WO2022269614A1 - Peritoneal separation apparatus - Google Patents

Peritoneal separation apparatus Download PDF

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Publication number
WO2022269614A1
WO2022269614A1 PCT/IL2022/050674 IL2022050674W WO2022269614A1 WO 2022269614 A1 WO2022269614 A1 WO 2022269614A1 IL 2022050674 W IL2022050674 W IL 2022050674W WO 2022269614 A1 WO2022269614 A1 WO 2022269614A1
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WO
WIPO (PCT)
Prior art keywords
effector
tube
elongated tube
cavity
longitudinal axis
Prior art date
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PCT/IL2022/050674
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French (fr)
Inventor
David HAZZAN
Gilad Lavi
Original Assignee
Tel Hashomer Medical Research, Infrastructure And Services Ltd.
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Application filed by Tel Hashomer Medical Research, Infrastructure And Services Ltd. filed Critical Tel Hashomer Medical Research, Infrastructure And Services Ltd.
Publication of WO2022269614A1 publication Critical patent/WO2022269614A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0281—Abdominal wall lifters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/062—Measuring instruments not otherwise provided for penetration depth
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0815—Implantable devices for insertion in between organs or other soft tissues

Definitions

  • the present disclosure relates to an apparatus for mechanically displacing tissue during laparoscopic procedures (e.g., hernia procedures).
  • the disclosure relates to an apparatus introduced into the space between the peritoneum and the muscle tissue; and, once in place, actively operated to separate thereof and generate working space therewithin.
  • Endoscopic or laparoscopic procedures are characterized by the provision of an elongated cannula structure having a relatively thin diameter with a proximal and distal end. The distal end is passed through the surrounding tissue into the body cavity wherein the surgical procedure or examination is to be affected, thus providing a conduit for the insertion of surgical instrumentation.
  • laparoscopic techniques were used primarily for diagnostic purposes to view the internal organs, without the necessity of convention surgery. Since the 1930s, laparoscopy has been used for performing procedures (e.g., hernias). Performing a minimally invasive procedure could be facilitated by the use of a plurality of cannula structures to allow operation of a variety of instruments simultaneously during a said procedure. For example, one cannula may provide a conduit for an endoscope for vision and illumination within the operative cavity while other cannulas provide conduits for control of specialized surgical instruments designed for performing specific procedural functions. Most of the laparoscopic procedures are performed in the abdomen. During such procedures, it is necessary to raise and hold the abdominal wall to generate a working space.
  • procedures e.g., hernias.
  • retractors are ordinarily in the form of a broad paddle structure or multiple fingers attached to a handle; thus, such structures are not usable in laparoscopic procedures since the retractor is too large to be inserted through the cannula structure into the operative body cavity.
  • expanders are collapsible ones that have taken the form of radial fingers which are activatable to extend relative to each other upon entering the body cavity. See, for example, U.S. Pat. No. 4,654,028 (Suma), 4,459,978 (Kotsanis). Dilators of this type are also known. See, e.g., U.S. Pat. Nos. 1,328,624 (Graham) and 972,983 (Arthur). In each case, once the retractive or dilatory function is completed, the fingers are compressed and withdrawn.
  • Another collapsible retractor structure includes a pair of collapsible fingers joined by a web of resilient material which, upon insertion into the cannula structure, can expand to form a retractive structure. See, for example, U.S. Pat. No. 4,190,042 (Sinnheim).
  • Such collapsible structures have certain inherent drawbacks associated therewith. For example, upon retraction loose tissue may become caught within the fingers and cause unintentional trauma to retracted tissue. Also, where the tissue is not readily dislodged, collapsing and withdrawing the retractor may be difficult and complicated.
  • Another type of laparoscopic retractors is based on an inflatable element, e.g., balloons (see, for example US publication no. US20150057501).
  • Hernia occurs when an organ, intestine or fatty tissue, squeezes through a hole or a weak spot in the surrounding muscle or connective tissue (namely, the abdominal wall).
  • hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue.
  • Hernia repair procedures are very common - more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias. Rutkow, I.M. (2003). Demographic and Socieconomic Aspects of Hernia Repair in the United States in 2003. Surgical Clinics of North America; 83(5):1045-51, v-vi.
  • TAPP transabdominal preperitoneal
  • TEP totally extraperitoneal
  • TEP is different in that the peritoneal cavity is not entered and mesh is used to seal the hernia from the peritoneum cavity (by creating a working space there between the peritoneum and the muscle layer).
  • PCT publication WO91/014392 discloses an apparatus for lifting the abdominal wall for peritoneal retraction, the apparatus comprising abdominal wall engaging means wherein the abdominal wall engaging means is insertable through a small laparoscopic incision of limited area in the abdominal wall and comprises a pair of angle-shaped elements movable relative to one another for extension from the exterior of the abdominal wall laterally beyond the limited area of the laparoscopic incision to interiorly engage an extensive area of the abdominal wall; and the apparatus comprises a lifting means for impart lifting force to the abdominal wall through the angle shaped elements.
  • U.S. patent No. US5,505,689 describes several different mechanical devices that are inserted through one or more punctures into the abdomen. All or part of the device is then lifted to lift the abdominal wall away from the underlying abdominal organs.
  • One of the devices described is a fan retractor that is inserted in a closed condition into the abdominal cavity, spread apart once inside the abdominal cavity, and brought into contact with the peritoneum inside the abdominal cavity. The apparatus is then lifted to lift the abdominal wall.
  • the known fan retractors are all intended for intra-abdominal placement. Fan retractors have a substantially constant stiffness along the length of their peritoneum -engaging elements. This causes the pressure that the peritoneum-engaging elements exert against the peritoneum to increase. High pressure can cause trauma to the peritoneum, and there is a risk that the ends of the peritoneum-engaging elements will penetrate the peritoneum.
  • gas insufflation Another significant disadvantage of gas insufflation is that instruments must be passed into the abdominal cavity through gas-tight seals, which significantly reduce the surgeon's feel of the instruments.
  • a sufficiently gas source adapted to maintain constant pressure to ‘automatically’ compensate for any possible leak in the system.
  • the present disclosure provides an apparatus for generating a working space during laparoscopic surgery, said apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; said distal end is adapted to be inserted into a cavity; b.
  • said at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape.
  • the apparatus is for use in the peritoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
  • TEP totally extraperitoneal
  • said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
  • said at least one effector when said at least one effector is in said deployed configuration and in said preformed shape, said at least one effector is adapted to articulate at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said effector as the same emerges out of said tube; where A may be in the range of 0 to 360 degrees.
  • rotational movement of said at least one elongated tube along said main longitudinal axis results in rotational movement of said at least one effector which results in said generation of said working space in the preperitoneal cavity.
  • said at least one elongated tube is stiffer than said at least one effector, such that the bending resistance of said tube is higher by at least 25%.
  • said at least one elongated tube is characterized by Young's modulus in the range of above 150 GPa.
  • said at least one effector is characterized by Y oung's modulus in the range of below 100 GPa.
  • At least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
  • said at least one effector is characterized by a blunt tip.
  • said apparatus additionally comprises at least one locking element.
  • said at least one locking element is adapted to secure said at least one elongated tube in position and orientation within said peritoneal cavity.
  • said at least one effector comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid. In some embodiments, said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
  • said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
  • said at least one effector is made of at least one super elastic material.
  • said super elastic material is nickel-titanium (NiTi).
  • said at least one effector is made of at least one shape memory material selected from a group consisting of copper-aluminum-nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • said at least one effector additionally comprising at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
  • said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation (creation) of said working space within said preperitoneal cavity.
  • said at least one protruding member when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
  • said at least one effector additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • said pre-shaped form of said at least one effector is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
  • said at least one effector is an elongated wire.
  • said rod comprises two ends.
  • said distal end of said at least one elongated tube comprising at least one anvil.
  • said at least one effector encircles said at least one anvil, such that said two ends are positioned in said proximal end of said at least one elongated tube.
  • distally advancing either end of said at least one effector results in the extraction of at least a portion of said at least one effector out of said at least one opening through said distal end of said at least one elongated tube and convert the same to said deployed configuration.
  • said distal end of said at least one elongated tube comprising at least one curved slope adapted to facilitate the extraction of said at least one effector into said body cavity by directing the same towards said opening.
  • the present disclosure provides a method for generating a working space in a body cavity, during laparoscopic procedure, method comprising steps of: providing an apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; b.
  • said at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape; introducing said distal end of said elongated tube into said body cavity; at least partially extracting said at least one effector through said at least
  • said laparoscopic surgery is a totally extraperitoneal (TEP) hernia repair procedure.
  • TEP totally extraperitoneal
  • said body cavity is the peritoneal cavity.
  • said working space is provided in said preperitoneal cavity without penetrating the peritoneum.
  • the method additionally comprises a step of providing real-time visual control by means of at least one laparoscope.
  • the method additionally comprises a step of co-axially introducing said at least one effector into said at least one elongated tube; thereby providing said at least one effector in said retracted configuration.
  • the method additionally comprises a step of providing said at least one effector in said deployed configuration and in said preformed shape, articulated at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said effector, as the same emerges out of said tube; where A may be in the range of 0 to 360 degrees.
  • the method additionally comprises step of rotating said at least one elongated tube along said main longitudinal axis; thereby rotating said at least one effector along a plane being substantially perpendicular to said main longitudinal axis, when said at least one effector is in said deployed configuration.
  • rotational movement of said at least one elongated tube along said main longitudinal axis results in rotational movement of said at least one effector which results in said generation of said working space in said preperitoneal cavity.
  • the method additionally comprises step of providing said at least one elongated tube stiffer than said at least one effector, such that the bending resistance of said tube is higher by at least 25%.
  • said at least one elongated tube is characterized by Young's modulus in the range of above 150 GPa.
  • said at least one effector is characterized by Young's modulus in the range of below 100 GPa.
  • At least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
  • said at least one effector has a blunt tip.
  • said apparatus has at least one locking element.
  • the method additionally comprises a step of fixating said at least one elongated tube in position and orientation within said preperitoneal cavity.
  • said at least one effector has at least one aperture along the body thereof.
  • said at least one aperture fluidly communicates with at least one source of fluid.
  • the method additionally comprises a step of providing at least one fluid through said at least one aperture to said preperitoneal cavity and insufflating the same.
  • the method additionally comprises a step of selecting said fluid from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
  • said least one effector is made of at least one super elastic material.
  • said super elastic material to be nickel-titanium (NiTi).
  • said at least one effector is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • the method additionally comprises a step of providing said at least one effector with at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
  • said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
  • said at least one protruding member when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
  • said at least one effector additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • the method additionally comprises step of providing said at least one effector in said pre-shaped form with n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
  • the present disclosure provides an apparatus for generating a working space in a body cavity during a laparoscopic procedure, said apparatus comprising: a. at least one elongated tube having a distal end and a proximal end comprising at least one opening; said distal end is adapted to be inserted into said cavity; b.
  • At least one effector co-axially, at least partially, housed within said at least one elongated tube and characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis;
  • said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said proximal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape.
  • the apparatus is for use to generate a working space in the peritoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
  • TEP totally extraperitoneal
  • said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
  • said at least one tube when said at least one tube is in said deployed configuration and in said preformed shape, said at least one tube is adapted to articulate an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said tube, when said effector is pull proximally; where A may be in the range of 0 to 360 degrees.
  • rotational movement of said at least one elongated tube along said main longitudinal axis along plane being substantially perpendicular to said main longitudinal axis, when said at least one elongated tube is in said deployed configuration results in said generation of said working space in the preperitoneal cavity.
  • said at least one effector is stiffer than said at least one elongated tube, such that the bending resistance of said effector is higher by at least 25%.
  • said at least one effector is characterized by Young's modulus in the range of above 150 GPa.
  • said at least one elongated tube is characterized by Young's modulus in the range of below 100 GPa.
  • At least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
  • said at least one elongated tube is characterized by a blunt tip.
  • said apparatus additionally comprises at least one locking element.
  • said at least one locking element is adapted to secure said at least one elongated tube in position and orientation within said peritoneal cavity.
  • said at least one elongated tube comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
  • said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
  • said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
  • said at least one elongated tube is made of at least one super elastic material.
  • said super elastic material is nickel-titanium (NiTi).
