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NZ719893B2 - Medicine injection device with a pain-reduction member - Google Patents
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NZ719893B2 - Medicine injection device with a pain-reduction member - Google Patents

Medicine injection device with a pain-reduction member Download PDF

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Publication number
NZ719893B2
NZ719893B2 NZ719893A NZ71989314A NZ719893B2 NZ 719893 B2 NZ719893 B2 NZ 719893B2 NZ 719893 A NZ719893 A NZ 719893A NZ 71989314 A NZ71989314 A NZ 71989314A NZ 719893 B2 NZ719893 B2 NZ 719893B2
Authority
NZ
New Zealand
Prior art keywords
protrusions
skin
laveryk
patient
injection device
Prior art date
Application number
NZ719893A
Other versions
NZ719893A (en
Inventor
Eric Chanie
Mahmut Tuncer
Original Assignee
Ares Trading Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ares Trading Sa filed Critical Ares Trading Sa
Priority claimed from PCT/EP2014/074557 external-priority patent/WO2015071390A1/en
Publication of NZ719893A publication Critical patent/NZ719893A/en
Publication of NZ719893B2 publication Critical patent/NZ719893B2/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/13General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3327Measuring
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/422Desensitising skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/42Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means

Abstract

The injection device (1, 10) comprises a medicine container, means for injecting medicine from the medicine container to a patient through a needle, a skin contact surface (10b) crossable by the needle and having protrusions (14) which are pressed around the injection site when the injection device (1, 10) is applied on the patient's skin for the injection, the protrusions (14) being arranged so as to reduce the pain caused by the penetration of the needle, and a sensor for detecting contact of the patient's skin with the skin contact surface (10b), wherein a predetermined force of application of the injection device (1, 10) on the patient's skin is required for the sensor to detect the patient's skin. According to another aspect of the invention, the protrusions (14) include first and second protrusions (14a, 14b), wherein the first protrusions (14a) come into contact with the patient's skin as the device is applied with a first force and the second protrusions (14b) come into contact with the patient's skin as the device is applied with a second force, the second force being greater than the first force. The device reduces the perception of pain the patient experiences when receiving an injection. This is achieved by the spikes which stimulate the large-diameter sensory nerve fibres proximate the injection site and block the pain signals from the small-diameter pain nerve fibres. Blocking the pain signals include totally or partially blocking, saturating or desensitising the nerve signals. The spikes (14) also draw the patient's attention away from the needle penetration into the skin. (1, 10) is applied on the patient's skin for the injection, the protrusions (14) being arranged so as to reduce the pain caused by the penetration of the needle, and a sensor for detecting contact of the patient's skin with the skin contact surface (10b), wherein a predetermined force of application of the injection device (1, 10) on the patient's skin is required for the sensor to detect the patient's skin. According to another aspect of the invention, the protrusions (14) include first and second protrusions (14a, 14b), wherein the first protrusions (14a) come into contact with the patient's skin as the device is applied with a first force and the second protrusions (14b) come into contact with the patient's skin as the device is applied with a second force, the second force being greater than the first force. The device reduces the perception of pain the patient experiences when receiving an injection. This is achieved by the spikes which stimulate the large-diameter sensory nerve fibres proximate the injection site and block the pain signals from the small-diameter pain nerve fibres. Blocking the pain signals include totally or partially blocking, saturating or desensitising the nerve signals. The spikes (14) also draw the patient's attention away from the needle penetration into the skin.

