FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13) AN ERGONOMICAL BIOPSY FORCEPS HANDLE ASSEMBLY
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

FIELD OF THE INVENTION
[0001] The present invention relates generally to field of surgery. More particularly, the invention relates to to an improved biopsy forceps handle for tissue collection during biopsy and a method of assembling the handle.
BACKGROUND
[0002] Tissue samples are often examined to determine the presence of a pathological disorder. When examining the tissues in a particular site in a patient's body, it is common for the examiner to take tissue samples from the site for analysis. This is referred to as a biopsy. The purpose for taking a biopsy sample is often to look for cellular shape changes represented in the collected sample. The identification of particular cellular shape changes in a collected specimen can be instrumental in the identification of cancer in a patient.
[0003] A number of different biopsy devices for taking the tissue samples are in use. Biopsies are often performed with a biopsy instrument having forceps with two opposing jaws attached to the distal end of an elongate tube (which can be flexible or rigid) having internal manipulating wire or wires. The jaws are provided with teeth to cut, shear, or tear away tissue samples. Various designs have addressed the mechanism by which the jaws pivot, and by which the actuating mechanism is attached to the jaws or to other elements which cause the jaws to open and close. These design elements combine to affect the important functional elements of the biopsy device. Conventionally, the jaws

are opened and closed by an actuating mechanism. The actuating mechanism is controlled by manipulating controls located at the proximal end of the elongate tube. The actuating mechanism moves proximally and distally within the lumen of the elongate tube. This causes the jaws to open, cut and hold the tissue sample The biopsy instrument is passed through an endoscope to a desired location and then the jaws are closed to grab and sever the biopsy sample. The instrument with the detached specimen is then withdrawn from the endoscope so that the sample is removed.
[0004] Conventional biopsy forceps, however, have a number of drawbacks. For example, the actuator and jaw mechanisms are formed from numerous and minuscule components which is at times difficult to assemble. The manufacture of biopsy forceps is therefore expensive, difficult, and time consuming. Sometimes the handle of the instrument may not be sufficient for accurate diagnosis as forceps jaws may be sometimes difficult to maneuver as needed to obtain bites when inserted to the target area because it has been found somewhat uncomfortable to many physicians requiring modifications to the handle. Furthermore, the internal wire may tend to slip if not assembled properly in the handle which may lead to improper functioning of the actuating mechanism.
[0005] Accordingly, there is a need for simplified device to collect the tissue during biopsy.This invention is therefore directed towards providing an improved biopsy handle assembly and a method of assembling, which is relatively simple in design and structure, and is highly effective for its intended purpose.

SUMMARY
[0006] Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems.
[0007] An object of the present invention is to provide an ergonomical biopsy forceps handle permitting ambidextrous use and which would fit all hand sizes.
[0008] Another object of the present invention is to provide a handle that would include optimal human factors design permitting leverage of force applied for actuating the forceps via push-pull mechanism.
[0009] Yet another object of the invention is to provide a biopsy forceps handle having a removable plastic block which is easy to assemble and held securely by the handle for opening and closing the forceps.
[0010] The present invention overcomes the disadvantages of prior art devices by providing ergonomical biopsy forceps handle assembly.
[0011] The biopsy forceps handle assembly of the present invention discloses a handle with a stationary part and a moving part. The stationary part of the handle comprises of a first cavity wherein the moving part of the handle is slidable. The invention further discloses a spring tube assembly and a cutting

pair of jaws mounted to a distal end of the spring tube assembly. The spring tube assembly houses a crimped jaw link wire which is retained in a second cavity of the extended part of the handle. A removable plastic block having teeth on arms is positioned in the first cavity of the handle which gets snap fitted with the movable part of the handle. The proximal end of the jaw link wire has a geometrical shape bend adapted to be secured in a configuration in the removable plastic block similar to the configuration of the jaw link wire bend. To actuate the device into open position, the physician holds the handle. Sliding the moving part of handle forwardly will cause the removable plastic block to slide within the cavity thereby opening the cutting pair of jaws and collect specimen of tissue to be severed from the patient. Pulling back the moving part of the handle rearwardly, will cause the removable plastic block to retract within the cavity thereby closing the cutting pair of jaws.
[0012] These and other features and advantages of the present invention will become apparent from the following description of the invention that is provided in connection with the accompanying drawings and illustrated embodiments of the invention.
[0013] It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the below mentioned detailed description and drawings.