  • said at least one tube is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • said at least one elongated tube additionally comprising at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
  • said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
  • said at least one protruding member when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
  • said at least one elongated tube additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • said pre-shaped form of said at least one elongated tube is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said tube, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees s.
  • the present disclosure provides a method for generating a working space in a body during a laparoscopic procedure, method comprising steps of: providing an apparatus comprising: a. at least one elongated tube having a distal end and a proximal end interconnected along a main longitudinal axis; b.
  • At least one effector co-axially, at least partially, housed within said at least one elongated tube and said at least one effector being characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis;
  • said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape;
  • said laparoscopic surgery is a totally extraperitoneal (TEP) hernia repair procedure.
  • TEP totally extraperitoneal
  • said body cavity is the peritoneal cavity.
  • said working space is provided in said preperitoneal cavity without penetrating the peritoneum.
  • the method additionally comprises a step of co-axially fully inserting said at least one effector into said at least one elongated tube; thereby providing said at least one elongated tube in said retracted configuration.
  • the method additionally comprises a step of providing said at least one tube in said deployed configuration and in said preformed shape articulated at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said tube, when said effector is pull proximally; where A may be in the range of 0 to 360 degrees.
  • the method additionally comprises step of rotating said at least one elongated tube along said main longitudinal axis; thereby generating said working space in said preperitoneal cavity.
  • the method additionally comprises step of providing said at least one effector stiffer than said at least one elongated tube, such that the bending resistance of said effector is higher by at least 25%.
  • said at least one effector is characterized by Young's modulus in the range of above 150 GPa.
  • said at least one elongated tube is characterized by Young's modulus in the range of below 100 GPa.
  • At least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
  • said at least one elongated tube has a blunt tip.
  • said apparatus has at least one locking element.
  • the method additionally comprises a step of fixating said at least one elongated tube in position and orientation within said preperitoneal cavity.
  • the method additionally comprises a step of providing said at least one elongated tube with at least one aperture along the body thereof.
  • said at least one aperture fluidly communicates with at least one source of fluid.
  • the method additionally comprises a step of providing at least one fluid through said at least one aperture to said preperitoneal cavity and insufflating the same.
  • the method additionally comprises a step of selecting said fluid from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
  • said least one elongated tube is made of at least one super elastic material.
  • said super elastic material to be nickel-titanium (NiTi).
  • said at least one tube is made of at least one shape memory material selected from a group consisting of copper-aluminum -nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • the method additionally comprises step of providing said at least one elongated tube with at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
  • said at least one protruding member when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
  • said at least one elongated tube additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • the method additionally comprises step of providing said at least one elongated tube in said pre-shaped form with n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said tube, regardless of said n bending planes , is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
  • the present disclosure provides a retractor for laparoscopic surgery comprising at least one pair of elongated co-axial elements characterized by a distal end at least partially introduced into a body cavity; and a proximal end interconnected by a main longitudinal axis; wherein one of which is housed within the second one and operable such that linear reciprocal movement of one relative to the other is provided; further wherein one of said elements is characterized by a pre-shaped form and at least and at least two configurations: a deployed configuration, in which at least one of said elements is at least partially extracted out of said second element; and, a retracted configuration, in which said at least one of said elements is fully housed within said second element.
  • the retractor is adapted for lifting the abdominal wall to generate a working space in the preperitoneal cavity.
  • the retractor adapted for a totally extraperitoneal (TEP) hernia repair procedure.
  • TEP totally extraperitoneal
  • said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
  • said at least one element when said at least one of said element is in said deployed configuration and in said preformed shape, said at least one element is adapted to articulate at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and the tip of at least one of said elements; where A may be in the range of 0 to 360 degrees.
  • said rotational movement results in said generation of said working space in the preperitoneal cavity.
  • one of said elements is stiffer than the second element, such that the bending resistance of said one of said elements is higher by at least 25%.
  • one of said elements is characterized by Young’s modulus in the range of above 150 GPa while the second is characterized by Young’s modulus in the range of below 100 GPa.
  • one of said elements is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
  • At least one of said elements is characterized by a blunt tip.
  • said retractor additionally comprises at least one locking element.
  • said at least one locking element is adapted to secure at least one of said elements in position and orientation within the peritoneal cavity.
  • At least one of said elements comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
  • said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
  • said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
  • At least one of said elements is made of at least one super elastic material.
  • said shape super elastic is nickel- titanium (NiTi).
  • said at least one element is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • At least one of said elements additionally comprising at least one protruding member disposed along at least partially the outer circumference of said element.
  • said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
  • said at least one protruding member when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
  • At least one of said elements additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • said pre-shaped form of said at least one effector is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said at least one element, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
  • said at least one effector is an elongated wire.
  • said rod comprises two ends.
  • said distal end of said at least one elongated tube comprising at least one anvil.
  • said at least one effector encircles said at least one anvil, such that said two ends are positioned in said proximal end of said at least one elongated tube.
  • distally advancing either end of said at least one effector results in the extraction of at least a portion of said at least one effector out of said at least one opening through said distal end of said at least one elongated tube and convert the same to said deployed configuration.
  • said distal end of said at least one elongated tube comprising at least one curved slope adapted to facilitate the extraction of said at least one effector into said body cavity by directing the same towards said opening.
  • said elongated wire is adapted to ablate a tissue within said body cavity.
  • said ablation is provided by means of RF energy.
  • said preformed shape of said wire is selected from a group consisting of circular, elliptical and any combination thereof.
  • said elongated wire is at least partially coated with at least one coating.
  • said elongated wire is at least partially lubricated with at least one lubricant.
  • said at least one coating or said at least one lubricant is adapted to reduce friction between said wire and said elongated tube.
  • said at least one coating or said at least one lubricant is biocompatible.
  • An apparatus for forming a working space in a body cavity, during a laparoscopic surgery comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; said distal end adapted to being inserted into a cavity; b.
  • said at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape.
  • TEP totally extraperitoneal
  • At least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
  • said at least one effector is characterized by a blunt tip.
  • said at least one effector comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
  • said at least one effector is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • said at least one effector additionally comprises at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
  • said at least one effector additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • a method for generating a working space in a body cavity during a laparoscopic surgery comprising the steps of: i. providing an apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; b.
  • said at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis;
  • said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape; ii.
  • said at least one effector additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • An apparatus for generating a working space during a laparoscopic procedure comprising: a. at least one elongated tube having a distal end and a proximal end comprising at least one opening; said distal end is adapted to be inserted into said cavity; b.
  • At least one effector co-axially, at least partially, housed within said at least one elongated tube and characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; wherein said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said proximal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape.
  • the apparatus according to embodiment 51 for use to generate a working space in the preperitoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
  • TEP totally extraperitoneal
  • said at least one elongated tube additionally comprises at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
  • said at least one tube additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • said pre-shaped form of said at least one elongated tube is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said tube, regardless of said n bending planes, is B; where n is an integer equal to or higher than 1 ; and B is in the range of 0 to 360 degrees.
  • a method for generating a working space in a body cavity during a laparoscopic procedure comprising steps of: i. providing an apparatus comprising: a. at least one elongated tube having a distal end and a proximal end interconnected along a main longitudinal axis; b.
  • At least one effector co-axially, at least partially, housed within said at least one elongated tube and said at least one effector being characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis;
  • said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape;
  • said at least one tube additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • a retractor for laparoscopic surgery comprising at least one pair of elongated co-axial elements characterized by a distal end at least partially introduced into a body cavity; and, a proximal end interconnected by a main longitudinal axis; wherein one of which is housed within the second one and operable such that linear reciprocal movement of one relative to the other is provided; and wherein one of said elements is characterized by a pre-shaped form and at least and at least two configurations: a deployed configuration, in which at least one of said elements is at least partially extracted out of said second element; and a retracted configuration, in which said at least one of said elements is fully housed within said second element.
  • the retractor according to embodiment 99 adapted for lifting the abdominal wall to generate a working space in the preperitoneal cavity.
  • the retractor according to embodiment 100 adapted for a TEP hernia repair procedure .
  • said at least one element is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • At least one of said elements additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
  • said pre-shaped form of said at least one effector has n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said at least one element, regardless of said n bending planes, is B; where n is an integer equal to or higher than 1; and B is in the range of 0 to 360 degrees.
  • Figs. 1A-1C illustrate apparatus 100 according to an embodiment of the present disclosure.
  • Fig. 2 illustrates the effector 20 in its pre-shaped bent form (or its deployed configuration).
  • Figs. 3A-3B illustrate two configurations of effector 20.
  • FIGs. 4-9 which illustrate a method of creating a working space in peritoneal cavity during a hernia repair procedure without penetrating the peritoneum, according to an embodiment of the present disclosure.
  • Figs. 10A-10B illustrate a closer view of the distal end 11 of tube 10.
  • Figs. 11A-11C illustrate another embodiment of the present disclosure.
  • Figs. 12-18 illustrate another embodiment of the present disclosure.
  • Figs. 19A-19C illustrate the cross-sectional area (top view) that is generated by the use of apparatus according to an embodiment of the present disclosure.
  • Fig. 20 illustrates several views of a pre-shaped effector (or tube) where the folding is arc-shaped bent in different directions.
  • Fig. 21 illustrates another embodiment of the present disclosure.
  • Figs. 22A-22D illustrate yet another embodiment of apparatus 200 according to an embodiment of the present disclosure.
  • Figs. 23-29 illustrate yet another embodiment of an apparatus according to an embodiment of the present disclosure.
  • the present disclosure relates to a method and an apparatus for displacing tissue(s) (namely, the peritoneum) and forming a working space in the peritoneal cavity during hernia repair procedure. More specifically, the present disclosure relates to an apparatus and method to generate a working space during a totally extraperitoneal (TEP) hernia repair procedure.
  • tissue(s) namely, the peritoneum
  • TEP totally extraperitoneal
  • TEP extraperitoneal
  • TAPP transabdominal preperitoneal
  • TEP hernia repair there is no entrance to the peritoneum cavity. Instead, the mesh seals your hernia from the outside of the peritoneum (the thin lining covering the abdominal organs).
  • the following disclosure relates to an apparatus for generation a working space for hernia repair procedure. More specifically, the following disclosure relates to an apparatus for generation a working space for TEP hernia repair procedure.
  • the terms “comprising” and “including” or grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This term encompasses the terms “consisting of’ and “consisting essentially of.” As used herein the term “about” refers to ⁇ 10%.
  • tenting refers hereinafter to the generation of space by retracting the peritoneum from the muscle layer. It is within the scope of the present disclosure that the maximum tenting achievable is in the range of 0 to about 50 mm.
  • shape memory materials refers hereinafter to materials featured by the ability to recover their original shape from a significant and seemingly plastic deformation when a particular stimulus is applied or removed.
  • stimulus that can be applied are temperature change (heating or cooling), electric or magnetic field, light, chemical contact with other material (e.g., pH change) application of external force (or removal thereof).
  • SMMs are copper-aluminum-nickel and nickel-titanium (NiTi), alloying zinc, copper, gold and iron.
  • Other types of SMMs are polymer based.
  • Pulseudoelasticity or “super elastic material” refers herein after to an elastic (reversible) response to an applied stress, caused by a phase transformation between the austenitic and martensitic phases of a crystal. It is exhibited in shape-memory alloys.
  • the present disclosure provides an apparatus for forming a working space in a body cavity during a laparoscopic procedure, said apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; said distal end is adapted to be inserted into said cavity; b.
  • said at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape.
  • the present disclosure further provides an apparatus for forming a working space in a body cavity during a laparoscopic procedure, said apparatus comprising: a. at least one elongated tube having a distal end and a proximal end comprising at least one opening; said distal end is adapted to be inserted into said cavity; b.
  • At least one effector co-axially, at least partially, housed within said at least one elongated tube and characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis;
  • said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said proximal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape.
  • the apparatus and method disclosed above could be used in totally extraperitoneal (TEP) hernia repair procedure to form a working space in the peritoneal cavity.
  • TEP totally extraperitoneal
  • a retractor for laparoscopic surgery comprising at least one pair of elongated co-axial elements characterized by a distal end at least partially introduced into a body cavity; and, a proximal end interconnected by a main longitudinal axis,; wherein one of which is housed within the second one and operable such that linear reciprocal movement of one relative to the other is provided; further wherein one of said elements is characterized by a pre-shaped form and at least and at least two configurations: a deployed configuration, in which at least one of said elements is at least partially extracted out of said second element; and, a retracted configuration, in which said at least one of said elements is fully housed within said second element.
