US20210077087A1 - Specimen retrieval device - Google Patents
Specimen retrieval device Download PDFInfo
- Publication number
- US20210077087A1 US20210077087A1 US17/108,012 US202017108012A US2021077087A1 US 20210077087 A1 US20210077087 A1 US 20210077087A1 US 202017108012 A US202017108012 A US 202017108012A US 2021077087 A1 US2021077087 A1 US 2021077087A1
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- United States
- Prior art keywords
- wound retractor
- ring
- distal
- kit
- proximal
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- Abandoned
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Definitions
- the present disclosure relates generally to surgical apparatuses for use in minimally invasive surgical procedures, such as endoscopic and/or laparoscopic procedures, and more particularly, the present disclosure relates to a surgical apparatus including a specimen retrieval bag assembly and a vacuum tube for accessing the bag assembly and collecting body tissue(s) and/or body fluid(s) during these procedures.
- Endoscopic surgery involves surgery through body walls, for example, viewing and/or operating on the ovaries, uterus, gall bladder, bowels, kidneys, appendix, etc.
- endoscopic surgical procedures including arthroscopy, laparoscopy, gastroentroscopy and laryngobronchoscopy, just to name a few.
- trocars are utilized for creating incisions through which the endoscopic surgery is performed.
- Trocar tubes or cannula devices are extended into and left in place in the abdominal wall to provide access for endoscopic surgical tools.
- a camera or endoscope is inserted through a trocar tube to permit the visual inspection and magnification of the body cavity.
- surgeon can then perform diagnostic and/or therapeutic procedures at the surgical site with the aid of specialized instrumentation, such as forceps, graspers, cutters, applicators, and the like, which are designed to fit through additional cannulas.
- specialized instrumentation such as forceps, graspers, cutters, applicators, and the like, which are designed to fit through additional cannulas.
- wound retractors are often placed across the opening.
- tumor tissue When removing certain tissues from the body cavity, for example tumor tissue, it is important that the tumor tissue does not come into contact with healthy or uninvolved tissue, so as in this way to avoid metastasis and avoid harming the patient.
- Minimally invasive surgical procedures may be limited where large size tumors or large masses of tissue have to be removed from a body cavity. If tumor tissue or tissue parts have to be removed, they may be introduced into an “extraction bag,” also referred to herein as a “specimen bag,” at the site where the tumor or diseased tissue has been detached from the surrounding tissue, after which the specimen bag is withdrawn from the body, normally through a trocar or similar device, thereby minimizing contact of the diseased tissue with healthy tissue.
- extraction bag also referred to herein as a “specimen bag”
- the present disclosure is directed to surgical apparatuses and kits for use in minimally invasive surgery.
- the surgical apparatus includes a wound retractor having a specimen bag attached thereto, for placement of diseased tissue therein.
- the kit of the present disclosure includes the surgical apparatus and a vacuum tube for assisting in removing tissue specimens from the body.
- a kit of the present disclosure includes a wound retractor and specimen bag assembly including a wound retractor and a specimen bag.
- the wound retractor includes a proximal ring, a distal ring, and a film disposed between the proximal ring and the distal ring, with the specimen bag attached to the distal ring of the wound retractor.
- the kit also includes a vacuum tube.
- the proximal ring of the wound retractor defines a generally circular opening and is deformable.
- the distal ring of the wound retractor defines a generally circular opening and is deformable.
- a length of the film of the wound retractor between the proximal ring and the distal ring is adjustable.
- the specimen bag is attached to the distal ring of the wound retractor by a method such as adhesive bonding, welding, heat-sealing, and combinations thereof.
- the wound retractor includes a tether.
- the vacuum tube includes a distal portion defining a generally circular opening, a narrower proximal portion defining a narrower, generally circular opening, and an elongate shaft defining a lumen between the distal portion and the narrower proximal portion.
- the vacuum tube includes a valve.
- the kit of the present disclosure further includes a vacuum source adapted to communicate with the vacuum tube.
- the vacuum source includes a syringe.
- a kit of the present disclosure includes a wound retractor and specimen bag assembly including a wound retractor and a specimen bag, the wound retractor including a proximal ring, a distal ring, and a film disposed between the proximal ring and the distal ring, the specimen bag being attached to the distal ring of the wound retractor.
- the kit also includes a vacuum tube, and a vacuum source including a syringe adapted to communicate with the vacuum tube.
- the proximal ring of the wound retractor defines a generally circular opening and is deformable.
- the distal ring of the wound retractor may also define a generally circular opening and is deformable.
- a length of the film of the wound retractor between the proximal ring and the distal ring is adjustable.
- the specimen bag is attached to the distal ring of the wound retractor by a method such as adhesive bonding, welding, heat-sealing, and combinations thereof.
- the wound retractor includes a tether.
- the vacuum tube includes a distal portion defining a generally circular opening, a narrower proximal portion defining a narrower, generally circular opening, and an elongate shaft defining a lumen between the distal portion and the narrower proximal portion.
- the vacuum tube includes a valve.
- a method of the present disclosure includes inserting a wound retractor and specimen bag assembly including a wound retractor having a proximal ring, a distal ring and a film disposed between the proximal ring and the distal ring, and a specimen bag attached to the distal ring, into a body cavity through a body opening; passing a tissue specimen through an opening defined by the proximal ring, the film and the distal ring of the wound retractor into the specimen bag; removing the proximal ring from the body cavity through the body opening so that the film is adjacent tissue encompassing the body opening; pulling the proximal ring away from the distal ring such that the distal ring is brought into abutment with an inner surface of the tissue surrounding the body opening; rolling the proximal ring about itself such that the film is furled about the proximal ring to bring the proximal ring into abutment with an outer surface of the tissue;
- the method of the present disclosure further includes rolling the proximal ring to retract the incision and bring the proximal ring into abutment with an outer surface of the tissue.
- FIG. 1 is a perspective view of components of a kit including an exemplary embodiment of the presently disclosed wound retractor and specimen bag assembly, with a vacuum tube and a vacuum source;
- FIG. 2 is a cross-sectional view of a patient's body, showing a wound, incision, and tissue specimen to be removed from the body cavity;
- FIG. 3 is a perspective view of the specimen bag and wound retractor assembly shown in FIG. 1 ;
- FIG. 4A is a cross-sectional view of the wound retractor and specimen bag assembly shown in FIG. 3 in a body cavity, adjacent tissue to be removed from the body cavity;
- FIG. 4B is a perspective, partial cross-sectional view during removal of the wound retractor and specimen bag assembly shown in FIG. 4A from a body cavity through the incision;
- FIG. 5 is a perspective view of the wound retractor and specimen bag assembly shown in FIG. 4B with the wound retractor inserted into the incision in tissue and the specimen bag positioned within the body cavity;
- FIG. 6 is a partial cross-sectional view of the wound retractor and specimen bag assembly shown in FIG. 5 , with a vacuum tube inserted through the wound retractor into the specimen bag and a vacuum source affixed to the vacuum tube;
- FIG. 7 is an enlarged view of the indicated area of detail shown in FIG. 6 ;
- FIG. 8 is a partial cross-sectional view of the wound retractor and specimen bag assembly shown in FIG. 6 , showing the vacuum source drawing a vacuum through the vacuum tube and pulling tissue from the specimen bag into the vacuum tube;
- FIG. 9 is an enlarged view of the indicated area of detail shown in FIG. 8 ;
- FIG. 10 is an alternate partial cross-sectional view of the wound retractor and specimen bag assembly shown in FIG. 6 , showing the vacuum source drawing a vacuum through the vacuum tube and pulling tissue from the specimen bag into the vacuum tube;
- FIG. 11 is an enlarged view of the indicated area of detail shown in FIG. 10 .