Description

Medicine injection device with a eduction member The present invention relates to an injection device for injecting medicine, typically in liquid form, to a patient. The t invention also relates to a pain- reduction member which equips or may equip such an ion device.
It is known in the art to use a pain—reduction member in combination with an injection device to reduce the pain caused by the penetration of the injection device needle into the skin. US 6,902,554 and US 054981 disclose pain- reduction members in the form of a plate g sions on one of its surfaces. The plate has a through hole for passage of a syringe . When pressed against the skin, the protrusions stimulate large-diameter sensory nerve fibres proximate the injection site and block the pain signals from the small- diameter pain nerve fibres. The protrusions also draw the patient’s attention away from the needle penetration into the skin.
A first problem with such known devices is that nothing obliges the patient to sufficiently press the pain-reduction member on the skin. If the said member is not iently pressed, the pain reduction effect will be negligible.
A second problem is that the patient cannot adjust the type of sensation provided by the protrusions.
To remedy the first problem, the present invention es according to a first aspect an injection device comprising: - a medicine container, - means for injecting medicine from the medicine container to a patient through a needle, - a skin contact surface crossable by the needle, said skin contact surface having protrusions which are pressed around the injection site when the injection device is applied on the patient’s skin for the injection, said protrusions being arranged so as to reduce the pain caused by the penetration of the needle, and [Annotation] k None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk - a sensor for detecting contact of the patient’s skin with the skin contact surface, wherein a predetermined force of application of the injection device on the patient’s skin is required for the sensor to detect the t’s skin.
Typically, the predetermined force of ation of the injection device on the patient’s skin is higher than the weight of the injection device.
The sensor is e.g. a capacitive or mechanical sensor.
In an embodiment, said sions comprise a set of first protrusions and a set of second protrusions.
Typically, the second protrusions have a r dimension, in the direction of the needle, than the first protrusions.
Advantageously, the second protrusions have sharper tips than the first protrusions.
To remedy the second problem mentioned above, i.e. to enable the patient to change the sensation provided by the protrusions, the present ion provides according to a second aspect an ion device comprising: - a medicine container, - means for ing medicine from the medicine container to a patient through a needle, and - a skin contact surface crossable by the , said skin contact surface having protrusions which are pressed around the injection site when the injection device is applied on the patient’s skin for the injection, said protrusions being ed so as to reduce the pain caused by the penetration of the needle, wherein said protrusions comprise a set of first protrusions and a set of second protrusions, n: (i) the first protrusions come into contact with the patient’s skin as the device is applied with a first force and the second protrusions come into contact [Annotation] k None set by laveryk ation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk with the patient’s skin as the device is applied with the second force, the second force being greater than the first force; and/or (ii) the first and second protrusions are configured such that the second protrusions engage the skin of the user subsequent to the ment of the first protrusions when the device is subject to a ng force above a predetermined amount.
Typically, the second protrusions have a smaller dimension, in the direction of the needle, than the first protrusions.
Advantageously, the second protrusions have sharper tips than the first protrusions.
Preferably, the first and second protrusions are arranged on the skin t surface in a mixed manner, more precisely in a separated and interspersed manner.
In a particular embodiment, the first sions are arranged on first circles, the second protrusions are arranged on second circles, concentric with the first circles, and the first and second circles are arranged in an alternating .
In both aspects of the invention: - the protrusions may extend in the direction of the needle, - the protrusions may be in the form of spikes, - the ion device may comprise a member removably mounted on a housing of the injection device and defining the skin contact surface and its protrusions, - the skin t surface may further comprise feet which are ed to rest on a flat surface, together with at least some of the protrusions (typically the first protrusions), when the injection device is placed on said flat surface, - the feet may have the same dimension, in the direction of the needle, than at least some of the protrusions (typically the first protrusions).
[Annotation] laveryk None set by laveryk ation] laveryk MigrationNone set by laveryk [Annotation] laveryk ed set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk ionNone set by laveryk ation] laveryk Unmarked set by laveryk The above-mentioned member may be elastically mounted on said housing and, to this effect, may comprise elastic tabs.
The above-mentioned member may comprise another through hole in a region facing the sensor.
The above-mentioned member may be arent and/or in the form of a plate.
The above-mentioned member may be larger in width and length than a bottom wall of the injection device.
