WO2014061030A2

WO2014061030A2 - Needle for injecting uniform delivery of active/drug in localized region

Info

Publication number: WO2014061030A2
Application number: PCT/IN2013/000625
Authority: WO
Inventors: Dr. Sumit PODDAR; Dipali PODDAR
Original assignee: Poddar Dr Sumit; Poddar Dipali
Priority date: 2012-10-16
Filing date: 2013-10-15
Publication date: 2014-04-24
Also published as: WO2014061030A3

Abstract

A fluid/medicament injecting needle for delivery of fluid/drug/medicaments in tissue ensuring uniform and desired distribution of the fluid/drug/medicaments over a localized region in the tissue. The fluid/medicament injecting needle involves plurality of holes disposed on the side wall of the needle arranged selectively extending along the length of the needle such that each said hole in the side wall has at its diametrically opposite end solid side wall to ensure uniform spreading of injectate in tissue.

Description

TITLE: NEEDLE FOR INJECTING UNIFORM DELIVERY OF ACTIVE/DRUG IN LOCALIZED REGION

FIELD OF THE INVENTION:

The present invention relates to a fluid/drug/medicaments delivery means and, in particular, needles for injections and the like adapted for uniform delivery of actives. More particularly, the invention is directed to needles which would enable efficient treatment for specialized applications such as those used for rabies immunoglobin administration, administering localized injections such as for administering local anesthesia and the like with desired more uniform distribution of the drug or medicaments in the region of its intended application. Advantageously, the present invention and, in particular, the needle for injection of the invention would benefit administration of drugs/medicaments for such stated treatment /conditions including rabies immunoglobin administration, administering localized injections which would be patient as well as physician friendly making the utility of needle for delivering actives more user friendly and avoiding unwanted loss of the expensive drug as well as ensuring effective delivery of the active in a localized manner spread uniformly in and around the wound region /area of localized application of the drug/medicaments. Thus, the needle of the invention would serve as an advancement in the art of treatment of localized conditions/indications such as injecting rabies immunoglobulin and injecting local anesthesia and the like through injection of active/drugs and the like.

BACKGROUND ART.:

It is well known that traditionally drugs/medicaments are injected to treat conditions involving injecting devices with traditional needle having a single bore or hole at the tip through which the active is pressed into the body by the injecting device.

Importantly, considering that such needles used for injection of actives have a single bore or hole, the drug/active can traverse into the body only through the single hole of the needle. This limited release of the drug/active through the single hole is found to have some serious limitation for certain applications such as where some urgent localized and uniform distribution of the drug/active is required in that the active can reach only the limited area in and around the hole of the needle and accordingly the remaining adjacent surrounding portion do not get the required delivery of the drug/active for immediate treatment/release. Thus while such traditional needles do continue to serve the basic purpose of injecting drugs/actives for treating various conditions, there are certain conditions /requirements especially where some urgent localized and uniform distribution of the drug/active is required, injecting of actives through such conventional needles with single hole is fou nd to be not only not effective for the purposes of desired drug delivery in localized regions but also is found to lead to loss of expensive drug/active since by the time it may reach the region of treatment in an around the spot of the needle piercing the body, the desired effect may either be not achieved with in the stipulated time or may be lost in transit through the body.

Apart from the above general limitations of conventional simple bore needle based injections in uniform distribution of actives/d rugs in localized regions, there are certain conditions/indications where such convectional needle not only fail to achieve desired uniform drug delivery but also exposes the area of treatment/body to further infection and added painful condition which at times can be fatal. The treatment of rabies immunoglobulin administration as an anti rabies therapy to take care of conditions of localized wounds due to dog bites and the like is found to suffer from serious problems due to such limitation of the conventional single bore needle based injection of rabies immunoglobulin. It is important to mention that unlike the need for injecting a drug/active to traverse into the body for subsequent long term effect through the blood, in case of situations of required urgent localized RIG administration resulting from dog bites and the like, the subject is usually having a wound area which needs immediate and complete treatment involving the injection of drug/active such as RIG and in such case use of injections with single bore needle is not at all effective in meeting the urgent demand for uniform administration of the drug throughout the wound region. It is to be noted that in cases where the uniform distribution of drug is desired involving such single bore needle the attending physician has to go for multiple pricks/ injections in various locations surrounding the wound area to totally cover the affected region. Such multiple prick/ injections not only seriously aggravates the pain of the subject being administered with the drug/actives but more importantly, such multiple pricks in an around the wound region expose the subject to further infection which can have very fatal consequences.

