NL2024668B1 - Device for reciprocally puncturing skin - Google Patents

Device for reciprocally puncturing skin Download PDF

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Publication number
NL2024668B1
NL2024668B1 NL2024668A NL2024668A NL2024668B1 NL 2024668 B1 NL2024668 B1 NL 2024668B1 NL 2024668 A NL2024668 A NL 2024668A NL 2024668 A NL2024668 A NL 2024668A NL 2024668 B1 NL2024668 B1 NL 2024668B1
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Netherlands
Prior art keywords
driving
drive
needle
rod
longitudinal direction
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NL2024668A
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Dutch (nl)
Inventor
Jan De Jong Erik
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Medical Prec B V
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Publication date
Application filed by Medical Prec B V filed Critical Medical Prec B V
Priority to CA3147219A priority Critical patent/CA3147219A1/en
Priority to EP20756997.1A priority patent/EP4010059A1/en
Priority to US17/632,298 priority patent/US20220288373A1/en
Priority to CN202080071327.1A priority patent/CN114828935A/en
Priority to AU2020331379A priority patent/AU2020331379A1/en
Priority to JP2022507443A priority patent/JP2022543156A/en
Priority to PCT/NL2020/050504 priority patent/WO2021029767A1/en
Application granted granted Critical
Publication of NL2024668B1 publication Critical patent/NL2024668B1/en
Priority to IL290420A priority patent/IL290420A/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0076—Tattooing apparatus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3476—Powered trocars, e.g. electrosurgical cutting, lasers, powered knives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150175—Adjustment of penetration depth

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (AREA)
  • Medical Informatics (AREA)
  • Anesthesiology (AREA)
  • Virology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Device for puncturing skin in a reciprocal manner, wherein the device for puncturing skin comprises: a reciprocally movable needle; a driving device comprising driving mechanism and a driving rod that is arranged for driving the reciprocally movable needle between a retracted and extended position; wherein the driving mechanism are arranged for reciprocally driving the driving rod in a longitudinal direction along the longitudinal axis of the driving rod; wherein the driving device further comprises a suspension system arranged in between a frame member of the driving device and the driving rod and, wherein the suspension system is arranged for elastically suspending the driving rod in the longitudinal direction in the frame, such that the driving rod is freely movable in longitudinal direction and wherein the suspension system is further arranged for biasing the driving rod to a longitudinal neutral position.

Description

Device for reciprocally puncturing skin The present invention relates to a device for reciprocally puncturing skin.
In radiation therapy, or simply radiotherapy, a patient is typically locally subjected to a radiation beam to control or kill malignant cells. It is important that these beams are directed as accurately as possible onto the target to on the one hand ensure optimal therapy of these malignant cells and to on the other hand minimize damage to surrounding tissue upon exposure to the radiation beam.
To properly direct the radiation beams to the tissue as pre-operatively planned, it is known to apply small skin marks on the patient which can be used to automatically direct and align the beams as planned, for instance based on CT-scans of the patient. As radiation therapy typically involves subjecting the target to radiation beams repeatedly over time, sometimes several months, these marks need to remain during the course of therapy to ensure continued proper alignment. It is therefore known to introduce ink into the skin of the patient as skin mark.
Typically, for applying these marks, a small knife or scalpel is used. This knife is dipped in ink and subsequently introduced into the patient’s skin. This can be a painful process, in particular in regions on the patient with superficial bone structures such as the thorax. Further, dipping the ink takes time and may result in accidental drips of ink, while at the same time accidental punctures due to the exposed knife are a risk.
Device for introducing ink in skin, for instance tattooing devices for puncturing skin in a reciprocal motion are as such known from the field of tattooing or permanent makeup. Permanent marks are typically however not preferred by patients. Clearly, the use of a tattooing device for applying these radiation therapy marks would lead to undesired permanent marks.
It is a goal of the present invention, next to other goals, to provide an improved and/or more efficient driving device for a device for puncturing skin wherein at least one of the above mentioned problems is at least partially alleviated.
This goal, amongst goals, is achieved by a driving device for a device for puncturing skin in a reciprocal manner comprising a reciprocally movable needle, wherein the driving device comprises: a driving mechanism or means and a driving rod that is arranged for driving the reciprocally movable needle between a retracted and extended position; wherein the driving mechanism are arranged for reciprocally driving the driving rod in a longitudinal direction along the longitadinal axis of the driving rod;
wherein the driving device further comprises a suspension system arranged in between a frame member of the driving device and the driving rod and, wherein the suspension system is arranged for elastically suspending the driving rod in the longitudinal direction in the frame, such that the driving rod is movable in longitudinal direction and wherein the suspension system is further arranged for biasing the driving rod to a longitudinal neutral position.
Preferably, the extended position is set such that, when driving the reciprocally movable needle, the needle and therewith any ink, is only introduced in the epidermis of the patient’s skin. Other than for instance in the field of tattooing, where the ink is introduced in the tissue underlying the epidermis, this will result in a non-permanent mark. It was however found that the superficial marks as applied using the needle module of the current invention remain sufficiently long to allow continued proper alignment during the course of radiotherapy.
The thickness of the layers of skin may vary between patients. Preferably, said extended position is such that a needle penetration depth is 1,5 mm or less, even more preferably 1,2 mm or less, even more preferably 1,0 mm or less. The lower limit is defined such that the ink is introduced sufficiently deep in the skin and may for instance be 0,1 mm, preferably 0,2 mm. A preferred working range is between approximately 0,2 mm and approximately 0,8 mm.
As the suspension system elastically suspends the driving rod in the longitudinal direction in such a manner that, if the elastic force of the elastic suspension is overcome, the driving rod is still allowed to move in the longitudinal direction, i.e. the driving rod is not fixedly constrained in the longitudinal direction. Such a construction enables one to find a frequency range of driving the driving rod wherein the driving rod can be efficiently driven, i.e. requiring less power than when driven at a less beneficial frequency range, be driven. For instance, the device can be very efficiently driven around a resonance frequency (or Eigenfrequency) of the suspended driving rod.