- minimally invasive surgical procedures encompass laparoscopic procedures and endoscopic procedures, and refer to procedures utilizing scopes or similar devices having relatively narrow operating portions capable of insertion through or a small incision in the skin.
- minimally invasive procedures include, for example, cholecystectomies, appendectomies, nephrectomies, colectomies, splenectomies, and the like.
- distal refers to that portion of a wound retractor and specimen bag assembly which is farthest from the user
- proximal refers to that portion of the wound retractor and specimen bag assembly of the present disclosure which is closest to the user.
- the wound retractor and specimen bag assembly of the present disclosure includes a wound retractor with a specimen bag affixed thereto.
- the wound retractor component includes a sleeve member possessing at least two rings, including a proximal ring and a distal ring, with a film extending between the two rings.
- the specimen bag component is attached to the distal ring of the wound retractor.
- the specimen bag assembly is passed through an incision and placed within a body cavity, and tissue to be removed therefrom, referred to in embodiments as a “tissue specimen”, is passed through the wound retractor component and placed within the specimen bag.
- the proximal ring of the wound retractor component is then removed from the body cavity and placed adjacent the skin on an outside surface of the body adjacent the incision, with the distal ring of the sleeve member and the specimen bag remaining within the body, so that the film extends through the incision and is adjacent the tissue encompassing the incision.
- the presently disclosed wound retractor and specimen bag assembly is suitable for use in any procedure where access to the interior of the body is limited to one or more relatively small incisions, as in minimally invasive procedures.
- Kits of the present disclosure include both the wound retractor and specimen bag assembly described above, as well as a vacuum tube assembly.
- the vacuum tube assembly permits removal of tissue specimens from the specimen bag without the need for breaking up the tissue, sometimes referred to herein as morcellation of tissue, with a scalpel or some other morcellation device.
- FIG. 1 illustrates a kit of the present disclosure including a wound retractor and specimen bag assembly 10 in accordance with the present disclosure.
- the wound retractor and specimen bag assembly 10 encompasses both a wound retractor 100 and a specimen bag 200 .
- the kit of the present disclosure also includes a vacuum tube 300 and a vacuum source, in embodiments a syringe 400 , for drawing a vacuum through the vacuum tube 300 .
- the wound retractor and specimen bag assembly 10 is adapted for insertion into wound “W” through an incision “I” and placement within a body cavity “BC” ( FIG. 4A ) as described in further detail below.
- the incision “I” may be a single incision, e.g., through the abdominal or peritoneal lining, or a naturally occurring orifice (i.e. mouth, anus, or vagina).
- the wound retractor 100 includes a proximal ring 120 , a distal ring 140 , and a generally cylindrical film 130 disposed therebetween.
- the wound retractor and specimen bag assembly 10 further defines a longitudinal axis “L” shared by the proximal ring 120 , the distal ring 140 , and the film 130 , as well as the specimen bag 200 .
- proximal ring 120 and the distal ring 140 may each be detachably coupled or permanently attached to a proximal end portion 132 and a distal end portion 134 , respectively, of the film 130 by any means within the purview of those skilled in the art, e.g., glue, suture, impulse welding, chemical or mechanical bonding, an over molding process, etc.
- the proximal ring 120 , film 130 , and distal ring 140 are monolithically integrated such that the wound retractor 100 is a unitary structure.
- Attachment of the film 130 to the rings 120 , 140 can be continuous around the rings 120 , 140 or may be discontinuous, provided the rings 120 , 140 are sufficiently secured to the film 130 to allow the film 130 to be rolled about the proximal ring 120 as described below.
- the proximal ring 120 and the distal ring 140 are axially aligned along longitudinal axis “L” with the film 130 disposed therebetween, as noted above.
- the proximal ring 120 has a generally circular configuration that defines a circular opening 122 (see FIG. 1 ) and is rollable about the proximal ring 122 to tension the film 130 and retract the incision “I”. More specifically, the proximal ring 120 can be rolled towards or away from the distal ring 140 along the longitudinal axis “L” to furl or unfurl the film 130 about the proximal ring 120 .
- the distal ring 140 also has a generally circular configuration that defines a generally circular opening (not shown).
- proximal ring 120 and the distal ring 140 may be fabricated from resilient materials such that the proximal ring 120 and the distal ring 140 may temporarily deform into a generally oblong configuration during insertion of the wound retractor 100 through an incision “I” while reverting to a generally circular configuration during use.
- resilient materials such that the proximal ring 120 and the distal ring 140 may temporarily deform into a generally oblong configuration during insertion of the wound retractor 100 through an incision “I” while reverting to a generally circular configuration during use.
- thermoplastic polyurethanes sold under the name PELLETHANE® offers flexibility and a wide range of hardnesses.
- the proximal ring 120 may be fabricated from PELLETHANE® 2363-80A, PELLETHANE® 2363-90A, a 50/50 composition of PELLETHANE® 2363-80A and PELLETHANE® 2363-90A, or any alternatives known in the art.
- the distal ring 140 may be fabricated from, for example, PELLETHANE® 2363-90A for the extra small and small size, PELLETHANE® 2363-55D for the medium and large size, a 50/50 composition of PELLETHANE® 2363-90A and PELLETHANE® 2363-55D for the large size, or any alternatives within the purview of those skilled in the art.
- the proximal ring 120 and the distal ring 140 may be fabricated from the same or different materials.
- the film 130 defines a generally cylindrical shape to form a lumen between the proximal ring 120 and the distal ring 140 .
- the circular configuration of the proximal and distal rings 120 and 140 respectively, maintains the film 130 in an expanded state to maintain the lumen in a non-collapsed state.
- the film 130 is coupled to the proximal ring 120 at the proximal end portion 132 and is coupled to the distal ring 140 at the distal end portion 134 , such that the film 130 does not slide or move relative to a surface of either the proximal ring 120 or the distal ring 140 .
- the film 130 may be fabricated from a clear, non-elastomeric material, e.g., a polyurethane. Alternately, it is envisioned that the film 130 may be formed from a variety of materials including opaque and clear materials.
- the length “X” ( FIG. 3 ) between the proximal ring 120 and the distal ring 140 is adjustable. More specifically, the length “X” can be decreased by rolling the proximal ring 120 towards the distal ring 140 to furl the film 130 about the proximal ring 120 . Similarly, the length “X” can be increased by rolling the proximal ring 120 away from the distal ring 140 to unfurl the film 130 from about the proximal ring 120 . As discussed above, as the proximal ring 120 is rolled towards or away from the distal ring 140 , the film 130 furls or unfurls about the proximal ring 120 .
- the wound retractor 100 may come in a variety of sizes to appropriately fit and accommodate a range of incision diameters.
- the outer diameter of the proximal ring 120 and the distal ring 140 may be about 2.5 inches; for a small wound retractor, the outer diameter of the proximal ring 120 and the distal ring 140 may be about 3 .
- the outer diameter of the proximal ring 120 and the distal ring 140 may be about 5.1 inches; for a large wound retractor, the outer diameter of the proximal ring 120 and the distal ring 140 may be about 7.5 inches; and for an extra-large wound retractor, the outer diameter of the proximal ring 120 and the distal ring 140 may be about 9.4 inches.