  • the apparatus comprises a tube 10 having a distal end 11 and a proximal end 12 interconnected along a main longitudinal axis 13.
  • the distal end 11 is adapted to be inserted into the preperitoneal cavity of a patient undergoing a hernia repair procedure, while the proximal end 12 is maintained outside the preperitoneal cavity.
  • the apparatus further comprises at least one effector 20 being co-axial with said tube 10.
  • Tube 10 is adapted to at least partially house said at least one co-axial effector 20, such that the effector can be reciprocally (and linearly) moved within tube 10 along said main longitudinal axis 13.
  • the distal end 11 of tube 10 comprises at least one aperture 14 throughout which the effector 20 can be extracted thereout when the tube is positioned within the peritoneal cavity.
  • effector 20 is made of SMMs and is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which the effector 20 protrudes at least partially out of the tube 10; and, a retracted configuration, in which the effector 20 is fully housed within the tube 10.
  • tube 10 is stiffer than effector 20, such that when the effector 20 is within tube 10 (i.e., in the retracted configuration), the shape of the effector is substantially the same as the tube (namely, a generally linear shape, substantially parallel to the main longitudinal axis 13); and, when the effector is extracted outside tube 10 (the deployed configuration), the shape of the effector is a preformed shape (a bent/articulated shape) at an angle A;
  • A is the projection of 3D angle between the main longitudinal axis of the apparatus and said effector, as the same emerges out of said tube, regardless the number of bending planes the effector has bended in between;
  • Angle A is in the range of 0 to 360 degrees (more preferably perpendicular) with respect to said main longitudinal axis 13.
  • angle A is the angle between projection of 3D angle between two axes, the device main longitudinal axis 13 and the main axis of the effector 20.
  • the effector in said pre-shaped form could have n bending planes; the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes , is B; where n is an integer equals to or higher than 1 ; B is in the range of 0 to 360 degrees.
  • tube 10 is stiffer than effector 20, such that the bending resistance of said tube is higher by at least 25%.
  • said at least one effector is made of super elastic Nitinol and characterized by Young's modulus in the range of below 100 GPa.
  • said at least one elongated tube is made of stainless steel and is characterized by Young's modulus in the range of above 150 GPa.
  • the effector 20 is made of super elastic material being nickel-titanium (NiTi).
  • the effector 20 is made of SMMs selected from a group consisting of copper-aluminum-nickel and nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
  • the apparatus 100 additionally comprises at least one locking element or stopper 30 disposed at the proximal end 12 of tube 10 and slidably movable along the tube’s main longitudinal axis 13.
  • the stopper is adapted to secure tube 10 in its position and orientation around the entry point (see numerical ref. 95 in Fig. 4) of the patient’s abdominal cavity (as will be disclosed hereinbelow).
  • the stopper comprises at least one screw 31 (not shown in the Fig.), such that rotational movement, clockwise or counterclockwise, of the screw results in the fastening thereof, at its position, on tube 10 (to thereby prevent linear movement of the same).
  • screw 31 is rotated and thus, fastened on the tube (applying pressure thereon) and securing the same in its position.
  • the stopper 30 is operable to secure the tube against change in orientation about entry point 95 and fixating the depth of penetration of tube 10.
  • FIG. 2 illustrating the effector 20 in its pre-shaped bent form (or its deployed configuration (outside tube 10).
  • FIG. 3A illustrates the effector 20 in its retracted configuration (i.e., housed within tube 10)
  • Fig. 3B illustrates the effector 20 being extracted out of the tube 10.
  • Fig. 3B illustrates the effector 20 being extracted out of the tube 10 (through opening 14 at the distal end 11 of tube 10) - i.e., in its deployed configuration. In this configuration, the effector assumes it pre-shaped form (in this case - a bend one).
  • FIGs. 4-9 illustrate a method of creating a working space in peritoneal cavity during a hernia repair procedure without penetrating the peritoneum, according to one embodiment of the present disclosure.
  • Fig. 4 illustrates apparatus 100 of the present disclosure before penetration. Also illustrated is an endoscope 90 utilized to visualize the procedure.
  • Fig. 5 illustrates the apparatus of the present disclosure (namely, tube 10) penetrating the fat and muscle layer 91, reaching the peritoneum 92.
  • Fig. 6 illustrates the tenting up 93 the interior of the abdominal wall (of the peritoneum) by means of tube 10 pressing thereon.
  • the stopper 30 is moved along the longitudinal axis of tube 10 to be in contact with the patient skin (near the entry point 95).
  • screw 31 is fastened to tube 10, thereby securing and fixating the position and orientation of tube 10 relative to said entry point 95.
  • the effector 20 is converted to its deployed configuration (by being extracted from tube 10); thereby, the effector assumes its pre-shaped configuration (e.g., a bent configuration), see Figs. 8-9.
  • Rotation of the tube around its main longitudinal axis results in rotational movement of the effector in a plane being at an angle being in the range of 0 to 360 degrees (more preferably perpendicular) with respect to said main longitudinal axis to thereby generate the required working space in the preperitoneal cavity without penetrating the peritoneum.
  • the rotational movement of the effector results in imparting rotational force (similar to sweeping movement) to thereby generate the required space.
  • FIG. 10A-10B illustrating a closer view of the distal end 11 of tube 10, aperture 14 throughout which effector 20 can exit and enter the peritoneal cavity.
  • FIG. 10A illustrates the effector 20 being enclosed within tube
  • Fig. 10B illustrates the effector emerging out of opening 14 of the distal end 11 of tube 10.
  • the effector exits the tube, it reverts to its deployed configuration and its pre shaped form (i.e., bent).
  • Figs. 10A-10B also illustrate an embodiment in which said effector comprises a plurality of openings 23 along its body. Said opening are adapted to enable passage of fluids (e.g., gas being carbon dioxide, air, nitrogen; or liquid being saline).
  • the effector is in fluid communication with at least one fluid container adapted to provide fluid to said peritoneal cavity through said at least one opening 23 of said effector 20.
  • said fluids can be used to insufflate the peritoneal cavity. Further disclosure of said embodiment is provided in Fig. 1 IB.
  • the effector has a blunt tip (e.g., rounded spherical tip) to prevent any damage to the muscle layer or the peritoneum.
  • a blunt tip e.g., rounded spherical tip
  • Fig. 11A illustrating the effector 20 and the blunt tip 22 thereof.
  • the effector 20 additionally comprising at least one opening 23 along its body.
  • Such openings allow the introduction of a flow of fluid(s) into the generated working space to insufflate the same.
  • the fluid could be any gas selected from a group consisting of carbon dioxide, air and any combination thereof or liquid being saline.
  • said fluids may be insufflated into the peritoneal cavity through said at least one opening 23 of said effector 20 (without any use of mechanical element - e.g., balloon(s)).
  • Fig. 11C illustrating another embodiment of the present disclosure in which the distal end (i.e. the tip) of the effector additionally comprising at least one protruding member 16 disposed along the outer circumference of the effector’s tip.
  • protruding member 16 is adapted, by sweeping the tissue, to facilitate the generation of working space when the effector is rotated by sweeping the surrounding tissue.
  • the effector additionally comprises at least one marker disposed along at least partially the outer circumference thereof.
  • the marker (see numerical reference 50 in Fig. 22A) is adapted to help the user get an estimation of depth and maintaining said at least one effector substantially at the same orientation.
  • the shape of the tube is substantially the same as the effector (namely, a generally linear shape); and, when the effector is extracted outside the tube 101 (the deployed configuration), the shape of the tube is a preformed shape (namely, a bent form).
  • the effector is stiffer than the tube, such that the bending resistance of said effector is higher by at least 25%.
  • said at least one tube is made of super elastic Nitinol and characterized by Young's modulus in the range of below 100 GPa.
  • said at least one effector is made of stainless steel and is characterized by Young's modulus in the range of above 150 GPa.
  • Fig. 12 illustrates the effector 201 (being substantially linear shaped) and tube 101 being in said preformed shape (as effector 201 is introduced into said tube).
  • tube 101 is bent in a two folded form (see numerical references (18 and 19). It is within the scope of the present disclosure where there can be n bending planes; the projection of 3D angle between said main longitudinal axis and the tip of said elongate tube, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees
  • FIG. 13-18 illustrating the method of creating a working space within the peritoneal cavity according to said second embodiment.
  • effector 201 is introduced into elongated tube 101; thereby transforming the shape thereof from said preformed shape (bent) to substantially the shape of the effector (namely, substantially linear).
  • Fig. 13 illustrates the introduction of tube 101 through the fat and muscle layer 91, reaching the peritoneum 92. Also illustrated in the Fig, is the tenting up 93 the interior of the abdominal wall (of the peritoneum) by means of tube 10 pressing thereon.
  • the stopper 30 is moved along the longitudinal axis of tube 101 so as to be in contact with the patient skin (near the entry point 95). Once the stopper is placed as close as possible to the patient’s skin (see Fig. 14), screw 31 is fastened to tube 101, thereby securing and fixating the position and orientation of tube 101 relative to said entry point 95.
  • the effector 201 is at least partially extracted from tube 101 (by pulling backwards, towards the proximal direction, thereof); thereby, the tube assumes its pre-shaped configuration (e.g., a bent configuration), see Fig. 15.
  • the apparatus could be rotated along its main longitudinal axis thereby rotating the tube 101 as well.
  • Such rotational movement generates a working space without penetrating the peritoneal (by a sweeping movement of the same).
  • the user can release screw 31 and pull the same proximally (see. Fig. 16).
  • tube 101 is pushed distally to the maximum available position (generated by the tenting) - see Fig. 17.
  • the effector can be further pushed back (proximally, see arrow), thereby enabling tube 101 to fold (bend) again (see first and second fold illustrated by numerical references 18 and 19). In this position, rotation of the tube along the main longitudinal axis of the effector 101 (or apparatus 200), will generate a greater working space.
  • FIG. 19A-19C illustrating the cross-sectional area (top view) that is generated by the use of apparatus of the present disclosure.
  • Fig. 19A illustrates the cross-sectional area of the effector (or the tube, should the tube have a pre-shaped form, as disclosed in the second embodiment).
  • Fig. 19B illustrates the cross-sectional area of the effector (or the tube, should the tube have a pre-shaped form, as disclosed in the second embodiment), when the same is in its pre shaped form (i.e., bent).
  • Fig. 19C illustrates the cross-sectional area of the effector (or the tube, should the tube have a pre-shaped form, as disclosed in the second embodiment), when the same is in its 2 nd folded bending.
  • the diameter of the cross-section area generated by the 2 nd fold is about 1.4 times of the initial diameter (i.e., of the first fold).
  • FIG. 20 illustrating several views of a pre-shaped effector 20 of apparatus 100 (the first embodiment disclosed in Figs. 1-11) or the elongated tube 101 of apparatus 200 (the second embodiment disclosed in Figs. 12-19) where the folding is arc shaped bent in different directions.
  • the Fig. illustrates a continuous, smooth bending radii to enable ease of straightening the same back when extracted.
  • the pre-shaped form could be n bending planes; the projection of 3D angle between said main longitudinal axis and the tip of said effector 20 (of the first embodiment) or tube 101 (of the second embodiment), regardless of said n bending planes in between, is B (for example Bl, B2, B3); where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
  • Fig. 20 illustrates an embodiment where n is ‘endless’. Thus, there are endless number of bending planes.
  • Fig. 21 illustrating another embodiment of the present disclosure in which the distal end (i.e. the tip) of the elongated tube additionally comprising at least one protruding member 16 disposed along the outer circumference of the tube’s tip.
  • protruding member 16 is adapted, by sweeping the tissue, to facilitate the generation of working space when the effector is rotated by sweeping the surrounding tissue.
  • the tube additionally comprises at least one marker disposed along at least partially the outer circumference thereof.
  • the marker is adapted to help the user get an estimation of depth and maintaining said at least one effector substantially at the same orientation.
  • Figs. 22A-22D illustrating the markers (notches) embodiment.
  • the proximal end of effector 201 comprises a plurality of notches (markers) 50 along the circumference thereof.
  • - stopper 30 is moved to maintain the required position and the user marks it as reference for the next move (see Fig. 22B).
  • markers/notches 50 in the effector 201 mark the stopper’s 30 position and provide the user information on the depth of penetration.
