• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    set of needles for drug pump. a set of needles adapted for fluid communication with a cartridge containing a substance to be distributed to an individual, the set of needles characterized by a pusher (70) arranged to apply a pusher force on a needle (28, 116) to causing the needle (28, 116) to protrude out of a housing (30, 112) to pierce the subject, and the pusher release device (60) including a pusher limiter (62), which initially blocks the movement of the drive device (70) and which releases the drive device (70) when the safety lock (32, 122) moves to a position that allows the needle holder (26, 118) to be moved, to cause the needle (28, 116) to protrude out of the housing (30, 112).
    公开号:BR112012017833B1
    申请号:R112012017833-4
    申请日:2011-01-19
    公开日:2020-09-15
    发明作者:Oz Cabir
    申请人:Medimop Medical Projects Ltd；
    IPC主号:
    专利说明:

    Field of the Invention
    [001] The present invention generally relates to external drug pumps, and particularly a set of needles for a drug pump, particularly suitable for elderly, disabled or physically impaired people. Summary of the Invention
    [002] External drug pumps are typically used to deliver substances to patients, which contain large molecules that cannot be digested when administered orally, such as insulin. Typically, the pump is attached to the patient's abdomen and delivers the substance to the patient via a cannula or needle that is inserted into the patient's skin.
    [003] Patent Application No. 12/245818 filed on December 30, 2008, and Patent Application PCT / US09 / 69552, filed on December 27, 2009, for the same inventor, describes a set of needles for administer a drug from a vial. (The terms "drug" and "substance" are used interchangeably throughout the specification and claims, and cover any materials administered to an individual. The term "cartridge" throughout the specification and claims covers any container for a drug , such as, but not limited to, a cartridge, vial, syringe, bottle, ampoule and many others, and is not limited to any size or shape). The needle set includes a needle held in a needle holder, and an activation mechanism to activate the delivery of the substance through the needle, such as a push button that initiates the delivery of the substance. The activation mechanism includes a safety lock that prevents the needle from accidentally stinging a person and prevents inadvertent administration of the drug. The safety lock initially prevents movement of the needle holder. When the security lock is placed on the subject, the security lock moves to a position that allows the needle holder to move to cause the needle to protrude out of the housing to pierce the subject, to allow the delivery of the substance on the individual.
    [004] A problem with this set of needles in the prior art is that the elderly, disabled or physically impaired people may find it difficult to push the pressure button to activate the distribution of the substance. Summary of the Invention
    [005] The present invention seeks to provide a set of needles for a drug pump, particularly suitable for the elderly, disabled or physically impaired, thereby solving the problem of the prior art, as described in greater detail hereinafter.
    [006] A set of needles adapted for fluid communication with a cartridge containing a substance to be distributed to an individual, the set of needles including a needle attached to a needle holder, is then provided according to one embodiment of the present invention. , the needle holder confined to move in a wrapper, and an activation mechanism to activate the distribution of the substance through the needle, the activation mechanism including a safety lock that initially prevents movement of the needle holder, where when the security lock is placed on the individual, the security lock moves to a position that allows the needle holder to be moved to cause the needle to protrude out of the housing to pierce the individual to allow the administration of the substance to the individual .
    [007] According to an embodiment of the present invention, the security lock is pivotally mounted on a base around a pivot. The safety lock can be arranged to selectively pivot in and out of a complementary shaped groove formed at the base.
    [008] In accordance with an embodiment of the present invention, the safety lock includes a first fastener at a distal end thereof and a second fastener proximal to and spaced from the first fastener, the first and second fasteners arranged to selectively lock the movement of the needle holder.
    [009] According to an embodiment of the present invention, the safety lock initially prevents the movement of the needle holder because it is in a position where the first fastener is propped against an ear that protrudes from the bottom of the holder of the needle, thereby arresting the movement of the needle holder.
