| JP2000292429 | NOZZLE |
| JPH09504726 | INDUSTRIAL APPLICABILITY: Closed system blood sampling device |
| JP2009219886 | MICRONEEDLE TRANSPORT DEVICE |
NAZEEH TAWFEEK MOHAMED (EG)
OMARA SHARIF (NL)
| WO2014029423A1 | 2014-02-27 | |||
| WO2015056257A1 | 2015-04-23 |
| US20150157211A1 | 2015-06-11 | |||
| US4269192A | 1981-05-26 | |||
| EP2540214A1 | 2013-01-02 |
| CLAIMS We claim: 1- A disposable medical device for introducing light and piercing the somatic and vascular tissues of a patient’s body to enhance visualization of the infiltrated sharp tip using an endo -transillumination intravenous cannula needle device, comprising: Two units and their assembly, the first unit is the needle body and consists of a hypodermic needle equipped with an illuminating tip, said needle with optical fiber core inserted coaxially inside its inner hub, a needle fixing bushing attached to a bulk hollow body with external grip, guiding notches and grooves for fitting with a second unit which is the lighting source housing wherein he three micro batteries for supplying a LED, closed by a battery cap. Both units are fitted to use with a prior art cannula catheter. 2- The device assembly according to claim 1 using said hypodermic needle with coaxial fiber occupying the needle canal and having a cleaved fiber end tip. 3- The device assembly according to claim 2 wherein said needle body and grip have an optical fiber adaptor for fitting an illumination source. 4- The device assembly according to clam 3 wherein said battery house, cover and a LED adaptor tubular extension are fitted to the needle body unit of claim 1 5- The method according to claim 1 wherein the determination of intravascular positioning of cannula needle is performed via said endo-transillumination of the pierced vein based on light entrapment in the vascular tubing and diffuse scattering in somatic tissues and not by prior art flashback chamber method. 6- The method according to claim 1 wherein said endo-transillumination of non-cavitated somatic tissues through an infiltrated sharp needle tip is a safer replacement for X-ray during tissue surgery and suturing. 7- The method according to claim 1 wherein the said use of any source of coherent or incoherent light illuminates the endo-transillumination intravenous cannula needle. 8- The method according to claim 1 wherein the said use of the endo-transillumination intravenous cannula needle is used as a disposable medical device. 9- The method according to claim 6 wherein the said endo-transillumination intravenous cannula needle device can be employed for non-medical use or in industrial/military inspection or similar applications. |
| AMENDED CLAIMS received by the International Bureau on 02 March 2020 (02.03.2020) CLAIMS 1. We claim a disposable medical device for introducing light and piercing the somatic and vascular tissues of a patient’s body to enhance visualization of the infiltrated sharp tip using an endo- transillumination intravenous cannula needle device, comprising: Three units and their assembly, the first unit is the needle body and consists of a hypodermic needle equipped with a diffractive optic diffuser illuminating tip, said needle with an optical fiber core having a microstructured window, sealed off with anti-infiltration cup, inserted coaxially inside its inner hub, a needle fixing bushing attached to a bulk hollow body with external grip, guiding notches and grooves for fitting with a second unit which is the single mode laser source housing therein three micro batteries for supplying a single mode laser diode, and closed by a battery cap. Both units are fitted to use with an illuminating tip plastic cannula catheter. The third unit is a pair eye glasses equipped by two adjustable angle polarization filters, used by the practitioner to enhance the scene of the needle tip during insertion of endo-illumination intravenous cannula. 2. The device assembly according to claim 1 using said hypodermic needle with coaxial fiber occupying the needle canal and having a cleaved fiber end equipped with diffractive optical diffuser window tip and inclusive anti- infiltration tip. 3. The device assembly according to claim 1 wherein said needle body and grip have an optical fiber adaptor for fitting a single mode laser diode transmitter. 4. The device assembly according to clam 1 wherein said battery house, cover and a single mode laser diode adaptor tubular extension are fitted to the needle body unit of claim 1 5. The method according to claim 2 where the prevention of fragmentation of optical fiber during needle insertion is achieved by adding a transparent anti-infiltration to protect the patient from sharp fiber fragments infiltrating the circulatory system. 6. The method according to claim 1 where the use of a of pair eye glasses equipped with two adjustable angle polarization filters by the practitioner enhances the scene of the needle tip during insertion of the endo-transillumination intravenous cannula. 7. The method according to claim 1 wherein the said use of a single mode laser diode illuminates the endo-transillumination intravenous cannula needle and its plastic catheter tip. 8. The method according to claim 2 wherein the said use of a diffractive optic diffuser illuminates the tip to enhance the scattering properties of the laser during the insertion of the needle tip inside somatic tissues. 9. The method according to claim 1 wherein the said illumination of the plastic catheter tip helps the practitioner in estimating the relative position of the needle relative to the skin surface. |
FIELD OF INVENTION
[001] The present invention is a medical disposable device, for introducing and/or withdrawing fluids into or from a patient’s body. It also introduces light into body tissues.
