A needle for harvesting a tissue during biopsy

Abstract

In an embodiment of a present invention, a needle for harvesting a tissue during biopsy is disclosed. The needle (212) for harvesting a tissue during biopsy includes a body (310) and a plurality of echogenic marks (306). The body (310) is cylindrical in shape. The body (310) has a first end (308), a second end. The first end (308) comprises a plurality of major spikes (302) and a plurality of minor spikes (304). Each of the major spikes and each of the minor spikes are arranged alternately on a circumference of a first end (308). The second end is coupled to a cap (122). The plurality of echogenic marks (306) is grooved equidistant on a circumference of the body (310) to reflect an ultrasound wave directed by an ultrasound transducer for real time visualization.

Description

A NEEDLE FOR HARVESTING A TISSUE DURING BIOPSYTECHNICAL FIELD

[0001] The present disclosure relates generally to a needle for harvesting a tissue during biopsy and more particularly the invention relates to an endoscopic ultrasonic fine needle configured for use in conjunction with minimally -invasive procedures to improve the cell harvesting ability.BACKGROUND

[0002] A biopsy is a procedure, used to collect a sample of a patient's tissue or fluid of an affected / damaged area. The endoscopic ultrasound (EUS) technology helped physicians and patients by providing enhanced ability of a physician to visualize a needleand to obtain a sample patient's tissue or fluid of an affected / damaged area. Biopsies are useful in diagnosing various forms of cancer and other diseases affecting a localized area of tissue. The Biopsy procedure takes tissue and / or fluid samples from muscles, bones and organs, such as the liver or lungs. A biopsy sample is obtained by invasive surgical procedures. The endoscopic ultrasound (EUS) technology that performs both endoscopy and ultrasound at the same time. The endoscopic ultrasound (EUS) inserts a needle under an object with a precise aim in real time along a safe path.

[0003] A fine needle aspiration and a fine needle biopsy is directed through a working channel of an endoscope to a target in a patient’s body. Both the fine needle aspiration (FNA) and the fine needle biopsy (FNB) procedure generally use a needle for collecting the target sample. To obtain samples from patients in a minimally invasive manner, an echogenic needles are used. An existing needle is inefficient while collecting samples. Cell tissue is not collected effectively depending on the position, nature, and size of a lesion and an operation of the puncture through the needle. As the cell has a high density, they are not collected in the needle even after aspiration. The collection rate for solid tumors such asfibroids, lesions with fibrosis, vitrification, or calcification is low. The existing needles used are not sufficient for examination and diagnosisSUMMARY

[0004] Embodiments of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems.

[0005] In an embodiment of a present invention, a needle for harvesting a tissue during biopsy is disclosed. The needle for harvesting a tissue during biopsy includes a body and a plurality of echogenic marks. The body is cylindrical in shape. The body has a first end and a second end. The first end comprises a plurality of major spikes and a plurality of minor spikes. Each of the major spikes and each of the minor spikes are arranged alternately on a circumference of the first end. The second end is coupled to a cap. The plurality of echogenic marks is grooved equidistant on a circumference of the body. The plurality of echogenic marks is configured to reflect an ultrasound wave directed by an ultrasound transducer for real time visiualization.

[0006] This summary is provided to introduce aspects related to the needle for harvesting a tissue during biopsy. This summary is not intended to identify essential features of the claimed subject matter nor is it intended for use in determining or limiting the scope of the present subject matter.BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS

[0007] The foregoing detailed description of embodiment's is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the disclosure, there is shown in the present document example constructions of the disclosure; however, the disclosure is not limited to the specific system or method disclosed in the document and the drawings.

[0008] The present disclosure is described in detail with reference to the accompanying figures. In the figures, the left-most digit(s) of a reference numberidentifies the figure in which the reference number first appears. The same numbers are used throughout the drawings to refer various features of the present subject matter.

[0009] Figure 1 illustrates a perspective view of an endoscopic ultrasound- fine needle biopsy (EUS-FNB) device depicting the configuration of the different parts, in accordance with an embodiment of the subject matter.

[0010] Figure 2 illustrates a cross-sectional view of an endoscopic ultrasound- fine needle biopsy (EUS-FNB) device depicting the configuration of the different parts of the endoscopic ultrasound- fine needle biopsy device, in accordance with an embodiment of the subject matter.

[0011] Figure 3 illustrates a perspective view of a needle, depicting a structure of the needle, in accordance with an embodiment of the subject matter.

[0012] Figure 4 illustrates a cross-sectional view of a needle, depicting an internal structure of the needle, in accordance with an embodiment of the subject matter.