    [0010] In accordance with an embodiment of the present invention, a control button having an axis is provided. An inclined tongue protrudes from a periphery of the axis at a lower end of the axis. When the safety lock is placed on the individual and the control button is moved, the tilted tongue employs a force against a ramp formed in the needle holder, thus making the needle holder move and rotate as that the needle moves away from the wrapper. The needle holder can rotate sufficiently so that the ear is held by the second clip. Moving the safety lock away from the subject causes the second fastener to move away from the ear and cause the needle holder to continue to rotate due to the tilted tongue still using a force on the ramp. The needle holder rotates until the tilted tongue moves away from the ramp, after which the needle holder moves so that the ear is attached to a shoulder formed in the envelope, thereby trapping the needle in the envelope.
    [0011] According to an embodiment of the present invention, when the control knob is moved so that the inclined tongue employs the force against the ramp, the control knob is locked in the housing. Brief Description of Drawings
    [0012] The present invention will be understood and appreciated more fully from the following detailed description taken in conjunction with the drawings in which: Figure 1 is a simplified illustration of the apparatus for administering a substance to an individual, from the prior art ( Patent Application No. US 12/345818 or PCT Patent Application No. PCT / US09 / 69552); Figure 2 is a simplified illustration of a safety lock for the prior art device in the down position, this being the nominal (initial) position as long as the device has not yet been placed on the user's body, and a needle holder cannot be pushed down; Figure 3 is a simplified illustration of the prior art security lock in the up position, which is the position when the device was placed on the user's skin; Figure 4 is a simplified illustration for raising the prior art apparatus away from the patient's body after completing drug delivery, which causes the safety lock to move back to the down position; Figure 5 is a simplified illustration of the prior art needle holder that moves back upwards and is stopped in the up position with the needle retracted back into the apparatus casing; Figure 6 is a simplified illustration of the polarization device delivery apparatus used in administering a substance to an individual, constructed and operative in accordance with an embodiment of the present invention; Figure 7 is a simplified illustration of a safety lock on the device for releasing the polarization device of Figure 6 in the up position, which is the position when the device was placed on the user's skin; Figure 8 is a simplified illustration of an actuator that moves a bias device holder out of a housing so as not to block a bias device that can cause the device needle to pierce the patient's skin, according to a embodiment of the present invention; Figure 9 is a simplified illustration of the polarizing device that urges the needle into a piercing position, according to an embodiment of the present invention; e Figure 10 is a simplified illustration of the polarization device release device lifted away from the patient's body after finishing the drug administration, which causes the safety lock to move back to the down position and the needle be retracted back into the casing. Figures 11A and 11B are illustrations of simplified views of the polarization device delivery device employed in another device (drug pump) to deliver a substance to an individual, constructed and operative in accordance with an embodiment of the present invention. Figure 12 is a simplified illustration of the interior of the apparatus in the position of Figures 11A-11B; Figures 13A and 13B are simplified perspective illustrations of the apparatus of Figures 11A-11B, in a second stage, after application of the apparatus on the patient's body, according to an embodiment of the present invention; Figure 14 is a simplified illustration of the interior of the apparatus in the position of Figures 13A-13B; Figure 15 is a simplified perspective illustration of the apparatus of Figures 11A-11B, in a third stage, in which the needle protrudes out of the pump and is inserted into the body, according to an embodiment of the present invention; Figure 16 is a simplified illustration of the interior of the apparatus in the position of Figure 15; Figures 17A and 17B are simplified perspective illustrations of the apparatus of Figures 11A-11B, in a fourth and final stage, after removing the apparatus from the patient's body, in which a protector blocks the needle after use, according to one modality of the present invention; and Figure 18 is a simplified illustration of the interior of the apparatus in the position of Figures 17A-17B. Detailed Description of the Modalities
    [0013] Reference is now made to Figure 1, which illustrates the apparatus 10 for administering a substance, for example, insulin, to an individual, from the prior art (Patent Application No. US 12/345818 or PCT Patent Application) PCT / US09 / 69552).
