WO2016101069A1 - Multiple needle assembly - Google Patents

Abstract

The present disclosure provides a needle assembly having multiple cannulas, each having a needle tip. Providing multiple needles reduces the pain of needle insertion through the simultaneous introduction of multiple needles.

Description

I

Multiple Needle Assembly

CROSS REFERENCE TO RELATED APPLICATION(S)

[0001] This application claims the benefit under 35 U.S.C. §1 19(e) of U.S. Application Serial No. 62/096,066, filed December 23, 2014, the entire content of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

FIELD OF THE INVENTION

[0002] The present invention relates to a medical device. In particular, the invention relates to a needle assembly having multiple needles to reduce the pain of needle insertion through the simultaneous introduction of multiple needles.

BACKGROUND INFORMATION

[0003] The hypodermic needle was invented independently by Charles Gabriel Pravaz in France and by Alexander Wood in England in 1853. Since then, needles have become the most widely used medical device, with an estimated 16 billion injections administered worldwide. Needle-related procedures are a common source of pain discomfort and distress, especially for children. The proposed invention is intent upon being effective for improving needle pain in children (and adults) by limiting the perception of the number of "pokes" required to introduce materiel to the body, in particular but not limited to under the skin. Currently, needles are available in a wide range of lengths and gauges (i.e., diameters) either to enable delivery of drugs, vaccines, and other substances into the body or for extraction of fluids and tissue.

[0004] The current state of the art includes the traditional needle with luer-Iock attached syringe, with a needle of varying diameter having a sharpened needlepoint and hollow needle lumen for introduction of material to the patient. Introduction would be either into a blood vessel, into the muscle, under the skin or to another location to someone knowledgeable in the art. To increase patient acceptance, smaller needle diameters and lower insertion forces have been shown to reduce the frequency of painful injections.

[0005] Hypodermic needles are in widespread use and are effective, but patients are unhappy with the pain, anxiety, needle phobia, and difficulty of use have made them widely unpopular with children and adults alike. Consequently, there is poor compliance in initiating and adhering to needle-dependent therapies, such as is the case with avoiding a visit to the doctor to suture a wound, when suturing a wound is the prudent course of action.

[0006] Accordingly, a need exists for less painful needles to deliver or withdraw substances from the body.

SUMMARY OF THE INVENTION

[0007] The present invention relates to a multi-cannula needle assembly. In one embodiment, the invention provides a tripartite needle, equally spaced, with three needlepoints, three needle bodies and three needle lumens, wherein the assembly has only a single luer lock for attachment to a single syringe. In various embodiments the assembly may have 2, 3, 4, 5, 6, 7, 8, 9, 10 or more cannulas, each having a needle point. All needlepoints are able to enter the skin at the same time. As a result, only one needle stick is sensed, thereby limiting the anticipated sticks into the skin, and the resultant pain is reduced.

[0008] In one aspect, the invention provides a multi-cannula needle assembly. The assembly includes: a) a plurality of elongated cannulas, each cannula having a proximal end and a distal end, each distal end comprising a needle point; and b) a central hub having a proximal end, a distal end, and a plurality of independent lumens, each lumen being fluidly coupled to the proximal end of each cannula at the distal end of the central hub.

[0009] In another aspect, the invention provides a method of aspiring fluid from a subject using the assembly of the present invention. The method includes: a) inserting each needle tip into tissue of the subject, wherein each needle tip pierces the tissue simultaneously thereby reducing pain; and b) aspiring fluid from the tissue via actuation of the syringe, thereby aspiring fluid from the subject.

[0010] In another aspect, the invention provides a method of injecting fluid into a subject using the assembly of the present invention. The method includes: a) inserting each needle tip into tissue of the subject; wherein each needle tip pierces the tissue simultaneously thereby reducing pain; and b) injecting fluid into the tissue via actuation of the syringe, thereby injecting fluid into the subject.

[0011] By increasing the number of needles that go into the skin at the same time, the body senses only one needle stick, not numerous separate needle sticks that are introduced at separate times (see Figure 2).

[0012] The most commonly studied needle procedures where this would be appropriate are anesthetic introduction and immunization, or any time when multiple needles are required to be used in a short period of time.