It is further preferred if the suspension system is arranged such that the driving rod has a predefined resonance frequency in the longitudinal direction and wherein the driving mechanism are arranged for reciprocally driving the driving rod in a driving frequency, wherein the driving frequency is based on the resonance frequency. By arranging the suspension system such that the suspended driving rod has a predefined resonance frequency, the driving frequency range in which the reciprocating needle can be driven by the driving rod is known a priori. Hereby, one obtains a reliable and energy efficient manner of driving the reciprocating needle. As less power is required for reciprocally driving the driving rod and needle at, and/or around, the resonance frequency, this means that less power is to be supplied, consumed and converted by the driving mechanism for driving the driving rod, whereby the driving mechanism can be made smaller and cheaper. In addition, as less energy is consumed, also less heat is generated, which would otherwise need to be disposed of in order to prevent overheating of the device. These benefits can be achieved in particular by driving the device with a driving frequency in a range of 70% to 130% of the resonance frequency, preferably in a range of 80% to 120% of the resonance frequency, more preferably in a range of 90% to 110% of the resonance frequency, most preferably in a range of 95% to 105% of the resonance frequency.
In a preferred embodiment, the suspension system comprises two elastic elements that are arranged in between the driving rod and the frame member, and, preferably, wherein the first elastic element is arranged for biasing the driving rod in a first longitudinal direction with respect to the frame member and wherein the second elastic element is arranged for biasing the driving rod in a second longitudinal direction with respect to the frame member, wherein the second longitudinal is opposite to the first longitudinal direction. In other words, the two elastic elements are arranged to generate opposing elastic forces with respect to each other. Elastic elements will, when elastically deformed, generate an elastic force in reaction to the deformation. These types of elements are therefore highly suited for biasing the driving rod to the longitudinal neutral position, while at the same time allowing the driving rod to be displaceable in the longitudinal direction. It is further preferred that each elastic element is arranged to contact the frame member on a first end of the elastic element and the driving rod on a second end of the elastic element, such that, when in rest, the driving rod is biased to a neutral position, wherein the neutral position is located on, or in between, the retracted and extended positions. Preferably, in this neutral position the needle is not exposed from a housing. Hereby, the elastic elements can be arranged substantially parallel and at a distance with respect to each other. By locating the elastic elements near the ends of the driving rod, a compact construction of the suspension system is obtained. Also, the arrangement of the suspension system is such that the driving rod and elastic elements are arranged along the longitudinal direction of movement, such that the suspension system can be constructed in a relatively simple manner. Preferably, the elastic elements are arranged such that, upon movement of the driving rod in a first longitudinal direction from the neutral position, an increased deformation of at least the first elastic clement is caused and that, upon movement of the driving rod in a second longitudinal direction from the neutral position, whereby the second longitudinal direction is opposite from the first longitudinal direction, an increased deformation of at least the second elastic element is caused. Hereby, the driving rod is biased towards the neutral position. Suitable elastic elements are, for instance, compression springs, tension springs, coil-springs (compression and/or tension), made from metals such as (spring-) steel, suitable natural and/or synthetic rubber-like materials and/or other suitable synthetic and/or natural materials. Other types of suitable elastic elements are for instance also gas-springs
In a preferred embodiment, the driving device further comprising a controller, wherein the controller is arranged to control an amplitude of longitudinal displacement of the driving rod with respect to the neutral position and wherein the controller is, preferably, arranged for controlling the amplitude of longitudinal displacement by controlling a driving force generated by the driving mechanism and/or by means of controlling the driving frequency.
The controller is able to control the driving mechanism of the driving device, thereby enabling that the amplitude of the longitudinal displacement of the driving rod, which is reciprocally driven, can be set and controlled.
Hereby, the needle is driven by the driving rod between a retracted and extended position (which positions are based on the amplitude of the longitudinal motion), whereby the extended position is set such that it is prevented that the needle disposes ink in the tissue underlying the epidermis, which would then result in permanent markings, which is undesired.
Furthermore, if the driving frequency of the driving mechanism can be varied, as described above, this would then also results in a change of the ratio between the driving frequency and the predefined resonance frequency.
Due to this change in the ratio of frequencies, also in case of a fixed amplitude of the excitation force (i.e. the driving force), the amplitude of the reciprocal motion of the driving rod will also change.
If the difference between the driving frequency and the resonance frequency becomes less, the amplitude of motion will increase, if the difference becomes larger, the amplitude of motion will decrease.
Hence, the amplitude of motion of the driving rod can be controlled by the controller through a change in the driving frequency, the driving force and/or a combination of both.
By controlling the driving force, the amplitude of motion can simply be adapted by varying the force generated by the driving mechanism.
It is then further preferred that the driving device further comprises a measurement unit, wherein the measurement unit is arranged to measure a state variable, such as a displacement, velocity and/or acceleration of the driving rod along the longitudinal direction and/or the driving force in the tongitudinal direction of the driving mechanism, and wherein the controller is arranged to control, based on the measured state variable, the amplitude of longitudinal displacement.
Hereby, a closed loop feedback system is obtained based on the actual measured state variables, wherein the amplitude of displacement of the reciprocating motion of the driving rod, and thereby the retracted and extended position of the needle, can be accurately controlled by the controller, such that an accurate and energy- efficient device for puncturing skin in a reciprocal manner is obtained.