- Specimen bags of the present disclosure are made of flexible and durable materials within the purview of those skilled in the art, in embodiments, polymeric materials.
- the specimen bags are inflatable and capable of allowing a surgeon to introduce cutting devices into the specimen bag to reduce the size of the tissue specimen therein, thereby facilitating removal of the specimen bag from the body.
- Materials used to form the specimen bags are antistatic, pyrogen-free, non-toxic and sterilizable.
- materials used to form the film portion of the wound retractor described above may be used to form the specimen bag.
- the specimen bag is formed of materials that are different from those used to form the film of the wound retractor.
- the specimen bag may be opaque or clear.
- the specimen bag 200 may be joined to the distal ring 140 of the wound retractor at the distal portion 134 of the film 130 by methods within the purview of those skilled in the art, including, but not limited to, adhesive bonding, welding, heat-sealing, combinations thereof, and the like.
- the specimen bag 200 can be integrally formed with the film 130 , in embodiments of the same material.
- both the proximal ring 120 and the distal ring 140 may be collapsed from the generally circular configuration to a generally oblong configuration (not shown) for insertion, along with the specimen bag 200 , through incision “I”. More specifically, as the practitioner squeezes opposing sides of the proximal ring 120 and the distal ring 140 radially inwards, the generally circular openings of the proximal ring 120 and the distal ring 140 are deformed from the generally circular configuration to a generally oblong configuration (not shown) such that the proximal ring 120 and the distal ring 140 assume a smaller profile for ease of insertion through incision “I”. Once inserted, the practitioner releases the proximal ring 120 and distal ring 140 and the resiliency of the material urges the proximal ring 120 and the distal ring 140 towards their generally circular configurations.
- a vacuum tube 300 may be inserted through the lumen of the wound retractor 100 into the specimen bag 200 to remove tissue specimen “TS” from the body cavity “BC”.
- the kit ( FIG. 1 ) of the present disclosure includes a vacuum tube 300 .
- the vacuum tube 300 has an elongate body 310 defining a lumen 314 ( FIG. 6 ).
- the elongate body 310 has a distal portion 312 defining a generally circular opening and, compared with the distal portion 312 , a narrower proximal portion 316 .
- the narrower proximal portion 316 compared with the distal portion 312 , defines a narrower lumen with a narrower, generally circular opening 318 .
- the vacuum tube 300 may be formed of hard, rigid materials. Suitable materials for forming the vacuum tube include, for example, polyolefins such as polyethylene (including ultra high molecular weight polyethylene) and polypropylene including atactic, isotactic, syndiotactic, and blends thereof; polyethylene glycols (PEGs); polyethylene oxides; copolymers of polyethylene and polypropylene; polyisobutylene and ethylene-alpha olefin copolymers; fluorinated polyolefins such as fluoroethylenes, fluoropropylenes, fluoroPEGs, and polytetrafluoroethylene; polyamides; polyamines; polyimines; polyesters such as polyethylene terephthalate, polyethylene naphthalate, polytrimethylene terephthalate, and polybutylene terephthalate; polyethers; polybutester; polytetramethylene ether glycol; 1 , 4 -butanedio
- the kit of the present disclosure also includes a vacuum source, in embodiments a syringe 400 , for drawing a vacuum through the vacuum tube 300 , thereby removing the tissue specimen “TS” from the specimen bag 200 by drawing the tissue specimen “TS” into the distal portion 312 of the vacuum tube 300 .
- a vacuum source in embodiments a syringe 400
- Other possible sources for drawing a vacuum include, for example, a mechanically or manually operated pump (not shown), a simple electric vacuum pump (not shown), or other similar means.
- the narrower proximal portion 316 of the vacuum tube 300 is couplable to the vacuum source, in embodiments the syringe 400 .
- Means for coupling the narrower proximal portion 316 of the vacuum tube 300 to the vacuum source are within the purview of those skilled in the art and include, for example, friction fitting, the use of seals within the lumen of circular opening 318 of the narrower proximal portion 316 of the vacuum tube 300 , a luer-type coupling, combinations thereof, and the like.
- FIGS. 2 and 4-11 a method of operating the surgical apparatus 10 in accordance with the present disclosure will be described.
- the surgeon in order to access a tissue specimen “TS” positioned within a body cavity “BC” ( FIG. 2 ), the surgeon first collapses and deforms the proximal ring 120 and the distal ring 140 of the wound retractor 100 into an oblong configuration for insertion into wound “W” through incision “I” ( FIG. 4A ).
- the proximal ring 120 and distal ring 140 resume their generally circular configuration so that the surgical apparatus 10 is adjacent the tissue specimen “TS” to be removed from the body cavity ( FIG. 4A ).
- the surgeon can then introduce tissue specimen “TS” through the proximal ring 120 , the film 130 , and the distal ring 140 into the specimen bag 200 by use of a forceps, grasper, or any other suitable medical device.
- tissue specimen “TS” has been introduced into the specimen bag 200 , the surgeon then collapses and deforms the proximal ring 120 using a forceps, grasper, or similar instrument and withdraws the proximal ring 120 through the incision “I”.
- the proximal ring 120 has a tether 124 thereon (shown in phantom in FIG. 4B ), which may be pulled proximally by the surgeon to withdraw the proximal ring 120 from the body cavity “BC”.
- the surgeon may pull the proximal ring 120 (indicated by arrows “A” in FIG. 4B ) to remove the proximal ring 120 from the incision “I” after the specimen “TS” is positioned within the specimen bag 200 .
- the proximal ring 120 is removed from the body cavity through incision “I” so that it rests on the outer skin 4 adjacent incision “I” and the surgeon adjusts the film 130 and the proximal ring 120 , e.g., pulling the proximal ring 120 proximally to tension the film 130 , such that the distal ring 140 comes into abutment with an inner surface 8 of wound “W”.
- the distal ring 140 is positioned adjacent the inner surface 8 of wound “W”, and reverts to its generally circular configuration so that the generally circular opening of distal ring 140 encompasses the inner surface 8 of the wound “W” ( FIG. 5 ).
- the proximal ring 120 With the distal ring 140 in abutment with the inner surface 8 of wound “W”, the proximal ring 120 is rolled distally towards the distal ring 140 and the outer surface 4 of wound “W” to a desired position, such that the film 130 is furled about the proximal ring 120 (not shown) and thereby tensioned.
- wound retractor 100 may pass through a lumen 114 of the wound retractor 100 with the distal ring 140 in abutment to the inner surface 8 of wound “W”, and the proximal ring 120 rolled to a desired position and/or brought into abutment to the outer surface 4 of wound “W”.
- the wound retractor 100 may be tensioned further to provide retraction of incision “I”, increasing the incision diameter.
- a vacuum tube 300 is introduced through the lumen 114 of wound retractor 100 ( FIG. 6 ).
- a syringe 400 or any other device capable of drawing a vacuum, may then be attached to the narrower proximal portion 316 of the vacuum tube 300 to draw a vacuum within the lumen 314 of the vacuum tube 300 , thereby drawing the tissue specimen “TS” contained within the specimen bag 200 into the distal end portion 312 of the vacuum tube 300 .
- the plunger 410 of the syringe 400 may first be pushed distally (indicated by arrows “P” in FIGS. 10 and 11 ) to evacuate air from the syringe 400 .
