WO2023239765A2 - Mechanical displacement devices, systems, and methods to enhance extraction of surgical specimens - Google Patents

Mechanical displacement devices, systems, and methods to enhance extraction of surgical specimens Download PDF

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Publication number
WO2023239765A2
WO2023239765A2 PCT/US2023/024672 US2023024672W WO2023239765A2 WO 2023239765 A2 WO2023239765 A2 WO 2023239765A2 US 2023024672 W US2023024672 W US 2023024672W WO 2023239765 A2 WO2023239765 A2 WO 2023239765A2
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WO
WIPO (PCT)
Prior art keywords
sack
extraction
tissue
flexible wall
pulley
Prior art date
Application number
PCT/US2023/024672
Other languages
French (fr)
Other versions
WO2023239765A3 (en
Inventor
Todd L. Demmy
Original Assignee
Roswell Park Cancer Institute Corporation Health Research, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roswell Park Cancer Institute Corporation Health Research, Inc. filed Critical Roswell Park Cancer Institute Corporation Health Research, Inc.
Publication of WO2023239765A2 publication Critical patent/WO2023239765A2/en
Publication of WO2023239765A3 publication Critical patent/WO2023239765A3/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00287Bags for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00367Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like
    • A61B2017/00398Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like using powered actuators, e.g. stepper motors, solenoids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension

Definitions

  • Various implementations include a tissue extraction system configured for passage through a minimally invasive opening to capture and remove a tissue structure.
  • the system includes an extraction sack and a derrick.
  • the extraction sack is for deposition within a person’s body.
  • the derrick includes a frame supporting a pulley system.
  • the pulley system facilitates pulling the extraction sack with the tissue therein through the minimally invasive opening.
  • the tissue extraction system comprises and/or further includes an extraction sack comprising a flexible wall and a toroidal ring.
  • the flexible wall defines an inner chamber and an inflation port.
  • the toroidal ring is disposed within the inner chamber of the flexible wall.
  • the flexible wall of the extraction sack while in the patient, can be doubled over onto itself and pulled through the toroidal ring to form a double walled sack that can be inflated to eject the tissue structure.
  • a tissue extraction system including an extraction sack and a derrick.
  • the extraction sack is for disposing within a body of a person.
  • the derrick includes a base, a fixed pulley, a free pulley, a cable and a coupler.
  • the base is configured to contact the body.
  • the fixed pulley is coupled to the base.
  • the cable has a first portion, a second portion and a middle portion.
  • the second portion is spaced axially apart from the first portion.
  • the middle portion is disposed between the first and second portions.
  • the first portion of the cable is static with respect to the fixed or free pulley.
  • the middle portion extends around the fixed pulley and the free pulley.
  • the coupler is configured to couple to the extraction sack to the free pulley.
  • the application of a force to the second portion of the cable causes the free pulley to move from a first to a second position.
  • the free pulley is closer to the second pulley (in the second position) than in the first position.
  • the extraction sack includes a flexible wall and a toroidal ring.
  • the flexible wall defines an inner chamber.
  • the flexible wall also defines an inflation port in fluid communication with the inner chamber.
  • the toroidal ring is disposed within an inner cavity of a body of a person and is a separate structure from the flexible wall of the extraction sack.
  • the ring may comprise a semi rigid material.
  • the sack may also include a drawstring for constricting a portion of the wall.
  • a conduit configured to couple to the inflation port.
  • Another embodiment includes a method of extracting a tissue from a body is included.
  • the method includes inserting an extraction sack through an opening a body of a person such that the extraction sack is disposed within the body of the person, wherein the sack defines an open end.
  • the method also includes inserting tissue within the sack.
  • the open end of the sack is extracted (inserted) through the opening in the body of the person.
  • a derrick such as the derrick described above, is disposed on the body of the person at the opening.
  • the method includes coupling the coupler to the open end of the sack.
  • the method can include applying force to the second portion of the cable to cause the free pulley to move from the first position to the second position such that the sack exits the body of the person.
  • FIG. 1 A shows an elevation view of a tissue extraction system of one embodiment including a derrick and an extraction sack.
  • FIG. IB shows an elevation view of the top portion of the derrick of the system of FIG. 1A.
  • FIG. 2 shows an elevation view of the system of FIG. 1A mounted to a simulated patient in the form of a sheet of plywood.
  • FIG. 3 is a side elevation view of the sack of FIG. 1A.
  • FIG. 4 is a perspective view of a retractor used in the system of FIG. 1A.
  • FIG. 5 is a plan view of a set of simulated ribs through which tissue can be extracted using the system of FIG. 1A.
  • FIG. 6 is a schematic showing different uses of the retractor of FIG. 4.
  • FIG. 7 is a view of a base of the derrick of FIG. 2 mounted on the plywood with a simulated rib opening.
  • FIG. 8 is a malleable ring for support and anchoring of the sack of FIG. 3 in the system of FIG. 1A.
  • FIG. 9 is a perspective view of a coupler for connecting the malleable ring of FIG. 8 to a pulley system of FIG. 1A.
  • FIG. 10 is a perspective view of the coupler of FIG. 9 coupling the sack the bottom of the pulley system of FIG. 1A.
  • FIG. 11 is a perspective view of the base of the derrick shown in FIG. 1 A.
  • FIG. 12 is a side view of an inflatable extraction sack of another embodiment extending through the ribs of a patient.
  • FIG. 13 is perspective view of an open-mouthed configuration of the extraction sack of FIG. 12 holding simulated tissue therein.
  • FIG. 14 is another view of the extraction sack of FIG. 12.
  • FIG. 15 is a plan view of another embodiment of a sack including a toroidal ring defining a mouth of the sack.
  • FIG. 16 is a side elevation view of the sack of FIG. 15.
  • FIG. 17 is a perspective view of the sack of FIG. 15 in a partially inflated (with a fluid such as air or water) configuration.
  • the devices, systems, and methods disclosed herein provide mechanical means for facilitating extraction of tissue through a constricted opening such as a small aperture or port site.
  • the implementations described herein provide systems and methods for using mechanical leverage and/or hydraulic pressure to facilitate organ, or other tissue, removal to reduce incision size in patients. These implementations described herein also provide a way for a user to avoid large manual forces for tissue extraction through a port.
  • tissue extraction system 10 configured for passage through a minimally invasive opening 20 to capture and remove a tissue structure 18 through the minimally invasive opening.
  • the system in one embodiment, as shown in FIGS. 1A, IB and 2, includes an extraction sack 12 and a derrick 14.
  • the extraction sack 12 is for deposition within a person’s body.
  • the derrick includes a frame 15 supporting a pulley system 16.
  • the pulley system 16 facilitates pulling the extraction sack 12 with the tissue structurel8 therein through the minimally invasive opening 20.
  • the tissue extraction system 10 comprises and/or further includes an extraction sack 12 comprising a flexible wall 24 and a toroidal ring 26.
  • the flexible wall 24 defines an inner chamber and an inflation port 76.
  • the toroidal ring 26 is disposed within the inner chamber of the flexible wall 24.
  • the flexible wall 24 of the extraction sack while in the patient, can be doubled over onto itself and pulled through the toroidal ring 26 to form a double walled sack 30 that can be inflated to eject the tissue structure 18.
  • the derrick 14 can include a base plate 32, a pair of legs 34, hinge bars 36, a strain gauge 38 and a hook assembly 40.
  • the base plate 32, legs 34 and hinge bars 36 are part of the frame 15 of the derrick 14.
  • the frame supports the pulley system 16 to facilitate extraction of the sack 12 with tissue structure 18 therein.
  • the base plate 32 is generally any surface meant to rest against the patient around the opening 20 and provide support for the rest of the assembly.
  • the illustrated base plate 32 for example includes a pair of square tubes 42 that are spaced apart and extend parallel to each other. Each of the tubes 42 defines a central opening housing each of a pair of inner tubes 44.
  • the inner tubes extend outwards from the open ends of the tubes 42, as shown in FIGS. 7, 10 and 11 for example.
  • the base plate 32 also includes a pair of threaded rods 46 that transfix the exposed ends of the inner tubes 44. As shown in FIG. 10, the threaded rods include pairs of nuts, including a wing nut, bracketing the exposed ends of the transfixed inner tubes 44. An operator can adjust the spacing of the outer tubes 42 and thus the width of the base plate 32 by adjusting the nuts on the threaded rods 46.
  • the base plate as shown in FIG. 7 simulates the patient with a sheet of plywood as the skin and subcutaneous tissue and metal bars 54 spaced 7/8 inches apart replicating rib spacing.
  • the metal bars 54 are attached to tensioning bands to replicate the forces used to push through ribs.
  • a pair of opposing openings 48 for receiving a retractor blade 50 are defined in the tubes 42.
  • FIG. 4 shows one type of retractor blade 50 that includes a shaft and a hook.
