Field of the invention
The present invention relates, in general, to the field of biomedical devices used in surgical procedure and, in particular, to a tissue isolator designed to isolate tissue for morcellation and prevent seeding of benign or potentially cancerous tissue during the morcellation procedure. The present invention further prevents accidental damage to the surrounding healthy tissue.
Background
Various bags for morcellation and extraction of tissue have been developed in the prior arts. Unfortunately, many surgical techniques using bags for morcellation are difficult to accomplish due to various constraints present in the bags such as the shape, material and difficulty in placing the bag in the abdomen. The insertion and removal of the bag inside the abdomen requires special skill of usage of the bag by the user and thus requires special techniques to be used as per the design of the bag by the user.
In US20120158010, to Dmitri Menn, Gene A. Stellon, the specimen retrieval pouch defines a longitudinal axis and includes a closed bottom portion and an open upper portion. The closed bottom portion includes a plurality of spikes configured to grasp a specimen positioned within the confines closed bottom portion. The upper closed portion includes one or more axial folds that are movable from a folded configuration to an unfolded configuration when a predetermined force is applied to a portion of the specimen retrieval pouch.
In US20140236167,to Shibley et al., the cap is placed on the bag mounted to the retractor after the rim of the single port bag is removed out through the incision and the cap is used as an access device for an instrument for morcellation or a surgeon's hand/arm.
However the present invention below describes an isolator which is easy to use and at the same time allows for easy manipulation and handling of the isolator inside the peritoneum for insertion of tissue and also ease in handling during insertion and removal of the isolator into the abdomen.

Summary of the invention
The following invention describes a tissue isolator which is biocompatible. The tissue isolator provides a safe conducive environment for the morcellation of tissue. The tissue isolator comprises of two or more openings which can be used by the surgeon at a time. The openings comprises of pull threads attached/ embedded/ glued/ sealed to the openings to pull the isolator opening out of the abdomen or to further manipulate and position the openings internally inside the peritoneum for insertion of tissue inside the isolator.
Any of the openings can be optionally in closed form so that it gives the surgeon the liberty to puncture the closed form opening as per the surgery requirements. The opening 3 allows insertion of trocar, instrument or camera through it so that the tissue can be easily seen and operated upon easily through a number of openings in the isolator for its cutting and removal.
The isolator has various types of markings on it for identification of openings and to manipulate the isolator further preventing twisting during orientation of the isolator in any direction for insertion of tissue and removal of the opening out of the abdominal port or even identification of closed opening for puncturing the isolator on that location.
The method for tissue isolation and extraction is provided in the description.
Brief Description of Drawing
FIG. 1 illustrates the tissue isolator of the present invention.
FIG. la illustrates the detail view of the opening 3 of the tissue isolator.
FIG. 1 b illustrates the opening in closed form on the body of the isolator.
FIG.2a and FIG. 2b illustrates the string or strip or ring present at the opening of the isolator.
FIG.2c and FIG.2d illustrates the procedure for opening the isolator.
FIG.3a to FIG.3c illustrates the conical deployer of the invention.
FIG.4a and FIG.4c illustrates the grasper for holding the isolator opening edge.
FIG.5a and FIG.5b illustrates the deployer with holes.
FIG.6a and FIG.6a illustrates the markings on the isolator.

Description of the invention
The present invention describes a tissue isolator for isolation and extraction of morcellated tissue from a body. The purpose of using the isolator during morcellation is to prevent the spreading of cancerous tissue inside the body if the tissue is malignant and not easily diagnosed by the surgeon or prevention of spreading of potentially cancerous tissue. The isolator also helps in safe morcellation of tissue.
The present invention provides a tissue isolator designed for isolation and extraction of morcellated tissue during a surgical procedure such as a laparoscopic procedure, intraabdominal, endoscopic procedures, power morcellation, vaginal morcellation, total laparoscopic hysterectomy (TLH), laparoscopy assisted vaginal hysterectomies, and other endoscopic procedures for removing benign or malignant tissues.
As illustrated in FIGS.l and la, it describes a tissue isolator 1 having two Or more openings 3, 4 above the neck regions 24 and 25 respectively of the isolator and a central working region 27 which is wider than the neck region for power morcellation of tissue. At least one pull thread 6 is attached/ embedded at the openings 3, 4. Pull thread 6 (FIG.la which is a detail view 2 of opening 3) can be attached/ embedded/ glued/ sealed 26 to the opening 3 so that surgeon can easily hold and pull the thread to manipulate or pull the isolator opening 3 out of the abdomen or below till the abdominal wall of the peritoneum. The pull thread 6 can be attached/ embedded/ glued/ sealed to opening 4 so that the surgeon pulls the opening 4 out of the abdominal port after insertion of tissue using pull thread 6. The two or more openings 3, 4 allows easy manipulation, operation and cutting of tissue.
The second opening 3 above the neck 24 may optionally be in a closed form. The closed form may later be punctured as per requirement by the surgeon either when the isolator opening 3 is inside the abdomen or when it is pulled outside the abdominal port or when it is near the abdominal wall inside the peritoneum to introduce trocar or camera or any instrument inside when it is opened. The openings 3 can optionally be on the body of the isolator in closed form or open form.