  • Fig. 22C the effector 201 is pulled out to the proximal end, thereby the tube is converted to the extended configuration and gets partially to its pre-shape (bent configuration).
  • B denotes the 1 st notch that appears when the effector is pulled out (distally).
  • Fig. 22D the stopper is released, moved proximally for one notch (see C in Fig. 22C), and the whole device is pushed distally into the peritoneal cavity as much as stopper allows.
  • the effector is pulled out (proximally) another notch (see B).
  • the final shape (double bending) of tube 101 is also evident in Fig. 22D.
  • the first embodiment presents less complexity to operate
  • the second embodiment Figs. 12 -20
  • operational complexity increases in the first embodiment
  • tenting is essential to generate the needed working space by means of the effector introduced therewithin and its extended configuration (the bent pre-shaped form).
  • the bent configuration may be a single-plane bending, two-plane or an endless (continuous) -plane bending (e.g., a spiral).
  • the tube (outer element) generates the tenting, remaining in place and allowing the effector (the inner element) to reach its extended (bent) configuration.
  • the tube (the outer element) may be fixed by an operator (e.g. surgeon) in order to prevent further insertion, the effector (the inner element) may be pushed distally into the peritoneal cavity and the apparatus may be rotated in order to generate a working space (including inflating, etc.).
  • the same element that introduces the tenting is the element that eventually will reconfigure to the deployed configuration and bend.
  • device 200 is inserted in its retracted (straight) configuration until the desired tenting is generated.
  • the stopper is attached to the body (namely, to insertion point 95).
  • This position (of the stopper relative to the tube) may also be used as a reference point for the next step in the procedure. This reference point is marked by the marker/notch on the tube.
  • the next step is to pull the effector (the inner element) distally until a first marker/notch appears on the exposed section. This should serve as an indicator that the first bent of the tube has taken place tenting is halted.
  • an operator may release the stopper and move it backwards by one notch (as appears on the tube). It should be noted that the interval between the notches is as close as possible to the size of a typical tent. The entire device may be inserted into the cavity until the stopper reaches the penetration point again (numerical ref. 95). It should be noted that an accidental pulling of the apparatus is not feasible due to its internal bending. Once tenting is re-generated, an operator may pull back the effector, at an additional one notch movement, until the tube’s configuration is at its desired configuration (e.g., full bending). Thus, while in the 2 nd embodiment, the markers (notches) are essential, in the 1 st embodiment, the markers are not mandatory.
  • a better suitable infrastructure for future robotic operation is provided as well as the facilitation of a simple, easy to expand to other indications procedure.
  • device 300 comprises a metal alloy (e.g., nitinol) elongated wire 302 having a pre-shaped configuration; reversibly insertable into the main tube 301.
  • a metal alloy e.g., nitinol
  • the main tube 301 comprises, at its distal end 307 (illustrated in Figs. 25) at least one opening 306 with an internal anvil 308 (illustrated in Fig. 25) adapted to facilitate the elongated wire 302 to assume its configuration (as will be detailed below) through opening 306 as it departures tube 301 and into the body cavity.
  • portion (or one end) 302a of elongated wire 302 is threaded within tube 301 up to the distal most end 307 and encircle anvil 308 to revert back to the proximal end of device 300 (portion or the second end 302b of wire 302).
  • device 300 also comprises at least one opening 305 for introduction of inflating medium into the cavity.
  • the inflating medium could be any fluid or gas selected from a group consisting of carbon dioxide, air and any combination thereof or liquid being saline.
  • Device 300 also comprises at least one element for advancing at least a portion of wire
  • element 304 is provided with stopping means 303 (e.g., clamping screw) to secure the position of element 304 and therefrom the position of a portion of wire 302 (either 302a or 302b).
  • stopping means 303 e.g., clamping screw
  • the operator can advance the disc -like element 304 (and thus, advance a portion of wire 302 (either 302a or 302b)) to any position desired and then tight the stop 303.
  • the operator can loosen the stopping means, pull back the disc -like element 304 (and thus, a portion of wire 302 (either 302a or 302b)) to the desired position and the clamp the stop
  • element 304 can also be used for retracting wire 302 (either 302a or 302b)) by the end of process.lt should be further noted that although element 304 is represented in e.g., Fig. 23 as a clamping screw, any other advancement mechanism (e.g., a ratchet mechanism, an electric drive mechanism, see e.g., Fig. 29, and any combination thereof) is within the scope of the present disclosure.
  • Fig. 23 illustrates device 300 in the closed position, for example during storage.
  • the tube 301 is designed such that the inner diameter thereof is adapted to prevent both portions of wire 302 (302a or 302b) from buckling when applying axial thrust force (linear movement into and out of the main tube 301).
  • Fig. 24 illustrating device 300, when wire 302 is fully inserted into tube 301.
  • element 304 is moved to the distalmost position thereof and the maximum wire 302 has protruded through opening 306. It is noted that element 304 can be moved back and forth as much times as needed; therefore it may reach same position several times.
  • element 304 could advance portion 302a or 302b or both simultaneously within tube 301 and out of tube 301 into the cavity. Such movement will determine the size of wire 302’s pre -shaped configuration.
  • wire 302 Once wire 302 has exited opening 306 into the cavity it assumes it's pre-shaped configuration. As seen in Fig. 24, once wire 302 has exited opening 306 it conforms to its pre shaped configuration. In this case a semi-circular one, bent relatively to tube 301.
  • pre-shaped (of said wire) form could be any shape selected from circular, elliptic or any desirable shape.
  • FIG. 25A illustrating opening 306 in the distal most end 307 of tube 301 and anvil 308.
  • wire 302 is looped around anvil 308 such that the proximal end of device 300 comprises the two portions (or two ends), 302a and 302b, of wire 302.
  • the bottom-most part of the opening 306 includes a curved slope 310 facilitate the extraction of wire 302 to the body cavity by directing the same towards opening 306 (seen in Figs. 25C-25E).
  • Figs. 25B-25E illustrates a view of the distal most end 307 of tube 301. While Figs. 25B and 25E illustrates atop view, Figs. 25C-25D illustrates a side view.
  • FIG. 26A-26B illustrating a closer view of wire 302 (Fig. 26A) and the distal end thereof (Fig. 26B), both in storage position.
  • Fig. 27A illustrating the elongated wire 302 before insertion into tube 301 in its open (non-restricted) configuration; namely, its pre-shaped form.
  • the pre-shaped form of wire 302 could be any shape selected from circular, elliptic or any desirable shape.
  • prevention of buckling of wire 302 (302a or 302b) when pushed forward within tube 301 is enabled.
  • one way to prevent such buckling is by furnishing tube 301’s inner diameter to match the diameter of both 302a or 302b; and thus, will not enable buckling of wire 302.
  • the two portions of wire 302 (302a and 302b) are e.g., crimped or trapped together to form a rigid guide rod (e.g., made of stainless steel) 311.
  • Such use can be advantageous for a couple of reasons: first, it will prevent the buckling of the portion 302a and 302b of wire 302; secondly, it will facilitate the use of robotic propulsion.
  • rod 311 could be in mechanical communication by means of e.g., ratchet, cog wheel, serrated rod, and any other equivalent mechanism with a drum (which is connected to an axial motor) to convert rotational movement to linear movement.
  • FIG. 28A-28B illustrating side and upper views of device 300 when wire 302 is fully extracted from opening 306 of the distalmost end 307 of device 300.
  • reference A represents the tendency of wire 302 to spread laterally (due to its pre-shaping thermal treatment) to achieve lateral stiffness.
  • wire 302 assumes its pre-shaping - the lateral spread.
  • reference B represents an arch that allows a portion of wire to pass over anvil 308 while being pushed forward towards the distal end of tube 301.
  • Reference C represents an arch that provides wire 302 with lateral inclination (bending) rather than axial progression and to better fit with the cavity shape.
  • Figs. 29 illustrating another example of element 304. According to this embodiment utilizing electric propulsion for advancing portion 302a or 302b of wire 302.
  • portions 302a and 302b will be wrapped around a drum connected to an axial motor. Rotation in one direction will result in advancing either portions 302a and/or 302b; while rotation in the second direction will result in pulling either portions 302a and/or 302b back.
  • the drum and motor will be affixed to the tube 301.
  • wire 302 can be used to ablate (and thereby to dissect) the tissue (e.g., by means of RF energy).
  • wire 302 could be coated or lubricated with any desirable coating or lubrication to, e.g., decrease the friction of the same relative to tube 301; or portion 302a relatively to portion 302b.
  • said coating or said is biocompatible.

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Abstract

The present disclosure relates to an apparatus for mechanically displacing tissue during laparoscopic procedures (e.g., hernia procedures). More specifically, the disclosure relates to an apparatus introduced into the space between the peritoneum and the muscle tissue; and, once in place, actively operated to separate thereof and generate working space therewithin.

Description

PERITONEAL SEPARATION APPARATUS
TECHNOLOGICAL FIELD
The present disclosure relates to an apparatus for mechanically displacing tissue during laparoscopic procedures (e.g., hernia procedures).
More specifically, the disclosure relates to an apparatus introduced into the space between the peritoneum and the muscle tissue; and, once in place, actively operated to separate thereof and generate working space therewithin.
BACKGROUND ART
References considered to be relevant as background to the presently disclosed subject matter are listed below:
- U.S. Pat. No. 4,654,028
- U.S. Pat. No. 4,459,978
- U.S. Pat. No. 1,328,624
- U.S. Pat. No. 972,983
- U.S. Pat. No. 4,190,042
US publication no. US20150057501
Rutkow, I.M., Surgical Clinics of North America 2003, 83(5): 1045-51, v-vi
- PCT publication W091/014392 U.S. patent No. US5, 505, 689
Acknowledgement of the above references herein is not to be inferred as meaning that these are in any way relevant to the patentability of the presently disclosed subject matter.
BACKGROUND
Endoscopic or laparoscopic procedures are characterized by the provision of an elongated cannula structure having a relatively thin diameter with a proximal and distal end. The distal end is passed through the surrounding tissue into the body cavity wherein the surgical procedure or examination is to be affected, thus providing a conduit for the insertion of surgical instrumentation.
Early laparoscopic techniques were used primarily for diagnostic purposes to view the internal organs, without the necessity of convention surgery. Since the 1930s, laparoscopy has been used for performing procedures (e.g., hernias). Performing a minimally invasive procedure could be facilitated by the use of a plurality of cannula structures to allow operation of a variety of instruments simultaneously during a said procedure. For example, one cannula may provide a conduit for an endoscope for vision and illumination within the operative cavity while other cannulas provide conduits for control of specialized surgical instruments designed for performing specific procedural functions. Most of the laparoscopic procedures are performed in the abdomen. During such procedures, it is necessary to raise and hold the abdominal wall to generate a working space. Unlike conventional surgical procedures, in which the function of holding tissue and organs in a given location to facilitate access and viewing is accomplished by a retractor, such retractors are ordinarily in the form of a broad paddle structure or multiple fingers attached to a handle; thus, such structures are not usable in laparoscopic procedures since the retractor is too large to be inserted through the cannula structure into the operative body cavity.
Other types of expanders are collapsible ones that have taken the form of radial fingers which are activatable to extend relative to each other upon entering the body cavity. See, for example, U.S. Pat. No. 4,654,028 (Suma), 4,459,978 (Kotsanis). Dilators of this type are also known. See, e.g., U.S. Pat. Nos. 1,328,624 (Graham) and 972,983 (Arthur). In each case, once the retractive or dilatory function is completed, the fingers are compressed and withdrawn. Another collapsible retractor structure includes a pair of collapsible fingers joined by a web of resilient material which, upon insertion into the cannula structure, can expand to form a retractive structure. See, for example, U.S. Pat. No. 4,190,042 (Sinnreich). Such collapsible structures have certain inherent drawbacks associated therewith. For example, upon retraction loose tissue may become caught within the fingers and cause unintentional trauma to retracted tissue. Also, where the tissue is not readily dislodged, collapsing and withdrawing the retractor may be difficult and complicated. Another type of laparoscopic retractors is based on an inflatable element, e.g., balloons (see, for example US publication no. US20150057501).
One of the procedures where there is an urging need for creation of working space is hernia procedure. Hernia occurs when an organ, intestine or fatty tissue, squeezes through a hole or a weak spot in the surrounding muscle or connective tissue (namely, the abdominal wall).
Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue.
