Abstract: Surgical system to be used in transluminal endoscopic surgical procedure have been disclosed. The system comprises of a retractor, an instrument port, a retraction fin, a pouch to contain the tissue prior to removal from the patient’s body, a morcellator for debulking of large tissues. The invention also discloses a method to use the system in combination with other instruments for transluminal or transvaginal surgical procedure.
DESC:Field of the Invention
The present invention generally relates to the field of surgical system, and more particularly relates to a system designed for transluminal or transvaginal removal of abnormal tissues.
Background of the Invention
Transvaginal removal of abnormal tissues such as uterus, ovaries, fallopian tubes, myoma, cyst, etc is gaining popularity over Laparoscopic procedure because it is a scarless procedure. The procedure is called Vaginal Natural Orifice Transluminal Endoscopy (vNOTES). This procedure is beneficial from a patient’s standpoint as there are no scars on the abdomen, causes less pain after the surgery and reduces the chances of post-surgical complications. The procedure is completely performed through the natural orifice of the patient’s Vagina. However, there are very limited surgical systems currently available in market designed to perform such procedures in an effective manner.
Systems and devices currently available in the market such as those disclosed in US Patent Nos. 7,163,510 and 8,308,639 do provide access to the surgical site. However, such systems are more geared towards laparoscopic or hand-assisted laparoscopic surgery in the abdoiminal cavity. They do not cater to some of the challenges of transvaginal approach.
Vaginally assisted laparoscopic surgery is a variation of vNOTES and is performed wherein most of the instruments are introduced through the vagina and at least one, say laparoscope is inserted through the abdominal port. In these types of procedures, most of the scars are avoided without comprosing the advantage of laparoscopic surgery.
Summary of the Invention
The present invention provides a system designed for performing transluminal endoscopic procedure for removing abnormal tissues.
In an aspect of the present invention, the system comprises a retractor and an instrutment port. The retractor is designed to be passed through and distend the vaginal opening to create a clear passage for surgical instrument to be passed through.
In another aspect of the present invention, the system further comprises a retraction fin designed to retract peripheral organs in creating a clear surgical field.
In another aspect of the present invention, the system further comprises an optional belt harness designed to hold the instrument port against patient’s vaginal opening.
In another aspect of the present invention, the system further comprises an optional containment pouch and morcellator designed to remove abnormal tissue safely.
These and other aspects and advantages of the present invention are described in the following detailed description of the invention.
Brief Description of the Drawings
FIG. 1 is a schematic illustration the retractor (100) in accordance with the embodiment of the present invention;
FIG. 2a is an illustration cross secitional view of the outer ring (102) and FIG. 2b is an illustration of cross sectional view of inner ring (101) of the retractor (100) in accordance with the embodiment of the present invention;
FIG. 3 shows additional embodiment of the inner ring (101) with low profile;
FIG. 4 is an illustration shapes of the inner ring ad outer ring (102) of the retractor (100) in accordance with the embodiment of the present invention;
FIG. 5 shows an embodiment of the retractor (100) with light in the inner ring (101);
FIG. 6 is an illustration of the retractor (100) with markings in accordance with the embodiment of the present invention;
FIG. 7 shows details of the retraction fin (410);
FIG. 8 shows the shapes of flexible rim (411) of retraction fin (410);
FIG. 9 and 10 show further details of the retraction fin (410);
FIG. 11 to 13 show the details of the attachment member (412) of the retraction fin (410);
FIG. 14 is a schematic illustration of the instrument port (500) in accordance with the embodiment of the present invention;
FIGS. 15a and 15b are schematic illustrations of releasable latch (601) of the instrument port (500) in accordance with the embodiment of the present invention;
FIG. 16 is an illustration of the instrument port (500) in accordace with another embodiment of the present invention;
FIG. 17 is an illustration of features of the instrument port (500) in accordance to the embodiment of the present invention;
FIG. 18 and 19 are illustrations of features of the instrument port (500) in accordance to the embodiment of the present invention;
FIG. 20 is an illustration of belt harsness (1000) in accordiance to the embodiment of the present invention;
