Device For Inserting A Needle
20220409810 · 2022-12-29
Inventors
- Loïck Cassagne (Saint-Alban-de-Roche, FR)
- Thibaut Pierquin (CALUIRE ET CUIRE, FR)
- Pierre Pintus (CRACHIER, FR)
- Gaëtan Grenot (LYON, FR)
Cpc classification
A61M5/14244
HUMAN NECESSITIES
A61M5/158
HUMAN NECESSITIES
A61M2005/14256
HUMAN NECESSITIES
International classification
A61M5/158
HUMAN NECESSITIES
Abstract
The insertion device for inserting a needle into a site having a body provided with a bearing wall for resting on the site, a needle support on which a needle is mounted, the needle support being mounted so as to be able to move relative to the bearing wall between a position before insertion, at least one insertion position, and at least one retracted position, an electric motor comprising a rotation shaft, the electric motor being intended to move the needle support in translation between the different positions of the needle support, a detection unit configured to provide a value relative to the operation of the electric motor, and an electronic unit configured to cooperate with the detection unit in order to control the depth of insertion of the needle.
Claims
1. A insertion device for inserting a needle into a site comprising: a body provided with a bearing wall for bearing on the site, a needle support on which a needle is mounted, the needle support being mounted so as to be able to move relative to the bearing wall between: a pre-insertion position in which the needle is retracted with respect to the bearing wall, at least one insertion position in which the needle protrudes with respect to the bearing wall, and at least one retracted position in which the needle is once again retracted with respect to the bearing wall, an electric motor comprising a rotation shaft, the electric motor being configured to move the needle support in translation between the different positions of the needle support, at least one detection unit configured to provide a value relative to the operation of the electric motor, an electronic unit configured to cooperate with the at least one detection unit to control a depth of insertion of the needle.
2. The insertion device according to claim 1, wherein the at least one detection unit comprises a first detection unit configured to determine a value relative to the movement of the electric motor, selected from a speed of rotation associated with a duration of rotation, an angle of rotation, a number of revolutions and a number of pulses of the electric motor.
3. The insertion device according to the claim 2, wherein the first detection unit comprises an encoder arranged on the shaft of the electric motor and a counter connected to the encoder to count the number of pulses of the electric motor.
4. The insertion device according to claim 2, wherein the at least one detection unit further comprises a second detection unit configured to determine a value relative to a load of the electric motor, selected from an electric current and a torque of the electric motor.
5. The insertion device according to claim 4, wherein the needle support is coupled, at least while the needle is being inserted, with a braking member adapted to generate at least one hard point when moving the needle support relative to the body, and wherein the electronic unit and the second detection unit are configured to determine any peak of electric current of the electric motor related to the at least one hard point.
6. The insertion device according to claim 1, comprising: a catheter mounted so as to be movable with respect to the needle and configured to dispense a product into the site, a pump connected to a reservoir so as to transfer product from the reservoir to the catheter, the electric motor being configured to supply the pump to transfer the product.
7. The insertion device according to claim 5, further comprising a base having a guide housing defining a guide axis, the guide housing being configured to receive the needle support and define at least two hard points, each hard point corresponding to at least one preset depth insertion position.
8. A method for using the insertion device according to claim 1, comprising at least one insertion insertion step, during which the electric motor rotates in a first direction of rotation move the needle support from the pre-insertion position to the at least one insertion position, and at least the following sub-steps are performed: a detection sub-step D, during which the detection unit detects a first value relative to the movement of the electric motor, and a comparison sub-step C, during which the electronic unit compares the first value relative to the movement of the electric motor with a first preset reference to provide information relative to the insertion depth, wherein in a configuration C-1, if the first value relative to the movement of the electric motor is greater than or equal to the first preset reference, the electric motor stops rotating, and the at least one insertion step is finished; and wherein in a configuration C-2, if the first value relative to the movement of the electric motor is less than the first preset reference, no modification is made to the direction of rotation of the electric motor.
