HK1223010A1

HK1223010A1 - An inflatable pneumoperitoneum device

Info

Publication number: HK1223010A1
Application number: HK16111398.7A
Authority: HK
Inventors: ．博納迪奧; F．博纳迪奥; ．哈爾平; L．D．哈尔平; ．威廉斯; S.威廉斯
Original assignee: 阿特波斯有限公司
Priority date: 2013-06-26
Filing date: 2014-06-25
Publication date: 2017-07-21

Description

Inflatable pneumoperitoneum device

Technical Field

The present invention relates to a pneumoperitoneum device. The invention also relates to a method comprising the use of the device.

Disclosure of Invention

In accordance with the present invention, an artificial pneumoperitoneum device (e.g., bag) for receiving tissue, tissue spacers and/or extracts in laparoscopic procedures is provided.

In one aspect, the invention provides an apparatus for use during laparoscopic surgery, the apparatus comprising an inflatable bag having a tissue receiving opening at a proximal end thereof and a cuff at the proximal opening, the cuff having a closed configuration for delivery and retrieval of the bag and an open configuration to receive tissue, the cuff being biased into the open configuration.

In one aspect, the present invention provides an inflatable artificial pneumoperitoneum bag for receiving tissue during laparoscopic surgery, the bag having a tissue receiving opening at a proximal end thereof and a cuff at the proximal opening, the cuff having a closed configuration for delivery and retrieval of the bag and an open configuration to receive tissue, the cuff being biased into the open configuration, the bag having: a body extending from the band and the body of the bag being more flexible than the band; and a biasing element to bias the cuff into the open configuration.

In one embodiment, the bag has a body extending from the band and the body of the bag is more flexible than the band. The band may be constructed of a material different from the material of the body of the bag. The band may be constructed of a material that is more rigid than the material of the body of the bag.

In one embodiment, the body of the bag comprises a neck region extending from the cuff. The neck region may be more flexible than the cuff.

In some embodiments, the cuff extends for a distance of between 2cm and 20cm, between 2cm and 10cm, or about 5 cm.

In one embodiment, the bag includes a biasing element (e.g., a ring) extending at least partially around the opening. The biasing element (e.g., ring) is preferably flexible to facilitate access through the incision and/or the instrument access port. That is, the biasing element (e.g., a ring) can bias the cuff into the open configuration.

In one instance, the biasing element (e.g., a ring) comprises a loop (e.g., an O-ring) extending around the band. The loop may be constructed of a shape memory material such as nitinol. The loop may comprise a single loop element that is opened or closed.

In one case, the collar includes a plurality of collar members.

In some embodiments, at least one of the collar members is movable relative to another of the collar members. At least one of the collar members is movable in a circumferential direction relative to the other ring element.

In one case, the apparatus includes a holder for opening the bag.

The retainer may include at least one ring element extending at least partially around the opening. The ring member may be flexible to facilitate access through the incision and/or the instrument access port. In one instance, the ring element comprises an O-ring.

In one embodiment, the retainer includes a ring member.

There may be two separate ring members.

In one embodiment, the apparatus (e.g., bag) includes a cord for each of the loop components.

In some embodiments, the bag can include a cord extending proximally from the cuff. The cuff may include a tab for use in gripping the pouch. In one instance, the pouch includes tabs disposed on opposite sides of the band.

The or each tab may comprise an indicator to indicate a preferred orientation of the bag.

In one embodiment, the bag is configured to be foldable into a reduced size for insertion through the incision or opening.

In one aspect, the retainer has an insertion configuration and an expanded deployed configuration. The retainer may be biased into the deployed configuration.

The present invention also provides an apparatus comprising an introducer sheath or pull-wire bag (pouch) for receiving the bag in an insertion configuration. The introducer sheath or pull-wire bag may be at least partially inserted through the opening and/or incision and/or access port.

In one case, the apparatus includes an actuator for delivering the bag from the pull-string bag upon insertion. The actuator may include a tab. In one case, the actuator includes a plunger.

In one embodiment, the device includes a user cord attached to the bag.

In one case, the bag includes a neck region. The neck region may be adjacent to the holder.

In one embodiment, the bag itself includes a port. The port may be an outlet port and/or an inlet port. The bag may include a plurality of ports.

In some embodiments, the port comprises a valve. The valve may comprise a throttle or a sleeve valve (cuffvalve). In one instance, the valve comprises a resilient material such as a gel.

In some embodiments, the device includes a proximal cord and a distal cord.

The distal strand is movable relative to the proximal strand.

In one instance, the proximal cord comprises a loop through which the distal cord is movable.

A lock may be present to limit movement of the distal cord. In one case, the lock is provided by or on the proximal or distal cord. The lock may include a protrusion on the distal cord engageable by the proximal cord.

In one embodiment, the device further comprises an access port to which the bag is mounted or mountable. The access port may include a retractor having a distal anchor element for positioning within the interior of the wound, a proximal member for positioning outside of the wound opening, and a retractor member extending proximally from the distal anchor element for retracting a side of the incision laterally.

The bag can be mounted to the proximal member of the retractor.

In one embodiment, the device further comprises a cover for closing the proximal side of the retractor. The cover may include access means for the instrument or surgeon's hand/arm. The access device can be mounted to a proximal member of the retractor.

The invention also provides apparatus for use in laparoscopic surgery comprising a bag of the invention and a retractor. The device may further include an access port.

The invention also provides a viscera holder comprising the apparatus of the invention.

In another aspect, the present invention provides a method for performing laparoscopic surgery, comprising the steps of:

inserting a bag according to the invention through the opening;

inflating the bag;

delivering the tissue into the bag before or after inflating the bag; and

surgery is performed on the tissue located in the inflated bag.

In one embodiment, the opening is an opening to a body cavity.

The opening may be provided at least in part by a cut-out.

In one embodiment, the method includes providing a trocar and inserting the bag through the trocar.

The method can include positioning a retractor in the opening and inserting the bag through the retracted opening.

The tissue may be delivered into the bag prior to inflating the bag.

The method can include the step of mounting the bag to the retractor either before or after delivering the tissue into the bag.

In one embodiment, the method includes passing the instrument into the inflated bag to perform the procedure.

In one instance, the method includes inserting a trocar into the bag.

The method may include the steps of providing an access port in the bag and passing an instrument and/or tissue through the access port.

In one embodiment, the method includes sealing the access port before and/or after passing instruments and/or tissue through the access port.

The device of the present invention includes at least one instrument seal configured to be disposed in sealing relation to the body of a patient to effect a seal around at least one instrument extending through the device. The device preferably has a distal anchor member for positioning within the interior of the wound. The device preferably also has a retractor member extending proximally from the distal anchor member to retract the sides of the wound opening laterally. Preferably, the device comprises a first instrument seal to effect a seal around a first instrument extending through the device and a second instrument seal to effect a seal around a second instrument extending through the device. By providing both sealing arrangements, this ensures that insertion or manipulation or removal of the second instrument does not negatively affect the seal around the first instrument. The device may include a third instrument seal to effect a seal around a third instrument extending through the device. The first instrument seal may be spaced apart from the second instrument seal. The first instrument seal may be formed separately from the second instrument seal. The first instrument seal may have a larger radial dimension than the second instrument seal. The instrument seal may be a valve. Alternatively, the seal is formed of a gel-like elastomeric material.

In one instance, the device includes a proximal member for positioning outside of the wound opening. The retractor member can extend at least between the distal anchor member and the proximal member. The retractor member may extend in two layers between the distal anchor member and the proximal member. The first end of the retractor member can be secured to the proximal member. The retractor member is movable relative to the distal anchor member. The second end of the retractor member is movable relative to the proximal member. The retractor member can extend distally from the proximal member to the distal anchor member, can be looped around the distal anchor member, and can extend proximally from the distal anchor member to the proximal member. The proximal member may include an inner component and an outer component. The retractor member may extend between the inner component and the outer component.

In another embodiment, the instrument seal is spaced proximally of the proximal member. The device may include at least one connector member to connect the proximal member to the at least one instrument seal. The connector member facilitates lateral movement of the instrument while maintaining the seal. The connector member may comprise a bushing. The connector member may be constructed of a laterally flexible material. The connector member may be constructed of a longitudinally rigid material. The connector member may be constructed of a rubber-like material. The connector member may be constructed of a longitudinally flexible material.

In another instance, the instrument seal is mounted to the connector member. The instrument seal may be releasably mounted to the connector member. The instrument seal may include a mounting feature to mount the instrument seal to the connector member. The mounting member may be constructed of a rigid material. The instrument seal may include a sealing member to effect a seal around an instrument extending through the device, the sealing member being overmolded over at least a portion of the mounting member.

In one embodiment, a method for performing laparoscopic surgery may include inserting a bag through a patient opening; delivering tissue into a pouch opening of the pouch; retrieving the bag opening through the patient opening; sealing the bag; inflating the bag to form an artificial pneumoperitoneum that expands the abdomen, conforms to the abdominal cavity, and provides additional working and viewing space; and performing a procedure on the tissue located in the inflated bag.

In another embodiment, a method for performing laparoscopic surgery includes inserting a bag into an abdominal cavity through a patient opening; delivering tissue into the bag in the abdominal cavity after insufflation (insufflated); sealing the bag; inflating the bag to apply a retractive force to a substance located outside the bag, thereby enlarging the abdominal cavity; performing surgery on tissue located in the inflated pouch; and allowing the abdominal cavity to deflate such that the inflated bag is located in the uninflated abdominal cavity.

In yet another embodiment, a method for performing laparoscopic surgery includes inserting a bag into an abdominal cavity through a patient opening; delivering tissue into the bag; sealing the bag; inflating the bag to retract surrounding structures and organs and to push the bag against the abdominal wall; penetrating the bag through one or more trocars at a location pushing the bag against the abdominal wall; performing surgery on tissue located in the inflated pouch; and venting the abdominal cavity to atmosphere prior to performing a procedure on the tissue located in the inflated bag.

In another embodiment, a method for performing laparoscopic surgery includes insufflating an abdominal cavity to provide a working and viewing space; removing tissue within the working and viewing space; inserting a bag into the working and viewing space; transferring the excised tissue into the bag; sealing the bag; inflating the bag to replace the working and viewing space of the insufflated abdominal cavity with the working and viewing space within the bag; and performing a procedure on the tissue located in the inflated bag.

The method for performing laparoscopic surgery may further include one or more of the following features: the opening may be an exposed incision in the abdominal wall; the opening can be one of through an opening of a retractor device coupled to an incision or through an opening of a trocar coupled to an incision; inserting the bag through the opening may include inserting the bag through the valve; the expansion of the abdomen includes the pouch contacting both the anterior abdominal wall and the abdominal viscera; the opening may be an opening through the retractor device, and sealing of the bag may include sealing the bag to a proximal end of the retractor device with a cover; the delivery of tissue into the bag may be performed in the abdominal cavity after insufflation; the operation performed in the inflated bag may be performed in the uninflated abdominal cavity; inflating the bag may include inflating the bag to retract surrounding structures and organs and to push the bag against the abdominal wall; penetrating the bag with one or more trocars at a location that can push the bag against the abdominal wall; the performing of the procedure may include sealably inserting a morcellator into the bag and morcellating the tissue; and retrieving the tissue by pulling the bag out through the opening.