  • a pair of the retractor blades 50 are used by placing a pair of opposing retractor blades on either side of an opening in a patient, either through a patient’s ribs (such as between two ribs shown in FIG.
  • the retractor blades protect the edges of the wound or other opening in the patient. Application just against the skin and muscle leaves the retractor blades not occupying as much space in the tightest area to be traversed. Conversely the opening 20 may be made larger, for passage of larger sacks, by directly applying force to the rib cage.
  • the shafts of the retractor blades 50 extend through the opposing openings 48 defined through the pair of square tubes 42. Thus, the shafts of the blades are accessible for manual pulling of the retractor blades 50 to hold or expand the opening 20 in the patient.
  • the opposing openings 48 for example may be defined by sections of square channels with a diameter of about 7 mm to accommodate a range of retractor sizes, such as a BOOKW ALTER retractor system.
  • the derrick 14 is constructed to swing open to allow insertion of optional retractors and to protect the patient opening 20 from excessive lateral retraction forces.
  • the wing nuts and other parts of the assembly described above allow the operator to adjust the opening of the derrick and the spacing of the retractors.
  • the legs 34 of the frame extend up from the base plate 32 to two hinge bars 36 and the strain gauge 38 at the top of the derrick 14 - opposite the patient.
  • Each of the legs 34 includes a pair of leg members 52.
  • the proximal ends of each pair of the leg members 52 are coupled to one of the two hinge bars 36, and each leg member 52 is spaced apart from the other leg member 52 of the pair by a spacer block 53.
  • the spacer block positions the leg members 52 of each pair in a parallel, spaced relationship.
  • the leg members 52 may be constructed by square tubular members. At their distal ends (close to the patient) the tubular members are attached to the square tubes 42 that are part of the base plate 32 via opposingly directed pairs of L-brackets 54.
  • FIGS. 1 A and IB includes a strain gauge 38, in other embodiments, the system does not include a strain gauge.
  • FIGS. 7 and 11 show the L-brackets extending away from each other with one bottom bracket leg aligned with the plywood (tissue) and the other bracket leg extending 90 degrees upward along the outside and inside of the leg members 50.
  • Each pair of L-brackets secures one leg member 52 to one of the square tubes 42 via a plurality of bolts or other fasteners.
  • the distal portions of the leg members 52 and associated pair of L-brackets 54 are spaced from each other to provide space for the opposing openings 48. In one embodiment, this facilitates receipt of the shaft or stem of the retractor blades 50 through the openings 48.
  • FIGS. 1 A, IB and 2 show the proximal ends of the legs 34 where each pair of leg members are connected using fasteners and are connected to each other via hinge bars 36.
  • the vertical legs 34 can scissor about the hinge bars 36 to adjust the size of the base plate 32 as well as the height of the derrick 14.
  • the hinge bars 36 also provide a proximal connection for the pulley system 16.
  • the frame 15 itself can be expressed as any structure that supports the pulley system 16 or other leverage system for enhancing the mechanical strength and lowering the effort of the operator in removing the extraction sack 12 from the patient.
  • the frame 15 for example may be shaped as a box instead of a triangular derrick shape or may be a series of rings stacked and connected with crossbars for connection of the pulley system.
  • the frame 15 may also support multiple means for exerting leverage on the extraction sack 12 such as motors, winches, screws and the like to give the operator options for extraction.
  • the tissue extraction system 10 may also include the strain gauge 38 which is supported by the proximal ends of the legs 34.
  • the strain gauge 38 may include a hook or other connector that couples it to the proximal end of the pulley system 16.
  • the strain gauge is configured to measure the loads being exerted through the pulley system on the extraction sack 12.
  • the loads are correlated with the stress put on the tissue opening 20, allowing the operator to modulate the forces put on the patient to control the impact on the minimally invasive opening. Movement and forces within the system 10 can be monitored using a range of sensors like optical encoders to track motion in three dimensions and piezoelectric sensors for forces and moments being exerted by the system on the extraction sack and/or patient.
  • the pulley system 16 can include a fixed pulley 56, a free pulley 58, a cable 60, a coupler 62 and an adaptor assembly 64.
  • the fixed pulley 56 is fixed to the top of the frame 15 near or at the hinge bars 36 via a hook or other connector.
  • the fixed pulley 56 can comprise one or more (two in the illustrated embodiment) rotating wheels for receiving one or more windings of the cable 60.
  • the fixed pully anchors the end of the block-and- tackle arrangement that facilitates the operator’s extraction of the sack 12.
  • the fixed pulley 56 need not be a rotating wheel supported by a bearing - it can also be any surface that supports the cable 60 for force multiplication.
  • the fixed pulley 56 may be a cam surface for example over which the cable 60 slides on the way to the free pulley 58.
  • the free pulley 58 provides another surface for supporting the cable 60 for force multiplication and is configured to move with respect to the frame 15. Like the fixed pulley 56, other forms of a bearing surface can be used as the free pulley 58 such as a cam surface. Also, the free pulley 58 can have multiple wheels, such as the pair of collinear, adjacent wheels shown in FIG. 10. The bottom of the free pulley 58 supports a D-ring or other connection that can connect to the coupler 62. Or the coupler 62 can include the D-ring and other intervening structure as long as the load is coupled to the pulley system 16.
  • the coupler 62 is shown as a carabiner that is configured to attach to the extraction sack 12 via, for example, the adaptor assembly 64.
  • the adaptor assembly 64 is configured to provide a secure attachment between the pulley system 16 and the extraction sack 12.
  • the adaptor assembly 64 can, in one embodiment, include a ring 66, a pair of parallel support members 68, a plurality of clamp hooks 70 and a plurality of fasteners such as bolts 72.
  • the ring 66 is comprised of a semi-flexible or malleable strip material forming an elongate, closed loop.
  • the ring 66 is sized to have the open end of the extraction sack 12 wrapped therearound and secured, such as with a drawstring, as shown in FIGS. 10 and 11.
  • the ring 66 when extracted, evenly distributes tension around the circumference of the fabric or other material of the extraction sack 12. In addition, it maintains the opening 20 geometry to allow the tissue to extrude through the ribs and provides a robust attachment for the retraction hooks 70 without tearing through extraction the sack 12.
  • the parallel support members 68 are strips defining several openings for receiving bolts 72 to secure the clamp hooks 70 and a central bolt that extends between and connects the members.
  • a central one of the bolts 72 includes a butterfly nut on one end and has a threaded member extending between the support members 68. The threaded member is configured for coupling with the carabiner 62 of the pulley system 16.
  • Two clamp hooks 70 are connected to each of the support members 68 and are connected via a par of bolts 72. The clamp hooks 70 swing free and extend around the ring 66, trapping the extraction sack 12 wrapped therearound for further security, as shown in FIGS. 10 and 11.
  • the tissue extraction system 10 can employ a range of other ways to couple the extraction sack 12 with the mechanical force multiplier such as the pulley system 16.
  • the pulley system 16 provides the mechanical force multiplier by routing the cable 60 through the fixed pulley 56 and free pulley 58.
  • the cable 60 includes a first portion, a second portion and a middle portion.
  • the second portion is spaced axially (along the length of the cable) apart from the first portion.
  • the middle portion is disposed axially between the first and second portions.
  • the first portion is static, such as by being attached to the frame 15 of the derrick 14 and runs over the fixed pulley 56 before transitioning to being the middle portion.
  • the middle portion runs between the fixed pulley 56 and the free pulley 58 and then the distal, second portion can be pulled to move the free pulley toward the fixed pulley.
  • the free pulley 58 is moving up and is attached, via its center, to a coupling assembly - such as the coupler 62 and the adaptor assembly 64 - which is attached to the extraction sack 12, with the tissue structure 18 therein, is moved through the patient opening and away from the patient.
  • a coupling assembly - such as the coupler 62 and the adaptor assembly 64 - which is attached to the extraction sack 12, with the tissue structure 18 therein
  • the illustrated pulley system 16 is manually driven it can also be driven with automated power, such as via a motor, like a battery powered screw drive, to reduce the fatigue and workloads for the operator’s extraction of tissue structures.
  • the peak extraction force generally is less than 100 kg and approximately 25 kg in most instances.
  • the pulley system 16 needs to reduce such force levels along with some factor of safety.
  • the system can include a jackscrew, hydraulic press, or any other type of mechanical force multiplier device instead of, or in combination with, the pulley system to provide the mechanical force multiplier described above.
  • the extraction sack 12 has the flexible wall 24 to facilitate inflation and ejection of the tissue structure 18 through the minimally invasive opening 20. In this manner the extraction sack 12 is hydraulically enhanced to facilitate tissue removal.
  • the extraction sack can be used by itself or in combination with the derrick 14 to reduce fatigue and workloads for the operator.
  • the inflatable version of the extraction sack 12 includes the flexible wall 24 forming the inner chamber and the inflation port 76, as shown in FIG. 12, for example.
  • the extraction sack 12 also includes the toroidal ring 26 disposed within the inner chamber of the flexible wall 24.