In a preferred embodiment of the device, the driving mechanism or means comprises an electromagnetic coil that is arranged to one of the frame member and the driving rod and wherein a magnetic {or ferromagnetic) portion is arranged on the other of the frame member and the driving rod, and wherein one of the electromagnetic coil and the magnetic portion, at least partially, surround the other of the electromagnetic coil and magnetic portion. The electromagnetic coil is arranged to allow an electric current to pass the coil, whereby an electromagnetic field is generated. As the one of the electromagnetic coil and the magnetic portion, at least partially, surround the other of the electromagnetic coil and magnetic portion, the electromagnetic field generated either attracts or 5 repulses the magnetic portion. The attractive or repulsive force thereby accelerates the driving rod along the longitudinal direction. The reciprocal motion is obtained by passing an alternating and/or dynamically controlled electric current with the driving frequency through the coils, thereby generating a alternating electromagnetic field with a frequency equal to the driving frequency. The amplitude of reciprocal longitudinal motion of the driving rod, and thereby the motion of the movable needle, can thereby be controlled by varying either the frequency of the alternating current through the coil, and/or by varying the amplitude of the alternating current, whereby the strength of the field and thereby the driving force is varied. Preferably, the driving mechanism comprise a plurality of electromagnetic coils, wherein, preferably, the controller is arranged for controlling and/or switching at least two of said electromagnetic coils with a different current and/or voltage for generating a respective plurality of magnetic fields. Hereby, the motion of the driving rod can be controlled more precisely, such that the possibility of an overshoot of the movable needle past the extended position, which could lead to permanent markings, is reduced. Also, the plurality of the electromagnetic coils increases the driving force that the driving mechanism can deliver, while also improving the efficiency of the device. It is further preferred that the plurality of electromagnetic coils are arranged on one of the frame member and the driving rod and are arranged parallel along the longitudinal axis of the driving rod, and wherein at least a part of the magnetic portion extends along the longitudinal axis between at least two electromagnetic coils in the extended and retracted position. Hereby, the at least two electromagnetic coils can cooperate to force the driving rod to move according to the required motion. This is for instance achieved by generating a set of cooperative attractive and repulsive forces that act on the driving rod. It is further noted that the driving mechanism or means can further comprise a plurality of the magnetic portions that are arranged to cooperate with the plurality of electromagnetic coils to further optimize driving the driving rod.
In a preferred embodiment of the device, the measurement unit comprises a secondary magnetic portion that is arranged in, or on, one of the frame member and the driving rod, and wherein the measurement unit further comprises a measurement coil that is arranged in, or on, the other of the frame member and the driving rod a longitudinal position that at least partially overlaps with a longitudinal position of the secondary magnetic portion. The relative motion between the secondary magnetic portion and the measurement coil generates changing magnetic fields, which, for instance, induce changing currents in the measurement coil. The motion of the driving rod with respect to the frame can be determined from these changing currents by, for instance, a suitable measurement interpreter or by the controller. It is further preferred that the secondary magnetic portion and the measurement coil are arranged and at distance from, and/or are insulated from, the magnetic portion(s) and/or the electromagnetic coil(s) of the driving mechanism. Influences and/or disturbances from the electromagnetic fields that originate from the electromagnetic coils of the driving mechanism are hereby minimized. These influences and/or disturbances can lead to measurement errors. It is further noted that a magnetic portion as mentioned throughout the text can be, or comprise, a permanent magnet, a section made from ferromagnetic materials, an electromagnetic coil and/or the like. In a preferred embodiment, the driving device comprises a guiding mechanism arranged for allowing only movement of the driving rod along the longitudinal direction. Hereby, the driving rod is securely retained in the driving device is all directions other than the longitudinal direction. The risk of a magnetic and/or electric short-circuit from the electrical coils contacting the opposing magnetic portions is hereby also minimized, whereby a reliable driving device can be obtained. In a preferred embodiment, the predefined resonance frequency of the suspended driving rod is in the range of 30Hz - 250Hz, preferably in the range of 50Hz - 200 Hz, more preferably in the range of 75Hz - 150Hz, most preferably around 100Hz or around 80Hz. A resonance frequency in this frequency range can be relatively easily obtained, without requiring the use of extra stiff and/or light materials, such that an economically attractive device is obtained. Also, the frequency is sufficient for relatively quickly placing markers that are sufficient for its intended use, such that a long and potentially painful process of placing markers is prevented as much as possible.
A preferred embodiment of the device is obtained if the reciprocally movable needle is comprised in a dismountable needle module, wherein the driving device is arranged to mount the needle module by means of a releasable force- and/or form-locked connection. Sterile needles are needed for each patient and/or other receiver of temporary markings. The use of dismountable needle modules enables that the needle module, comprising the needle, can easily be removed without the use of tools. It is then further preferred that the releasable force- and/or form-locked connection is a bayonet connection comprising a male and a female connector, and wherein the driving device comprises one of the male and female connectors. A bayonet connection is a reliable, practically fail-proof, connection that requires no use of specialized equipment for both locking and unlocking of needle modules to the driving device. Furthermore, a user can easily verify that the bayonet connection is correctly locked, which improves the safety of the device during use.
The goal amongst goals is further achieved by a device for puncturing skin in a reciprocal manner, comprising a reciprocally movable needle and a driving device according to any of the preceding claims. In a preferred embodiment of the device, the reciprocally movable needle is comprised in a needle unit that is arranged in a needle module, wherein the needle unit is arranged to be movable in the longitudinal direction with respect to the needle module. The device can, for instance, be very efficiently driven around a resonance frequency (or Eigenfrequency) of the suspended driving rod. The other advantages of such a device have been described earlier. It is further preferred that, when driving device is at rest, the movable needle is folly retained in the device, such that a needle tip is prevented from accidentally puncturing the skin of individual, such as a user.
It is further preferred that the device comprises a spacer element that is arranged in between the needle module and the driving device for arranging the needle module at a predefined distance from the driving device. Thereby, the distance the needle tip extends from the needle module can be altered, which results in a further reduction of possible unwanted permanent markings.
