WO2015188118A1 - Dispositif laparoscopique de résection de tissu mini-invasif - Google Patents

Dispositif laparoscopique de résection de tissu mini-invasif Download PDF

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Publication number
WO2015188118A1
WO2015188118A1 PCT/US2015/034514 US2015034514W WO2015188118A1 WO 2015188118 A1 WO2015188118 A1 WO 2015188118A1 US 2015034514 W US2015034514 W US 2015034514W WO 2015188118 A1 WO2015188118 A1 WO 2015188118A1
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WO
WIPO (PCT)
Prior art keywords
auger
elongate
sheath
morcellator
mouth
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Application number
PCT/US2015/034514
Other languages
English (en)
Inventor
Stuart Richard HART
Mario Alves SIMOES
Omar CARAMBOT
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University Of South Florida
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Publication date
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Publication of WO2015188118A1 publication Critical patent/WO2015188118A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00681—Aspects not otherwise provided for
    • A61B2017/00685—Archimedes screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A61B2017/320024—Morcellators, e.g. having a hollow cutting tube with an annular cutter for morcellating and removing tissue

Definitions

  • Laparoscopic surgery a type of minimally invasive surgery, has increased over the past 10 years due to a dramatic decrease in post-operative patient recovery time, minimized risk of infections, less pain, and reduced scarring.
  • laparoscopic surgery uses several small incisions from five (5) millimeters to fifteen (15) millimeters. These incisions are known as ports that hold hollow tubular trochars that are designed for the passing of instruments and devices. Typically, these ports are inserted through the subject or patient’s abdominal wall into the peritoneal cavity to provide the surgeon with access to necessary organs.
  • This complex system allows surgeons to perform surgeries with smaller incisions than traditional operations (ASCRS, 2008). According to the U.S.
  • a hysterectomy surgical removal of the uterus
  • cesarean section women in the United States with more than 600,000 of these operations performed each year. Of these, 42% were performed laparoscopically. It is estimated that one in three women in the U.S. has undergone a hysterectomy by the age of 60.
  • surgeons need clear visibility and range of device control at all times to avoid damaging nearby vital organs and blood vessels while reducing scars and pain for the patient.
  • the operation can last from an hour to a few hours.
  • the tissue can be drawn up manually inside the device’s central lumen into the inner stationary sheath as the exposed blade cuts the tissue.
  • the greatest shortcoming of the GYNECARE MORCELLEX tissue morcellator is the uncertainty of the exposed blade that can cause damage to vital organs that surround the abdomen (Zullo, 2012).
  • Another possible prior art device, LINA XCISE disposable laparoscopic morcellator consists of similar features, and therefore has the same flaws, as the GYNECARE MORCELLEX, but provides a cordless disposable morcellator, intended for tissue morcellation during laparoscopic gynecological procedures.
  • Another commercial device known as the MYOSURE Tissue Removal System is a device having a distal end with a side window that rotates and reciprocates so as to cut tissue.
  • the cut tissue is sucked out of the body through the body/sheath of the device.
  • the device has a diameter of about 6.5 mm, so although a smaller incision site is necessary, the targeted tissue must be broken down into significantly smaller portions for suction out of the body. Additionally, this device runs across similar flaws as previously described, such as remnants remaining in the body (particularly here where tissue must be broken down so much).
  • U.S. Patent No. 7,510,563 to Cassidy et al. and U.S. Patent No. 7,226,459 to Cassidy et al. have a similar cutting window with a cutting blade exposed when the window is opened.
  • the blade is rotated, thereby cutting tissue and bringing the cut tissue into the cutting window for aspiration.
  • the tissue within the cutting window must catch on a sharp hook disposed on the opposite side of the cutting window as the blade. Then the blade slices the tissue and rotates to advance the tissue out of the body through a suction mechanism.
  • the sharp hook and blade are exposed to peripheral tissue, and the cutting window significantly limits the amount of tissue that can be cut in an efficient manner.
  • This device utilizes a circular rotating blade to cut tissue while a grasping device is inserted through the proximal end of a sheath to the distal end of the sheath to manually grasp and pull tissue while the cutting blade cuts tissue.
  • Savage is provides a device designed to fit inside the lumen of the morcellator, allowing the grasper to be inserted and removed while maintaining positive pressure within the abdomen of the patient. As the tissue is pulled proximally back through the lumen of the morcellator, the cutting blade cuts the tissue.
  • this device requires excessive manual effort from the surgical team, it would be easy for a portion of the tissue to become entirely cut off from the remaining tissue and be improperly left within the subject.
  • 5,443,472 to Li discloses a morcellation system primarily consisting of two main mechanisms.
  • One mechanism acts as a capture device to capture a tissue mass while the other mechanism acts as a morcellator to cut and remove tissue from the body.
  • the mass is captured in a net-like, tissue containment structure that can articulate at an angle while the cutting device is positioned inside.
  • the cutting device has a blade opening, and the net-like structure is used to squeeze the mass into the opening created by the blade opening. From this point, the surgeon squeezes the handle to close the blade, which cuts the tissue, and the action of opening the blade causes the piece of tissue that was cut to move proximally through the device.
  • barbs exist that allow only one way proximal movement through the tube of the device.
  • U.S. Patent No. 5,520,634 to Fox et al. relates to a morcellator that is structured with a rotatable cutting head (e.g., a blade) and a motor that communicates the rotation of the cutting head, along with suction through the cutting head to aspirate the masses that are cut.
  • the cutting head is“relatively retractable” but extends out of the sheath, thereby exposing the blade to other non-targeted tissue within the body.
  • the device is designed to go through an abdominal port and thus is limited to the size of the port.
  • U.S. Patent No. 5,569,284 to Young et al. teaches a morcellator that includes a tubular portion with an elongated auger rotatably positioned within its bore. An aperture near the distal end of the tubular portion permits access for body tissue to contact the auger.
  • the device is limited to fifteen (15) mm and is inserted in an abdominal port to come in contact with the tissue.
  • the auger has a cover flap over the aperture, where the cover flap that opens to allow the auger to contact the tissue for cutting and transporting out of the body.
  • the cover flap opens at an angle and thus the amount of tissue that can be efficiently cut is quite limited.
  • U.S. Patent No. 5,215,521 to Cochran et al. discloses a device that is designed to contain a bag within a sheath until the bag is deployed within a body to enclose and hold a mass within the body. The bag holds the mass in place to allow the surgeon to use a morcellator to break down the mass until the bag containing the morcellized mass can be removed through the device sheath and port.
  • U.S. Patent No. 6,468,228 to Topel et al. relates to a morcellator that includes a helical coil inserted through the hollow sheath and extends from the distal cutting end of sheath to embed into a tissue mass and affix itself in the mass.
  • U.S. Patent No. 8,282,572 to Bilsbury teaches a bag deployment device that uses a sheath to guide and insert the bag into the body.
  • the device uses a flexible metal to push and expand the bag/funnel once outside of the sheath.
  • the bag is intended to capture the tissue within the body and fit within the sheath for removal outside of the body.
  • U.S. Patent No. 5,591 ,187 to Dekel discloses a device that includes a hollow cylindrical sheath with a rotatable auger disposed therein for rotational cutting.
  • the distal end of the auger includes a cutting blade outside of the sheath. Additionally, the distal end of the auger has an opening that receives a corkscrew-like structure that extends furthest distally from the auger and is used to engage the tissue mass to be cut.
  • the corkscrew-like structure engages the tissue mass and positions the tissue mass for cutting by the serrated blade. Then the tissue is drawn into the sheath by the auger, which is being manually rotated by the user.
  • Major drawbacks of this device include peripheral or extraneous tissue being exposed to both the cutting blade and the corkscrew-like structure. This may be particularly true when there are smaller pieces of tissue that need to be removed, and the corkscrew-like structure is incapable of engaging it. Additionally, the tissue must be extracted manually, and as such, small pieces of tissue may be left in the body.
  • the device provides an inefficient and dangerous manner of removing tissue from a body. The devices currently used for laparoscopic surgeries lead to problems that are evident during an operation.
  • the current invention is a morcellator for removing a targeted tissue mass inside the body of a subject or patient through a laparoscopic port or vagina of the subject or patient.
  • the morcellator includes a gripping apparatus for stabilizing the morcellator when it is inserted into the patient’s body.
  • An elongate sheath is included and has proximal and distal ends. The proximal end of the sheath is coupled to the gripping apparatus. The distal end of the sheath is coupled to a mouth, which has a substantially hollow interior. The mouth has a window that allows open communication between the interior of the mouth and the external environment.
  • a pair of elongate jaws extends within the interior of the mouth.
  • the jaws are positioned in fixed, spaced relation to each other.
  • the distal portion of each jaw has blades to cut the tissue to be morcellated.