FIGS. 21a and 21b are illustrations of the pouch (1100) in accordiance to the embodiment of the present invention;
FIG. 22 is an illustraton of markings on the pouch (1100) in accordance to the embodiment of the present invention;
FIGS. 23 and 24 are illustrations of material used for the pouch (1100) in accordance to the embodiment of the present invention;
FIG. 25 is an illustration of the stiffening element at the opening (1101) of the pouch (1100) in accordance to the embodiment of the present invention;
FIGS. 26 and 27 are illustration of shapes of the opening (1101) of the pouch (1100) in accordance to the embodiment of the present invention;
FIGS. 28a and 28b are illustration of optional secondary opening (1801) of the pouch (1100) in accordance to the embodiment of the present invention;
FIG. 29 is an illustration of the morcellator (1900) in accordance to the embodiment of the present invention;
FIGS. 30a to 30d are illustration of types of core guard feature of the morcellator (1900) in accordance to the embodiment of the present invention;
FIGS. 31 to 40 represents method of using the system in accordance to the embodiment of the present invention;
FIG. 41 is an illustration of usage of the belt harness (1000) in accordance to the embodiment of the present invention; and
FIG. 42 shows the main components of the system in dis-assembled and assembled condition.
Detailed Description of the Embodiments
The present invention provides a surgical system for performing transluminal endoscopic procedure for removing abnormal tissues.
Specific embodiments of the present invention are now described in detail with reference to the figures, wherein the reference numbers indicate identical or functionally similar elements. The terms “distal” or “proximal” are used in the following description with respect to a position or direction relative to the treating physician. “Distal” or “distally” are a position distant from or in a direction away from the physician. “Proximal” or “proximally” or “proximate” are a position near or in a direction toward the physician.
The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. In the present disclosure, the singular forms “a”, “an” and “the” includes the plural reference. It is to be appreciated that certain features of the invention which are, for clarity, described herein in the context of separate embodiments, may also be provided in combination in a single embodiment. That is, unless obviously incompatible or excluded, each individual embodiment is deemed to be combinable with any other embodiment(s) and such combinations are considered to be another embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any sub-combination.
The system of the present invention comprises a retractor (100) and an instrument port (500). The system further optionally comprises a retraction fin (410), a pouch (1100), and a morcellator (1900).
FIG. 1 is an illustration of the retractor (100), in accordance to the embodiment of the present invention, the retractor (100) comprises an inner ring (101), an outer ring (102), and an elongated flexible body (103) attached to the inner ring (101) and the outer ring (102). The inner ring (101) is made from a stiffer material with properties such that it can be flexed but has enough strength to retract vaginal wall tissue and organs. The purpose of the inner ring is to retract the vaginal wall and organs such as bladder and bowel and create a clear passage for instruments. The outer ring (102) is made from a flexible material that allows flipping of the ring about its own axis. This flipping action has three effects – it winds the flexible body (103) around the outer ring (102), it reduces the distance between the inner ring (101) and outer ring (103), and it retracts the vaginal wall becase of the force applied by the flexible body. The flexible body (103) is made from the transparent material opaque material or a combination of transparent and opaque material.
Referring to FIG. 2a, the outer ring (102) can have a cross section that is ellipse (201), rectangle (202), ‘C’ shape (203), ‘I’ shape (204) or any such section having vertical dimension greater thn horizontal dimension. The cross section can be solid, hollow or made from two different materials (205, 206) with one soft and one stiffer material. The cross section can also be a combination of an outer section made from one matrial (207) and two or more inner sections (208, 209) made of another material. The inner sections may be of the same material or different materials. Having asymmetry in the cross section allows to flip the outer ring about itself.
The outer ring (102) can be made from slightly flexible material such as silicone, polyurethane, thermoplastic elastomer, PVC, reinforced polymer, Stainless steel core with polymer outer layer or any other suitable material. Preferably, the outer ring (102) is of circular shape with a diameter in the range of 20 - 250mm.