In yet another embodiment, an inflatable artificial pneumoperitoneum bag comprises: a length and a width; an artificial pneumoperitoneum bag neck having a first end and a second end, the first end forming a bag opening; an artificial pneumoperitoneum bag body portion forming a closed cavity in fluid communication with the second end of the neck portion, the body portion having a length and a width greater than the length and the width of the neck portion; and a ring at the bag opening, the ring configured to bias the bag opening toward an open state.

In yet another embodiment, an inflatable artificial pneumoperitoneum bag includes a first planar sheet portion and a second planar sheet portion having joined edges to form a pneumoperitoneum bag having: a length and a width; a neck having a first end and a second end, the first end forming a bag opening; a body portion forming a closed cavity in fluid communication with the second end of the neck, the body portion having a length and a width greater than a length and a width of the neck; and a ring at the bag opening, the ring configured to bias the bag opening toward an open state.

The inflatable artificial pneumoperitoneum bag may further comprise one or more of the following features: the length of the bag is between 300mm and 600mm when the bag is uninflated, and the maximum width of the bag is between 200mm and 500mm when the bag is uninflated; the neck has a diameter of between 100mm and 220mm when in an open state; the neck has a length of between 100mm and 300mm when the bag is uninflated; the widthwise extending cross-section of the body portion comprises an oval shape when the bag is inflated; the bag comprises a planar sheet portion of sterilized polyester polyurethane having a bonded edge; the bag is symmetrical about two planes perpendicular to each other; the neck comprises an edge extending parallel to a longitudinal axis of the bag; and the ring is formed of a shape memory material and is received in the neck portion through the loop.

In another embodiment, a method includes forming an artificial pneumoperitoneum in a patient using an artificial pneumoperitoneum bag, the artificial pneumoperitoneum bag comprising: a length and a width; a neck having a first end and a second end, the first end forming a bag opening; a body portion forming a closed cavity in fluid communication with the second end of the neck, the body portion having a length and a width greater than a length and a width of the neck; and a ring at the bag opening, the ring configured to bias the bag opening toward an open state.

In another embodiment, a method includes forming an artificial pneumoperitoneum in a patient using an artificial pneumoperitoneum bag, the artificial pneumoperitoneum bag comprising a first planar sheet portion and a second planar sheet portion, the first planar sheet portion and the second planar sheet portion having joined edges to form a pneumoperitoneum bag, the pneumoperitoneum bag having: a length and a width; a neck having a first end and a second end, the first end forming a bag opening; a body portion forming a closed cavity in fluid communication with the second end of the neck, the body portion having a length and a width greater than a length and a width of the neck; and a ring at the bag opening, the ring configured to bias the bag opening toward an open condition, and the forming of the artificial pneumoperitoneum comprises positioning the joining edge in alignment with the side wall of the abdomen.

The method for performing laparoscopic surgery may further include one or more of the following features: the length of the bag is between 300mm and 600mm when the bag is uninflated, and the maximum width of the bag is between 200mm and 500mm when the bag is uninflated; the neck has a diameter of between 100mm and 220mm when in an open state; the neck has a length of between 100mm and 300mm when the bag is uninflated; the widthwise extending cross-section of the body portion comprises an oval shape when the bag is inflated; the bag is formed from a flat sheet portion of sterilized polyester polyurethane having joined edges; the bag is symmetrical about two planes perpendicular to each other; the neck comprises an edge extending parallel to a longitudinal axis of the bag; the ring is formed of a shape memory material and is received in the neck by a loop.

According to the present invention, there is provided an inflatable artificial pneumoperitoneum bag comprising:

a length and a width;

an artificial pneumoperitoneum bag neck having a first end and a second end, the first end forming a bag opening;

an artificial pneumoperitoneum bag body portion forming a closed cavity in fluid communication with the second end of the neck portion, the body portion having a length and a width greater than the length and the width of the neck portion; and

a ring at the bag opening, the ring configured to bias the bag opening toward an open state.

In one embodiment, the length of the bag is between 300mm and 600mm when the bag is uninflated, and the maximum width of the bag is between 200mm and 500mm when the bag is uninflated.

In one instance, the neck has a diameter of between 100mm and 220mm when in the open state.

The neck may have a length of between 100mm and 300mm when the bag is uninflated.

In one embodiment, the widthwise extending cross-section of the body portion comprises an oval shape when the bag is inflated.

In one instance, the bag comprises a flat sheet portion of sterilized polyester polyurethane having joined edges.

In one embodiment, the bag is symmetrical about two planes perpendicular to each other.

In one case, the neck comprises an edge extending parallel to the longitudinal axis of the bag.

In one embodiment, the ring is formed of a shape memory material and is received in the neck by a loop.

The present invention also provides an inflatable artificial pneumoperitoneum bag, comprising:

a first planar sheet portion and a second planar sheet portion having joined edges to form a pneumoperitoneum bag having

A length and a width;

a neck having a first end and a second end, the first end forming a bag opening;

a body portion forming a closed cavity in fluid communication with the second end of the neck, the body portion having a length and a width greater than a length and a width of the neck; and

In one embodiment, the neck has a length of between 100mm and 300mm when the bag is uninflated.

In one instance, the cross-section of the body portion that extends the width thereof includes an oval shape when the bag is inflated.

In one embodiment, the bag comprises a sterilized polyester polyurethane.

In one case, the bag is symmetrical about two planes perpendicular to each other.

In one embodiment, the neck comprises an edge extending in parallel with the longitudinal axis of the bag.

In one aspect, the ring is formed of a shape memory material and is received in the neck by a loop.

The invention also provides a method comprising:

an artificial pneumoperitoneum is formed in a patient using an artificial pneumoperitoneum bag comprising

The length and the width of the film are,

In one embodiment, the length of the bag is between 300mm and 600mm when the bag is uninflated, and the maximum width of the bag is between 200mm and 500mm when the bag is uninflated. In one case, the neck may have a diameter of between 100mm and 220mm when in the open state. The neck may have a length of between 100mm and 300mm when the bag is uninflated. In one instance, the cross-section of the body portion that extends the width thereof includes an oval shape when the bag is inflated. The bag may comprise a planar sheet portion of sterilized polyester polyurethane having joined edges. The bag may be symmetrical about two planes perpendicular to each other. The neck may include an edge extending parallel to a longitudinal axis of the bag. The ring may be formed of a shape memory material and received in the neck by a loop.

The invention also provides a method comprising:

The length and the width of the film are,

a ring at the bag opening, the ring configured to bias the bag opening toward an open state; and

the forming of the artificial pneumoperitoneum includes positioning the joining edge in alignment with the side wall of the abdomen.

In one embodiment, the length of the bag is between 300mm and 600mm when the bag is uninflated, and the maximum width of the bag is between 200mm and 500mm when the bag is uninflated. The bag may be symmetrical about two planes perpendicular to each other.

The present invention also provides a method for performing laparoscopic surgery, comprising:

inserting the bag through the patient opening;

delivering tissue into a pouch opening of the pouch;

retrieving the bag opening through the patient opening;

sealing the bag;

inflating the bag to form an artificial pneumoperitoneum that expands the abdomen and provides additional work and viewing space; and

surgery is performed on the tissue located in the inflated bag.

In one embodiment, the patient opening is an exposed incision in the abdominal wall. The patient opening can be one of through an opening of a retractor device coupled to an incision or through an opening of a trocar coupled to an incision. In one embodiment, inserting the bag through the patient opening includes inserting the bag through the valve. In one embodiment, the expansion of the abdomen includes the pouch contacting both the anterior abdominal wall and the abdominal viscera. In one instance, the patient opening is an opening through the retractor device, and sealing of the bag includes sealing the bag to a proximal end of the retractor device with a cover. In one embodiment, the delivery of tissue into the bag is performed in the abdominal cavity after insufflation. The operation is performed in an inflated bag in the uninflated abdominal cavity. Inflation of the bag may form an artificial pneumoperitoneum expanding the abdomen, including pushing the bag against the abdominal wall, and the method further includes penetrating the bag with one or more trocars at a location pushing the bag against the abdominal wall. In one embodiment, the performing of the procedure includes sealingly inserting a morcellator into the bag and morcellating the tissue, and the method further includes retrieving the tissue by pulling the bag out through the opening.

inserting a bag into the abdominal cavity through the patient opening;

delivering tissue into the bag in the insufflated abdominal cavity;

sealing the bag;

inflating the bag to apply a retractive force to the material located outside the bag, thereby enlarging the abdominal cavity;

performing surgery on tissue located in the inflated pouch; and

the abdominal cavity is allowed to deflate so that the inflated bag is located in the uninflated abdominal cavity.

In one embodiment, applying a retractive force to a substance located outside the pouch includes the pouch contacting both the abdominal anterior wall and the abdominal viscera. The patient opening can be one of through an opening of a retractor device coupled to an incision or through an opening of a trocar coupled to an incision. The insertion of the bag through the opening may include inserting the bag through the valve. The patient opening can be an opening through the retractor device, and sealing of the bag includes sealing the bag to a proximal end of the retractor device with a cover. The method may further comprise pulling the open end of the bag through the patient opening prior to inflating the bag. Allowing the abdominal cavity to deflate may be performed prior to performing the procedure on the tissue located in the inflated bag. Inflation of the bag may be performed in the uninflated abdominal cavity. Inflating the bag to apply the retraction force may include pushing the bag against the abdominal wall, the method further comprising penetrating the bag with one or more trocars at a location where the bag may be pushed against the abdominal wall. The performing of the procedure may include sealingly inserting a morcellator into the bag and morcellating the tissue, and the method may further include retrieving the tissue by pulling the bag out through the opening.

inserting a bag into the abdominal cavity through the patient opening;

delivering tissue into the bag;

sealing the bag;

inflating the bag to retract surrounding structures and organs and to push the bag against the abdominal wall;

penetrating the bag through one or more trocars at a location pushing the bag against the abdominal wall;

performing surgery on tissue located in the inflated pouch; and

the abdominal cavity is vented to atmosphere prior to performing a procedure on the tissue located in the inflated bag.

In one embodiment, the patient opening is one of through an opening of a retractor device coupled to an incision or through an opening of a trocar coupled to an incision. In one instance, the patient opening is an opening through the retractor device, and sealing of the bag includes sealing the bag to a proximal end of the retractor device with a cover. The method may further comprise pulling the open end of the bag through the patient opening prior to inflating the bag, and wherein retraction of surrounding structures and organs comprises the bag contacting both the anterior abdominal wall and abdominal viscera. The delivery of tissue into the bag may be performed in the cavity after insufflation. Inflating the bag may be performed in the uninflated abdominal cavity.

insufflating the abdominal cavity to provide a working and viewing space;

removing tissue within the working and viewing space;

inserting a bag into the working and viewing space;

transferring the excised tissue into the bag;

sealing the bag;

inflating the bag to replace the working and viewing space of the insufflated abdominal cavity with the working and viewing space within the bag; and

surgery is performed on the tissue located in the inflated bag.