  • the flexible wall 24 can be comprised of any flexible material that is relatively gas-impermeable (enough to generate the ejection forces on the tissue structure 18) and/or liquid impermeable.
  • the flexible wall is comprised of some sturdy and impervious fabric or membrane formed, such as by sealing multiple sheets, into a spherical or cylindrical inflatable bladder.
  • the flexible wall 24 is formed around the toroidal ring 26 that is shaped and formed of materials for wound protection.
  • the extraction sack 12 in one configuration extends through ribs 74 with the toroidal ring 26 outside the patient and the bulk of the sack remaining in the patient. Because the extraction sack 12 is formed of the flexible wall 24 being doubled over, the extraction sack 12 has a double walled structure.
  • the extraction sack 12 also includes an inflation port 76.
  • the inflation port is configured to pass inflation fluids into the interior of the flexible wall 24 creating a “birthing process” style ejection of the tissue structure 18 from inside the ribs, through the ribs (urging them apart) and then out of the mouth of the sack.
  • the inflation port 76 in one aspect is positioned at the bottom of where the sack 12 is formed in the patient. But the operator can rearrange the sack 12 to have the inflation port 76 positioned outside the patient or in some other selected position.
  • the inflation port 76 can be formed by any structure that facilitates communication with a pressurized fluid source but limits leakage during the birthing or ejection process. Multiple inflation ports may also be used for the convenience of the operator.
  • the extraction sack 12 could also include multiple inflation chambers for additional control of the ejection process.
  • the extraction sack 12 can also be filled from a catheter located beside the sack or within the inner portion of the flexible wall 24 making up the side of the double walled sack 30.
  • FIG. 13 shows the extraction sack 12 formed within the rib cage and the tissue structure 18 loaded through the mouth of the sack which is supported in the open condition by the toroidal ring 26.
  • the mouth of the sack and the toroidal ring 26 are pulled through the rib cage (or other minimally invasive opening 20) into the configuration of FIGS. 12 and 14.
  • the extraction sack 12 is then inflated to urge the tissue structure 18 through the ribs.
  • FIGS. 15-17 show another embodiment of the extraction sack 12 formed of a clear plastic providing good visualization of the toroidal ring 26 and the tissue structure 18.
  • FIG. 15 to form the sack from the flexible wall 24 inside the patient, half of the deflated flexible wall 24 is inverted and folded into the center of the toroidal ring 26.
  • the ring holds the sack open to ease insertion of the tissue structure 18, as shown in FIG. 16.
  • the toroidal ring 26 anchors the extraction sack 12 to the surface of the patient within the base plate 32 and around the minimally invasive opening 20.
  • a pressurized fluid line is attached to the inflation port 76 and fills the extraction sack 12 with pressurized air or other fluid.
  • the intramural pressure of the extraction sack 12 pulls the portion of the wall structure tucked into the toroidal ring 26 over the toroidal ring 26.
  • the pressure within the extraction sack 12 urges the bottom of the tucked portion of the wall structure up through the opening of the toroidal ring 26.
  • the tissue structure 18 is then pushed through the opening of the toroidal ring 26. Because the toroidal ring is adjacent to or within the minimally invasive opening 20 the tissue structure 18 is also urged out of the opening in a “birthing” process.
  • the double wall 30 of the sack 12 becomes a single- walled inflatable member with a rounded shape.
  • the birthing process is created because the external portion of the flexible wall 24 is deformable but unable to stretch, pushing the inner portion of the flexible wall and its contents out of the center of the toroidal ring 26.
  • toroidal ring 26 is not fixed, the inner portion of the flexible wall 24 rolls around the shape of the toroid to facilitate extraction of the tissue structure 18. Any shape that expands to create a stable platform could work but the ring/loop/toroid is most likely to distribute forces evenly and allow the sack to roll out when inflated.
  • a gaseous fluid such as air will result in faster ejection of the tissue structure than liquids such as water.
  • Various other implementations include a method of removing tissue from within a patient.
  • the method includes providing the derrick 14 and extraction sack 12 as described above, inserting the sack 12 through the minimally invasive opening 20 in a patient while the sack 12 is in the collapsed configuration, tucking half the flexible wall 24 through the toroidal ring 26 to form the sack with the mouth opening, disposing a tissue structure within the inner volume of the sack 12, extracting the mouth of the extraction sack 12 and the toroidal ring 26 through the opening 20 and, optionally, attaching the toroidal ring and sack to the pulley system 16 and simultaneously, or in alternation, inflating the extraction sack and pulling on the sack with the pulley system to eject the tissue structure 18.
  • Advantages of the embodiments and implementations of the invention include extraction of surgically dissected human tissue through small apertures or port sites, avoiding painful larger extraction openings.
  • Mechanical and hydraulic forces are combined to ease manual workloads.
  • the system amplifies or replaces surgeon extraction forces for a range of conventional and novel surgical approaches.
  • the base frame and retractors of the derrick can be adjusted to prevent excessive retraction in two dimensions, avoiding, for example, rib fractures with extraction of large organs.
  • Vertical elements of the derrick create a traction point for multiple optional mechanical force generators, such as block and tackle systems.
  • Use of pulleys for example remove tissue more easily and prevent over expansion of the port or wound.
  • the retractor blades can absorb the lateral extraction forces, especially between ribs.
  • the inflatable extraction sack aids in internal forces and can be combined with aided external forces of the derrick in a single system.
  • the inflatable extraction sack can add internal forces to aid pulling forces.
  • the positive pressure can create a relatively large force as opposed to suction pressures or pulling pressures.
  • the use of the ring can hold the sack open and eliminates the need for expanding frames. Delivery of the toroidal ring outside the patient and supporting it on the skin surface or within the opening to protect the skin and incision or wound.
  • the toroidal ring can be coupled to the derrick and then the remaining hemi-spheroid sack can be inflated and pulled simultaneously. Once the specimen is “birthed” the sack can be deflated and easily removed.
  • the system is also useful with automated surgical procedures, such as robotic surgery.
  • a tissue extraction system comprising: an extraction sack for disposing within a body of a person; and a derrick comprising: a base for contacting the body, a fixed pulley coupled to the base, a free pulley, a cable having a first portion, a second portion axially spaced apart from the first portion, and a middle portion disposed axially between the first portion and the second portion, wherein the first portion of the cable is static with respect to the fixed pulley or the free pulley, wherein the middle portion of the cable extends around the fixed pulley and the free pulley, and a coupler configured to couple the extraction sack to the free pulley; wherein application of a force to the second portion of the cable causes the free pulley to move from a first position to a second position, wherein the free pulley is closer to the fixed pulley in the second position than it is in the first position.
  • Exemplary Aspect 2 The tissue extraction system of exemplary aspect 1, wherein the derrick further comprises one or more legs extending from the base, wherein the fixed pulley is coupled to the base by the one or more legs.
  • Exemplary Aspect 3 The tissue extraction system of exemplary aspect 1, wherein the derrick further comprises a strain gauge for measuring a force on the fixed pulley.
  • Exemplary Aspect 4 The tissue extraction system of exemplary aspect 1, wherein the coupler comprises one or more clamps.
  • Exemplary Aspect 5 The tissue extraction system of exemplary aspect 1, wherein the coupler comprises one or more hooks for coupling the extraction sack to the free pulley.
  • Exemplary Aspect 6 The tissue extraction system of exemplary aspect 5, wherein the one or more hooks comprise one or more carabiners.
  • Exemplary Aspect 7 The tissue extraction system of exemplary aspect 1, wherein the base defines one or more retractor openings each configured to accept at least one retractor blade, wherein the at least one retractor blade is oriented toward the free pulley when disposed within the one or more retractor openings.
  • Exemplary Aspect 8 The tissue extraction system of exemplary aspect 1, wherein the derrick further comprises a motor for applying the force to the second portion of the cable.
  • Exemplary Aspect 9 The tissue extraction system of exemplary aspect 1, wherein the extraction sack further comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber; and a toroidal ring disposed within an inner cavity of the body of the person, the toroidal ring being separate from the flexible wall.
  • Exemplary Aspect 10 The tissue extraction system of exemplary aspect 9, wherein the toroidal ring comprises a semi rigid material.
  • Exemplary Aspect 11 The tissue extraction system of exemplary aspect 9, further comprising a drawstring for constricting a portion of the flexible wall.
  • Exemplary Aspect 12 The tissue extraction system of exemplary aspect 9, further comprising a conduit coupled to and in fluid communication with the inflation port.
  • a tissue extraction sack comprising: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber; and a toroidal ring disposed within an inner cavity of a body of a person, the toroidal ring being separate from the flexible wall.
  • Exemplary Aspect 14 The tissue extraction sack of exemplary aspect 13, wherein the toroidal ring comprises a semi rigid material.
  • Exemplary Aspect 15 The tissue extraction sack of exemplary aspect 14, further comprising a drawstring for constricting a portion of the flexible wall.