  • the blades can take on a variety of configurations including blades positioned essentially in alignment with the jaw, perpendicular to the jaw, diagonally aligned down the length of the jaw, or any combination thereof. These blades can be aligned along each jaw, similar to teeth that oppose the teeth on the other jaw.
  • the blades cut or shred the tissue and draw it inwardly toward the inside of the mouth via rotation of the jaws.
  • the morcellator further includes an auger that extends within the interior of both the sheath and the mouth. The auger is positioned in fixed, spaced relation underneath the jaws.
  • the auger transports the cut or shredded tissue proximally toward the gripping apparatus and out of the body via rotation of the auger.
  • the morcellator further includes a control apparatus that control the rotation of the jaws and the auger.
  • the gripping apparatus may be a pistol grip positioned in perpendicular relation to the longitudinal axis of the sheath.
  • the control apparatus in this case can be a trigger mechanism on the pistol grip to power rotation of the auger and jaws.
  • the distal end of the auger channel can optionally include a cutting blade to further shred the targeted tissue mass as the tissue mass travels proximally through the auger.
  • the morcellator may further include a cup assembly positioned in overlying relation to the window of the mouth.
  • the cup assembly would have an open top with top edge and open bottom with bottom edge. The bottom edge would be attached to the outer edges of the window. The top edge would be formed of a wire frame that stabilizes the cup assembly in an upright position.
  • the interior of the sheath can include a supplementary channel, such that the cup assembly can be partially folded into the supplementary channel, while remaining attached to the outer edges of the window, thus covering the window in the compressed position.
  • a deploy apparatus can be included that fits in the supplementary channel, such that it can deploy the cup assembly from its compressed position into an upright/expanded position.
  • the morcellator may further include a safety tip at the distal end of the morcellator.
  • the safety tip can manipulate or push extraneous tissue to better reach or target the tissue mass.
  • the morcellator may further include a cover apparatus for covering or filling the window of the mouth.
  • the cover apparatus typically would have a closed position that protects extraneous tissue from the teeth or blades and an open position that exposes the teeth to the tissue.
  • the cover apparatus can be a bay rotating outer sheath disposed in outer relation to the mouth.
  • the cover apparatus can be a bay sliding outer sheath disposed in outer relation to the elongate sheath and mouth. This outer sheath is slidable in a proximal-distal direction to cover and uncover the mouth.
  • the morcellator may further include an exit port positioned at the proximal end of the elongate sheath, such that the targeted tissue mass can exit the morcellator through that port via the auger.
  • the control apparatus may include a motor unit and gear assembly in communication with each jaw and the auger.
  • the gear assembly can be a plurality of spur gears with a specific configuration as follows.
  • a driving gear is securely coupled to the auger.
  • a first driven gear is meshably engaged to the driving gear.
  • a conjointly-rotating driving gear is positioned in fixed spaced relation to the first driven gear and is concentric with the first driven gear.
  • the conjointly-rotating driving gear is securely coupled to one of the jaws.
  • a second driven gear is meshably engaged to the conjointly-rotating driving gear.
  • the second driven gear is securely coupled to the other jaw.
  • rotation of the initial driving gear rotates the plurality of gears, the jaws, and the auger.
  • the gear assembly may include jaw gears in communication with the distal end of each jaw to drive rotation of the jaws.
  • the gear assembly would also include an auger jaw in communication with the distal end of the auger to drive rotation of the auger.
  • the gear assembly would further include a pivot gear meshably engaged with one of the jaws to control a direction of the jaw.
  • the direction of rotation of the auger gear would also be controlled by rotation of the pivot gear.
  • a set of teeth associated with one jaw and another set of teeth associated with the other jaw can have a staggered, interlocking relationship with each other. In a further embodiment, these teeth can be offset by about five (5) degrees between the sets of teeth.
  • the morcellator may further include cutters or hook-like protrusions disposed on the teeth to facilitate drawing the tissue mass inwardly between the jaws toward the auger.
  • the current invention is a morcellator for removing a uterus of a subject or patient through a vagina of the subject or patient.
  • the morcellator includes an elongate sheath having three (3) channels therewithin along the length of the sheath.
  • the elongate sheath has a maximum length of about thirty (30) millimeters.
  • the sheath has a maximum diameter of about thirty (30) millimeters.
  • a pistol grip is coupled to the proximal end of the sheath in perpendicular relation to the sheath.
  • a mouth is coupled to the distal end of the sheath and has a substantially hollow interior.
  • a window in the mouth provides open communication between the interior of the mouth and the external environment.
  • a pair of elongate jaws is disposed within two (2) of the three (3) channels within the sheath.
  • the jaws extend into the interior of the mouth.
  • the jaws have opposing teeth that have a staggered, interlocking relation (approximately 5 o offset) with each other and draw the uterus inwardly between the jaws.
  • the morcellator further includes an auger in the third channel of the three (3) channels in the sheath.
  • a cutting blade can be disposed at a distal end of the third channel to further shred the tissue mass as the tissue mass travels proximally through the auger.
  • Each of the three (3) channels have spaced relation to each other.
  • the auger lies beneath the jaws and is substantially centered between the jaws.
  • the jaws grab and cut or shred the uterus via cutters having a predetermined depth, whereas the auger transports the cut or shredded uterus proximally out of the patient’s body.
  • a safety tip is positioned at a distal end of the morcellator to push or manipulate extraneous tissue to reach or target the uterus.
  • the morcellator further includes a cover apparatus for covering or filling the window of the mouth.
  • the cover apparatus has a closed position for protecting extraneous tissue from the teeth and an open position for exposing the teeth to the tissue.
  • a motor unit and gear assembly are also coupled to the jaws and auger for controlling the simultaneous rotation of the jaws and auger.
  • the gear assembly is configured as follows. Jaw gears are in communication with the distal end of each jaw to drive rotation of the jaws.
  • the gear assembly would also include an auger jaw in communication with the distal end of the auger to drive rotation of the auger.
  • the gear assembly would further include a pivot gear meshably engaged with one of the jaws to control a direction of the jaw. The direction of rotation of the auger gear would also be controlled by rotation of the pivot gear.
  • a trigger mechanism is disposed on the pistol grip to power rotation of the auger and jaws.
  • the current invention is a method of morcellating a targeted tissue mass (e.g., uterus for hysterectomy) inside the body of a female subject or patient.
  • a morcellator is inserted into the vagina of the patient to reach the targeted tissue mass.
  • the morcellator comprises a gripping apparatus for stabilizing the morcellator when inserted into the patient, an elongate sheath coupled to the gripping apparatus on its proximal end, and a mouth coupled to the distal end of the sheath.
  • the morcellator further comprises a pair of elongate jaws extending along the interiors of the sheath and mouth, where the jaws have opposing teeth.
  • the morcellator also includes an auger extending along the interiors of the sheath and mouth underneath the jaws.
  • the morcellator further includes a control apparatus for controlling rotation of the jaws and auger. Once inserted into the body, the morcellator is actuated or activated to initiate rotation of the jaws and auger.
  • the teeth of the morcellator contact the targeted tissue mass and draws the tissue inwardly toward the auger.
  • the auger transports the tissue proximally toward the gripping apparatus and out of the patient’s body.
  • FIG. 1 is a perspective view of an embodiment of the invention.
  • FIG. 2 is a top view of the embodiment of FIG. 1.
  • FIG. 3 is a perspective view of the embodiment of FIG. 1.
  • FIG. 4 is a side view of the embodiment of FIG. 1.
  • FIG. 5 is a back view of the embodiment of FIG. 1.
  • FIG. 6 is a front view of the embodiment of FIG. 1.
  • FIG. 7 is a perspective wire-frame view of the embodiment of FIG. 1.
  • FIG. 8 is a perspective exploded view of the embodiment of FIG. 1.
  • FIG. 9 is a top exploded view of the embodiment of FIG. 1.
  • FIG. 10 is a top exploded view of the distal end, in particular the mouth, of the embodiment FIG. 1.
  • FIG. 11 is a side exploded view of the distal end, in particular the mouth, of the embodiment FIG. 1.
  • FIG. 12 is a perspective view of the sheath of the embodiment of FIG. 1.
  • FIG. 13 is a perspective view of a handle as used in an embodiment of the current invention.
  • FIG. 14 is a perspective cross-sectional view of the handle of FIG. 13.
  • FIG. 13 is a perspective view of a handle as used in an embodiment of the current invention.
  • FIG. 15 is a top view of the mouth of an embodiment of the current invention, in particular depicting the teeth, drive shafts, and auger contained therein.
  • FIG. 16 is a perspective view of an embodiment of the current invention that utilizes a deploy apparatus for deploying a cup assembly into an expanded position.
  • FIG. 17 is a side view of an auger transporter utilized in an embodiment of the current invention.