In one embodiment, the method further comprises pulling the open end of the pouch through the patient opening prior to inflating the pouch, and wherein inflation of the pouch comprises the pouch contacting both the abdominal anterior wall and the abdominal viscera. The method may further comprise deflating the abdominal cavity after delivering the excised tissue into the bag. Inflation of the bag may be performed in the uninflated abdominal cavity.

Brief description of the drawings

The invention will be more clearly understood from the following description of embodiments of the invention, given by way of example only with reference to the accompanying drawings, in which:

figure 1 is an isometric view of a pneumoperitoneum device according to the present invention;

FIG. 2 is another isometric view of the apparatus of FIG. 1;

figures 3 to 5 are views of another pneumoperitoneum device according to the present invention;

fig. 6 to 18 are diagrams illustrating the use of the apparatus of fig. 1 to 5;

FIGS. 19 to 20 are diagrams showing another use of the apparatus of FIGS. 1 to 5;

figures 23 to 24 are diagrams showing a further use of the apparatus of figures 1 to 5;

figures 25 to 30 are diagrams illustrating the various ways in which the device according to the invention may be introduced;

fig. 31 to 35 are diagrams showing the device in use;

FIG. 36 is a diagram of another apparatus according to the present invention;

figures 37 to 45 are diagrams showing the device of figure 36 in use;

FIG. 46 is a diagram of another apparatus according to the present invention;

figures 47 to 54 are diagrams showing the device of figure 46 in use;

FIG. 55 is a diagram of yet another apparatus according to the present invention;

fig. 56 to 63 are diagrams showing the device of fig. 55 in use;

FIG. 64 is a diagram of another apparatus according to the present invention;

fig. 65 to 74 are diagrams showing the device of fig. 64 in use;

FIG. 75 is a diagram of a device according to the present invention for use as a viscera holder;

fig. 76 to 78 are diagrams showing the device of fig. 75 in use;

FIG. 79 is a pictorial view of the device of FIGS. 75-78 with an associated grommet;

figures 80 and 81 are diagrams showing the device of figures 75 to 78 in use;

fig. 82-87 are isometric views of an alternative grommet;

FIG. 88 is an isometric view of another device according to the present invention with the multiple lumen access port removed;

FIG. 89 is an isometric partial cut-away view of the device of FIG. 88 with the access port in place for use;

FIG. 90 is an isometric view of an apparatus according to the present invention;

FIG. 91 is another view of the device of FIG. 90 with the access port in place for use;

FIGS. 92(a) and 92(b) are isometric views of a single lumen access port for use with the device of the present invention;

figure 93 is an isometric view of a pneumoperitoneum device having an outlet port exiting from the device, according to another embodiment of the present invention;

FIG. 94 is an isometric view similar to FIG. 93 of another device having a plurality of outlet ports;

figure 95 is an isometric view showing such a device of figures 93 and 94 in use;

FIGS. 96-98 are views of various seals that may be used in association with the device;

figures 99 to 110 illustrate a method of using an apparatus according to the invention;

FIGS. 111 to 113 are views showing locking details of the device of FIGS. 99 to 110;

figures 114 to 117 are views of an apparatus according to the invention for use in the colon;

FIG. 118 is an isometric view of another apparatus according to the invention;

FIG. 119 is an isometric view of yet another apparatus according to the present invention;

figure 120 is an isometric view of a pneumoperitoneum device according to the present invention loaded in an introducer;

FIG. 121 is an isometric view of a bag according to the present invention;

FIG. 122 is a cross-sectional view taken along line A-A of FIG. 121;

fig. 123-126 are isometric views showing insertion of the bag through the opening;

FIGS. 127 and 128 are isometric views showing the delivery of tissue into the bag;

fig. 129 and 130 are isometric views showing the closure of the bag;

FIGS. 131-133 are isometric views showing the bag being presented to the tissue opening, the bag being subsequently inflated, and a procedure, such as morcellation, being performed on the tissue in the inflated bag;

FIGS. 134-138 are diagrams showing various alternative arrangements of trocars and instruments used in performing surgery on tissue in an inflated bag;

fig. 139-143 are a plurality of views of a biasing collar including collar segments movable relative to one another;

fig. 144-149 are multiple views of another biasing collar;

FIGS. 150-153 are a plurality of views of yet another biasing collar;

fig. 154-156 are a plurality of views of another biased collar;

FIGS. 157-160 are diagrams illustrating another bag set of the present invention;

fig. 161 to 164 show another bag set of the invention in use;

FIG. 165 is an isometric view showing the closing of the bag set;

FIGS. 166-168 are isometric views of yet another bag set according to the invention with a positioning ring in place in a band of the bag;

FIGS. 169(a) to 169(c) and 170 illustrate the mounting of the band to the bag of FIG. 168;

FIG. 171 shows a protective covering for a bag set;

fig. 172-176 illustrate an introducer used in deploying and manipulating a bag;

fig. 177-180 are views of other introducers having various pressure dissipation features;

fig. 181-184 illustrate another bag set having a generally oval shape;

figures 185 and 186 show the positioning ring of the bag;

fig. 187(a) to 187(f) are views showing loading of a bag set into an introducer;

FIG. 188 is an illustration of a bag set with reinforced sections;

fig. 189 shows an introducer with a valve;

fig. 190(a) to 190(c) illustrate the use of the pouch device in a transvaginal procedure;

FIG. 191 is a view of a portion of a bag with a threaded plug or trocar in place;

fig. 192(a) and 192(b) show closure of the pouch shroud (chimney) prior to deflation;

figures 193(a) to 193(c) illustrate the use of the device of the present invention with a variety of access devices; and

figure 194 is an isometric view of an artificial pneumoperitoneum device in accordance with the present invention;

fig. 195 is a view of an introducer sheath for use with the device of fig. 194;

fig. 196 is a view of a plunger for use with an introducer sheath;

fig. 197 and 198 illustrate the introducer sheath and plunger in use;

FIG. 199 is a view of a pocket of the device of FIG. 194;

FIG. 200 is a cross-sectional view of a detail of the bag set of FIG. 199;

FIGS. 201a and 201b are views of the open end of the bag set;

fig. 202 shows a collar (collar) of a string threaded through the bag set;

FIG. 203 is a cross-sectional view of a detail of FIG. 202;

fig. 204 shows a junction between ends of a cord;

FIG. 205 shows the attachment of a cord to the joint of FIG. 204;

fig. 206 to 209 illustrate folding of the device for loading into an introducer;

FIG. 210 shows the introducer and plunger after delivery of the device;

figures 211 to 218 show the artificial pneumoperitoneum device in different stages of use;

fig. 219 and 200 show the seal between the introducer and plunger;

figures 221 and 222(a) to 222(c) show the mounting of a solid ring to a collar of the apparatus of the invention;

FIG. 223 illustrates another method of attaching a ring to a device of the present invention;

figures 224 to 253 show an artificial pneumoperitoneum device of the invention in stages during use;

figures 254 to 256 show the device of the invention in transvaginal use;

figure 257 shows closure of the device in pneumoperitoneum;

FIG. 258 illustrates use of the device in surgery involving use of additional ports;

figures 259 and 260 show an artificial pneumoperitoneum device of the invention used in a different manner;

figures 261 to 266 illustrate other artificial pneumoperitoneum devices of the present invention;

figure 267 shows the use of the device with a threaded trocar;

FIGS. 268-276 illustrate various plugs for use with a trocar;

FIGS. 277 through 280 illustrate an inflatable plug and its use; and

fig. 281 to 285 illustrate a cannula needle shield.

Detailed Description

The present invention provides an artificial pneumoperitoneum device for tissue isolation and/or extraction in laparoscopic surgery.

The device is used to safely reduce and remove excised tissue from within the abdomen through a small laparoscopic incision. The bag forms an artificial pneumoperitoneum that contains the sample and eliminates the spread of tissue and cellular fluids within the abdominal cavity. The device facilitates effective and safe isolation of tissues/organs within the artificial pneumoperitoneum for improved surgical and subsequent safe tissue extraction.

A tissue bag is inserted within the abdominal cavity through an incision in the abdominal wall or vagina.

In one case, the pouch with one or more openings is placed within the abdomen. The excised tissue is placed in the opening of the deflated bag. The opening or openings of the bag are pulled apart outside the abdomen and the bag is inflated. Instruments including laparoscopic visualization are placed in an inflated bag retained within the abdominal cavity. Visualization tools may also be provided on the outside of the bag. Morcellating/crushing/reducing and removing tissue retained within the pouch. The bag with the tissue/blood/fluid remaining inside is deflated and removed. The main advantage is that the tissue to be removed is retained in the bag, which prevents harmful substances, such as cancer cells, from being released in the body cavity.

Referring to the drawings, and initially to figures 1 and 2 thereof, there is shown an apparatus for use in laparoscopic surgery comprising a bag 1, the bag 1 having an opening 2 to receive tissue and a ring element 3 extending around the opening 2. The bag is inflatable.

Referring to fig. 3-5, another bag set according to the present invention is shown similar to the bag set of fig. 1 and 2, and like parts are assigned like reference numerals. In this case, the bag 1 has a necked down region 5 to reduce the amount of material near the ring 3. This facilitates the attachment of the bag 1 to an external element.

The bag set 1 is adapted for use during laparoscopic surgery to facilitate surgery in relation to tissue in an insufflated cavity while maintaining pneumoperitoneum.

The bag set 1 can be mounted to a retractor. One such retractor includes a distal anchor ring 10, a retractor member 11, such as a bushing, and a proximal ring assembly 12.

One such retractor is described in US2005-0090717a, the entire contents of which are incorporated herein by reference. The distal anchoring ring 10 is positioned within the interior of the wound in use. In this case, the distal anchoring ring 10 is provided in the form of an O-ring. The proximal ring assembly 12 is positioned, in use, outside of the wound opening. The retractor member 11 may be employed to pull back the sides of the wound opening laterally. In this case, the retractor member is provided in the form of a sleeve.

The proximal end of retractor 11 may be closed by a cover, which in this case includes instrument access device 30, and instrument access device 30 may have a plurality of instrument ports 31 to effect a seal around instruments extending through device 30. The instrument access device 30 may be releasably mounted to the proximal ring assembly 12. At least some of the instrument ports may include a laterally soft and longitudinally stiff strut (talk) 32.

FIG. 6 illustrates the introduction of an instrument 51 through the instrument access port 31 in the view provided by the camera 52.

Fig. 7 shows an organ or tissue, such as the uterus 35, that has been separated from its retaining structure.