  • Exemplary Aspect 16 The tissue extraction sack of exemplary aspect 13, further comprising a conduit coupled to and in fluid communication with the inflation port.
  • Exemplary Aspect 17 A method of extracting a tissue from a body of a person, the method comprising: inserting an extraction sack through an opening a body of a person such that the extraction sack is disposed within the body of the person, wherein the extraction sack defines an open end; inserting tissue within the extraction sack; inserting the open end of the extraction sack through the opening in the body of the person; disposing a derrick on the body of the person at the opening, the derrick comprising: a base for contacting the body of the person, a fixed pulley coupled to the base, a free pulley, a cable having a first portion, a second portion axially spaced apart from the first portion, and a middle portion disposed axially between the first portion and the second portion, wherein the first portion of the cable is static with respect to the fixed pulley or the free pulley, wherein the middle portion of the cable extends around the fixed pulley and the free pulley, and a coupler configured to couple the
  • Exemplary Aspect 18 The method of exemplary aspect 17, wherein the derrick further comprises one or more legs extending from the base, wherein the fixed pulley is coupled to the base by the one or more legs.
  • Exemplary Aspect 19 The method of exemplary aspect 17, wherein the derrick further comprises a strain gauge for measuring a force on the fixed pulley.
  • Exemplary Aspect 20 The method of exemplary aspect 17, wherein the coupler comprises one or more clamps.
  • Exemplary Aspect 21 The method of exemplary aspect 17, wherein the coupler comprises one or more hooks for coupling the extraction sack to the free pulley.
  • Exemplary Aspect 22 The method of exemplary aspect 21, wherein the one or more hooks comprise one or more carabiners.
  • Exemplary Aspect 23 The method of exemplary aspect 17, wherein the base defines one or more retractor openings each configured to accept at least one retractor blade, wherein the at least one retractor blade is oriented toward the free pulley when disposed within the one or more retractor openings.
  • Exemplary Aspect 24 The method of exemplary aspect 17, wherein the derrick further comprises a motor for applying the force to the second portion of the cable.
  • Exemplary Aspect 25 The method of exemplary aspect 17, wherein the extraction sack further comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber, and a toroidal ring disposed within an inner cavity of the body of the person, the toroidal ring being separate from the flexible wall, wherein the method further comprises causing a fluid to flow through the inflation port and into the inner chamber to cause a portion of the extraction sack and the tissue to move through the toroidal ring and exit the body of the person.
  • Exemplary Aspect 26 The method of exemplary aspect 25, wherein the toroidal ring comprises a semi rigid material.
  • Exemplary Aspect 27 The method of exemplary aspect 25, further comprising a drawstring for constricting a portion of the flexible wall.
  • Exemplary Aspect 28 The method of exemplary aspect 25, further comprising a conduit coupled to and in fluid communication with the inflation port.
  • Exemplary Aspect 29 The method of exemplary aspect 25, wherein the fluid is water.
  • Exemplary Aspect 30 A method of extracting a tissue structure from a body of a person, the method comprising: inserting an extraction sack through a body opening such that the extraction sack is disposed within the body of the person, wherein the extraction sack comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber, and a toroidal ring disposed within the inner chamber, the toroidal ring being separate from the flexible wall; inserting a portion of the flexible wall of the extraction sack through the toroidal ring to form a double walled sack defining an open end at the toroidal ring; inserting the tissue structure within the double walled sack; pulling the open end and ring of the double walled sack out through the body opening; and causing a fluid to flow through the inflation port and into the inner chamber to cause the portion of the extraction sack and the tissue to move through the ring and exit through the body opening.
  • Exemplary Aspect 31 The method of exemplary aspect 30, wherein the ring comprises a semi rigid material.
  • Exemplary Aspect 32 The method of exemplary aspect 30, further comprising a drawstring for constricting a portion of the wall.
  • Exemplary Aspect 33 The method of exemplary aspect 30, further comprising a conduit coupled to and in fluid communication with the inflation port.
  • Exemplary Aspect 34 The method of exemplary aspect 30, wherein the fluid is water.

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Abstract

Various implementations include a tissue extraction system configured for passage through a minimally invasive opening to capture and remove a tissue structure. The system includes an extraction sack and a derrick. The extraction sack is for deposition within a person's body. The derrick includes a frame supporting a pulley system. The pulley system facilitates pulling the extraction sack with the tissue therein through the minimally invasive opening. The tissue extraction system comprises and/or further includes an extraction sack comprising a flexible wall and a toroidal ring. The flexible wall defines an inner chamber and an inflation port. The toroidal ring is disposed within the inner chamber of the flexible wall. The flexible wall of the extraction sack, while in the patient, can be doubled over onto itself and pulled through the toroidal ring to form a double walled sack that can be inflated to eject the tissue structure.

Description

MECHANICAL DISPLACEMENT DEVICES, SYSTEMS, AND METHODS TO ENHANCE EXTRACTION OF SURGICAL SPECIMENS
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims benefit of U.S. Provisional Application No. 63/349,646, filed June 7, 2022, which is hereby incorporated herein by reference in its entirety.
BACKGROUND
[0002] Physicians often need to remove tissue structures/surgical specimens from patients for health and diagnostic reasons such as microscopic evaluations. Extraction of a surgical specimen such as an organ traditionally requires creation of a larger wound than the wound needed to disconnect it from surrounding tissue. In many operations, this larger wound is also traumatized by stretching forces. Such a wound can create unwanted cosmetic results and can cause pain if there is prolongation of convalescence. Further, compared to the wound needed to disconnect a surgical specimen from surrounding tissue, traditional wounds for extraction of a surgical specimen can create increased risk of complications like pneumonia because of the effects larger wounds have on respiratory mechanics.
[0003] In addition, existing systems for extraction of tissues through ports tend to require large manual efforts and be physically taxing for surgeons.
[0004] Thus, there exists a need for an improved minimally invasive system and method to remove tissue, such as organs, from a living patient.
SUMMARY OF THE INVENTION
[0005] Various implementations include a tissue extraction system configured for passage through a minimally invasive opening to capture and remove a tissue structure. The system includes an extraction sack and a derrick. The extraction sack is for deposition within a person’s body. The derrick includes a frame supporting a pulley system. The pulley system facilitates pulling the extraction sack with the tissue therein through the minimally invasive opening. The tissue extraction system comprises and/or further includes an extraction sack comprising a flexible wall and a toroidal ring. The flexible wall defines an inner chamber and an inflation port. The toroidal ring is disposed within the inner chamber of the flexible wall. The flexible wall of the extraction sack, while in the patient, can be doubled over onto itself and pulled through the toroidal ring to form a double walled sack that can be inflated to eject the tissue structure.
[0006] Another embodiment includes a tissue extraction system including an extraction sack and a derrick. The extraction sack is for disposing within a body of a person. The derrick includes a base, a fixed pulley, a free pulley, a cable and a coupler. The base is configured to contact the body. The fixed pulley is coupled to the base. The cable has a first portion, a second portion and a middle portion. The second portion is spaced axially apart from the first portion. The middle portion is disposed between the first and second portions. The first portion of the cable is static with respect to the fixed or free pulley. The middle portion extends around the fixed pulley and the free pulley. The coupler is configured to couple to the extraction sack to the free pulley. The application of a force to the second portion of the cable causes the free pulley to move from a first to a second position. The free pulley is closer to the second pulley (in the second position) than in the first position. When the free pulley is coupled to the extraction sack, it urges the extraction sack out of the opening in the patient.
[0007] In another aspect, the extraction sack includes a flexible wall and a toroidal ring. The flexible wall defines an inner chamber. The flexible wall also defines an inflation port in fluid communication with the inner chamber. The toroidal ring is disposed within an inner cavity of a body of a person and is a separate structure from the flexible wall of the extraction sack.
[0008] The ring, for example, may comprise a semi rigid material. The sack may also include a drawstring for constricting a portion of the wall. Also included may be a conduit configured to couple to the inflation port.
[0009] Another embodiment includes a method of extracting a tissue from a body is included. The method includes inserting an extraction sack through an opening a body of a person such that the extraction sack is disposed within the body of the person, wherein the sack defines an open end. The method also includes inserting tissue within the sack. The open end of the sack is extracted (inserted) through the opening in the body of the person. A derrick, such as the derrick described above, is disposed on the body of the person at the opening. Also, the method includes coupling the coupler to the open end of the sack. Further, the method can include applying force to the second portion of the cable to cause the free pulley to move from the first position to the second position such that the sack exits the body of the person. BRIEF DESCRIPTION OF THE DRAWINGS
[0010] Example features and implementations are disclosed in the accompanying drawings. However, the present disclosure is not limited to the precise arrangements and instrumentalities shown.
[0011] FIG. 1 A shows an elevation view of a tissue extraction system of one embodiment including a derrick and an extraction sack.
[0012] FIG. IB shows an elevation view of the top portion of the derrick of the system of FIG. 1A.