[0013] Certain aspects of the presently disclosed subject matter having been stated hereinabove, which are addressed in whole or in part by the presently disclosed subject matter, other aspects will become evident as the description proceeds when taken in connection with the accompanying Examples and Figures as best described herein below.

BRIEF DESCRIPTION OF THE FIGURES

[0014] In the drawings, like elements are assigned like reference numerals. The drawings are not necessarily to scale, with the emphasis instead placed upon the principles of the present invention. Additionally, each of the embodiments depicted are but one of a number of possible arrangements utilizing the fundamental concepts of the present invention. The drawings are briefly described as follows:

[0015] Figure 1 is an illustration of a prior art needle assembly having a single cannula connected to a central hub.

[0016] Figure 2 is a top view of a tripartite needle assembly 10 in one embodiment of the invention.

[0017] Figure 3 is a top view of the needle assembly 10 of Figure 2 coupled to a syringe in one embodiment of the invention.

[0018] Figure 4 is a top perspective view of the central hub 20 of a tripartite needle assembly 10 in one embodiment of the invention.

[001 ] Figure 5 is a top perspective view of the central hub 20 of a tripartite needle assembly 10 in one embodiment of the invention in which central hub includes threads 30 for attachment to a syringe. [U020J Figure 6 is a top perspective view of a tripartite needle assembly 10 in one embodiment of the invention.

[0021] Figure 7 is a cross sectional view of a central hub portion 20 showing multiple lumens 40 in one embodiment of the invention.

[0022] Figure 8 is an expanded side view of the threaded portion 30 of central hub 20 disconnected from syringe 100 in one embodiment of the invention.

DETAILED DESCRIPTION

[0023] The invention relates to a needle assembly, specifically, a needle assembly having multiple cannulas, each with a needle point. When describing the present invention, all terms not defined herein have their common art-recognized meanings. To the extent that the following description is of a specific embodiment or a particular use of the invention, it is intended to be illustrative only, and not limiting of the claimed invention. The following description is intended to cover all alternatives, modifications and equivalents that are included in the spirit and scope of the invention, as defined in the appended claims. It is also to be understood that the terminology used herein is for purposes of describing particular embodiments only, and is not intended to be limiting, since the scope of the present invention will be limited only in the appended claims.

[0024] As used in this specification and the appended claims, the singular forms "a", "an", and "the" include plural references unless the context clearly dictates otherwise. Thus, for example, references to "the method" includes one or more methods, and/or steps of the type described herein which will become apparent to those persons skilled in the art upon reading this disclosure and so forth.

[0025] Motivated to make less painful needles, the inventor discovered that when multiple needle pokes occur at the same time, as was discovered upon self-application of a wound clamp as described in U.S. Patent Appl. Serial No. 14/103,641 , in which 8 needles all enter the skin at the same time, it is perceived as one poke. By creating a single poke but simultaneously with multiple needles, the perceived pain will be the same but the number of pokes will be less as is divided by the number of needles in the device

[0026] Reducing needle size reduces pain and generally increases patient acceptance. Guided by these observations, tine needles and microneedles have been developed to minimize pain. Similarly, The limitations of hypodermic needles can be addressed by eliminating the needle altogether. Jet injectors accelerate liquid droplets across the skin at high velocity and are used clinically to administer insulin, vaccines, and other drugs.

[0027] However, pain reduction must be balanced against limitations of injection depth, volume, and formulations introduced by reduced (or none) needle dimensions. Smaller needles are not suitable for all applications. For example, rapid delivery of large volumes and administration of formulations with large particulates require larger needles. Furthermore, scaling down needle length also prevents injection into deeper tissues. Transdermal patches have also been developed to passively deliver drugs across the skin, but this approach has been limited to hydrophobic and small molecules.

[0028] Embodiments of the present invention refer to the term "treatment site." A treatment site may include, but is not limited to in or around a body tissue, a blood vessel or a body lumen such as a coronary blood vessel. The treatment site may refer to a site where a therapeutic treatment is to be taken place at. For instance, an agent may be injected at the treatment site for a particular purpose or treatment. Alternatively, a bodily sample may be taken at the treatment site for a particular purpose or treatment. The treatment site may also refer to a site where a diagnostic procedure may occur or an imaging of the site may occur as desired or necessary for many procedures. Additionally, embodiments of the present invention frequently refer to the term "agent." An agent can be a treatment agent or a bio- agent component such as medication or drugs used in the prevention, alleviation, or cure of disease or injury.

