Administration apparatus for medical use
11058817 · 2021-07-13
Assignee
Inventors
- Hirofumi Sugimoto (Ehime, JP)
- Toshiaki IIO (Ehime, JP)
- Seiji Kikuchi (Ehime, JP)
- Yoshiki Takeuchi (Ehime, JP)
- Kouichi MATSUDA (Ehime, JP)
Cpc classification
A61M5/3146
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M2005/208
HUMAN NECESSITIES
A61M2005/31518
HUMAN NECESSITIES
A61M5/31541
HUMAN NECESSITIES
A61M5/31535
HUMAN NECESSITIES
A61M5/14566
HUMAN NECESSITIES
A61M2205/12
HUMAN NECESSITIES
A61M2005/2073
HUMAN NECESSITIES
A61M2205/52
HUMAN NECESSITIES
International classification
A61M5/00
HUMAN NECESSITIES
A61M5/315
HUMAN NECESSITIES
A61M5/20
HUMAN NECESSITIES
A61M5/145
HUMAN NECESSITIES
Abstract
An expansion/compression mechanism of a piston rod assembly is composed of a bush shaft, a first cylindrical piston rod that is screwed with the bush shaft, a second cylindrical piston rod that is screwed with the first piston rod, and a piston rod holding member for housing the bush shaft and these piston rods. Therefore, the piston rods move linearly in multiple stages.
Claims
1. An administration apparatus for medical use which performs administration of a drug, said apparatus comprising: a drug cartridge having an end closed with a plunger, and containing a drug inside; a cartridge holder for housing the drug cartridge; a piston rod for pressing the plunger in the drug cartridge to move the plunger; an injection motor which moves the piston rod; a needle assembly for administering the drug emitted from the other end of the drug cartridge with movement of the piston rod; a controller which controls the injection motor; and a contact sensor for detecting whether or not a portion of the administration apparatus in the vicinity of the needle assembly contacts a target region, wherein the controller is configured to perform an air releasing operation for releasing air in the drug cartridge and the needle assembly by controlling the injection motor so as to move the piston rod before a drug administration operation, and to suppress the air releasing operation when the contact sensor detects that the portion of the administration apparatus contacts the target region.
2. The administration apparatus for medical use as defined in claim 1, wherein the controller is configured to permit the drug administration operation after detecting that the air releasing operation is performed before performing the drug administration operation.
3. The administration apparatus for medical use as defined in claim 1, further comprising a switch for starting the air releasing operation and a switch for starting the drug administration operation, wherein the controller is configured to permit the drug administration operation performed by turn-on of the switch for starting the drug administration operation after the air releasing operation.
4. The administration apparatus for medical use as defined in claim 1, further comprising a display unit and a speaker, wherein in a situation in which the control unit suppresses the air releasing operation, the control unit is configured to provide notification of suppression of the air releasing operation by using at least one of the speaker and the display unit.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
Embodiment 1
(25)
(26) In
(27) Further, a drug cartridge containing a drug, an end of which is closed with a plunger (not shown), is inserted in the administration apparatus. When the needle assembly 6 pierces the target region, a piston rod (not shown) that presses the plunger moves, whereby the drug emitted from an end of the drug cartridge is injected into the patient's body.
(28) When the patient replaces the drug cartridge, the target-region contact cover 7 is slid in a direction of arrow A as shown in
(29) Next, as shown in
(30) An outline of cartridge replacement is as described above. Hereinafter it will be described in more detail using
(31) In
(32) When the patient replaces the drug cartridge 2, as shown in
(33) Thereafter, replacement of the drug cartridge 2 can be performed. After a new drug cartridge 2 is attached, the administration apparatus 1 is set in an injection-ready state by performing a reverse of the above-mentioned operation.
(34) Further, during injection, only the needle portion of the needle assembly is exposed out of the contact cover. Therefore, at all other times, a periphery of the needle holder is covered, thereby preventing an accident such as needle insertion by mistake.
(35) Further, a device for detecting a position of the contact cover may be provided to prevent an accident such as needle insertion by mistake during use. To be specific, the contact cover is detected by a position detection device that is provided in the administration apparatus when the contact cover is in a used position.
(36) Next, a drug cartridge holding state will be described with reference to
(37) A detection lever 18 is attached to the needle holder 4.
(38) The press member 19 comprises a spring member 20 and a stopper member 21.
(39) In the above-mentioned construction, presence/absence of the needle assembly 6 and the drug cartridge 2 can be detected by detecting a position of the press member 19.