It is also relevant to mention that in case of such multiple prick based administration of drug/active, it is extremely difficult to maintain the desired dosage level of administration to cure the symptom in the localized area which in turn can either affect the subject d ue to non uniform distribution of the drug and/or lead to loss of expensive drug/active which adds to the complexities of treating such conditions with confidence.

The traditional single bore needle based injections are also presently in use for administering local anaesthesia and considering that such local anaesthesia is intended to cover a specific region of the body and not limited to any single spot in the body, the use of such single bore needles are at times found to be ineffective or not a ready and confirmatory approach to developing local anesthetic effect in and around the intended region of the body. This is because the single bore needle can inject the drug/active through a single spot and it may either require doctor to go for multiple pricks to cover the region intended for the anesthetic affect or in case of emergency the doctor may need to unnecessary wait for longer period of time to ensure that the active injected through the single bore needle traverses the intended region for the desired anesthetic effect. It is thus apparent from the above state of the art of administering inject able formulations/actives trough single bore needle that it is not only short of achieving desired efficacy of administration but has serious limitations in that in certain very specific cases of administration ,in particular, for localized and immediate action of actives/injectables such single bore needles are found to be not suitable for desired and intended treatments. Moreover, the same suffers from serious problems of exposing the subject to unwanted infections resulting for multiple pricks of such single bore needles and also alleviates the pain and suffering of the subject to a greater extent which is the least desired.

OBJECT OF THE INVENTION:

It is thus the basic object of the present invention to provide for a fluid/drug/medicaments delivery means and, in particular, needles for injections and the like adapted for uniform delivery of actives in localized regions effectively and efficiently.

Another object of the present invention is specifically directed to needles for injections for delivering drug/medicaments such as hypodermic needles with very fine internal dimensions such as the 20-24 no. needles which would enable efficient treatment for specialized conditions such as those used for rabies immunoglobin administration, administering localized injections such as for administering local anesthesia and the like with on one hand desired more uniform distribution of the drug/medicaments in the region of its intended application and on the other hand ensuring that the same does not expose the subject to unwanted additional pain avoiding possibilities of multiple pricks and also not to expose the subject during injection of actives/drugs to further unwanted infections that can be serious and fatal to the patient.

5 Yet another object of the present invention is directed to needle for injection which would benefit administration of drug/medicaments for such stated treatment /conditions including rabies immunoglobin administration, administering localized injections and which would be patient as well as physician friendly making the utility of needle for delivering actives more user friendly and avoiding unwanted loss of the expensive drug as well as ensuring

0 effective delivery of the active in a localized manner spread uniformly in and around the wound region /area of localized application of the drug/active.

Another object of the present invention is directed to advancement in the art of treatment of localized conditions/indications such as injecting rabies immunoglobulin and injecting 15 local anesthesia and the like through injection of active/drugs and the like.

SUMMARY OF THE INVENTION:

Thus according to the basic aspect in the present invention, there is provided a fluid/medicament injecting needle adapted for uniform spreading of injectate in tissue -f0 effectively and efficiently comprising: an elongate needle portion having a blocked front end adapted for ready penetration into tissue and contiguous side wall defining a fine needle cannula and a rear open end for operative connection to an injecting member;

?⁵

plurality of holes disposed on the side wall and extending from exterior of the side wall to the interior of the needle cannula wherein the said plurality of holes are arranged selectively extending along the length of the needle such that each said hole in the side wall has at its diametrically opposite end solid side wall to ensure uniform spreading of injectate in tissue $0 through said selective holes in the side wall.