Fig. 8 shows the insertion of the bag device 1 into the abdominal cavity at the start of the operation or as and when required. The bag 1 is inserted in a small and flat state so as to be easily inserted through a small opening such as an incision. As shown in fig. 8, the bag set 1 is inserted through an opening to the atmosphere and thus in this embodiment the abdominal cavity is not insufflated. The bag may also be introduced through the valve without removing the access cover 30. One such arrangement is shown in fig. 10, and this enables the bag set to be inserted into the insufflated abdominal cavity.

When the bag 1 is inserted into the insufflated or non-insufflated abdominal cavity, the bag 1 is opened (fig. 9). The organ is then easily manipulated for insertion into the bag 1, as shown in fig. 11. The rigidity of the O-ring 3 keeps the bag open for insertion into the organ.

Fig. 12 shows the organ positioned in the bag 1 and the O-ring 3 grasped for manipulating the bag towards the opening. As shown in fig. 12, removal of the access cover 30 provides an uninflated abdominal cavity prior to inflation of the bag set 1. The uninflated nature of the abdominal cavity helps to inflate the bag set 1 as shown in fig. 16 and apply a retracting force to the material located outside the bag, creating additional space (fig. 76). It is understood that if there are one or more openings to the abdominal cavity that enable insufflation gas to escape the abdominal cavity, the bag set 1 may be inflated while the abdominal cavity is insufflated. One such opening may be provided through an open trocar device or trocar incision opening for performing tissue resection as described above. The O-ring 3 is pulled through the opening (fig. 13) and the bag 1 is mounted to the proximal ring assembly 12 and the cap 30 is mounted to the proximal ring assembly 12 (fig. 14). Fig. 15 shows the device in place, with the organ contained within the bag 1.

The bag 1 is then inflated through the insufflation port 40. Inflation of the bag has the added benefit of applying a retracting force to the material located outside the bag 1, creating additional space (fig. 16). Thus, the artificial pneumoperitoneum formed in the uninflated abdominal cavity and in the inflatable bag set 1 serves to distend the abdomen and provide additional working and viewing space within the bag set 1.

Fig. 17 shows the effect on the organ in the inflated bag 1. In this case, the organ is morcellated. The substance is all safely retained within the pouch and is not released into the cavity, which can cause significant difficulties.

When the organ has been morcellated, the bag is easily removed through the initial opening. All waste, blood, tissue etc. is safely removed and sealed within the bag 1.

Figure 19 shows the insertion of the bag set through a standard exposure incision. Once the sample has been inserted into the bag 1 (fig. 20), the ring 3 is pulled through the incision (fig. 21) and inserted into the trocar 60 to form a gas seal (fig. 22). It would also be possible to insert the bag set 1 directly through a trocar.

In all cases, there may be one or more access trocars used in addition to the primary port. Thus, the present invention includes procedures involving two or more incision laparoscopies.

For example, fig. 23 and 24 illustrate an arrangement in which an additional trocar 70 is inserted. In some cases, the additional trocar 70 may be extended through the bag while maintaining the seal.

A bag 1 with a certain preferred depth is shown. However, a flat material may be used to form the holder in situ, and the edges of the material are pulled through the cut and sealed on the outside, for example by the access device 30.

The present invention provides a method of inserting a big bag into the abdominal cavity to allow insertion of a sample into the bag. The bag is then sealed and inflated and the operation is performed within the bag.

Figures 25 to 30 show various ways in which the bag 79 may be introduced into the abdomen.

In fig. 25, the device may be inserted directly through the incision 80.

Referring to fig. 26, the device may be inserted through trocar 81.

In fig. 27, a device can be inserted through the base retractor 82.

Referring to fig. 28, a device may be inserted through low-profile port 83.

As shown in fig. 29, the device may be inserted through a multi-port device 84. The multi-port device may be, for example, a device of the type described in US8,187,178 or US20110071389A, the entire contents of both of which are incorporated herein by reference.

Referring to fig. 30, the device may be inserted through the base 85 of a multi-port device.

As shown in fig. 31, once the bag 79 has been inserted, the specimen is placed inside.

In fig. 32, the lip of the bag 79 is pulled through the opening.

In fig. 33, the bag 79 is sealed by reinserting the trocar 60 in place of the cover or insertion of the morcellator 78. If desired, an additional seal may be applied to the neck of the bag 79.

As shown in FIG. 34, once the bag 79 is inflated, an additional trocar may be inserted into the abdomen in the normal manner and puncture the bag 79. Fig. 34 also shows a morcellator 78 being inserted through the trocar 60.

Fig. 35 shows the morcellator 78 inserted without a trocar. If desired, a sealing ring 77 may be applied around the shaft of the shredder 78 to contain the gas.

Referring to fig. 36-45, a method of inserting big bag 100 into the abdominal cavity is shown, big bag 100 being automatically opened to allow insertion of a specimen. The bag 100 is foldable and has a top opening 105 that can be biased into an open configuration by a retaining element, which in this case comprises semi-circular ring members 101, 102 with attached cord elements 104, 103, respectively. The drawstring bag 110 is used to house the bag 100 in a folded/collapsed configuration. The drawstring bag 110 has a grip tab 111 and a drawstring 115.

Fig. 36 shows the main components of the bag set automatically opened.

Fig. 37 shows the folded bag 100 inside the drawstring bag 110. In fig. 38, the pull-cord bag 110 is inserted into the abdominal cavity with the aid of the gripping tabs 111. When the drawstring bag is inside, the distal drawstring 104 is pulled forward and the bag 100 is released. The rear puller wire 115 is pulled in the opposite direction to assist in the release.

Referring to fig. 40, it will be noted that as the distal end of the bag 100 is pulled forward, the rear of the bag 100 is pulled in the opposite direction as it is attached to the drawstring bag 110 with the string 103. This action opens the mouth of the bag 100 sufficiently to facilitate sample insertion.

Fig. 41 shows the placement of the specimen on top of the bag opening 105.

Referring to fig. 42, by pulling the distal drawstring 104 back over the specimen, the bag 100 begins to unfold and the specimen travels deeper inside the bag 100. Referring to fig. 43, the specimen travels further into the bag 100 as the front and rear retaining elements 101, 102 of the bag opening are pulled outward.

Figure 44 shows the rim of the bag being opened and the slit being cleared of excess bag material.

Referring to fig. 45, the opening is resealed by attaching a cover, by inserting a trocar, or by inserting a morcellator through the opening.

Referring to fig. 46-54, another apparatus according to the present invention is shown. The device is similar to that of figures 36 to 45 and like parts are assigned like reference numerals. In this case, a bag 120 is housed inside the cartridge 121, for delivery and automatically opens when it is withdrawn from the cartridge 121 after its insertion into the abdominal cavity. In this case, the ring member 102 is still attached to the barrel 121. A cord 125 extends between the distal end of the barrel 121 and the loop element 102. The loop element 101 has a string element 126, which string element 126 is grasped by an instrument 127 for pulling the bag 120 out of the barrel 121.

Fig. 46-54 illustrate the bag 120 housed in the cartridge 121, the cartridge 121 being insertable into a valve located on an access port/trocar 130. The cartridge 121 remains in place during the procedure.

Referring to fig. 46, the loaded cartridge 121 is placed through the valve onto the port 130. Fig. 47 shows a distal pull cord 126, the distal pull cord 126 being positioned such that it is easily grasped with an instrument 127. In fig. 48, the instrument 127 is inserted and the pull cord 126 is grasped.

Referring to fig. 49, as the instrument/gripper 127 is pushed forward, the bag 120 is released from the barrel 121. As shown in fig. 50, once the bag is far enough, the tether 125, which connects the back side of the bag 120 to the barrel 121, begins to open the bag 120.

Referring to fig. 51, when the mouth of the bag 120 is opened sufficiently, a specimen can be placed inside. When the distal drawstring 126 is pulled back as shown in fig. 52, this forces the bag 120 to unfold and the specimen to travel deeper into the bag 120.

Referring to fig. 53, the cover/trocar 130 is then removed and the rim of the bag 120 is pulled through the incision and mounted to the retractor 135. Figure 54 shows the cap, trocar, or morcellator reattached. The bag 120 is then inflated.

Referring to fig. 55-63, a removable cartridge 140 with a manually opened bag 141 for insertion through a single port 142 is shown. These views illustrate one method of inserting a big bag 141 that will be opened manually by the user when inserted into the abdominal cavity. Fig. 55-63 illustrate a bag 141 housed in a cartridge 140, the cartridge 140 being inserted into a valve 142 located on the access port/trocar 130. The bag 141 is withdrawn from the cartridge 140 using the plunger 145 and the cartridge 140 is removed. As shown for example in fig. 54, inflating the bag set 1 forms the artificial pneumoperitoneum and pushes the bag against the abdominal wall. This arrangement enables one or more skeletal trocars 70 to extend through the abdominal wall and directly and sealingly pierce the inflated bag device 1 with the bag device pushed against the abdominal wall. See, for example, fig. 24, 34, and 35. Further facilitating the sealing of the additional trocar 70 to the bag set 1 after inflation is the fact that the bag set 1 after inflation exerts a retracting force on the matter located outside the bag set and is thereby secured in place against the abdominal wall.

Referring to fig. 55, the bag 141 is loaded into the cartridge 140, and the cartridge 140 is then inserted through the valve 130 located on the port/trocar 142. When the barrel 140 is in place, a plunger 145 is inserted through the proximal end of the barrel 140 as shown in fig. 56. Pushing the plunger 145 downward as shown in fig. 57 forces the bag 141 to be expelled into the abdominal cavity.

Referring to fig. 58, when the bag 141 has been ejected, the cartridge 140 can be removed, leaving the activation cord 147 in place. The instrument 148 is inserted as shown in fig. 59 and the instrument 148 is used to grasp the distal pull cord 149, which distal pull cord 149 is attached to the front strap or loop member/element 101 located on the bag 141.

Referring to fig. 60, the specimen is then lifted into the open mouth of the bag 141. The surgeon may use the activation string 147 to control the mouth of the bag 141. When the front and rear loop elements 101, 102 of the bag 141 are grasped as shown in fig. 61, the bag 141 may be pulled toward the incision, forcing the specimen to travel deeper into the bag 141.

Fig. 62 shows valve/trocar 130 removed and the rim of the bag pulled through the incision. In fig. 63, the rim of the bag 141 is opened and the valve/trocar 130 is replaced to seal the bag 141. The bag 141 is then inflated and the operation is performed therein.

Referring to fig. 64-74, a removable cartridge 150 with a manually opened bag 151 (laparoscopically) is illustrated. These figures illustrate one method of inserting the big bag 151, the big bag 151 being manually openable by a user when inserted into the abdominal cavity.

Referring to fig. 64, the loaded cartridge 150 is inserted through the pre-cut. When the cartridge 150 is in place, the plunger 152 is inserted as shown in fig. 65. The plunger 152 is pushed all the way down and the bag 151 is ejected as shown in fig. 66 and 67.