(40) Further, when replacing the drug cartridge, the needle holder 4 is moved in a direction in which the needle assembly 6 is attached, by the detection lever 18 and the piston rod holding member 16, whereby the piston rod is moved back to an initial position. Thus, operability during cartridge replacement is improved.
(41) As described above, in the first embodiment of the present invention, since the front end of the drug cartridge 2 is exposed by drawing the needle holder 4 from a body of the administration apparatus 1 and swinging the holder 4, the drug cartridge 2 is detachable with the cartridge holder 3 being held by the administration apparatus 1. Therefore, in contrast to the conventional administration apparatus, the patient is free from a burden that the patient must separate the cartridge holder from the administration apparatus body every time the patient replaces the cartridge. Further, the patient can arbitrarily perform replacement of the drug cartridge regardless of a needle assembly attachment state, thereby facilitating handling.
(42) The administration apparatus for medical use according to the present invention is applicable to both of a hand operated administration apparatus and a motor-operated administration apparatus.
Embodiment 2
(43) Next, an administration apparatus for medical use according to a second embodiment of the present invention will be described.
(44) Further, the piston rod 12 and the piston rod 14 are provided with convex-shaped rotation prevention parts 13 and 15, respectively. Further, as shown in
(45) Next, actual operation will be described with reference to
(46) Further, since the rotation prevention part 15 of the piston rod 14 cannot rotate because it contacts the piston rod rotation prevention part 17 of the piston rod holding member 16, a rotational force transferred from the piston rod 12 to the piston rod 14 is converted into a driving force for moving the piston rod 14 forward, whereby the piston rod 14 slides in a direction of arrow A as shown in
(47) Since the rotation prevention part 15 of the piston rod 14 still contacts the piston rod rotation prevention part 17 of the piston rod holding member 16, the piston rod 12 that has stopped rotation slides in the direction of arrow A in synchronization with the piston rod 14. Further, an instant when the rotation prevention part 15 of the piston rod 14 is apart from the piston rod rotation prevention part 17 of the piston holding member 16, the rotation prevention part 13 of the piston rod 12 contacts the piston rotation prevention part 17 of the piston holding member 16, and therefore, the piston rod 14 slides in the drug cartridge 2 in synchronization with sliding of the piston rod 12 (refer to
(48) As described above, in the administration apparatus for medical use according to the second embodiment, an expansion/compression mechanism of the piston rod assembly is composed of the bush shaft 11, the cylindrical piston rod 12 that is screwed with the bush shaft 11, the cylindrical piston rod 14 that is screwed with the piston rod 12, and the piston rod holding member 16 that stores these piston rods, whereby motion of the piston rods is expanded linearly in plural stages to make the apparatus very compact, resulting in an administration apparatus for medical use having excellent portability.
(49) While in this second embodiment a motor-operated administration apparatus for medical use has been described, the present invention is not restricted thereto. For example, a hand-operated administration apparatus for medical use which manually drives a driving gear 10 using a spring or the like is also within the scope of the present invention.
Embodiment 3
(50) Next, an administration apparatus for medical use according to a third embodiment of the present invention will be described with reference to
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(52) Initially,
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(54) In
(55) A user holds the body 102 with his hand, presses a contact sensor against a region to which the drug should be administered, and pushes an administration switch 104 that is provided on a side surface of the body 102. Then, a needle-insertion motor 105 rotates forward, and this rotational force propagates to a slide cap 107 through a slide rod 106 that is directly connected to the needle-insertion motor 105. The rotational force of the needle-insertion motor 105 is converted into a force of linear motion by the slide cap 107. The slide cap 107 moves in a direction of the arrow when the needle-insertion motor 105 rotates forward. A needle-removal sensor is turned off as the slide cap 107 starts to move. The slide cap 107 moves by a predetermined amount in the direction of the arrow. At this time, a needle-insertion sensor 109 is turned on, and rotation of the needle-insertion motor 105 stops.
(56) The slide cap 107 is coupled to an inner frame assembly part 110. When the needle-insertion motor 105 rotates forward, the inner frame assembly part 110 moves in the direction of the arrow. The inner frame assembly part 110 is coupled to an injection assembly part 111. The injection assembly part 111 moves in the direction of the arrow when the needle-insertion motor 105 rotates forward, and inserts an injection needle 112 into a target region.
