Patent Grant
10342957
This application is the U.S. national stage application of International Patent Application No. PCT/SG2015/050440, filed Nov. 9, 2015, which claims priority to Singapore Application No. 10201407623V, filed Nov. 14, 2014, the disclosures of each of which are incorporated herein by reference in their entirety.
This invention relates to a medical device for introducing a medicament into or under the skin of a patient.
The term “medicament” is understood herein to mean a substance or autologous tissues for use in the medical treatment of a patient, both therapeutic and cosmetic. The term includes by way of example fluids, liquids, pastes, gels or fat tissues or cells that are intended to act as fillers.
The use of medicaments, such as fillers or fat tissue, in or under the skin of a patient is becoming an increasingly common procedure for medical reasons and for cosmetic reasons.
There are known permanent and temporary fillers and other medicaments that are introduced, for example by being injected, in or under the skin of a patient in order to reduce the appearance of lines and wrinkles, plump the face, contour the face or body parts and even fill voids under the skin of the patient. These techniques facilitate augmentation, sculpting and reshaping of the face, cheek, chin, lips, breasts, hands, and other body parts of the patient.
There are a number of options for introducing fillers and other medicaments into the various planes of the skin of a patient or under the skin of the patient described above, including hypodermic needles, catheters, and cannulas (including blunt tip cannulas).
Accidental injection of fillers and other medicaments into blood veins can have serious side effects for patients, including, infection, skin necrosis, skin decomposition, permanent scarring and blindness.
The term “blood vein” is understood herein to include veins, arteries, and blood vessels generally.
As facial sculpting and augmentation becomes increasingly popular, more people are choosing to undergo such procedures. Accordingly, it is desirable to design improved medical devices for introducing fillers and other medicaments into patients.
In broad terms, the invention provides a device for introducing a medicament into a patient comprising a cannula having an inlet end for the medicament and a discharge end for the medicament and a blood flow passageway that provides a visual indication that the discharge end of the cannula is in a blood vein.
In more particular, although by no means limiting terms, the invention provides a device for introducing a medicament into a patient, the device comprising a cannula having an inlet end for the medicament and a discharge end for the medicament, and a passageway having an opening that is proximal to or level with the discharge end of the cannula, wherein, in use, when the device is accidently positioned in the patient with the discharge end of the cannula and the inlet opening of the passageway penetrating a blood vein there is a flow of blood from the vein through the inlet opening of the passageway and into the passageway that provides a visual indication that the discharge end of the cannula is in the vein.
In use of the device, a medical specialist inserts the device into a patient and selects a target site for the medicament and introduces the medicament via injection through the cannula into the target site. If the medical specialist accidentally positions the device so that the discharge end of the cannula and the inlet opening of the passageway penetrate a blood vein, the pressure of the blood flow in the vein forces blood into the passageway and this provides a visible indication that the device has penetrated the vein. This quickly alerts the medical specialist not to commence introducing the filler or other medicament at the chosen delivery point via the cannula of the device and to withdraw the device and to insert a new device with a new cannula in a new target site. It can be appreciated that the device is an effective means for reducing the accidental introduction of fillers and other medicaments into veins with its possible serious implications.
The discharge end of the cannula may be blunt.
The cannula may be flexible.
The cannula may be a micro cannula.
The cannula may be made from any suitable material. By way of example, the cannula may be made from a medical grade plastic or metal.
The passageway may have an outlet opening that is proximal the inlet end of the cannula.
The cannula may be any suitable transverse cross-section. By way of example, the cannula may be circular in transverse section.
The passageway may be any suitable passageway. By way of example, the passageway may be annular in transverse section.
The cannula and the annular passageway may be coaxial.
The annular passageway may be in the form of an annular tube that fits over the cannula.
An outer wall of the passageway may be transparent.
The device may further comprise a reservoir for storing medicament, with the reservoir being in fluid communication with the inlet end of the cannula.
The device may further comprise an ejector for forcing the medicament from the reservoir along the cannula towards and from the discharge end.
The ejector may be in fluid communication with the inlet opening of the passageway and operable to aid blood flow from the vein should the pressure of the blood be low and not provide a positive backflow when there is accidental puncture of the blood vein. Typically, retracting the ejector creates a negative pressure in the passageway that aids aid blood flow along the passageway.
The ejector may be a plunger.
The device may further comprise a reservoir for collecting blood, with the reservoir being in fluid communication with the inlet end of the passageway.
Various features, aspects, and advantages of the invention will become more apparent from the following description of embodiments of the invention, along with the accompanying drawings in which like numerals represent like components.
Embodiments of the invention are illustrated by way of example, and not by way of limitation, with reference to the accompanying drawings, of which:
The invention will now be described more fully hereinafter with reference to the accompanying drawings, in which various embodiments, although not the only possible embodiments, of the invention are shown. The invention may be embodied in many different forms and should not be construed as being limited to the embodiments described below.