  • FIG. 18 is a schematic drawing of a cup assembly utilized in an embodiment of the current invention.
  • FIG. 19 is a schematic drawing of the blades guarded by a safety tip without the cup assembly of FIG. 18.
  • FIG. 20 is an exploded perspective view of an alternate embodiment of the current invention as may be utilized in traditional laparoscopic ports.
  • FIG. 21 is s perspective view of an alternate embodiment of the current invention utilizing a safety sheath.
  • FIG. 22 is a perspective view of the distal end, in particular the mouth, of the embodiment FIG. 21.
  • FIG. 23A is a perspective view of an alternative embodiment of the current invention.
  • FIG. 23B is an upper perspective wireframe view of the embodiment of FIG. 23A.
  • FIG. 23C is a rear perspective wireframe view of the embodiment of FIG. 23A.
  • FIG. 23D is a side wireframe view of the embodiment of FIG. 23A.
  • FIG. 24 depicts all parts used in the embodiment FIG. 23A as detached from one another.
  • FIG. 25A is a front perspective view of the mouth of an embodiment of the current invention.
  • FIG. 25B is a wireframe view of FIG. 25A.
  • FIG. 25C is a rear perspective wireframe view of the mouth depicted in FIG. 25A.
  • FIG. 26 is an exploded view of the mouth of FIG. 25A.
  • FIG. 27 is a rear exploded view of an embodiment of the current invention.
  • FIG. 28A is a rear perspective, close-up wireframe view of a gear assembly utilized in an embodiment of the current invention.
  • FIG. 28B is front perspective, close-up wireframe view of the gear assembly of FIG. 28A.
  • FIG. 29A is a side perspective view of a cup assembly utilized in an embodiment of the current invention.
  • FIG. 29B is a front perspective view of the cup assembly of FIG. 29A.
  • FIG. 30A is a perspective view of a bay door assembly utilized in an embodiment of the current invention for covering the mouth of the morcellator, where the bay door assembly is in a closed position.
  • FIG. 30B is a perspective view of the bay door assembly of FIG. 30A in an open position.
  • FIG. 30C is a rear perspective view of the bay door assembly of FIG. 30A in an open position.
  • FIG. 31 A is a perspective view of a bay rotating sheath assembly utilized in an embodiment of the current invention for covering the mouth of the morcellator, where the bay rotating sheath assembly is in a closed position.
  • FIG. 31 B is a perspective view of the bay rotating sheath assembly of FIG. 31 A in a half-open position.
  • FIG. 31 C is a perspective view of the bay rotating sheath assembly of FIG. 31 A in an open position.
  • FIG. 32A is a perspective view of a bay sliding sheath assembly utilized in an embodiment of the current invention for covering the mouth of the morcellator, where the bay sliding sheath assembly is in a closed position.
  • FIG. 32B is a perspective view of the bay sliding sheath assembly of FIG. 32A in a half-open position.
  • FIG. 32C is a perspective view of the bay sliding sheath assembly of FIG. 32A in an open position.
  • FIG. 33 depicts the distal end of a morcellator, according to an embodiment of the current invention, with a gear assembly shown and used to change the direction of rotation.
  • FIG. 33 depicts the distal end of a morcellator, according to an embodiment of the current invention, with a gear assembly shown and used to change the direction of rotation.
  • FIG. 33 depicts the distal end of a morcellator, according to an embodiment of the current invention, with
  • FIG. 34 is an expanded view of a jaw (shear cutter assembly) showing the blade teeth offset.
  • FIG. 35 shows a deeper cutter blade design and a shallow cutter blade design.
  • FIG. 36 is an elevated view showing the auger, according to an embodiment of the current invention.
  • FIG. 37 depicts a shaft that the auger fits into once the auger enters the main body of the morcellator. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
  • the sheath can then be used as an adjustable blade barrier to allow an increase or decrease in surface area of the blade exposed. This design will reduce surgery time, while reducing surgical fatigue.
  • the device is utilized for cutting, coring, and extracting tissue during laparoscopy operations.
  • the device consists of a handle, hand guard, hollow retractable sheath, barrel, auger for tissue transportation, cup assembly, and two spiral-cutting rotating blades housed at the end of the barrel.
  • the interaction of the device with the tissue is a direct touch interaction.
  • the sheath of the morcellator is inserted in the vaginal port. Once the distal end of the sheath is inserted, the cutting blades are engaged in a rotational motion, and tissue contact may begin on the opening side of the sheath.
  • the cutting auger transports the tissue down the sheath to the proximal end where it can be removed.
  • the device has two blades that are counter rotating at the face of the device. In an embodiment, these blades interlock with each other or are otherwise staggered and can have small hook like protrusions, which are designed to grasp and pull tissue inwards. While the tissue is being pulled in by these hooks, the sides of the blades are designed to cut and pull the tissue in the device towards the auger.
  • the inside of the morcellator has an auger feed screw which rotates to motivate the cut tissue transport down the barrel and out of the body.
  • the surgeon can adjust how much tissue needs to be cut by moving the retractable sheath to allow for an increase or decrease in surface area on the exposed blades.
  • the end of the device can expose a cup shaped material. This material would allow the tissue to be placed in the cup and to be guided to the cutting blades while keeping smaller tissue pieces in one area.
  • the present invention aims to make laparoscopic surgeries safer, more efficient, and less stressful for the physician and surgical team by providing a device and methodology that can remove tissue faster while protecting or housing the blade for safety of the subject or patient’s internal bodies and extraneous tissues.
  • the blades typically are recessed within the distal end of the morcellator so as to minimize any risk to surrounding organs. Further, it is no longer acceptable to morcellate in an uncontained environment within the abdomen; rather, morcellation should take place in a controlled environment, such as within a containment bag (for example the containment bag of U.S. Patent No. 9,044,210 to Hoyte et al.) in the abdomen. Even in a containment bag, conventional morcellators pose a high risk of tearing through or perforating the bag, which then leads to risking damage to surrounding organs. Having the blades recessed eliminates these risks.
  • a containment bag for example the containment bag of U.S. Patent No. 9,044,210 to Hoyte et al.
  • the device is a surgical morcellation device that can be used during hysterectomies to remove various degrees of uterine tissue through a vaginal port.
  • the invention comprises a device that provides a safe solution to the problems referenced in the prior art by increasing the size of the barrel shaft and using a larger port that is inserted into the vagina to reduce surgery time.
  • the vagina serves as a natural portal into the abdominal cavity, is easily distensible to accommodate larger incisions for wider diameter instruments, and leaves no visible abdominal scar.
  • the structure of the current invention includes spiral feed blades and an auger, both of which are used to transport the tissue down the device.
  • the structure further includes a retractable sheath that safely houses the blades, thereby providing an adjustable blade surface area.
  • the current invention makes morcellation surgeries safer and more effective for women by reducing scarring and recovery time and not requiring additional incisions to be made into their abdominal cavities.
  • One objective of the invention is to provide a safe, ergonomic, and time-efficient laparoscopic tissue removal device for use during traditional and complex hysterectomy surgeries. Surgeons are often confronted with the problem of tissue being left behind within the body cavity during surgery; the current invention aims to reduce the possibility of this problem.
  • the invention is a significant advancement over the prior art because it has both a larger barrel and an auger feed screw for increased flow along with a cup assembly and tip for superior safety in certain embodiments.
  • One of the advantages of an embodiment of the present invention is a closed safety tip at the end of the device that significantly reduces the risk of an exposed blade during a procedure.
  • the improved design enhances the user experience for physicians, hospitals, and medical institutions.
  • a significant advantage of the apparatus is its ability to both cut tissue and transport tissue in a single apparatus.
  • the device can include a variety of cover mechanisms that safely houses the cutting blades, for example a retractable sheath.
  • a retractable sheath can be used as an adjustable blade barrier to allow an increase or decrease in surface area of the blade exposed. This design, among others with certain cover mechanisms reduce surgery time, while reducing surgical fatigue of the surgical team.
  • the device can be used for cutting, coring, and extracting tissue during laparoscopy operations.
  • the device includes a handle, a hand guard, a hollow retractable sheath, a barrel, an auger for tissue transportation, a cup assembly, and two spiral-cutting rotating blades housed at the end of the barrel.
  • the interaction of the device with the tissue is a direct touch interaction.
  • the sheath of the morcellator is inserted into the vaginal port. Once the distal end of the sheath is inserted, the cutting blades are engaged in a rotational motion, and tissue contact may begin on the opening side of the sheath. Once cut, the cutting auger transports the tissue down the sheath to the proximal end where it can be removed.
  • proximal and distal refer to spatial positions relative to the subject or patient; thus, the proximal end of the sheath is the end of the sheath closer to the surgical team than the distal end of the sheath.