9. The method for using the insertion device, according to 8, wherein the insertion device further comprises a catheter mounted so as to be movable with respect to the needle and configured to dispense a product into the site, and a pump connected to a reservoir so as to transfer product from the reservoir to the catheter, the electric motor being configured to supply the pump to transfer the product, wherein the method further comprises a retraction step after the configuration C-1, wherein the electric motor rotates in a second direction of rotation to move the needle support from the at least one insertion position to the at least one retracted position and to start the pump at the same time.
10. The method for using the insertion device according to claim 9, wherein the at least one detection unit comprises a first detection unit configured to determine a value relative to the movement of the electric motor, selected from a speed of rotation associated with a duration of rotation, an angle of rotation, a number of revolutions and a number of pulses of the electric motor, the method further comprising a priming step before the at least one insertion step, wherein the electric motor rotates in a second direction of rotation to start the pump and to transfer product from the reservoir to the catheter, and at least the following sub-steps are performed: a detection sub-step Dbis, during which the first detection unit detects the first value relative to the movement of the electric motor, and a comparison sub-step Cbis, during which the electronic unit compares the first value relative to the movement of the electric motor with a second preset reference to provide information relative to the priming of the pump, wherein in a configuration Cbis-1, if the first value relative to the movement of the electric motor is greater than or equal to the second preset reference, the priming step is finished and to the insertion step is performed; and wherein in a configuration Cbis-2, if the first value relative to the movement of the electric motor is less than the second preset reference, no modification is made to the direction of rotation of the electric motor.
11. The method for using the insertion device according to claim 8, wherein the at least one detection unit further comprises a second detection unit, wherein the needle support is coupled, at least while the needle is being inserted, with a braking member adapted to generate at least one hard point when moving the needle support relative to the body, wherein the electronic unit and the second detection unit are configured to determine any peak of electric current of the electric motor related to the at least one hard point, and wherein during the insertion step, the second detection unit is used to detect a second value relative to a load of the electric motor, selected from an electric current and a torque of the electric motor, and wherein: first and second peaks of the second value relative to the load of the electric motor are detected, and a number of peaks after the first and second peaks is detected, and this number of peaks is interpreted as hard point passages and an insertion depth is deduced by the peaks following the first and second peaks.
12. The method for using an insertion device according to claim 8, wherein the at least one detection unit further comprises a second detection unit, wherein during the detection sub-step D, the second detection unit is used to detect a second value relative to a load of the electric motor, selected from an electric current and a torque of the electric motor, during the sub-step C, the second value relative to the load of the electric motor is compared with a third preset reference, in a configuration C-3, if the second value relative to the load of the electric motor is greater than or equal to the third preset reference, the first detection unit is used to detect the first value relative to the movement of the electric motor; in a configuration C-4, if the second value relative to the load of the electric motor is less than the third preset reference, the second detection unit is continued to be used to detect the second value relative to the load of the electric motor.
13. The method for using an insertion device according to claim 9, comprising the following steps which follow the retraction step: step Dter, during which the first detection unit detects the first value relative to the movement of the electric motor, step Cter, during which; the electronic unit compares the first value relative to the movement of the electric motor with a fourth preset reference to provide information relative to aquantity of product dispensed, wherein in a configuration Cter-1, if the first value relative to the movement of the electric motor is greater than or equal to the fourth preset reference, the electric motor stops rotating and the insertion step is finished; and wherein in a configuration Cter-2, if the first value relative to the movement of the electric motor is less than the fourth preset reference, no modification is made to the direction of rotation of the electric motor.