[0029] Embodiments of the present invention pertain to a delivery apparatus that can perform a procedure such as delivering an agent to a treatment site, withdrawing a fluid or other substance from a treatment site, delivering or deploying a device at a treatment site, or performing other procedures at the treatment site. The delivery apparatus and method described herein are particularly suitable, but not limited to, local drug delivery in which an agent composition (possibly including multiple agents and/or a sustained-release agents) is introduced via multiple needle deliveries to a treatment site within a mammalian host (e.g., a patient).

[0030] The present invention address pain reduction by providing a needle assembly having multiple needle points which simultaneously piece the skin. In one embodiment as depicted in Figures 2-3, the invention provides a tripartite needle, 3 needles containing a single luer-lock attachment. However, it is envisioned that the assembly may include 2, 3, 4, 5, 6, 7, 8, 9, 10 or more cannulas, each having a needle point and associated hub coupling.

[0031] By allowing fluid to be simultaneously introduced through the multiple connected needles, the number of perceived needle pokes is reduced to one per insertion. The diameter of each needle is not prescribed, so microneedles and small diameter needles can be used just as large diameter needles can be used for this purpose.

[0032] With reference to Figures 2-8, a needle assembly 10 may include multiple cannulas 15, of substantially constant diameter, a needle tip portion 25 for each cannula 15, and a connector portion or central hub 20.

[0033] As such, the invention provides a multi-cannula needle assembly 10. The assembly includes: a) a plurality of elongated cannulas 15, each cannula 15 having a proximal end 16 and a distal end 17, each distal end 17 comprising a needle point 25; and b) a central hub 20 having a proximal end 21 , a distal end 22, and a plurality of independent lumens 40, each lumen 40 being fluidly coupled to the proximal end 16 of each cannula 15 at the distal end 22 of the central hub 20.

[0034] The length of the individual cannulas 15 can vary according to the desired application. Additionally, the gauge of each cannula 15 may vary according to the application. For example, the gauge of the cannula 15 may be between 7 and 34, e.g., 7, 8, 9, 10, 1 1 , 12, 13, 14, 15, 16, 17, 18, 19, 20, 21 , 22, 23, 24, 25, 26, 26s, 27, 28, 29, 30, 31 , 32, 33 or 34. Additionally, any combination of cannulas having different gauges may be employed so long as their lengths are configured such that upon injection, all enter tissue at the same time.

[0035] The central hub portion 20 is adapted to couple to each cannula 1 5 and connect to a standard hypodermic syringe 100. Needle tip portions 25 may be substantially blunt so as to prevent the penetrating of blood vessels by diverting blood vessels around the cannula shaft when the needle tip portion 15 is inserted into subcutaneous tissue. Each needle tip 1 has at least one outlet 50 to allow fluids to exit or enter.

[0036] It is also envisioned that each cannula 15 may have any type of needle tip 25. For example, needle tips 25 may be any of the following.

[0037] Cone shaped. [0038] Dual gauged - needles have a narrow gauge at the tip suitable for megabore on- column injection.

[0039] Beveled - bevel tip for optimum penetration and prevention of coring.

[0040] Square tipped - needle with chamfered and polished edges.

[0041] Side holed.

[0042] Domed tip.

[0043] As shown in the embodiment of the Figures, the cannulas 15 are arranged in a planar geometry. However, it is envisioned that they may be configured in a variety of geometries. For example, the cannulas 15 may be arranged in an arc or circle, or portion thereof, such as a semi-circle. The cannulas 1 may be arranged in a triangle, square, pentagon, hexagon, heptagon, octagon, nonagon or decagon. One in the art could envision that any type of geometry may be employed.

[0044] In various embodiments, the needle tip 25 can be constructed from a variety of materials. For example, it may be constructed of a surgical grade steel, such as 14-gauge stainless steel, so that the needle is substantially rigid. The needle tip 25 may also be constructed of a material that is reusable and can be autoclaved to provide a sterile instrument.

[0045] In embodiments, the needle assembly 10 may include cannulas 15 that are configured such that cannulas 15 may be individually retracted.