[0013] FIG. 2 shows an elevation view of the system of FIG. 1A mounted to a simulated patient in the form of a sheet of plywood.
[0014] FIG. 3 is a side elevation view of the sack of FIG. 1A.
[0015] FIG. 4 is a perspective view of a retractor used in the system of FIG. 1A.
[0016] FIG. 5 is a plan view of a set of simulated ribs through which tissue can be extracted using the system of FIG. 1A.
[0017] FIG. 6 is a schematic showing different uses of the retractor of FIG. 4.
[0018] FIG. 7 is a view of a base of the derrick of FIG. 2 mounted on the plywood with a simulated rib opening.
[0019] FIG. 8 is a malleable ring for support and anchoring of the sack of FIG. 3 in the system of FIG. 1A.
[0020] FIG. 9 is a perspective view of a coupler for connecting the malleable ring of FIG. 8 to a pulley system of FIG. 1A.
[0021] FIG. 10 is a perspective view of the coupler of FIG. 9 coupling the sack the bottom of the pulley system of FIG. 1A.
[0022] FIG. 11 is a perspective view of the base of the derrick shown in FIG. 1 A.
[0023] FIG. 12 is a side view of an inflatable extraction sack of another embodiment extending through the ribs of a patient.
[0024] FIG. 13 is perspective view of an open-mouthed configuration of the extraction sack of FIG. 12 holding simulated tissue therein. [0025] FIG. 14 is another view of the extraction sack of FIG. 12.
[0026] FIG. 15 is a plan view of another embodiment of a sack including a toroidal ring defining a mouth of the sack.
[0027] FIG. 16 is a side elevation view of the sack of FIG. 15.
[0028] FIG. 17 is a perspective view of the sack of FIG. 15 in a partially inflated (with a fluid such as air or water) configuration.
DETAILED DESCRIPTION
[0029] The devices, systems, and methods disclosed herein provide mechanical means for facilitating extraction of tissue through a constricted opening such as a small aperture or port site. The implementations described herein provide systems and methods for using mechanical leverage and/or hydraulic pressure to facilitate organ, or other tissue, removal to reduce incision size in patients. These implementations described herein also provide a way for a user to avoid large manual forces for tissue extraction through a port.
[0030] Various implementations include a tissue extraction system 10 configured for passage through a minimally invasive opening 20 to capture and remove a tissue structure 18 through the minimally invasive opening. The system in one embodiment, as shown in FIGS. 1A, IB and 2, includes an extraction sack 12 and a derrick 14. The extraction sack 12 is for deposition within a person’s body. The derrick includes a frame 15 supporting a pulley system 16. The pulley system 16 facilitates pulling the extraction sack 12 with the tissue structurel8 therein through the minimally invasive opening 20. In another embodiment, as shown for example in FIG. 12, the tissue extraction system 10 comprises and/or further includes an extraction sack 12 comprising a flexible wall 24 and a toroidal ring 26. The flexible wall 24 defines an inner chamber and an inflation port 76. The toroidal ring 26 is disposed within the inner chamber of the flexible wall 24. The flexible wall 24 of the extraction sack, while in the patient, can be doubled over onto itself and pulled through the toroidal ring 26 to form a double walled sack 30 that can be inflated to eject the tissue structure 18. Advantages of these features, alone and in combination, include reducing enlargement of the opening in the patient and the manual workload of the health care personnel.
[0031] As shown in FIGS. 1 A, IB and 2, the derrick 14 can include a base plate 32, a pair of legs 34, hinge bars 36, a strain gauge 38 and a hook assembly 40. The base plate 32, legs 34 and hinge bars 36 are part of the frame 15 of the derrick 14. Generally, the frame supports the pulley system 16 to facilitate extraction of the sack 12 with tissue structure 18 therein.
[0032] The base plate 32 is generally any surface meant to rest against the patient around the opening 20 and provide support for the rest of the assembly. The illustrated base plate 32 for example includes a pair of square tubes 42 that are spaced apart and extend parallel to each other. Each of the tubes 42 defines a central opening housing each of a pair of inner tubes 44. The inner tubes extend outwards from the open ends of the tubes 42, as shown in FIGS. 7, 10 and 11 for example. The base plate 32 also includes a pair of threaded rods 46 that transfix the exposed ends of the inner tubes 44. As shown in FIG. 10, the threaded rods include pairs of nuts, including a wing nut, bracketing the exposed ends of the transfixed inner tubes 44. An operator can adjust the spacing of the outer tubes 42 and thus the width of the base plate 32 by adjusting the nuts on the threaded rods 46.
[0033] The base plate as shown in FIG. 7 simulates the patient with a sheet of plywood as the skin and subcutaneous tissue and metal bars 54 spaced 7/8 inches apart replicating rib spacing. The metal bars 54 are attached to tensioning bands to replicate the forces used to push through ribs. Defined in the tubes 42 are a pair of opposing openings 48 for receiving a retractor blade 50. For example, FIG. 4 shows one type of retractor blade 50 that includes a shaft and a hook. Generally, a pair of the retractor blades 50 are used by placing a pair of opposing retractor blades on either side of an opening in a patient, either through a patient’s ribs (such as between two ribs shown in FIG. 5) or just against the skin and muscle, as shown in FIG. 6. The retractor blades protect the edges of the wound or other opening in the patient. Application just against the skin and muscle leaves the retractor blades not occupying as much space in the tightest area to be traversed. Conversely the opening 20 may be made larger, for passage of larger sacks, by directly applying force to the rib cage. The shafts of the retractor blades 50 extend through the opposing openings 48 defined through the pair of square tubes 42. Thus, the shafts of the blades are accessible for manual pulling of the retractor blades 50 to hold or expand the opening 20 in the patient.
[0034] The opposing openings 48 for example may be defined by sections of square channels with a diameter of about 7 mm to accommodate a range of retractor sizes, such as a BOOKW ALTER retractor system. Generally, the derrick 14 is constructed to swing open to allow insertion of optional retractors and to protect the patient opening 20 from excessive lateral retraction forces. The wing nuts and other parts of the assembly described above allow the operator to adjust the opening of the derrick and the spacing of the retractors.
[0035] As shown in FIGS. 1 A and IB, the legs 34 of the frame extend up from the base plate 32 to two hinge bars 36 and the strain gauge 38 at the top of the derrick 14 - opposite the patient. Each of the legs 34 includes a pair of leg members 52. The proximal ends of each pair of the leg members 52 are coupled to one of the two hinge bars 36, and each leg member 52 is spaced apart from the other leg member 52 of the pair by a spacer block 53. The spacer block positions the leg members 52 of each pair in a parallel, spaced relationship. Like other parts of the derrick 14, the leg members 52 may be constructed by square tubular members. At their distal ends (close to the patient) the tubular members are attached to the square tubes 42 that are part of the base plate 32 via opposingly directed pairs of L-brackets 54.
[0036] Although the embodiment shown in FIGS. 1 A and IB includes a strain gauge 38, in other embodiments, the system does not include a strain gauge.
[0037] FIGS. 7 and 11 show the L-brackets extending away from each other with one bottom bracket leg aligned with the plywood (tissue) and the other bracket leg extending 90 degrees upward along the outside and inside of the leg members 50. Each pair of L-brackets secures one leg member 52 to one of the square tubes 42 via a plurality of bolts or other fasteners. The distal portions of the leg members 52 and associated pair of L-brackets 54 are spaced from each other to provide space for the opposing openings 48. In one embodiment, this facilitates receipt of the shaft or stem of the retractor blades 50 through the openings 48.
[0038] FIGS. 1 A, IB and 2 show the proximal ends of the legs 34 where each pair of leg members are connected using fasteners and are connected to each other via hinge bars 36. The vertical legs 34 can scissor about the hinge bars 36 to adjust the size of the base plate 32 as well as the height of the derrick 14. The hinge bars 36 also provide a proximal connection for the pulley system 16.
[0039] It should be noted that although a particular structure and configuration of the derrick 14 and its frame 15 is illustrated in the figures, the frame itself can be expressed as any structure that supports the pulley system 16 or other leverage system for enhancing the mechanical strength and lowering the effort of the operator in removing the extraction sack 12 from the patient. The frame 15 for example may be shaped as a box instead of a triangular derrick shape or may be a series of rings stacked and connected with crossbars for connection of the pulley system. The frame 15 may also support multiple means for exerting leverage on the extraction sack 12 such as motors, winches, screws and the like to give the operator options for extraction.
[0040] The tissue extraction system 10 may also include the strain gauge 38 which is supported by the proximal ends of the legs 34. The strain gauge 38 may include a hook or other connector that couples it to the proximal end of the pulley system 16. The strain gauge is configured to measure the loads being exerted through the pulley system on the extraction sack 12. In addition, the loads are correlated with the stress put on the tissue opening 20, allowing the operator to modulate the forces put on the patient to control the impact on the minimally invasive opening. Movement and forces within the system 10 can be monitored using a range of sensors like optical encoders to track motion in three dimensions and piezoelectric sensors for forces and moments being exerted by the system on the extraction sack and/or patient.