- the plunger 410 may possess a small one-way valve to permit the evacuation of air from the syringe 400 .
- the one-way valve can be any type of trap allowing the one way flow of air, out of the syringe 400 .
- an example of a suitable one-way valve includes a ball valve 500 .
- the air present in the syringe 400 evacuates itself thru the ball valve 500 when the plunger 410 is pushed distally (indicated by arrows “P” in FIGS. 10 and 11 ). No air goes back down into the syringe 400 .
- the ball valve 500 possesses spokes 512 , 514 which prevent the ball 500 from blocking a proximal opening 530 of the ball valve 500 , while at the same time permitting air to pass from the syringe 400 , through a distal opening 516 of the ball valve 500 , through the proximal opening 530 of the ball valve 500 , and out of the syringe 400 .
- the vacuum tube 300 includes a valve within the narrower proximal portion 316 of the vacuum tube 300 .
- the valve may include a ball valve 318 , including a ball 320 , and projections 322 , 324 projecting into a lumen 328 of the ball valve 318 .
- the projections 322 , 324 prevent the ball 320 from blocking a proximal opening 330 of the ball valve 318 , while at the same time permitting air (indicated by arrows “Z” in FIG.
- valves such as one-way valves, check valves, or any other valve arrangement, may be included within the narrower proximal portion 316 of the vacuum tube 300 to assist in drawing and maintaining a vacuum within the lumen 314 of the vacuum tube 300 .
- the plunger 410 of the syringe 400 is pushed distally (indicated by arrows “P” in FIGS. 10 and 11 ) so that the air within the syringe 400 evacuates itself thru the ball valve 500 .
- the plunger 410 of the syringe 400 is then pulled proximally (indicated by arrows “Y” in FIG. 8 ) to create a vacuum capable of drawing tissue specimen “TS” from the specimen bag 200 into the distal end portion 312 of the vacuum tube 300 .
- the above cycle (pushing the plunger 410 of the syringe 400 distally and then pulling the plunger 410 of the syringe 400 proximally) may be repeated to ensure an adequate vacuum state is created, capable of drawing tissue specimen “TS” from the specimen bag 200 into the distal end portion 312 of the vacuum tube 300 .
- the process may be repeated multiple times in order to achieve the vacuum necessary to draw the tissue specimen “TS” into the vacuum tube 300 .
- the plunger 410 of the syringe 400 is pushed down at least a second time to repeat the cycle (indicated by arrows “P” in FIGS. 10 and 11 ), in preparation for another proximal pull (indicated by arrows “Y” in FIG. 8 ) to evacuate more air (indicated by arrows “Z” in FIG. 9 ) from the vacuum tube 300 .
- the ball valve 500 of the plunger 410 of the syringe 400 allows for repetition of the cycle to create an adequate vacuum without the need to disconnect the syringe 400 after each proximal pull.
- the vacuum tube 300 may be removed from the wound retractor 100 .
- the surgeon may grab those additional pieces of tissue with a forceps or other grasper, and/or use a vacuum source for removal of any remaining portion of the tissue specimen “TS” from the specimen bag 200 .
- the volume of the tissue specimen “TS” in the specimen bag 200 , as well as any fluids from the tissue specimen “TS”, may be reduced to a point that specimen bag 200 , with any remaining tissue and/or fluids therein, may pass through incision “I” without need for any further vacuum.
- a pin (not shown) or some similar means may be used to lift the ball 320 so that it no longer blocks the distal opening 326 of the narrower proximal portion 316 of the vacuum tube 300 , to let air into the vacuum tube 300 , and assist in releasing the tissue specimen “TS” from the vacuum tube 300 .
- the vacuum tube 300 may have a plug 600 .
- the vacuum tube 300 may have a threaded opening 610 and the plug 600 may be threaded and rotatably received within the threaded opening 610 . Rotation of the plug 600 allows for its attachment and/or removal from the vacuum tube 300 . Removal of the plug 600 from the threaded opening 610 lets air into the vacuum tube 300 , and assists in releasing the tissue specimen “TS” from the vacuum tube 300 .
- the surgeon then collapses and deforms the distal ring 140 of the wound retractor 100 using a forceps, grasper, or similar instrument and the distal ring 140 and specimen bag 200 are withdrawn through the incision “I”.
- the distal ring 140 has a tether thereon (not shown), which may be pulled proximally by the surgeon to remove the distal ring 140 and the specimen bag 200 from the body cavity “BC”.
- any tissue remaining therein can be removed from the specimen bag 200 for further examination or the specimen bag 200 can be discarded.
- kits and specimen bags of the present disclosure provide safe tissue extraction at the end of minimally invasive surgical procedures. Diseased tissue may be removed from the body without seeding of spilled tissue cells inside the abdomen.
- the design of the wound retractor/specimen bags of the present disclosure, with the vacuum tube described above, allows for the surgeon to remove tissue from the body without the need for morcellators or other mechanical devices that otherwise could tear the specimen bag and possibly release tissue contents back into the body of the patient. It is further envisioned that the methods of using the specimen bags of the present disclosure may be modified to accommodate needs of a given procedure and/or the preferences of the surgeon. It is further envisioned that the embodiments disclosed herein may be used to remove any tissue or object from the body.
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Abstract
Description
- This application is a continuation of U.S. patent application Ser. No. 16/158,389, filed Oct. 12, 2018, which claims the benefit of and priority to U.S. Provisional Patent Application No. 62/621,189 filed Jan. 24, 2018, the entire disclosures of each of which are incorporated by reference herein.
- The present disclosure relates generally to surgical apparatuses for use in minimally invasive surgical procedures, such as endoscopic and/or laparoscopic procedures, and more particularly, the present disclosure relates to a surgical apparatus including a specimen retrieval bag assembly and a vacuum tube for accessing the bag assembly and collecting body tissue(s) and/or body fluid(s) during these procedures.
- Minimally invasive surgery, such as endoscopic surgery, reduces the invasiveness of surgical procedures. Endoscopic surgery involves surgery through body walls, for example, viewing and/or operating on the ovaries, uterus, gall bladder, bowels, kidneys, appendix, etc. There are many common endoscopic surgical procedures, including arthroscopy, laparoscopy, gastroentroscopy and laryngobronchoscopy, just to name a few. In these procedures, trocars are utilized for creating incisions through which the endoscopic surgery is performed. Trocar tubes or cannula devices are extended into and left in place in the abdominal wall to provide access for endoscopic surgical tools. A camera or endoscope is inserted through a trocar tube to permit the visual inspection and magnification of the body cavity. The surgeon can then perform diagnostic and/or therapeutic procedures at the surgical site with the aid of specialized instrumentation, such as forceps, graspers, cutters, applicators, and the like, which are designed to fit through additional cannulas. To protect the opening from accidental penetration by the surgical instruments, wound retractors are often placed across the opening.
- When removing certain tissues from the body cavity, for example tumor tissue, it is important that the tumor tissue does not come into contact with healthy or uninvolved tissue, so as in this way to avoid metastasis and avoid harming the patient. Minimally invasive surgical procedures, however, may be limited where large size tumors or large masses of tissue have to be removed from a body cavity. If tumor tissue or tissue parts have to be removed, they may be introduced into an “extraction bag,” also referred to herein as a “specimen bag,” at the site where the tumor or diseased tissue has been detached from the surrounding tissue, after which the specimen bag is withdrawn from the body, normally through a trocar or similar device, thereby minimizing contact of the diseased tissue with healthy tissue.