In a preferred embodiment, the driving device is arranged for releasable mounting of the needle module and/or the spacer element and comprises a first section of a releasable force- and/or form- locked connection, wherein the first section of the releasable force- and/or form-locked connection is arranged for engaging and connecting to a second section of the a releasable force- and/or form-locked connection that is arranged on the spacer element and/or the needle module. Sterile needles are needed for each patient and/or other receiver of temporary markings. The use of dismountable needle modules enables that the needle module, comprising the needle, can easily be removed without the use of tools. Preferably, the releasable force- and/or form-locked connection is a bayonet connection comprising a male and a female connector, and wherein the driving device comprises one of the male and female connectors and the needle module and/or spacer element comprises the other of the male and female connectors for forming the bayonet connection. As mentioned, a bayonet connection is a reliable, practically fail-proof, connection that requires no use of specialized equipment for both locking and unlocking of needle modules to the driving device. Furthermore, a user can easily verify that the bayonet connection is correctly locked, which improves the safety of the device during use. The present invention is further illustrated by the following figures, which show a preferred embodiment of the device according to the invention, and are not intended to limit the scope of the invention in any way, wherein: Figure | schematically shows a cross-sectional view of an embodiment of the device for reciprocally puncturing skin. Figure 2 schematically shows an equivalent dynamic model of the suspended driving rod.
Figure 3A shows the steady-state variation of the amplitude of longitudinal displacement of the driving rod (denoted as the “Amplitude of response”) with respect to the relative driving frequency. Figure 3B shows the steady-state variation of the normalized force per unit of longitudinal displacement of the driving rod (denoted as the “Amplitude of response”) with respect to the relative driving frequency.
Figure 1 schematically shows a cross-sectional view of an embodiment of the device 1 for reciprocally puncturing skin. The device 1 can comprise needle module 4, wherein a movable needle unit 41, comprising one or a plurality needles 45, is arranged. The needle unit 41 is arranged to be reciprocally driven in a first longitudinal direction 1, wherein a needle tip 42 is arranged for extending out of the distal end 43 of the needle module housing 44. The maximum displacement of the needle tip 42 in the first longitudinal direction I of a single cycle in the reciprocal motion, is referred to as the extended position. The extended position thereby determines the maximum penetration depth of the needle tip 42 into the skin. Preferably, said extended position is such that a needle penetration depth is 1,5 mm or less, even more preferably 1,2 mm or less, even more preferably 1,0 mm or less. The lower limit is defined such that the ink is introduced sufficiently deep in the skin and may for instance be 0,1 mm, preferably 0,2 mm. A preferred working range is between approximately 0,2 mm and approximately
0.8 mm. Preferably, the needle module 4 further comprises a safety spring 47 that ensures that the needle tip 42 is in the retracted position, i.e. the needle tip 42 is fully enclosed by the needle module housing 44. Hereby, cuts and/or injuries by the needle tip 42, when handling the separated needle modules 4, are prevented. The needle unit 41 can be arranged to be driven by a distal portion 22 of driving rod 20 of driving device 2. The driving rod 20 is preferably arranged in the center of the driving device 2, such that a substantially axisymmetric construction of the driving device 2 is obtained. In that case, the driving device 2 and/or a housing 10 that serves as a frame member for forming a base construction of the driving device 2 and the driving rod 20 share a common central axis L1. Preferably, the needle unit 41 and needle 45 also share the common central axis L1, such that a simple and efficient transfer of motion between the driving rod 20 and the needle unit 41 can be arranged.
The needle module 4 can be connected to the driving device by means of a spacer 3 for setting a predefined distance between the driving device 2 and the needle module 4. The spacer 3 in fact defines the distance of the needle module housing 44 and the distal end of the driving device 12. The needle unit 41 directly engages with the driving rod 20, such that the spacer 3 does not influence the relative position of the needle unit 41 with respect to the driving device 2. Hence, the spacer 3 thereby directly affects the position of the needle tip 42 with respect to the distal end 43 of the needle module 4 in such a manner that, as seen from the neutral position, a shorter spacer 3 results in that the needle tip 42 will be positioned closer to the distal end 43 of the needle module 4, whereas a longer spacer 3 results in the opposite effect. The distance that the needle tip 42 extends from the needle module housing 44 during use of the device 1, is thereby a function of the amplitude of motion wherein the driving rod 20 is driven and the length of the spacer 3.
Spacer 3 comprises, on its proximal side 34, a driving device connection comprising male and female spacer connector 31, 32, and wherein the spacer 3 comprises one of the male and female spacer connectors 31, 32 on, or near, its distal end 12. The spacer 3 then comprises the other of the male and female spacer connectors 31, 32 on, or near, its proximal end 34, which is on the opposite end of the distal end 35, where a needle module connection, comprising male and female needle module connector 33, 36, and wherein the spacer 3 comprises one of the male and female needle module connectors 33, 36 on, or near, its distal end 12. The needle module 2 then comprises the other of the male and female needle module connectors 33, 36. The needle module connection and/or driving device connections are preferably bayonet connections.
A leaf spring element 15 is arranged at, or near, the distal end 12 of the driving device 2 and serves to assure a precise and reliable connection between the needle module 4 and the spacer 3. Spacer 3 is mountable to the driving device 2 by moving the proximal end 34 of the needle module over the distal end 12 of the driving device 2 in an opposite longitudinal direction 11, which is the direction from the distal end 12 to the proximal end 13 of the driving device. Hereby, the leaf spring element 15 is pushed in, resulting in an elastic reaction force in the first longitudinal direction 1. From this point, the spacer 3 is rotated clockwise, or counter-clockwise, around the central axis 11, until a set of cooperation protrusions and/or recessions arranged on the male and female connectors 31, 32 engage through a snapping-type of operation. The leaf spring element 15 hereby ensures that the set of cooperation protrusions and/or recessions remains engaged, to prevent accidental decoupling. The spacer 3, for instance after use, is dismountable from the driving device 2 by the performing these steps in an opposite order. The needle module 2 is connectable to the spacer 3 using similar steps. Furthermore it is noted that the spacer 3 can be an integral part of the driving device 2, or an integral part of the needle module 4. In the former case, the needle unit 4 is directly connectable to the driving device 2 via the connection comprising needle module connectors 33, 36. In the latter case, the needle unit 4 is directly connectable to the driving device 2 via the connection comprising spacer connectors 31,32.