[0041] As shown in FIGS. 1 A, IB, 2 and 10, for example, the pulley system 16 can include a fixed pulley 56, a free pulley 58, a cable 60, a coupler 62 and an adaptor assembly 64. The fixed pulley 56 is fixed to the top of the frame 15 near or at the hinge bars 36 via a hook or other connector. The fixed pulley 56 can comprise one or more (two in the illustrated embodiment) rotating wheels for receiving one or more windings of the cable 60. The fixed pully anchors the end of the block-and- tackle arrangement that facilitates the operator’s extraction of the sack 12. The fixed pulley 56 need not be a rotating wheel supported by a bearing - it can also be any surface that supports the cable 60 for force multiplication. The fixed pulley 56 may be a cam surface for example over which the cable 60 slides on the way to the free pulley 58.
[0042] The free pulley 58 provides another surface for supporting the cable 60 for force multiplication and is configured to move with respect to the frame 15. Like the fixed pulley 56, other forms of a bearing surface can be used as the free pulley 58 such as a cam surface. Also, the free pulley 58 can have multiple wheels, such as the pair of collinear, adjacent wheels shown in FIG. 10. The bottom of the free pulley 58 supports a D-ring or other connection that can connect to the coupler 62. Or the coupler 62 can include the D-ring and other intervening structure as long as the load is coupled to the pulley system 16. The coupler 62 is shown as a carabiner that is configured to attach to the extraction sack 12 via, for example, the adaptor assembly 64. [0043] The adaptor assembly 64 is configured to provide a secure attachment between the pulley system 16 and the extraction sack 12. As shown in FIGS. 9-11, the adaptor assembly 64 can, in one embodiment, include a ring 66, a pair of parallel support members 68, a plurality of clamp hooks 70 and a plurality of fasteners such as bolts 72. As shown in FIG. 8, the ring 66 is comprised of a semi-flexible or malleable strip material forming an elongate, closed loop. The ring 66 is sized to have the open end of the extraction sack 12 wrapped therearound and secured, such as with a drawstring, as shown in FIGS. 10 and 11. The ring 66, when extracted, evenly distributes tension around the circumference of the fabric or other material of the extraction sack 12. In addition, it maintains the opening 20 geometry to allow the tissue to extrude through the ribs and provides a robust attachment for the retraction hooks 70 without tearing through extraction the sack 12.
[0044] The parallel support members 68 are strips defining several openings for receiving bolts 72 to secure the clamp hooks 70 and a central bolt that extends between and connects the members. As shown in FIG. 9, a central one of the bolts 72 includes a butterfly nut on one end and has a threaded member extending between the support members 68. The threaded member is configured for coupling with the carabiner 62 of the pulley system 16. Two clamp hooks 70 are connected to each of the support members 68 and are connected via a par of bolts 72. The clamp hooks 70 swing free and extend around the ring 66, trapping the extraction sack 12 wrapped therearound for further security, as shown in FIGS. 10 and 11. Notably, the tissue extraction system 10 can employ a range of other ways to couple the extraction sack 12 with the mechanical force multiplier such as the pulley system 16.
[0045] The pulley system 16, in one embodiment, provides the mechanical force multiplier by routing the cable 60 through the fixed pulley 56 and free pulley 58. In particular, the cable 60 includes a first portion, a second portion and a middle portion. The second portion is spaced axially (along the length of the cable) apart from the first portion. The middle portion is disposed axially between the first and second portions. The first portion is static, such as by being attached to the frame 15 of the derrick 14 and runs over the fixed pulley 56 before transitioning to being the middle portion. The middle portion runs between the fixed pulley 56 and the free pulley 58 and then the distal, second portion can be pulled to move the free pulley toward the fixed pulley. Because the free pulley 58 is moving up and is attached, via its center, to a coupling assembly - such as the coupler 62 and the adaptor assembly 64 - which is attached to the extraction sack 12, with the tissue structure 18 therein, is moved through the patient opening and away from the patient.
[0046] Although the illustrated pulley system 16 is manually driven it can also be driven with automated power, such as via a motor, like a battery powered screw drive, to reduce the fatigue and workloads for the operator’s extraction of tissue structures. The peak extraction force generally is less than 100 kg and approximately 25 kg in most instances. Thus, the pulley system 16 needs to reduce such force levels along with some factor of safety.
[0047] In some embodiments, the system can include a jackscrew, hydraulic press, or any other type of mechanical force multiplier device instead of, or in combination with, the pulley system to provide the mechanical force multiplier described above.
[0048] In other embodiments, as shown in FIGS. 12-20, the extraction sack 12 has the flexible wall 24 to facilitate inflation and ejection of the tissue structure 18 through the minimally invasive opening 20. In this manner the extraction sack 12 is hydraulically enhanced to facilitate tissue removal. The extraction sack can be used by itself or in combination with the derrick 14 to reduce fatigue and workloads for the operator. The inflatable version of the extraction sack 12 includes the flexible wall 24 forming the inner chamber and the inflation port 76, as shown in FIG. 12, for example. The extraction sack 12 also includes the toroidal ring 26 disposed within the inner chamber of the flexible wall 24.
[0049] The flexible wall 24 can be comprised of any flexible material that is relatively gas-impermeable (enough to generate the ejection forces on the tissue structure 18) and/or liquid impermeable. Generally, the flexible wall is comprised of some sturdy and impervious fabric or membrane formed, such as by sealing multiple sheets, into a spherical or cylindrical inflatable bladder. The flexible wall 24 is formed around the toroidal ring 26 that is shaped and formed of materials for wound protection.
[0050] As shown in FIGS. 12 and 14, prior to inflation, the extraction sack 12 in one configuration extends through ribs 74 with the toroidal ring 26 outside the patient and the bulk of the sack remaining in the patient. Because the extraction sack 12 is formed of the flexible wall 24 being doubled over, the extraction sack 12 has a double walled structure. The extraction sack 12 also includes an inflation port 76.
[0051] The inflation port is configured to pass inflation fluids into the interior of the flexible wall 24 creating a “birthing process” style ejection of the tissue structure 18 from inside the ribs, through the ribs (urging them apart) and then out of the mouth of the sack. The inflation port 76 in one aspect is positioned at the bottom of where the sack 12 is formed in the patient. But the operator can rearrange the sack 12 to have the inflation port 76 positioned outside the patient or in some other selected position. The inflation port 76 can be formed by any structure that facilitates communication with a pressurized fluid source but limits leakage during the birthing or ejection process. Multiple inflation ports may also be used for the convenience of the operator. The extraction sack 12 could also include multiple inflation chambers for additional control of the ejection process. The extraction sack 12 can also be filled from a catheter located beside the sack or within the inner portion of the flexible wall 24 making up the side of the double walled sack 30.
[0052] FIG. 13 shows the extraction sack 12 formed within the rib cage and the tissue structure 18 loaded through the mouth of the sack which is supported in the open condition by the toroidal ring 26. After the tissue is loaded into the extraction sack 12 the mouth of the sack and the toroidal ring 26 are pulled through the rib cage (or other minimally invasive opening 20) into the configuration of FIGS. 12 and 14. As will be described later, the extraction sack 12 is then inflated to urge the tissue structure 18 through the ribs.
[0053] FIGS. 15-17 show another embodiment of the extraction sack 12 formed of a clear plastic providing good visualization of the toroidal ring 26 and the tissue structure 18. As shown in FIG. 15, to form the sack from the flexible wall 24 inside the patient, half of the deflated flexible wall 24 is inverted and folded into the center of the toroidal ring 26. When inside, the ring holds the sack open to ease insertion of the tissue structure 18, as shown in FIG. 16. When drawn outside, the toroidal ring 26 anchors the extraction sack 12 to the surface of the patient within the base plate 32 and around the minimally invasive opening 20.
[0054] A pressurized fluid line is attached to the inflation port 76 and fills the extraction sack 12 with pressurized air or other fluid. As shown in FIG. 17, The intramural pressure of the extraction sack 12 pulls the portion of the wall structure tucked into the toroidal ring 26 over the toroidal ring 26. Also, the pressure within the extraction sack 12 urges the bottom of the tucked portion of the wall structure up through the opening of the toroidal ring 26. As shown in FIG. 17, the tissue structure 18 is then pushed through the opening of the toroidal ring 26. Because the toroidal ring is adjacent to or within the minimally invasive opening 20 the tissue structure 18 is also urged out of the opening in a “birthing” process. Eventually the double wall 30 of the sack 12 becomes a single- walled inflatable member with a rounded shape. Viewed from another perspective, without being wed to theory, the birthing process is created because the external portion of the flexible wall 24 is deformable but unable to stretch, pushing the inner portion of the flexible wall and its contents out of the center of the toroidal ring 26. Because toroidal ring 26 is not fixed, the inner portion of the flexible wall 24 rolls around the shape of the toroid to facilitate extraction of the tissue structure 18. Any shape that expands to create a stable platform could work but the ring/loop/toroid is most likely to distribute forces evenly and allow the sack to roll out when inflated. Generally, a gaseous fluid such as air will result in faster ejection of the tissue structure than liquids such as water.