The present invention further provides a device to apply a ng force to a skin of a user proximate to an injection zone comprising a plurality of first protrusions arranged to engage the skin of the user, characterised in that the device further comprises a plurality of second protrusions, wherein: (i) the first and second protrusions are configured such that the second protrusions engage the skin of the user uent to the engagement of the first protrusions when the device is subject to a pressing force above a predetermined amount; and/or (ii) the first protrusions come into contact with the patient’s skin as the device is applied with a first force and the second protrusions come into contact with the patient’s skin as the device is applied with the second force, the second force being greater than the first force.
Typically, the second protrusions have a r dimension, in the direction of the pressing force, than the first protrusions.
Advantageously, the second protrusions have sharper tips than the first protrusions.
It is noted that the protrusions of the ion do not pierce the skin. The protrusions depress the skin.
In any of the injection devices or the device to apply a pressing force as defined above, the protrusions may have a height within 1.8 mm and 3.3 mm, a bagfiameter within 0.9 mm and 1.8 mm and a tip radius within 0.2 mm and 0.7 [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk ation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk mm. The first protrusions may have a height of about 3 mm, a base diameter of about 1.6 mm and a tip radius of about 0.5 mm and the second protrusions may have a height of about 2 mm, a base diameter of about 1 mm and a tip radius of about 0.3 mm.
The present invention further provides a method for injecting medicine to a patient using any of the devices defined above, the method comprising the steps of pressing the protrusions against the patient’s skin and performing the injection.
Other features and ages of the present invention will become nt upon reading the following detailed description made with nce to the appended gs in which: Figure 1 is a partial perspective view of an injection device, Figure 2 is a ctive view of the injection device fitted with a pain- reduction member, Figure 3 is a top perspective view of the pain-reduction member, Figure 4 is a bottom plane view of the ion device fitted with the pain- reduction member, Figure 5 is a perspective view of the injection device fitted with a pain- reduction member according to a variant of the invention, Figure 6 is a bottom plane view of the injection device fitted with the pain- reduction member according to the said variant of the invention, Figure 7 is a partial sectional view of the pain-reduction member according to the said variant of the invention, Figure 8 is a mmatic view showing an alternative shape of a spike of the pain-reduction member, and Figure 9 is a diagrammatic view g how spike dimensions of the pain- ion member are measured.
Figure 1 shows a medicine injection device 1 of the type disclosed in WO 2005/077441 and . This injection device 1 comprises a housing 2 hag a bottom wall 3. A through hole 4 in the bottom wall 3 permits passage of a [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by k needle 5. The needle 5 is connected to a medicine container 6 inside the housing 2. A mechanism 7, including an electric motor, is also provided inside the housing 2 for holding and moving vertically the medicine container 6 with its needle 5 so that these elements 5, 6 can take a retracted position, fully inside the housing 2, and an operating position in which the needle 5 protrudes from the h hole 4 to pierce the skin of a patient. The mechanism 7 further controls movement of a piston in the medicine container 6 to perform the injection after the needle 5 has pierced the patient’s skin. A skin sensor 8 is provided in or near the bottom wall 3 to detect ity of human skin to the said wall. The skin sensor 8 may be capacitive, as disclosed in , or of a different type, such as mechanical. An electronic control unit 9 in the housing 2 allows piercing of the t’s skin by the needle 5 and injection of ne only after the skin sensor 8 has detected that the ion device 1 is placed on the skin.
In order to reduce the pain caused by the penetration of the needle 5 into the patient’s skin, the injection device 1 may be fitted with a pain—reduction member 10 as shown in Figures 2 and 3. The pain-reduction member 10 is in the form of a plate mountable against the bottom wall 3. On a peripheral portion of one, 10a, of its two surfaces, the pain—reduction member 10 has tabs 11 which form a sleeve receiving the bottom portion of the injection device 1. At least some of the tabs 11 are elastically deformable and have curved ends 12 which may engage a groove 13 of the housing 2 to hold the pain-reduction member 10 against the bottom wall 3. The pain-reduction member 10 may thus be easily attached ached from the injection device 1. On its surface 10b opposite the one 10a g the tabs 11, the eduction member 10 has protrusions including spikes 14 and feet 15 (see Figures 2 and 4). The surface 10b with its spikes 14 and feet 15 forms the skin contact surface of the injection device 1, intended to contact the patient’s skin around the injection site, when the ion device 1 is fitted with the pain-reduction member 10.