The driving rod 20 is for the most part enclosed by the housing 10, which surrounds and protects most of the inner parts of the driving device, whereby the distal portion 22 is allowed to extend from the housing 11 in order to engage the needle unit 41. The driving rod 29 can be suspended by suspension system 5 to be substantially only movable in the first longitudinal and opposite longitudinal directions I, 11. The driving rod 20 is elastically suspended in the longitudinal directions 1,11 by means of, for instance, two compression coil-springs 51, 52. The coil-springs 51, 52 can be equal to each other, but can also have properties different from one and the other. These coil-springs are arranged in between the driving rod 20 and housing 10, such that they deform upon a relative displacement of the driving rod 20 with respect to the housing 10 in at least the longitudinal directions 1, U. Coil-springs 51, 52 can be arranged between an inner wall 13 extending (radially) inwardly from housing 10 and an abutment shoulder 53 that is formed by an outwardly extending protrusion (in the radial direction) on the driving rod 20. These coil-springs can be arranged in such a manner on, or near, the distal portion 22 and/or proximal end 23 of the driving rod 20. By arranging the coil-springs 51, 52 with a certain predefined pre-loading, the driving rod 20 will be biased towards a neutral position when the device 1 is at rest, wherein the elastic forces of the coil-springs 51, 52 are statically in equilibrivim with each other.
The driving device 2 comprises the drive means 14 which is formed by an electromagnetic coil 11, or a plurality of coils, and a magnetic portion 21. The electromagnetic coil 11 can be formed on the inner side of the housing 10 which then encloses most of the inner parts of the driving device 2, as explained above. The magnetic portion 21 that can comprise, for instance, a ferromagnetic element (i.e. an iron section, core or the like), permanent magnet and/or a plurality of these, is comprised in the driving rod
20. The electromagnetic coil 11 at least partially surrounds the magnetic portion 21, such that an magnetic field that is generated by the electromagnetic coil 11 interacts with the magnetic portion 21 to generate a driving forces that forces the driving rod 20 to start moving. A reciprocal motion of the driving rod 20 can, for instance, be obtained by supplying an alternating current to the electromagnetic coil 11, which results in an alternating magnetic field and thereby in successively pushing the driving rod 20 in the first longitudinal direction I of its distal portion 22, or pulling the driving rod 20 in the opposite longitudinal direction II.
Measurement unit 6 can further be comprised in the driving device 2, wherein the measurement unit 6 is arranged to measure a state variable, such as a displacement, velocity and/or acceleration of the driving rod 20 along the longitudinal directions Il] and/or the driving force in the longitudinal directions 111 of the driving mechanism. A measurement coil 61 can be, for instance, arranged on the inner side of the housing 10, wherein the measurement coil 61 is arranged at a distance and/or insulated from the electromagnetic coil 11. On the driving rod 20, at a longitudinal position that corresponds at least partially with the longitudinal position of the measurement coil 61, a secondary magnetic or ferromagnetic section 62 is arranged, which is arranged at a distance and/or insulated from the magnetic portion 21 by, for instance, an insulator 63. The movement of the secondary magnetic or ferromagnetic section 62 through the measurement coil 61 induces inductive currents in the measurement coil 61, which can be measured and used for determining the movement of the driving rod 20 with respect to the housing 10.
Driving device 2 can further comprise a controller 7 that can be arranged for controlling the amplitude of longitudinal displacement by controlling a driving force generated by the driving mechanism and/or by means of controlling the driving frequency. This is for instance done by controlling the current and/or frequency of the alternating (or dynamically controlled) current that the electromagnetic coil 11 uses for driving the driving rod 20. Furthermore, the controller 7 can be arranged to control, based on the measured state variable, such as the displacement of the driving rod 20, that is measured by the measurement unit 6, the amplitude of longitudinal displacement. Hereby a closed loop control system can be obtained that used the directly measured acceleration, velocity or displacement of the driving rod 20 to dynamically control the amplitude and/or frequency of the current that is fed to the electromagnetic coil 11.
Figure 2 schematically shows the equivalent dynamic model of the suspended driving rod 20 to explain the working principle and technical advantage of the embodiment shown in figure 1. The driving rod 20 is hereby characterized as the mass m of the system, whereas the coil-springs 51, 52 are represented by stiffness’s £7, k2 and are arranged between the driving rod 20 and housing 10, and dashpots c/, c2 represent in a simplified equivalent manner, the losses due to friction, damping and other energy losses present in the device 1. For simplicity, it is assumed that the mass of the needle unit 41 and stiffness of safety spring 47 are negligible with respect to the mass and stiffness of the suspended driving rod 20. Nonetheless, the working principle also holds if this would not be the case. The resonance frequency of the suspended driving rod 20 is determined from the dynamic equation of the equivalent system shown in figure 2: mit + cit + ku =F, wherein k = k1 + k2; c = cl + ¢2; u, tt, ii denote the respective longitudinal displacement, velocity and acceleration of the driving rod 20; F denotes the applied (driving) force. The respective (undamped) resonance frequency wg and damping ratio of such a system is easily determined to be: — k . — € wg = [3 {= ok Assuming a relatively low damping, which results in low energy losses and is hence beneficial for the efficiency of the device, the steady-state dynamic amplification factor A of the system is determined to be: my (20900)? + (we? — w?)?
wherein w denotes the driving frequency of the system. By normalizing the mass of the system and by normalizing the driving frequency with respect to the resonance frequency, the dynamic amplification factor is shown in figure 3A. Here it is noted that, by driving the suspended driving rod 20 with a driving frequency that is equal to, and/or around, the resonance frequency, a large amplitude of displacement (amplitude of response) is obtained.
