This application is a 371 of International Application PCT/RU2012/000607 filed 24 Jul. 2012 entitled “Device For The Painless And Minimally Invasive Parenteral Administration Of Pharmaceutical Preparations And Sampling Of Blood”, which was published on 7 Feb. 2013 with International Publication Number WO 2013/0191419 A1 and which claims priority from Russian Patent Application 2011131946, filed 1 Aug. 2011, the content of which are incorporated herein by reference.
The present invention relates to painless and low invasive parenteral administration of pharmaceutical preparations and blood sampling.
The invention may be used in medical institutions and is also suitable for personal use according to the above purpose.
A number of analogs of the claimed device are commercially available.
In particular, Site-Rite 5 (available from BARD Access, US) is known, which is a special ultrasound scanner for catheterization of central veins, provided with a linear multi-frequency 5-11 MHz sensor and a guidance puncture needle. This set (ultrasound scanner, sensor) costs over 1 million rubles.
Known is a device provided with a piezosensor disposed within a needle bore, wherein the Doppler effect is used to find the venous bed (US Patent Application No. 2007-0016069). Under visual inspection of a medical technician, transdermal puncture is performed whereafter the blood flow direction is identified using light and sound indications on an external device. However, since the ultrasonic beam and the needle have the same directivity, the so called “needle yawing” occurs. After the vein has been found, it is punctured. The sensor is then removed from the vein bore and further manipulations are performed.
The disadvantages of this device include:
painful sensations felt until the vein is found;
probable formation of an air gap within the needle between the sensor and the tissues so that the sensor operation is disturbed;
the sensor may be used only once;
uncased sensor cannot be used due to its unstable operation as a result of becoming clogged with the pieces of tissues from the space between the needle walls and the plate itself or complete non-conductibility to the dense tissues because of an air cushion;
high cost of the case-type sensor.
In addition, known is a so called Vein Viewer device available from Christie (U.S. Pat. No. 5,969,754), wherein based on a difference in absorptivity between the skin and the veins due to the presence of hemoglobin in the former, veins are detected by means of the IR technique and visualized on an illuminated projection directly onto the area under study thereby facilitating the task. This technique was originally used for verification of the so called “venous ID” and its inherent complete authenticity of a human. This device may only be operated by skilled professionals and physicians, is intended for use at hospitals and is expensive (25,000 USD). Similar equipment is also used by AccuVien (priced at 6,900 USD).
This device is the closest prior art.
The disadvantages of all the above cited prior art devices include:
precision targeting of the needle is impossible to puncture the vein due to the presence of the “human factor” because the needle is introduced by a human operator;
the laser aperture has to be positioned exactly at an angle of 90 degrees to the vein to avoid the lateral image shift resulting in presentation of a “virtual” vein whose projection disagrees with the actual vein;
the “actual” vein size may differ since unless the laser aperture is at 18 cm from the skin surface, a “play of projection” occurs;
no pre-anesthesia is provided in the device as such;
a high cost of the device.
The claimed device differs from the prior art primarily in the following:
the procedure of administering the pharmaceutical preparation is painless and low-invasive;
pre-anesthesia is provided;
the vein bore is hit with a high accuracy (above 99.9%);
the “human factor” is minimized;
injections may be made without assistance;
lower production costs;
a low “injection” cost.
The claimed device comprises a basic modification composed of a set including a cuff similar to the cuff for measuring the arterial tension, a fastening frame, a slide disk, a needle holder cartridge, an anesthetic flask, a scanning device and a light and/or sound component.
The needle holder, the needle holder cartridge and the anesthetic flask tube are all disposable.
The cuff is designed such that a built-in scanning device for locating the vein is arranged therein. It is programmed to determine the vein thickness and depth. The scanning device and the light and/or sound component are not the subject matter of the present invention.
The cuff comprises a strip of fabric for wrapping around the patient's arm and fixing thereon. Fixation may be accomplished by various means.
In particular, fixation may be accomplished by pumping of air into the flat soft bag inside the cuff. However, pumping is limited by the air pressure (not more than 60 mm Hg).
The cuff ends may by connected to each other for example using a Velcro-type fastener.
A working cutout for arranging the fastening frame therein is provide in the cuff.
The fastening frame is a rectangle provided on the inner part of its longitudinal side with stepwise teeth holding the slide disk. The frame lower part arranged from the patients' arm side is provided along its perimeter with a projecting edge immediately contacting the patient's arm surface. In the recess formed between the frame inner edge and the projecting edge, a lower edge of the slide disk is arranged. On one of the transversal sides of the frame, a receiver bushing is provided with a through hole in the form of a bore, truncated from the patient's arm side, and a fastening projection on the outer side of the bushing for holding and fastening the anesthetic flask. The frame is further provided with working holes arranged in pairs, with connection grooves formed therein for fastening the frame to the cuff.
The slide disk arranged within the fastening frame is made of two half-disks, a front one and a rear one. In a free state, the half-disks are kept at distance from one another by spring-loaded members. This design allows the disks to be removed and replaced and also to cause the disk to move along the frame and to rotate around its own axis since when the two half-disks are pressed together, the slide disk teeth disengage from the frame teeth. The lower part of the half-disks is provided with stepwise teeth for engaging the half-disks in the fastening frame. The half-disks have a base provided with a projecting lower edge. The rear half-disk is formed with a bore for receiving the holder cartridge. On the inner walls of the bore for receiving the cartridge, fixing teeth are formed engaging the teeth on the cartridge clips. Within an end projection of the rear half-disk, a bore is formed for receiving the scanning device.