  • distal end of the device is the cutting end inside of the patient or subject’s body
  • proximal end of the device is the gripping end outside of the patient or subject’s body.
  • the present invention is a minimally invasive laparoscope surgical morcellation device used during hysterectomies to remove various degrees of uterine tissue.
  • the present invention reverses the process to a bottom-up approach through a new vaginal port/platform.
  • This embodiment of the present invention implements this new platform, which is structured specifically for entry through the vagina.
  • the vagina serves as a natural portal into the abdominal cavity, is easily distensible to accommodate larger incisions for wider diameter instruments, and leaves no visible abdominal scars.
  • having the port relocated to the vagina dramatically decreases the risk of herniation, provides surgeons with a platform for a wide variety of tools and devices, and decreases strain on the physician’s hands.
  • the present invention is used for cutting, shredding, and extracting tissue.
  • the interaction of the device with the tissue is a direct touch interaction.
  • the sheath of the present invention is inserted in the vaginal port and mounted in place. Once the distal end of the sheath is inserted, a cup assembly can be pushed out manually to uncover the cutting blades and provide a funnel like flow for the tissue to be excised by the cutting blades.
  • the cutting blades are then engaged in a rotational motion and tissue contact is initiated by surgical team bringing the tissue to the device using abdominal ports.
  • the auger transports the tissue particles down the sheath to the proximal end where it can be removed.
  • the device has two (2) blades that are counter-rotating at the face of the device. These blades interlock with each other or are otherwise staggered and have small cutters or hook- like protrusions, which are designed to grab and pull tissue inwards. While the tissue is being pulled in by these hooks the sides of the blades are designed to cut and pull the tissue in the device towards the auger.
  • the inside of the morcellator has an auger feed screw that rotates to help transport the cut tissue down the barrel and out of the patient’s body.
  • the surgeon can adjust how much tissue that needs to be cut by moving the retractable sheath, thereby permitting an increase or decrease in the surface area on the exposed blades.
  • the distal end of the device can expose a cup-shaped material. This allows the tissue to be placed in the cup and guided to the cutting blades, while keeping smaller tissue pieces in one area.
  • the present invention includes a handle, hand guard, barrel, auger for tissue transportation, cup assembly, closed safety tip, and two spiral-cutting rotating blades housed at the end of the barrel.
  • the device is preferably made from medical grade stainless steel and thermoplastic for the handle and hand guard.
  • the present invention can have a barrel diameter of about thirty (30) mm, which is double size of a traditional morcellator with a standard diameter of only fifteen (15) mm.
  • the present invention size increase is due to the vaginal platform having a 35 mm opening to accommodate larger devices. Having a larger barrel size provides a greater removal rate for the unwanted tissue, thus causing a decrease in surgery time.
  • the increased outer diameter allows for an increase if the interior barrel diameter to 28 mm, which allows for an increase in the auger size, thus more efficient removal of the excised tissue.
  • the morcellator according to the instant invention can have a range of diameters, including, but not limited to, a range of about fifteen (15) mm to about thirty (30) mm.
  • a 15-mm morcellator can be used with traditional laparoscopic ports, whereas a 30-mm morcellator can be used via a vaginal port.
  • Auger Transporter The interior of the sheath/barrel of the present invention has an auger feed screw that rotates to help transport cut tissue down the barrel and out of the body for proper disposal. The auger increases the tissue removal rate, thus decreasing the total time of an operation.
  • Cup assembly In order to help guide the tissue to the distal end of the morcellator during a procedure, the end of the device can expose a cup shaped material or assembly. This allows the tissue to be placed in or scooped by the cup and guided to the cutting blades.
  • the cup also serves as a safety barrier to keep all tissue masses (small, medium, large) in one area so that no tissue pieces are left behind in the body.
  • the morcellator can be manufactured with the cup assembly built into the morcellator. Alternatively, the cup assembly can be a separate attachment. The cup assembly will become more apparent as this specification continues.
  • Safety Tip The morcellator of the current invention may include a closed tip added to the distal end of the morcellator.
  • the device can have two spiral blades that counter-rotate at the face of the device.
  • the blades interlock with each other and can have small cutters or hook-like protrusions, which are designed to grab and pull tissue inwards. As the blade hooks pull in the tissue, the sides of the blades are designed to cut and pull the tissue in the barrel towards the auger.
  • Sterilization Sterilization is a major component when dealing with any medical device or instrument that will be in contact with the human body.
  • the Centers for Disease Control and Prevention (“CDC”) lists a number of sterilization requirements for different types of surgical devices. Any device that has contact with bodily fluids or tissues during routine use is considered to be a critical item that needs to be 100% sterile to reduce the chances of microbial transmission (Rutala & Weber, 2009). The present invention falls under this category and as such will require complete sterilization prior to packaging.
  • Example 1 In an example, depicted in various aspects in FIGS. 1 -15, the current invention is a laparoscopic morcellator denoted generally by the reference numeral 10.
  • Morcellator 10 includes three distinct aspects: handle 1 4, sheath 1 2 containing hollow lumen 13 (FIG. 12), and mouth 20 containing drive shafts 26 with interlocking teeth 24 attached thereto and disposed therearound (FIG. 15).
  • Handle 14 is typically cylindrical and adapted to conform to a user’s hand, though any structure or conformation is contemplated. Grooves 16 may be disposed on handle 14 to provide an ergonomic design. Other types of ridges, grooves, finger indentations, and the like are contemplated by the current invention to enhance the comfort of the user and/or function of the overall structure. Handle 14 may be connected to mouth 20 through auger 32 or other cylinder (e.g., cylinder 15) disposed within the hollow lumen of sheath 12. In an embodiment, handle 14 can be hollow, as indicated in FIGS. 13 and 1 4, to facilitate this connection to mouth 20.
  • handle 14 may be rotatable about sheath 12 and can be detachable from sheath 12 to allow for other types of handles to be connected. If handle 14 is connected to mouth 20, then rotation of handle 14 would rotate mouth 20 to allow mouth 20 to have flexibility to contact various surrounding tissues within the body.
  • handle 14 may include blade operating handle or tool (not shown), the rotation of which can rotate mouth 20 or teeth 24 of mouth 20.
  • Handle guard 18 can be positioned between sheath 12 and handle 14 to protect the user’s hand and to prevent morcellator 10 from being fully inserted into the body of the subject.
  • Sheath 12 is elongate and includes hollow lumen 13, as indicated in FIG. 12, disposed along the longitudinal extent of the interior of sheath 12.
  • Sheath 1 2 further includes a proximal end and a distal end, where the proximal end is attached to handle 14 extending therefrom and the distal end is in communication with mouth 20 extending therefrom.
  • the distal end of sheath 12 telescopically receives mouth 20, such that mouth 20 can retract within hollow lumen 13 of sheath 12 and can rotate inside and outside hollow lumen 13 of sheath 12.
  • Sheath 12 further includes supplementary channel 28 that has an exit point on the proximal end of sheath 12 and an exit point on the distal end of sheath 1 2.
  • Supplementary channel 28 has a hollow interior running along the length of sheath 12.
  • Channel doors 29 may be included on the proximal end of sheath 12 and/or on the distal end of sheath 12. Channel doors 29 are used to close off either or both exit points of supplementary channel 28, so the interior of the body of the subject is not in open communication with the external environment through channel 28. For example, this is done so that extraneous materials cannot erroneously fall into the body of the subject from the external environment through channel 28.
  • supplementary channel 28 can be used for a variety of reasons.
  • a laparoscopic camera can be inserted through channel 28, so that the surgical team can view the procedure without the need to create an additional laparoscopic port in the subject’s body. As depicted in FIG.
  • auger 32 includes elongate axle 36 and helicoid 38 disposed therearound along the length of elongate axle 36, thereby resembling the threads of a wood screw, though the current invention contemplates round or abnormally shaped (e.g., hexagonal) augers.
  • Auger 32 is positioned within hollow lumen 13 of sheath 12 along the length of sheath 12.
  • Auger 32 further extends into the substantially hollow interior of mouth 20 and is positioned in internal relation to teeth 24 and drive shafts 26 relative to mouth casing 21 , such that auger 32 is enclosed within sheath 12 and is nearly enclosed within mouth 20 but is in communication with the external environment through the spaces among teeth 24.
  • auger 32 may further extend into the hollow interior of handle 14, dependent on the type of handle that is used with morcellator 10.
  • Auger 32 is structured to rotate about the longitudinal axis within hollow lumen 13 and the interior of mouth 20.
  • tissue or other material comes into contact with auger 32 during rotation, the material can be further morcellated by helicoid 38, drawn up lumen 13 and transported along the longitudinal extent of sheath 12.
  • the extent of morcellation and speed of transportation can be dependent on the rotational force of auger 32 and the preset pitch of the ribs of helicoid 38.