BRIEF DESCRIPTION OF THE FIGURES
[0014] The summary above, as well as the following detailed description of illustrative embodiment, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, example constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.
[0015] Embodiment of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
[0016] Fig 1. Illustrates a perspective view of the biopsy forceps handle in accordance with an exemplary embodiment of the present disclosure;
[0017] Fig. 2 illustrates sectional view of biopsy forceps handle taken along section A-A in accordance with an exemplary embodiment of the present disclosure;
[0018] Fig. 3 Illustrates a removable plastic block with an exemplary embodiment of the present disclosure;

[0019] Fig.4(a)-4(f) illustrates illustrates the method of assembling the handle with an exemplary embodiment of the present disclosure.
[0020] Fig.5 illustrates the alternative embodiment of the biopsy forceps handle.
[0021] In the above accompanying drawings, a number relates to an item identified by a line linking the number to the item. When a number is accompanied by an associated arrow, the number is used to identify a general item at which the arrow is pointing.
[0022] Further the figures depict various embodiment of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiment of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein.
DETAILED DESCRIPTION OF EMBODIMENTS
[0023] The following detailed description illustrates embodiment of the present disclosure and manners by which they can be implemented. 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.
[0024] The person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. It should be understood that this invention is not limited to the particular methodology, protocols, and the like, described herein and as such may vary. The terminology used herein is for the purpose of describing particular embodiment only and is not intended to limit the scope of the present invention, which is defined solely by the claims.
[0025] Referring now to the drawings, Figures. 1-5 illustrates a biopsy forceps handle according to the present invention. It should be noted that Figure 1-5 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure.
[0026] In an aspect of the present disclosure, a biopsy forceps handle and a method of assembling the biopsy handle to the jaw link wire to collect the tissue is disclosed.
[0027] Referring now to the drawings, Fig. 1 illustrates a biopsy device 100 comprising a handle 102 having a moving part 102(a) and a stationary part 102(b), a spring tube assembly 104 and a tissue cutting pair of jaws 106 mounted to a distal end 108 of the spring tube assembly 104. The spring tube

assembly 104 may be sufficiently flexible to be passed through a working channel of an endoscope (not shown). The stationary part 102(b) of the handle 102 comprises a longitudinally extending first cavity 110 therethrough in which a removable plastic block 112 is connected to the moving part of handle 102(a).
[0028] The handle stationary part 102(b) further comprises a means in which a physician can put his thumb (hereafter referred as thumb ring 114) and grasp the moving part of handle 102(a) by placing his two fingers into pair of lateral finger holds 116 to achieve slidable movement of the handle moving part 102(a) relative to the thumb ring 116 when actuating the forceps between open and closed position.The Handle moving part 102(a) has a middle portion 118,interior surface of that is configured to slide along the outside of stationary part of handle 102(b) and first cavity 110.
[0029] Fig 1. is merely an example. As will become apparent to a person of ordinary skill, a wide variety of handle configuration could be used with the present invention. The handle may be a thumb ring, a scissors-type handle, a pin vise, or any other conventional handle.
[0030] Fig 2. illustrates sectional view 200 of the handle 102 taken along section A-A. As can be seen, the handle 102 is further extended with a reduced in diameter (hereinafter referred as extended part of handle 212) having a second cavity 202 to retain a crimped jaw link wire 204 housed in the spring tube assembly 106. The jaw link wire 204 extends from the spring tube assembly 106 via a brass bush 214 that is configured to get arrested into the slot 206 to