- Improved wound retractors and specimen bags, including those capable of use with a vacuum source, for use in minimally invasive surgical procedures remain desirable.
- The present disclosure is directed to surgical apparatuses and kits for use in minimally invasive surgery. The surgical apparatus includes a wound retractor having a specimen bag attached thereto, for placement of diseased tissue therein. In embodiments, the kit of the present disclosure includes the surgical apparatus and a vacuum tube for assisting in removing tissue specimens from the body.
- In some embodiments, a kit of the present disclosure includes a wound retractor and specimen bag assembly including a wound retractor and a specimen bag. The wound retractor includes a proximal ring, a distal ring, and a film disposed between the proximal ring and the distal ring, with the specimen bag attached to the distal ring of the wound retractor. The kit also includes a vacuum tube.
- In embodiments, the proximal ring of the wound retractor defines a generally circular opening and is deformable.
- In some embodiments, the distal ring of the wound retractor defines a generally circular opening and is deformable.
- In embodiments, a length of the film of the wound retractor between the proximal ring and the distal ring is adjustable.
- In other embodiments, the specimen bag is attached to the distal ring of the wound retractor by a method such as adhesive bonding, welding, heat-sealing, and combinations thereof.
- In some embodiments, the wound retractor includes a tether.
- In embodiments, the vacuum tube includes a distal portion defining a generally circular opening, a narrower proximal portion defining a narrower, generally circular opening, and an elongate shaft defining a lumen between the distal portion and the narrower proximal portion.
- In some embodiments, the vacuum tube includes a valve.
- In other embodiments, the kit of the present disclosure further includes a vacuum source adapted to communicate with the vacuum tube. In some embodiments, the vacuum source includes a syringe.
- In yet other embodiments, a kit of the present disclosure includes a wound retractor and specimen bag assembly including a wound retractor and a specimen bag, the wound retractor including a proximal ring, a distal ring, and a film disposed between the proximal ring and the distal ring, the specimen bag being attached to the distal ring of the wound retractor. In embodiments, the kit also includes a vacuum tube, and a vacuum source including a syringe adapted to communicate with the vacuum tube.
- In some embodiments, the proximal ring of the wound retractor defines a generally circular opening and is deformable. The distal ring of the wound retractor may also define a generally circular opening and is deformable.
- In embodiments, a length of the film of the wound retractor between the proximal ring and the distal ring is adjustable.
- In some embodiments, the specimen bag is attached to the distal ring of the wound retractor by a method such as adhesive bonding, welding, heat-sealing, and combinations thereof.
- In other embodiments, the wound retractor includes a tether.
- In embodiments, the vacuum tube includes a distal portion defining a generally circular opening, a narrower proximal portion defining a narrower, generally circular opening, and an elongate shaft defining a lumen between the distal portion and the narrower proximal portion.
- In other embodiments, the vacuum tube includes a valve.
- Methods of the present disclosure are also provided. In embodiments, a method of the present disclosure includes inserting a wound retractor and specimen bag assembly including a wound retractor having a proximal ring, a distal ring and a film disposed between the proximal ring and the distal ring, and a specimen bag attached to the distal ring, into a body cavity through a body opening; passing a tissue specimen through an opening defined by the proximal ring, the film and the distal ring of the wound retractor into the specimen bag; removing the proximal ring from the body cavity through the body opening so that the film is adjacent tissue encompassing the body opening; pulling the proximal ring away from the distal ring such that the distal ring is brought into abutment with an inner surface of the tissue surrounding the body opening; rolling the proximal ring about itself such that the film is furled about the proximal ring to bring the proximal ring into abutment with an outer surface of the tissue; introducing a vacuum tube through the proximal ring into the specimen bag; attaching a vacuum source to the vacuum tube; drawing a vacuum through the vacuum tube to draw a portion of the tissue specimen within the specimen bag into the distal portion of the vacuum tube; and removing the vacuum tube possessing the portion of the tissue specimen from the wound retractor.
- In embodiments, the method of the present disclosure further includes rolling the proximal ring to retract the incision and bring the proximal ring into abutment with an outer surface of the tissue.
- Various embodiments of the presently disclosed wound retractor and specimen bag assembly are described herein with reference to the drawings wherein:
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FIG. 1 is a perspective view of components of a kit including an exemplary embodiment of the presently disclosed wound retractor and specimen bag assembly, with a vacuum tube and a vacuum source; -
FIG. 2 is a cross-sectional view of a patient's body, showing a wound, incision, and tissue specimen to be removed from the body cavity; -
FIG. 3 is a perspective view of the specimen bag and wound retractor assembly shown inFIG. 1 ; -
FIG. 4A is a cross-sectional view of the wound retractor and specimen bag assembly shown inFIG. 3 in a body cavity, adjacent tissue to be removed from the body cavity; -
FIG. 4B is a perspective, partial cross-sectional view during removal of the wound retractor and specimen bag assembly shown inFIG. 4A from a body cavity through the incision; -
FIG. 5 is a perspective view of the wound retractor and specimen bag assembly shown inFIG. 4B with the wound retractor inserted into the incision in tissue and the specimen bag positioned within the body cavity; -
FIG. 6 is a partial cross-sectional view of the wound retractor and specimen bag assembly shown inFIG. 5 , with a vacuum tube inserted through the wound retractor into the specimen bag and a vacuum source affixed to the vacuum tube; -
FIG. 7 is an enlarged view of the indicated area of detail shown inFIG. 6 ; -
FIG. 8 is a partial cross-sectional view of the wound retractor and specimen bag assembly shown inFIG. 6 , showing the vacuum source drawing a vacuum through the vacuum tube and pulling tissue from the specimen bag into the vacuum tube; -
FIG. 9 is an enlarged view of the indicated area of detail shown inFIG. 8 ; -
FIG. 10 is an alternate partial cross-sectional view of the wound retractor and specimen bag assembly shown inFIG. 6 , showing the vacuum source drawing a vacuum through the vacuum tube and pulling tissue from the specimen bag into the vacuum tube; and -
FIG. 11 is an enlarged view of the indicated area of detail shown inFIG. 10 . - The present disclosure provides a wound retractor and specimen bag assembly and vacuum tube for use in minimally invasive surgical procedures. As used herein with reference to the present disclosure, minimally invasive surgical procedures encompass laparoscopic procedures and endoscopic procedures, and refer to procedures utilizing scopes or similar devices having relatively narrow operating portions capable of insertion through or a small incision in the skin.
- The aspects of the present disclosure may be modified for use with various methods for retrieving tissue specimens during minimally invasive surgical procedures, sometimes referred to herein as minimally invasive procedures. Examples of minimally invasive procedures include, for example, cholecystectomies, appendectomies, nephrectomies, colectomies, splenectomies, and the like.
- As used herein, the term distal refers to that portion of a wound retractor and specimen bag assembly which is farthest from the user, while the term proximal refers to that portion of the wound retractor and specimen bag assembly of the present disclosure which is closest to the user.
