Handheld device for inserting a needle into a heterogeneous material, in particular for intravenous catheterization
阅读说明:本技术 用于将针***非均质材料中、尤其是用于静脉导管***的手持装置 (Handheld device for inserting a needle into a heterogeneous material, in particular for intravenous catheterization ) 是由 莱昂纳多·塞拉德马托斯 成卓奇 布莱恩·L·戴维斯 达尔文·戈登·卡尔德威尔 于 2018-05-28 设计创作,主要内容包括:一种用于将针(16)的尖端(18)精确地定位到血管(V)中的期望目标位置处的手持设备(10),其包括:壳体(12),其适于由操作者手持;轴(14),轴沿着纵向轴线(x)延伸并且在其远端处承载针(16),轴(14)安装在壳体(12)中;分离或致动装置(22,22’),其分别能够在操作上将轴(14)与壳体(12)分离;检测装置(26),其被布置为提供指示针尖(18)必须插入其中的血管的至少一个物理特性的信号;以及控制装置(24),其与分离或致动装置(22,22’)和检测装置(26)在操作上连接,并且被配置成基于从检测装置(26)接收的信号来确定针尖(18)是否已经到达目标位置,并且分别操作分离或致动装置(22,22’)以使轴(14),并且因此使针(16)与壳体(12)分离,或者使轴(14),并且因此使针(16)相对于壳体(12)主动地移动。(A handheld device (10) for accurately positioning a tip (18) of a needle (16) at a desired target location in a blood vessel (V), comprising: a housing (12) adapted to be held by an operator; a shaft (14) extending along a longitudinal axis (x) and carrying a needle (16) at its distal end, the shaft (14) being mounted in the housing (12); -separating or actuating means (22, 22') respectively able to operatively separate the shaft (14) from the housing (12); a detection arrangement (26) arranged to provide a signal indicative of at least one physical characteristic of a blood vessel into which the needle tip (18) must be inserted; and control means (24) operatively connected with the detachment or actuation means (22, 22') and the detection means (26) and configured to determine whether the needle tip (18) has reached the target position based on a signal received from the detection means (26) and to operate the detachment or actuation means (22, 22') to detach the shaft (14) and thus the needle (16) from the housing (12) or to detach the shaft (14) and thus the needle (16) actively relative to the housing (12), respectively.)
1. A hand-held device (10) for inserting a needle (16) into a heterogeneous material, such as a blood vessel (V), comprising:
a housing (12) adapted to be held by an operator;
a shaft (14) extending along a longitudinal axis (x) and carrying the needle (16) at its distal end, the shaft (14) being mounted in the housing (12) and generally coupled with the housing (12) so as to move with the housing as a single piece along the longitudinal axis (x); and
a separation device (22) operable to separate the shaft (14) from the housing (12) such that the shaft (14) is movable relative to the housing along the longitudinal axis (x);
characterized in that the device further comprises:
a detection device (26) arranged to provide a signal indicative of at least one physical characteristic of a material into which the needle tip (18) must be inserted; and
a control device (24) operatively connected with the separation device (22) and the detection device (26) and configured to determine whether the needle tip (18) has reached the target position based on a signal received from the detection device (26) and to operate the separation device (22) to separate the shaft (14) from the housing (12) and thus the needle (16) from the housing (12).
2. The device of claim 1, wherein the decoupling device (22) is configured to normally clamp the shaft (14) to couple the shaft to the housing (12) and operable to release the shaft (14) to allow the shaft to move relative to the housing (12) along the longitudinal axis (x).
3. The device of claim 1 or 2, wherein the disengagement device (22) comprises an electrically-operated clutch operable between an engaged position in which the electrically-operated clutch clamps the shaft (14) such that the shaft (14) is coupled to the housing (12); in the disengaged position, the electrically-operated clutch releases the shaft (14), thereby allowing the shaft (14) to move relative to the housing (12).
4. The device of claim 1 or 2, wherein the separation device (22) comprises a tubular pressurized container mounted in the housing (12) so as to move as a single piece therewith and defining a central passage (34) through which the shaft (14) extends, whereby the container clamps the shaft (14) within the passage (34) when pressurized and does not clamp the shaft (14) when deflated, thereby allowing the shaft (14) to move relative to the container.
5. A hand-held device (10) for inserting a needle (16) into a heterogeneous material, such as a blood vessel (V), comprising a housing (12) adapted to be held by an operator and a shaft (14) extending along a longitudinal axis (x) and carrying said needle (16) at its distal end, said shaft (14) being mounted in said housing (12) and generally coupled with said housing (12) so as to move together with said housing as a single piece along said longitudinal axis (x),
characterized in that the device further comprises:
an actuating device (22') for actively moving the shaft (14) relative to the housing (12) in either direction along the longitudinal axis (x);
a detection device (26) arranged to provide a signal indicative of at least one physical characteristic of a material into which the needle tip (18) must be inserted; and
a control device (24) operatively connected with the actuation device (22') and the detection device (26) and configured to determine whether the needle tip (18) has reached the target position based on a signal received from the detection device (26) and to operate the actuation device (22') to move the shaft (14) relative to the housing (12) and thus the needle (16) relative to the housing (12).