Referring to FIG. 2b, the inner ring (101) can have a cross section that is circular (210), ellipse (211), rectangle (212), square (213), hexagon (214) or any other suitable section. The cross section can be solid, hollow (215) or made from two different materials (216, 217) with one soft and one stiffer material. The cross section can also be a combination of an outer section (218) made from one material and two or more inner sections (219, 220) made of another material. The inner sections may be of the same material or different materials.
The inner ring (101) can be made from slightly flexible material such as silicone, polyurethane, thermoplastic elastomer, PVC, reinforced polymer, Nitinol or any other suitable material. Flexibility in the material allows it to be squeezed and passed into the vaginal opening.
In an embodiment as shown in FIG. 3, the inner ring (101) can be made from a combination of two or more materials. The core (230) of the inner ring can be made from superelastic material such as Nitinol whereas the outer covering (231) can be made from smooth and flexible material such as Polyurethane, Thermoplastic elastomer, Silicone, PVC, etc. The advantage of such a construction is that it imparts the required memory to the inner ring while maintaining a low profile as compared to a polymer ring (232). This makes it easier to squeeze and insert into the patient’s body.
Referring to FIG. 4, the inner ring (101) can be circular in shape (310) with diameter in the range of 20 - 250mm. Alternatively, the shape of the inner ring (101) can be oval (311), a circular shape bent out of plane (312), oval shape bent out of plane (313). Any of these alternative shapes may be useful in order to retract the peripheral organs such as urinary bladder on the anterior side and bowel on the posterior side, thereby creating a clear surgical field. The inner ring (101) can be of the same size as the outer ring (102). It can be smaller than the outer ring (102) or also bigger than the outer ring (102).
In an embodiment as in FIG. 5, the inner ring (101) can have a light inside it to visualize the internal structures of the patient’s body during surgery.
The flexible body (103) can be made from a flexible film-like material such as TPU, Nylon, TPU coated Nylon, PVC, Silicone or any suitable material. The purpose of the body (103) is to connect the inner ring (101) and outer ring (102) and protect the incision or opening of the patient’s body from the contents from the inside of the patient’s body. The flexible body (103) creates a kind of a conduit to safely exchange instruments or remove contents from inside the patient’s body to the outside. As shown in Fig. 6, the flexible body (103) can optionally have markings (320) to indicate its alignment and orientation. The marking (320) can be helpful in indicating whether the retractor (100) has any twist during insertion. The flexible body (103) can be transparent, translucent, opaque, or it may have a combination of transparency, opacity with any suitable colors.
Referring to FIG. 7, the retraction fin (410) may be provided on the inner ring (101). The retraction fin (41) is designed to retract peripheral organs such as the urinary bladder on the anterior side and bowel on the posterior side, thereby creating a clear surgical field. The retraction fin (410) can be pre-attached to the inner ring (101) of the retractor (100) or alternatively it can be made removably attachable from the inner ring (101) of the retractor (100).
The retraction fin (410) has a flexible rim (411) on its periphery and it may optionally have a membrane like body (413). The flexible rim (411) can have one or more attachment members (412) that enable it to be either pre attached or removably attached to the inner ring (101) of the retractor (100).
The flexible rim (411) of the retraction fin can be made from materials such as TPU, Silicone, PVC, PP, Thermoplastic elastomer, Nitinol covered with a polymer sleeve, or any suitable material that can flex, but can regain its original shape when kept free. The cross section of the flexible rim (411) can be more or less circular.
Referring to FIG. 8, the flexible rim (411) can be of any shape such as oval (425), ellipse (426), dog bone (427), etc. Further any of the shape can be either plain or made into a 3D shape that is bent out of plane. The shape of the flexible rim (411) is made such that it provides optimal retraction to of the organs without creating undue stress on the organs. As shown in FIG. 9, the length ‘L’ of the fin can range between 50 to 500 mm while the width ‘W’ can be approximately equal to the diameter or width of the inner ring (101)
The retraction fin (410) can optionally have a fin body (413) made from a thin flexible material such as TPU, Nylon, TPU coated Nylon, PVC, Silicone or any suitable material. The fin body (413) can provide additional support or retraction to the organs if needed. The fin body (413) can optionally have markings (420) to enable its visualization during the surgical procedure. Some of the markings can be in the form of a linear scale (421) that can be useful to quickly measure any dimensions inside the body if needed.The fin body (413) can be transparent, translucent, opaque, or it may have a combination of transparency, opacity with any suitable colors.