BACKGROUND OF THE INVENTION
[002] In modern medical practice, intravenous cannulation or venipuncture is a typical process used for blood sampling, blood transfusion and fluid/drug injection into patients’ bodies. This process requires an experienced practitioner with appropriate medical and visual skills capable of localizing an appropriate needle puncture spot over the targeted vein.
[003] During the cannulation process, practitioners usually rely on blood diffusion through the flashback chamber at the rear end of the puncture needle to detect intravascular penetration and stop needle tip infiltration.
[004] If the practitioner fails to align the needle tip axially with the vein stream, the process may cause a severe traumatic effect to the patient’s body due to hematoma and embolism caused by needle infiltration.
[005] Subsequently, many non-invasive techniques have been used to help practitioners locate the targeted vein before and/or during cannulation and venipuncture processes, such as bicolor vein trans illuminators and infrared vein viewers.
[006] Bicolor vein trans-illuminators are based on the difference in diffuse reflectance coefficients between vascular and somatic tissues for trans -illumination by red and green light. Similarly, infrared vein viewers use infrared trans-illumination to visualize vascular tissues with high contrast.
[007] The mentioned techniques are relatively expensive and require supplementary accessories such as holders and optical aids that may not be available in emergency cases. It also limits the mobility of the practitioner in some cases where the patient is non-cooperative. [009] Consequently, there exists a need for a device providing simplicity and ease of use to enable safe venipuncture and cannulation. It must be inexpensive, disposable, easy to manufacture, time saving, and convenient to current use and practice.
SUMMARY OF THE INVENTION
[0010] The invention consists of two parts, namely the needle body and the Light Emitting Diode (LED) / battery housing, used in conjunction with prior art: the needle tip cover and the plastic catheter body.
[0011] In one embodiment, the described invention is an intravenous cannula needle that is equipped with an optical fiber illumination device, such that the needle tip becomes a source of light used to internally trans-illuminate the human tissues at the puncture point to facilitate intravascular cannulation and visualization, based on the difference in diffuse scattering coefficients between veins and tissues during endo-illumination.
[0012] The optical fiber core passes through the inner tube of the stainless-steel needle. Unlike traditional cannulas, the hollow aspect of the tip of the needle is replaced by the optical fiber and the flashback chamber is omitted from the design.
[0013] To use the invention, the practitioner detaches the cannula plastic cover, starts the LED/battery power and inserts it into the needle body so that its sharp tip glows. Then the practitioner inserts the cannula needle gently through the patient’s skin over the targeted vein, as per traditional cannulation.
[0014] When the needle tip penetrates the skin, the tissue glows and the vein becomes visible. As the needle continues to pierce the vein and becomes intravascular, the surrounding tissues stop glowing and the vein is illuminated due to light entrapment. Subsequently, the practitioner detaches the needle, and leaves the plastic catheter inside the vein.
[0015] The needle is then detached and disposed of safely. The LED/battery house may be sterilized and re-used.
OBJECTIVES AND ADVANTAGES
[0016] This invention eases intravenous cannulation process and minimizes the probability of hematoma and embolism. Additionally, it enhances visualization of needle infiltration with minimal costs and minimizes blood residue contamination by elimination of the flashback chamber at the needle body and hub. Finally, it may be used for the sake of endo-transillumination of biological tissues as a safer replacement for X-ray imaging.
DETAILED DESCRIPTION OF THE INVENTION
[0017] According to an embodiment of the current invention, figs. 1A and IB (please refer to Drawings file) illustrate the assembly of a prior art intravenous cannula equipped with an endo-transillumination needle device. It consists of four parts, namely the needle plastic cover (10), the plastic catheter body (16), the needle body (23) and the LED / battery housing (26).