- The wound retractor and specimen bag assembly of the present disclosure includes a wound retractor with a specimen bag affixed thereto. The wound retractor component includes a sleeve member possessing at least two rings, including a proximal ring and a distal ring, with a film extending between the two rings. The specimen bag component is attached to the distal ring of the wound retractor. In use, the specimen bag assembly is passed through an incision and placed within a body cavity, and tissue to be removed therefrom, referred to in embodiments as a “tissue specimen”, is passed through the wound retractor component and placed within the specimen bag. The proximal ring of the wound retractor component is then removed from the body cavity and placed adjacent the skin on an outside surface of the body adjacent the incision, with the distal ring of the sleeve member and the specimen bag remaining within the body, so that the film extends through the incision and is adjacent the tissue encompassing the incision. The presently disclosed wound retractor and specimen bag assembly is suitable for use in any procedure where access to the interior of the body is limited to one or more relatively small incisions, as in minimally invasive procedures.
- Kits of the present disclosure include both the wound retractor and specimen bag assembly described above, as well as a vacuum tube assembly. The vacuum tube assembly permits removal of tissue specimens from the specimen bag without the need for breaking up the tissue, sometimes referred to herein as morcellation of tissue, with a scalpel or some other morcellation device.
- Embodiments of the present disclosure will now be described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
-
FIG. 1 illustrates a kit of the present disclosure including a wound retractor andspecimen bag assembly 10 in accordance with the present disclosure. The wound retractor andspecimen bag assembly 10 encompasses both awound retractor 100 and aspecimen bag 200. The kit of the present disclosure also includes avacuum tube 300 and a vacuum source, in embodiments asyringe 400, for drawing a vacuum through thevacuum tube 300. - Referring also to
FIGS. 2-4B , the wound retractor andspecimen bag assembly 10, including thewound retractor 100 and thespecimen bag 200, is adapted for insertion into wound “W” through an incision “I” and placement within a body cavity “BC” (FIG. 4A ) as described in further detail below. The incision “I” may be a single incision, e.g., through the abdominal or peritoneal lining, or a naturally occurring orifice (i.e. mouth, anus, or vagina). - The
wound retractor 100 includes aproximal ring 120, adistal ring 140, and a generallycylindrical film 130 disposed therebetween. The wound retractor andspecimen bag assembly 10 further defines a longitudinal axis “L” shared by theproximal ring 120, thedistal ring 140, and thefilm 130, as well as thespecimen bag 200. It is envisioned that theproximal ring 120 and thedistal ring 140 may each be detachably coupled or permanently attached to aproximal end portion 132 and adistal end portion 134, respectively, of thefilm 130 by any means within the purview of those skilled in the art, e.g., glue, suture, impulse welding, chemical or mechanical bonding, an over molding process, etc. In some embodiments, theproximal ring 120,film 130, anddistal ring 140 are monolithically integrated such that thewound retractor 100 is a unitary structure. Attachment of thefilm 130 to therings rings rings film 130 to allow thefilm 130 to be rolled about theproximal ring 120 as described below. - The
proximal ring 120 and thedistal ring 140 are axially aligned along longitudinal axis “L” with thefilm 130 disposed therebetween, as noted above. Theproximal ring 120 has a generally circular configuration that defines a circular opening 122 (seeFIG. 1 ) and is rollable about theproximal ring 122 to tension thefilm 130 and retract the incision “I”. More specifically, theproximal ring 120 can be rolled towards or away from thedistal ring 140 along the longitudinal axis “L” to furl or unfurl thefilm 130 about theproximal ring 120. Thedistal ring 140 also has a generally circular configuration that defines a generally circular opening (not shown). - It is envisioned that the
proximal ring 120 and thedistal ring 140 may be fabricated from resilient materials such that theproximal ring 120 and thedistal ring 140 may temporarily deform into a generally oblong configuration during insertion of thewound retractor 100 through an incision “I” while reverting to a generally circular configuration during use. For example, thermoplastic polyurethanes sold under the name PELLETHANE®, offers flexibility and a wide range of hardnesses. Theproximal ring 120, for example, may be fabricated from PELLETHANE® 2363-80A, PELLETHANE® 2363-90A, a 50/50 composition of PELLETHANE® 2363-80A and PELLETHANE® 2363-90A, or any alternatives known in the art. Thedistal ring 140 may be fabricated from, for example, PELLETHANE® 2363-90A for the extra small and small size, PELLETHANE® 2363-55D for the medium and large size, a 50/50 composition of PELLETHANE® 2363-90A and PELLETHANE® 2363-55D for the large size, or any alternatives within the purview of those skilled in the art. Theproximal ring 120 and thedistal ring 140 may be fabricated from the same or different materials. - The
film 130 defines a generally cylindrical shape to form a lumen between theproximal ring 120 and thedistal ring 140. The circular configuration of the proximal anddistal rings film 130 in an expanded state to maintain the lumen in a non-collapsed state. Thefilm 130 is coupled to theproximal ring 120 at theproximal end portion 132 and is coupled to thedistal ring 140 at thedistal end portion 134, such that thefilm 130 does not slide or move relative to a surface of either theproximal ring 120 or thedistal ring 140. Thefilm 130 may be fabricated from a clear, non-elastomeric material, e.g., a polyurethane. Alternately, it is envisioned that thefilm 130 may be formed from a variety of materials including opaque and clear materials. - The length “X” (
FIG. 3 ) between theproximal ring 120 and thedistal ring 140 is adjustable. More specifically, the length “X” can be decreased by rolling theproximal ring 120 towards thedistal ring 140 to furl thefilm 130 about theproximal ring 120. Similarly, the length “X” can be increased by rolling theproximal ring 120 away from thedistal ring 140 to unfurl thefilm 130 from about theproximal ring 120. As discussed above, as theproximal ring 120 is rolled towards or away from thedistal ring 140, thefilm 130 furls or unfurls about theproximal ring 120. It should be appreciated that as thefilm 130 is furled about theproximal ring 120, it reduces the length “X” of thefilm 130, so the tension in the film between theproximal ring 120 anddistal ring 140 is increased to provide a radially outward force within the incision “I”. - It is envisioned that the
wound retractor 100 may come in a variety of sizes to appropriately fit and accommodate a range of incision diameters. For example, for an extra small wound retractor, the outer diameter of theproximal ring 120 and thedistal ring 140 may be about 2.5 inches; for a small wound retractor, the outer diameter of theproximal ring 120 and thedistal ring 140 may be about 3.9 inches; for a medium sized wound retractor, the outer diameter of theproximal ring 120 and thedistal ring 140 may be about 5.1 inches; for a large wound retractor, the outer diameter of theproximal ring 120 and thedistal ring 140 may be about 7.5 inches; and for an extra-large wound retractor, the outer diameter of theproximal ring 120 and thedistal ring 140 may be about 9.4 inches. - Specimen bags of the present disclosure are made of flexible and durable materials within the purview of those skilled in the art, in embodiments, polymeric materials. The specimen bags are inflatable and capable of allowing a surgeon to introduce cutting devices into the specimen bag to reduce the size of the tissue specimen therein, thereby facilitating removal of the specimen bag from the body. Materials used to form the specimen bags are antistatic, pyrogen-free, non-toxic and sterilizable. In embodiments, materials used to form the film portion of the wound retractor described above may be used to form the specimen bag. In other embodiments, the specimen bag is formed of materials that are different from those used to form the film of the wound retractor. The specimen bag may be opaque or clear.