In an embodiment as shown in FIG. 10, the retraction fin (410) can have one or more pulling tab (430) attached to the flexible rim (411). The function of the pulling tab (430) is to enable a laparoscopic tool such as grasper to hold and manipulate the anterior and posterior sides of the fin. The pulling tab (430) can be made from suture material such as silk, PTFE, Polyester, PP or similar. The pulling tab (430) can also be made from the same material as the fin body (413).
The design of the attachment member (412) is such that it can firmly hold the inner ring (101) of the retractor (100) and the flexible rim (411) of the retraction fin (410) when the device is in use. The attachment member (412) can be optionally slidable to some extent along the flexible rim (411) so as to increase or decrease the protrusion of the retraction fin (410) on the anterior side as needed.
In an embodiment as in FIG. 11a, the attachment member (412) is pre-attached to the flexible rim (411). It may be fixed or slideable over the flexible rim (411). The attachment member (412) further has a slit (440) through which it can latch on to the inner ring (101) of the retractor (100). The attachment member (412) can be pre-attached to the inner ring (101) or it can be attached prior to use.
In another embodiment as depicted in FIG 12, the inner ring (101) of the retractor (100) can have a narrow section (140) to allow for attachment of the attachment member (412) retraction fin (410). The attachment member (412) has a narrow slit that can accommodate only the narrow section (140) of the inner ring (101). Once attached, the attachment member (412) should be twisted to its final position such that it remains firmly attached during use. For removal, the attachment member (412) should be twisted back and taken out aligning with the narrow section (140).
In another embodiment as shown in FIG. 13a, the attachment member (412) can be in the form of a clip (450) which is fixed or slidably attached to the flexible rim (411) of the retraction fin (410). The clip (450) can be releasably locked around the inner ring (101) of the retractor (100), thus enabling attachment and removal of the retraction fin from the attachment member.
As depicted in FIG. 13b, the clip (450) can optionally be designed such that once locked, it needs to be released with the help of a tool (451) to prevent inadvertent detachment of the retraction fin from the inner ring.
FIG. 14 illustrates an instrument port (500), in accordance with the embodiment of the present invention. The instrument port (500) comprises a rigid body (501) and a soft wall (502) made from a self sealing material. The port (500) may further have an insufflation connection (503) and a smoke evacuation connection (504) on its body (501). The rigid body (501) can have a ring-like structure. The wall (502) can have a dome-like shape with hollow space inside. The hollow space can be used as a temporary storage for tissue structures during surgery. The wall (502) can optionally have a support structure (505) that helps it retain its shape. The support structure (505) can be removably attached to the body (501) or it may be integral with the body (501). The body (501) can optionally have one or more bracket (506) for attaching a belt harness (1000) (not shown) during use.
Referring to FIG. 15a, the body (501) can have one or more releasable latches (601) for holding the outer ring (102) of the retractor (100) firmly against an optional gasket (602) thereby creating a leak-proof attachment between the retractor (100) and instrument port (500).
In an embodiment as illustrated in FIG. 15b, the releasable latch (601) can be made in such a fashion that it automatically opens and latches onto the outer ring (102) of the retractor. To achieve this action, the releasable latch (601) may have a feature such as a slope (602) configured to drive the latch into open position when it comes in contact with the outer ring (102) of the retractor (100). Further, the latch may be spring loaded so that once the outer ring (102) goes into its required position, the latch (602) can automatically close thereby holding the outer ring (102) firmly. Gripping feature (603) can be provided on the latch to hold and easily release it whenever needed.
The wall (502) can be made of a self sealing material such as silicone gel, SEBS gel, or similar other material. The wall (502) can enable passage of trocars or instruments through it, while still being leak-proof. Thus, the wall (502) can allow for flexibility in location of passing the instruments or trocars. The material of the wall (502) is such that after removing the instruments or trocars, it seals itself thereby creating a leak-proof barrier.