  • a sharper pitch would encourage a larger distance of transportation of a tissue mass per turn of auger 32.
  • a flatter pitch would encourage a smaller distance of transportation of the tissue mass per turn of auger 32.
  • the proximal end of auger 32 may be coupled to handle 1 4 such that manual or automated rotation of handle 14 would proportionately rotate auger 32.
  • the proximal end of auger 32 may be electrically coupled to a drive shaft and motor (not shown) for automated activation, deactivation, and control of the rotation of auger 32.
  • Auger 32 drives morcellated tissue toward the exterior of the body (e.g., toward handle 14) and out of the body of the subject. Auger 32 may also be rotated in the opposite direction, such that the tissue mass can be directed toward mouth 20. As depicted in FIGS. 10, 11 , and 15, mouth 20 is disposed on and extends from the distal end of sheath 12.
  • Mouth 20 includes mouth casing 21 , teeth 24, drive shafts 26, and window 25, and contains the distal end of auger 32.
  • Mouth casing 21 is formed of a protective material and protects the substantially hollow interior of mouth 20 on all sides other than window 25 (FIG. 10).
  • Window 25 leads from the external environment into the substantially hollow interior of mouth 20, such that the interior is in communication with the external environment via window 25.
  • Auger 32 extends longitudinally from interior 13 of sheath 12 into the substantially hollow interior of mouth 20 at the distal end of morcellator 10.
  • Teeth 24 are disposed within window 25 of mouth 20 and may even protrude from window 25 to catch additional tissue masses within the body. As indicated in FIGS.
  • teeth 24 of jaw 27a lie opposed to teeth 24 of jaw 27b.
  • Teeth 24 of jaws 27a interlock, or otherwise window, teeth 24 of jaw 27b, as clearly depicted in FIG. 15, such that teeth 24 that are adjacent to one another along a single jaw do not overlap each other.
  • teeth 24 of jaw 27a does not overlap with teeth 24 of jaw 27b since the teeth window each other.
  • teeth 24 of jaw 27a are arranged in a staggered fashion with teeth 24 of jaw 27b. This allows tissue mass to be captured and torn/shredded, while still directing tissue mass into the interior of mouth 20 and ultimately to auger 32 for exiting morcellator 32.
  • Teeth 24 are separately mounted securely around corresponding drive shaft 26.
  • drive shafts 26 rotate simultaneously (typically counter-rotate), thus also rotating teeth 24 in a direction suitable for grasping and cutting tissue mass and pulling tissue mass into the interior of mouth 20 to auger 32.
  • teeth 24 may be serrated or include a hook or cutter component, such that when teeth 24 rotate, tissue mass can be pinched and cut off.
  • An example of a cutter that may be used in conjunction with teeth 24 is indicated in FIG. 6 by the reference numeral 23. Cutters 23 can draw tissue into mouth 20 for cutting by teeth 24.
  • each jaw 27a,27b may be made up of a single piece of material for ease of manufacture.
  • each of jaws 27a,27b may resemble a drill bit, where teeth 24 resemble the cutting edge/lands/margins of the drill bit with flute space disposed therebetween.
  • teeth 24 of jaws 27a,27b being staggered.
  • auger 32 lies beneath jaws 27a,27b and is fully enclosed within mouth 20 at the distal end of morcellator 20.
  • Auger 32 extends proximally through sheath 12 and is enclosed within sheath 12.
  • Auger support 33 can be positioned at the proximal end of auger 32 to hold auger 32 in place concentrically.
  • Jaws 27a,27b each extend adjacent to auger 32 proximally along interior 13 of the extent of sheath 1 2.
  • Jaw 27a exits through port 27a’ and jaw 27b exits through port 27b’, as seen in FIGS. 5 and 12, to a system of motors and gears (not shown in these figures) that drive the rotation of jaws 27a,27b.
  • jaws 27a,27b and auger 32 are straight and parallel along sheath 12 until each exits handle 14 or handle guard 1 8, it is contemplated that jaws 27a,27b and auger 32 can exit morcellator 10 perpendicularly or otherwise at an angle if structurally and functionally feasible and more beneficial. For example, this may occur if the motor shaft and gears (not shown in these figures) require space within morcellator 10.
  • a collection structure may be placed at the proximal end of morcellator 10, such that tissue mass directed by auger 32 toward the proximal end of morcellator 10 can fall into and be collected by the collection structure.
  • tissue mass directed by auger 32 toward the proximal end of morcellator 10 can fall into and be collected by the collection structure.
  • only jaws 27a,27b would have an angled extent and exit point out of morcellator 10.
  • mouth 20 may beveled when extending from sheath 12 with window 25 being angled relative to the line of axis of sheath 12, as indicated in FIGS. 1 , 3, 4, 8, and 1 1. The angle provides greater surface area for teeth 24 to contact the tissue mass.
  • Mouth 20 may terminate distally in safety tip 30, as seen in FIGS. 3, 6, and 8.
  • Safety tip 30 is used to protect tissue masses in the body from morcellator 10. A user of morcellator 10 can push extraneous tissue out of the way of morcellator 10 prior to cutting the targeted tissue mass. Thus, the extraneous tissue can be protected from harm by safety tip 30.
  • fastening mechanisms 31 may be utilized to affix mouth 20 to sheath 12. Other conventional fastening mechanisms are contemplated by the current invention as well.
  • screw ports 39 may be utilized to fasten handle 14, handle guard 1 8, and/or machinery (e.g., motors, gears, etc.) (not shown) to sheath 1 2.
  • machinery e.g., motors, gears, etc.
  • Other conventional fastening mechanisms are contemplated by the current invention as well.
  • mouth 20 and a portion of sheath 12 of morcellator 10 is inserted into the body via a vagina or a laparoscopic port. Extraneous tissue can be pushed or manipulated by safety tip 30 to facilitate targeting of the target tissue mass by the user.
  • Morcellator 10 can then be activated, thus rotating drive jaws 27a,27b (i.e., each drive shaft 26 and each corresponding set of teeth 24).
  • morcellator 12 may include cup assembly 40 for guiding or funneling tissue mass within the subject’s body toward mouth 20 and placing the mass on mouth 20 for morcellation.
  • the bottom closed edge of cup assembly 40 can line the edge of mouth casing 21 that forms the frame of window 25 leading into the interior of mouth 20, as can be seen at reference point 41 in FIG. 18.
  • cup assembly 40 can be compressed and folded against the edge of mouth casing 21 , such that the body of cup assembly 40 lies on top of mouth 20, thereby protecting the internal tissue masses from teeth 24. Subsequently, once mouth 20 is inserted into the body, cup assembly 40 can be expanded to guide a tissue mass into mouth 20. To provide stability in the expanded position of cup assembly 40, as seen in FIG. 18, the open edge of cup assembly 40 can be lined with wire frame 44. Thus, in a compressed position, wire frame 44 would be folded inwardly and proximally to substantially cover mouth 20 and teeth 24. Upon insertion, wire frame 44 can be pushed into an expanded, open, and stable position, as indicated in FIG. 18.
  • a tissue mass can be placed in cup assembly 40 utilizing a laparoscopic grasper positioned through the subject’s abdominal cavity or even possibly a grasper inserted through supplementary channel 28.
  • cup assembly 40 holds the tissue mass in place as teeth 24 morcellates the mass and auger 32 directs the mass toward the exterior of the body. This prevents any tissue from remaining within the subject’s body during or after the surgical procedure.
  • cup assembly 40 can be utilized to scoop a tissue mass within the subject’s body and stably guide the tissue mass to mouth 20 for morcellation by teeth 24 and subsequent removal via auger 32.
  • Cup assembly 40 typically is formed of a flexible material that facilitates the folding or manipulation of cup assembly 40 within mouth 20 or sheath 1 2 for subsequent deployment once inside the subject’s body.
  • cup assembly 40 can be folded or otherwise compressed within supplementary channel 28 during insertion of morcellator 10 into the subject’s body.
  • wire frame 44 may be pulled into supplementary channel 28 to ensure the cup assembly 40 is stretched taut over mouth 20 to maximize protection from teeth 24 and to minimize the size of morcellator 10 entering into the body.
  • deploy apparatus 34 can be used to push or otherwise deploy cup assembly 40 from supplementary channel 28 (i.e., compressed position) into the expanded position seen in FIG. 18.
  • Deploy apparatus 34 can include grip portion 35 and shank portion 37. The distal end of shank portion 37 may or may not be attached to the proximal end of wire frame 44 of cup assembly 40.
  • morcellator 1 00 includes handle 114, hand guard 118, hollow sheath 112, and auger 1 32 for cutting and transportation of tissue masses.
  • This embodiment of the invention is fabricated with mouth 120 having a longitudinal axis parallel to that of sheath 112, rather than being beveled or otherwise angled as in mouth 20 of Example 1 seen in FIG. 4.