- The
specimen bag 200 may be joined to thedistal ring 140 of the wound retractor at thedistal portion 134 of thefilm 130 by methods within the purview of those skilled in the art, including, but not limited to, adhesive bonding, welding, heat-sealing, combinations thereof, and the like. Alternatively, thespecimen bag 200 can be integrally formed with thefilm 130, in embodiments of the same material. - As discussed above, both the
proximal ring 120 and thedistal ring 140 may be collapsed from the generally circular configuration to a generally oblong configuration (not shown) for insertion, along with thespecimen bag 200, through incision “I”. More specifically, as the practitioner squeezes opposing sides of theproximal ring 120 and thedistal ring 140 radially inwards, the generally circular openings of theproximal ring 120 and thedistal ring 140 are deformed from the generally circular configuration to a generally oblong configuration (not shown) such that theproximal ring 120 and thedistal ring 140 assume a smaller profile for ease of insertion through incision “I”. Once inserted, the practitioner releases theproximal ring 120 anddistal ring 140 and the resiliency of the material urges theproximal ring 120 and thedistal ring 140 towards their generally circular configurations. - In embodiments, where there is concern that the tissue specimen “TS” within the
specimen bag 200 is diseased, for example cancerous, and it is desired to minimize contact of the tissue specimen “TS” with healthy tissue, but morcellation or other means for breaking up the tissue within thespecimen bag 200 are not feasible or desired (for fear of damaging thespecimen bag 200 and/or the wound retractor 100), avacuum tube 300 may be inserted through the lumen of thewound retractor 100 into thespecimen bag 200 to remove tissue specimen “TS” from the body cavity “BC”. - The kit (
FIG. 1 ) of the present disclosure includes avacuum tube 300. Thevacuum tube 300 has anelongate body 310 defining a lumen 314 (FIG. 6 ). Theelongate body 310 has adistal portion 312 defining a generally circular opening and, compared with thedistal portion 312, a narrowerproximal portion 316. The narrowerproximal portion 316, compared with thedistal portion 312, defines a narrower lumen with a narrower, generallycircular opening 318. - The
vacuum tube 300 may be formed of hard, rigid materials. Suitable materials for forming the vacuum tube include, for example, polyolefins such as polyethylene (including ultra high molecular weight polyethylene) and polypropylene including atactic, isotactic, syndiotactic, and blends thereof; polyethylene glycols (PEGs); polyethylene oxides; copolymers of polyethylene and polypropylene; polyisobutylene and ethylene-alpha olefin copolymers; fluorinated polyolefins such as fluoroethylenes, fluoropropylenes, fluoroPEGs, and polytetrafluoroethylene; polyamides; polyamines; polyimines; polyesters such as polyethylene terephthalate, polyethylene naphthalate, polytrimethylene terephthalate, and polybutylene terephthalate; polyethers; polybutester; polytetramethylene ether glycol; 1,4-butanediol; polyurethanes; acrylic polymers; methacrylics; vinyl halide polymers and copolymers such as polyvinyl chloride; polyvinyl alcohols; polyvinyl ethers such as polyvinyl methyl ether; polyvinylidene halides such as polyvinylidene fluoride and polyvinylidene chloride; polychlorofluoroethylene; polyacrylonitrile; polyaryletherketones; polyvinyl ketones; polyvinyl aromatics such as polystyrene; polyvinyl esters such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins such as ethylene-methyl methacrylate copolymers; acrylonitrile-styrene copolymers; acrylonitrile butadiene styrene resins; ethylene-vinyl acetate copolymers; alkyd resins; polycarbonates; polyoxymethylenes; polyphosphazines; polyimides; epoxy resins; aramids; silicones; and copolymers and combinations thereof. - The kit of the present disclosure also includes a vacuum source, in embodiments a
syringe 400, for drawing a vacuum through thevacuum tube 300, thereby removing the tissue specimen “TS” from thespecimen bag 200 by drawing the tissue specimen “TS” into thedistal portion 312 of thevacuum tube 300. Other possible sources for drawing a vacuum include, for example, a mechanically or manually operated pump (not shown), a simple electric vacuum pump (not shown), or other similar means. The narrowerproximal portion 316 of thevacuum tube 300 is couplable to the vacuum source, in embodiments thesyringe 400. Means for coupling the narrowerproximal portion 316 of thevacuum tube 300 to the vacuum source, in embodiments thesyringe 400, are within the purview of those skilled in the art and include, for example, friction fitting, the use of seals within the lumen ofcircular opening 318 of the narrowerproximal portion 316 of thevacuum tube 300, a luer-type coupling, combinations thereof, and the like. - With reference to
FIGS. 2 and 4-11 , a method of operating thesurgical apparatus 10 in accordance with the present disclosure will be described. As depicted inFIGS. 2 and 4A-5 , in order to access a tissue specimen “TS” positioned within a body cavity “BC” (FIG. 2 ), the surgeon first collapses and deforms theproximal ring 120 and thedistal ring 140 of thewound retractor 100 into an oblong configuration for insertion into wound “W” through incision “I” (FIG. 4A ). Once thewound retractor 100 and thespecimen bag 200 are placed through incision “I” and theproximal ring 120 and thedistal ring 140 are released, theproximal ring 120 anddistal ring 140 resume their generally circular configuration so that thesurgical apparatus 10 is adjacent the tissue specimen “TS” to be removed from the body cavity (FIG. 4A ). The surgeon can then introduce tissue specimen “TS” through theproximal ring 120, thefilm 130, and thedistal ring 140 into thespecimen bag 200 by use of a forceps, grasper, or any other suitable medical device. - Once tissue specimen “TS” has been introduced into the
specimen bag 200, the surgeon then collapses and deforms theproximal ring 120 using a forceps, grasper, or similar instrument and withdraws theproximal ring 120 through the incision “I”. In other embodiments, theproximal ring 120 has atether 124 thereon (shown in phantom inFIG. 4B ), which may be pulled proximally by the surgeon to withdraw theproximal ring 120 from the body cavity “BC”. As depicted inFIG. 4B , the surgeon may pull the proximal ring 120 (indicated by arrows “A” inFIG. 4B ) to remove theproximal ring 120 from the incision “I” after the specimen “TS” is positioned within thespecimen bag 200. - As shown in
FIG. 5 , theproximal ring 120 is removed from the body cavity through incision “I” so that it rests on the outer skin 4 adjacent incision “I” and the surgeon adjusts thefilm 130 and theproximal ring 120, e.g., pulling theproximal ring 120 proximally to tension thefilm 130, such that thedistal ring 140 comes into abutment with aninner surface 8 of wound “W”. Thedistal ring 140 is positioned adjacent theinner surface 8 of wound “W”, and reverts to its generally circular configuration so that the generally circular opening ofdistal ring 140 encompasses theinner surface 8 of the wound “W” (FIG. 5 ). - With the
distal ring 140 in abutment with theinner surface 8 of wound “W”, theproximal ring 120 is rolled distally towards thedistal ring 140 and the outer surface 4 of wound “W” to a desired position, such that thefilm 130 is furled about the proximal ring 120 (not shown) and thereby tensioned. - Referring to
FIG. 5 , once thewound retractor 100 and thespecimen bag 200 are in position, surgical tools and instruments may pass through alumen 114 of thewound retractor 100 with thedistal ring 140 in abutment to theinner surface 8 of wound “W”, and theproximal ring 120 rolled to a desired position and/or brought into abutment to the outer surface 4 of wound “W”. Thewound retractor 100 may be tensioned further to provide retraction of incision “I”, increasing the incision diameter. - Referring briefly to
