Description:FIELD OF THE INVENTION
[001] The present invention relates to the field of Nano science, and more particularly, the present invention relates to the Needle enabled with Nano-coated stellate assembly (NEENA).
BACKGROUND FOR THE INVENTION:
[002] The following discussion of the background to the invention is intended to facilitate an understanding of the present invention. However, it should be appreciated that the discussion is not an acknowledgment or admission that any of the material referred to was published, known, or part of the common general knowledge in any jurisdiction as of the priority date of the application. The details provided herein the background if belongs to any publication is taken only as a reference for describing the problems, in general terminologies or principles or both of science and technology in the associated prior art.
[003] Visualization of tissue morphology is required for majority of pathological diagnosis. While getting a chunck of tissue, also known as biopsy, gives more information regarding architecture, pattern and cells morphology, obtaining biopsy from certain area like smaller node, thoracic nodes, lung mass seated deep in thorax, kidney mass and liver mass are having risk of complications. In many clinical scene, fine needle aspiration often precedes the proper biopsy. Fine needle aspiration cytology [FNAC] gives useful informations about cell morphology and gives diagnosis in an easy way. FNAC is office procedure, having less procedural complication and rapid to get result. FNAC is not deemed at par with histobiopsy as the tip of needle might not get the informative diseased site of the tissue. Majority of disease has heterogenous distribution of diseased cells and normal or inflammatory cells, thus one point cell morphology might not be representative.
[004] FNAC is the initial and often the only accessible option of tissue diagnosis/ cytology in various ailments. As FNAC needle is having single opening at tip and it takes out cellular sample from the tip of the needle, it may not be representative in a patchy involved node/ tissue. Attempts have been made by doing multiple punctures in various directions of the same tissue/ organ to get multiple yield. While a positive report of diseased morphology is of use, a negative test is not confirmatory and require tissue diagnosis by more invasive biopsy later. To summarize, FNAC still has poor yield procedure. The benefit of FNAC is that, it is easy to do and quick to get report. No operative preparation is needed, and complication rates are very low. Considering these, improving yield of FNAC is required.
[005] FNAC is being done by using a fine needle of 22 or 24 G . For deep seated mass, a long needle, lumbar puncture needle can be used. A syringe is being fitted at the hub of the needle and after introducing needle to the mass, gentle pressure is being applied to the syringe creating negative suction. Thus, small amount of liquid is getting aspirated in the hub of needle. Then the needle along with syringe, is removed and extracted material is pushed on slide to prepare the final spread of cytology.
[006] The problems faced while using conventional FNAC are:
- It has a poor yield. The cytology spread represents a single point where the tip was located during aspiration. Attempts of multiple punctures and withdrawing with negative pressure have been done to ensure more representation but often leads to dilution of sample. Although it is a simple procedure to do and rapid to analyze, it requires a biopsy to validate result in majority of cases.
- A device designed and Patented [Fine Needle Cytology Aspiration Device, US 005 655 541] was having adjustable suction port preventing sample dilution of each aspiration attempt however it has single point aspiration thus yield is low.
[007] In light of the foregoing, there is a need for the Needle enabled with Nano-coated stellate assembly that overcomes problems prevalent in the prior art.
OBJECTS OF THE INVENTION:
[008] Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.
[009] The principal object of the present invention is to overcome the disadvantages of the prior art by providing the Needle enabled with Nano-coated stellate assembly.
[010] An object of the present invention is to provide the Needle enabled with Nano-coated stellate assembly that is designed to improve the yield of FNAC. It has multiple pores at the side and one at tip. Needle is covered with a sheath thus closing side pores.
[011] Another object of the present invention is to provide the Needle enabled with Nano-coated stellate assembly, wherein once introduced in the organ/ node/ tissue, desired length of side pores can be opened by withdrawing outer sheath thus making the NEENA, a multi-pored FNAC needle.
[012] Another object of the present invention is to provide the Needle enabled with Nano-coated stellate assembly that allows withdrawn samples to get attached to the stellate, preventing dilution of samples by non-representative samples.
[013] Another object of the present invention is to provide the Needle enabled with Nano-coated stellate assembly that improves the yield of FNAC by getting multiple, non-diluted cellular samples from variable depth of target tissue.
[014] Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY OF THE INVENTION:
[015] The present invention provides a Needle enabled with Nano-coated stellate assembly.