[Annotation] k None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk The skin t surface 10b is preferably ntially flat, as represented, but could also be . The pain-reduction member 10 further has first and second through holes 16, 17. The first h hole 16 is aligned with the through hole 4 of the bottom wall 3 and its on is thus to let the needle 5 pass for the injection. The second through hole 17 faces the skin sensor 8 and avoids the pain- reduction member 10 disturbing the skin detection. One or both of the through holes 4, 16 which allow passage of the needle 5 may be closed by a pierceable The spikes 14 are arranged around the passage of the needle 5, Le, in bottom view (see Figure 4), around the through hole 16, and extend in the direction of the needle 5. More precisely, the spikes 14 are arranged on several concentric circles that are coaxial with the through holes 4, 16. Thus, when the injection device 1 is placed on the skin for the injection, the spikes 14 are pressed against the skin around the injection site to provide the pain-reduction effect upon the needle 5 penetrating the skin. The density and spacing of the spikes 14 are selected to stimulate the large—diameter sensory nerve fibres proximate the ion site and to block the pain signals from the small-diameter pain nerve fibres. Blocking the pain signals include totally or partially blocking, saturating or itising the nerve signals. The spikes 14 also draw the patient’s attention away from the needle penetration into the skin. To increase the pain-reduction effect, the pain—reduction member 10 has larger width and length than the bottom wall 3, as is visible in Figure 2. In order for the t to keep a good visibility of the through hole 4 from which the needle 5 will protrude for the injection, the pain- reduction member 10 is made of a transparent material.
The feet 15 are located in a region of the pain-reduction member 10 that is furthest from the through hole 16 and have the same height as the spikes 14. In combination with the spikes 14, the feet 15 allow the pain-reduction member 10 to be stable and horizontal when placed on a horizontal surface.
[Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk ation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] k Unmarked set by laveryk The al of the pain-reduction member 10 is preferably a polymer such as polypropylene (preferably of the homopolymer type) and is typically made as a one-piece device, e.g. by a moulding process.
According to an advantageous feature of the invention, when the injection device 1 is fitted with the pain-reduction member 10, a predetermined force of application of the injection device 1, 10 on the skin is required for the skin sensor 8 to detect the skin and therefore to allow the injection. In other words, to perform the injection the patient must apply the injection device 1, 10 on the skin with sufficient force. The predetermined force of ation of the injection device 1, 10 on the skin is typically higher than the weight of the injection device 1, 10, Le. than the force of gravity applied on the injection device 1, 10. This ensures that the spikes 14 will be sufficiently pressed against the skin to efficiently reduce the pain associated with the penetration of the needle 5 into the skin. If the skin sensor 8 is a capacitive sensor, its sensitivity is determined by features such as the shape and size of the measuring electrode(s) and the tive change detection threshold of the corresponding electronic circuit. Particularly, for given shape and size of the electrode(s), it is le to adjust the threshold from which it is considered that a detected capacitive change indicates that the ion device 1 is properly placed on the skin. In the present invention, the sensitivity of the skin sensor 8 is thus set at a sufficiently low value to achieve the desired effect, i.e. to require a sufficient pressure to be exerted by the spikes 14 on the skin to reach the detection old. If the skin sensor 8 is ical, the said effect may be achieved by suitably positioning a movable contact of the sensor between the bottom wall 3 and the nce plane defined by the tips of the spikes 14 and feet 15.
According to a variant of the invention, shown in Figures 5 and 6, the spikes 14 include first spikes 14a and second spikes 14b. The first spikes 14a have the same height as the feet 15. The second spikes 14b, on the other hand, have a smaller height (or ) than the first spikes 14a so that when the pain- reogion member 10 is placed on a flat rigid surface, the tips of the first spikes [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk ionNone set by laveryk [Annotation] laveryk Unmarked set by laveryk 14a rest on the surface (together with the feet 15) while the second spikes 14b do not contact the surface. Thus, when the pain-reduction member 10 is placed on the patient’s skin, upon applying a first force on the member 10 the patient will essentially feel the first spikes 14a and upon applying a second force higher than the first force the patient will feel both the first and second spikes 14a, 14b.
Moreover, preferably, the tips of the second spikes 14b are sharper than the tips of the first spikes 14a so as to provide a ier effect on the patient than the first spikes 14a. By applying the entioned second force the patient will have a different ion than by applying only the first force. The patient may thus choose which one of the sensations he/she wants. Particularly, if the sensation provided by the first spikes 14a is judged not sufficient for reducing the pain caused by penetration of the needle 5 into the skin, the patient may decide to more strongly press the injection device 1 and pain-reduction member 10 on his/her skin so as to feel a greater number of spikes, including the sharper-tip second spikes 14b.
In an alternative embodiment, the skin contact surface 10b is curved such that a first portion of the skin contact surface is displaced from the ion device1 and a second portion of the skin contact surface is adjacent to the injection device 1. On the skin contact surface 10b opposite the e 10a bearing the tabs 11, the eduction member 10 has protrusions including spikes 14. The displaced portion of the skin contact surface has a first set of spikes protruding therefrom. The adjacent portion of the skin contact e has a second set of spikes protruding therefrom. In this embodiment the first and second sets of spikes have the same height as each other. However, the first set of spikes reach further away from the injection device given that they protrude from a e that is ced from the injection device.
