it from the cylindrical portion of the disposable inserter  300 . 
       FIG. 1 c    shows the user pressing both buttons  304  located on the two sides of the cylindrical portion of the inserter  300 . The buttons in additional embodiments can be located at any part of the inserter  300 , or cradle. Pressing both buttons, initiates the insertion of the cannula into the skin. The user must press both buttons concomitantly, in order to perform insertion. This is a safety means, to avoid unintentional insertion, in case only one button  304  is pressed. The cradle  20  and the inserter fixed to it  300 , are adhered to the skin when the user presses the buttons  304 . 
       FIG. 1 d    shows the user releasing the disposable inserter  300 , after insertion has been performed. The cannula assembly  330  was inserted into the well  22  protruding from the cradle  20 . At this stage the cannula  332  made out of Teflon®, or any other bio-compatible material, is located within the skin, and the septum  334  is parallel to the upper plane of the well, allowing the connection of the micropump (not shown), and the receiving of a connecting lumen to deliver insulin from the pump into the skin via the cannula  332 . The user releases the inserter from the cradle, by pulling the handle  302 , upwards. A geometrical indentation  306 , is designed to allow the inserter release only when the user pull the inserter up, by having a deflection upwards, folding the two parts of the inserter base  308 , to release both ends of the inserter base  308  from the snaps of the cradle  309  and  309 ′. At this point, the entire insertion mechanism resides in the cylindrical portion of the inserter  300 . 
       FIG. 1 e    shows that the user disposes the inserter, which was released in  FIG. 1 d    into a special can for needle and inserters. The disposable inserter, when disposed has no loaded mechanisms within, there for the risk of needle pricking after insertion is reduced. Disposing the inserter, and using a new inserter, and the fact that the inserter is pre-loaded, allows the user not to deal with loading needle, and cannulas. This is a major advantage as far as risk of needle pricking. 
       FIG. 2  shows an exploded view of the disposable insertion system, that is the disposable inserter  300  and the cradle  20 . The figure shows the assembly of the different parts and subassemblies of the device. The inserter base  311  is located between the peripherals of the cradle  20 . It is fixed at least 4 points of contact in order to allow a robust connection. The mechanism assembly  3000  which includes the needle assembly, retraction spring, and cannula assembly is assembled together and is put through the inner diameter of the cylindrical portion of the inserter  300 . In order to allow the mechanism to function properly as will be explained further the two red slider latches  332  and  332 ′ (not shown) are aligned with the housing holes  308  and  308 ′(not shown). They will allow the positioning of the red slider  330  after insertion and neutralize the insertion spring, and release the retraction spring, so that the insertion needle retraction will take place. The insertion spring  320  is placed on the upper protrusions of the red slider  338  and on the other end it is connected to the cork  370 . After the inserter is closed by the cork  370 , with all the components of the mechanism within, the protective ring  390  is put on the cylindrical portion of the inserter  300 , so that it covers the entire surface area of the pressing buttons. 
       FIG. 3 a    shows the mechanism assembly  3000  after assembly. The needle insertion  336  goes through the cannula  322  and picks outside, so that insertion will be flawless. The entire cannula assembly  3300  is in contact with the red slider  330 . The cannula cover and septum, which define the upper plane of the cannula assembly  3300  are tangent to the lower plane of the red slider  330 . The cannula assembly  330  is held on the insertion needle  336  due to friction forces. During assembly, and when resides in the housing prior to insertion, the two red slider latches must be pushed inwards, as shown by the arrows in the figure , in order to hold the needle assembly (not shown) and the retraction spring (not shown) which are in a loaded position within the red slider  330 . 
       FIG. 3 b    shows an exploded view of the mechanism assembly  3000 . The mechanism assembly includes the cannula assembly  3300 , needle assembly  338  and retraction spring. The needle assembly composing the needle hub  337  and the insertion needle  336  is sliding through the red slider  330 , while the retraction spring  340 , is concentric to the needle assembly  338  symmetric axis. When assembled, the red slider latches must be in an opened position to allow the needle hub  337  to go through the inner diameter of the red slider until the red slider latches  332  and  332 ′ can hold the insertion assembly  338  in the indent diameter  337 ′ of the needle hub  337 . In this position the retraction spring  340  is connected on one end to the bottom surface of the red slider  330  and to the bottom surface of the needle hub  337 , and it is in a loaded position wanting to expand and retract the needle. 
       FIG. 4 a    shows the red slider part  330  with its features. The red slider latches  332  and  332 ′ are the ones which are holding the needle assembly  338  and the insertion spring  340  loaded during the insertion. This is done by a force exerted inwards. The red slider latches retract and deflected outwards when they arrive to the height where the housing holes (not shown) are located. This fixes the red slider  330  in place and holding the insertion spring in a free state. And allows the retraction spring  340  to retract and pull the needle assembly  338  from the user&#39;s skin. The deflection of the red slider latches  332  and  332 ′ is allowed due to the through hole  339  of the red slider  330 . The bulges  333  and  333 ′ are aiding the grip of the red slider latches in the housing holes when insertion ended and cannula assembly is in the well. The protrusions of the red slider  383 , are supports for the insertion spring  320 . The indent  331  is to allow the press buttons  304  to be deflected with no interference. 
       FIG. 4 b    shows the inner volume of the red slider  330 . The insertion needle  336  can go through the red slider through a hole  342  and then the cannula assembly  3300  can be connected. Indent  341  is a dedicated support for the retraction needle  340  in the red slider  330  while in a loaded state. 