(57) After this needle-insertion operation, an injector motor 113 rotates forward, and this rotational force is decelerated by a deceleration gear box 114 directly connected to the injection motor 113, whereby a gear main shaft 115 of the deceleration gear box 114 is rotated. A front end of the gear main shaft 115 rotates a primary gear 116. This rotational force propagates to a tertiary gear 118 through a secondary gear 117. The tertiary gear 118 is coupled to a primary rod 119. Since the primary rod 119 is engaged with a secondary rod 120, rotational force of the primary rod 119 propagates to the secondary rod 120. Since the secondary rod 120 is engaged with a tertiary rod 121, a rotational force of the secondary rod 120 propagates to the tertiary rod 121. A rotational force of the tertiary rod 121 is restricted by a groove that is provided inside the cartridge holder 103, and the tertiary rod 121 moves in the direction of the arrow. When the tertiary rod 121 moves ahead in the syringe 101 by a predetermined amount, the secondary rod 120 that has rotated also pushes the syringe 101. Then, the tertiary rod 121 pushes a plunger in the syringe 101 so that a drug is pushed out of the injection needle 112, whereby an injection operation is performed. A dose is adjusted by counting rotations of the injection motor 113 by a rotation sensor 122.
(58) The primary rod 119, the secondary rod 120, and the tertiary rod 121 have the same construction as the piston rod assembly described for the first embodiment.
(59) After the injection operation, the injection motor 113 rotates backward to return the secondary rod 120 and the tertiary rod 121 to initial positions. Thereafter, the needle-insertion motor 105 rotates backward to move the slide cap 107 in a direction opposed to the arrow. The slide cap 107 is coupled to the inner frame assembly pat 110. When the needle-insertion motor 105 rotates backward, the inner frame assembly part 110 rotates in the direction opposed to the arrow. The inner frame assembly part 110 is coupled to the injection assembly part 111. Accordingly, the injection assembly part 111 moves in the direction opposed to the arrow together with the inner frame assembly part 110 when the needle-insertion motor 105 rotates backward, whereby the injection needle 112 is removed from the target region.
(60) When the slide cap 107 returns to an initial position, the needle-removal sensor 108 is turned on to stop the needle-insertion motor 105, whereby a needle removal operation is completed.
(61) Next, an external construction of the administration apparatus for medical use according to the present invention will be described with reference to
(62) In
(63) Reference numeral 124 denotes an air releasing switch for starting air releasing in the syringe or injection needle.
(64) Reference numeral 125 is a setting switch for setting such a dose of drug to be injected into a body.
(65) Reference numeral 126 denotes a contact sensor for checking whether or not the administration apparatus contacts a region to be subjected to administration.
(66) Reference numeral 127 denotes a display unit for displaying a set dose of drug to be injected into the body, and a condition in the administration apparatus, for example, an amount of remaining drug. Further, the display unit 127 notifies a user of abnormal operation or the like.
(67) Reference numeral 128 denotes an injection needle port as an opening through which the injection needle passes during needle insertion and needle removal.
(68) Next, an electrical circuit construction of the administration apparatus having the constructions shown in
(69) Reference numeral 129 denotes a speaker for notifying a user of an end of operation, abnormal operation, or the like by voice.
(70) Reference numeral 132 denotes an origin point sensor for detecting that the piston for injecting the drug in the syringe is positioned in an origin point.
(71) Reference numeral 131 denotes a motor driver for outputting a signal for driving the injection motor 113 and the needle-insertion motor 105 according to a command from a microprocessor 130.
(72) The microprocessor 130 is a controller which outputs a command for operating the injection motor 113 or the needle-insertion motor 105 by turning on the air releasing switch 124 or the administration switch 104 according to a program.
(73) Next, a sequence of air releasing and drug injection by the microprocessor 130 of the administration apparatus according to the third embodiment will be described with reference to the flowchart shown in
(74) Next, it is judged whether or not the air releasing switch 124 is pressed (step a2). When the air releasing switch 124 is pressed, the process goes to step a3.
(75) In step a3, the needle-insertion motor 105 is operated at a low speed using a reduction in driving voltage, or PWM (Pulse Width Modulation) control for changing an ON/OFF ratio of a pulse width of a signal, during a period from when the needle-removal sensor 108 is turned on to when the needle-insertion sensor 109 is turned on. Next, in step a4, the injection motor 113 is rotated forward by an amount required for air releasing, and air releasing is performed by moving the piston rods 119˜121.
(76) Next, in step a5, the needle-insertion motor 105 is rotated backward at a low speed to move the injection needle up to a position where the needle-insertion sensor 109 is on, thereby completing processing (step a9).
(77) On the other hand, when not the air releasing switch 124 but the administration switch 104 is pushed in step a2, the process goes to step a6. In step a6, needle insertion is performed at a high speed to reduce pain of a patient associated with needle insertion.