Hernia repair procedures are very common - more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias. Rutkow, I.M. (2003). Demographic and Socieconomic Aspects of Hernia Repair in the United States in 2003. Surgical Clinics of North America; 83(5):1045-51, v-vi.
During Laparoscopic hernia repair, several small incisions in the abdomen are made that allow surgical tools into the openings to repair the hernia. The most common laparoscopic hernia repair procedures are transabdominal preperitoneal (TAPP) repair and totally extraperitoneal (TEP) repair. In TAPP the surgeon goes into the abdominal cavity through the muscle wall of the abdomen and through the peritoneum (the lining covering the organs) and places a mesh through a peritoneal incision over possible hernia sites. The mesh is later fixed by tacks or glued to the weakened area in the abdomen wall to strengthen it.
TEP is different in that the peritoneal cavity is not entered and mesh is used to seal the hernia from the peritoneum cavity (by creating a working space there between the peritoneum and the muscle layer).
As in TEP the peritoneal cavity is not entered (there is no incision to the peritoneum and entrance into the abdominal cavity), the risks of serious complications, such as the surgeon accidentally damaging the bowel, are lower.
During the procedure (either TAPP or TEP), mechanical retraction is used to lift the abdominal wall away from the underlying abdominal organs during laparoscopic procedures is a known need in hernia procedures.
PCT publication WO91/014392 discloses an apparatus for lifting the abdominal wall for peritoneal retraction, the apparatus comprising abdominal wall engaging means wherein the abdominal wall engaging means is insertable through a small laparoscopic incision of limited area in the abdominal wall and comprises a pair of angle-shaped elements movable relative to one another for extension from the exterior of the abdominal wall laterally beyond the limited area of the laparoscopic incision to interiorly engage an extensive area of the abdominal wall; and the apparatus comprises a lifting means for impart lifting force to the abdominal wall through the angle shaped elements.
Another example is U.S. patent No. US5,505,689 describes several different mechanical devices that are inserted through one or more punctures into the abdomen. All or part of the device is then lifted to lift the abdominal wall away from the underlying abdominal organs. One of the devices described is a fan retractor that is inserted in a closed condition into the abdominal cavity, spread apart once inside the abdominal cavity, and brought into contact with the peritoneum inside the abdominal cavity. The apparatus is then lifted to lift the abdominal wall. The known fan retractors are all intended for intra-abdominal placement. Fan retractors have a substantially constant stiffness along the length of their peritoneum -engaging elements. This causes the pressure that the peritoneum-engaging elements exert against the peritoneum to increase. High pressure can cause trauma to the peritoneum, and there is a risk that the ends of the peritoneum-engaging elements will penetrate the peritoneum.
Other known procedures presently use carbon dioxide (or any other suitable gas, e.g., air) insufflation to tent up the interior of the abdominal wall to thereby to insufflate the abdominal cavity. This requires gas seals to be present at all entry ports through the abdominal wall (usually located between the inner diameter of the port and the outer diameter of the inserted tool), and because of the doming effect of insufflation, the laparoscopic instruments (graspers, scissors, electrocautery instruments, etc.) need long shafts (on the order of 30.5 to 33 cm (12 to 13 inches)) to reach the treatment site. Such instruments are difficult to control and result in exaggerated movements during instrument application. Another significant disadvantage of gas insufflation is that instruments must be passed into the abdominal cavity through gas-tight seals, which significantly reduce the surgeon's feel of the instruments. As an alternative to the sealing, one can utilize a sufficiently gas source adapted to maintain constant pressure to ‘automatically’ compensate for any possible leak in the system.
Therefore, there is still a long felt need for a safe and effective mechanical device for separating the peritoneum from the muscle tissue for the creation of working space therewithin for e.g., hernia repair surgeries, while minimizing damage to surrounding tissues.
GENERAL DESCRIPTION
In one of its aspects, the present disclosure provides an apparatus for generating a working space during laparoscopic surgery, said apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; said distal end is adapted to be inserted into a cavity; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape.
In some embodiments, the apparatus is for use in the peritoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
In some embodiments, said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
In some embodiments, when said at least one effector is in said deployed configuration and in said preformed shape, said at least one effector is adapted to articulate at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said effector as the same emerges out of said tube; where A may be in the range of 0 to 360 degrees.
In some embodiments, rotational movement of said at least one elongated tube along said main longitudinal axis results in rotational movement of said at least one effector which results in said generation of said working space in the preperitoneal cavity.
In some embodiments, said at least one elongated tube is stiffer than said at least one effector, such that the bending resistance of said tube is higher by at least 25%.
In some embodiments, said at least one elongated tube is characterized by Young's modulus in the range of above 150 GPa.
In some embodiments, said at least one effector is characterized by Y oung's modulus in the range of below 100 GPa.
In some embodiments, at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
In some embodiments, said at least one effector is characterized by a blunt tip.
In some embodiments, said apparatus additionally comprises at least one locking element.
In some embodiments, said at least one locking element is adapted to secure said at least one elongated tube in position and orientation within said peritoneal cavity.
In some embodiments, said at least one effector comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid. In some embodiments, said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
In some embodiments, said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
In some embodiments, said at least one effector is made of at least one super elastic material.
In some embodiments, said super elastic material is nickel-titanium (NiTi).
In some embodiments, said at least one effector is made of at least one shape memory material selected from a group consisting of copper-aluminum-nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
In some embodiments, said at least one effector additionally comprising at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
In some embodiments, said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation (creation) of said working space within said preperitoneal cavity.
In some embodiments, said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
In some embodiments, said at least one effector additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
In some embodiments, said pre-shaped form of said at least one effector is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
In some embodiments, said at least one effector is an elongated wire.
In some embodiments, said rod comprises two ends.
In some embodiments, said distal end of said at least one elongated tube comprising at least one anvil.
In some embodiments, said at least one effector encircles said at least one anvil, such that said two ends are positioned in said proximal end of said at least one elongated tube.
In some embodiments, distally advancing either end of said at least one effector results in the extraction of at least a portion of said at least one effector out of said at least one opening through said distal end of said at least one elongated tube and convert the same to said deployed configuration.
In some embodiments, said distal end of said at least one elongated tube comprising at least one curved slope adapted to facilitate the extraction of said at least one effector into said body cavity by directing the same towards said opening.
By another aspect, the present disclosure provides a method for generating a working space in a body cavity, during laparoscopic procedure, method comprising steps of: providing an apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape; introducing said distal end of said elongated tube into said body cavity; at least partially extracting said at least one effector through said at least one opening in said distal end of said at least one elongated tube; thereby reconfiguring said at least one effector to said deployed configuration; thereby providing said working space in said body cavity.
In some embodiments of the method defined above, said laparoscopic surgery is a totally extraperitoneal (TEP) hernia repair procedure.
In some embodiments of the method defined above, said body cavity is the peritoneal cavity. In some embodiments of the method defined above, said working space is provided in said preperitoneal cavity without penetrating the peritoneum.
In some embodiments of the method defined above, the method additionally comprises a step of providing real-time visual control by means of at least one laparoscope.
In some embodiments of the method defined above, the method additionally comprises a step of co-axially introducing said at least one effector into said at least one elongated tube; thereby providing said at least one effector in said retracted configuration.
In some embodiments of the method defined above, the method additionally comprises a step of providing said at least one effector in said deployed configuration and in said preformed shape, articulated at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said effector, as the same emerges out of said tube; where A may be in the range of 0 to 360 degrees.
In some embodiments of the method defined above, the method additionally comprises step of rotating said at least one elongated tube along said main longitudinal axis; thereby rotating said at least one effector along a plane being substantially perpendicular to said main longitudinal axis, when said at least one effector is in said deployed configuration.
In some embodiments of the method defined above, rotational movement of said at least one elongated tube along said main longitudinal axis results in rotational movement of said at least one effector which results in said generation of said working space in said preperitoneal cavity.
In some embodiments of the method defined above, the method additionally comprises step of providing said at least one elongated tube stiffer than said at least one effector, such that the bending resistance of said tube is higher by at least 25%.
In some embodiments of the method defined above, said at least one elongated tube is characterized by Young's modulus in the range of above 150 GPa.
In some embodiments of the method defined above, said at least one effector is characterized by Young's modulus in the range of below 100 GPa.
In some embodiments of the method defined above, at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
In some embodiments of the method defined above, said at least one effector has a blunt tip.
In some embodiments of the method defined above, said apparatus has at least one locking element. In some embodiments of the method defined above, the method additionally comprises a step of fixating said at least one elongated tube in position and orientation within said preperitoneal cavity.
In some embodiments of the method defined above, said at least one effector has at least one aperture along the body thereof.
In some embodiments of the method defined above, said at least one aperture fluidly communicates with at least one source of fluid.
In some embodiments of the method defined above, the method additionally comprises a step of providing at least one fluid through said at least one aperture to said preperitoneal cavity and insufflating the same.
In some embodiments of the method defined above, the method additionally comprises a step of selecting said fluid from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
In some embodiments of the method defined above, said least one effector is made of at least one super elastic material.
In some embodiments of the method defined above, said super elastic material to be nickel-titanium (NiTi).
In some embodiments of the method defined above, said at least one effector is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
In some embodiments of the method defined above, the method additionally comprises a step of providing said at least one effector with at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
In some embodiments of the method defined above, said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
In some embodiments of the method defined above, said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
In some embodiments of the method defined above, said at least one effector additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation. In some embodiments of the method defined above, the method additionally comprises step of providing said at least one effector in said pre-shaped form with n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
In another aspect, the present disclosure provides an apparatus for generating a working space in a body cavity during a laparoscopic procedure, said apparatus comprising: a. at least one elongated tube having a distal end and a proximal end comprising at least one opening; said distal end is adapted to be inserted into said cavity; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube and characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said proximal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape.
In some embodiments of the apparatus defined above, the apparatus is for use to generate a working space in the peritoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
In some embodiments of the apparatus defined above, said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
In some embodiments of the apparatus defined above, when said at least one tube is in said deployed configuration and in said preformed shape, said at least one tube is adapted to articulate an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said tube, when said effector is pull proximally; where A may be in the range of 0 to 360 degrees.
In some embodiments of the apparatus defined above, rotational movement of said at least one elongated tube along said main longitudinal axis along plane being substantially perpendicular to said main longitudinal axis, when said at least one elongated tube is in said deployed configuration results in said generation of said working space in the preperitoneal cavity.
In some embodiments of the apparatus defined above, said at least one effector is stiffer than said at least one elongated tube, such that the bending resistance of said effector is higher by at least 25%.
In some embodiments of the apparatus defined above, said at least one effector is characterized by Young's modulus in the range of above 150 GPa.
In some embodiments of the apparatus defined above, said at least one elongated tube is characterized by Young's modulus in the range of below 100 GPa.
In some embodiments of the apparatus defined above, at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
In some embodiments of the apparatus defined above, said at least one elongated tube is characterized by a blunt tip.
In some embodiments of the apparatus defined above, said apparatus additionally comprises at least one locking element.
In some embodiments of the apparatus defined above, said at least one locking element is adapted to secure said at least one elongated tube in position and orientation within said peritoneal cavity.
In some embodiments of the apparatus defined above, said at least one elongated tube comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
In some embodiments of the apparatus defined above, said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
In some embodiments of the apparatus defined above, said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
In some embodiments of the apparatus defined above, said at least one elongated tube is made of at least one super elastic material. In some embodiments of the apparatus defined above, said super elastic material is nickel-titanium (NiTi).
In some embodiments of the apparatus defined above, said at least one tube is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
In some embodiments of the apparatus defined above, said at least one elongated tube additionally comprising at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
In some embodiments of the apparatus defined above, said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
In some embodiments of the apparatus defined above, said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
In some embodiments of the apparatus defined above, said at least one elongated tube additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
In some embodiments of the apparatus defined above, said pre-shaped form of said at least one elongated tube is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said tube, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees s.
In another aspect, the present disclosure provides a method for generating a working space in a body during a laparoscopic procedure, method comprising steps of: providing an apparatus comprising: a. at least one elongated tube having a distal end and a proximal end interconnected along a main longitudinal axis; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube and said at least one effector being characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape; introducing said distal end of said elongated tube into said body cavity; at least partially retracting proximally said at least one effector through said at least one opening in said proximal end of said at least one elongated tube; thereby reconfiguring said at least one elongated tube to said deployed configuration; thereby providing said working space in said body cavity.