[0055] Lateral distraction and peak extraction forces experienced using conventional manual extraction techniques of 14.7+/-1.3 lbs. and 29.7+/-4.0 lbs., respectively. At times extraction peak forces exceeded 50 lbs., replicating the occasional high efforts observed clinically in removing specimens causing patient movement and prolonged operative times. Embodiments of the present invention lowered the incidence of such forces and patient movement and reduced operative times.
[0056] Various other implementations include a method of removing tissue from within a patient. The method includes providing the derrick 14 and extraction sack 12 as described above, inserting the sack 12 through the minimally invasive opening 20 in a patient while the sack 12 is in the collapsed configuration, tucking half the flexible wall 24 through the toroidal ring 26 to form the sack with the mouth opening, disposing a tissue structure within the inner volume of the sack 12, extracting the mouth of the extraction sack 12 and the toroidal ring 26 through the opening 20 and, optionally, attaching the toroidal ring and sack to the pulley system 16 and simultaneously, or in alternation, inflating the extraction sack and pulling on the sack with the pulley system to eject the tissue structure 18.
[0057] Advantages of the embodiments and implementations of the invention include extraction of surgically dissected human tissue through small apertures or port sites, avoiding painful larger extraction openings. Mechanical and hydraulic forces are combined to ease manual workloads. The system amplifies or replaces surgeon extraction forces for a range of conventional and novel surgical approaches. The base frame and retractors of the derrick can be adjusted to prevent excessive retraction in two dimensions, avoiding, for example, rib fractures with extraction of large organs. Vertical elements of the derrick create a traction point for multiple optional mechanical force generators, such as block and tackle systems. Use of pulleys for example remove tissue more easily and prevent over expansion of the port or wound. The retractor blades can absorb the lateral extraction forces, especially between ribs. The inflatable extraction sack aids in internal forces and can be combined with aided external forces of the derrick in a single system. The inflatable extraction sack can add internal forces to aid pulling forces. The positive pressure can create a relatively large force as opposed to suction pressures or pulling pressures. The use of the ring can hold the sack open and eliminates the need for expanding frames. Delivery of the toroidal ring outside the patient and supporting it on the skin surface or within the opening to protect the skin and incision or wound. The toroidal ring can be coupled to the derrick and then the remaining hemi-spheroid sack can be inflated and pulled simultaneously. Once the specimen is “birthed” the sack can be deflated and easily removed. The system is also useful with automated surgical procedures, such as robotic surgery.
[0058] A number of embodiments or implementations have been described. The description in the present disclosure has been presented for purposes of illustration but is not intended to be exhaustive or limited to the implementations disclosed. It will be understood that various modifications and variations will be apparent to those of ordinary skill in the art and may be made without departing from the spirit and scope of the claims. Accordingly, other implementations are within the scope of the following claims. The implementations described were chosen to best explain the principles of the tissue extraction system and a method of formation, and to enable others of ordinary skill in the art to understand the tissue extraction system for various implementations with various modifications as are suited to the particular use contemplated.
[0059] The terminology used herein is for the purpose of describing particular implementations only and is not intended to be limiting of the disclosure. As used herein, the singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, operations, elements, components, and/or groups thereof.
EXEMPLARY ASPECTS: [0060] Exemplary Aspect 1. A tissue extraction system, the system comprising: an extraction sack for disposing within a body of a person; and a derrick comprising: a base for contacting the body, a fixed pulley coupled to the base, a free pulley, a cable having a first portion, a second portion axially spaced apart from the first portion, and a middle portion disposed axially between the first portion and the second portion, wherein the first portion of the cable is static with respect to the fixed pulley or the free pulley, wherein the middle portion of the cable extends around the fixed pulley and the free pulley, and a coupler configured to couple the extraction sack to the free pulley; wherein application of a force to the second portion of the cable causes the free pulley to move from a first position to a second position, wherein the free pulley is closer to the fixed pulley in the second position than it is in the first position.
[0061] Exemplary Aspect 2. The tissue extraction system of exemplary aspect 1, wherein the derrick further comprises one or more legs extending from the base, wherein the fixed pulley is coupled to the base by the one or more legs.
[0062] Exemplary Aspect 3. The tissue extraction system of exemplary aspect 1, wherein the derrick further comprises a strain gauge for measuring a force on the fixed pulley.
[0063] Exemplary Aspect 4. The tissue extraction system of exemplary aspect 1, wherein the coupler comprises one or more clamps.
[0064] Exemplary Aspect 5. The tissue extraction system of exemplary aspect 1, wherein the coupler comprises one or more hooks for coupling the extraction sack to the free pulley.
[0065] Exemplary Aspect 6. The tissue extraction system of exemplary aspect 5, wherein the one or more hooks comprise one or more carabiners.
[0066] Exemplary Aspect 7. The tissue extraction system of exemplary aspect 1, wherein the base defines one or more retractor openings each configured to accept at least one retractor blade, wherein the at least one retractor blade is oriented toward the free pulley when disposed within the one or more retractor openings.
[0067] Exemplary Aspect 8. The tissue extraction system of exemplary aspect 1, wherein the derrick further comprises a motor for applying the force to the second portion of the cable.
[0068] Exemplary Aspect 9. The tissue extraction system of exemplary aspect 1, wherein the extraction sack further comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber; and a toroidal ring disposed within an inner cavity of the body of the person, the toroidal ring being separate from the flexible wall.
[0069] Exemplary Aspect 10. The tissue extraction system of exemplary aspect 9, wherein the toroidal ring comprises a semi rigid material.
[0070] Exemplary Aspect 11. The tissue extraction system of exemplary aspect 9, further comprising a drawstring for constricting a portion of the flexible wall.
[0071] Exemplary Aspect 12. The tissue extraction system of exemplary aspect 9, further comprising a conduit coupled to and in fluid communication with the inflation port.
[0072] Exemplary Aspect 13. A tissue extraction sack comprising: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber; and a toroidal ring disposed within an inner cavity of a body of a person, the toroidal ring being separate from the flexible wall.
[0073] Exemplary Aspect 14. The tissue extraction sack of exemplary aspect 13, wherein the toroidal ring comprises a semi rigid material.
[0074] Exemplary Aspect 15. The tissue extraction sack of exemplary aspect 14, further comprising a drawstring for constricting a portion of the flexible wall.
[0075] Exemplary Aspect 16. The tissue extraction sack of exemplary aspect 13, further comprising a conduit coupled to and in fluid communication with the inflation port.
[0076] Exemplary Aspect 17. A method of extracting a tissue from a body of a person, the method comprising: inserting an extraction sack through an opening a body of a person such that the extraction sack is disposed within the body of the person, wherein the extraction sack defines an open end; inserting tissue within the extraction sack; inserting the open end of the extraction sack through the opening in the body of the person; disposing a derrick on the body of the person at the opening, the derrick comprising: a base for contacting the body of the person, a fixed pulley coupled to the base, a free pulley, a cable having a first portion, a second portion axially spaced apart from the first portion, and a middle portion disposed axially between the first portion and the second portion, wherein the first portion of the cable is static with respect to the fixed pulley or the free pulley, wherein the middle portion of the cable extends around the fixed pulley and the free pulley, and a coupler configured to couple the extraction sack to the free pulley, wherein application of a force to the second portion of the cable causes the free pulley to move from a first position to a second position, wherein the free pulley is closer to the fixed pulley in the second position than it is in the first position; coupling the coupler to the open end of the extraction sack; and applying force to the second portion of the cable to cause the free pulley to move from the first position to the second position such that the extraction sack exits the body of the person.
[0077] Exemplary Aspect 18. The method of exemplary aspect 17, wherein the derrick further comprises one or more legs extending from the base, wherein the fixed pulley is coupled to the base by the one or more legs.
[0078] Exemplary Aspect 19. The method of exemplary aspect 17, wherein the derrick further comprises a strain gauge for measuring a force on the fixed pulley.
[0079] Exemplary Aspect 20. The method of exemplary aspect 17, wherein the coupler comprises one or more clamps.
[0080] Exemplary Aspect 21. The method of exemplary aspect 17, wherein the coupler comprises one or more hooks for coupling the extraction sack to the free pulley.
[0081] Exemplary Aspect 22. The method of exemplary aspect 21, wherein the one or more hooks comprise one or more carabiners.
[0082] Exemplary Aspect 23. The method of exemplary aspect 17, wherein the base defines one or more retractor openings each configured to accept at least one retractor blade, wherein the at least one retractor blade is oriented toward the free pulley when disposed within the one or more retractor openings.