    [0014] A cartridge 12 (also called a vial, the terms being used interchangeably) is mounted on a base of the housing 14. For some applications, a mechanism for perforating the cartridge 18 is movable (ie rotating) ) coupled to the base of the casing 14 and pierces the distal end of the cartridge 12. The substance to be administered flows from the cartridge 12 to an activation mechanism 20 via a tube (not shown). The activation mechanism 20 has a control button 22 and is typically coupled to the base of the housing 14. The activation mechanism 20 is configured to insert a cannula and / or a needle through the subject's skin and to deliver the substance via the cannula. and / or the needle. The modalities of the invention are described with reference to a needle alone, but also apply to a needle arranged in a cannula or any other delivery device. The term "needle" is used throughout the specification and claims to cover all said delivery devices.
    [0015] Device 10 typically includes a motor, a battery and a control unit (all not included). After the needle has penetrated the patient's skin, the control unit controls the operation of the engine to deliver a controlled amount of the substance to the patient at a controlled rate of delivery. Of course, the needle set of the present invention can be used in other applications and does not need to be used with a controlled motorized delivery system.
    [0016] Reference is now made to Figures 2 and 3, which illustrate a safety lock of the prior art. The control button 22 has an axis 24 which is arranged to move (vertically downwards in the direction of the drawings) against a needle holder 26 (Figure 3) that holds a needle 28. The axis 24 and the needle holder 26 are the two confined to move in a wrapper 30 (ie tubular), but there is a difference in their movements. Axis 24 is confined to translate downward into housing 30 with no rotation. In comparison, the needle holder 26 can not only translate but can also rotate in the casing 30, as will be explained in more detail below.
    [0017] The movement of the needle holder 26 is selectively prevented by a safety lock 32, which is pivotally mounted on the base of the housing 14 around a pivot 34. The safety lock 32 is arranged to selectively pivot inwards and out of a complementary shaped groove 37 (Figure 1) formed at the base of the housing 14. The safety lock 32 includes a first fastener 36 at a distal end thereof and a second fastener 38 proximal to and spaced from the first fastener 36 The fasteners can be in the shape of wings or other projections or any other suitable structure to secure the movement of the needle holder 26 as will be explained below.
    [0018] Figure 2 shows the safety lock 32 in the down position, which is its nominal (initial) position since the device 10 has not been placed on the user's body. In this position, the first fastener 36 rests on an ear 40 that protrudes from a lower part of the needle holder 26. It should be noted that pushing the ear 40 down against a surface 42 of the first fastener 36 will not cause movement down the needle holder 26 because this will simply pivot the first fastener 36 around the pivot 34 causing another surface 44 of the first fastener 36 to score against the bottom surface of the housing 30. So when the safety lock 32 is in the down position, the needle holder cannot be pushed down (in the direction of the drawing, of course).
    [0019] Figure 3 shows the safety lock 32 in the up position (that is, it pivoted up around the pivot 34), which is in the position when the device 10 was placed on the user's skin. The first fastener 36 has been moved away from the ear 40 of the needle holder 26, so that the control button 22 can now be pressed down to move the needle holder 26 down, thereby piercing the patient's skin. Needle 28 remains inserted in the patient for the duration of the drug administration. Pressing the control button 22 down causes the axis 24 to become locked in the down position in the housing 30, such as by means of one or more grooves (not shown here), which project radially outwardly from axis 24, sliding through one or more beveled resilient tongues (not shown here) mounted in housing 30. After the slots have slid through tongues, the slots become resiliently locked in place by snapping back into their place on them.
    [0020] After finishing the administration of the drug, the device 10 is pushed out of the patient's body. This causes the safety lock 32 to move back to the down position as shown in Figure 4, thereby moving the second fastener 38 out of the ear 40. A polarizing device 47, such as a polarized leaf spring between the first fastener 36 and the base of the enclosure 14, they can be used to provide a return force on the safety lock 32 to move it back to the down position. An inclined tongue 50 applies a downward force on the ramp 52, thus allowing the needle holder 26 to rotate counterclockwise until the inclined tongue 50 slides off the ramp 52. At this point, the needle holder 26 jumps back up and ear 40 is attached to a shoulder 54 formed in wrapper 30 as shown in Figure 5. In this position, needle holder 26 does not move back down because of ear 40 that is attached against the shoulder 54. Consequently, the needle 28 is trapped back inside the apparatus 10 in a safe position, and the apparatus 10 can be safely discarded.