In another embodiment, as illustrated in FIG. lb, the opening can be on the body 46 of the isolator in closed form.
The pull thread 6 will be at the opening which is in closed form 46 on the body of the isolator either on the inner wall of the isolator 1 or outer wall, the isolator 1 which can later be pulled out by the surgeon after puncturing the opening using pull thread if it is inner side of the isolator. The isolator will be pulled out using pull thread if the pull thread 6 is on outer wall at the closed form 46 as shown in FIG.lb and the closed form 46 punctured later to form an opening. The pull thread 6 will prevent damage to the isolator while pulling the isolator to puncture.
In another embodiment of the invention as shown in FIG.l, the opening 3 can be a small hole 5 at the end of the openingas shown in detailed view of FIG. la.
As illustrated in FIG.2a and FIG.2b, the isolator opening 4 will be optionally having formable strip 23. It can be in two forms; either at least two strips 22 will be attached on both sides as shown in FIG.2a and at least one strip loop 23 attached at the opening as shown in FIG.2b. The strip loop can be a ring such as nitinol or any other flexible loop material such as an engineering polymer, stainless steel, nickel titanium super elastic alloy, elastomer or other elastic material or tape.
As shown in FIG.2c and FIG.2d, the strip 23 can be made of any formable material, which can bend easily by the laparoscopic grasper 20. FIG.2a shows holding of the strip 23 by the grasper 20, while FIG.2b shows pulling of the isolator opening towards the abdominal port for either insertion of tissue or for removing the opening out of the abdominal port after insertion of tissue.
In one of the embodiments, the strip 23 can a string of polymer, attached or embedded in the one of the openings or made out of the material of the opening.
As shown in FIG.2c, after insertion of the isolator inside the abdomen and prior to the insertion of tissue inside the isolator, the opening of the isolator is opened by graspers 20. Thus the opening can bend easily and remains open till the tissue is completely inserted inside the isolator by grasper.

In another embodiment as shown in FIG.3a, there is a conical/ runnel shape deployer 7 to help easy insertion of isolator into the abdomen. The conical deployer will be having holding grasper tab 8 at the second end 29 and the first end 28 will be having angular cut 9 as shown in FIG.3b. The angular cut at the opening will help in easy access of the folded isolator (FIG. 3 c) by the grasper 11 after insertion of conical funnel angular cut 9 tip through the abdominal port. The second end 29 is wider than the first end 28.
As shown in FIG.3c, the isolator 1 is inserted in the conical deployer from the second end 29. The conical deployer first end 28 is thus inserted in the abdominal port 12. As soon the first end enters though the opening, the grasper 11 will pull 10 the folded isolator 1 inside the abdomen.
In another embodiment as shown in FIG.4a and FIG.4b, there will be an articulating grasper 31 as shown in FIG.4a used to hold edge of the opening 4 of the isolator. After entering through the abdominal port 32, the tip 30 of the grasper 31 orients the articulating joint 13 to open the isolator edge to insert the tissue 33 through the opening as shown in FIG.4b. The articulating joint 13 can be hinged joint or spring or EAP (Electro Active Polymer).
In another embodiment as shown in FIG.5a, the isolator can be completely sterilized in folded state 17 and kept inside the deployer 14. The deployer 14 will be having holes/ slots 18 to pass EtO gas through it during sterilization as shown in FIG. 5 a. The deployer will be having grasping or holding flange 15as shown in FIG.5a, thus the user will hold the flange 15 and press 19 the plunger 16 to deploy the isolator inside the abdomen as shown in FIG.5b.
The material of the isolator is of high strength due to which it can withstand any accidental puncture due to its strength after it is inflated or before inflation.
The invention disclosed herewith promises to aid in detecting the orientation of the isolator and thereby allowing the surgeon to manipulate the isolator without twisting.
As shown in FIG.6, the isolator has markings to help surgeons manipulate the isolator and ensure thatthere are no twists in the isolator when it is pulled out. The mark can be in the shape of a circle of different color or any such indication. The mark can also be running along the length of the isolator, either on one side or both sides.

The marking can be in the form of a coloured feature on either a single wall 35 or on multiple walls of the isolator. The marking can be circle 34, line, ellipse, polygon or any other shape. Colour of the marking can be red, black, green, blue or any other colour or it can be of two or more colours. It can also be in the form of pattern such as parallel lines, criss-cross lines. The marking can also be a vertical line 38 running along the length of the isolator, either on one side or both sides or vertical discontinuous lines 39 on the isolator. There can be vertical lines 42 on the wall of the isolator.
The marking can be lines in circle form 45 on the second opening 3 for identification of opening 3 while the surgeon locates the second opening 3. There are identification marks in the form of name 41 or isolator design 40 for identification. There can even be arrow marking 46 for identification of the pulling direction of the openings 3,4.
In a prefered embodiment as shown in FIG.6a, the marking can be in form of a coloured circle on a single wall of the isolator. The marking can be such that the main colour 36 or pattern is visible from only one side of the isolator. From other side, it can be masked by a different colour, masking colour 37. (For Example, on one side, the marking can be red and from other side, it may be masked by blue).
Due to this marking, the surgeon may be able to locate the marked wall during manipulation of the isolator and can take out the openings of the isolator without creating any twist (For example the surgeon can take the red side of the marking facing the laparoscope as a reference and take out the openings of the isolator such that the reference is always facing the laparoscope.) As a result, the openings can be pulled out in correct orientation and twisting of the isolator may be prevented
The method of using the isolator involves inserting the isolator 1 into the abdominal port through the conical funnel as described in FIGS.3a-3c or through blunt tip obturator.