In some embodiments of the method defined above, said laparoscopic surgery is a totally extraperitoneal (TEP) hernia repair procedure.
In some embodiments of the method defined above, said body cavity is the peritoneal cavity.
In some embodiments of the method defined above, said working space is provided in said preperitoneal cavity without penetrating the peritoneum.
In some embodiments of the method defined above, the method additionally comprises a step of co-axially fully inserting said at least one effector into said at least one elongated tube; thereby providing said at least one elongated tube in said retracted configuration.
In some embodiments of the method defined above, the method additionally comprises a step of providing said at least one tube in said deployed configuration and in said preformed shape articulated at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said tube, when said effector is pull proximally; where A may be in the range of 0 to 360 degrees. In some embodiments of the method defined above, the method additionally comprises step of rotating said at least one elongated tube along said main longitudinal axis; thereby generating said working space in said preperitoneal cavity.
In some embodiments of the method defined above, the method additionally comprises step of providing said at least one effector stiffer than said at least one elongated tube, such that the bending resistance of said effector is higher by at least 25%.
In some embodiments of the method defined above, said at least one effector is characterized by Young's modulus in the range of above 150 GPa.
In some embodiments of the method defined above, said at least one elongated tube is characterized by Young's modulus in the range of below 100 GPa.
In some embodiments of the method defined above, at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
In some embodiments of the method defined above, said at least one elongated tube has a blunt tip.
In some embodiments of the method defined above, said apparatus has at least one locking element.
In some embodiments of the method defined above, the method additionally comprises a step of fixating said at least one elongated tube in position and orientation within said preperitoneal cavity.
In some embodiments of the method defined above, the method additionally comprises a step of providing said at least one elongated tube with at least one aperture along the body thereof.
In some embodiments of the method defined above, said at least one aperture fluidly communicates with at least one source of fluid.
In some embodiments of the method defined above, the method additionally comprises a step of providing at least one fluid through said at least one aperture to said preperitoneal cavity and insufflating the same.
In some embodiments of the method defined above, the method additionally comprises a step of selecting said fluid from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
In some embodiments of the method defined above, said least one elongated tube is made of at least one super elastic material. In some embodiments of the method defined above, said super elastic material to be nickel-titanium (NiTi).
In some embodiments of the method defined above, said at least one tube is made of at least one shape memory material selected from a group consisting of copper-aluminum -nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
In some embodiments of the method defined above, the method additionally comprises step of providing said at least one elongated tube with at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
It is another object of the present disclosure to provide the method as defined above, wherein said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
In some embodiments of the method defined above, said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
In some embodiments of the method defined above, said at least one elongated tube additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
In some embodiments of the method defined above, the method additionally comprises step of providing said at least one elongated tube in said pre-shaped form with n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said tube, regardless of said n bending planes , is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
By another aspect, the present disclosure provides a retractor for laparoscopic surgery comprising at least one pair of elongated co-axial elements characterized by a distal end at least partially introduced into a body cavity; and a proximal end interconnected by a main longitudinal axis; wherein one of which is housed within the second one and operable such that linear reciprocal movement of one relative to the other is provided; further wherein one of said elements is characterized by a pre-shaped form and at least and at least two configurations: a deployed configuration, in which at least one of said elements is at least partially extracted out of said second element; and, a retracted configuration, in which said at least one of said elements is fully housed within said second element. In some embodiments of the retractor defined above, the retractor is adapted for lifting the abdominal wall to generate a working space in the preperitoneal cavity.
In some embodiments of the retractor defined above, the retractor adapted for a totally extraperitoneal (TEP) hernia repair procedure.
In some embodiments of the retractor defined above, said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
In some embodiments of the retractor defined above, when said at least one of said element is in said deployed configuration and in said preformed shape, said at least one element is adapted to articulate at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and the tip of at least one of said elements; where A may be in the range of 0 to 360 degrees.
In some embodiments of the retractor defined above, said rotational movement results in said generation of said working space in the preperitoneal cavity.
In some embodiments of the retractor defined above, one of said elements is stiffer than the second element, such that the bending resistance of said one of said elements is higher by at least 25%.
In some embodiments of the retractor defined above, one of said elements is characterized by Young’s modulus in the range of above 150 GPa while the second is characterized by Young’s modulus in the range of below 100 GPa.
In some embodiments of the retractor above, one of said elements is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
In some embodiments of the retractor defined above, at least one of said elements is characterized by a blunt tip.
In some embodiments of the retractor defined above, said retractor additionally comprises at least one locking element.
In some embodiments of the retractor defined above, said at least one locking element is adapted to secure at least one of said elements in position and orientation within the peritoneal cavity.
In some embodiments of the retractor defined above, at least one of said elements comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
In some embodiments of the retractor defined above, said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same. In some embodiments of the retractor defined above, said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
In some embodiments of the retractor defined above, at least one of said elements is made of at least one super elastic material.
In some embodiments of the retractor defined above, said shape super elastic is nickel- titanium (NiTi).
In some embodiments of the retractor defined above, said at least one element is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
In some embodiments of the retractor defined above, at least one of said elements additionally comprising at least one protruding member disposed along at least partially the outer circumference of said element.
In some embodiments of the retractor defined above, said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
In some embodiments of the retractor defined above, said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
In some embodiments of the retractor defined above, at least one of said elements additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
In some embodiments of the retractor above, said pre-shaped form of said at least one effector is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said at least one element, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
In some embodiments of the apparatus defined above, said at least one effector is an elongated wire.
In some embodiments of the apparatus defined above, said rod comprises two ends.
In some embodiments of the apparatus defined above, said distal end of said at least one elongated tube comprising at least one anvil. In some embodiments of the apparatus defined above, said at least one effector encircles said at least one anvil, such that said two ends are positioned in said proximal end of said at least one elongated tube.
In some embodiments of the apparatus defined above, distally advancing either end of said at least one effector results in the extraction of at least a portion of said at least one effector out of said at least one opening through said distal end of said at least one elongated tube and convert the same to said deployed configuration.
In some embodiments of the apparatus defined above, said distal end of said at least one elongated tube comprising at least one curved slope adapted to facilitate the extraction of said at least one effector into said body cavity by directing the same towards said opening.
In some embodiments of the apparatus defined above, said elongated wire is adapted to ablate a tissue within said body cavity.
In some embodiments of the apparatus defined above, said ablation is provided by means of RF energy.
In some embodiments of the apparatus defined above, said preformed shape of said wire is selected from a group consisting of circular, elliptical and any combination thereof.
In some embodiments of the apparatus defined above, said elongated wire is at least partially coated with at least one coating.
In some embodiments of the apparatus defined above, said elongated wire is at least partially lubricated with at least one lubricant.
In some embodiments of the apparatus defined above, said at least one coating or said at least one lubricant is adapted to reduce friction between said wire and said elongated tube.
In some embodiments of the apparatus defined above, said at least one coating or said at least one lubricant is biocompatible.
EMBODIMENTS
In the following, embodiments of this disclosure are described by means of numbered embodiments. These numbered embodiments are intended as an addition to the above disclosure and are not limiting.
1. An apparatus for forming a working space in a body cavity, during a laparoscopic surgery, said apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; said distal end adapted to being inserted into a cavity; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape.
2. The apparatus according to embodiment 1, for use to generate a working space in the preperitoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
3. The apparatus according to embodiment 2, wherein said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
4. The apparatus according to embodiment 1, wherein when said at least one effector is in said deployed configuration and in said preformed shape, said at least one effector is adapted to articulate at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said effector, as said effector emerges out of said tube; and wherein A may be in the range of 0 to 360 degrees.
5. The apparatus according to embodiment 1 , wherein rotational movement of said at least one elongated tube along said main longitudinal axis results in rotational movement of said at least one effector which results in said generation of said working space in the preperitoneal cavity.
6. The apparatus according to embodiment 1, wherein said at least one elongated tube is stiffer than said at least one effector, such that the bending resistance of said elongated tube is higher by at least 25%.
7. The apparatus according to embodiment 1, wherein said at least one elongated tube is characterized by Young's modulus in the range of above 150 GPa.
8. The apparatus according to embodiment 1, wherein said at least one effector is characterized by Young's modulus in the range of below 100 GPa.
9. The apparatus according to embodiment 1, wherein at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof. 10. The apparatus according to embodiment 1, wherein said at least one effector is characterized by a blunt tip.
11. The apparatus according to embodiment 1, wherein said apparatus additionally comprises at least one locking element.
12. The apparatus according to embodiment 11, wherein said at least one locking element is adapted to secure said at least one elongated tube in position and orientation within said peritoneal cavity.
13. The apparatus according to embodiment 1, wherein said at least one effector comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
14. The apparatus according to embodiment 13, wherein said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
15. The apparatus according to embodiment 13 or 4, wherein said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
16. The apparatus according to embodiment 1, wherein said at least one effector is made of at least one super elastic material.
17. The apparatus according to embodiment 17, wherein said super elastic material is nickel-titanium (NiTi).
18. The apparatus according to embodiment 1, wherein said at least one effector is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
19. The apparatus according to embodiment 1, wherein said at least one effector additionally comprises at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
20. The apparatus according to embodiment 19, wherein said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
21. The apparatus according to embodiment 20, wherein said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
22. The apparatus according to embodiment 1, wherein said at least one effector additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
23. The apparatus according to embodiment 1 , wherein said pre-shaped form of said at least one effector is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
24. A method for generating a working space in a body cavity during a laparoscopic surgery, the method comprising the steps of: i. providing an apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape; ii. introducing said distal end of said elongated tube into said body cavity; iii. at least partially extracting said at least one effector through said at least one opening in said distal end of said at least one elongated tube; and reconfiguring said at least one effector to said deployed configuration; thereby providing said working space in said body cavity.
25. The method according to embodiment 24, wherein said laparoscopic surgery is a totally extraperitoneal (TEP) hernia repair procedure.
26. The method according to embodiment 24, wherein said body cavity is the preperitoneal cavity.
27. The method according to embodiment 26, wherein said working space is provided in said preperitoneal cavity without penetrating the peritoneum. 28. The method according to embodiment 24, additionally comprising a step of providing real-time visual control by means of at least one laparoscope.
29. The method according to embodiment 24, additionally comprising a step of co-axially introducing said at least one effector into said at least one elongated tube; thereby providing said at least one effector in said retracted configuration.
30. The method according to embodiment 24, additionally comprising a step of providing said at least one effector in said deployed configuration and in said preformed shape articulated at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said effector, as the same emerges out of said tube; where A may be in the range of 0 to 360 degrees.
31. The method according to embodiment 24, additionally comprising a step of rotating said at least one elongated tube along said main longitudinal axis; thereby rotating said at least one effector along a plane being substantially perpendicular to said main longitudinal axis, when said at least one effector is in said deployed configuration.
32. The method according to embodiment 31, wherein the step of rotating said at least one effector results in said generation of said working space in said preperitoneal cavity.
33. The method according to embodiment 24, wherein said at least one elongated tube is stiffer than said at least one effector, such that the bending resistance of said elongated tube is higher by at least 25%.
34. The method according to embodiment 24, wherein said at least one elongated tube is characterized by Young's modulus in the range of above 150 GPa.
35. The method according to embodiment 24, wherein said at least one effector is characterized by Young's modulus in the range of below 100 GPa.
36. The method according to embodiment 24, wherein at least one of said at least one effector, said at least one tube or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
37. The method according to embodiment 24, wherein said at least one effector has a blunt tip.
38. The method according to embodiment 24, wherein said apparatus has at least one locking element.
39. The method according to embodiment 38, additionally comprising a step of fixating said at least one elongated tube in position and orientation within said preperitoneal cavity.
40. The method according to embodiment 24, wherein said at least one effector has at least one aperture along the body thereof. 41. The method according to embodiment 40, wherein said at least one aperture fluidly communicates with at least one source of fluid.
42. The method according to embodiment 40 or 41, additionally comprising a step of providing at least one fluid through said at least one aperture to said preperitoneal cavity and insufflating the same.
43. The method according to embodiment 40 or 41, wherein said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
44. The method according to embodiment 24, wherein said at least one effector is made of at least one super elastic material.