[016] This invention is a mechanical designed instrument that has use for FNAC. It has an assembly of three parts. Part A is the needle body. It is made of stainless steel with holes at tip and sides. The hole at tip is beveled with cutting edge for easy tissue penetration. The needle has side holes, 3 on each side at a gap of 3mm. Thus, the needle has 7 holes to retrieve samples.
[017] Part B is the metallic stellate coated with nano-particleTeflon to make it nonstick. It has an uneven surface with nano wells. The stellate is 1mm shorted allowing aspiration from the terminal hole as well. Its proximal part is having a hub which has attachment part for syringe to allow aspiration. The hub has holes in the sliding part adjoining hub to the solid stellate core allowing aspiration from the holes of the needle.
[018] Part C is the sheath over the needle which has slidable junction with the hub of needle. It can be pulled up to uncover retrieval holes at side.
[019] The assembly of NEENA has part B, the stellate is in center of part A, the needle and it is covered by part C, the slidable sheath. The hub of part B holds all three parts together.
[020] Functioning of NEENA- The FNAC needle assembly ,NEENA will be introduced to the node or tumor targeted by direct vision or by ultrasound guidance. After the introduction to the target tumor/ node, part C, the outer sheath will be pulled up to allow opening of side holes. Extend of hole exposure will be decided by the depth of needle inside the tumor/node. Syringe will be attached to the hub of the NEENA and gentle pressure will be applied allowing aspiration of samples from holes at side as well as tip. The samples pulled in will attach to the teflon coated stellate. Its uneven surface prevents its spill and mixing. Thereafter the NEENA will be withdrawn from the tumor/node.
[021] The part B, stellate will be removed from the assembly and collected samples will be retrieved from the stellate and labelled as the number of holes thus allowing more distinct representation of the target.

BRIEF DESCRIPTION OF DRAWINGS:
[022] Reference will be made to embodiments of the invention, examples of which may be illustrated in accompanying figures. These figures are intended to be illustrative, not limiting. Although the invention is generally described in the context of these embodiments, it should be understood that it is not intended to limit the scope of the invention to these particular embodiments.
[023] No Figure.
DETAILED DESCRIPTION OF DRAWINGS:
[024] While the present invention is described herein by way of example using embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described and are not intended to represent the scale of the various components. Further, some components that may form a part of the invention may not be illustrated in certain figures, for ease of illustration, and such omissions do not limit the embodiments outlined in any way. It should be understood that the drawings and the detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the scope of the present invention as defined by the appended claim.
[025] As used throughout this description, the word "may" is used in a permissive sense (i.e. meaning having the potential to), rather than the mandatory sense, (i.e. meaning must). Further, the words "a" or "an" mean "at least one” and the word “plurality” means “one or more” unless otherwise mentioned. Furthermore, the terminology and phraseology used herein are solely used for descriptive purposes and should not be construed as limiting in scope. Language such as "including," "comprising," "having," "containing," or "involving," and variations thereof, is intended to be broad and encompass the subject matter listed thereafter, equivalents, and additional subject matter not recited, and is not intended to exclude other additives, components, integers, or steps. Likewise, the term "comprising" is considered synonymous with the terms "including" or "containing" for applicable legal purposes. Any discussion of documents, acts, materials, devices, articles, and the like are included in the specification solely for the purpose of providing a context for the present invention. It is not suggested or represented that any or all these matters form part of the prior art base or were common general knowledge in the field relevant to the present invention.
[026] In this disclosure, whenever a composition or an element or a group of elements is preceded with the transitional phrase “comprising”, it is understood that we also contemplate the same composition, element, or group of elements with transitional phrases “consisting of”, “consisting”, “selected from the group of consisting of, “including”, or “is” preceding the recitation of the composition, element or group of elements and vice versa.
[027] The present invention is described hereinafter by various embodiments with reference to the accompanying drawing, wherein reference numerals used in the accompanying drawing correspond to the like elements throughout the description. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiment set forth herein. Rather, the embodiment is provided so that this disclosure will be thorough and complete and will fully convey the scope of the invention to those skilled in the art. In the following detailed description, numeric values and ranges are provided for various aspects of the implementations described. These values and ranges are to be treated as examples only and are not intended to limit the scope of the claims. In addition, several materials are identified as suitable for various facets of the implementations. These materials are to be treated as exemplary and are not intended to limit the scope of the invention.