Once the isolator is introduced inside the abdomen, the tissue is inserted inside the isolator either by pulling the isolator opening with a grasper as shown in FIG.2c and FIG.2d or the isolator opens itself because of the flexible nature of the opening due to flexible ring shown in FIG.2b.
After the insertion of tissue inside the isolator using grasper or any other means, the surgeon pulls the isolator first opening 4 out of the abdominal port by using the pull thread 6 as shown in FIG.l, the pull thread can also be kept optionally out of the abdominal port by the surgeon while inserting the isolator completely inside the abdomen thus helping to cause the opening to open up for insertion of tissue when the thread is pulled from outside. The pulling of the isolator out of the abdominal port prevents escape of the mass or specimen out of the opening of the isolator which gets closed after it is pulled out.
The pull thread if kept out reduces the effort of searching the thread inside the abdomenand removing the thread out of the abdomen after the isolator is introduced completely inside the abdomen. The surgeon will take the markings as identifications for pulling the opening 3, 4 out of the abdominal port and the other markings such as horizontal lines 42 can be used as guiding principles by the surgeon for insertion of tissue.
The surgeon pulls the second opening 3 out by pulling the thread. The opening 3 if closed may be punctured. Any instrument or camera or trocar can be introduced through opening 3. While morcellator is introduced in opening 4 for morcellation of tissue. Any instrument, cutting instrument, tenaculam, suction apparatus can be introduced apart from morcellator handpiece. The isolator is inflated using inflation gas. The isolator expands inside the peritoneum. Morcellator is introduced inside the isolator using blunt tip obturator. Removing the blunt obturator from morcellator and introducing tissue grasper through the lumen of hand piece of morcellator.
The tissue is morcellated under visualization using camera or telescope connected to a monitor screen. Once morcellated the tissue is pulled out slowly by grasper through the lumen of handpiece. The morcellator is removed out of the isolator cavity. The isolator is deflated so that the isolator collapses. The isolator along with blood particles and other remaining small tissue pieces is removed from the abdominal port eventually by pulling the opening 4 from one side after the procedure is complete.

WE CLAIM
A tissue isolator for receiving tissue comprising at least two openings, at least one pull thread, and optionally an orientation indicator.
The tissue isolator of claim 1 has the pull thread is attached to the said opening,
A tissue isolator as claimed in claim 1, wherein any one of the second openings can optionally be in closed form either on the body of the isolator or at the termination of the neck region where it ends.
A tissue isolator as claimed in claim 1, wherein the opening terminates after the neck region of the isolator or optionally can be on the body of the isolator.
A tissue isolator as claimed in claim 1, wherein the opening can either be punctured by the surgeon after removal of the isolator opening outside the abdominal port or can be punctured just below the abdominal wall without removing it outside the abdominal port.
A tissue isolator as claimed in claim 1, wherein the pull thread of opening is kept outside of the abdominal port by the surgeon while insertion of isolator completely inside the abdominal port.
A tissue isolator as claimed in claim 1, wherein the tissue isolator optionally has atleast one flexible ring or strip which allows for easy opening of the isolator as soon as it is inside the abdomen.
A tissue isolator as claimed in claim 1, wherein the opening is to be opened using a grasper for insertion of tissue.
A tissue isolator as claimed in claim 1, wherein the isolator is inserted inside the abdomen using a conical deployer or a blunt obturator or deployer with holes.
A tissue isolator receiving tissue comprising at least one opening and an orientation indicator, wherein the said indicator prevent twisting of the said isolator during the surgery.
11. A method for isolation and extraction of tissue comprising the steps of :-
a. Inserting the isolator inside the abdomen
b. Optionally keeping the pull thread of the isolator of first opening outside the
abdominal port.
c. Inserting tissue inside the isolator.

d. Pulling the first opening of the isolator out of the abdominal without twisting with
the help of identification markings as guide.
e. Optionally puncturing the second opening if closed.
f Optionally pulling the second opening out of the isolator with the help of pull
thread or keeping it inside just below the abdominal wall, g. Inflating the isolator before or after step e or f above, h. Monitoring and visualizing the tissue using camera or telescope connected to
monitor screen, i. Introducing the morcellator inside the isolator j. Morcellating the tissue inside the isolator. Removing the morcellator out of the
isolator cavity, k. Deflating the isolator by removing the gas. 1. Removing the isolator outside the port once the procedure is complete.