By inverting this relation, a normalized force per unit displacement relationship is obtained. Or, in other words, the relationship between a required force to obtain a certain displacement as a function of the normalized frequency. This relation is shown in figure 3B, where it is seen that at the resonance frequency a minimum force is required for driving the suspended driving rod 20 at a unit displacement. Hereby a device 1 for reciprocally puncturing skin is obtained that can be very efficiently driven around the Eigenfrequency of the suspended driving rod 20. In addition, the longitudinal displacement of the driving rod 20, and thereby the needle tip 42, can be controlled by controlling the driving frequency of the driving mechanism based on, or as a function of, the resonance frequency. The relation shown in figure 3B also enable feedforward control by the controller 7, as the a priori knowledge on the relation between longitudinal displacement of the driving rod 20 and the driving force generated electromagnetic coil 11 and/or the driving frequency can be available to the controller 7.
Note that the present invention is not limited to the embodiment shown, but extends also to other embodiments falling within the scope of the appended claims.

Claims (22)

ConclusiesConclusions 1. Aandrijfinrichting voor het aandrijven van een inrichting voor het op een reciproke wijze doorprikken van de huid omvattende een reciprook beweegbare naald, waarbij de aandrijfinrichting omwat: een aandrijfmechanisme en een aandrijfstang die is ingericht voor het aandrijven van de reciprook beweegbare naald tussen een teruggetrokken en uitgestrekte positie; waarbij het aandrijfmechanisme is ingericht om de aandrijfstang reciprook te bewegen in een longitudinale richting langs de longitudinale as van de aandrijfstang; waarbij de aandrijfinrichting verder een ophangsysteem omvat dat is aangebracht tussen een frame-clement van de aandrijfinrichting en de aandrijfstang, en waarbij het ophangsysteem is ingericht voor het elastisch ophangen van de aandrijfstang in de longitudinale richting in het frame, zodanig dat de aandrijfstang beweegbaar is in longitudinale richting en waarbij het ophangsysteem verder is ingericht voor het voorspannen van de aandrijfstang naar een longitudinale neutrale positie.A driving device for driving a device for piercing the skin in a reciprocal manner comprising a reciprocally movable needle, the driving device comprising: a driving mechanism and a driving rod adapted to actuate the reciprocally movable needle between a retracted and a retracted needle. extended position; wherein the drive mechanism is configured to reciprocally move the drive rod in a longitudinal direction along the longitudinal axis of the drive rod; wherein the driver further comprises a suspension system disposed between a frame member of the driver and the driver rod, and the suspension system is adapted to elastically suspend the driver rod in the longitudinal direction in the frame such that the driver rod is movable in the longitudinal direction. longitudinal direction and wherein the suspension system is further configured to bias the drive rod to a longitudinal neutral position. 2. Aandrijfinrichting volgens conclusie 1, waarbij het ophangsysteem zodanig is ingericht dat de aandrijfstang een vooraf bepaalde resonantiefrequentie in de longitudinale richting heeft en waarbij het aandrijfmechanisme is ingericht voor het reciprook aandrijven van de aandrijfstang in een aandrijffrequentie, waarbij de aandrijffrequentie gebaseerd is op de resonantiefrequentie.Drive device according to claim 1, wherein the suspension system is arranged such that the drive rod has a predetermined resonance frequency in the longitudinal direction and the drive mechanism is arranged to reciprocally drive the drive rod in a drive frequency, the drive frequency being based on the resonance frequency . 3. Aandrijfinrichting volgens conclusie 2, waarbij de aandrijffrequentie zich in het bereik van 70% tot en met 130% van de resonantiefrequentie bevindt.Drive device according to claim 2, wherein the drive frequency is in the range of 70% to 130% of the resonant frequency. 4. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies, waarbij de uitgestrekte positie zodanig is dat de een naaldpenetratiediepte 1,5 mm of minder is.Drive device according to at least one of the preceding claims, wherein the extended position is such that a needle penetration depth is 1.5 mm or less. 5. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies, waarbij het ophangsysteem twee elastische elementen omvat die zijn aangebracht tussen de aandrijfstang en het frame-element, en, bij voorkeur, waarbij het eerste elastische element is ingericht voor het voorspannen van de aandrijfstang in een eerste longitudinale richting ten opzichte van het frame- element en waarbij het tweede elastische element is ingericht voor het voorspannen van de aandrijfstang in een tweede longitudinale richting ten opzichte van het frame-clement, waarbij de tweede longitudinale richting tegengesteld is aan de eerste longitudinale richting.Drive device according to at least one of the preceding claims, wherein the suspension system comprises two elastic elements arranged between the drive rod and the frame element, and, preferably, wherein the first elastic element is adapted to bias the drive rod in a first longitudinal direction relative to the frame member and the second elastic member configured to bias the drive rod in a second longitudinal direction relative to the frame member, the second longitudinal direction being opposite the first longitudinal direction . 6. Aandrijfinrichting volgens conclusie 5, waarbij elk elastisch element is aangebracht om contact te maken met het frame-element aan een eerste uiteinde van het elastische element en de aandrijfstang aan een tweede uiteinde van het elastische element, zodanig dat in rust de aandrijfstang is voorgespannen naar cen neutrale positie, waarbij de neutrale positie zich bevindt op, of tussen, de teruggetrokken en uitgestrekte posities.Drive device according to claim 5, wherein each elastic element is arranged to contact the frame element at a first end of the elastic element and the drive rod at a second end of the elastic element, such that at rest the drive rod is biased. to a neutral position, where the neutral position is at, or between, the retracted and extended positions. 7. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies, waarbij de aandrijfinrichting verder een regelaar omvat, waarbij de regelaar is ingericht om een amplitude van longitudinale verplaatsing van de aandrijfstang ten opzichte van de neutrale positie te regelen en IO waarbij de regelaar, bij voorkeur, is ingericht voor het regelen van de amplitude van longitudinale verplaatsing door het regelen van een aandrijfkracht gegenereerd door het aandrijfmechanisme en/of door middel van het regelen van de aandrijffrequentie.Drive device according to at least one of the preceding claims, wherein the drive device further comprises a controller, wherein the controller is arranged to control an amplitude of longitudinal displacement of the drive rod from the neutral position and I0 wherein the controller, preferably , is adapted to control the amplitude of longitudinal displacement by controlling a driving force generated by the driving mechanism and / or by controlling the driving frequency. 8. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies, waarbij de aandrijfinrichting verder een meeteenheid omvat, waarbij de meeteenheid is ingericht voor het meten van een toestandsvariabele, zoals een verplaatsing, snelheid en/of versnelling van de aandrijfstang langs de longitudinale richting en/of de aandrijfkracht in de longitudinale richting van het aandrijfmechanisme, en waarbij, bij voorkeur, de regelaar is ingericht om, op basis van de gemeten toestandsvariabele, de amplitude van longitudinale verplaatsing te regelen.Drive device according to at least one of the preceding claims, wherein the drive device further comprises a measuring unit, wherein the measuring unit is adapted to measure a state variable, such as a displacement, speed and / or acceleration of the drive rod along the longitudinal direction and / or the driving force in the longitudinal direction of the driving mechanism, and wherein, preferably, the controller is arranged to control, based on the measured state variable, the amplitude of longitudinal displacement. 9. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies, waarbij het aandrijfmechanisme een elektromagnetische spoel omvat die is aangebracht op één van het frame- element en de aandrijfstang en waarbij een magnetisch gedeelte is aangebracht op de ander van het frame-element en de aandrijfstang, en waarbij één van de elektromagnetische spoel en het magnetische gedeelte, ten minste gedeeltelijk, de ander van de elektromagnetische spoel en het magnetische gedeelte omgeeft.Drive device according to at least one of the preceding claims, wherein the drive mechanism comprises an electromagnetic coil arranged on one of the frame element and the drive rod and a magnetic portion is arranged on the other of the frame element and the drive rod. , and wherein one of the electromagnetic coil and the magnetic portion surrounds, at least in part, the other of the electromagnetic coil and the magnetic portion. 10. Aandrij finrichting volgens ten minste één van de voorgaande conclusies, waarbij het aandrijfmechanisme een aantal elektromagnetische spoelen omvat, waarbij de regelaar bij voorkeur is ingericht voor het regelen en/of schakelen van ten minste twee van de elektromagnetische spoelen met een verschillende stroom en/of spanning voor het genereren van een respectief aantal magnetische velden.Drive device according to at least one of the preceding claims, wherein the drive mechanism comprises a number of electromagnetic coils, wherein the controller is preferably adapted to control and / or switch at least two of the electromagnetic coils with a different current and / or or voltage to generate a respective number of magnetic fields. 11. Aandrijfinrichting volgens conclusie 10, waarbij het aantal elektromagnetische spoelen op één van het frame-element en de aandrijfstang zijn aangebracht en parallel langs de longitudinale as van de aandrijfstang zijn aangebracht, en waarbij ten minste een deel van het magnetische gedeelte zich uitstrekt langs de longitudinale as tussen twee elektromagnetische spoelen in de uitgestrekte en teruggetrokken positie.The drive device of claim 10, wherein the plurality of electromagnetic coils are disposed on one of the frame member and the drive rod and are arranged in parallel along the longitudinal axis of the drive rod, and wherein at least a portion of the magnetic portion extends along the drive rod. longitudinal axis between two electromagnetic coils in the extended and retracted position. 12. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies 8 - 11, waarbij de meeteenheid een secundair magnetisch gedeelte omvat dat is aangebracht in, of op, één van het frame-element en de aandrijfstang, en waarbij de meeteenheid verder een meetspoel omvat die is aangebracht in, of op, de ander van het frame-element en de aandrijfstang een longitudinale positie die ten minste gedeeltelijk overlapt met een longitudinale positie van het secundaire magnetische gedeelte.Drive device according to at least one of the preceding claims 8-11, wherein the measuring unit comprises a secondary magnetic portion disposed in, or on, one of the frame member and the driving rod, and wherein the measuring unit further comprises a measuring coil which is disposed in, or on, the other of the frame member and the drive rod a longitudinal position at least partially overlapping with a longitudinal position of the secondary magnetic portion. 13. Aandrij finrichting volgens conclusie 12, waarbij het secundaire magnetische gedeelte en de meetspoel zijn opgesteld en op afstand van en/of zijn geïsoleerd van het magnetische gedeelte(n) en/of de elektromagnetische spoel(en) van het aandrij vingsmechanisme.Drive device according to claim 12, wherein the secondary magnetic portion and the sensing coil are arranged and spaced from and / or insulated from the magnetic portion (s) and / or the electromagnetic coil (s) of the drive mechanism. 14. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies, waarbij de aandrijfinrichting een geleidingsmechanisme omvat dat is ingericht om alleen beweging van de aandrijfstang langs de longitudinale richting toe te staan.Drive device according to at least one of the preceding claims, wherein the drive device comprises a guide mechanism adapted to permit movement of the drive rod only along the longitudinal direction. 