In the present fluid/medicament injecting needle, the said needle side wall comprises plurality of identical holes linearly arranged parallel to longitudinal axis of the needle cannula, extending along the length of the needle and disposed on the two diametrically $5 opposed sides of the side wall ensuring between every two consecutive side wall holes in one side of the needle cannula, there is atleast one side wall hole in the opposite side of the said needle cannula.

According to another aspect in the present fluid/medicament injecting needle, the tip of the front end of the needle is blocked for any fluidic communication for directing the injectate along the side holes.

According to yet another aspect in the present fluid/medicament injecting needle, the disposing of the side holes on the both sides of the needle cannula and extending along the length of the needle facilitates localized spreading of the injectate around the needle when it is penetrated wholly into the tissue for administration.

According to a further aspect in the present fluid/medicament injecting needle, the needle side wall support at the back of the each of the side hole effecting from the disposing of the side hole at the intermediate position of two consecutive side holes in the opposite side of the needle side wall facilitates releasing of injectate with optimum force and velocity from each of the side holes extending through out the length of the needle.

In accordance with another aspect in the present fluid/medicament injecting needle, the releasing of injectate with optimum force and velocity through out the length of the needle facilitates uniform spreading of the injectate into a localized region of the tissue around the needle.

According to a further aspect in the present fluid/medicament injecting needle, the inside diameter of the said needle cannula progressively decreases such that front needle cannula inside diameter are smaller than rear needle cannula inside diameter adapted to maintain constant injectate releasing pressure through out the length of the needle. In a preferred embodiment of the present fluid/medicament injecting needle the outside diameter of the said needle cannula progressively decreases from rear end to front end similar to the inside diameter adapted to provide conical outer shape of the needle for ready and easy penetration into the tissue whereas in other embodiment the fluid/medicament injecting needle, the outside diameter of the said needle cannula remain constant from rear end to front end adapted to provide cylindrical outer shape of the needle for increasing structural integrity to the said needle. According to yet another aspect in the present fluid/medicament injecting needle, the side holes on the both sides of the needle cannula are arranged in equal interval and at mid- position of two consecutive side holes in the opposite side of the needle cannula for releasing the injectate both side of the needle at equal interval which create bisymmetric localized spreading of the injectate in the tissue.

According to yet another aspect in the present invention, the present fluid/medicament injecting needle is adapted to deliver drug/medicaments which would enable efficient treatment for specialized conditions such as those used for rabies immunoglobin administration ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

According to a further aspect in the present fluid/medicament injecting needle, the said needle is a 20-24 gauge sized with fine cannula dimensions and side holes with diameter 0.2-0.5 mm disposed on an interval 4-6 mm.

In accordance with another aspect in the present invention, the use of a fluid/medicament injecting needle for substantially uniform rabies immunoglobin administration ensures uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

In accordance with another aspect in the present invention, the use of a fluid/medicament injecting needle for substantially uniform administration of anaesthetic drugs ensure uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

According to a further aspect in the present invention there is provided a method of treatment of treatment of rabies immunoglobin administration as an anti rabies therapy to take care of conditions of localized wounds comprising the step of administering the rabies immunoglobin administration using the present fluid/medicament injecting needle for ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

According to a further aspect in the present invention there is provided a method of carrying out anesthesia comprising uniform administration of anaesthetic drugs ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks using the present fluid/medicament injecting needle.

BRIEF DESCRIPTION OF THE ACCOMPANYING FIGURES:

Figure 1 is an illustration of a conventional single bore 20-24 needle regularly in use for injecting actives/drugs.

Figure 2 is a schematic illustration of a preferred embodiment of fluid/medicament injecting needle 20-24 size according to the invention involving selectively disposed side holes in criss cross arrangement adapted for single prick uniform distribution of drug/ active.

Figure 2(a) is the schematic illustration of the cross section of the preferred embodiment of fluid/medicament injecting needle 20-24 size. Figure 3 shows the illustration of a preferred embodiment of fluid/medicament injecting needle 20-24 size with selectively disposed side holes

Figure 3(a) is the schematic illustration of the cross section of the preferred embodiment of fluid/medicament injecting needle 20-24 size.