With reference to
Typically the device 10 is flexible, allowing a medical specialist to manoeuvre the device 10 to a plurality of delivery points in or under the skin of a patient.
In use of the device 10, when a medical specialist accidently positions the device 10 in or under the skin of a patient with the discharge end 14 of the cannula 8 and the inlet opening 24 of the passageway 20 penetrating a blood vein, there is an immediate flow of blood from the vein through the inlet opening 24 of the passageway 20 and into and along the passageway 20 that provides a visual indication that the discharge end 14 of the cannula 8 is in the vein. The blood flow alerts the medical specialist that the cannula is in the wrong position. The medical specialist withdraws the device 10 from the vein (without any medicament having been injected into the vein) and removes the device 10 from the patient and inserts a new device 10 in a new position. If there is no blood flow in the passageway 20 in this new position, the medical specialist can safely inject a required volume of a filler or other suitable medicament into the patient via the cannula. It is evident from the above that the device 10 is an effective means for detecting when a cannula 8 is in a blood vein before any medicament is injected into the vein.
The passageway 20 shown in
With further reference to
The device 10 also comprises an ejector (not shown) for forcing the medicament from the reservoir 70 along the cannula 8 towards and from the discharge end 14 of the cannula 8. The ejector may be a plunger (not shown) that is located in the reservoir 70 for sliding movement from a retracted position to an extended position, with the movement forcing the medicament 5 from the reservoir 70 along the passageway 15 in the cannula 8 and out of the discharge end 14 of the cannula 8. The ejector may be any suitable ejector.
The hub 50 is made from a plastic material, preferably a medical grade plastic material or any other suitable material. The hub 50 can be made from a transparent material. The hub 50 can also include a graduated marking thereon to measure the volume of the medicament 5 as it is being dispensed.
The inlet end 12 of the cannula 8 is disposed within the hub 50 and is in fluid communication with the medicament reservoir 70.
The discharge end 14 of the cannula 8 has a blunt tip 18 and an aperture 16 for discharging the medicament set aback from the tip 18. This minimises mixing of the medicament and blood when the cannula 8 and the passageway 20 penetrate a blood vein. As noted above, mixing of medicament 5 and blood can have serious side-effects for a patient. Furthermore, contact with blood can taint the medicament. If a tainted medicament is injected into the face of a patient, the blood cells within the tainted medicament become deposited within the tissue of the patient and are visible as a bruise on the skin, thereby creating an unsightly discoloration.
The embodiment illustrated in
Different cannula diameters can be used as required, typically ranging from 20 mm to 80 mm depending on the area of a body to be treated and the viscosity of the filler or concentrate to be injected. The depth of the delivery point under the skin also has a bearing on the size of cannula required. The lower the viscosity of the filler and lesser the depth to be achieved, the smaller the gauge of a cannula is required.
The medicament 5 may be any suitable medicament for a required treatment. Some typically used absorbable fillers include body fat, collagen, hyaluronic acid, calcium hydroxylapatite, CaHA and Poly-L-lactic acid (PLLA). The cannula can also be used to inject gels and highly viscous fluids such as polymethylmethacrylate beads (PMMA microspheres) that are not absorbed by the body but remain in place to fill cavities under the skin. The above fillers can be combined with additional medicaments, such as lidocaine to numb the sensation of the injection when inserting the fillers.
It will be appreciated by persons skilled in the art that numerous variations and modifications may be made to the above-described embodiments, without departing from the scope of the following claims. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.
By way of example, in other embodiments of the invention the ejector may be in communication with the inlet opening 24 of the passageway 20 and operable to aid blood flow from the vein should the pressure of the blood be low and not provide a positive backflow when there is accidental puncture of the blood vein. By way of example, the ejector may be arranged such that retracting the ejector creates a negative pressure in the passageway 20 and aids blood flow along the passageway 20.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, a limited number of the exemplary methods and materials are described herein.
Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention as it existed before the priority date of each claim of this application.
Throughout this specification the word “comprise”, or variations such as “comprises” or “comprising”, will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.
| Number | Date | Country | Kind |
|---|---|---|---|
| 10201407623V | Nov 2014 | SG | national |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/SG2015/050440 | 11/9/2015 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2016/076794 | 5/19/2016 | WO | A |
| Number | Name | Date | Kind |
|---|---|---|---|
| 4317445 | Robinson | Mar 1982 | A |
| 4961729 | Vaillancourt | Oct 1990 | A |
| 5312345 | Cole | May 1994 | A |
| 5688246 | Waitz | Nov 1997 | A |
| 5833668 | Aguilar | Nov 1998 | A |
| 20130245607 | Eversull | Sep 2013 | A1 |
| Number | Date | Country |
|---|---|---|
| 0139091 | May 1985 | EP |
| 2606828 | Jun 2013 | EP |
| Entry |
|---|
| International Search Report in International Application No. PCT/SG2015/050440, filed Nov. 9, 2015. |
| Number | Date | Country | |
|---|---|---|---|
| 20170319792 A1 | Nov 2017 | US |