45. The method according to embodiment 44, wherein said super elastic material is nickel- titanium (NiTi).
46. The method according to embodiment 24, additionally comprising a step of providing said at least one effector with at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
47. The method according to embodiment 46, wherein said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
48. The method according to embodiment 47, wherein said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
49. The method according to embodiment 24, wherein said at least one effector additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
50. The method according to embodiment 24, additionally comprising a step of providing said at least one effector in said pre-shaped form with n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
51. An apparatus for generating a working space during a laparoscopic procedure, said apparatus comprising: a. at least one elongated tube having a distal end and a proximal end comprising at least one opening; said distal end is adapted to be inserted into said cavity; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube and characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; wherein said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said proximal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape.
52. The apparatus according to embodiment 51, for use to generate a working space in the preperitoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
53. The apparatus according to embodiment 52, wherein said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
54. The apparatus according to embodiment 51, wherein when said at least one tube is in said deployed configuration and in said preformed shape, said at least one tube is adapted to articulate at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said tube, when said effector is pulled proximally; where A may be in the range of 0 to 360 degrees.
55. The apparatus according to embodiment 51, wherein the rotational movement of said at least one elongated tube along said main longitudinal axis along plane being substantially perpendicular to said main longitudinal axis, when said at least one elongated tube is in said deployed configuration results in said generation of said working space in the preperitoneal cavity.
56. The apparatus according to embodiment 51, wherein said at least one effector is stiffer than said at least one elongated tube, such that the bending resistance of said effector is higher by at least 25%.
57. The apparatus according to embodiment 51, wherein said at least one effector is characterized by Young's modulus in the range of above 150 GPa.
58. The apparatus according to embodiment 51, wherein said at least one elongated tube is characterized by Young's modulus in the range of below 100 GPa. 59. The apparatus according to embodiment 51, wherein at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
60. The apparatus according to embodiment 51, wherein said at least one elongated tube is characterized by a blunt tip.
61. The apparatus according to embodiment 51, wherein said apparatus additionally comprises at least one locking element.
62. The apparatus according to embodiment 61, wherein said at least one locking element is adapted to secure said at least one elongated tube in position and orientation within said preperitoneal cavity.
63. The apparatus according to embodiment 51, wherein said at least one elongated tube comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
64. The apparatus according to embodiment 63, wherein said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
65. The apparatus according to embodiment 63 or 64, wherein said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
66. The apparatus according to embodiment 51, wherein said at least one elongated tube is made of at least one super elastic material.
67. The apparatus according to embodiment 66, wherein said super elastic material is nickel-titanium (NiTi).
68. The apparatus according to embodiment 51, wherein said at least one elongated tube additionally comprises at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
69. The apparatus according to embodiment 68, wherein said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
70. The apparatus according to embodiment 69, wherein said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
71. The apparatus according to embodiment 51 , wherein said at least one tube additionally comprising at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation. 72. The apparatus according to embodiment 51, wherein said pre-shaped form of said at least one elongated tube is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said tube, regardless of said n bending planes, is B; where n is an integer equal to or higher than 1 ; and B is in the range of 0 to 360 degrees.
73. A method for generating a working space in a body cavity during a laparoscopic procedure, the method comprising steps of: i. providing an apparatus comprising: a. at least one elongated tube having a distal end and a proximal end interconnected along a main longitudinal axis; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube and said at least one effector being characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape; ii. introducing said distal end of said elongated tube into said body cavity; iii. at least partially retracting proximally said at least one effector through said at least one opening in said proximal end of said at least one elongated tube; thereby reconfiguring said at least one elongated tube to said deployed configuration; thereby providing said working space in said preperitoneal cavity without penetrating the peritoneum.
74. The method according to embodiment 73, wherein said laparoscopic surgery is a TEP hernia repair procedure.
75. The method according to embodiment 74, wherein said body cavity is the preperitoneal cavity. 76. The method according to embodiment 73, wherein said working space is provided in said preperitoneal cavity without penetrating the peritoneum.
77. The method according to embodiment 73, additionally comprising a step of providing real-time visual control by means of at least one laparoscope.
78. The method according to embodiment 73, additionally comprising a step of co-axially fully inserting said at least one effector into said at least one elongated tube; thereby providing said at least one elongated tube in said retracted configuration.
79. The method according to embodiment 73, additionally comprising a step of providing said at least one tube in said deployed configuration and in said preformed shape, articulated at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said tube, when said effector is pulled proximally; where A may be in the range of 0 to 360 degrees.
80. The method according to embodiment 73, additionally comprising a step of rotating said at least one elongated tube along said main longitudinal axis; thereby generating said working space in said preperitoneal cavity.
81. The method according to embodiment 73, wherein said at least one effector is stiffer than said at least one elongated tube, such that the bending resistance of said effector is higher by at least 25%.
82. The method according to embodiment 73, wherein said at least one effector is characterized by Young's modulus in the range of above 150 GPa.
83. The method according to embodiment 73, wherein said at least one elongated tube is characterized by Young's modulus in the range of below 100 GPa.
84. The method according to embodiment 73, wherein at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
85. The method according to embodiment 73, wherein said at least one elongated tube has a blunt tip.
86. The method according to embodiment 73, wherein said apparatus has at least one locking element.
87. The method according to embodiment 86, additionally comprising a step of fixating said at least one elongated tube in position and orientation within said preperitoneal cavity.
88. The method according to embodiment 73, additionally comprising a step of providing said at least one elongated tube with at least one aperture along the body thereof. 89. The method according to embodiment 88, wherein said at least one aperture fluidly communicates with at least one source of fluid.
90. The method according to embodiment 88 or 89, additionally comprising a step of providing at least one fluid through said at least one aperture to said preperitoneal cavity and insufflating the same.
91. The method according to embodiment 88 or 89, additionally comprising a step of selecting said fluid from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
92. The method according to embodiment 73, wherein said least one elongated tube is made of at least one super elastic material.
93. The method according to embodiment 92, wherein said super elastic material is nickel- titanium (NiTi).
94. The method according to embodiment 73, additionally comprising a step of providing said at least one elongated tube with at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
95. The method according to embodiment 94, wherein said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
96. The method according to embodiment 95, wherein said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
97. The method according to embodiment 73, wherein said at least one tube additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
98. The method according to embodiment 73, additionally comprising a step of providing said at least one elongated tube in said pre-shaped form with n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said tube, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1 ; B is in the range of 0 to 360 degrees
99. A retractor for laparoscopic surgery comprising at least one pair of elongated co-axial elements characterized by a distal end at least partially introduced into a body cavity; and, a proximal end interconnected by a main longitudinal axis; wherein one of which is housed within the second one and operable such that linear reciprocal movement of one relative to the other is provided; and wherein one of said elements is characterized by a pre-shaped form and at least and at least two configurations: a deployed configuration, in which at least one of said elements is at least partially extracted out of said second element; and a retracted configuration, in which said at least one of said elements is fully housed within said second element.
100. The retractor according to embodiment 99, adapted for lifting the abdominal wall to generate a working space in the preperitoneal cavity.
101. The retractor according to embodiment 100, adapted for a TEP hernia repair procedure .
102. The retractor according to embodiment 100, wherein said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
103. The retractor according to embodiment 99, wherein said preformed shape being articulated at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and the tip of said at least one element; where A may be in the range of 0 to 360 degrees.
104. The retractor according to embodiment 99, wherein rotational movement of one of said elements along said main longitudinal axis results in rotational movement of the second element along plane being at an angle A with respect to said main longitudinal axis, when said second element is in said deployed configuration; where A is the projection of 3D angle between said main longitudinal axis and the tip of at least one of said elements; where A can be in the range of 0 to 360 degrees.
105. The retractor according to embodiment 104, wherein said rotational movement results in the generation of said working space in the preperitoneal cavity.
106. The retractor according to embodiment 99, wherein one of said elements is stiffer than the second element, such that the bending resistance of said one of said elements is higher by at least 25%.
107. The retractor according to embodiment 99, wherein one of said elements is characterized by Young's modulus in the range of above 150 GPa while the second is characterized by Young's modulus in the range of below 100 GPa.
108. The retractor according to embodiment 99, wherein one of said elements is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
109. The retractor according to embodiment 99, wherein at least one of said elements is characterized by a blunt tip. 110. The retractor according to embodiment 99, wherein said retractor additionally comprises at least one locking element.
111. The retractor according to embodiment 110, wherein said at least one locking element is adapted to secure at least one of said elements in position and orientation within the preperitoneal cavity.
112. The retractor according to embodiment 99, wherein at least one of said elements comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
113. The retractor according to embodiment 112, wherein said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
114. The retractor according to embodiment 112 or 113, wherein said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
115. The retractor according to embodiment 99, wherein at least one of said elements is made of at least one super elastic material.
116. The retractor according to embodiment 115, wherein said super elastic material is nickel-titanium (NiTi).
117. The retractor according to embodiment 99, wherein said at least one element is made of at least one shape memory material selected from a group consisting of copper-aluminum- nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
118. The retractor according to embodiment 99, wherein at least one of said elements additionally comprises at least one protruding member disposed along at least partially the outer circumference of said element.
119. The retractor according to embodiment 118, wherein said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
120. The retractor according to embodiment 119, wherein said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
121. The retractor according to embodiment 99, wherein at least one of said elements additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation. 122. The retractor according to embodiment 99, wherein said pre-shaped form of said at least one effector has n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said at least one element, regardless of said n bending planes, is B; where n is an integer equal to or higher than 1; and B is in the range of 0 to 360 degrees.
123. The method according to embodiment 24, additionally comprising a step of repeating, as much as needed, steps (ii) and (iii) to generate said working space.
124. The method according to embodiment 73, additionally comprising a step of repeating, as much as needed, steps (ii) and (iii) to generate said working space.
125. The apparatus according to embodiment 1, wherein said at least one effector is an elongated wire.
126. The apparatus according to embodiment 125, wherein said rod comprises two ends.
127. The apparatus according to embodiment 126, wherein said distal end of said at least one elongated tube comprising at least one anvil.
128. The apparatus according to any one of embodiments 125 to 127, wherein said at least one effector encircles said at least one anvil, such that said two ends are positioned in said proximal end of said at least one elongated tube.
129. The apparatus according to any one of embodiments 125 to 128, wherein distally advancing either end of said at least one effector results in the extraction of at least a portion of said at least one effector out of said at least one opening through said distal end of said at least one elongated tube and convert the same to said deployed configuration.
130. The apparatus according to any one of embodiments 125 to 129, wherein said distal end of said at least one elongated tube comprising at least one curved slope adapted to facilitate the extraction of said at least one effector into said body cavity by directing the same towards said opening.
131. The apparatus according to embodiment 125, wherein said elongated wire is adapted to ablate a tissue within said body cavity.
132. The apparatus according to embodiment 131, wherein said ablation is provided by means of RF energy.
133. The apparatus according to embodiment 1, wherein said preformed shape of said wire is selected from a group consisting of circular, elliptical and any combination thereof.
134. The apparatus according to embodiment 125, wherein said elongated wire is at least partially coated with at least one coating. 135. The apparatus according to embodiment 125, wherein said elongated wire is at least partially lubricated with at least one lubricant.
136. The apparatus according to embodiment 134 or 135, wherein said at least one coating or said at least one lubricant is adapted to reduce friction between said wire and said elongated tube.
137. The apparatus according to embodiment 134 or 135, wherein said at least one coating or said at least one lubricant is biocompatible.
BRIEF DESCRIPTION OF THE DRAWINGS
Some embodiments of the disclosure are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the disclosure. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the disclosure may be practiced. In the drawings:
Figs. 1A-1C illustrate apparatus 100 according to an embodiment of the present disclosure.
Fig. 2 illustrates the effector 20 in its pre-shaped bent form (or its deployed configuration).
Figs. 3A-3B illustrate two configurations of effector 20.
Figs. 4-9 which illustrate a method of creating a working space in peritoneal cavity during a hernia repair procedure without penetrating the peritoneum, according to an embodiment of the present disclosure.
Figs. 10A-10B illustrate a closer view of the distal end 11 of tube 10.
Figs. 11A-11C illustrate another embodiment of the present disclosure.
Figs. 12-18 illustrate another embodiment of the present disclosure.
Figs. 19A-19C illustrate the cross-sectional area (top view) that is generated by the use of apparatus according to an embodiment of the present disclosure.
Fig. 20 illustrates several views of a pre-shaped effector (or tube) where the folding is arc-shaped bent in different directions.
Fig. 21 illustrates another embodiment of the present disclosure.