Figure 4 shows the illustration of another preferred embodiment of fluid/medicament injecting needle 20-24 size with selectively disposed side holes in accordance with the present invention. Figure 4(a) shows the cross sectional view of the preferred embodiment of fluid/medicament injecting needle 20-24 size.

Figure 5 shows releasing of the injectate from the fluid/medicament injecting needle 20-24 size of the present invention.

Figure 6 and 7 illustrate the benefit of the closed front end of the needle 20-24 size of the invention which favours unwanted loss of fluids/medicaments in directions not required for the purposes of uniform distribution of the active in a wound region / localized action. DETAILED DESCRIPTION OF THE INVENTION WITH REFERENCE TO THE ACCOMPANYING FIGURES:

Reference is first invited to accompanying figure 1 which illustrates the conventional single bore needle commonly used for administration of drugs, fluid or medicaments in tissues for the purpose of treating wounds or administering local anesthesia. As would be apparent form the conventional knowledge in use of such single bore needle for the afore said purposes, it is extremely difficult to administer the drugs, fluid or medicaments uniformly over the tissue or wound region or the area of local anesthesia since the single bore needle is supposed to deliver the drugs, fluid or medicaments only in the region where it pierces the body. It is thus only a one spot specific administration of the active/drug and in order to cover the active in the entire localized region of the wound/ area of anesthesia, it is either required to wait for the drug to reach such regions in due time or alternatively arrange for multiple prick based further administration of the active/drug to cover the region of the treatment. This is not only extremely painful but is accompanied with exposure to unwanted infection which can lead to serious and fatal conditions.

Reference is now invited to accompanying figure 2 which illustrates according to an embodiment the needle for injecting actives for localized and uniform spread in the required regions of treatment in accordance with the present invention as illustrated in the accompanying figure 2, in order to facilitate the uniform distribution of the active drug through single prick application involving the needle of the invention, the needle as illustrated is provide with selectively disposed holes along its side walls in the longitudinal direction with the tip of the needle front being blocked. As would be clearly apparent from the accompanying representation of the needle of the invention, the eleongate needle portion (1) comprise a blocked front end (2) adapted for ready penetration into tissue and contiguous side wall (3) defining a needle cannula (4) and a rear open end (5) for operative connection to an injecting member. The side wall (3) of the needle cannula (4) comprises plurality of holes (6) along the length of the needle which are extended from exterior of the side wall to the interior of the needle cannula.

As shown in the figure the said plurality of holes (6) are arranged selectively extending along the length of the needle such that each said hole in the side wall has at its diametrically opposite end solid side wall to ensure required obstruction and force for uniform spreading of injectate in tissue through said selective holes in the side wall. In particular, the holes in the side wall of the needle, which are preferably identical in size and shapes, are linearly arranged parallel to longitudinal axis (7) of the needle cannula, extending along the length of the needle and disposed on the two diametrically opposed sides of the side wall ensuring between every two consecutive side holes in one side of the needle cannula, there is atleast one side hole in the opposite side of the said needle cannula.

The presence of needle side wall support at the back of the each of the side hole due to the disposing of the side hole at the intermediate position of two consecutive side holes in the opposite side of the needle side wall facilitates releasing of injectate with optimum force and velocity from each of the side holes extending through out the length of the needle. More specifically, the presence of side wall, at the opposite side of the each of the side wall, extended from the anterior side hole to the posterior side hole of the opposite side ensure the releasing of the injectate with desired and optimum force and velocity from each of the side wall and thereby ensure uniform spreading of the injectate into a localized region of the tissue around the needle.

In fluid/medicament injecting needle of the present invention, the disposing of the side holes on the both sides of the needle cannula and extending along the length of the needle facilitates localized substantially uniform spreading of the injectate around the needle covering the wound area/required area for active distribution such as for anesthetic purposes when it is penetrated wholly into the tissue for administration.