[0013] Figure 5 illustrates a perspective view of a needle with a stylet depicting a structure of the needle, in accordance with an embodiment of the subject matter.

[0014] Figure 6 illustrates a perspective view of a needle with six spikes depicting four major spikes and two minor spikes needle, in accordance with an embodiment of the subject matter.

[0015] Figure 7 illustrates a perspective view of a needle with six spikes depicting two major spikes and four minor spikesneedle, in accordance with an embodiment of the subject matter.

[0016] Figure 8 illustrates a perspective view of a needle with three spikes depicting different lengths of the spikesof the needle, in accordance with an embodiment of the subject matter.

[0017] Figure 9 illustrates a perspective view of a needle with three spikes depicting different lengths of the spikes of the needle, in accordance with an embodiment of the subject matter.

[0018] In the above accompanying drawings, a non -underlined number relates to an item identified by a line linking the non -underlined number to the item. When a number is non-underlined and accompanied by an associated arrow, the nonunderlined number is used to identify a general item at which the arrow is pointing.

[0019] Further, the figures depict various embodiments of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein.DETAILED DESCRIPTION

[0020] Some embodiments of this disclosure, illustrating all its features, will now be discussed in detail. The words "comprising", "having", "containing”" and "including" and other forms thereof, are intended to be equivalent in meaning and be open ended in that an item or items following any one of these words is not meant to be an exhaustive listing of such item or items, or meant to be limited to only the listed item or items. It must also be noted that as used herein and in the appended claims, the singular forms "a", "an" and "the" include plural references unless the context clearly dictates otherwise. Althougha needle for harvesting a tissue during biopsy, similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present disclosure, the exemplary the needle for harvesting a tissue during biopsyis now described.

[0021] Various modifications to the embodiment will be readily apparent to those skilled in the art and the generic principles herein may be applied to other embodiments. For example, although the present disclosure will be described in the context of the needle for harvesting a tissue during biopsy, one of ordinary skill in the art will readily recognize that an apparatus can be utilized in any situation, for effectively collecting cell tissues and avoiding injury to neighboringstructures. Thus, the present disclosure is not intended to be limited to the embodiment's illustrated but is to be accorded the widest scope consistent with the principles and features described herein.

[0022] A device such as a fine needle aspiration and a fine needle biopsy is directed through a working channel of an endoscope to a target in a patient’s body. Both the fine needle aspiration (FNA) and the fine needle biopsy (FNB) procedure generally use a needle for collecting the target sample. To obtain samples from patients in a minimally invasive manner, an echogenic needles are used. The echogenic needle allows for carefully targeting samples deep inside the patient's body without any external punctures. The echogenic needles are viewable under ultrasound. An endoscopic ultrasound-fine needle aspiration (EUS - FNA) and an endoscopic ultrasound-fine needle biopsy (EUS - FNB) combine endoscopic visualization with ultrasound imaging and a sampling device. The endoscopic ultrasound-fine needle aspiration (EUS - FNA) and the endoscopic ultrasound-fine needle biopsy (EUS - FNB) allows physicians to use traditional endoscopic visualization to guide a track through the gastrointestinal tract and the use of ultrasound imaging provides images of organs and structures. The needles are elongated and are passed through the biopsy channel of the endoscope. The needles are visualized ultrasonically as they penetrate to the desired sampling location to collect a tissue or biological liquid sample. Generally, the FNA and / or the FNB are used to acquire sufficient samples of tissue for a diagnosis. Different needle tip configurations are used to collect different sample types. For example, an intact multi-cell sample useful for histology, cells and fragments useful for cytology.

[0023] An existing needle is inefficient while collecting samples. Cell tissue is not collected effectively depending on the position, nature, and size of a lesion and an operation of the puncture through the needle. In one embodiment, the needle uses only about half or less of the inner diameter of a lumen to obtain tissue. In another embodiment, the needle tip design results in the tearing of targettissue, which results in a less-than-ideal core sample and unnecessary trauma to the surrounding tissue, which causes further complications to the patient. For example, internal bleeding, or bruising that requires further treatment. In another embodiment, as a state of the lesion, such as the hardness and size of the lesion, the stroke is not performed accurately, because the lesion is small or the hardness of the lesion. If the lesion is small or hard, the collection rate is low for such lesions. A cell has a high density. The cell is not collected in the needle even after aspiration. The collection rate is low for solid tumors such as fibroids, lesions with fibrosis, vitrification, or calcification. The existing needles used are not sufficient for examination and diagnosis. There is a need for such a needle that navigates a track in a manner consistent with the desires and aims of users to accurately obtain samples.