In another embodiment of the present invention, the wall (502) as illustrated in FIG. 16 can be made of semi-flexible material with one or more openings (701) at pre-determined locations to allow instruments or trocars to be passed through. The openings (701) can be protruding outward from the wall. The openings (701) can have self sealing material at the entry point of instruments or trocars are to be passed, or they can have seals at those entry points. One or more of the openings can optionally have a side port for insufflation or smoke evacuation.
In another embodiment of the present invention, the wall (502) as illustrated in FIG. 17, can have an optional openable window (801) for introducing other surgical tools such as sutures, needles, etc. during surgical procedure. In another variant, as shown in FIG. 18, the wall (502) can have an optional holder or pocket (901) to temporarily store surgical tools such as needles, sutures, etc. prior to starting the surgical procedure. Having such arrangements like window or holder can save surgical time as the instrument port need not be removed for introducing any additional tools.
In an embodiment as described in FIG. 19, the instrument port can have a semi-rigid body (550) with a base ring (551) and a thin membrane-like wall (552) that is fixed onto the body (550). The wall (551) can have one or more finger-like projections (553) with a seal (554) at their ends. The projections are meant to enable passage of trocars or instruments into the port. The seal is meant to create a leak-proof sealing with or without instruments being passed through them. The body (550) can be made from materials such as TPU, Elastomer, PP, Nylon or similar other material that has slight flexibility. The wall (552) can be made from film-like materials such as TPU, Nylon, TPU coated Nylon, PVC, Silicone or any suitable material. The projections (553) can be made from materials such as TPU, Nylon, TPU coated Nylon, PVC, Silicone or any suitable material.The seal (554) can have a combination valve (560) construction made from materials such as silicone, TPU, EPDM, Neoprene, or similar. Alternatively, the seal (554) can be in the form of a septum (561) that can be made from self sealing material such as silicone gel, SEBS gel, or similar other material. The base ring (551) of the body (550) can have a cross section that can engage with the outer ring (102) of the retractor (100).The cross section of the base ring (551) of the body (550) can have a groove (560) that can accommodate the outer ring (102) of the retractor (100). Further, the body can have a latching lip (561) that locks and seals the outer ring (102) to form a leakproof seal around it. The outer ring (102) can have an I shaped section (204). The locking of the outer ring (102) with the body (550) can be further secured by a thread (562) that goes around and tightens the latching lip (561) of the body (550). In an embodiment, the locking of the outer ring (102) with the body (550) can be secured by means of a clamp that goes around the latching lip (561). The clamp can be tightened by any means such as ratcheting, threading or similar means.
FIG. 20 illustrates a belt harness (1000) in accordance with the embodiment of the present invention. The belt harness (1000) is designed to securely hold the instrument port (500) against the patient’s vaginal opening. The belt harness (1000) can be made up of rigid fabric or it can have elastic. The belt harness (1000) can have adjustment buckles (1001) to be able to fit on patients of different body types.
The present invention further discloses a pouch designed to contain the tissue prior to its removal transluminally or transvaginally.
In accordance to an embodiment of the present invention, as illustrated in FIG. 21a, the pouch (1100) can have an opening (1101), an elongated neck (1102) and a body (1103). In a preferred embodiment, the length of the pouch from the opening till end of the body can range from 100mm to 1000mm so that the pouch is able to go inside the abdominal cavity with its opening coming out transluminally or transvaginally. The pouch (1100) is made from leak-proof materials such as thermoplastic polyurethane (TPU), ripstop nylon, ripstop nylon with TPU coating or similar other material. This is required to prevent any leaking of the contents into the abdominal cavity. The pouch (1100) may need to be insufflated if the tissue is required to be debulked for removal transluminally or transvaginally.
In accordance to another embodiment of the present invention, as illustrated in FIG. 21b, the pouch (1100) can have an elongated shape that gradually increases away from the opening. In accordance to another embodiment of the present invention, as illustrated in FIG. 21c, the pouch can have an elongated neck (1102) that runs straight or narrows down, and a larger body (1103) that creates a pot-like appearance. This shape can create a clear field inside the abdomen.