The side holes on the both sides of the needle cannula are arranged in equal interval and at mid-position of two consecutive side holes in the opposite side of the needle cannula for releasing the injectate both side of the needle at equal interval which creates bisymmetric localized substantially uniform spreading of the injectate in the tissue. The uniform distribution of the injectate i.e. fluid/drugs/medicament along the sides of the needle covers the entire wound area/region of anesthesia and on the other hand avoid unwanted administration of f!uid/drugs/medicament any particular location of the area of treatment. The no. of side holes and the inter hole distance is varied depending on the area of treatment and condition of the tissue on which the treatment will be performed.

In another embodiment of the present fluid injecting needle as shown in the accompanying figure 2 or 3 the inside diameter (8) of the said needle cannula can also progressively decrease in a linear order such that the front needle cannula inside diameter is smaller than rear needle cannula inside diameter. Such internal configuration of the^' needle cannula further facilitates maintaining desired injectate releasing pressure through out the length of the needle. In other words the decreasing internal diameter of the needle cannula towards the front end of the needle constricts the fluid or medicaments flowing channel through needle cannula which progressively increase the pressure inside needle cannula. The progressive increase in the pressure nearer to the front end of the needle compensates the falling in the pressure at the side holes nearer to the front end due to the higher distance from the injecting member.

In a embodiment of the present fluid injecting needle as shown in the accompanying figure 2 and 2(a), the outside diameter (9) of the said needle cannula also progressively decreases from rear end to front end similar to the inside diameter adapted to provide conical outer shape of the needle for ready and easy penetration into the tissue.

In another embodiment of the present fluid injecting needle as shown in the accompanying figure 3 and 3(a) the outside diameter (9) of the said needle cannula remain constant from rear end to front end adapted to provide cylindrical outer shape of the needle for increasing structural integrity to the said needle.

In a further embodiment of the present fluid injecting needle as shown in the accompanying figure 4 and 4(a) the inside diameter (8) of the said needle cannula remain constant from rear end to front end. Thus by way of the use of the advanced needle of the invention it is possible to uniformly administer the drug/medicaments in localized manner in and around spread or distributed wound region without the need for painful multiple pricks with hazards of exposed added infection. Thus it is possible that involving the needle of the invention it is possible to pierce through the base of the wound region/ region of anaesthesia along its middle path and there after pressing and delivering the injectables along the sides of the needle through the selectively disposed holes to systematical ly cover the uniformly spread the drug/medicaments in the wound region/localized area of anaethesia. Such a manner of administration of active involving the needle of the invention is extremely beneficial for administering rabies immunoglobulin in wound regions as well as attending to a fast and specific anaesthesia in localized regions with required confidence of optimum and effective drug administration.

It is also found by way of the present invention that the blocked tip in combination with the selectively and strategically disposed side holes as discussed herein before importantly facilitate better administration of the drug in confidence by the attending physician and also minimizes the loss of expensive drug/medicaments. It is also extremely relevant to mention that the selectively disposed holes along the side walls take care of uniform distribution of the drug on release through the strategically disposed holes which in turn avoid any unwanted non-uniform cloud like active dispersion which is undesired in situations such as administering rabies immunoglobulin/ anaesthasia requiring localized treatment/attention . It is thus possible to administer uniformly the drug/medicaments through the needle holes with desired force and velocity due to the stated arrangement of the holes in the diametrically opposite sides with the close tip.

Importantly, it has been found by way of extensive studies under the present advancement that such selective disposition of holes in diametrically opposite sides of the^' needle along its length (not in same plane) in combination with the closed tip of the needle front end delivers the drug/medicaments in localized regions of treatment more effectively. The results obtained from the extensive studies are provided hereunder by way of Examples:

EXAMPLE : 15 PATIENTS EACH AFTER ADMINISTERING RABIES IMMUGLOBULIN :

Abdominal

Wall/

Exclamities

Outside Wound 3 3 3 3 Management

Average Amount 6 ml 6 ml 6 ml 6 ml of RIG

Vaccination WHO Guideline WHO Guideline WHO Guideline WHO Guideline

Allergic reaction Nil Nil Nil Nil

No. of Needle

prick

a. Single Wound

<3.5cm 1.5* 1* 1* 1* >3.5-4 cm 3* 2.5* 2* 2* b. Multiple 4.5* 3* 2.5* 1* Wound

Indurations & 2.25 cm* 2.75 cm* 3.0 cm* >4 cm* swelling of

infiltration site

* Mean value.

