FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)A NEEDLE FOR HARVESTING A TISSUE DURING BIOPSY
Applicant:
BIORAD MEDISYS PRIVATE LIMITED
AN INDIAN COMPANY REGISTERED UNDER THE COMPANIES ACT
WITH ADDRESS: SURVEY NO. 48, 3 & 48 7, PASHAN – SUS ROAD, SUS,
PUNE, MAHARASHTRA 411021
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE SUBJECT
MATTER AND THE MANNER IN WHICH IT IS TO BE PERFORMED.
TECHNICAL FIELD
[001] 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
5 minimally-invasive procedures to improve the cell harvesting ability.
BACKGROUND
[002] 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
10 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
15 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.
[003] A fine needle aspiration and a fine needle biopsy is directed
20 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
25 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
as fibroids, lesions with fibrosis, vitrification, or calcification is low. The
existing needles used are not sufficient for examination and diagnosis
5 SUMMARY
[004] Embodiments of the present disclosure present technological
improvements as solutions to one or more of the above-mentioned
technical problems.
[005] In an embodiment of a present invention, a needle for harvesting a
10 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
15 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.
20 [006] 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.
25
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS
[007] 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
5 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.
[008] The present disclosure is described in detail with reference to the
accompanying figures. In the figures, the left-most digit(s) of a reference
10 number identifies 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.
[009] Figure 1 illustrates a perspective view of an endoscopic ultrasoundfine needle biopsy (EUS-FNB) device depicting the configuration of the
15 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
20 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
25 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
5 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.
10 [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
15 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 non-underlined number is used to identify a general
20 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
25 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
5 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
10 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.
15 [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 theneedle for harvesting a tissue during
biopsy, one of ordinary skill in the art will readily recognize that an
20 apparatus can be utilized in any situation, for effectively collecting cell
tissues and avoiding injury to neighboring structures. 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.
25 [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
5 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
10 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
15 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
20 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
25 diameter of a lumen to obtain tissue. In another embodiment, the needle
tip design results in the tearing of target tissue, which results in a lessthan-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
5 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
10 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
15 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
20 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
25 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 to a proximal end
5 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
10 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
15 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
20 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
25 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
5 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 spikes becomes a triangular shape. With an acute
10 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.
15 [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
20 navigate a tortuous path along the way to the target tissue. In one
embodiment, the needle is made up of material preferably cobaltchromium 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 push25 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
5 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
10 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.
15 [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
20 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.
25 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
5 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
10 (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
15 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
20 relative to the 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
25 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.
5 [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
10 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
15 visualization.
[0033] Figure 4 illustrates a cross-sectional view of a needle. The crosssectional 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
20 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 of the core being procured.
25 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
5 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
10 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.
15 [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
20 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
25 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.
5 [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
10 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.
15 [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
20 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.
25
We claim,
1. A needle (212) for harvesting a tissueduring biopsycomprises:
a body (310), wherein the body (310) is cylindrical in shape,
wherein the body (310) comprises a first end (308) and a second
5 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);
10 a plurality of echogenic marks (306), wherein the plurality of
echogenic marks (306) is grooved equidistant on a circumference of
the body (310), wherein theplurality of echogenic marks (306) is
configured to reflect an ultrasoundwave directed by an ultrasound
transducerfor real time visiualization.
15 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)
20 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
25 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,
5 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
10 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.
15 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).
Dated this on,
5th Day of April, 2024