Referring to fig. 68, an instrument 155 is inserted through the trocar/access port 156 and used to grasp a distal pull cord 157 of a frontal strap attached to the bag. Once the distal drawstring 157 is held, continued pulling on the activation cord 158 opens the mouth of the bag 151 and forces the excess material to spread apart. The specimen can now be lifted into the open mouth of the bag as shown in fig. 69. The surgeon may control the mouth of the bag 151 to some extent using the activation string 158.

Referring to fig. 70, with the back end of the bag 151 grasped, the bag 151 may be pulled toward the incision, forcing the specimen to travel deeper into the bag 151. The valve/trocar is removed and the rim of the bag is pulled through the incision as shown in fig. 71. The rim of the bag 151 is opened and the shredder is inserted to seal the bag as shown in fig. 72. The pouch is then inflated and the procedure is performed therein.

As shown in fig. 73 and 74, when the bag 151 is inflated, a trocar 159 may be pierced through to allow access to additional instruments 160.

Referring to fig. 75-87, the use of the bag 170 as described above as a viscera holder is illustrated. The bag 170 is first inserted and, if necessary, positioned (fig. 75). When the bag 170 is inflated, the surrounding structures and organs (abdominal viscera) are retracted as shown in fig. 76.

As shown in fig. 77 and 78, it may be advantageous to fill or partially fill the bag 170 with a liquid. These benefits may include: 1) the sample floats to the top of the bag and thus the risk of damage to the bag at the base can be reduced. 2) The liquid reduces the accumulation of smoke in the bag. 3) The blood will be diluted and may thus be able to have enhanced visibility.

Referring to fig. 79, when the bag 170 is in place and the neck has been pulled through the cut, there is typically a large amount of excess material in the cut. Grommet 175 may be inserted through the bag/incision to keep excess material away from the incision, as shown in fig. 80. This will help prevent damage to the bag 170 and aid visibility and gas flow. With grommet 175 in place, an instrument can be easily inserted as shown in fig. 81.

The grommet 175 may be used with multi-port or single-port access devices (fig. 82).

In some cases, the grommet 175 has a built-in gas injection/exhaust line 176 (fig. 83).

As shown in fig. 84, the grommet may include a series of slits 177 that enable it to conform to a variety of cut sizes.

The grommet may include a valve system 178 as shown in fig. 85.

An instrument locking mechanism 179 (fig. 86) may also be included.

In some cases, as shown in fig. 87, the grommet may have a series of cavities 180 to facilitate gas/insufflation.

Referring to fig. 88 and 89, a bag set 200 according to the present invention is illustrated. In this case, the bag 200 is shown in an inflated configuration within a body cavity such as the abdomen. A tissue sample 201 is contained within the bag. An incision is made in the abdomen 202 and the incision is retracted using the retractor 203 as described above. In this case, the retractor 203 has an outer proximal ring 204 and a multi-lumen access port 205 is releasably mounted to the ring 204. The bag 200 extends through the retracted incision and terminates in a retainer ring 206.

Fig. 90 and 91 illustrate a bag set similar to that shown in fig. 88 and 89, but in this case a single instrument lumen access port 211 is mountable to the proximal member of the retractor assembly. The access port 211 can have a sleeve portion extending through the retractor or can be an access port 212 with a short proximal leg.

The bag set may itself have an access port to facilitate the entry and exit of instruments into and out of the bag and/or to facilitate the entry of tissue samples into the bag.

Referring to fig. 93, the bag has a single access port 220. However, there may be a plurality of such access ports as shown in fig. 94. The passage of tissue sample 225 through access port 220 is illustrated in fig. 95. The access port 220 may be provided with any suitable valve, such as a throttling valve, for example, a drawstring 226 as shown in fig. 96, a sleeve valve 227 as shown in fig. 97, or a resilient valve 228 as shown in fig. 98. The valve 228 may be constructed of any suitable plastic, rubber or gel material.

Referring to fig. 99-110, there are shown steps in a method involving the use of the bag set of the present invention. In the example shown, the device is of the type described above. The method involves the use of a bag set 250, a retractor 251, an external access port system 252 and is used to obtain tissue 253 (e.g., a specimen or organ) through an opening 254 in the body (in this particular example, in the abdomen 255). The bag set has a transport configuration in which it is received in the cartridge 260 in a stowed state. A plunger 261 is used to transport the stowed bag set out of the cartridge 260. The bag set 250 has an opening that is biased into an open configuration by a retainer ring 265. The ring 265 may be constructed of a shape memory material as described above. A proximal cord, in this example in the form of a loop or loop 267, is provided on one side of the loop 265 and a distal cord 268 extends from a side of the loop 265 generally opposite the proximal cord 267.

In fig. 99, the bag set is placed in a delivery configuration in a cartridge or pull-string bag 260. In this case, the access port device 252 is in place on top of the retractor 251 and the cartridge 260 is inserted through a lumen of the access port (fig. 100). A plunger 261 is used to push the bag set 250 out of the barrel 260 (fig. 101). In this particular case, the bag set is not tethered to the user while being transported. Upon delivery into a body cavity (e.g., the abdomen), the retractor ring is free to move to its normally expanded configuration in which it opens the pocket opening (fig. 102). The bag is folded up in the delivery configuration. Using the various instruments 268, the clinician manipulates a tissue sample, organ, etc., and then delivers it through the open mouth of the bag into the bag 250 (fig. 103, 104). Fig. 105 and 106 show one particular way in which the bag containing the tissue is retrieved. A grasper-type instrument 273 is guided through the proximal loop 267 and used to grasp the distal cord 268 (fig. 105). The distal tether 268 is pulled through the proximal loop 267, which ensures that the clinician has control over the bag as it is moved up toward the body opening (fig. 106). When the retaining ring 265 is engaged with the retractor 251, the retaining ring 265 contracts so that it can be pulled up through the body opening (fig. 107). The access port 252 is removed and the retaining ring 265 is free to expand again (fig. 108).

The access port 252 is reattached and the bag inflated to increase the surgical field. The tissue sample can then be easily manipulated further without any risk of releasing potentially harmful substances into the body cavity (fig. 109, 110).

In some cases, there may be a locking feature that prevents relative movement of one strand with respect to the other strand in certain directions. One such locking feature is shown in fig. 111-113. The distal cord has a one-way step feature 280, which one-way step feature 280 allows the distal cord to pass through the proximal loop, but once it has passed, prevents reverse motion as shown in fig. 113. This ensures greater control over the movement of the retaining ring 265 to facilitate closure of the bag when the ring 265 is retracted.

As discussed above, the devices of the present invention may be used in any suitable body cavity. One such use is in the colon and one embodiment for such use is shown in fig. 114 to 117. The device may be inserted as described above. Once in place and inflated, the clinician can examine the colon wall for any unusual features such as hyperplasia. One such hyperplasia 280 is shown in fig. 115. In this case, when the hyperplasia 280 is identified, some or all of the hyperplasia 280 may be accessed by cutting holes in the wall of the bag, wherein the bag is held in place by its engagement with the rest of the colon. At least a portion of the hyperplasia 280 can be excised and removed through the pouch using a variety of instruments. As described in other embodiments, the main advantage is that the tissue to be removed is held in the pocket, which prevents potentially harmful substances, such as cancer cells, from being released in the body cavity.

Referring to fig. 118, another bag set 400 of the present invention is shown. The bag set has a neck or collar region 401 between a retaining ring 402 and the body of the bag. Because the retaining ring 402 has a diameter that is smaller than the diameter of the bag, it is easier to insert through the access port. As shown in fig. 118, the bag set 400 includes a joined planar sheet portion forming a neck region 401 and a body portion 403. As also shown in fig. 118, the body portion 403 forms a closed cavity in fluid communication with the neck region 401, and the body portion 403 has a length and width greater than the length and width of the neck region 401. As also shown in fig. 118, the retaining ring 402 is configured to bias the bag opening toward an open condition.

Fig. 119 shows another bag set 410 and shows how the body of the bag can be folded in a stowed, delivery configuration.

Referring to fig. 121 and 122, there is shown a bag 500 for use in laparoscopic surgery, the bag 500 having an opening 502 for receiving tissue and a cuff or collar 503 extending around the opening 502. The bag 500 may be inflatable.

The bag 500 includes a body 505 extending from a cuff 503. The body 505 is more flexible than the cuff 503 to assist in holding the bag 500 open in the expanded configuration. The cuff 503 may be constructed of a material different from the material of the bag 500 or may comprise the same or similar material that is thicker than the material of the body 505 of the bag 500. In one instance, the band 503 is constructed of a plastic material and the body 505 of the bag 500 is constructed of a plastic material that is more flexible than the material of the band 503. However, the cuff 503 is flexible enough to allow closure of the opening 502. The bond 507 between the band 503 and the body 505 of the bag may be reinforced in any suitable manner, such as by using a double layer band material as shown in fig. 22.

The band 503 has an axial length that is important in maintaining the opening 502 in a fully open configuration. This has the following major advantages: tissue can be more easily manipulated into the opening 502 by a surgeon performing laparoscopic surgery through a small opening. When the bag 500 is in the open configuration, the surgeon can concentrate on manipulating the tissue/material to be inserted into the bag 500 without the additional task of complex manipulation of the bag 500 while manipulating the material. Thus, the pouch 500 greatly facilitates laparoscopic surgery.

The cuff 503 extends axially a length sufficient to ensure that the opening 502 remains open to provide an axially extending delivery nozzle into the body 505 of the bag 500. For example, the band 503 may extend an axial length of from 2 to 20cm, 2 to 10cm, or about 5 cm. Alternative dimensions for the band or collar 503 and dimensions for other features of the bag will be discussed in more detail below.

In the present invention, the band 503 is biased into an open configuration. In this case, the bag 500 includes a biasing element to bias the cuff 503 into the open configuration.

The biasing element may comprise a loop 510 extending around the cuff 503. The loop may be constructed of a shape memory material such as nitinol. The loop 510 extends around the cuff 503 in any suitable manner. For example, it can pass through the band as shown or can extend through a platform or pathway disposed in or on the band 503.

The cuff 503 has tabs 511, 512 which can be used to more easily grasp the bag during laparoscopic surgery.

A cord 515 extends from the cuff 503 and can be used to initiate opening and/or closing of the bag 500.

Referring to fig. 120, the bag 500 is folded and housed in an introducer sheath or pull-string bag 520 ready for deployment. Any suitable insertion tool may be used to deliver the bag 500 through the opening. The bag 500 may be deployed in any suitable manner, such as by using a plunger 516 that is user-activated to deliver the bag from an introducer 520.

The deployment of the bag 500 through an opening (e.g., a distraction incision 525) is shown in fig. 123-126. The band 503 opens upwardly as soon as the bag begins to exit the drawstring bag and, when fully deployed, defines an axially extending open mouth. Fig. 127 and 128 illustrate the manipulation of tissue 530 into the open mouth of the bag 500 using an instrument such as a grasper 531. When the tissue 530 is in the bag 500, the cord 515 is used to pull open the cuff 503 that initially closes the opening and is then pulled through the tissue opening 525. When the proximal end of the pouch 500 has passed through the tissue opening, the pouch 500 may be inflated and a procedure may be performed on the isolated tissue within the pouch 500. This can be done in several different ways, depending on the procedure being performed. For example, the bag inlet can be closed with an access port 540 as shown in fig. 133, which facilitates access to any suitable instrument for performing a procedure such as morcellation of tissue within the bag 500. Alternatively, the captured tissue can be used without an access port — see fig. 134, 135, and 138. Alternatively, a trocar 545 may be provided through which the instrument extends (fig. 136). There may be an additional trocar 550 (see, e.g., fig. 137) used.