14. A kit for assembling an insertion device for inserting a needle into a site, comprising: a body provided with a bearing wall for bearing on the site, a needle support, the needle support being mounted so as to be movable with respect to the bearing wall between: a pre-insertion position in which the needle is retracted with respect to the bearing wall, at least one insertion position in which the needle protrudes with respect to the bearing wall, and at least one retracted position in which the needle is once again retracted with respect to the bearing wall, an electric motor comprising a rotation shaft, the electric motor being configured to move the needle support in translation between the different positions of the needle support, a detection unit configured to provide a value relative to the operation of the electric motor, and an electronic unit configured to cooperate with the detection unit to control a depth of insertion of the needle.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0072] It will be easier to understand the invention on reading the description below, given as an example and referring to the attached drawings, on which:
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[0075]
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DETAILED DESCRIPTION OF THE INVENTION
[0079]
[0080] The pharmaceutical products likely to be used in the insertion device include for example peptides, proteins, hormones, active substances of biological origin, nucleotide-based active substances, nutritional formulae and other substances.
[0081] These active substances may include, but are not limited to, insulins, insulin analogues such as insulin lispro or insulin glargine, insulin derivatives, C-peptide, GLP-1 receptor agonists such as dulaglutide or liraglutide, glucagon, glucagon analogues, glucagon derivatives, gastric inhibitor polypeptides (GIP), GIP analogues, GIP derivatives, oxyntomodulin analogues, oxyntomodulin derivatives, therapeutic antibodies, such as monoclonal antibodies and any therapeutic agent that can be delivered by the above device.
[0082] The medication as it is used in the device can be formulated with one or more excipients.
[0083] The insertion device 1 is therefore carried by the user during the injection, for example on the waist.
[0084]
[0085] The insertion device 1 also comprises a pump 14, for example a peristaltic pump as shown on
[0086]
[0087] As shown on
[0088] The needle support 24 is coupled, at least while the needle is being inserted, with braking member adapted to generate hard points when moving the needle support 24 relative to the body 2.
[0089] For example, the needle support 24 comprises a blocking member 25, defining another part of the braking member, consisting of an elastic hook 251 mounted on a flexible portion, the blocking member 25 being configured to cooperate with complementary blocking member 26 also defining a part of the braking member and comprising a first vertical stop 261 and a second vertical stop 262 carried by the base 22, the cooperation between the blocking member 25 and the complementary blocking member 26 being shown more clearly on
[0090] As shown on
[0091] According to the invention, the needle support 24 is mounted so as to be movable with respect to the bearing wall 19 between: [0092] a pre-insertion position in which the needle 21 is retracted with respect to the bearing wall 19, [0093] at least one insertion position in which the needle 21 protrudes with respect to the bearing wall 19, and [0094] at least one retracted position in which the needle 21 is once again retracted with respect to the bearing wall 19.
[0095] To do this, the injection unit 10 comprises a complementary drive element 3 (see
[0096] The injection unit 10 also comprises a catheter 30 carried by a catheter support 31, as shown on
[0097] As shown on
[0098] The catheter support 31 is connected in translation to the needle support 24 during insertion of the needle 21. Since the needle 21 is housed inside the catheter 30, insertion of the needle 21 into the site allows simultaneous insertion of the catheter 30.
[0099]
[0100]
[0101] When the injection device 1 is ready to be used by a patient or by a member of the medical staff, the needle support 24 is in a pre-insertion position in which the needle 21 is retracted with respect to the bearing wall 19. The needle support 21 is kept in this pre-insertion position by the interaction between the hook 251 and the complementary blocking member 26 (
[0102] When the user places the insertion device 1 on a site to be injected, the bearing wall 19 is for example in direct contact with the site. The user then activates the electric motor 13, using a control button for example, to rotate the electric motor 13 as well as the rotating element 4 in the second direction of rotation S2 as shown on
[0103] During the priming phase, the series of teeth 44 carried by the rotating element 4 in contact with the rack 33 carried by the complementary drive element 3 drives the latter in an upward direction with respect to the guide axis (B), i.e. in a direction away from the bearing wall 19. Simultaneously, the elastic element 32 presses down on the locking pin 36, i.e. in a downward direction with respect to the guide axis (B) and therefore towards the bearing wall 19. Thus, the complementary drive element 3 exerts a very small back and forth movement so that the complementary drive element 3 continues to interact with the series of teeth 44 of the rotating element 4. The complementary drive element 3 is therefore brought into contact with the drive exerted by the rotation of the rotating element 4 in the second direction of rotation S2 and can therefore continue priming the insertion device 1. This priming phase is shown on the diagram of
[0104] When priming of the insertion device 1 is finished, the electric motor 13 rotates in a first direction of rotation 51, which is opposite to the second direction of rotation S2, to drive the needle support 24 towards a preset insertion position. The change in the direction of rotation of the electric motor 13 increases the electric current and generates a first peak of electric current which is shown on
[0105] Then, the series of teeth 44 engages with the rack 33 and converts the rotation of the rotating element 4 into translation of the complementary drive element 3 towards the bearing wall 19. The complementary drive element 3 itself drives the needle support 24 and the catheter support 31 in the same direction towards the bearing wall 19 as shown on
[0106] Detection of the second peak of electric current resets the pulse counter as shown on
[0107] When moving the needle support 24 to one of the insertion positions, the electronic unit 8 compares the number of pulses measured by the counter with a first preset reference which is a number of reference pulses relative to the insertion.