    [0021] Reference is made to Figure 6, which illustrates the apparatus for releasing the polarization device 60 to administer a substance to an individual, constructed and operative in accordance with an embodiment of the present invention. The elements of the present invention that are identical or equivalent to the elements described above for the prior art are designated with the same reference numerals.
    [0022] As previously described, in the prior art apparatus, after drug administration, the needle holder 26 retracts back into the casing 30 by the action of the counterclockwise rotation and the ear 40 which is attached to the shoulder 54 formed in housing 30. In the present invention, this same arrangement can be used. Alternatively or additionally, a polarizing device 59, such as a coil spring, can be used to retract the needle holder 26 back into the casing 30 after drug administration. The polarizing device 59 is arranged to apply an inciting force on the needle 28 in the direction of the arrow 57 (upwards in the direction of the drawings).
    [0023] With the polarization device release device 60, the user does not have to apply a force for the mechanical operation of the device. Instead, there is no control button to push down, or alternatively the control button can be touch sensitive or operated with light pressure, and a bias device 70, such as a coil spring, is released to push down needle 28 as described below. The bias device 70 is stronger than the bias device 59. The bias device 70 is arranged to apply an inciting force on the needle 28 in the direction of the arrow 71 (downwards in the direction of the drawings).
    [0024] The apparatus 60 includes a holder of the polarizing device 62, such as a tongue or mounted as a tooth on an axis 63, and enters the housing 30 through an opening 64. An actuator 66 is provided to move the holder of the device polarization 62. For example, actuator 66 can be, without limitation, a stepper motor, linear actuator, solenoid and the like. In the illustrated non-limiting embodiment, actuator 66 is a stepper motor that turns a drive gear 68 that mixes with a spur gear 72 mounted on shaft 63. The bias device holder 62 can be screwed onto a threaded part 74 of shaft 63.
    [0025] A security lock position sensor 76 is provided to sense when security lock 32 moves to the upward position of Figure 7. The security lock position sensor 7 6 can be, without limitation, a tuning fork or any other type of switch or sensor suitable for sensing the movement of the safety lock 32 to the up position. The safety lock position sensor 76 is in communication with a controller 78, which controls the position of the actuator 66. As mentioned above, the prior art apparatus 10 typically includes a motor, a battery and a control unit. Actuator 66 can be the same motor and controller 78 can be that same control unit, or they can be separate units.
    [0026] Figure 6 shows a safety lock 32 in the down position, which is its nominal (initial) position as long as the drug delivery device has not yet been placed on the user's body, which corresponds to Figure 2 prior art. As described above, in this position, the needle holder 26 cannot be pushed down (in the direction of the drawing). In the present invention, in this position, the holder of the bias device 62 is within the housing 30 and blocks the bias device 70, preventing it from pushing the needle 28 downwards.
    [0027] Figure 7 shows a safety lock 32 in the up position (which corresponds to Figure 3 of the prior art), which is in the position when the drug delivery device was placed on the user's skin. The safety lock position sensor 76 senses the movement of the safety lock 32 to the up position and the signal controller 78 that the safety lock 32 is now in the up position. Controller 78 starts actuator operation 66 there. In a preferred embodiment, controller 78 initiates actuator operation 66 after a predetermined time delay (for example, 5 to 15 seconds) to ensure that the drug is actually placed on purpose on the patient to administer the drug.
    [0028] When actuated, actuator 66 moves the holder of polarization device 62 out of opening 64, as shown in Figure 8. In the illustrated non-limiting mode, actuator 66 rotates drive gear 68, which in turn rotates spur gear 72 to rotate shaft 63. Rotating shaft 63 causes the catch of the bias device 62 to move linearly out of the opening 64 along the threaded part 74. When the catch of the bias device 62 reaches the end of the threaded part 74, it rotates freely on the axis 63 and no longer moves.