In this alternative embodiment the first spikes have the same height as the feet 15 so that when the eduction member 10 is placed on a flat rigid surge, the tips of the first spikes rest on the surface (together with the feet 15) [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk ation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk while the second spikes do not contact the surface. Thus, when the pain-reduction member 10 is placed on the patient’s skin, upon applying a first force on the member the patient will essentially feel the first spikes and upon applying a second force higher than the first force the patient will feel both the first and second spikes.
The ess of the tips of the spikes 14a, 14b is defined by the area of the surface that comes into contact with the skin. The smaller the surface area of the tip, the sharper the tip. In the case of l spikes with cal tips as shown in Figure 7, a r tip is a tip whose radius is smaller. Thus, in this case, the radius R2 of the tips of the second spikes 14b is preferably smaller than the radius R1 of the tips of the first spikes 14a. If d, the radii R1, R2, or only the radius R2, may be very small such that the corresponding tips may approximate perfect, discrete points. However, many other shapes are possible for the spikes 14a, 14b, such as truncated spikes with flat tips 14c as shown in Figure 8.
Preferably, the first and second spikes 14a, 14b are mixed to each other.
The first and second spikes 14a, 14b may be on respective concentric circles that are coaxial with the trough holes 4, 16, with the concentric circles for the first spikes 14a alternating with the concentric circles for the second spikes 14b as visible in Figure 6.
In further ments, more than two sets of spikes could be provided. In particular, a set of third spikes could be provided which would have a smaller height than the second spikes 14b so as to engage the patient’s skin when the eduction member 10 is applied with a third force greater than the second force required for the second spikes 14b to engage the skin. The third spikes could have sharper tips than the second spikes 14b.
In the ion as described above, the injection device 1 and the pain- reduction member 10 are two separate devices that can be assembled to one another. In a variant however, the pain-reduction member 10 could be integral with thegusing 2 of the injection device 1.
[Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk [Annotation] k None set by laveryk [Annotation] laveryk ionNone set by laveryk [Annotation] laveryk Unmarked set by laveryk The present ion as described above is particularly effective in reducing the pain caused by the penetration of the needle for patients having low pain tolerance. Tests have been carried out among ten subjects having the following characteristics: Category Value Age (years) Mean 1r standard deviation Range 23 - 40 Female 10 (100%) Caucasian 10 (100%) Body mass index ) Mean 1r standard deviation 24.4 1r 2.8 Among these ten subjects, six met the pre-specified definition of a low pain tolerance and were the focus of the analysis. These six subjects, immediately after receiving an injection of a placebo dose with the injection device 1 not fitted with the pain-reduction member 10, ed pain scores higher than 30 mm on a 100 mm Visual Analogue Scale (VAS). sive injections of placebo doses were carried out on each of these six subjects, with an injection device respectively fitted with pain-reduction members A, B, C, the order of the pain—reduction members A, B, C being randomly changed from one subject to another. For each subject the elapsed time between two successive injections was 30 s and the ions were atively made on the right and the left arms on different injection sites. Immediately after an injection (within 5 minutes), the subject indicated the magnitude of the pain associated with the injection she just received, by drawing a line on the Visual Analogue Scale. ation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk ation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk ed set by k The pain-reduction members A, B, C are distinguished from one another by the dimensions of their spikes. The pain-reduction members A and B are of the type shown in Figures 2 to 4, Le. they each have only one size of spikes 14. The pain-reduction member C, on the other hand, is of the type as shown in Figures 5 to 7, Le. it has two sizes of spikes 14a, 14b. With reference to Figure 9, the dimensions of the spikes of the eduction members A, B, C are detailed in the table below: Dimensions (in mm) A B C spacing (g) ~5 (4.1—6.6) ~5 (4.1-6.6) ~5 (4.1-6.6) height (h) 2 3 base diameter (b) 1.2 1.6 1.6/1 tip radius (r) 0.4 0.6 0.5/0.3 For the six subjects the pain felt during an injection was lower when the injection device was fitted with one of the pain-reduction members A, B, C than when the injection device was not fitted with any eduction member. The mean difference between the value on the Visual Analogue Scale when the injection device was fitted with one of the pain—reduction members A, B, C and the value on the Visual Analogue Scale when the injection device was not fitted with any pain-reduction member is indicated in the table below: Pain-reduction Mean absolute VAS change (mm) member [Annotation] laveryk None set by k [Annotation] k MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk The same mean difference, but expressed as a percentage of the value on the Visual Analogue Scale noted after an injection performed without a pain- reduction member, is indicated in the table below: Pain-reduction member Mean relative VAS change (%) It can be seen in particularthat the pain—reduction member C, with its spikes of different heights, base diameters and tip radii, provides the best results. The VAS score is reduced by 15 mm and by 22% with t to the VAS score obtained with the injection device not fitted with a pain-reduction member. 1003292375