[0024] In an embodiment, an endoscopic ultrasound-fine needle biopsy (EUS- FNB) device is disclosed. The endoscopic ultrasound-fine needle biopsy (EUS- FNB) device comprises an elongated handle body having a proximal portion, a distal portion, and a central portion. The handle body also comprises an attachment portion located at a distal portion configured to be attached with an endoscope or other device for insertion into a living body in an operative configuration. The handle body portion is ergonomically designed. The handle body portion comprises a first knob secured to a distal end with the central portion and a second knob formed substantially similarly to the first knob configured to selectively limit a proximal-distal movement of the distal portion relative to the central portion and movement of the central portion relative to the proximal handle portion. A lumen extends through the endoscopic ultrasound -fine needle biopsy (EUS-FNB) device from a proximal end to a distal end. In one embodiment the endoscopic ultrasound- fine needle biopsy (EUS-FNB) device is made up of a polymer, metal, or other known material. As the needle is inserted into a directed object through the lumen, the needle is moved proximally and distally relative to the proximal handle portion by application of directed force toa proximal end of a needle. The needle has an inclination angle to cut the tissue. An inclination angle affects the forces on the needle upon insertion. The needle is configured for acquiring a tissue sample during biopsy procedure.

[0025] The needle is constructed in such a way as to efficiently puncture and collect the tissue in the lumen of the needle. The needle is covered by a sheath. The first end of the needle comprises a plurality of major spikes and a plurality of minor spikes. The plurality of major spikes and the plurality of minor spikes target the lesion. The needle is stroked thereby scraping a tissue from a lesion and collecting the tissue inside the lumen and collect tissue. The collected tissue is sent for further examination.

[0026] In an embodiment of a present invention, a needle for harvesting tissue during biopsy is disclosed. The needle for harvesting tissue during biopsy includes a body and a plurality of echogenic marks. The body is cylindrical. The body has a first end and a second end. The first end comprises a plurality of major spikes and a plurality of minor spikes. Each of the major spikes and each of the minor spikes are arranged alternately on the circumference of the first end. In one embodiment, the first end of the needle comprises franseen with three major pointed needle spikes and three minor pointed spikes arranged alternately and separated from one another circumferentially for precise targeting and sampling. The second end is coupled to a cap. The plurality of echogenic marks is grooved equidistant on the circumference of the body. The plurality of echogenic marks is configured to reflect an ultrasound wave directed by an ultrasound transducer for real-time visualization.

[0027] In another embodiment, the needle used is a beveled end type or a plurality of pointed spikes type. As the franseen-type needle is inserted into tissue. The plurality of major spikes that are at the outer edge of the circular profile of tissue is procured. As the plurality of major spikes and a plurality of minor spikes are advanced, the plurality of minor spikes along with the plurality of major spikes together exert splitting forces on the tissue. The plurality of spikesbecomes a triangular shape. With an acute angle pointing perpendicular to the core of tissue and the base of the triangle defining the perimeter of the core is procured. In one embodiment, the three minor spikes along with the three major spikes together exert splitting forces on the tissue. The six spikes become six triangular shapes.

[0028] The stylet is concentrically fitted in through passage of the needle. The stylet comprises a tip at first end, and the tip extends from the needle through a lumen during insertion in the object. The shape of the stylet is of a pointed tip or round shape. In one embodiment, the stylet is made up of a superelastic nitinol alloy permitting the stylet / needle combination to navigate a tortuous path along the way to the target tissue. In one embodiment, the needle is made up of material preferably cobalt-chromium or stainless steel to provide greater needle hardness and excellent tensile properties. The construction of the needle in the embodiment provides superior needle penetration, improved push-ability, and kink resistance, along with increased resistance to the needle. In one embodiment, the length of the plurality of major spikes varies in the range 0.2 - 1.2 mm and the length of the plurality of minor spikes varies in the range 0.2-0.7 mm. The body of needle comprising theplurality of echogenic marks. The plurality of echogenic marks are grooved equidistant on the circumference. The plurality of echogenic marksis used to reflect an ultrasound signal which gives improved reflection of an ultrasound wave directed by an ultrasound transducer towards the needle. In one embodiment, the plurality of echogenic marks is grooved in the form of diamond or prism shape making an acute angle with respect to the surface in order to enhance the visibility of the surface. The depth of each groove ranging upto 0.05 mm and length of each side of groove ranges from 0.02 mm to 0.10 mm. The plurality of echogenic marks is provided with the prism or diamond shape in order to have an increased surface area and is provided with sharp edges which reflect the ultrasound signals in a more efficient way by providing precise guidance within the target site.