    [0029] As soon as the holder of the polarization device 62 has moved out of the opening 64, the polarization device 70 is no longer blocked and it now pushes the needle 28 down (overcoming the weaker polarization device 59) , as shown in Figure 9. Needle 28 now pierces the patient's skin and delivers the drug. As described for the prior art apparatus, the axis 24 becomes locked in the downward position in the housing 30.
    [0030] After finishing the drug administration, the device is moved away from the patient's body. As described for the prior art apparatus, this causes the safety lock 32 to move back to the down position as shown in Figure 10, and the needle 28 is trapped back inside the apparatus in a secure position, and the device can be safely disposed of.
    [0031] Reference is made to Figures 11A to 11B and 12, which illustrate the device for releasing the polarization device 60 employed in another device 110 (also called a drug pump 110) to deliver a substance to an individual, constructed and operative according to an embodiment of the present invention. The elements of the polarization device release device 60 are designated with the same reference numerals as above.
    [0032] The activation mechanism 20 is also used in this modality. However, unlike the modalities described above, in device 110, the needle is not retracted back into the envelope after drug administration, but there is a protector that blocks the needle after use to prevent accidental needle sticks, as is described in more detail hereinafter.
    [0033] In apparatus 110, the cartridge (not shown) is shown on a base of housing 112 (or simply housing 112), as shown in Figures 11A-11B. A hollow needle (not shown) is provided in housing 112 to pierce a septum at a distal end of the cartridge. The substance to be administered flows from the cartridge eventually to a needle 116 held in a needle holder 118 (confined to move in a housing 117), as controlled by the biasing device 60. As described above, with the polarization device release device 60, there is no control button to push down. Instead, the biasing device 70 is released to push the needle 116 down, in the same manner as described above.
    [0034] The movement of the needle holder 118 is selectively prevented by a safety lock 122, which is pivotally mounted on the base of the housing 112 around a pivot 124. The safety lock 122 is arranged to selectively pivot inwards and out of a complementary shaped groove 12 6, formed at the base of the housing 112. The safety lock 122 can be polarized by a polarizing device 128, such as a coil spring. Safety lock 122 is formed with a needle opening 129 to allow needle 116 to pass through it.
    [0035] In the first stage shown in Figures 11A, 11B and 12, prior to operation, safety lock 122 blocks the path of needle 116 to prevent premature, inadvertent activation (the locking mechanism as described, for example, in the Order Patent No. US 12/245818 or PCT Patent Application No. PCT / US09 / 69552).
    [0036] A microsensor 120, such as a photo microsensor, can be provided to perceive the position of the needle for use in conjunction with the control unit to control the various stages of pump operation. In addition to the microsensor photo 120, another sensor 130 (Figure 12) can be provided to perceive the position and operation of the safety lock 122. For example, sensor 130 can be a magnet sensor 130 that senses whether a magnet 132 is mounted on the distal end of security lock 122 is close to sensor 130 or not.
    [0037] In the second stage shown in Figures 13A, 13B and 14, the device 110 is placed on the patient's body (not shown), and the safety lock 122 has been pivoted to be flush with the base of the housing 112. The needle 116 is now aligned to be advanced through the opening of needle 129 of safety lock 122. An indication can be provided for the pump 110 to be in the body by magnet sensor 130 noticing magnet 132 in safety lock 122 (or any other mechanism perception). (It should be noted that the polarization device release device 60 is not shown in Figure 14 for the sake of simplicity).
    [0038] As described above, the biasing device 70 of the biasing device release device 60 is then released to push the needle 116 down into the patient's body, in the same manner as described above. Needle 116 advances through needle opening 129 of safety lock 122 to the position shown in Figures 15 and 16 (the third stage of operation). The perception mechanism can provide an indication indicating that needle 116 is inserted. Needle 116 remains locked in the insertion position.
    [0039] Reference is made to Figures 17A, 17B and 18. In the fourth and final stage of operation, after administering the substance, the pump 110 is removed from the patient's body, thus releasing the safety lock 122 to pivot to the down position. However, as needle 116 is already protruding out of the housing and remains locked in the projected outward position, needle 116 does not align with the opening of needle 129 of safety lock 122, as best seen in Figure 18. Then , the safety lock 122 serves as a protector that locks the needle tip 116 after using the pump 110 to prevent accidental needle sticks.