In accordance to the another embodiment of the present invention, as illustrated in FIG. 21d, the pouch can have an asymmetric shape with the posterior side (1104) more flattened while the anterior side (1105) bulging upwards. This can create an anatomical shape during use. It may help to keep the surgical field clear and other organs away from the surgical site.
In accordance to another embodiment of the present invention, as illustrated in FIG. 22, the pouch (1100) can have various markings (1201) at its opening, on its neck and on its body to indicate orientation, twisting of the neck, and identification of the body when performing the procedure.
In accordance to the embodiment of the present invention, as illustrated in FIG. 23, the pouch (1100) may optionally have a different material at its neck to minimize twisting.
The pouch can be made of transparent material, semi-transparent material or opaque material. In accordance to alternate embodiment of the present invention, as illustrated in FIG. 24, the pouch can be made of a combination of different materials with transparency at the body for visualization of other nearby organs.
The opening (1101) of the pouch (1100) can have a stiffening element (1501) that keeps the opening of the pouch open, as illustrated in FIG. 25. The stiffening element can be in the form of a ring made from metal wire (example super-elastic nitinol) or a ring made from a plastic material or a ring made from elastomeric material.
In an alternate embodiment, as illustrated in FIG. 26, the opening (1101) of the pouch (1100) can have a 3D shape with one or more lips (1601) coming out of plane. The opening can be stiffened by a stiffening element (1602). The lips (1601) may provide an added advantage of allowing easy introduction of the tissue into the pouch or allow for easy holding and manoeuvring of the pouch out of the vaginal cavity.
In an alternate embodiment, as illustrated in FIG. 27, the opening (1101) of the pouch (1100) can be oblique. The opening (1101) can be stiffened by a stiffening element. The oblique shape may provide an added advantage of allowing easy introduction of the tissue into the pouch or allow for easy holding and manoeuvring of the pouch out of the vaginal cavity.
In an alternate embodiment, as illustrated in FIG. 28a, the pouch (1100) can have an opening (1101) and optionally have at-least one secondary opening (1801). In an alternate embodiment, as illustrated in FIG. 28b, the secondary opening (1801) can be at the end of an elongated tail (1802) with size considerably smaller than the first opening (1101). The secondary opening can be configured to receive instruments such as grasper, camera, etc.
The present invention further discloses a morcellator (1900) designed for debulking of large tissues.
In accordance to an embodiment of the present invention, as illustrated in FIG. 29, the morcellator (1900) comprises of a handle (1901), an elongated tubular cutting element (1902), An elongated outer tube (1903) covering the cutting element (1902) from outside and is co-axial with the cutting element (1902) and an optional elongated inner tube (1904) covering at least some portion of the cutting element (1902) from inside and is co-axial with the cutting element (1902). All the elongated tubes (1903) are configured so as to allow for an instrument such as tenaculum or grasper to pass through the inner-most tube. The length of the elongated tubes outside of the handle can range from 100mm to 1000mm so as to be able to reach the abdominal cavity transluminally or transvaginally. The diameter of the cutting element (1902) can be between 5mm to 40mm. The clearances between the outer tube (1903), cutting element (1902) and inner tube (1904) can be kept as minimum as feasible for effective performance of the morcellator.
Similar to a transluminal procedure, in the transvaginal approach also, the morcellator will have to be used after insufflating the abdomen through the vaginal opening. This will create a pneumoperitoneum thereby creating enough space to carry out morcellation with minimal risk to other nearby organs.
The Morcellator (1900) can have a mechanical cutting action wherein the cutting element (1902) has a sharp cutting edge at its distal tip. The cutting element is capable of rotating about its axis. Alternatively, the cutting element (1902) can have an electrical cutting action.