It would be apparent from the above results that the needle of the present invention achieved the desired end attributes for safe, patient friendly administration of the drug with least number of pricks. Advantageously, the selective combination of diametrically opposite disposed side holes with tip block provided for the desired back pressure to facilite the above advantages of administration involving the needle of the invention. Such an arrange of holes is found to be special and surprising in efficacy of administration since the same apart from providing the advantages in administration also provides for a combination which would maintain the needle in good rigid unbreakable condition during administration.

A further comparative study was carried out for evaluating the spreading the drugs /medicaments administrated in the tissue by involving different needle embodiments as mentioned in the above table. In the present comparative study equal amount of drugs /medicaments is applied to same type of tissue by using the above said needles. The spreadi ng of the drugs /medicaments in the tissue noted is illustrated in the accompanying figures 6 and 7.

Reference is now invited from accompanying figures 6(a), 6(b), 6(c), 6(d) which schematically illustrates drug/medicaments delivery pattern in the tissue involving the above said needle embodiments.

The drug/medicaments delivery pattern in the tissue by involving conventional single bore needle having only open front end for fluidic transmission is shown in the figure 6(a). In the conventional single bore needle, due to the ejection of the drug/medicaments only from the front end, all the drug/medicaments spreads only in the front side of the needle. Thus drug/medicaments administered region (11) does not traverse the entire wqund region such as animal bite based distributed wide area wounds/area of treatment (10). The exact spreadi ng of the administrated drug/medicaments by involving conventional single bore needle is shown in the accompanying figure 7(a).

The drug/medicaments delivery pattern in the tissue by involving needle with open front end and side holes disposed in same plane (i.e. multiple side holes disposed around the needle in a single plane) in the side of the needle cannula needle is shown in the figure 6(b). In such needle embodiment, the drugs/medicaments due to the front open needle fails to achieve the desired uniform distribution over the intended wound area coverage .The exact spreading of the administrated drug/medicaments by involving needle with open front end and side holes disposed in same plane in the side of the needle cannula needle is shown in the accompanying figure 7(b).

Next the drug/medicaments delivery pattern in the tissue by involving needle with side holes disposed in diametrically opposite sides (not on same plane) of the needle cannula along its length in combination with the open front end is shown in the figure 6(c). In such needle embodiment, due to the positional advantage, a large amount of the drugs/medicaments eject from the front tip of the needle. Thus a small amount of the drugs/medicaments ejects from the side holes. Also the drugs/medicaments releasing pressure at the side holes are decrease considerably due to the open font tip. Thus the drug/medicaments administered region (11) does not spreads as required and the distant wound region/area of treatment (10) along the length of the needle does not get any drugs/medicaments due to the releasing of inadequate amount of drug/medicaments with low releasing pressure from the side holes. The exact spreading of the administrated drug/medicaments by involving needle with side holes disposed in diametrically opposite sides of the needle cannula along its length in combination with the open front end is shown in the accompanying figure 7(c). Finally the drug/medicaments delivery pattern in the tissue by involving needle of the present invention i.e. needle with side holes disposed in diametrically opposite sides (not in same plane) of the needle cannula along its length in combination with the close front end is shown in the figure 6(d). In such needle embodiment, due to the blocked front end of the needle and the selective placement of the side hole as mentioned above, uniform amount of drugs/medicaments eject from all the side holes. Also the selectively designed needle cannula interior maintains a uniform injectate releasing pressure in all the side holes. These two factors ensure the uniform spreading of drug/medicaments and the administered region (11) covers the entire wound region/area of treatment (10). The exact spreading of the administrated drug/medicaments by involving needle with side holes disposed in diametrically opposite sides of the needle cannula along its length in combination with the open front end is shown in the accompanying figure 7(d).