[0029] During operation, the attachment portion is connected to operate an ultrasonic endoscope. The operator directly observes the fine needle is correctly inserted into the affected part due to the plurality of echogenic marks grooved on the body of the needle. The plurality of echogenic marks grooved helps to insert the needle correctly during the procedure. The stylet is opened and the distal portion of the handle body adjusts the sheath with the help of a second knob. The needle is covered by a sheath. The needle is inserted into an object based on ultrasound reflection from the plurality of echogenic marks. The needle is actuated by adjusting the first knob on the proximal end of the central portion of the handle body. The needle is pushed forward to the proximal end to puncture the lesion. The needle is stroked and moved back and forth to scrape tissue of cellular thickness from a lesion. During back and forth reciprocations of the needle along its longitudinal axis of symmetry is done at a faster pace. The plurality of major spikes and a plurality of minor spikes of the needle are penetrated to the affected part efficiently. The stylet effectively collects the tissues and stores them inside the lumen of the needle. After puncturing and collecting the tissue into the needle, the collected tissue is sent for examination and diagnosis.

[0030] Referring now to the drawings, particularly by their reference numbers, Figure 1 illustrates an endoscopic ultrasound-fine needle biopsy (EUS-FNB) device 100. The endoscopic ultrasound-fine needle biopsy (EUS-FNB) device 100 comprises an elongated handle body 102 having a sheath 116, a distal end 110, a proximal end 108, a first knob 118, a second knob 120 and a cap 122, a proximal portion 102-a, a distal portion 102 -b, and a central portion 102-c. The handle body also comprises an attachment portion 104 located at a distal portion 102-b configured to be attached with an endoscope or other device for insertion into a living body in an operative condition. The handle body portion 102 comprises a first knob 118 secured to a distal end 110 of the central portion 102-c and a second knob 120 formed substantially similarly to the first knob 118 configured to selectively limit a proximal-distal movement of the distal portion 102-b relative tothe central portion 102-c and movement of the central portion 102-c relative to the proximal handle portion 102-a.

[0031] Figure 2 illustrates a cross-sectional view of an endoscopic ultrasound-fine needle biopsy (EUS-FNB) device 100. The cross-sectional view comprises a sheath 116, a distal end 110, a proximal end 108, a first knob 118, a second knob 120, and a cap 122. The lumen 206 is circular in cross -section. A lumen 206 extends through the device 100 from a proximal end 108 to a distal end 110. The lumen 206 is configured to receive a needle 212, stylet 214, or another medical device. The needle 212 is protected by a sheath 116 to prevent contamination. The stylet 214 is connected to a cap 122 that is adapted to keep stylet 214 safely contained in the handle body 102.

[0032] Figure 3 illustrates a needle 212. The needle 212 for harvesting a tissue during biopsy includes a body 310 and a plurality of echogenic marks 306. The body 310 is cylindrical. The body 310 has a first -end 308, and a second end 320. The first end 308 comprises a plurality of major spikes 302 and a plurality of minor spikes 304. Each of the major spikes and each of the minor spikes are arranged alternately on a circumference of a first end 308. The second end is coupled to a cap 122. The plurality of echogenic marks 306 is grooved equidistant on the circumference of the body 310. The plurality of echogenic marks 306 is configured to reflect an ultrasound wave directed by an ultrasound transducer for real-time visualization.

[0033] Figure 4 illustrates a cross-sectional view of a needle. The cross-sectional view of a needle 400 comprises a franseen-type with three major spikes 402 and three minor spikes 404 arranged alternately and separated from one another circumferentially for precise targeting and sampling. As the franseen-type needle is inserted into the tissue the three minor spikes 404 along with the three major spikes 402 together exert splitting forces on the tissue. The six spikes become six triangular shapes, with an acute angle pointing perpendicular to the core of the tissue that is to be procured and the base of the triangle defining the perimeter ofthe core being procured. The inner portion of the spike prevents the split from propagating into the core of the tissue thereby making a clean cut.

[0034] Figure 5 illustrates a perspective view of a needle with a stylet 214. The stylet 214 is sized and shaped to match the dimensions of those of the inner surface of the needle 212 and concentrically fitted into the through passage of the needle 212 such that in a distal position, the tip 502 of the stylet 214 extends distally out of the distal end of the needle 212. The stylet 214 navigates a tortuous path along the way to the target tissue.