  • Example 3 Referring to FIGS.
  • this embodiment of the invention is adapted for the vaginal port and referred to by the reference numeral 212.
  • This embodiment is similar to the one depicted in FIGS. 1 -15, but further includes outer sheath 212 slidably positioned in outer relation to the inner sheath (not shown) disposed therewithin.
  • outer sheath 212 has a diameter larger than the inner sheath and is slidably disposed so as to slide over mouth 220 to safely cover rotating blades 224 and auger 232.
  • the outer diameter of morcellator 200 with outer sheath 212 can be about 30 mm, and the diameter of inner sheath (not shown) can be about 22 mm.
  • This embodiment would not include a cup assembly that covers the cutting blades, such as that seen in FIG. 18.
  • Outer sheath 21 2 is retractable and safely houses cutting blades 224 and auger 232 and can be used as an adjustable blade barrier to allow an increase or decrease in surface area of the amount of blades 224 exposed.
  • the sheath of the morcellator is inserted into the vaginal port. Once the proximal end of the sheath is inserted, the cutting blades are engaged in a rotational motion, and tissue contact may begin on the opening side of the sheath. Once cut, the cutting auger transports the tissue down the sheath to the distal end where it can be removed.
  • FIGS. 23A-28B depict an alternative embodiment of the current invention.
  • the morcellator of this embodiment is generally denoted by the reference numeral 300.
  • FIG. 23A depicts the exterior aspects of morcellator 300. These exterior aspects include elongate sheath 312, handle 314, proximal body 316, mouth 320, and shoot 318.
  • Morcellator 300 may further include optional bay sliding sheath assembly 31 7 that can slide over top mouth 320.
  • handle 314 resembles a pistol grip and is positioned substantially perpendicular to the longitudinal axis of sheath 312.
  • Proximal body 316 connects handle 314 to the proximal end of sheath 31 2.
  • Sheath 312 is straight and is intended to be inserted into a laparoscopic port or vagina of a subject.
  • Mouth 320 extends from the distal end of sheath 312 and is concentric with sheath 312.
  • Shoot 318 is located at the proximal end of sheath 31 2 and can be positioned perpendicular to the axis of sheath 31 2.
  • Shoot 318 acts as an exit point for the tissue mass when the tissue mass has been excised and traveled proximally through sheath 312.
  • FIGS. 23B-23D are various angled wireframe views of morcellator 300 that depict the interior aspects of morcellator 300. These interior aspects include jaws 327a,327b, and further include auger 332, gear assembly 322, and motor unit 324. Each jaw 327a,327b is formed of straight or tapered shank 329 enclosed within sheath 312 and shredding body 334 enclosed within mouth 320 in communication with external environment via window 325.
  • Each jaw 327a,327b may be formed of a single material and extend proximally in a straight manner along the length of sheath 312 and into mouth 320.
  • shredding body 334 can be formed of a series of lands 336 (lands 336 of each jaw 327a,327b may interlock as described in Example 1 ) and flutes 338 that can cut tissue mass, though other forms of cutting or shredding teeth are contemplated by the current invention.
  • the proximal end of sheath 312 is coupled to gear assembly 322, which will become clearer as this specification continues.
  • Auger 332 has a substantially similar length as each jaw 327a,327b and is disposed beneath jaws 327a,327b and within mouth 320.
  • auger 332 may have a length different from jaws 327a,327b, as seen in FIG. 24, but the distal end of jaws 327a,327b and auger 332 are similarly positioned within morcellator 300. Further, the term“beneath” is used relative to morcellator 300 being in an upright position, as seen in FIG. 23D, though morcellator 300 can be used in any position and at any suitable angle necessary for the surgical procedure. Further, auger 332 is substantially centered between jaws 327a,327b when positioned beneath jaws 327a,327b.
  • FIG. 24 depicts several of the external and internal aspects or parts utilized in this embodiment of the current invention. These aspects or parts include, but are not limited to, handle 314, proximal body 316, rotating disc 346 with keyed channel 348, driving spur gear 350 attached to the distal face of keyed shaft 352, driven spur gear 354, conjointly-rotating driving spur gear 356, driven spur gear 358, sheath 312, jaws 327a,327b, auger 332, and mouth 320. Each of these aspects are described herein. FIGS.
  • FIG. 25A-25C depict mouth 320 and the distal end of sheath 312.
  • sheath 312 is not hollow; rather, a plurality of channels can be disposed along the extent of sheath 312, two (2) channels utilized for jaws 327a,327b and one (1 ) channel utilized for auger 332.
  • Jaws 327a,327b exit the distal end of sheath 312 through ports 327a’ and 327b’, respectively, and auger 332 exits the distal end of sheath 312 through port 333.
  • jaws 327a,327b and auger 332 are contained within mouth 320. This aspect can further be seen in the exploded view of FIG.
  • mouth 320 may further include safety tip 330 to protect extraneous tissue mass from morcellator 300.
  • Safety tip 330 can be flat, as seen in FIG. 25A, or rounded, thus allowing the user to push or manipulate extraneous tissue when attempting to reach the targeted tissue mass.
  • shredding body 334 of each jaw 327a,327b is contained within mouth 320 and possibly a portion of sheath 312, though it is contemplated that a majority of each jaw 327a,327b enclosed by sheath 312 is straight or tapered shank 329.
  • Fastening mechanisms 331 may be utilized on the distal end of mouth 320 to affix mouth 320 to sheath 312. Other conventional fastening mechanisms are contemplated by the current invention as well.
  • Mouth casing 321 forms the protective outer layer of mouth 320 on all sides other than window 325, as directed in FIGS. 25A and 26.
  • Window 325 allows open communication between the hollow interior of mouth 320 and the external environment, though the current invention contemplates various mechanisms of covering window 325. Examples of these mechanisms will become clear as this specification continues.
  • FIG. 25C shows more clearly the positioning of auger 332 relative to jaws 327a,327b. Auger 332 is positioned beneath jaws 327a,327b and substantially centered between jaws 327a,327b.
  • FIG. 27 is an exploded view of the proximal end of morcellator 10.
  • Rotating disc 346 with keyed channel 348 is positioned within proximal body 316 above perpendicular handle 314, which encloses at least a portion of the motor unit (not shown in this figure).
  • Rotating disc structure 346,348 is coupled to the motor unit, which, when activated, rotates rotating disc structure 346,348.
  • Keyed shaft 352 is keyed into channel 348 of rotating disc structure 346,348.
  • Driving spur gear 350 is securely attached to the distal end of keyed shaft 352, such that when keyed shaft 352 rotates, driving spur gear 350 rotates as well.
  • Spur gears 354,356,358 are meshably engaged with driving spur gear 350 and/or with each other in a manner that when rotating disc structure 346,348 rotates, gears 354,356,358 will rotate as well.
  • the purpose of this arrangement is so that jaws 327a,327b and auger 332 will rotate simultaneously.
  • the proximal end of auger 332 is securely attached to driving spur gear 350 in a conventional manner.
  • Jaws 327a,327b are securely attached to conjointly rotating driving spur gear 356 and driven spur gear 358, respectively, in a conventional manner.
  • any suitable arrangement of gears in gear assembly 322 is envisioned. In an embodiment, as depicted in FIGS.
  • gear assembly 322 includes rotating disc 346 with keyed channel 348, keyed shaft 352, driving spur gear 350, driven spur gear 354, conjointly-rotating driving spur gear 356, and driven spur gear 358.
  • Keyed shaft 352 aligns with and is inserted through keyed channel 348, such that rotation of rotating disc 346 rotates keyed shaft 352 as well.
  • Driving spur gear 350 is securely attached to the distal end of keyed shaft 352. As seen in FIG. 28A, the proximal end of keyed shaft 352 is tool- engageable. Thus, keyed shaft 352 can be rotated manually or electrically through aperture 323b, if desired or needed. Still referring to FIGS.
  • driving spur gear 350 is meshably engaged with driven spur gear 354.
  • Conjointly-rotating driving spur gear 356 is coupled to driven spur gear 354 in spaced concentric relation to driven spur gear 354 and distal to driven spur gear 354.
  • Conjointly-rotating driving spur gear 356 is meshably engaged with driven spur gear 358.
  • conjointly-rotating spur gear 356 is driven by rotation of driving spur gear 350
  • conjointly-rotating spur gear 356 becomes a driving gear by actuating the rotation of driven spur gear 358.
  • the proximal end of auger 332 is securely coupled to driving spur gear 350.
  • the proximal end of jaw 327b is securely coupled to conjointly-rotating driving spur gear 356.
  • motor unit 324 is positioned within handle 31 4 perpendicular to gear assembly 322. Motor unit 324 is electrically coupled to gear assembly 322 via power takeoff shaft 326. Motor unit 324 is capable of activating, deactivating, and controlling the rotation of gear assembly 322.