FIG. 6 , where the tissue specimen “TS” in the specimen bag is too large to be removed through the incision, avacuum tube 300 is introduced through thelumen 114 of wound retractor 100 (FIG. 6 ). As depicted inFIGS. 6-11 , asyringe 400, or any other device capable of drawing a vacuum, may then be attached to the narrowerproximal portion 316 of thevacuum tube 300 to draw a vacuum within thelumen 314 of thevacuum tube 300, thereby drawing the tissue specimen “TS” contained within thespecimen bag 200 into thedistal end portion 312 of thevacuum tube 300. - Where the
syringe 400 is used as the vacuum source, theplunger 410 of thesyringe 400 may first be pushed distally (indicated by arrows “P” inFIGS. 10 and 11 ) to evacuate air from thesyringe 400. As depicted inFIGS. 10 and 11 , theplunger 410 may possess a small one-way valve to permit the evacuation of air from thesyringe 400. The one-way valve can be any type of trap allowing the one way flow of air, out of thesyringe 400. As shown inFIGS. 10 and 11 , an example of a suitable one-way valve includes aball valve 500. The air present in thesyringe 400 evacuates itself thru theball valve 500 when theplunger 410 is pushed distally (indicated by arrows “P” inFIGS. 10 and 11 ). No air goes back down into thesyringe 400. - As shown in
FIG. 11 , theball valve 500 possessesspokes ball 500 from blocking aproximal opening 530 of theball valve 500, while at the same time permitting air to pass from thesyringe 400, through adistal opening 516 of theball valve 500, through theproximal opening 530 of theball valve 500, and out of thesyringe 400. - As depicted in
FIGS. 6-9 , thevacuum tube 300 includes a valve within the narrowerproximal portion 316 of thevacuum tube 300. In embodiments, as depicted inFIGS. 6-9 , the valve may include aball valve 318, including aball 320, andprojections lumen 328 of theball valve 318. Theprojections ball 320 from blocking aproximal opening 330 of theball valve 318, while at the same time permitting air (indicated by arrows “Z” inFIG. 9 ) to pass from thespecimen bag 200, through adistal opening 326 of theball valve 318, through thelumen 328 of theball valve 318, through theproximal opening 330 of theball valve 318, and out of the narrowerproximal portion 316 of thevacuum tube 300. Other valves, such as one-way valves, check valves, or any other valve arrangement, may be included within the narrowerproximal portion 316 of thevacuum tube 300 to assist in drawing and maintaining a vacuum within thelumen 314 of thevacuum tube 300. - In use, the
plunger 410 of thesyringe 400 is pushed distally (indicated by arrows “P” inFIGS. 10 and 11 ) so that the air within thesyringe 400 evacuates itself thru theball valve 500. Theplunger 410 of thesyringe 400 is then pulled proximally (indicated by arrows “Y” inFIG. 8 ) to create a vacuum capable of drawing tissue specimen “TS” from thespecimen bag 200 into thedistal end portion 312 of thevacuum tube 300. Where necessary, the above cycle (pushing theplunger 410 of thesyringe 400 distally and then pulling theplunger 410 of thesyringe 400 proximally) may be repeated to ensure an adequate vacuum state is created, capable of drawing tissue specimen “TS” from thespecimen bag 200 into thedistal end portion 312 of thevacuum tube 300. The process may be repeated multiple times in order to achieve the vacuum necessary to draw the tissue specimen “TS” into thevacuum tube 300. - For example, the
plunger 410 of thesyringe 400 is pushed down at least a second time to repeat the cycle (indicated by arrows “P” inFIGS. 10 and 11 ), in preparation for another proximal pull (indicated by arrows “Y” inFIG. 8 ) to evacuate more air (indicated by arrows “Z” inFIG. 9 ) from thevacuum tube 300. Theball valve 500 of theplunger 410 of thesyringe 400 allows for repetition of the cycle to create an adequate vacuum without the need to disconnect thesyringe 400 after each proximal pull. - Once the tissue specimen “TS” is pulled into the
distal end portion 312 of thevacuum tube 300, thevacuum tube 300 may be removed from thewound retractor 100. In embodiments, if the tissue specimen “TS” to be removed separates and portions thereof remain in thespecimen bag 200 as tissue specimen “TS” is pulled into thedistal end portion 312 of thevacuum tube 300, the surgeon may grab those additional pieces of tissue with a forceps or other grasper, and/or use a vacuum source for removal of any remaining portion of the tissue specimen “TS” from thespecimen bag 200. In other embodiments, the volume of the tissue specimen “TS” in thespecimen bag 200, as well as any fluids from the tissue specimen “TS”, may be reduced to a point thatspecimen bag 200, with any remaining tissue and/or fluids therein, may pass through incision “I” without need for any further vacuum. - In embodiments, once the
vacuum tube 300 is removed from thewound retractor 100, a pin (not shown) or some similar means may be used to lift theball 320 so that it no longer blocks thedistal opening 326 of the narrowerproximal portion 316 of thevacuum tube 300, to let air into thevacuum tube 300, and assist in releasing the tissue specimen “TS” from thevacuum tube 300. Alternatively, as depicted inFIGS. 10 and 11 , in embodiments, thevacuum tube 300 may have aplug 600. As depicted inFIG. 11 , in embodiments thevacuum tube 300 may have a threadedopening 610 and theplug 600 may be threaded and rotatably received within the threadedopening 610. Rotation of theplug 600 allows for its attachment and/or removal from thevacuum tube 300. Removal of theplug 600 from the threadedopening 610 lets air into thevacuum tube 300, and assists in releasing the tissue specimen “TS” from thevacuum tube 300. - Once the
vacuum tube 300 has been removed from thewound retractor 100, the surgeon then collapses and deforms thedistal ring 140 of thewound retractor 100 using a forceps, grasper, or similar instrument and thedistal ring 140 andspecimen bag 200 are withdrawn through the incision “I”. In other embodiments, thedistal ring 140 has a tether thereon (not shown), which may be pulled proximally by the surgeon to remove thedistal ring 140 and thespecimen bag 200 from the body cavity “BC”. - After the
specimen bag 200 is removed from the body cavity “BC”, any tissue remaining therein can be removed from thespecimen bag 200 for further examination or thespecimen bag 200 can be discarded. - The kits and specimen bags of the present disclosure provide safe tissue extraction at the end of minimally invasive surgical procedures. Diseased tissue may be removed from the body without seeding of spilled tissue cells inside the abdomen. The design of the wound retractor/specimen bags of the present disclosure, with the vacuum tube described above, allows for the surgeon to remove tissue from the body without the need for morcellators or other mechanical devices that otherwise could tear the specimen bag and possibly release tissue contents back into the body of the patient. It is further envisioned that the methods of using the specimen bags of the present disclosure may be modified to accommodate needs of a given procedure and/or the preferences of the surgeon. It is further envisioned that the embodiments disclosed herein may be used to remove any tissue or object from the body.
- It will be understood that various modifications may be made to the embodiments disclosed herein. For example, other methods for introducing specimen bags of the present disclosure into the body of a patient may be used. Additionally, other specimen bag shapes may be used. Further, the terminology of similar components with the various embodiments should not be construed as specific to any particular embodiment. Thus, the above description should not be construed as limiting, but merely as exemplifications of preferred embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
Claims (21)
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2020
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Also Published As
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EP3517051A1 (en) | 2019-07-31 |
CN110063759A (en) | 2019-07-30 |
US20190223855A1 (en) | 2019-07-25 |
US10874386B2 (en) | 2020-12-29 |
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