15. Aandrij finrichting volgens ten minste één van de voorgaande conclusies 2 - 14, waarbij de vooral bepaalde resonantiefrequentie van de opgehangen aandrijfstang in het bereik is van 30Hz - 250Hz, bij voorkeur in het bereik is van 50Hz - 200 Hz, met meer voorkeur in het bereik is van 75Hz - 150Hz, met de meeste voorkeur rond 80Hz is.Drive device according to at least one of the preceding claims 2 - 14, wherein the especially determined resonance frequency of the suspended drive rod is in the range of 30Hz - 250Hz, preferably is in the range of 50Hz - 200Hz, more preferably in the range of 30Hz - 250Hz. the range is from 75Hz - 150Hz, most preferably around 80Hz. 16. Aandrijfinrichting volgens ten minste één van de voorgaande conclusies, waarbij de reciprook beweegbare naald is omvat in een afneembare naaldmodule, waarbij de aandrijfinrichting is ingericht om de naaldmodule te monteren door middel van een losneembare kracht- en/of vormgesloten verbinding.Drive device according to at least one of the preceding claims, wherein the reciprocally movable needle is comprised in a detachable needle module, wherein the drive device is adapted to mount the needle module by means of a detachable force and / or form-fit connection. 17. Aandrijfinrichting volgens conclusie 16, waarbij de losmaakbare kracht- en/of vormgesloten verbinding een bajonetverbinding is die een mannelijke en een vrouwelijke connector omvat, en waarbij de aandrijfinrichting één van de mannelijke en vrouwelijke connectoren omvat.Drive device according to claim 16, wherein the releasable force and / or form-fit connection is a bayonet connection comprising a male and a female connector, and wherein the drive device comprises one of the male and female connectors. 18. Inrichting voor het op een reciproke wijze doorprikken van de huid, omvattende een reciprook beweegbare naald en een aandrijfinrichting volgens ten minste één van de voorgaande conclusies.Apparatus for piercing the skin in a reciprocal manner, comprising a reciprocally movable needle and a driving device according to at least one of the preceding claims. 19. Inrichting volgens conclusie 18, waarbij de reciprook beweegbare naald is opgenomen in een naaldeenheid die is aangebracht in een naaldmodule, waarbij de naaldeenheid is ingericht om beweegbaar te zijn in de longitudinale richting ten opzichte van de naaldmodule.The device of claim 18, wherein the reciprocally movable needle is contained in a needle unit disposed in a needle module, the needle unit being arranged to be movable in the longitudinal direction relative to the needle module. 20. Inrichting volgens conclusie 19, verder omvattende een afstandselement dat is aangebracht tussen de naaldmodule en de aandrijfinrichting voor het aanbrengen van de naaldmodule op een vooraf bepaalde afstand van de aandrij finrichting.The device of claim 19, further comprising a spacer disposed between the needle module and the driver for mounting the needle module at a predetermined distance from the driver device. 21. Inrichting volgens conclusie 19 of 20, waarbij de aandrijfinrichting is ingericht voor het losneembare monteren van de naaldmodule en/of het afstandselement en een eerste gedeelte van een losneembare kracht- en/of vormgesloten verbinding omvat, waarbij het eerste gedeelte van de losneembare kracht- en/of vormgesloten verbinding is ingericht voor het aangrijpen en verbinden aan een tweede gedeelte van de losneembare kracht- en/of vormgesloten verbinding die is aangebracht op het afstandselement en/of de naaldmodule.A device according to claim 19 or 20, wherein the drive device is adapted to detachably mount the needle module and / or the spacer element and comprises a first portion of a detachable force and / or form-fit connection, wherein the first portion of the detachable force - and / or form-fit connection is adapted to engage and connect to a second part of the releasable force- and / or form-fit connection which is arranged on the spacer element and / or the needle module. 22. Inrichting volgens conclusie 21, waarbij de losneembare kracht- en/of vormgesloten verbinding een bajonetverbinding is die een mannelijke en een vrouwelijke connector omvat, en waarbij de aandrijfinrichting één van de mannelijke en vrouwelijke connectoren omvat en de naaldmodule en/of afstandselement de ander van de mannelijke en vrouwelijke connectoren omvat voor het vormen van de bajonetverbinding.The device of claim 21, wherein the releasable force and / or form-fit connection is a bayonet connection comprising a male and a female connector, and wherein the driving device comprises one of the male and female connectors and the needle module and / or spacer element the other. of the male and female connectors to form the bayonet connection.
NL2024668A 2019-08-09 2020-01-14 Device for reciprocally puncturing skin NL2024668B1 (en)

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Application Number Priority Date Filing Date Title
CA3147219A CA3147219A1 (en) 2019-08-09 2020-08-10 Device for reciprocally puncturing skin
EP20756997.1A EP4010059A1 (en) 2019-08-09 2020-08-10 Device for reciprocally puncturing skin
US17/632,298 US20220288373A1 (en) 2019-08-09 2020-08-10 Device for reciprocally puncturing skin
CN202080071327.1A CN114828935A (en) 2019-08-09 2020-08-10 Device for reciprocally puncturing skin
AU2020331379A AU2020331379A1 (en) 2019-08-09 2020-08-10 Device for reciprocally puncturing skin
JP2022507443A JP2022543156A (en) 2019-08-09 2020-08-10 A device that reciprocally punctures the skin
PCT/NL2020/050504 WO2021029767A1 (en) 2019-08-09 2020-08-10 Device for reciprocally puncturing skin
IL290420A IL290420A (en) 2019-08-09 2022-02-07 Device for reciprocally puncturing skin

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US5471102A (en) * 1994-05-09 1995-11-28 Becker; Gregory R. Reciprocating shaft device
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US20080082023A1 (en) * 2005-03-03 2008-04-03 Frank Deck Puncturing system for withdrawing a body fluid
US20160346519A1 (en) * 2007-06-29 2016-12-01 Actuated Medical, Inc. Reduced Force Device for Intravascular Access and Guidewire Placement
CN108042905A (en) * 2017-12-04 2018-05-18 李雪 A kind of tattooning penlike device of electromagnetic propulsion
WO2019112430A1 (en) * 2017-12-06 2019-06-13 Medical Precision B.V. Device and needle module for puncturing skin

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Publication number Priority date Publication date Assignee Title
GB1331024A (en) * 1971-03-11 1973-09-19 Jzd Mir Device for marking animals
US5471102A (en) * 1994-05-09 1995-11-28 Becker; Gregory R. Reciprocating shaft device
US20080082023A1 (en) * 2005-03-03 2008-04-03 Frank Deck Puncturing system for withdrawing a body fluid
US20080055028A1 (en) * 2006-08-31 2008-03-06 Thomas Mask Inline electromagnetic tool actuator
US20160346519A1 (en) * 2007-06-29 2016-12-01 Actuated Medical, Inc. Reduced Force Device for Intravascular Access and Guidewire Placement
CN108042905A (en) * 2017-12-04 2018-05-18 李雪 A kind of tattooning penlike device of electromagnetic propulsion
WO2019112430A1 (en) * 2017-12-06 2019-06-13 Medical Precision B.V. Device and needle module for puncturing skin

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