    [0040] It will be appreciated by persons skilled in the art that the present invention is not limited by what has been particularly shown and described previously. Instead, the scope of the present invention includes the two combinations and subcombination of the aspects described above, as well as the modifications and variations of this that could occur to a person skilled in the art at the time of reading the previous description and who is not in prior art.
    权利要求:
    Claims (11)
    [0001]
    1. An apparatus (110), comprising: an activation mechanism (20) operative to implant a needle (116) to project out of a housing (112); and a security lock (122); characterized by the fact that said security lock (122) is movably mounted in said housing (112) and produced with a needle opening (129) to allow said needle (116) to pass through it, in which said security lock (122) has a first position in which said needle (116) is aligned to pass through said needle opening (129) and a second position in which said security lock (122) is moved with respect to said housing (112) so that said needle (116) is misaligned with respect to said needle opening (129) and is blocked by a part of said security lock (122) spaced from said needle opening (129).
    [0002]
    2. Apparatus (110), according to claim 1, characterized by the fact that said security lock (122) is pivotally mounted in said housing (112) around a pivot (124) and in said second position said security lock (122) is rotated away from said housing (112).
    [0003]
    Apparatus (110), according to claim 1, characterized by the fact that said security lock (122) is pivotally mounted in said housing (112) around a pivot (124) and in said first position, said security lock (122) is flush with said housing (112).
    [0004]
    4. Apparatus (110), according to claim 1, characterized by the fact that it also comprises a microsensor (120) that captures a position of said needle (116).
    [0005]
    Apparatus (110), according to claim 1, characterized by the fact that it also comprises a sensor (130) that captures a position of said security lock (122).
    [0006]
    Apparatus (110) according to claim 1, characterized in that said security lock (122) is polarized by a polarization device (128).
    [0007]
    7. Pump (110) for delivering a fluid to an individual comprising: a housing (112); a needle holder (118) including a needle (116) having a distal end, the needle holder (118) being movable within the housing (118) from a first position where the needle (116) is located entirely inside the casing (112) and a second position where the distal end of the needle (116) extends out of the casing (112) to penetrate the subject's skin and deliver the fluid to the subject; and a security lock (122) including a needle opening (129) extending through it, characterized in that the security lock (122) is movable from a position where the security lock (122) is flush with a housing surface (112) with the needle opening (129) aligned with the distal end of the needle (116) so that when the needle holder (118) is moved to the second position, the needle (116) extends through the needle opening (129), outside the housing (112) to penetrate the subject's skin and a second position where a part of the security lock (122) is separated from the housing surface, the opening of the needle (129) is not aligned with the distal end of the needle (116) and a part of the safety lock (122) is engaged and blocks access to the distal end of the needle (116).
    [0008]
    8. Pump (110) according to claim 7, characterized by the fact that the safety lock (122) is pivotally mounted on the housing (112) around a pivot (124) and in the second position the part the safety lock (122) is turned away from said housing (112).
    [0009]
    Pump (110) according to claim 7, characterized by the fact that it also comprises a sensor (120) that captures the position of the needle holder (118).
    [0010]
    10. Pump (110), according to claim 7, characterized by the fact that it also comprises a sensor (130) that captures a position of the safety lock (122).
    [0011]
    11. Pump (110) according to claim 7, characterized in that said safety lock (122) is polarized by a polarization device (128).
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    法律状态:
    2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|
    2019-08-27| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|
    2020-04-22| B09A| Decision: intention to grant|
    2020-09-15| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 19/01/2011, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US12/689,249|2010-01-19|
    US12/689,249|US8348898B2|2010-01-19|2010-01-19|Automatic needle for drug pump|
    IL20863410A|IL208634D0|2010-10-11|2010-10-11|Needle protector for pump|
    IL208634|2010-10-11|
    PCT/US2011/021604|WO2011090955A1|2010-01-19|2011-01-19|Needle assembly for drug pump|
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