  • motor unit 324 is activated to initiate rotation of rotating disc 346, which rotates keyed shaft 352.
  • Rotation of keyed shaft 352 rotates driving spur gear 350, which in turn rotates auger 332, driven spur gear 354, and conjointly-rotating driving spur gear 356.
  • Rotation of conjointly-rotating driving spur gear 356 rotates jaw 327b and driven spur gear 358.
  • Rotation of driven spur gear 358 rotates jaw 327a.
  • activation of motor unit 324 results in simultaneous rotation of auger 332, jaw 327b, and jaw 327a.
  • the current invention contemplates a variety of mechanisms that can cover or fill window 325 while morcellator 300 is not in use or during insertion of morcellator 300 into the subject’s body.
  • Window 325 can remain covered or filled until just prior to cutting by shredding body 334 of each jaw 327a,327b.
  • the cover can be removed to expose auger 332 and shredding body 334 of each jaw 327a,327b to the internal tissue masses.
  • Various non-limiting mechanisms for covering window 325 are provided in Examples 5-8.
  • 29A and 29B illustrate an optional addition to morcellator 300, said addition being cup assembly 340 with supplementary channel 328 extending along the extent of sheath 312 for enclosing and deploying cup assembly 340.
  • the bottom edge of cup assembly 340 is attached to mouth 320, for example by being attached to mouth casing 321 or the outer edges of window 325.
  • this can be seen in FIG. 29B at reference numeral 342.
  • Cup assembly 340 has a compressed position and an expanded position. In a compressed position, cup assembly 340 would be enclosed within supplementary channel 328, though cup assembly 340 would provide a coverage over window 325 in the compressed position because of the attachment of the bottom edge of cup assembly 340 to mouth 320.
  • cup assembly 340 Prior to excising of tissue mass, cup assembly 340 can be deployed into the expanded position seen in FIGS. 29A and 29B. Cup assembly 340 can scoop or otherwise direct tissue mass toward mouth 320 for morcellation by shredding body 334 and transportation (and further morcellation) by auger 332. Cup assembly 340 includes wire frame 344 along its top edge when in its expanded position. Wire frame 344 stabilizes cup assembly 340 in an upright position.
  • FIGS. 30A-30C depict a mechanism for covering window 325 using bay doors 360.
  • FIG. 30A shows mouth 320 when bay doors 360 are closed, whereas FIGS. 30B and 30C show mouth 320 when bay doors 360 are open in the direction of the arrows to expose shredding body 334 of each jaw 327a,327b.
  • Bay doors 360 may be a single door (not shown) or multiple figures as seen in FIGS. 30A-30C. Further, bay doors 360 can open in any direction, for example transversely (not shown) or longitudinally as seen in FIGS. 30A-30C.
  • a triggering mechanism (not shown) would be included in proximity to handle 314 or proximal body 316 for opening and closing bay doors 360. Methodologically, morcellator 300 would be inserted into the subject’s body with bay doors 360 closed, as in FIG. 30A. Subsequently, prior to contacting the targeted tissue mass, bay doors 360 can be opened using triggering mechanism (not shown), thus exposing the tissue mass to the shredding body of each jaw 327a,327b for morcellation.
  • Example 7 FIGS.
  • FIG. 31 A-31 C depict a mechanism for covering window 325 using bay rotating outer sheath 362.
  • Bay rotating outer sheath 362 has a cutout in the shape of window 325.
  • FIG. 31 A shows mouth 320 when bay rotating outer sheath 362 is rotated to completely cover window 325.
  • FIG. 31 B depicts rotation of bay rotating outer sheath 362 in the direction of the arrow to expose half of window 325.
  • FIG. 31 C depicts window 325 when bay rotating outer sheath 362 has been fully rotated in the direction of the arrow such that the cut out of outer sheath 362 is aligned with window 325, thus fully exposing window 325.
  • Bay rotating outer sheath 362 may have any suitable length that facilitates its rotation.
  • morcellator 300 would be inserted into the subject’s body with bay rotating outer sheath 362 rotated to close off window 325, as in FIG. 31 A. Subsequently, prior to contacting the targeted tissue mass, bay rotating outer sheath 362 can be rotated to expose as much of shredding body as desired by the user. For example, if the user desires to morcellate only a relatively small piece of tissue, the user may desire to open only half of window 325, as in FIG. 31 B.
  • FIGS. 32A-32C depict a mechanism for covering window 325 using bay sliding outer sheath 364.
  • Bay sliding outer sheath 364 is an outer sheath that typically has no cutouts but slides distally to cover window 325 and slides proximally to expose shredding body.
  • FIG. 32A shows mouth 320 when bay sliding outer sheath 364 has slid distally to fully cover window 325.
  • FIG. 32B depicts mouth 320 when bay sliding outer sheath 364 has slid proximally to expose half of window 325.
  • FIG. 32C depicts mouth 320 when bay sliding outer sheath 364 has slid proximally to the proximal edge of window 325 to fully expose window 325.
  • Bay sliding outer sheath 364 may have any suitable length that facilitates proximal-distal movement. This movement/sliding may be achieved manually if the length extends to proximal body 316 (i.e., outside of the body), or it may be done automatically upon activating a trigger mechanism (not shown) in a conventional manner.
  • Methodologically, morcellator 300 would be inserted into the subject’s body with bay sliding outer sheath 364 slid distally to the distal edge of window 325, thus closing off window 325, as in FIG. 32A.
  • bay sliding outer sheath 364 can be slid proximally to expose as much of shredding body as desired by the user. For example, if the user desires to morcellate only a relatively small piece of tissue, the user may desire to open only half of window 325, as in FIG. 32B. Alternatively, the user may desire to expose all of shredding body by sliding bay sliding outer sheath 364 fully proximally beyond the proximal edge of window 325.
  • Example 9 Reference, including reference numerals, is made herein to morcellator 10 of Example 1 , though the mechanism illustrated and described herein can be applied to any of the embodiments of the current invention.
  • FIG. 33 shows the distal end of the morcellator showing a gear assembly, generally denoted by the reference numeral 46, that is used to drive and control (speed, direction of rotation, etc.) jaws 27a,27b and teeth 24.
  • Gear assembly 46 includes jaw gears 48a,48b, auger gear 50, and pivot gear 52.
  • Jaw gears 48a,48b are in communication with distal end 26’ of drive shafts 26, such that when jaw gears 48a,48b rotate, drive shafts 26 rotate, thus respectively rotating jaws 27a,27b.
  • auger gear 50 is in communication with distal end 32’ of auger 32, such that when auger gear 50 rotates, auger 32 rotates.
  • pivot gear 52 drives rotation of jaw gear 48a and auger gear 50 in a clockwise or counterclockwise direction.
  • jaw gear 48a drives rotation of jaw gear 48b.
  • Pivot gear 52 can rotate in either clockwise or counterclockwise and thus can permit a change of direction of rotation of jaws 27a,27b and auger 32, depending on needs.
  • FIG. 33 Also shown in FIG. 33 are jaws 27a,27b with blade teeth 24 slightly offset to draw tissue into mouth 20 of morcellator 10.
  • FIG. 34 illustrates the offset at about 5 o per blade tooth 24 for a total of about 30 o from center to end.
  • FIG. 34 is a further expanded view of jaw (shear cutter assembly) 27a,27b with the blade teeth offset at about 5 o . It is envisioned, however, that the offset can be more or less than about 5 o per blade tooth and as such, more or less than the approximate 30 o shown in FIG. 34.
  • FIG. 35 is a cross-sectional view of jaw 27a,27b and in particular with two (2) distinct designs of teeth 24 and cutter blades 23: a deep cutter blade assembly and a shallow cutter blade assembly. The shallower cutter blade assembly would be better suited to grip the tissue.
  • the design choice, exclusively or in combination in one jaw or multiple jaws, may be determined by a user, as needed.
  • FIG. 36 is a view of morcellator 1 0 showing the auger and the entry point of auger 32 into shaft 15 of sheath 12 (see FIG. 14 also).
  • This embodiment also includes handle 14 with trigger mechanism 58 to power and control rotation of auger 32 and/or jaws 27a,27b, as understood by one of ordinary skill in the art.
  • This embodiment further includes exit port 60 through morcellated tissue can exit proximally.
  • FIG. 37 is a close-up view of the entry point of auger 32 into shaft 15. As can be seen, auger 32 can enter and fit snugly into shaft 15 when auger 32 enters sheath 1 2 of morcellator 10.
  • the entrance to auger shaft 15 can be sharp or have cutting edge 62 in order to further shred the morcellated tissue before the tissue is moved proximally through sheath 1 2 and exit port 60 of morcellator 10 to be removed from the patient or subject.