It wou ld be apparent from the above referred figures that the drugs/medicaments administrated in the tissue by involving the needle of the present invention spreads uniformly into the tissue. In fact the illustrations clearly show that when the needle with only the front opening was used there was absolutely no possibility of reaching the active drug in locations under the tissue other than at the front of the needle while in case of needle with open front end and side holes disposed in a single side of the needle cannula or needle with side holes disposed in diametrically opposite sides of the needle cannula along its length in combination with the open front end lead to non uniform distribution of the active drug evidencing possible loss of the drug and its ineffective distribution affecting the treatment regime with desired concentrations of the active.

The specification of the needle with open front end and side holes disposed in a same side of the needle cannula and the needle with side holes disposed in diametrically opposite sides of the needle cannula (not in same plane) along its length in combination with the open front end and the needle of the present invention used for the above study is provided hereunder

a single plane of diametrically and side holes the needle opposite sides disposed in cannula (not in same diametrically

plane) of the opposite sides (not needle cannula in same plane) of along. the needle cannula along.

Size (gauge) 20-24 20-24 20-24 20-24

Hole size 0.2-0.5 mm 0.2-0.5 mm 0.2-0.5 mm 0.2-0.5 mm

No. of hole 1 6-16 6-16 6-16

Length 26-38 mm 26-38 mm 26-38 mm 26-38 mm

Position of Tip of the Parallel both sides Criss-cross Criss-cross holes needle

Distance N.A. 4-6 mm 4-6 mm 4-6 mm

between two

consecutive

side holes

Shape Round-body Round-body Round-body Round -body

Tip Open and Open and pointed Open and pointed Closed and pointed pointed

Chance of Minimum Brittle can break Minimum Minimum

Breaking within the tissue

Pressure Maximum in Inadequate Disproportionate Substantially

front of the Uniform

needle

Purpose of Injecting Not suitable for Not suitable for Perfectively use drugs RIG RIG suitable for RIG administration administration administration

Coverage of Disproportiona Inadequate and Disproportionate Substantially total area te, more in Disproportionate Uniform coverage front of the of wound area needle

Uniformity of More in front Non uniform Non uniform Symmetric around distribution the needle of fluid The accompanying figures 6 and 7 clearly indicates that, the drugs /medicaments administrated in the tissue by involving need le of the present invention with criss cross holes in diametrically opposed side walls and closed tip at the front spreads in a symmetric manner which ensure the presence of drugs /medicaments in equal amount over the entire wound region/ region of anaesthesia in the tissue.

The uniform delivery of the drug/medicaments over a spread region in the tissue by involving the needle of the present invention, enable efficient treatment for specialized conditions such as those used for rabies immunoglobin administration ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks and consequentially avoiding poccible contamination/virus infiltration in wound /affected /treatment area. Advantageously, it has also been found by way of the present invention that the stated selective criss-cross disposition of the holes with blocked front tip in case of needles with such fine dimensions such as the 20-24 sized hypodermic needles also favour required rigidity to the construction and is safe for administration of drug unlike other randomly created holes or other configurations which render such needles brittle and prone to breakage and thus unsafe foe use.

It is thus possible by way of the present advancement to provide for needles for injections and the like adapted for uniform delivery of actives in localized regions of treatment. Advantageously, the present invention and, in particular, the needle for injection of the invention would benefit administration of drugs/medicaments/actives for treatment/conditions including rabies immunoglobin administration, administering localized injections which would be patient as well as physician friendly making the utility of needle for delivering actives more user friendly and avoiding unwanted loss of the expensive drug as well as ensuring effective delivery of the active in a localized manner spread uniformly in and around the wound region/area of localized application of the drug/active. Thus, the needle of the invention would serve as an advancement in the art of treatment of localized conditions/indications such as injecting rabies immunoglobulin and injecting local anesthesia and the like through injection of active/drugs and the like.

Claims

WE CLAIM:

1. A fluid/medicament injecting needle adapted for uniform spreading of injectate in tissue effectively and efficiently comprising an elongate needle portion having a blocked front end adapted for ready penetration into tissue and contiguous side wall defining a needle cannula and a rear open end for operative connection to an injecting member; plurality of holes disposed on the side wall and extending from exterior of the side wall to the interior of the needle cannula; the said plurality of holes are arranged selectively extending along the length of the needle such that each said hole in the side wall has at its diametrically opposite end solid side wall to ensu re uniform spreading of injectate in tissue through said selective holes in the side wall.