prevent the longitudinal movement of spring tube assembly 106 within the handle 102. Further a proximal end 208 of the jaw link wire 204 is secured by a geometrical shape bend preferably a triangular bend 210 adapted to be secured in a configuration in the removable plastic block 112 similar to the configuration of the triangular bend 210. (shown in fig 3).
[0031] Fig. 2 is merely an example. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The spring tube assembly can either be a relatively rigid or flexible, of varying lengths and diameters, depending upon the desired clinical application. The spring tube assembly may be useful for Bronchoscopy, Gastroscopy, Enteroscopy, Colonoscopy or other linear access applications as will be apparent to those of skill in the art . Further, the geometrical shape bend is not limited to triangle and can be of different shapes like Z or S shape , circular or U type (as shown in Fig. 6)
[0032] Fig. 3 illustrates a removable plastic block 112 that is adapted to securely arrest the jaw link wire 204. The removable plastic block comprises of an E shape block having an upper arm 302, a middle arm 304 and a lower arm 306. The upper arm 302 and lower arm 306 have an upper tooth 308 and lower tooth 310 respectively extending away from the surface of the wall of arms. The middle arm 304 comprises of the configuration to secure the jaw link 204. Further the middle arm 304 has a hinge in the middle of the arm that is configured to open and close the other half of the arm (just like a door or a cabinet) and is adapted to have the same configuration of plurality of protrusions 312 on the inner side of the arm to securely hold the triangular

shaped bend 210 at the proximal side 208 of the jaw link 204 that fits securely around the configuration 314 in the middle arm 304 of the removable plastic block 112 . Further, the upper 308 and lower teeth 310 at the upper 302 and lower 306 arms respectively snap fit into the moving part of the handle 102(a).
[0033] Fig. 3 is merely an example. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. The configuration to secure the jaw link wire in the middle arm of the removable plastic block can be modified according to the geometrical bends.
[0034] Referring to Fig. 4(a)-4(f), illustrates the method of assembling jaw link wire 204 to be gripped into the removable plastic block 112 that is adapted to be inserted in the cavities of handle 102 in the manner described below. The jaw link wire 204 is inserted into the slot 402 provided in the removable plastic block 112 as shown in fig 4a and 4b. Once the jaw link wire 204 is arrested in the configuration 314, the other half of the arm is rotated in the direction as shown in fig. 4c and 4d thereby closing the arm and securing the jaw link wire 204 in the configuration 314. The jaw link wire 204 is placed inside the second cavity 202 and the handle stationary part 102(b) as shown in exploded view in fig 4(e). After the positioning of the jaw link wire 204, the second cavity 202 is closed by placing a cover 404. The removable plastic block 112 is slided enough to snap fit in the portion of moving handle part 102(a).
[0035] The tissue cutting pair of jaws 106 located at distal end 108 of spring tube assembly 104 is in closed position. To actuate the device into open

position, the physician holds the handle 102 keeping it stationary and putting his thumb and fingers in thumb ring 114 and lateral finger holds 116. Sliding the moving part of handle 102(a) forwardly will cause the removable plastic block to slide within the cavity 110 thereby opening the cutting pair of jaws 106 and collect specimen of tissue to be severed from the patient . Pulling back the moving part of the handle 102(a) rearwardly, will cause the removable plastic block to retract within the cavity 110 thereby closing the cutting pair of jaws 106 ensuring that the biopsy specimen tissue will not be lost. Once this has been achieved, the spring coil assembly 104 of the biopsy forceps device 100 can then be withdrawn from the endoscope.
[0036] Fig 5. illustrates alternate embodiment of the biopsy device 500 comprising a handle 502 having a moving part 502(a) and a stationary part 502(b), a spring tube assembly 504 and a tissue cutting pair of jaws (not shown) mounted to a distal end of the spring tube assembly 504. The spring tube assembly 504 may be sufficiently flexible to be passed through a working channel of an endoscope (not shown). The moving part of handle 502(a) is a split type configuration which is attached to the stationary part 502(b) of the handle 502 . The two parts of the split type configuration is attached to each other via a plurality of protrusions 506 present on the surface of the moving part of the handle 502(a) which gets seated in the depressions 508 present on the surface of the moving part 502(a) of the handle 502. The jaw link wire 510 gets arrested in the inbuilt configuration 512 that is adapted to be the similar configuration of the geometrical shape 514 of the jaw link wire 510. The jaw link wire 510 is placed inside the second cavity 516 and the handle stationary