[0108] When the needle support 24 has nearly reached the bearing wall 19, the notches 52 carried by the catheter support 31 start to come into contact with the locking member 51, one after the other. If the needle support 24 reaches the preset insertion position, the corresponding notch which is already in contact with the locking member 51 continues to cooperate with the locking member 51 to keep the catheter support 31 in position. In this configuration, the number measured is greater than or equal to this number of reference pulses relative to the insertion, the electric motor 13 stops rotating and insertion step I is finished. If the needle support 24 has not reached the preset insertion position, the electric motor 13 continues to rotate in the first direction of rotation S1 and the rack 33 continues to move until the needle support 24 reaches the preset insertion position.
[0109] Once the catheter 30 has been inserted into the site by inserting the needle 21, the needle support 24 separates from the catheter support 31 and moves from its insertion position to its retracted position. To do this, the electric motor 13 rotates again in the second direction of rotation S2 so that the drive unit 4, 44 drives the complementary drive element 3 and the needle support 24 in an upward direction with respect to the guide axis (B), towards the retracted position of the needle support 24. Since the driving force of the electric motor 13 is greater than the clipping between the notches 52 and the locking member 51, the elastic element 32 and the locking pin 36 no longer cooperate and the complementary drive element 3 separates from the catheter support 31. The change in the direction of rotation of the electric motor 13 increases the electric current and generates a third peak of electric current which is shown on
[0110] The needle support 24 is connected in translation with the complementary drive element 3 by the hooking formed by the blocking member 25 via the elastic hook 251 on the first horizontal portion 34 of the complementary drive element 3.
[0111] As the needle 21 is being removed, the electric motor 13 rotates in the second direction of rotation S2 and therefore operates the pump 14 in order to transfer a preset quantity of product from the reservoir 7 to the catheter 30. This corresponds to phase “4” as shown on
[0112] When the needle support 24 reaches the retracted position, the elastic hook 251 and the complementary blocking member 26 cooperates again to lock the needle support 24 in this retracted position, as shown on
[0113] The injection device 1 is for example assembled using an assembly kit comprising: [0114] a body 2 provided with a bearing wall 19 for bearing on the site, [0115] a needle support 24, the needle support 24 being mounted so as to be movable with respect to the bearing wall 19 between: [0116] a pre-insertion position in which the needle 21 is retracted with respect to the bearing wall 19, [0117] at least one insertion position in which the needle 21 protrudes with respect to the bearing wall 19, and [0118] at least one retracted position in which the needle 21 is once again retracted with respect to the bearing wall 19, [0119] an electric motor 13 comprising a rotation shaft 20, the electric motor 13 being configured to move the needle support 24 in translation between the different positions of the needle support 24, [0120] a detection unit 16, 17 configured to provide a value relative to the operation of the electric motor 13, [0121] an electronic unit 8 configured to cooperate with the detection unit 16, 17 in order to control the depth of insertion of the needle 21.
[0122] The invention is not limited to the embodiments described and other embodiments will be clearly apparent to those skilled in the art.