(78) Next, in step a7, the injection motor 113 is operated to inject a set dose of drug.
(79) Next, in step a8, after this injection is ended, the needle-insertion motor 105 is rotated in a reverse direction at a high speed to move the injection needle from a position of a needle-insertion state to a position of a needle-removal state, thereby completing processing (step a9).
(80) As described above, in the administration apparatus for medical use according to the third embodiment, when the air releasing switch 124 is pressed using the plural piston rods 119 to 121, air releasing can be easily performed by the motor with movements of the piston rods 119 to 121. Further, since the injection motor 113 is operated at a low speed during air releasing, it is possible to reduce a risk of a drug adhered to the injection needle or the like being splattered when the user visually checks air releasing.
Embodiment 4
(81) Next, an administration apparatus for medical use according to a fourth embodiment of the present invention will be described. The administration apparatus according to the fourth embodiment always performs air releasing of a drug cartridge and/or an injection needle before performing drug administration to increase a level of safety of the apparatus. A construction of the apparatus according to the fourth embodiment is identical to that described with respect to
(82) Hereinafter, operation of the microprocessor 130 of the administration apparatus for medical use according to the fourth embodiment will be described with reference to
(83) When air releasing switch 124 or administration switch 104 is pressed, a sequence is started (step b1).
(84) Initially, it is judged whether or not the air releasing switch 124 is pressed (step b2). When a pressed switch is not the air releasing switch 124 but the administration switch 104, step b2 is performed again. When the pressed switch is the administration switch 104, since administration is not performed, it is informed to a user that the administration switch 104 is pressed, using speaker 129 by voice or using display unit 127, or using both of the speaker 129 and the display device 127.
(85) On the other hand, when the air releasing switch 124 is pressed in step b2, the process goes to step b3. In step b3, it is judged whether or not contact sensor 126 is on. Since there is a danger that the needle might be inserted into the user by mistake when the contact sensor 126 is on, step b3 is performed again. At this time, since air releasing is not performed when the contact sensor 126 is on, it is informed to the user that the contact sensor 126 is on, using the speaker 129 by voice or using the display device 127, or using both the speaker 129 and the display unit 127.
(86) On the other hand, when the contact sensor 126 is not on in step b3, the process goes to step b4. In step b4, injection motor 113 is driven to release air in syringe 101 or injection needle 112.
(87) Next, the user visually checks whether or not air releasing is satisfactorily performed, and presses the air releasing switch 124 again when it is not satisfactorily performed.
(88) When air releasing is performed satisfactorily, the administration switch 104 is pressed. In step b5, it is judged which of the administration switch 104 and the releasing switch 124 is pressed. When the air releasing switch 124 is pressed, the process goes to step b3. When the administration switch 104 is pressed, the process goes to step b6.
(89) In step b6, it is judged whether or not the contact sensor 126 is on. When the contact sensor 126 is not on, there is a possibility that the administration apparatus is not in contact with a predetermined target region of the user, and therefore, step b3 is performed again. Since no injection is performed when the contact sensor 126 is not on, it is informed to the user that the contact sensor 126 is not on, using the speaker 129 by voice or using the display device 127, or using both the speaker 129 and the display device 127. When the contact sensor 126 is on, the process goes to step b7.
(90) In step b7, a set dose of drug is injected by driving the injection motor 113 to complete processing (step b8).
(91) As described above, according to the fourth embodiment, the injection operation by pressing the administration switch 104 is enabled after detecting that the air releasing switch 124 is pressed before pressing the administration switch 104, using plural piston rods 119 to 121. Therefore, air releasing can be performed with reliability before drug injection to reduce a risk of injecting air into a human body, whereby a level of safety of the apparatus is increased.
Embodiment 5
(92) An administration apparatus according to a fifth embodiment of the present invention will be described hereinafter. Since construction of the administration apparatus according to the fifth embodiment is identical to that described with respect to
(93) Hereinafter, an electrical circuit structure of the administration apparatus according to the fifth embodiment will be described.
(94)
(95) The setting circuit 133 is composed of an electronic circuit capable of storing an amount of operation of injection motor 113 which is obtained by converting an amount of injection outputted from microprocessor 130.
(96) The dose storing circuit 135 is composed of an electronic circuit for storing doses of drug that have been administered in the past. To be specific, it stores a latest dose, or plural doses in the past, or an average of plural doses in the past.
(97) The dose comparison circuit 134 is composed of an electronic circuit for comparing a dose that is set by the setting circuit 133 with a dose (doses) that is stored by the dose storing circuit 135.