The collar/cuff 503 may be collapsible to enable tissue to be rolled into the pouch opening 502 rather than being lifted into the pouch opening 502.

The bag 500 can be mounted to a retractor. One such retractor includes a distal anchor ring, a retractor member such as a bushing, and a proximal ring assembly. One such retractor is described in US2005-0090717, the entire contents of which are incorporated herein by reference. The distal anchoring loop is positioned within the wound interior in use. In this case, the distal anchoring ring is provided in the form of an O-ring. The proximal ring assembly is positioned, in use, outside of the wound opening. The retractor member may be used to retract the sides of the wound opening laterally. In one instance, the retractor member is provided in the form of a sleeve.

The proximal end of the retractor is closable by a cover that includes an instrument access device 540 that may have a plurality of instrument ports to effect a seal around instruments extending through the device. The instrument access device may be releasably mounted to the proximal ring assembly of the retractor. At least some of the instrument interfaces may include a laterally flexible and longitudinally stiff post. One such instrument access port is described in US8,187,178 or US2011-0071389a, the entire contents of both of which are incorporated herein by reference.

Fig. 127 shows an organ or tissue, such as a uterus, that has been severed/resected from its holding structure.

Fig. 123 to 126 show the insertion of the bag set into the abdominal cavity at the start of the procedure or as and when required. The bag is inserted in a small flattened state for easy insertion through a small opening such as an incision. The bag can also be introduced through the valve without removing the access cover.

When the bag is inserted, it is opened. Organ 530 is then ready to be manipulated for insertion into the bag, as shown in fig. 128. The relative stiffness of the cuff 503 keeps the bag open to facilitate insertion of the organ.

Fig. 129 shows the organ and cuff 503 positioned within the bag grasped to facilitate manipulation of the bag toward the opening. The band 503 is pulled out through the opening. The bag can be mounted to a proximal ring assembly of the retractor and the cover can be mounted to the proximal assembly. Fig. 131 shows the device in place with the organ enclosed within the pouch.

The bag is then inflated through the insufflation port (fig. 132). Inflation of the bag has the additional benefit of: a retracting force is applied to the material located outside the bag, thereby creating additional space.

Fig. 133 shows the organ being affected by the balloon in the inflated bag. The organ may be morcellated. The substance is held safely all within the bag and is not released into the cavity, which would cause major difficulties. The bag is held on the outside, for example by clipping/connecting to a retractor.

When the organ has been morcellated, the bag is easily removed through the original opening. All waste, blood, tissue, etc. is safely removed and sealed within the bag.

The bag set may be inserted through a standard exposure incision. Once the sample has been inserted into the bag, an opening such as cuff 503 is pulled back through the incision and can be inserted into a trocar to form a gas seal. The bag set can also be inserted directly through a trocar as shown in fig. 136.

In some cases, there may be one or more access trocars used in addition to the primary port. Thus, the present invention includes procedures involving two or more incision laparoscopies.

For example, fig. 137 shows an arrangement in which an additional trocar is inserted. In some cases, the additional trocar may extend through the bag while maintaining the seal.

The present invention provides a method of inserting a big bag into the abdominal cavity to allow insertion of a sample into the bag. The bag is then sealed and inflated, and a procedure is performed within the bag.

As discussed above, the devices of the present invention may be used in any suitable body cavity. One such use is in the colon. The device may be inserted as described above. Once in place and inflated, the clinician can examine the colon wall for any unusual feature such as hyperplasia. In this case, when a hyperplasia is identified, part or all of the hyperplasia may be accessed by cutting a hole in the wall of the bag, which is held in place by its engagement with the rest of the colon. At least a portion of the hyperplasia may be resected and removed through the bag using a variety of instruments. As in the other embodiments, the main advantage is that the tissue to be removed is held in the bag, which prevents potentially harmful substances, such as cancer cells, from being released in the body cavity.

With reference to fig. 139-155, there are shown various embodiments of biased loop elements that may be used in the bag set of the present invention to help maintain the bag opening. In these cases, the loop includes multiple loop components that are movable relative to one another for stowage deployment and/or retrieval.

With reference to fig. 139-143, in this case there are two joined loop members 551a, 551b which are movable in a circumferential direction through the hoop 552. In some cases, the one-piece collar is sufficiently flexible to allow manipulation.

Referring to fig. 144 to 149, in this case the loop 560 is constructed in the manner of a lasso with legs 561 extending therefrom which can be pulled to reduce the diameter of the loop. On one end there is a closed loop 562 and on the other end there is a kink 563 which connects into the loop 562 in order to reduce the diameter of the loop 560.

Referring to fig. 150-153, in this case, there may be a closed loop 570, 571 at each end of the retaining loop 572. These can be used as rope attachment points.

With reference to fig. 154-156, in this case, the ends of the retaining loop 580 have bends 581, 582 and extend to define arms 583, 584 that facilitate manipulation of the loop for retrieval.

The device of the invention may include features to isolate the contents of the bag from the wound opening and thus prevent leakage of material as may occur in the case of the spread of cancer cells and the like.

Referring to fig. 157 to 160, in this case, the bag includes a small opening 600 that remains closed under insufflation pressure. The opening 600 is opened when a tool, such as a trocar 601, is inserted through the opening 600. The bag has excess material in the area of the opening 600 that defines a sleeve or shroud 603 that seals along a portion of the length of the trocar shaft when the shaft is in place in the opening 600. The opening 600 is located at the top of the bag in use, i.e. in the area contacting the abdominal wall. The trocar 601 may be inserted in a region of the abdominal wall distal to critical organs and manipulated under full vision to position the opening. The opening remains closed while there is internal insufflation pressure and the liner or shroud 603 collapses around the trocar to form a seal.

Referring to fig. 161-163, in such a case, any excess bag material 604 may be grasped using a grasper 605 inserted through a trocar 606. The ends of the excess material may then be cut away (fig. 162), thereby forming a sleeve 607 extending from the bag. The mask 607 is then sealed, for example using a threaded trocar 608 that is screwed into the mask 607 to form a seal. The shroud 607 prevents contact between the wound and debris formed during morcellation. In this case, the surgeon is provided with an additional port to the bag for use during the procedure. One such procedure may involve inserting a laparoscope or grasper, for example, through an auxiliary port.

Referring to fig. 164, in another embodiment, a plug 610 may be placed within the trocar 606, thereby sealing the bag to the trocar. A tool such as a laparoscope 611 may be inserted through the plug 610.

Referring now to fig. 165, in this case the bag has a strap 620 and a loop of cord 621 is threaded through the strap. The cord 621 has a lace 622 that can be used to pull the cord from a position outside the abdomen. The cuff 620 also has gripping tabs 623, 624. In this case, the gripper 625 may be used to grasp the tab 623 as shown, and then push the cuff toward the tab 624 toward the opposite side of the bag, thereby closing the bag. The tie 622 enables the bag to be securely held while being closed within the pneumoperitoneum.

In some cases, the bag is held in a normally open configuration by a retainer ring constructed of a shape memory material such as nitinol. It has been found that a single ring formed by attaching (e.g. welding) the ends of the ring-forming members together is most effective in achieving rapid deployment. Referring to fig. 185 and 186, the retaining ring of the bag may be manufactured in any suitable manner. In one aspect, for example, the shape memory material 675 is formed as a ring that is shaped and welded. The tether strap 676 may also be attached in any suitable manner.

In some cases, the strap of the bag may have features that facilitate mounting of the preformed ring to the bag.

In one embodiment shown in fig. 166, the pouch has a band 630 through which a loop 631 of shape memory material, such as nitinol, is guided. The interior catch area 632 for the retention ring 631 is formed by cutting out a panel in the bag material and folding down over the retention ring 631 and sealing using a suitable tool, such as a circular sealing tool. A tether strap 632 is mounted to the loop 631 and extends through the access port 633 to maintain control of the bag.

Referring to fig. 167, in this case, the compressed attachment 635 is folded over a closed retaining loop 636 comprised of a shape memory material such as nitinol and sealed, for example, by heat. The front grip tab 637 includes a reinforced attachment loop 638.

Fig. 168-170 illustrate another method of attaching a retaining loop 640 to a strap 641 of a bag in accordance with the present invention. In this case, the material of the collar or strap 641 is stamped with the cutting detail 642 extending from the aperture 643 (through which the retaining ring 640 is extended) to the edge of the strap. The band is formed as a collar 641 as shown in fig. 169(a) to 169 (c). The retaining ring 640 is inserted through the cutting detail 642 and into the receiving hole 643. Using a circular sealing tool, the tabs are folded down to form alternating overlaps. The cuff is then sealed, for example by heat sealing to close the aperture 643. In this manner, a closed loop 640 of shape memory material, such as nitinol, is attached to the bag to maximize the opening and facilitate laparoscopic insertion of tissue when the bag is within the abdomen.

In some embodiments, the abdominal bag is protected from damage during use of the morcellator. For example, as shown in fig. 171, an insert/sleeve 650 can be inserted to isolate the shredder from the material of the bag. The insert 650 may, for example, be rigid, flexible, or constructed of segmented rigid materials. An access port or cover 651 can be releasably mounted to the insert 650.

The means for introducing the bag into the insufflated abdomen may be adapted to control the opening of the bag. For example, as shown in fig. 172-176, the tip 655 of the introducer sheath 656 may have mirror image cuts 657 that enable the positioning ring of the bag to begin to expand before the entire bag is inserted. Such an introducer will assist in maneuvering the bag into a desired position before the bag becomes detached from the introducer. In addition, the deployed bag may be partially retracted into the introducer to enable further rigid movement of the bag to optimize positioning.

To limit blood or other matter being pushed into the introducer by positive insufflation pressure within the abdomen, the tip of the introducer may have pressure dissipation features. For example, as shown in fig. 177-180, the introducer tip may have various cutouts 660, holes 661, and/or pointed rounded features 662.

In another embodiment as shown in fig. 189, the introducer shaft 695 may have a valve 696 at the proximal end in order to restrict blood or other matter from entering the introducer. The valve 696 may be openable upon insertion of a push rod 697 which is used to deploy the bag set from the introducer.

It will be appreciated that the bag of the present invention may comprise different materials to meet different requirements for the various parts of the bag. For example, as shown in fig. 181 and 182, the body 665 of the pouch can be constructed of a relatively thin, flexible material, and the collar 666 can be constructed of a thicker, more rigid material. For example, the body 665 can include a sterilized polyester urethane such as SS-1495-95 (a 95 shore a durometer polyester urethane blown film with a high slip surface and good clarity), and the collar or neck 666 can include a sterilized polyether urethane such as ST-625-85 (a 85 shore a durometer polyether urethane formulated for medium/high slip with good sealability).