2. A fluid/medicament injecting needle as claimed in claim 1, wherein the said needle side wall comprises plurality of identical holes linearly arranged parallel to longitudinal axis of the needle cannula, extending along the length of the needle and disposed on the two diametrically opposed sides of the side wall ensuring between every two consecutive side holes in one side of the needle cannula, there is atieast one side hole in the opposite side of the said needle cannula.

3. A fluid/medicament injecting needle as claimed in any one of the claim 1 or 2, wherein tip of the front end of the needle is blocked for any fluidic communication adapted to direct the injectate along the side holes.

4. A fluid/medicament injecting needle as claimed in anyone of the claims 1 to 3, wherein disposing of the side holes on the both sides of the needle cannula and extending along the length of the needle facilitates localized spreading of the injectate around the needle when it is penetrated wholly into the tissue for administration.

5. A fluid/medicament injecting needle as claimed in anyone of the claims 1 to 4, wherein needle side wall support at the back of the each of the side hole effecting from the disposing of the side hole at the intermediate position of two consecutive side holes in the opposite side of the needle side wall facilitates releasing of injectate with optimum force and velocity from each of the side holes extending through out the length of the needle. ^'

6. A fluid/medicament injecting needle as claimed in anyone of the claims 1 to 5, wherein releasing of injectate with optimum force and velocity through out the length of the needle facilitates uniform spreading of the injectate into a localized region of the tissue around the needle.

7. A fluid/medicament injecting needle as claimed in anyone of the claim 1 to 6, wherein the inside diameter of the said needle cannula progressively decreases such that front needle cannula inside diameter are smaller than rear needle cannula inside diameter adapted to maintain constant injectate releasing pressure through out the length of the needle.

8. A fluid/medicament injecting needle as claimed in anyone of the claim 1 to 7, wherein the outside diameter of the said needle cannula progressively decreases from rear end to front end similar to the inside diameter adapted to provide conical outer shape of the needle for ready and easy penetration into the tissue.

9. A fluid/medicament injecting needle as claimed in anyone of the claim 1 to 7, wherein the outside diameter of the said needle cannula remain constant from rear end to front end adapted to provide cylindrical outer shape of the needle for increasing structural integrity to the said needle.

10. A fluid/medicament injecting needle as claimed in anyone of the claim 1 to 9, wherein the side wall holes on the both sides of the needle cannula are arranged in equal interval and at mid-position of two consecutive side holes in the opposite side of the needle cannula for releasing the injectate both side of the needle at equal interval.

11. A fluid/medicament injecting needle as claimed in claim 10, wherein releasing of the injectate both side of the needle at equal interval is adapted to create bisymmetric localized spreading of the injectate in the tissue.

12. A fluid/medicament injecting needle as claimed in anyone of the claim 1 to 10, wherein the said injecting needle is adapted to deliver drug/medicaments which would enable efficient treatment for specialized conditions such as those used for rabies immunoglobin administration ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

13. A fluid/medicament injecting needle as claimed in anyone of the claim 1 to 12 which is of 20-24 gauge sized needle with fine cannula dimensions and side holes with diameter 0.2- 0.5 mm disposed on an interval 4-6 mm.

14. Use of a fluid/medicament injecting needle as claimed in anyone of the claim 1 to 12 for substantially uniform rabies immunoglobin administration ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

15. Use of a fluid/medicament injecting needle as claimed in anyone of the claim 1 to 12 for substantially uniform administration of anaesthetic drugs ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

16. Method of treatment of treatment of rabies immunoglobin administration as an anti rabies therapy to take care of conditions of localized wounds comprising the step of administering the rabies immunoglobin administration using the fluid/medicament injecting needle as claimed in anyone of the claim 1 to 12 ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks.

17. Method of carrying out anesthesia comprising uniform administration of anaesthetic drugs ensuring uniform distribution of the drug/medicaments in the region of its intended application without involving multiple pricks using said fluid/medicament injecting needle as claimed in anyone of the claim 1 to 12.