6. The device according to claim 5, wherein the actuation means (22') is formed by a motorized linear mechanism (36, 38, 40) arranged to move the shaft (14) back and forth along the longitudinal axis (x) under the control of the control means (24) to hold the needle tip (18) in the target position to automatically compensate for any forward or backward movement of the housing (12) relative to the non-homogeneous material caused by the operator.
7. The device according to claim 6, wherein the motorised linear mechanism (36, 38, 40) comprises an electric motor (36) and a motion conversion mechanism (38, 40) arranged to convert a rotary motion generated by the electric motor (36) into a translational motion of the shaft (14) along the longitudinal axis (x).
8. The apparatus of any of claims 5 to 7, further comprising: a catheter (20) mounted around the needle (16) and an operating handle (46) movable relative to the housing (12) in a direction parallel to the longitudinal axis (x) for inserting the catheter (20) into the heterogeneous material.
9. The device according to claim 8, wherein the actuation device (22') is arranged to: when the needle tip (18) has reached the target location and the operating handle (46) is moved relative to the housing (12) to insert the catheter (20) into the heterogeneous material, the shaft (14) is moved relative to the housing (12) in a direction opposite to the direction of movement of the operating handle (46) to withdraw the needle (16) from the heterogeneous material.
10. The device according to claim 8 or claim 9, further comprising a support member (48) configured to support the device (10) on the heterogeneous material and being slidably mounted relative to the housing (12) in a direction parallel to the longitudinal axis (x), and a clutch device (52) switchable between a first position in which the clutch device allows the housing (12) to freely slide relative to the support member (48) and a second position in which the clutch device couples the housing (12) with the support member (48) thereby preventing relative movement of the housing (12) relative to the support member (48).
11. The device according to any one of the preceding claims, wherein the detection device (26) is configured to sense an acoustic or near-acoustic signal of the needle (16) or an electrical resistance between the needle tip (18) and the shaft (14).
Technical Field
The present invention relates to a handheld device for inserting a needle into a heterogeneous material, in particular for intravenous catheterization.
Background
EP0730880A, on which the preambles of independent claim 1 and independent claim 5 are based, discloses a manual catheter insertion device provided with a needle retraction actuation mechanism. The purpose of this known device is to improve the catheterization process, as it helps the medical technician to correctly handle the needle to avoid contaminated needle stick injuries. The device includes a generally hollow barrel housing a needle hub. The needle is secured to the distal end of the hub and is aligned to extend through an opening in the distal end of the barrel. The needle extends through the catheter hub and a catheter secured to the catheter hub. The device further includes a spring disposed within the barrel lumen to engage the needle hub to urge the needle hub toward the proximal end of the barrel. The latch actuator is releasably engaged with the catheter hub. A latch cooperating with the latch actuator is movable between a first position in which the latch holds the hub adjacent the distal end of the barrel and a second position; in the second position, the latch allows the spring to push the hub to the proximal end of the barrel. The operator may experience discomfort during needle insertion or during post-penetration needle extraction due to vibration caused by the actuation of the spring. Furthermore, this known device does not guide the insertion of the needle into the material.
Disclosure of Invention
It is therefore an object of the present invention to provide a hand-held device for accurately positioning the tip of a needle in a non-homogenous material, in particular for intravenous catheter insertion, which is safer and more comfortable to use than the above mentioned prior art.
The objects of the invention and others are fully achieved according to the invention by means of a device having the features set out in independent claim 1 and in independent claim 5.
Advantageous embodiments of the invention form the subject of the dependent claims, the content of which is intended to form an integral part of the following description.
In short, the invention is based on the following idea: providing an apparatus, the apparatus comprising: a separation or actuation means operatively arranged between the needle and the housing for separating the needle from the housing such that the needle does not move as a single piece along the longitudinal axis of the housing together with the housing or for moving the needle in a controlled manner along the longitudinal axis of the needle in an opposite direction with respect to the housing during insertion; also included is a detection device configured to detect that the needle tip has reached a target location in the heterogeneous material; and control means operatively connected to said separating or actuating means and to said detecting means, and configured to operate said separating or actuating means upon detection by said detecting means that the needle tip has reached the target position.
By virtue of this structure, the device of the invention allows to introduce the needle into the target heterogeneous material, thus stopping the needle tip in the correct position or retracting it, even if the operator moves the housing of the device forward into the material. This is particularly helpful when performing e.g. intravenous catheter insertion, especially for difficult patients, such as children, elderly patients or diabetics. Furthermore, with such a device, the operator requires less training to obtain good injection results.