The bag may also have any desired shape/configuration. For example, the pouch may have an oval or elliptical profile, as shown in fig. 181-184. This shape helps to push organs such as bowel segments away from the abdominal wall, which prevents bowel movement on top of the bag. As shown in fig. 184, the formation of an artificial pneumoperitoneum includes positioning the joined edge 671 of the bag in alignment with the side wall of the abdomen 672 such that one of the planar sheet portions of the bag faces and contacts the abdomen front wall and the other sheet portion of the bag faces and contacts the viscera. Tissue 670 is shown within the pocket in fig. 183 and 184.

The bag may be sized larger than the abdominal cavity of the patient to provide for apposition on the abdominal wall after inflation. The oversized nature of the bag and the loading of the bag into the introducer as described below in connection with fig. 187(a) through 187(f) enables any additional bag material to remain rolled up at the bottom of the bag after inflation. This helps to keep the folds or creases of the inflated bag from extending into the artificial pneumoperitoneum. Consistent with this, and as shown in fig. 181, the bag may be sized to include an overall bag length 661 of between 300mm and 600mm, or between 400mm and 550mm, or about 500mm, all in the un-inflated state. The bag may also include a maximum width 677 of between 200mm and 500mm, or between 300mm and 400mm, or about 350mm, with all in an uninflated state, such as maximum width 677 in body portion 665. The collar or neck 666 may include a constant width 663 of between 150mm and 350mm, or between 180mm and 320mm, or about 250mm with the neck 666 all in the uninflated state of the bag and when the neck 666 is flat as shown in fig. 181. The collar or neck 666 may also include a length 664 of between 100mm and 300mm, or between 100mm and 200mm, or about 150mm, when in an un-inflated state. The body 665 can include a body length 667 (excluding the neck) of between 200mm and 500mm, or between 300mm and 400mm, or about 350 mm. Likewise, the body 665 can be configured to have a maximum width to maximum length ratio of about 1: 1.

Also, as described above, the bag may also be held in the normally open configuration by a retainer ring constructed of a shape memory material such as nitinol. Referring to fig. 166-170, the retaining ring of the bag may be formed as a ring that is shaped and welded. The diameter of the bag opening may be between 100mm and 220mm, or between 120mm and 200mm, or about 160mm when the positioning ring is in the open configuration.

Referring again to fig. 181 and 182, the bag may be formed from shaped flat sheets placed on top of each other and attached (e.g., by welding) at the edge 671. When inflated (fig. 182), the pouch expands into a rounded oval shape, which may more closely align with the contours of the abdomen. As also shown in fig. 118, 181 and 182, the bag may be shaped to be symmetrical about two different planes (668, 669) that are perpendicular to each other. Further, as shown in fig. 118 and 181, the neck or collar portion (401, 666) can be shaped to extend parallel to the longitudinal axis 271 of the pouch, and thus the edge 674 of the neck or collar portion (401, 666) can extend parallel to the longitudinal axis 271 of the pouch.

The bag of the present invention may be manipulated in some cases to optimize ease of loading into the introducer and/or to optimize deployment. For example, as shown in fig. 187(a) through 187(f), the bag may be wider at certain sections 680. These additional width sections may be folded inwardly from the side to form pleats 681. The bag may then be rolled from bottom to top toward the neck 682 of the bag. The neck 682 of the bag can then be crimped down and loaded into introducer 683.

Referring to fig. 188, in some cases, sections of the bag may be constructed of different materials and/or have varying material thicknesses to provide desired characteristics. For example, the bottom section 690 of the bag may be constructed of a less common/more rigid material to resist the action of the shredder. The section 690 may be constructed, for example, from a tear resistant nylon material.

Fig. 190(a) to 190(c) illustrate the use of the pouch device of the present invention in a transvaginal procedure (e.g., hysterectomy). In some cases (fig. 190(a) and 190(b)), the bag set can be inserted and used directly without an access port. In other cases, the device may be used as described in other embodiments with access port 730 (fig. 190 (c)).

Referring to fig. 191, in some cases, the screwing action of the threaded trocar or plug 700 may help pull the bag up through the wound.

In some embodiments, a closure device or valve may be arranged in order to seal the aperture into the shroud before deflating the bag. For example, as shown in fig. 192(a) and 192(b), the closure device 710 may be inserted into a shroud, in a collapsed configuration, and deployed at the ends of the shroud. The closure device may be held in place using any suitable retaining means, such as a rubber pad 711.

The abdominal pouch arrangement of the present invention may be used with any suitable access port system 730, for example, as shown in fig. 193(a) through 193 (c). In some cases, the access port is mounted within the neck of the bag.

Referring to fig. 194 through 285, additional views of various artificial pneumoperitoneum devices and systems of the present invention are shown. These devices and systems have several features in common with the devices described above and the related disclosure should be read in conjunction with the following.

Figures 194 to 198 show an artificial pneumoperitoneum device 800, an introducer sheath 801 for the device 800 and a plunger 802 for delivering the device 800 from the sheath 801. The sheath 801 has an open proximal end 803 and a distal end 804, the proximal end 803 having a tapered configuration and an indicator arrow for indicating to a user the direction of travel of the plunger. Plunger 802 has a handle 805 at the proximal end and an enlarged sealing head 806 at the distal end. There are also seals 807 spaced along the length of the plunger 802. Referring also to fig. 210, a plunger 802 is sized to pass beyond the distal end of the introducer 801 to ensure that the device 800 is always fully ejected from the introducer sheath 801. When the distal seal 806 has been ejected from the introducer sheath 801, the plunger 802 will fill the introducer tube 801 sufficiently to prevent a significant loss of gas volume (pneomo), while being loose enough to ensure that the cord 809 portion of the device can be pulled freely.

As described in detail above and with reference also to fig. 199 and 200, the shape and size of the device has several unique advantages. Fig. 199 and 200 show the pouch portion of the device in a flat configuration (i.e., without an open loop structure). The pouch has a body region 810, a collar region 811, and a neck region 812 between the collar 811 and the body 810. The length L of the body is the same as the width W of the body 810 while the neck region 812 narrows. The neck region 812 is intended, in use, to line up with the cut or opening through which it is introduced. The collar 811 is more rigid than the neck and body and is typically welded to the neck 81 area.

A biasing element in the form of a nitinol loop 815 extends through the collar 811 and in this case through the collar 811. Pull tabs 816, 817 are mounted to the collar 811 and extend proximally from the collar 811. As mentioned above, the collar is constructed of a more rigid material than the body of the bag and, in addition to assisting in maintaining the opening, it also facilitates the secure mounting of various components such as the biased loop 815 and the tabs 816, 817.

Referring to fig. 201, in use, the seal 820 is pressed out of a closed cell foam with a cut in the middle. The string is passed through the incision and glued in place. The seal 820 seals the introducer, preventing blood from being absorbed onto the introducer and possibly aspirated from the handle. The proximal tab provides reinforcement for the two holes through which the nitinol wire passes.

Referring to fig. 202 through 205, the process for assembling the nitinol ring 815 is as follows:

the collar 811 is formed prior to the addition of the nitinol wire 815.

Nitinol wire rope 815 is threaded through the holes in the collar alternately inside and outside in the pattern as shown in fig. 202.

A nitinol wire rope 815 is located on the inside of the collar 811 distal to the collar.

A nitinol wire rope 815 is proximally located on the outside of the collar, where the rope 809 is attached.

A distal tab 817 captures the nitinol wire 815 on the inside of the collar 811.

Cold pressure welding process is used due to the requirement to pierce the nitinol through the holes.

The two ends of the nitinol wire 815 are placed inside a tube 825 (which may be made of nitinol), which tube 825 is then cold-pressed to hold the wire 815.

The cord 807 is formed over the crimp to ensure that the crimp first appears and covers any sharp edges.

The crimp region is the first portion of the cord to be pulled from the outside of the body by the cord 809.

Fig. 206-209 illustrate the folding/rolling of the device 800 to prepare it for loading. The process is as follows:

folding in an excessive width to make the same width as the flat opening.

Roll from bottom to shoulder/neck.

Curling the neck down. This ensures that the tissue sample has sufficient space to enable the device to be closed without the tissue being captured in the opening to the device.

The device is then loaded into the introducer 801.

Referring to fig. 211 and 212, it will be appreciated that the shape and width of the pouch arrangement 800 retracts the viscera 840 while desirably preventing the viscera from moving on the arrangement to become trapped between the arrangement and the abdominal wall.

Referring to fig. 213-215, it will be appreciated that once inflated, the bag set is free of wrinkles, creases, folds or excess material.

Referring to fig. 216, it will be noted that the pouch arrangement 800 is larger than most abdominal cavities, thus ensuring that all available space within the abdominal cavity is occupied by the pouch arrangement. The device, its loading and how it inflates minimizes internal creases in the material and keeps any excess material on the outside and therefore does not provide any accidental gripping risk on the inside. As the bag set 800 inflates, it only unwinds as much material as needed to fill the available space, thereby causing all excess material to roll up neatly on the outside.

With particular reference to fig. 217 and 218, it will be appreciated that the viscera 840 are retracted away from the shredder, making it difficult for the shredder to accidentally access the body of the bag set 800.

As will be appreciated from fig. 219 and 220, the zero seal and lip seal introducer 845 may be molded to the introducer handle penetrated by the plunger 802. In this case, the cord 809 extends out from the front of the introducer 801 and up the outside.

FIGS. 221 and 222 illustrate an alternative fabrication for assembly with a solid nitinol ring as described above; the cuff 811 is attached to a preformed nitinol ring 850.

FIG. 223 illustrates an alternative manufacturing process for assembly with a solid nitinol ring 850. This uses loops 851 rather than passing nitinol through the holes.

Referring to fig. 224, a bag set 800 is shown being introduced through the access port 860. A scope 861 is also inserted.

Fig. 225 and 226 illustrate introduction of the device 800 in a multi-port configuration, wherein a viewing instrument 861 is inserted through a separate port or trocar.

Referring to fig. 227 and 228, it will be appreciated that the bag set 800 is automatically opened as the bag set 800 is ejected from the introducer 801.

Fig. 228-230 show that as the bag set 800 is ejected from the introducer 801, the distal tab 817 appears with arrows printed on both sides to assist the surgeon in orienting — i.e., preventing the bag set from being inadvertently deployed upside down.

Fig. 231 and 232 illustrate tissue 870 being manipulated into the opening of the device, in some cases, with a flipping or rolling action.

Fig. 233 shows the surgeon pulling on the tether 809 until the open loop is pulled partially through the large instrument valve 875.

Figures 234 and 235 show that the device automatically closes as it is pulled up against the wound retractor 880.

Fig. 236 and 237 show the removal of the port and the surgeon continuing to pull on the cord 209 until the device collar, represented by a line, is exposed.