[0035] Figure 6 illustrates a needle with six spikes 600. The EUS -FNB needle with six spikes 600 comprising four major spikes 602 and two minor spikes 604. The four major spikes 602 and two minor spikes 604 are configured to effectively punch and collect the tissue.

[0036] Figure 7 illustrates a needle with six spikes 700. The needle with six spikes 700 comprising two major spikes 702 and four minor spikes 704. The two major spikes 702 and four minor spikes 704 are configured to effectively punch and collect the tissue.

[0037] Figure 8 illustrates a needle with three spikes 800. The needle with three spikes 800 comprises a first spike 802, a middle spike 804, and a third spike 806. The first spike 802 has a longer axial reach. The middle spike 804 is greater than the third spike 806 but smaller than the first spike 802, the third spike 806 is the smallest in length. The first spike 802 extends distally beyond the distal ends of the other spikes to allow the needle to achieve an initial anchoring in a target tissue mass and to provide stability as the rest of the tip when advances into the lesion.

[0038] Figure 9 illustrates a needle with three spikes 900. The needle 212 with three spikes comprises a first spike 902 and other two spikes 904. The first spike 902 has a longer axial reach i.e., extending further distally beyond the distal ends of the other two spikes 904. The first spike 902 is designed in such a way that the pointed tip of the spike 902 is further made pointed at an angle making its tip sharper such that it gives greater needle hardness and superior needle penetration.The first spike 902 allows the needle to achieve an initial anchoring in a target tissue mass, providing stability as the rest of the tip when advances into the lesion.

[0039] Exemplary embodiment's discussed above may provide certain advantages. Though not required to practice aspects of the disclosure, the following advantages may include.

[0040] Some embodiment's of the needle provide an improved and novel construction of a needle for fine needle aspiration biopsy that can reduce the load during needle penetration, increase the grip force on the tissue, and also improve the lesion reach rate during surgery.

[0041] Some embodiment's of the needle is used as a puncture needle that can obtain and improve a sufficient amount of tissue collected per time and reduce the number of punctures during surgery.

[0042] Some embodiments of the needle facilitate better visualization of the needle by ultrasound when the needle penetrates tissue avoiding injury to neighboring structures.

[0043] Although the description provides implementations of needles for harvesting tissue during biopsy, it is to be understood that the above descriptions are not necessarily limited to the specific features or methods of systems. Rather, the specific features and methods are disclosed as examples of implementations for the needle for harvesting tissue during biopsy.

Claims

CLAIM:

1. A needle (212) for harvesting a tissue during biopsy comprises: a body (310), wherein the body (310) is cylindrical in shape, wherein the body (310) comprises a first end (308) and a second end, wherein the first end (308) comprises a plurality of major spikes and a plurality of minor spikes, wherein each of the major spikes (302) and each of the minor spikes (304) are arranged alternately on a circumference of a tip, wherein the second end is coupled to a cap (122); a plurality of echogenic marks (306), wherein the plurality of echogenic marks (306) is grooved equidistant on a circumference of the body (310), wherein the plurality of echogenic marks (306) is configured to reflect an ultrasound wave directed by an ultrasound transducer for real time visualization.

2. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1, wherein during operation, the needle (212) is inserted into an object based on ultrasound reflection from the plurality of echogenic marks, wherein the needle (212) is stroked thereby scraping a tissue from a lesion and collecting the tissue inside the lumen (206), wherein the needle (212) is actuated by adjusting a first knob (118).

3. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1 comprises a stylet (214), wherein the stylet (214) is concentrically fitted in through passage of the needle (212), wherein the stylet (214) comprises a tip (502) at first end (308), and wherein the tip (502) extends from the needle (212) through a lumen (206) during insertion in the object.

4. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1, wherein the plurality of echogenic marks (306) is selected from a group of shapes wherein the group of shapes comprises a prism, a diamond and a triangle.

5. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1, wherein the tip(502) of the needle is selected from a group of shapes, wherein the group of shapes comprises a franseen, a beveled end, and a plurality of pointed spikes.

6. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1, wherein the needle is made up of cobalt-chromium or stainless steel.

7. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1, wherein the length of the major spikes varies in the range 0.2 - 1.2 mm and the length of the minor spikes varies in the range 0.2-0.7 mm.

8. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1, wherein the depth of each echogenic mark is up to 0.05 mm and length of each side of echogenic marks ranges from 0.02 mm to 0.10 mm.

9. The needle (212) for harvesting a tissue during biopsy as claimed in claim 1, wherein the needle (212) is covered by a sheath (116).

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