       FIG. 5 a    shows a cross section view of the inserter  300  in a loaded position. This state is prior to insertion initiation. The user presses both buttons  304  and  304 ′ in order to insert the cannula into the skin. Exerting force on the buttons, will tilt the buttons. The buttons  304  and  304 ′ are designed as torsion snap fit, which its torsion bar is a part of the housing  380 . Before the user press the buttons, the mechanism assembly and the red slider  300  in particular rests on the two protrusion snaps  3041  as shown in  FIG. 5   b.  When the user exert force, the buttons tilt and allow the insertion spring  320  to expand and to push the entire mechanism assembly downwards to insert the cannula into the skin and the snap the cannula assembly  3300  into the cradle well  22 . In order to prevent interference of the buttons with the mechanism, more specifically, to contact the insertion spring  320 , a protective wall  371  was design in the cork  370  to limit the motion and deflection of the buttons  304  and  304 ′. 
       FIG. 5 c    shows the inserter  300 , in the insertion phase. The cannula assembly  3300  is inserted into the cradle well  20 . The buttons  304  and  304 ′ were pressed and the red slider  330  moved downwards due to the insertion spring  430  which pushed the mechanism assembly down. The red slider latches  332  and  332 ′ are fixed in the housing holes  308  and  308 ′ using the bulges  333  and  333 ′ we described in  FIG. 4 a   . In this state, both the cannula  322  and the insertion needle  336  are inserted to the skin. The design determines that in this state the insertion spring is in its free state and it is neutralized both by the red slider latches  332  and  332 ′ fixed in the housing holes  308  and  308 , and due to the design of spring selection. 
       FIG. 5 c    shows the retraction phase. The cannula  322  is inserted and the cannula assembly  3300  is fixed in the cradle well  22 . However the needle assembly  338  is retracted automatically. The fixation of the two red slider latches  332  and  332 ′ in the housing holes  308  and  308 ′ due to their aspiration to return to their initial state and shape in which they were manufactured, releases the grip the two red slider latches  332  and  332 ′ held to the needle hub  337 . Therefore, the retraction spring  340  expands and pushes the needle assembly  338  upwards, retracting the needle from the user&#39;s skin and cannula volume  22 . The design will take a safety factor to the retraction displacement to make sure that a full retraction was operated. In this state both the retraction spring  340  and insertion spring  320  are in a free state. After this operating step of retraction, the user can disconnect the inserter  300  from the cradle  20  and continue according to  FIG. 1 d   - 1   e,  as depicted. 
     There is disclosed a disposable inserter adapted to be received by a skin adherable cradle for supporting an insulin pump, the disposable inserter comprising: a housing comprising a cannula assembly and an insertion mechanism; two buttons concomitantly actionable for actuation of the insertion mechanism, wherein the insertion mechanism is adapted to place a cannula assembly in a well disposed on the cradle. 
     In at least one embodiment, the insertion mechanism comprises insertion and retraction springs, the springs being maintained in the housing by two latches aligned with holes disposed in the housing. 
     In at least one embodiment, the disposable inserter further comprises a protective ring  390  which is put on the cylindrical portion of the inserter  300 , so that to cover the entire surface area of the two buttons. 
     In at least one embodiment, the buttons are designed as torsion snap fit, whereby the torsion bar is a part of the housing. 
     In at least one embodiment, upon actuation of the buttons the buttons are tilted and the insertion spring  320  is allowed to expand and to push the entire mechanism assembly downwards to insert the cannula into the skin and the cannula assembly  3300  into the cradle well  22 . 
     In at least one embodiment, the springs are preloaded. 
     In at least one embodiment, the disposable inserter comprises two parts whereby the first part includes a handle and the second part comprising the entire insertion mechanism whereby the first and the second part are connected via an indentation 
     In at least one embodiment, the disposable inserter comprises feedback elements indicating the status of the inserter whereby a visible green protective ring indicates the inserter is unused and a visible red slider or parts of it indicate the inserter is used. 
     There is disclosed a method of inserting a cannula into a body, comprising the steps of: placing an inserter base  308  of an inserter  300  on a skin adherable cradle adapted to receive a micropump, the inserter comprising a cannula assembly comprising a cannula ; removing a protective ring  390  preventing unintentional pressing of buttons triggering a insertion mechanism ; triggering the insertion mechanism by pressing concomitantly two buttons  304  and  304 ′, the buttons being preferably located on the two sides of the cylindrical portion of the inserter  300 , the insertion mechanism inserting the cannula assembly into a well located in the cradle and further inserting the cannula of the cannula assembly into the body ; disconnecting the inserter  300  from the cradle  20  after insertion of the cannula (by pulling upwards a handle  302 ). 
     In at least one embodiment, the method further comprises the step of connecting a pump to the cradle, the connection pricking a septum  334  of the cannula assembly with a connecting lumen  102  provided with the micropump. 
     There is disclosed an inserter comprising two parts whereby the first part includes a handle and the second part comprising the entire insertion mechanism whereby the first and the second part are connected via an indentation 
     There is disclosed an inserter comprising feedback elements indicating the status of the inserter whereby a visible green protective ring indicates the inserter is unused and a visible red slider or parts of it indicate the inserter is used.
       336  Insertion needle     337  Needle hub     338  Needle assembly     330  Red slider     311  inserter base     3000  Mechanism assembly     370  Cork     332  and  332 ′ Red slider latches     308  and  308 ′ Housing holes     383  Protrusions of red slider     304  Pressing buttons     322  Cannula     3300  Cannula assembly     337 ′ Indent diameter of needle hub     340  Retraction spring