Referring to fig. 238 and 239, the surgeon then pulls the tabs 816, 817 apart to open the device.

Fig. 240 and 241 are interior views of the bag set 200 prior to inflation. All gas is vented from the abdomen before the access port 860 is reattached.

This reattachment of the port 860 is shown in fig. 242.

Referring to fig. 243 and 244, an insufflation supply line 885 is connected to the access port 860 and inflates the bag set 800.

Referring to fig. 245, it will be noted that the viscera 840 retract and the pouch arrangement 800 lines the abdominal wall when the pouch arrangement 800 is inflated.

Referring to fig. 246 and 247, it will be noted that the pouch arrangement 800 prevents the intestine 840 from climbing up the arrangement.

With reference to fig. 248 and 249, it will be appreciated that the bag set 800 retracts the bowel 840 to a safe distance, thereby significantly avoiding accidental visual attachment to the morcellator or its tenaculum.

Fig. 250 and 251 show that under vision, the surgeon morcellates the tissue until no more large masses exist.

The pouch assembly of the present invention provides an artificial pneumoperitoneum wherein surgery may be performed on tissue isolated within the pouch.

Referring to fig. 252 and 253, the removal of the access port is shown and once deflated, the bag set 800 can be pulled out, pulling with it all debris from the morcellation.

The device of the present invention may also be used in transvaginal procedures, in which the device is introduced into the vagina, as shown in figures 254 to 256.

In some cases, the pouch assembly 800 may be closed in the abdomen after insufflation, as shown in fig. 257.

Referring to fig. 258, in some instances, an additional port 890 may be used through the bag set 800 to provide access for instruments or laparoscopes.

Referring to fig. 259, it is shown that the key device 800 may be deployed before the tissue has been excised. The device may be placed under the uterus 895 during dissection to capture any blood drops or tissue.

FIG. 260 shows the device being loaded with tissue while it is partially deployed. This is facilitated by the relatively rigid collar 811.

Referring to fig. 261-262, in this case, the device is constructed with excess material in the top region that can be grasped with a grasper to be pulled through the trocar.

Referring to fig. 263-266, an auxiliary or second skin 900 on the device is shown. Through the trocar incision 902, the gripping tabs 901 on the excess material 900 are pulled upward through the wound. A hole is cut in the excess material 900 and the trocar is reinserted further inside the excess material-which then protects the wound from any infection. The trocar is then penetrated into the main lumen of the device. This ensures that insertion of the trocar does not cause material to exit through the hole formed by the trocar.

Figure 267 shows puncturing the device with a threaded trocar 910, twisting the trocar will pull excess material in the device up through the wound, thus protecting it from infection.

Fig. 268-270 show plugs 940, 941, 942 that can be made of closed cell foam in several shapes-once the procedure is complete and before the insufflation is removed, this is pushed down through the trocar.

Fig. 271-273 illustrate that the plug 945 can have a rigid core to assist in pushing the plug through the trocar.

Referring to fig. 274-276, a plug 945 may be placed inside the inflated device. A grasper introduced through the second trocar 950 grasps the plug and pulls it up to the trocar. The trocar is pulled back and the plug is pulled into the puncture, thereby maintaining a seal against it.

Referring to fig. 277 through 280, an inflatable plug 960 is shown. Deflate-the plug 960 passes through the trocar. Once in place, the plug 960 is inflated using a large syringe. The plug may contain a one-way valve.

Fig. 281 to 285 show a cover 970 for a trocar 971 that can be inflated to occlude the hole in the device once the trocar 971 has been removed. Fig. 281 shows cover 970 uninflated. Fig. 282 shows cover 970 after inflation.

Various features of the invention are described and illustrated. It will be understood that at least some of the features described in connection with one embodiment may be used not only in this specifically described embodiment, but in other suitable embodiments. As used herein, the terms "about" or "approximately" are understood to mean close in value or quantity, but not exact. To the extent that such a definition of "about" or "approximately" is not considered sufficiently unambiguous, about is understood to mean plus or minus 5% of the relevant parameter.

The invention is not limited to the embodiments described above with reference to the drawings, which may vary in construction and detail.

Claims

1. An inflatable artificial pneumoperitoneum bag for receiving tissue during laparoscopic surgery, the bag having a tissue receiving opening at a proximal end thereof and a cuff at the proximal opening, the cuff having a closed configuration for delivery and retrieval of the bag and an open configuration to receive tissue, the cuff being biased into the open configuration, the bag having: a body extending from the cuff and the body of the bag being more flexible than the cuff; and a biasing element to bias the cuff into the open configuration.

2. The bag of claim 1, wherein the strap is constructed of a material that is different from the material of the body of the bag.

3. The bag of claim 2, wherein the strap is constructed of a material that is more rigid than a material of the body of the bag.

4. The bag of any of claims 1 to 3, wherein the body of the bag comprises a neck region extending from the cuff.

5. The bag of claim 4, wherein the neck region is more flexible than the band.

6. The bag according to any one of claims 1 to 5, wherein the cuff extends a distance of between 2cm and 20cm, such as between 2cm and 10cm, or the cuff extends a distance of about 5 cm.

7. The bag according to any one of claims 1 to 6, wherein the biasing element comprises a loop or ring extending around the strap.

8. The bag of claim 7, wherein the loop or ring is constructed of a shape memory material such as nitinol.

9. The bag of claim 7 or 8, wherein the loop comprises a single loop element.

10. The bag of claim 7 or 8, wherein the loop comprises a plurality of loop components.

11. The bag of claim 10, wherein at least one of the loop members is movable relative to another of the loop members.

12. The bag of claim 11, wherein at least one of the loop members is circumferentially movable relative to the other loop member.

13. The bag of any of claims 1 to 12, wherein the bag comprises a cord extending proximally from the cuff.

14. The bag of claim 13, wherein the tether is mounted to the biasing element.

15. The bag of any one of claims 1 to 12, wherein the cuff comprises a tab for use in gripping the bag.

16. The bag according to claim 15, wherein the bag comprises tabs arranged on opposite sides of the cuff.

17. A bag according to claim 15 or 16, wherein the or each tab includes an indicator to indicate a preferred orientation of the bag.

18. The bag of any one of claims 1 to 17, wherein the bag is configured to be foldable to a reduced size for insertion through an incision or opening.

19. The inflatable artificial pneumoperitoneum bag according to any one of claims 1 to 8, wherein said bag comprises:

a length and a width;

an artificial pneumoperitoneum bag body portion forming a closed cavity in fluid communication with the second end of the neck portion, the body portion having a length and width greater than a length and width of the neck portion; and

20. The inflatable artificial pneumoperitoneum bag according to claim 19, wherein the length of the bag is between 300mm and 600mm when the bag is uninflated, and the maximum width of the bag is between 200mm and 500mm when the bag is uninflated.

21. The inflatable artificial pneumoperitoneum bag according to claim 20, wherein the neck has a diameter between 100mm and 220mm when in the open state.

22. The inflatable artificial pneumoperitoneum bag according to claim 21, wherein the neck has a length between 100mm and 300mm when the bag is uninflated.

23. The inflatable artificial pneumoperitoneum bag according to any one of claims 19 to 22, wherein the widthwise extending cross section of the body portion comprises an oval shape when the bag is inflated.

24. The inflatable artificial pneumoperitoneum bag according to any one of claims 1 to 23, wherein the bag comprises a planar sheet portion of sterilized polyester polyurethane having joined edges.

25. The inflatable artificial pneumoperitoneum bag according to any one of claims 1 to 24, wherein the bag is symmetrical about two planes perpendicular to each other.

26. The inflatable artificial pneumoperitoneum bag according to any one of claims 1 to 25, wherein the neck comprises an edge extending parallel to a longitudinal axis of the bag.

27. The inflatable artificial pneumoperitoneum bag according to any one of claims 19 to 26, wherein the biasing element comprises a ring formed of a shape memory material and received in the neck through a receiving loop.

28. The bag of any one of claims 1 to 27, wherein the bag comprises an introducer for receiving the bag in an insertion configuration.

29. The bag of claim 28, wherein the introducer is configured to be at least partially inserted through an incision and/or access port.

30. A bag according to claim 28 or 29, wherein the bag comprises an actuator for delivering the bag from the introducer upon insertion.

31. The bag of claim 30, wherein the activator comprises a tab.

32. The bag of claim 30, wherein the activator comprises a plunger.

33. The bag of any of claims 1 to 32, wherein the bag comprises a port.

34. The bag of claim 33, wherein the port is an outlet port.

35. The bag of claim 33 or 34, wherein the port is an inlet port.

36. The bag of any of claims 33 to 35, wherein the bag comprises a plurality of ports.

37. The bag of any of claims 33 to 35, wherein the port comprises a valve.

38. The bag of claim 37, wherein the valve comprises a choke or a sleeve valve.

39. The bag of any one of claims 1 to 38, wherein the bag further comprises an access port to which the bag is mounted or mountable.

40. The bag of claim 39, wherein the access port includes a retractor having a distal anchor element for positioning within the interior of the wound, a proximal member for positioning outside of the wound opening, and a retractor member extending proximally from the distal anchor element for retracting a side of the incision laterally.

41. The bag of claim 40, wherein the bag is mountable to the proximal member of the retractor.

42. The bag of claim 40 or 41, wherein the bag further comprises a cover for closing the proximal side of the retractor.

43. The bag of claim 42, wherein the cover includes an access device for an instrument or a surgeon's hand/arm.

44. The bag of claim 43, wherein the access device is mountable to the proximal member of the retractor.

45. Apparatus for use in laparoscopic surgery, comprising a bag according to any one of claims 1 to 44 and a retractor.

46. The device of claim 45, wherein the device further comprises an access port.

47. A method for performing laparoscopic surgery, comprising the steps of:

inserting a bag according to any of claims 1 to 46 through an opening;

inflating the bag;

delivering the tissue into the pouch before or after inflating the pouch; and

performing a procedure on the tissue located in the inflated pouch.

48. The method of claim 47, wherein the opening is an opening to a body lumen.

49. The method of claim 47, wherein the opening is provided at least in part by a cut-out.

50. The method of any one of claims 47-49, where the method comprises providing a trocar and inserting the bag through the trocar.

51. A method as claimed in any of claims 47 to 49, wherein the method comprises providing a retractor in the opening and inserting the bag through the retracted opening.

52. The method of any one of claims 47-51, where the tissue is delivered into the bag prior to inflating the bag.

53. A method as claimed in any of claims 51 or 52, wherein the method includes the step of mounting the bag to the retractor either before or after delivery of the tissue into the bag.

54. A method according to any one of claims 47 to 53, wherein the method comprises inserting a trocar into the bag.

55. A method according to any one of claims 47 to 54, wherein the method includes passing an instrument into the inflated bag to perform a procedure.

56. The method of any one of claims 47 to 55, wherein the method includes the steps of providing an access port in the bag and passing an instrument and/or tissue through the access port.

57. The method of claim 56, wherein the method includes sealing the access port before and/or after passing an instrument and/or tissue through the access port.