[0018] Parts from (18) to (33) represent the needle body and the LED housing and form the endo- transillumination intravenous cannula needle device as an embodiment of the present invention. Parts from (10) to (17) are prior arts considered only for illustration of the invention assembly method with a traditional catheter cannula.
[0019] In a particular embodiment, figs. 2A and 2B show the assembly of an endo-transillumination needle device. Herein, a stainless-steel hypodermic needle (19) is attached to plastic bushing (20), inserted into a plastic body (23) with a grip (22) and internal tubing. An optical fiber (29) with a core diameter that is equal to the inner diameter of the hypodermic needle (19) is fitted to the internal tubing of the needle body (23) and fixed by a fitting disk (30).
[0020] In a related embodiment, three micro batteries (33) are used to energize a high efficiency LED (32). Both parts are embedded inside a plastic housing (26) and sealed by a special plastic cap (28) having tubular extension (27) such that the LED’s window confront part (29) and (30) as shown in fig.3.
[0021] The optical fiber is fixed inside the assembly of parts (19), (26) and (30) by appropriate adhesive to ensure mechanical stability and to prevent fragmentation of the fiber core under elastic tension of the needle.
[0022] The fiber cleaved end must not exceed the needle puncture tip opening (18) to avoid mechanical friction with biological tissues during the cannulation process that could lead to fragmentation of the fiber core and infiltration of the fragments into the blood stream of the patient. [0023] Parts (21), (24) and (25) ensure good alignment between the endo-transillumination needle device and cannula catheter assembly during cannulation.
[0024] Good alignment and contact between parts (30) and (31) is essential to ensure maximum light transmission through the fiber end.
[0025] To use the invention, the practitioner detaches the cannula plastic (10) cover, starts the LED/battery power by fixing the battery cap (28) and inserts it into the needle body so that its sharp tip (18) glows. Then the practitioner inserts the cannula needle gently through patient skin over the targeted vein, as per traditional cannulation performed with the prior art cannula.
[0026] When the needle tip penetrates the skin, the tissue glows and the vein becomes visible. As the needle continues to pierce the vein and becomes intravascular, the surrounding tissues stop glowing and the vein is illuminated due to light entrapment. Subsequently, the practitioner detaches the needle (18-33) and leaves the plastic catheter (11) inside the vein.
[0027] The needle (19) is then covered using part (10) and disposed of safely. The LED/battery house (26) may be sterilized and re-used.
[0028] In another embodiment a number of LED emission spectra can be used in this invention, ranging from white or colored light to infrared radiation if the practitioner uses a special camera viewer for the purpose of endo-transillumination of biological tissues or simulation phantoms as a safer replacement for X-ray imaging. In this context, the LED illuminator can be also replaced by any kind of high intensity illumination source including laser diodes.
[0029] It should be noticed that all part dimensions are tolerated to fit the prior art cannula catheter with accordance to the scale portrayed in the figures.
SUMMARY, RAMIFICATIONAND SCOPE
[0030] From the preceding illustrations, it will be seen that there is described a layout of an endo- tran si llumi nation intravenous cannula needle device, that relies on enhancing the visualization of the hypodermic needle during cannulation, by providing illumination to the needle tip using an optical fiber illuminator. Basing on the previous description, the scope of the invention shall not be limited on the given design example that is subject to changes by skilled artisans, but rather extends to the scientific methodology behind this embodiment.
[0031] Accordingly, the scope of the invention shall be determined by the appended claims and their prospective legal equivalence and not by the provided illustration example.
Drawings reference numerals
BRIEF DESCRIPTION OF THE DRAWINGS
Fig.lA. Isometric view of endo-transillumination intravenous cannula.
Fig.lB. Isometric view of endo-transillumination intravenous cannula discrete parts.
Fig.2A. Isometric view of endo-transillumination intravenous cannula needle device.
Fig.2B. Isometric view of endo-transillumination intravenous cannula needle device discreet parts. Fig.3. Sectional view of endo-transillumination intravenous cannula needle device and its discrete parts.
cannula needle protective cover catheter tube
bushing
catheter wings
Luer connector
injection port cap
catheter body
guiding indentation hypodermic needle tip hypodermic needle bushing
guiding groove
needle grip
needle body
guiding indentation guiding groove
battery housing
LED adaptor tubular extension battery house cap
optical fiber core
optical fiber end fitter
LED
LED leads
micro battery cells