Referring to FIG. 30a, the outer tube (1903) comprises of a special profile or core guard (1906) at its distal tip to prevent coring of the tissue during morcellation. In an alternate embodiment illustrated in FIG. 30b, the core guard (1906) can have an oblique shape. In an alternate embodiment illustrated in FIG. 30c, the core guard can be optionally like a flexible flap (1907) that aids to guide the tissue towards the cutting element and prevents it from falling down due to gravity. The flap can also potentially aid in keeping other organs such as bowels away from the cutting area. In an alternate embodiment illustrated in FIG. 30d, the core guard can be in the form of a funnel (1908).
The present invention also provided a method for using the system of the present invention.
FIG. 31 shows cross section of the abdomen, wherein the abnormal tissue (2100) such as uterus is partially separated from the vaginal wall by transvaginal approach.
Thereafter, as shown in Fig. 32, the inner ring (101) of the retractor (100) is passed through the vagina such that it retracts the peripheral organs. The outer ring (102) of the retractor is then flipped till it retracts the vaginal wall (2101) and creates sufficient tension on the flexible body (103) of the retractor (100). The optional markings on the body of the retractor can help to ensure correct orientation of the retractor.
Alternatively as shown in FIG. 33, the retraction fin (410) can be attached or pre-attached to the inner ring (101) of the retractor (100) and then passed through the vagina such that it retracts the peripheral organs. The outer ring (102) of the retractor is then flipped till it retracts the vaginal wall (2101) and creates sufficient tension on the flexible body (103) of the retractor (100). The optional markings on the body of the retractor can help to ensure correct orientation of the retractor.
As shown in FIG. 34, the instrument port (500) is then attached to the outer ring (102) of the retractor and the sealed body cavity is then insufflated through the insufflation valve (503) of the instrument port (500). The optional markings on the instrument port may help in orienting the port correctly.
Trocars (2301) are introduced into the wall (502) of the instrument port (500). As in FIG. 35, a laparoscopic camera (2401) is introduced through one of the trocars to enable visualization. Laparoscopic Instruments (2402) such as grasper, vessel sealer, can be passed into the other trocars. The uterus or abnormal tissue (2100) can then be completely separated from connective tissue, blood vessels, ligaments.
The above steps can be common for all sizes and shapes of tissue. Further, steps can be decided based on the size of the tissue to be removed.
In case the tissue is small enough to be directly taken out through the vaginal opening as shown in FIG. 36. The instrument port can be removed and then using graspers (2402), the tissue (2100) can be pulled out through the retractor (100). Once the procedure is complete, the retractor (100) is taken out.
In case the tissue is too big, then it needs to be morcellated and taken out. For morcellation procedure, the instrument port is first removed and the pouch (1100) can be passed into the body cavity as shown in FIG. 37.
As shown in FIG. 38, the instrument port (500) is reattached to the retractor (100) and body cavity is insufflated. Thereafter under vision, the tissue (2100) is placed inside the pouch (1100) using instruments such as graspers (2402).
As shown in FIG. 39, the instrument port is again removed and the opening (1101) of the pouch (1100) is then exteriorized through the retractor (100).
As in FIG. 40 The instrument port (500) is once again attached such that the opening of the pouch (1101) is held over the outer ring (102) of the retractor (100) and the pouch (1100) is insufflated. The distal end of the morcellator (1900) is passed through the wall (502) of the instrument port (500) and tissue morcellation is performed under vision. After morcellation is complete, all the devices are taken out.
As shown in FIG. 41, the belt harness (1000) can be used in the procedure to securely hold the instrument port (500). The belt harness (1000) can be easily attached and detached to the instrument port (500) whenever needed during the procedure.
FIG. 42 shows the main components of the system – retractor (100), optional retraction fin (410) and instrument port (500) in dis-assembled and assembled condition.
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations may be substituted for the specific embodiments shown and described without departing from the scope of the present invention. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.
,CLAIMS:We claim –
1. A system comprising a retractor (100) and an instrument port (500),
wherein the retractor (100) comprises an inner ring (101), an outer ring (102), and an elongated flexible body (103) attached to the inner ring (101) and the outer ring (102),
wherein the instrument port (500) comprises a rigid body (501) and a soft wall (502),
wherein the instrument port (500) can be releasably attached to the outer ring (102) of the retractor (100) in a leakproof manner.