(98) Next, operation of the microprocessor 130 of the administration apparatus according to the fifth embodiment will be described with reference to
(99) When a user stands ready to set a dose, a sequence starts (step c1).
(100) Initially, in step c2, a range of dose is calculated from the past set values that are stored in the dose holding circuit 135. The range of dose according to the past set values may be a range from −30% to +30% of the last dose, or a range that is obtained on basis of plural doses in the past. For example, using an average of data of past ten doses, a range from −30% to +30% of the average value is set as a range of dose. Moreover, a range of dose may be obtained by statistically calculating data of past ten doses using standard deviation or the like.
(101) Next, in step c3, the user determines an amount of injection and sets the amount in the setting circuit 133.
(102) Subsequently, in step c4, the dose comparison circuit 134 compares the value inputted by the user in step c3 with a value calculated in step c2. When a result of this comparison is within a predetermined range, the process goes to step c6. When the result of this comparison is out of the predetermined range, the process goes to step c5 to be described later.
(103) In step c5, it is informed to the user that the set value is out of the predetermined range, using the speaker 129 by voice or using the display unit 127, or using both the speaker 129 and the display unit 127. Then, the user judges whether or not the process can be shifted to an injection step. When the user permits shifting to the injection step, the process goes to step c7. When the user refuses, the process goes back to step c3.
(104) In step c6, injection of the set dose is performed by driving the injection motor 113 to complete the process (step c7).
(105) In step c5, after informing the user that the set value is out of the predetermined range using the speaker 129 by voice or the display unit 127 or using both the speaker 129 and the display unit 127, the process may go to step c3 without confirmation by the user.
(106) As described above, in the administration apparatus for medical use according to the fifth embodiment, when setting a dose using the setting switch 125, the set value is compared with past doses. When the result of this comparison is out of a predetermined range, it is informed to the user using the speaker 129 by voice or using the display unit 127, or using both the speaker 129 and the display unit 127. Depending on types of drugs, some drug might adversely affect a human body if a dose of the drug is significantly different from a proper dose. Therefore, when the dose changes significantly, a change of the dose is informed to the user before administration and then the user confirms the dose, or the user is inhibited to perform administration, whereby a level of safety of the motor-operated administration apparatus for medical use is increased.
Embodiment 6
(107) Next, an administration apparatus for medical use according to a sixth embodiment of the present invention will be described. Since construction of the administration apparatus according to the sixth embodiment is identical to that described with respect to
(108) An electrical circuit structure of the administration apparatus according to the sixth embodiment will be described with reference to a block diagram shown in
(109) Rotation sensor 122 is able to output operation of injection motor 113 as a frequency, and the frequency is output to microprocessor 130 and the count circuit 137.
(110) The count circuit 137 is composed of an electronic circuit for counting signals from the rotation sensor 122, and it is able to count an amount of operation of the injection motor 113.
(111) The setting circuit 133 is composed of an electronic circuit which is able to hold an amount of operation that is obtained by converting an amount of injection outputted from the microprocessor 130. Further, the setting circuit 133 is able to receive an instruction of an injection start or an injection end from the microprocessor 130, whereby it can make the count circuit 137 perform initialization.
(112) A dose can be detected by measuring an amount of movement of the piston rod or measuring a time when the piston rod moves at a constant speed.
(113) The comparison detection circuit 136 is composed of an electronic circuit for comparing a set value of the setting circuit 133 with a count value of the count circuit 137 to detect overdose or underdose of a drug. When the count value exceeds a predetermined value with respect to the set value before end of an operation, the comparison detection circuit 136 can stop operation of the motor driver 131, bypassing the microprocessor 130, and it can inform the microprocessor 130 that the predetermined value is exceeded. Further, when the count value is lower than a predetermined value with respect to the set value after the end of operation, the comparison detection circuit 136 can inform the microprocessor 130 that the count value is lower than the predetermined value.
(114) In the above-mentioned construction, it is possible to directly observe an actual dose electronic-circuit-wise by the comparison detection circuit 136, in addition to observing a dose by program processing using the microprocessor 130. Therefore, even when a program of the microprocessor 130 is operated abnormally, the comparison detection circuit 136 detects an abnormal event to perform a process such as compulsory stopping of the motor driver 131, whereby overdose or underdose of drug can be avoided. As a result, double safeguards can be presented, whereby a level of safety of the motor-operated administration apparatus for medical use can be increased.
(115) The administration apparatus for medical use according to the present invention is useful as a motor-operated injection apparatus or the like for a drug such as insulin, which provides easy replacement of drug cartridges and high portability.