part 502(b) as shown in fig 5. After the positioning of the jaw link wire 510 , the second cavity 516 is closed by placing a cover 518.
[0037] Various types of configuration of jaw link wires can be adapted as shown in fig 6.
[0038] It is observed that this inventive configuration results in lowered production costs and ease of manufacturing and assembly.
[0039] The present invention has both technical as well as economic significance with respect to the conventional devices for collecting tissue samples.
[0040] The above description is only one embodiment of the present invention, and those skilled in the art may implement the present invention in a modified form without departing from the essential characteristics of the present invention. Therefore, the scope of the present invention should not be limited to the above-described examples, but should be construed to include various embodiments within the scope equivalent to those described in the claims.

We Claim:
1. A biopsy forceps handle assembly 100 comprising:
a handle 102 comprising a moving part 102(a) and a stationary part 102(b) wherein,
the stationary part 102(b) of the handle 102 comprises of a first cavity 110 wherein,
a removable plastic block 112 is positioned within the said first cavity 110 of the handle 102 and configured to snap-fit with the movable part 102(a) of the handle 102;
a cutting pair of jaws 106 mounted to a distal end 108 of a spring tube assembly 104 wherein,
the spring tube assembly 104 is attached to an extended part 212 of the handle 102;
a jaw link wire 204 is housed within the spring tube assembly 104 and retained in a second cavity 202 of the extended part 212 of the handle 102; and
a proximal end 208 of the jaw link wire 204 comprises a geometrical shape bend 210 adapted to be secured in a configuration 314 in the said removable plastic block 112, the said configuration 314 of the geometrical shape bend 210 being similar to the jaw link wire bend 210.

2. The biopsy forceps handle assembly of claim 1, wherein the removable plastic block 112 comprises an upper arm 302 and a lower arm 306 with an upper tooth 308 and a lower tooth 310 for engagement with the movable part 102(a) of the handle 102.
5 3. The biopsy forceps handle assembly of claim 1, wherein the moving part 102(a) of the handle 102 is slidable within the first cavity 110 of the stationary part 102(b) of the handle 102.
4. The biopsy forceps handle assembly of claim 1, wherein sliding the moving
part 102 (a) of the handle 102 forwardly causes the removable plastic block
10 112 to slide within the first cavity 110, thereby opening the cutting pair of
jaws 106 to collect a specimen of tissue to be severed from a patient.
5. The biopsy forceps handle assembly of claim 1, wherein pulling back the
moving part 102(a) of the handle 102 rearwardly causes the removable
plastic block 112 to retract within the first cavity 110, thereby closing the
15 cutting pair of jaws 106.
6. The biopsy forceps handle assembly of claim 1, wherein the jaw link wire 204 is crimped.
7. A biopsy forceps handle assembly 500 comprising:
a handle 502 comprising a moving part 502(a) and a stationary part 20 502(b) wherein,

the moving part 502 (a) of the handle 502 is a split type of configuration that is attached to the stationary part 502(b) of the handle 502; and
a jaw link wire 204 is housed within the spring tube assembly 504 and
5 retained in a second cavity 516 and the handle stationary part 502(b)
wherein,
the said jaw link wire 510 gets arrested in the inbuilt
configuration 512 on the moving part 502(a) of the handle 502
that is adapted to be the similar configuration of the geometrical
10 shape 514 of the jaw link wire 510.
8. The biopsy forceps handle assembly of claim 7, wherein the two parts of the
split type configuration is attached to each other via a plurality of protrusions
506 present on the surface of the moving part 502 (a) of the handle 502 which
gets seated in the depressions 508 present on the surface of the moving part
15 502(a) of the handle 502.