  • Auger gear This term is used herein to refer to a gear mechanism that drives rotation of the auger.
  • Control apparatus This term is used herein to refer to any mechanism of controlling the rotation of the jaws and auger. Control can be activation, deactivation, increasing or decreasing speed of rotation, etc.
  • Cover apparatus This term is used herein to refer to any mechanism of protecting extraneous tissue from the shredding blades/teeth, typically by covering or filling the window of the mouth.
  • the cover apparatus can be removed or manipulated to expose the shredding blades/teeth within the mouth.
  • Cutters This term is used herein to refer to a structural part of the blades/teeth that are capable of pinching or grasping tissue during rotation of the jaws. Alternatively, the cutters can resemble a hook-like protrusion that is capable of cutting tissue during rotation of the jaws.
  • Cutting blade This term is used herein to refer to a structure that is capable of shredding tissue as the tissue mass travels past.
  • Deploy apparatus This term is used herein to refer to any mechanism of deploying the cup assembly into an expanded or open position. The deploy apparatus would be dependent on the user’s positioning of the cup assembly in compressed position.
  • the deploy mechanism of FIG. 16 can be used.
  • the deploy apparatus can be manual (as in FIG. 16 for example), automatic, or electronic.
  • Direction of rotation This term is used herein to refer to revolution of a structure in a clockwise or counterclockwise direction.
  • Distal This term is used herein to refer to proximity to the patient or subject. Thus, the distal end of a structure is closer to the patient or subject than to the user of the morcellator.
  • Exit port This term is used herein to refer to a proximally-disposed opening through which shredded tissue mass can exit the morcellator.
  • Extraneous tissue This term is used herein to refer to any tissue within the body of the subject or patient that is not being targeted by the user for morcellation.
  • Gear assembly This term is used herein to refer to any configuration of gears that facilitates the rotation of the jaws and auger.
  • Gripping apparatus This term is used herein to refer to any mechanism of stabilizing or spatially controlling the morcellator. This mechanism can be manual, for example using a handle, or automated/electronic, for example by attachment to machinery (e.g., extension from a robot).
  • Inwardly This term is used herein to refer to the spatial relationship between the jaws and auger relative to the line of path taken by tissue undergoing morcellation.
  • Jaw gears This term is used herein to refer to a gear mechanism that drives rotation of the elongate jaws.
  • Meshably engaged This term is used herein to refer to communication or coupling mechanism between two or more gears, such that rotation of one gear can rotate another gear.
  • Morcellator This term is used herein to refer to any device used for the removal of tissue from a patient or subject during laparoscopic surgery.
  • Motor unit This term is used herein to refer to any mechanism of mechanically powering and controlling the rotation of the jaws and auger.
  • Opposing blades This term is used herein to refer to blades/teeth that face each other from their respective jaws if two jaws are present, as may be seen in FIGS. 6, 15, 22, 25B, and/or 25C. Blades are designed to cut or shred tissue and may have any structure to achieve such function. Outer edges: This term is used herein to refer to the border of the window of the mouth, or a surface of the mouth that is in proximity to the border of the window. Pistol grip: This term is used herein to refer to the portion of the morcellator that is held by the user’s hand and orients the user’s hand in a forward, vertical orientation, or perpendicular to the sheath of the morcellator.
  • Pivot gear This term is used herein to refer to a driving gear mechanism that rotates in either clockwise or counterclockwise direction, thus controlling direction of rotation of one or more driven gears.
  • Proximal This term is used herein to refer to proximity to the user (e.g., surgeon, surgical team) of the morcellator. Thus, the proximal end of a structure is closer to the user of the morcellator than to the patient or subject.
  • Snugly fits This term is used herein to refer to the disposition of an elongate structure in a channel, such that the elongate structure is spatially stabilized (i.e., minimal movement around the channel) but is still capable of rotation without damaging the walls of the channel.
  • Staggered, interlocking relation This term is used herein to refer to the teeth of each jaw windowing each other, for example as seen in FIG. 15. This configuration of teeth may facilitate the shredding of tissue.
  • Targeted tissue mass This term is used herein to refer to the tissue intended to be excised and/or removed from the patient or subject.
  • Trigger mechanism This term is used herein to refer to a finger-operated lever used to power and/or control rotation of the auger and/or jaws. It is contemplated herein that the speed of rotation can be controlled by the amount of force placed upon the trigger mechanism.
  • Underneath This term is used herein to refer to a spatial relationship of the auger to the jaws when the morcellator is in an“upright” position or when the sheath is horizontally oriented, as in FIG. 23D for example.
  • Wire frame This term is used herein to refer to the top edge of the cup assembly, where the wire frame facilitates the expansion of the cup assembly and stabilizes the cup assembly in an upright position.
  • the wire frame can be formed of any suitable material, such as a polymer or metal. Selection of material for the wire frame may be dependent on the needs of the user. For example, a light metal may be desired by the user in order for the wire frame to be able to fold into the supplementary channel in its compressed position but still stabilize the cup assembly in the expanded position.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
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  • Surgical Instruments (AREA)

Abstract

La présente invention concerne un dispositif laparoscopique de résection de tissu mini-invasif, précisément un morcellateur. Le dispositif comprend, de l'extrémité proximale à l'extrémité distale, un mécanisme de préhension, une gaine allongée, et une embouchure, se terminant finalement en une pointe de sécurité. La gaine allongée et l'embouchure sont concentriques, de telle manière que deux lames/dents de coupe/broyage allongées et pivotantes et une une vis d'alimentation sans fin allongée peuvent être positionnées sur la longueur de la gaine et de l'embouchure. Les dents sont disposées de façon opposée et en quinconce (par exemple, décalage de 5°), de telle sorte que le contact avec la masse tissulaire saisit et le tissu et le tire vers l'intérieur en direction de la vis sans fin, qui transporte le tissu de manière proximale vers l'extérieur du corps du patient (par exemple, vers un orifice de sortie) Un ensemble unité motrice et engrenage peut être couplé aux dents et à la vis sans fin pour entraîner la rotation des dents et de la vis sans fin. Un ensemble coupelle peut être disposé dans une relation de chevauchement avec l'embouchure pour guider la masse de tissu en direction de l'embouchure.
PCT/US2015/034514 2014-06-05 2015-06-05 Dispositif laparoscopique de résection de tissu mini-invasif WO2015188118A1 (fr)

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Publication number Priority date Publication date Assignee Title
WO2020018046A3 (fr) * 2018-05-14 2020-03-19 Ondokuz Mayis Universitesi Rektorluk Dispositif de manipulation d'utérus
CN112155667A (zh) * 2020-10-12 2021-01-01 杭州埃杜医疗科技有限公司 刨削动力系统
WO2021165230A1 (fr) * 2020-02-17 2021-08-26 Université de Liège Dispositif d'élimination de tissu adipeux
CN114343790A (zh) * 2021-12-27 2022-04-15 齐齐哈尔医学院 仿生蛆口的乳腺肿瘤微创手术切割器

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WO2014123571A1 (fr) * 2013-02-05 2014-08-14 University Of South Florida Dispositif d'extraction de tissu par voie laparoscopique minimalement invasive

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US4844363A (en) * 1987-07-06 1989-07-04 Shredding Systems, Inc. Hopper ram for shredder
US5141168A (en) * 1990-04-30 1992-08-25 Mono Pumps Limited Macerating machine
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US20060089527A1 (en) * 2004-04-30 2006-04-27 Frank Doll Surgical instrument system
US20080249553A1 (en) * 2007-04-06 2008-10-09 William Harwick Gruber Method, system and device for tissue removal
US20120053606A1 (en) * 2008-06-23 2012-03-01 Schmitz Gregory P Selective tissue removal tool for use in medical applications and methods for making and using
US20110196400A1 (en) * 2010-02-11 2011-08-11 Ethicon Endo-Surgery, Inc. Rotatable cutting implement arrangements for ultrasonic surgical instruments
WO2014123571A1 (fr) * 2013-02-05 2014-08-14 University Of South Florida Dispositif d'extraction de tissu par voie laparoscopique minimalement invasive

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2020018046A3 (fr) * 2018-05-14 2020-03-19 Ondokuz Mayis Universitesi Rektorluk Dispositif de manipulation d'utérus
WO2021165230A1 (fr) * 2020-02-17 2021-08-26 Université de Liège Dispositif d'élimination de tissu adipeux
CN112155667A (zh) * 2020-10-12 2021-01-01 杭州埃杜医疗科技有限公司 刨削动力系统
CN114343790A (zh) * 2021-12-27 2022-04-15 齐齐哈尔医学院 仿生蛆口的乳腺肿瘤微创手术切割器
CN114343790B (zh) * 2021-12-27 2023-06-09 齐齐哈尔医学院 仿生蛆口的乳腺肿瘤微创手术切割器

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