Drawings
Further characteristics and advantages of the invention will become apparent from the following detailed description, given by way of non-limiting example only, with reference to the accompanying drawings, in which:
fig. 1 schematically shows a hand-held device for inserting a needle into a heterogeneous material according to the present invention;
fig. 2a and 2b are schematic views showing a first embodiment of a device according to the invention in a first operating state in which the needle is coupled to the housing of the device and in a second operating state, respectively; in a second state, the needle is separated from the housing;
fig. 3 is a schematic view showing a second embodiment of the device according to the invention in the second operating condition described above;
figures 4a and 4b are schematic views showing a third embodiment of the device according to the invention in the first and second operating conditions described above, respectively;
FIG. 5 is a schematic diagram showing a fourth embodiment of the apparatus according to the present invention;
6a, 6b and 6c are schematic views showing a fifth embodiment of the device according to the invention in a first, second and third operating state, respectively, wherein in the first operating state both the needle and the catheter are coupled to the handle and the housing is freely movable along the longitudinal axis of the needle relative to the support member; in a second operating state the needle tip has reached the blood vessel and the body is locked to the support member; in a third operating condition with the body still locked to the support member, the handle is advanced to move the catheter further into the blood vessel and simultaneously retract the needle;
figures 7a, 7b and 7c are schematic views showing a sixth embodiment of the device according to the invention in said first, second and third operating conditions, respectively; and
fig. 8a, 8b and 8c are schematic views showing a seventh embodiment of the device according to the invention in said first, second and third operating states, respectively.
Detailed Description
The invention will be described hereinafter with particular reference to a catheterization procedure, i.e. the application of a catheter into a blood vessel. However, this particular application should not be construed as limiting the scope of the invention as the invention may be used in many other applications such as tissue biopsy (e.g. from brain, liver, etc.), brachytherapy (i.e. insertion of radioactive seeds into a patient for cancer treatment), blood sampling (i.e. insertion of needles into blood vessels), or spinal cord puncture.
Fig. 1 shows a very schematic representation of a handheld catheter insertion device (hereinafter simply referred to as "device") according to the present invention, wherein the device is generally indicated at 10.
Referring to fig. 1, the
The
The
In order to inform the
The
Referring now to fig. 2a and 2b, a first embodiment of the invention is shown in which the
According to this embodiment, the
In the case of the
Fig. 3 shows a second embodiment of the invention, in which parts and elements identical or corresponding to fig. 2a and 2b are indicated with the same reference numerals, which differs from the first embodiment of fig. 2a and 2b in that the
In this case, the
Referring now to fig. 4a and 4b, a third embodiment of the invention is shown in fig. 4a and 4b, in which parts and elements identical or corresponding to those of fig. 2a and 2b are indicated by the same reference numerals, which embodiment differs substantially from the first embodiment of fig. 2a and 2b only in the structure of the
In the third embodiment, in practice, the
Referring now to fig. 5, in which parts and elements identical or corresponding to those in the previous figures have been given the same reference numerals, according to another embodiment of the invention, the device comprises an actuation unit 22 'instead of the
The motorised linear mechanism may comprise, for example, an
According to the illustrated embodiment, the
Fig. 6a to 6c, 7a to 7c and 8a to 8c show further embodiments of the device according to the invention, in which parts and elements identical or corresponding to those in fig. 5 have been given the same reference numerals, the device comprising an actuation unit arranged to actively move the shaft and thus the needle back and forth relative to the housing to compensate for any possible movement of the housing, and in which the catheter can be inserted into the vein while the needle is withdrawn from the vein.
Referring first to the embodiment shown in figures 6a to 6c, the
As shown in fig. 5a, a forked locking
When the
When the
Upon detecting by the
At this point, as shown in fig. 6c, the operator moves the
Thus, the device of fig. 6a to 6c allows the following three different actions to be performed:
i) separating the
ii) withdrawing the
iii) inserting the
The
a)
b) the
c) the
d) battery level.
The device may also be connected wirelessly or by wire to an external computer system (not shown) for transmitting in real time the measurements obtained by the sensor unit and/or internal parameters indicative of the operating state of the device and for remote control operation.
The embodiment of fig. 7a to 7c differs from the embodiment of fig. 6a to 6c mainly in that: as a swing arm for converting the translational movement of the
Finally, fig. 8a to 8c show a further embodiment, which differs substantially from the embodiment of fig. 7a to 7c only in that: the gear mechanism as a means for converting translational movement of the
As far as the
The advantages of the present invention over the prior art are apparent in view of the above description.
First of all, by means of the sensor unit of the invention, the invention allows to determine whether the needle tip has reached a target position, and by means of the separation or actuation unit, the invention allows to separate the needle from the housing of the device and thus avoid passing over the target, even if the operator moves the device further towards the material, or actively moves the needle back and forth with respect to the housing, the device of the invention allows the operator, even those who are not very skilled, to precisely position the needle tip in the desired position and to keep it in this position, thereby significantly reducing the working pressure of the operator, especially when difficult patients (such as children, elderly or diabetics) have to be treated.
Furthermore, the device of the invention has a light and compact structure, which facilitates the operation of the device by the operator and is also inexpensive to manufacture.
Naturally, the principle of the invention remaining the same, the embodiments and the constructional details may vary widely from those described and illustrated purely by way of non-limiting example, without thereby departing from the scope of the invention as defined in the appended claims.
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