[028] The present invention provides a Needle enabled with Nano-coated stellate assembly.
[029] This invention is a mechanical designed instrument that has use for FNAC. It has an assembly of three parts. Part A is the needle body. It is made of stainless steel with holes at tip and sides. The hole at tip is beveled with cutting edge for easy tissue penetration. The needle has side holes, 3 on each side at a gap of 3mm. Thus, the needle has 7 holes to retrieve samples.
[030] Part B is the metallic stellate coated with nano-particleTeflon to make it nonstick. It has an uneven surface with nano wells. The stellate is 1mm shorted allowing aspiration from the terminal hole as well. Its proximal part is having a hub which has attachment part for syringe to allow aspiration. The hub has holes in the sliding part adjoining hub to the solid stellate core allowing aspiration from the holes of the needle.
[031] Part C is the sheath over the needle which has slidable junction with the hub of needle. It can be pulled up to uncover retrieval holes at side.
[032] The assembly of NEENA has part B, the stellate is in center of part A, the needle and it is covered by part C, the slidable sheath. The hub of part B holds all three parts together.
[033] Functioning of NEENA- The FNAC needle assembly ,NEENA will be introduced to the node or tumor targeted by direct vision or by ultrasound guidance. After the introduction to the target tumor/ node, part C, the outer sheath will be pulled up to allow opening of side holes. Extend of hole exposure will be decided by the depth of needle inside the tumor/node. Syringe will be attached to the hub of the NEENA and gentle pressure will be applied allowing aspiration of samples from holes at side as well as tip. The samples pulled in will attach to the teflon coated stellate. Its uneven surface prevents its spill and mixing. Thereafter the NEENA will be withdrawn from the tumor/node.
[034] The part B, stellate will be removed from the assembly and collected samples will be retrieved from the stellate and labelled as the number of holes thus allowing more distinct representation of the target.
[035] Proposed device NEENA has the following advantages over existing FNAC devices
- 1. It has a better yield of tissue
- 2. sample dilution will be less
[036] Proposed Device is likely to have several advantages over existing devices.
Features Conventional FNAC using needle Fine Needle Cytology Aspiration Device, US005655541 Needle enabled with Nanocore assembly [NEENA]
Size/portability Simple thin needle Comparable size Comparable size
Sample yield poor Poor, from single site only Better, with multiple site aspiration
Representative sample Low probability Low probability Probable
Sample dilution Yes, in case of more negative pressure or multi-directional aspiration Low risk but all samples from single pint Minimal risk
Field use Office use Office use Need minimal training
[037] The disclosure has been described with reference to the accompanying embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein.
[038] The foregoing description of the specific embodiments so fully revealed the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the scope of the embodiments as described herein.
, Claims:1) A Needle enabled with Nano-coated stellate assembly, the assembly comprises:
- a needle body (Part A) made of stainless steel, said needle body having a beveled tip with a cutting edge and a plurality of side holes, wherein the plurality of side holes comprises three holes on each side of the needle body enabling multi-site sample retrieval;
- a stellate assembly (Part B) positioned within the needle body, said stellate assembly having a non-stick nano-particle Teflon coating with an uneven surface comprising nano-wells, said stellate assembly being shorter than the needle body to allow sample aspiration from the terminal hole of the needle body, wherein the stellate assembly includes a hub for attachment to a syringe, and wherein said hub has aspirating holes adjoining the stellate core to facilitate aspiration from the plurality of side holes and the terminal hole; and
- a sheath (Part C) slidably covering the needle body, wherein the sheath can be retracted to expose the plurality of side holes, allowing controlled aspiration of cellular samples from multiple depths of the target tissue.
2) The needle assembly as claimed in Claim 1, wherein the stellate assembly's nano-particle Teflon coating prevents sample spill, minimizes sample dilution, and enhances adherence of cellular samples to the uneven surface.
3) The needle assembly as claimed in Claim 1, wherein the sheath is retractable in a variable manner to selectively expose the plurality of side holes based on the depth of the needle in the target tissue.
4) The needle assembly as claimed in Claim 1, wherein the stellate assembly is configured to be removable from the needle body to facilitate retrieval and labeling of cellular samples obtained during aspiration.
5) The needle assembly as claimed in Claim 1, wherein the three holes on each side of the needle body spaced at a gap of 3 mm.