[0083] Exemplary Aspect 24. The method of exemplary aspect 17, wherein the derrick further comprises a motor for applying the force to the second portion of the cable.
[0084] Exemplary Aspect 25. The method of exemplary aspect 17, wherein the extraction sack further comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber, and a toroidal ring disposed within an inner cavity of the body of the person, the toroidal ring being separate from the flexible wall, wherein the method further comprises causing a fluid to flow through the inflation port and into the inner chamber to cause a portion of the extraction sack and the tissue to move through the toroidal ring and exit the body of the person.
[0085] Exemplary Aspect 26. The method of exemplary aspect 25, wherein the toroidal ring comprises a semi rigid material. [0086] Exemplary Aspect 27. The method of exemplary aspect 25, further comprising a drawstring for constricting a portion of the flexible wall.
[0087] Exemplary Aspect 28. The method of exemplary aspect 25, further comprising a conduit coupled to and in fluid communication with the inflation port.
[0088] Exemplary Aspect 29. The method of exemplary aspect 25, wherein the fluid is water.
[0089] Exemplary Aspect 30. A method of extracting a tissue structure from a body of a person, the method comprising: inserting an extraction sack through a body opening such that the extraction sack is disposed within the body of the person, wherein the extraction sack comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber, and a toroidal ring disposed within the inner chamber, the toroidal ring being separate from the flexible wall; inserting a portion of the flexible wall of the extraction sack through the toroidal ring to form a double walled sack defining an open end at the toroidal ring; inserting the tissue structure within the double walled sack; pulling the open end and ring of the double walled sack out through the body opening; and causing a fluid to flow through the inflation port and into the inner chamber to cause the portion of the extraction sack and the tissue to move through the ring and exit through the body opening.
[0090] Exemplary Aspect 31. The method of exemplary aspect 30, wherein the ring comprises a semi rigid material.
[0091] Exemplary Aspect 32. The method of exemplary aspect 30, further comprising a drawstring for constricting a portion of the wall.
[0092] Exemplary Aspect 33. The method of exemplary aspect 30, further comprising a conduit coupled to and in fluid communication with the inflation port.
[0093] Exemplary Aspect 34. The method of exemplary aspect 30, wherein the fluid is water.

Claims

CLAIMS What is claimed is:
1. A tissue extraction system, the system comprising: an extraction sack for disposing within a body of a person; and a derrick comprising: a base for contacting the body, a fixed pulley coupled to the base, a free pulley, a cable having a first portion, a second portion axially spaced apart from the first portion, and a middle portion disposed axially between the first portion and the second portion, wherein the first portion of the cable is static with respect to the fixed pulley or the free pulley, wherein the middle portion of the cable extends around the fixed pulley and the free pulley, and a coupler configured to couple the extraction sack to the free pulley; wherein application of a force to the second portion of the cable causes the free pulley to move from a first position to a second position, wherein the free pulley is closer to the fixed pulley in the second position than it is in the first position.
2. The tissue extraction system of claim 1, wherein the derrick further comprises one or more legs extending from the base, wherein the fixed pulley is coupled to the base by the one or more legs.
3. The tissue extraction system of claim 1, wherein the derrick further comprises a strain gauge for measuring a force on the fixed pulley.
4. The tissue extraction system of claim 1, wherein the coupler comprises one or more clamps.
5. The tissue extraction system of claim 1, wherein the coupler comprises one or more hooks for coupling the extraction sack to the free pulley.
6. The tissue extraction system of claim 5, wherein the one or more hooks comprise one or more carabiners.
7. The tissue extraction system of claim 1, wherein the base defines one or more retractor openings each configured to accept at least one retractor blade, wherein the at least one retractor blade is oriented toward the free pulley when disposed within the one or more retractor openings.
8. The tissue extraction system of claim 1, wherein the derrick further comprises a motor for applying the force to the second portion of the cable.
9. The tissue extraction system of claim 1 , wherein the extraction sack further comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber; and a toroidal ring disposed within an inner cavity of the body of the person, the toroidal ring being separate from the flexible wall.
10. The tissue extraction system of claim 9, wherein the toroidal ring comprises a semi rigid material.
11. The tissue extraction system of claim 9, further comprising a drawstring for constricting a portion of the flexible wall.
12. The tissue extraction system of claim 9, further comprising a conduit coupled to and in fluid communication with the inflation port.
13. A tissue extraction sack comprising: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber; and a toroidal ring disposed within an inner cavity of a body of a person, the toroidal ring being separate from the flexible wall.
14. The tissue extraction sack of claim 13, wherein the toroidal ring comprises a semi rigid material.
15. The tissue extraction sack of claim 14, further comprising a drawstring for constricting a portion of the flexible wall.
16. The tissue extraction sack of claim 13, further comprising a conduit coupled to and in fluid communication with the inflation port.
17. A method of extracting a tissue from a body of a person, the method comprising: inserting an extraction sack through an opening a body of a person such that the extraction sack is disposed within the body of the person, wherein the extraction sack defines an open end; inserting tissue within the extraction sack; inserting the open end of the extraction sack through the opening in the body of the person; disposing a derrick on the body of the person at the opening, the derrick comprising: a base for contacting the body of the person, a fixed pulley coupled to the base, a free pulley, a cable having a first portion, a second portion axially spaced apart from the first portion, and a middle portion disposed axially between the first portion and the second portion, wherein the first portion of the cable is static with respect to the fixed pulley or the free pulley, wherein the middle portion of the cable extends around the fixed pulley and the free pulley, and a coupler configured to couple the extraction sack to the free pulley, wherein application of a force to the second portion of the cable causes the free pulley to move from a first position to a second position, wherein the free pulley is closer to the fixed pulley in the second position than it is in the first position; coupling the coupler to the open end of the extraction sack; and applying force to the second portion of the cable to cause the free pulley to move from the first position to the second position such that the extraction sack exits the body of the person.
18. The method of claim 17, wherein the derrick further comprises one or more legs extending from the base, wherein the fixed pulley is coupled to the base by the one or more legs.
19. The method of claim 17, wherein the derrick further comprises a strain gauge for measuring a force on the fixed pulley.
20. The method of claim 17, wherein the coupler comprises one or more clamps.
21. The method of claim 17, wherein the coupler comprises one or more hooks for coupling the extraction sack to the free pulley.
22. The method of claim 21, wherein the one or more hooks comprise one or more carabiners.
23. The method of claim 17, wherein the base defines one or more retractor openings each configured to accept at least one retractor blade, wherein the at least one retractor blade is oriented toward the free pulley when disposed within the one or more retractor openings.
24. The method of claim 17, wherein the derrick further comprises a motor for applying the force to the second portion of the cable.
25. The method of claim 17, wherein the extraction sack further comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber, and a toroidal ring disposed within an inner cavity of the body of the person, the toroidal ring being separate from the flexible wall, wherein the method further comprises causing a fluid to flow through the inflation port and into the inner chamber to cause a portion of the extraction sack and the tissue to move through the toroidal ring and exit the body of the person.
26. The method of claim 25, wherein the toroidal ring comprises a semi rigid material.
27. The method of claim 25, further comprising a drawstring for constricting a portion of the flexible wall.
28. The method of claim 25, further comprising a conduit coupled to and in fluid communication with the inflation port.
29. The method of claim 25, wherein the fluid is water.
30. A method of extracting a tissue structure from a body of a person, the method comprising: inserting an extraction sack through a body opening such that the extraction sack is disposed within the body of the person, wherein the extraction sack comprises: a flexible wall defining an inner chamber, wherein the flexible wall defines an inflation port in fluid communication with the inner chamber, and a toroidal ring disposed within the inner chamber, the toroidal ring being separate from the flexible wall; inserting a portion of the flexible wall of the extraction sack through the toroidal ring to form a double walled sack defining an open end at the toroidal ring; inserting the tissue structure within the double walled sack; pulling the open end and ring of the double walled sack out through the body opening; and causing a fluid to flow through the inflation port and into the inner chamber to cause the portion of the extraction sack and the tissue to move through the ring and exit through the body opening.
31. The method of claim 30, wherein the ring comprises a semi rigid material.
32. The method of claim 30, further comprising a drawstring for constricting a portion of the wall.
33. The method of claim 30, further comprising a conduit coupled to and in fluid communication with the inflation port.
34. The method of claim 30, wherein the fluid is water.
PCT/US2023/024672 2022-06-07 2023-06-07 Mechanical displacement devices, systems, and methods to enhance extraction of surgical specimens WO2023239765A2 (en)

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DE19515280C2 (en) * 1995-04-26 1997-06-12 Siegfried Riek Device for removing tissue or the like from the abdominal cavity
EP3692935B1 (en) * 2014-04-23 2023-06-28 Applied Medical Resources Corporation Systems for tissue removal
KR102564232B1 (en) * 2014-09-17 2023-08-08 칼 짜이스 메디텍 캐터랙트 테크놀로지 인크. Devices and methods for the removal of lenticular tissue

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