[0046] The following examples are provided to further illustrate the embodiments of the present invention, but are not intended to limit the scope of the invention. While they are typical of those thai might be used, other procedures, methodologies, or techniques known to those skilled in the art may alternatively be used.

EXAMPLE 1

[0047] This experiment utilizes the needle assembly device of Figure 2 coupled to a syringe.

[0048] Experimental Description

[0049] 50ml of water with red food coloring was prepared for experiment. 20ml were drawn into a syringe. The syringe was then attached to the tripartite needle assembly with three cannulas attached to the central hub. Each cannula was coupled to a sealed straw at its needle tip.

[0050] 15ml of the red solution were injected from the syringe, through the central hub and three cannulas, into the three attached straws that had one end sealed. As was observed that equal amounts of the red fluid was transferred into each straw. The volume of red fluid in each straw was ~5ml, as was measured in a 50ml graduated cylinder. As such, the needle assembly was effective in equally distributing fluid to each needle tip.

[0051 J Conclusion

[0052] The fluid was successfully distributed throughout the three needles in the experiment.

EXAMPLE 2

[0053] This experiment utilizes the needle assembly device of Figure 2 coupled to a syringe.

[0054] Experimental Description

[0055] 50ml of water with red food coloring was prepared for experiment. 20ml was drawn into a syringe. The syringe was then attached to the tripartite needle assembly having three cannulas attached to the central hub. The needle tips were used to penetrate porcine skin tissue. 15ml of the prepared red solution was injected from the syringe, through the tripartite needle adaptor into the porcine skin tissue.

[0056] It was observed that a small amount of fluid leaked from each injection site. Upon cutting open the skin, red fluid was observed across the injection region in the subcutaneous fat indicating even distribution and injection of the prepared fluid.

[0057] Conclusion

[0058] The fluid was successfully distributed throughout the three needles in the experiment.

[0059] Although the invention has been described with reference to the above example, it will be understood that modifications and variations are encompassed within the spirit and scope of the invention. Accordingly, the invention is limited only by the following claims.

Claims

What is claimed is:

1. A needle assembly comprising:

a) a plurality of elongated cannulas, each cannula having a proximal end and a distal end, each distal end comprising a needle point; and

b) a central hub having a proximal end, a distal end, and a plurality of independent lumens, each lumen being fluidly coupled to the proximal end of each cannula at the distal end of the central hub.

2. The needle assembly of claim 1 , wherein each lumen is fluidly coupled to a syringe at the proximal end of the central hub.

3. The needle assembly of claim 1, wherein a fluid reservoir of the syringe is in fluid communication with each lumen simultaneously.

4. The needle assembly of claim 3, wherein each lumen is in fluid communication with the fluid reservoir via a common central lumen coupled to the syringe at the proximal end of the centra] hub.

5. The needle assembly of claim 1 , wherein the assembly comprises 2, 3, 4, 5, 6, 7, 8, 9, or 10 cannulas coupled to the central hub, each cannula being couple to an independent lumen of the central hub.

6. The needle assembly of claim 1 , wherein the syringe and central hub are coupled via a threaded connection.

7. The needle assembly of claim 1 , wherein the syringe and central hub are coupled via a luer connection.

8. The needle assembly of claim 1 , wherein the cannulas are each of an identical length so that each needle point pierces tissue simultaneously.

9. The needle assembly of claim 1 , wherein each cannula is fluidly coupled to a different syringe.

10. A method of aspiring fluid from a subject using the assembly according to any of claims 1 -9, the method comprising:

a) inserting each needle tip into tissue of the subject, wherein each needle tip pierces the tissue simultaneously thereby reducing pain; and

b) aspiring fluid from the tissue via actuation of the syringe, thereby aspiring fluid from the subject.

11. The method of claim 10, wherein the tissue is skin or a blood vessel.

12. The method of claim 1 1 , wherein the fluid is blood.

13. A method of injecting fluid into a subject using the assembly according to any of claims 1-9, the method comprising:

a) inserting each needle tip into tissue of the subject, wherein each needle tip pierces the tissue simultaneously thereby reducing pain; and

b) injecting fluid into the tissue via actuation of the syringe, thereby injecting fluid into the subject.

14. The method of claim 13, wherein the fluid is a therapeutic agent.

15. The method of claim 14, wherein the therapeutic agent is a drug.