The rear half-disk is provided with an end projection with two cylindrical holes on its sides with threaded connections for receiving a screw and a helical spring-loaded member received by an end recess of the front half-disk. An end portion of the front half-disk is also provided with two through holes with a widening at the outer side for receiving the countersunk screw heads and with a widening at the inner side for receiving the helical spring-loaded member. The holes in the rear and front half-disks are arranged coaxially and the screw length is selected such that when the half-disks move toward each other, the screw head will be slightly projecting from the hole so that the front half-disk motion will be only limited by the screw head. The screw is connected to the rear half-disk with a threaded connection. Clamping pads are arranged on the opposite side of the slide disk assembly.
Within the rear half-disk, a bore is formed for receiving the holder cartridge serving as a housing for the needle holder and comprising a chamfered end parallelepiped provided with a contact edge arranged at the point of contact with the skin and having a polymeric material attached thereto and hermetically sealing the hole. Clips with locks are arranged at the cartridge edges and the cartridge interior comprises a circular through hole with a thrust pad forming a truncated cylindrical bore along the inner walls of which guides are arranged for the holder ridges to prevent its rotation around its axis and also to fix the teeth for engaging the holder teeth.
The holder is a cylindrical element provided on its outer side with ridges for the holder cartridge guides, large and small fixing teeth engaging the teeth on the inner side of the holder cartridge, a sealed cover, a working saw cut ending with a projection and operable to limit the linear motion of the holder within the cartridge, wherein from the cylindrical element end directed toward the arm and beveled at an angle, a plurality of microneedles of a uniform length projects in communication with an internal receptacle by means of the bores passing into a common bore whose upper part widens to form a flared end, and wherein the points of microneedles form a visual plane parallel to the chamfered end of the holder provided with the sealed cover having a cone-shaped plug.
The anesthetic flask attached to the transversal side of the fastening frame using the receiver bushing with the through hole comprises a flask tube and an adapter which are connected by means of a threaded connection. The flask tube comprises a housing formed as a ridged cap with a cylindrical hollow projecting receptacle for anesthetic with a thread provided on the outer side thereof and a membrane on the end portion thereof. The adapter is provided with a cylindrical cell having a hollow puncture needle inside directed toward the membrane of the flask tube when connected. On the opposite side of the adapter, a bushing is arranged with a bore for anesthetic and on the outer portion, a lock is arranged for fastening to the receiver bushing of the fastening frame.
The cuff is applied to the patient's arm, in particular to the cubital vein (bend of elbow) and is fixed on the arm by any known method. In doing so, the working cutout with the fastening frame and the slide disk are located above the bend of elbow. The slide disk is caused manually to move along the fastening frame with the aid of clamping pads of the slide disk and to this end, the half-disks are pressed together and the fixing teeth on the half-disks disengage from the teeth on the fastening frame.
The detection of a vein by the scanning device sensor is recorded by means of a light and/or sound indication. Clamping of the half-disks is ceased and the slide disk is held in place.
The medical staff or the patient himself places the anesthetic flask onto the fastening frame.
The cartridge with the needle holder is inserted into the bore for receiving the slide disk cartridge. The set composed of the cartridge and the holder is taken out of a sealed sterile package and is disposable.
The anesthetic flask is screwed in so that the puncture needle punctures the receptacle and the anesthetic is sprayed onto the holder cartridge film. The film provides antisepsis and protects the microneedles against contact with the anesthetic.
After a few seconds, pressure is applied to the holder whose motion is strictly limited to the anatomic features of the human arm veins and is assicated with the vein indication process. As the holder moves, the needle penetrates the circulatory bed.
The scanning device sensor is selectively tuned to particular blood vessels, their size, wall thickness and depth. At the same time, the needle length is selected in a direct dependence with the indicating capabilities of the sensor.
Upon penetration the circulatory bed, the finger pad of the holder is turned back and via the cone-shaped widening of the sealed cover wherein the cone-shaped plug was disposed under the pad, the syringe nozzle, the cannula of a blood transfusion system or the cannula of a blood sampling vacuum tube is inserted.
The claimed device and the method for using the same will be described below with reference to the accompanying drawings.
The cuff 1 comprising a strip of fabric for fixing on the patient's arm is provided with a working cutout wherein the fastening frame 2 is disposed (
In a free state, the front and rear half-disks 3, 4 of the slide disk arranged within the fastening frame 2 (
In the rear half-disk 4 (
The lower portion of the fastening frame 2 (
The needle holder (
Attached to the transversal side of the fastening frame 2 using the receiver bushing 9 (
As shown in
The clamping pads 21, 26 (
The medical staff or the patient himself places the anesthetic flask (
A set composed of the cartridge 7 (
The flask tube 48 (
After a certain time required for the anesthetic to act, the cover 6 of the holder cartridge 7 (
Number | Date | Country | Kind |
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2011131946 | Aug 2011 | RU | national |
Filing Document | Filing Date | Country | Kind | 371c Date |
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PCT/RU2012/000607 | 7/24/2012 | WO | 00 | 3/27/2014 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2013/019149 | 2/7/2013 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
5167630 | Paul | Dec 1992 | A |
5969754 | Zeman | Oct 1999 | A |
6074364 | Paul | Jun 2000 | A |
20070016069 | Grunwald et al. | Jan 2007 | A1 |
20070123803 | Fujiwara et al. | May 2007 | A1 |
Number | Date | Country |
---|---|---|
1064035 | Nov 2003 | EP |
2 168 481 | Mar 2010 | EP |
1134199 | Jan 1985 | SU |
9948546 | Sep 1999 | WO |
Entry |
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RU Search Report, RU, Apr. 9, 2012, OOO Foras Lab. |
European search report for EP 12820737.0 mailed May 22, 2015. |
Number | Date | Country | |
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20140221926 A1 | Aug 2014 | US |