2. The system as claimed in claim 1, wherein the inner ring (101) is attached with a retraction fin (410).
3. The system as claimed in claim 2, wherein the retraction fin (410) comprises a flexible rim (411) having one or more attachment members (412).
4. The system as claimed in claim 3, wherein the attachment members (412) is pre-attached to the flexible rim (411).
5. The system as claimed in claim 3, wherein the attachment members (412) is pre-attached to the inner ring (101).
6. The system as claimed in claim 2, wherein the retraction fin (410) comprises one or more pulling tabs (430) attached to the flexible rim (411).
7. The system as claimed in claim 3, wherein the attachment members (412) is a clip (450).
8. The system as claimed in claim 1, wherein the rigid body (501) comprises one or more releasable latches (601).
9. The system as claimed in claim 1, wherein the soft wall (502) is having a support structure (505).
10. The system as claimed in claim 1, wherein the soft wall (502) comprises one or more openings (701) at predetermined locations.
11. The system as claimed in claim 1, wherein the instrument port (500) further comprises a semi-rigid body (550) with a base ring (551) and a thin membrane-like wall (552).
12. The system as claimed in claim 11, wherein the base ring (551) comprises one or more finger-like projections (553) with a seal (553) at their ends.
13. The system as claimed in claim 1 wherein the instrument port (500) has an insufflation connection (503) and a smoke evacuation connection (504),
14. The system as claimed in claim 1 further comprises a belt harness (1000) to hold the instrument port (500).
15. The system as claimed in claim 14, wherein the belt harness (1000) is having one or more adjustment buckles (1001).
16. The system as claimed in claim 1 further comprises a pouch (1100) and a morcellator (1900).
17. the system as claimed in claim 16, wherein the pouch (1100) comprises an opening (1101), an elongated neck (1102) and a body (1103).
18. The system as claimed in claim 17, wherein the pouch (1100) is having various markings (1201) at the opening (1101).
19. The system as claimed in claim 17, wherein the opening (1101) is having a stiffening element (1501).
20. The system as claimed in claim 17, wherein the pouch optionally comprises a secondary opening (1801).
21. The system as claimed in claim 16, wherein the morcellator (1900) comprises a handle (1901), an elongated tubular cutting element (1902), and an elongated outer tube (1903) covering the cutting element (1902).
22. A method of performing transluminal procedure for removing abnormal tissue, the method comprises the step of
(a) passing the retractor (100) through the patient’s vagina;
(b) attaching the instrument port (500) to the outer ring (102) of the retractor (100); and
(c) insufflating the body cavity through the insufflation connection (503) of the instrument port (500)
23. The method as claimed in claim 22, further include a step of securing the instrument port (500) using a belt harness (1000).
24. The method as claimed in claim 22 further include a step of placing tissue inside a pouch (1100).
25. The method as claimed in claim 22 further include a step of morcellating tissue using the morcellator (1900).
| # | Name | Date |
|---|---|---|
| 1 | 202221022497-PROVISIONAL SPECIFICATION [15-04-2022(online)].pdf | 2022-04-15 |
| 2 | 202221022497-FORM FOR SMALL ENTITY(FORM-28) [15-04-2022(online)].pdf | 2022-04-15 |
| 3 | 202221022497-FORM FOR SMALL ENTITY [15-04-2022(online)].pdf | 2022-04-15 |
| 4 | 202221022497-FORM 1 [15-04-2022(online)].pdf | 2022-04-15 |
| 5 | 202221022497-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [15-04-2022(online)].pdf | 2022-04-15 |
| 6 | 202221022497-EVIDENCE FOR REGISTRATION UNDER SSI [15-04-2022(online)].pdf | 2022-04-15 |
| 7 | 202221022497-DRAWINGS [15-04-2022(online)].pdf | 2022-04-15 |
| 8 | 202221022497-DRAWING [11-04-2023(online)].pdf | 2023-04-11 |
| 9 | 202221022497-COMPLETE SPECIFICATION [11-04-2023(online)].pdf | 2023-04-11 |