Claims (15)

1. Injection device comprising: - a medicine container, 5 - means for injecting medicine from the medicine container to a patient through a needle, - a sensor for detecting contact of the patient’s skin with the skin contact surface, wherein a force of application of the ion device on the patient’s skin higher than the weight of the injection device is required 10 for the sensor to detect the patient’s skin, and - a skin contact surface crossable by the needle, said skin contact surface having protrusions which are pressed around the injection site when the injection device is applied on the patient’s skin for the injection, said protrusions being arranged so as to reduce the pain 15 caused by the penetration of the , wherein said protrusions comprise a set of first protrusions and a set of second protrusions, n the first protrusions come into t with the patient’s skin as the device is applied with a first force and the second sions come into contact with the patient’s skin as the device is applied with a 20 second force, the second force being greater than the first force.
2. Injection device according to claim 1, wherein the sensor is a capacitive or mechanical sensor.
3. Injection device according to claim 1 or 2, wherein the second protrusions have a smaller dimension, in the direction of the , than the first protrusions. 1003292375
4. Injection device according to any one of claims 1 or 3, wherein the second protrusions have sharper tips than the first protrusions.
5. ion device according to any one of claims 1 to 4, wherein the first and 5 second protrusions are arranged on the skin contact surface in a mixed manner.
6. Injection device ing to any one of claims 1 to 5, wherein the first protrusions are arranged on first circles, the second protrusions are 10 arranged on second circles, tric with the first circles, and the first and second circles are arranged in an alternating .
7. Injection device according to any one of claims 1 to 6, wherein the protrusions are in the form of spikes.
8. ion device according to any one of claims 1 to 7, comprising a member removably mounted on a housing of the injection device and defining the skin contact surface and its protrusions. 20
9. Injection device according to any one of claims 1 to 8, comprising a member removably mounted on a housing of the injection device, said member defining the skin contact surface and its protrusions and comprising another through hole in a region facing the sensor. 25
10. ion device ing to claim 8 or 9, wherein the member is elastically mounted on said housing.
11. Injection device according to any one of claims 8 to 10, wherein the member is transparent. 1003292375
12. Injection device according to any one of claims 8 to 11, wherein the member is in the form of a plate. 5
13. Injection device according to any one of claims 1 to 12, wherein the skin contact surface r ses feet which are arranged to rest on a flat surface, together with at least some of the protrusions, when the injection device is placed on said flat surface. 10
14. Injection device according to any one of claims 1 to 13, wherein the protrusions have a height within 1.8 mm and 3.3 mm, a base diameter within 0.9 mm and 1.8 mm and a tip radius within 0.2 mm and 0.7 mm.
15. Injection device according to any one of claims 1 to 14, wherein the first 15 protrusions have a height of about 3 mm, a base diameter of about 1.6 mm and a tip radius of about 0.5 mm and the second protrusions have a height of about 2 mm, a base diameter of about 1 mm and a tip radius of about 0.3 [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk ation] laveryk ed set by laveryk [Annotation] laveryk None set by laveryk [Annotation] laveryk MigrationNone set by laveryk [Annotation] laveryk Unmarked set by laveryk
NZ719893A 2013-11-14 2014-11-14 Medicine injection device with a pain-reduction member NZ719893B2 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
EP13005352.3 2013-11-14
EP13005352 2013-11-14
EP14165814 2014-04-24
EP14165814.6 2014-04-24
PCT/EP2014/074557 WO2015071390A1 (en) 2013-11-14 2014-11-14 Medicine injection device with a pain-reduction member

Publications (2)

Publication Number Publication Date
NZ719893A NZ719893A (en) 2021-01-29
NZ719893B2 true NZ719893B2 (en) 2021-04-30

Family

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