Figs. 22A-22D illustrate yet another embodiment of apparatus 200 according to an embodiment of the present disclosure. Figs. 23-29 illustrate yet another embodiment of an apparatus according to an embodiment of the present disclosure.
DETAILED DESCRIPTION OF EMBODIMENTS
The present disclosure relates to a method and an apparatus for displacing tissue(s) (namely, the peritoneum) and forming a working space in the peritoneal cavity during hernia repair procedure. More specifically, the present disclosure relates to an apparatus and method to generate a working space during a totally extraperitoneal (TEP) hernia repair procedure.
It is noted that the following description is illustrative, but not limiting, of the device and methods of the present disclosure. Suitable modifications and adaptations of the variety of conditions and parameters normally encountered in the treatment of bacterial infections are within the spirit and scope of the disclosure.
The development of laparoscopic techniques has revolutionized hernia repairs, which is the most common procedure in general surgery worldwide.
Among endoscopic hemioplasties, totally extraperitoneal (TEP) and transabdominal preperitoneal (TAPP) approach are widely accepted alternatives to open surgery, both providing less postoperative pain, hospitalization time and early return to the day-by-day routine.
Unlike TAPP, in TEP hernia repair there is no entrance to the peritoneum cavity. Instead, the mesh seals your hernia from the outside of the peritoneum (the thin lining covering the abdominal organs).
The following disclosure relates to an apparatus for generation a working space for hernia repair procedure. More specifically, the following disclosure relates to an apparatus for generation a working space for TEP hernia repair procedure.
As used herein, the terms “comprising” and “including” or grammatical variants thereof are to be taken as specifying the stated features, integers, steps or components but do not preclude the addition of one or more additional features, integers, steps, components or groups thereof. This term encompasses the terms “consisting of’ and “consisting essentially of.” As used herein the term “about” refers to ±10%.
The term “tenting” refers hereinafter to the generation of space by retracting the peritoneum from the muscle layer. It is within the scope of the present disclosure that the maximum tenting achievable is in the range of 0 to about 50 mm.
The term “shape memory materials (SMMs)” refers hereinafter to materials featured by the ability to recover their original shape from a significant and seemingly plastic deformation when a particular stimulus is applied or removed. Examples of stimulus that can be applied are temperature change (heating or cooling), electric or magnetic field, light, chemical contact with other material (e.g., pH change) application of external force (or removal thereof). Examples of SMMs are copper-aluminum-nickel and nickel-titanium (NiTi), alloying zinc, copper, gold and iron. Other types of SMMs are polymer based.
The term “Pseudoelasticity” or “super elastic material” refers herein after to an elastic (reversible) response to an applied stress, caused by a phase transformation between the austenitic and martensitic phases of a crystal. It is exhibited in shape-memory alloys.
The present disclosure provides an apparatus for forming a working space in a body cavity during a laparoscopic procedure, said apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; said distal end is adapted to be inserted into said cavity; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape.
The present disclosure further provides an apparatus for forming a working space in a body cavity during a laparoscopic procedure, said apparatus comprising: a. at least one elongated tube having a distal end and a proximal end comprising at least one opening; said distal end is adapted to be inserted into said cavity; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube and characterized by a main longitudinal axis, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one elongated tube is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector is at least partially retracted out of said at least one opening in said proximal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is fully housed within said at least one elongated tube; wherein, when said at least one elongated tube is in said retracted configuration, the shape of said elongated tube is substantially the same as said at least one effector; and, when said at least one elongated tube is in said deployed configuration, the shape of said elongated tube is said preformed shape.
According to one embodiment, the apparatus and method disclosed above could be used in totally extraperitoneal (TEP) hernia repair procedure to form a working space in the peritoneal cavity.
Furthermore, the present disclosure discloses a retractor for laparoscopic surgery comprising at least one pair of elongated co-axial elements characterized by a distal end at least partially introduced into a body cavity; and, a proximal end interconnected by a main longitudinal axis,; wherein one of which is housed within the second one and operable such that linear reciprocal movement of one relative to the other is provided; further wherein one of said elements is characterized by a pre-shaped form and at least and at least two configurations: a deployed configuration, in which at least one of said elements is at least partially extracted out of said second element; and, a retracted configuration, in which said at least one of said elements is fully housed within said second element.
These and other objects will become more apparent when viewed in light of the following detailed description and accompanying drawings.
Reference is now made to Figs. 1A-1B which illustrate apparatus 100 according to an embodiment of the present disclosure. According to this embodiment, the apparatus comprises a tube 10 having a distal end 11 and a proximal end 12 interconnected along a main longitudinal axis 13. As will be illustrated hereinbelow, the distal end 11 is adapted to be inserted into the preperitoneal cavity of a patient undergoing a hernia repair procedure, while the proximal end 12 is maintained outside the preperitoneal cavity. According to this embodiment, the apparatus further comprises at least one effector 20 being co-axial with said tube 10. Tube 10 is adapted to at least partially house said at least one co-axial effector 20, such that the effector can be reciprocally (and linearly) moved within tube 10 along said main longitudinal axis 13. According to this embodiment, the distal end 11 of tube 10 comprises at least one aperture 14 throughout which the effector 20 can be extracted thereout when the tube is positioned within the peritoneal cavity.
Preferably effector 20 is made of SMMs and is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which the effector 20 protrudes at least partially out of the tube 10; and, a retracted configuration, in which the effector 20 is fully housed within the tube 10.
According to this embodiment, tube 10 is stiffer than effector 20, such that when the effector 20 is within tube 10 (i.e., in the retracted configuration), the shape of the effector is substantially the same as the tube (namely, a generally linear shape, substantially parallel to the main longitudinal axis 13); and, when the effector is extracted outside tube 10 (the deployed configuration), the shape of the effector is a preformed shape (a bent/articulated shape) at an angle A; A is the projection of 3D angle between the main longitudinal axis of the apparatus and said effector, as the same emerges out of said tube, regardless the number of bending planes the effector has bended in between; Angle A is in the range of 0 to 360 degrees (more preferably perpendicular) with respect to said main longitudinal axis 13.
Reference is now made to Fig. 1C illustrating angle A. As can be seen in Fig. 1C, angle A is the angle between projection of 3D angle between two axes, the device main longitudinal axis 13 and the main axis of the effector 20.
Alternatively, as will be described hereinafter in Fig. 20, it is within the scope of the present disclosure where the effector in said pre-shaped form could have n bending planes; the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes , is B; where n is an integer equals to or higher than 1 ; B is in the range of 0 to 360 degrees.
According to one embodiment, tube 10 is stiffer than effector 20, such that the bending resistance of said tube is higher by at least 25%.
According to one embodiment, said at least one effector is made of super elastic Nitinol and characterized by Young's modulus in the range of below 100 GPa.
According to one embodiment, said at least one elongated tube is made of stainless steel and is characterized by Young's modulus in the range of above 150 GPa.
According to one embodiment, the effector 20 is made of super elastic material being nickel-titanium (NiTi). According to one embodiment, the effector 20 is made of SMMs selected from a group consisting of copper-aluminum-nickel and nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
According to another embodiment, the apparatus 100 additionally comprises at least one locking element or stopper 30 disposed at the proximal end 12 of tube 10 and slidably movable along the tube’s main longitudinal axis 13. The stopper is adapted to secure tube 10 in its position and orientation around the entry point (see numerical ref. 95 in Fig. 4) of the patient’s abdominal cavity (as will be disclosed hereinbelow).
According to one embodiment, the stopper comprises at least one screw 31 (not shown in the Fig.), such that rotational movement, clockwise or counterclockwise, of the screw results in the fastening thereof, at its position, on tube 10 (to thereby prevent linear movement of the same). Once the tube is in its desired position, screw 31 is rotated and thus, fastened on the tube (applying pressure thereon) and securing the same in its position. In such manner the stopper 30 is operable to secure the tube against change in orientation about entry point 95 and fixating the depth of penetration of tube 10.
Reference is now made to Fig. 2 illustrating the effector 20 in its pre-shaped bent form (or its deployed configuration (outside tube 10).
Reference is now made to Figs. 3A-3B which illustrate the two configurations of the effector 20. While Fig. 3A illustrates the effector 20 in its retracted configuration (i.e., housed within tube 10), Fig. 3B illustrates the effector 20 being extracted out of the tube 10.
As the tube is stiffer than the effector, the effector will maintain a substantially linear shape (the shape of tube 10). As mentioned above, Fig. 3B illustrates the effector 20 being extracted out of the tube 10 (through opening 14 at the distal end 11 of tube 10) - i.e., in its deployed configuration. In this configuration, the effector assumes it pre-shaped form (in this case - a bend one).
Reference is now made to Figs. 4-9 which illustrate a method of creating a working space in peritoneal cavity during a hernia repair procedure without penetrating the peritoneum, according to one embodiment of the present disclosure.
Fig. 4 illustrates apparatus 100 of the present disclosure before penetration. Also illustrated is an endoscope 90 utilized to visualize the procedure.
Fig. 5 illustrates the apparatus of the present disclosure (namely, tube 10) penetrating the fat and muscle layer 91, reaching the peritoneum 92.
Fig. 6 illustrates the tenting up 93 the interior of the abdominal wall (of the peritoneum) by means of tube 10 pressing thereon. Once maximum tenting is achieved, the stopper 30 is moved along the longitudinal axis of tube 10 to be in contact with the patient skin (near the entry point 95). Once the stopper is placed as close as possible to the patient’s skin (see Fig. 7), screw 31 is fastened to tube 10, thereby securing and fixating the position and orientation of tube 10 relative to said entry point 95.
Next, the effector 20 is converted to its deployed configuration (by being extracted from tube 10); thereby, the effector assumes its pre-shaped configuration (e.g., a bent configuration), see Figs. 8-9.
Rotation of the tube around its main longitudinal axis results in rotational movement of the effector in a plane being at an angle being in the range of 0 to 360 degrees (more preferably perpendicular) with respect to said main longitudinal axis to thereby generate the required working space in the preperitoneal cavity without penetrating the peritoneum.
It should be noted that in the above disclosed embodiment, rotational movement of the effector relatively to the tube is prevented. Thus, when tube 10 is rotated, inherently, the effector is rotated in the same manner.
The rotational movement of the effector results in imparting rotational force (similar to sweeping movement) to thereby generate the required space.
Reference is now made to Figs. 10A-10B illustrating a closer view of the distal end 11 of tube 10, aperture 14 throughout which effector 20 can exit and enter the peritoneal cavity.
While Fig. 10A illustrates the effector 20 being enclosed within tube 10, Fig. 10B illustrates the effector emerging out of opening 14 of the distal end 11 of tube 10. As seen in the Fig., once the effector exits the tube, it reverts to its deployed configuration and its pre shaped form (i.e., bent).
Figs. 10A-10B also illustrate an embodiment in which said effector comprises a plurality of openings 23 along its body. Said opening are adapted to enable passage of fluids (e.g., gas being carbon dioxide, air, nitrogen; or liquid being saline). Thus, according to this embodiment, the effector is in fluid communication with at least one fluid container adapted to provide fluid to said peritoneal cavity through said at least one opening 23 of said effector 20. It should be pointed out that said fluids (whether liquid or gas) can be used to insufflate the peritoneal cavity. Further disclosure of said embodiment is provided in Fig. 1 IB.
According to one embodiment, the effector has a blunt tip (e.g., rounded spherical tip) to prevent any damage to the muscle layer or the peritoneum. Reference is now made to Fig. 11A illustrating the effector 20 and the blunt tip 22 thereof.
Reference is now made to Fig. 11B illustrating another embodiment of the present disclosure. According to this embodiment, the effector 20 additionally comprising at least one opening 23 along its body. Such openings allow the introduction of a flow of fluid(s) into the generated working space to insufflate the same.
The fluid could be any gas selected from a group consisting of carbon dioxide, air and any combination thereof or liquid being saline.
As mentioned above, said fluids (whether liquid or gas) may be insufflated into the peritoneal cavity through said at least one opening 23 of said effector 20 (without any use of mechanical element - e.g., balloon(s)).
Refence is now made to Fig. 11C illustrating another embodiment of the present disclosure in which the distal end (i.e. the tip) of the effector additionally comprising at least one protruding member 16 disposed along the outer circumference of the effector’s tip. Such protruding member 16 is adapted, by sweeping the tissue, to facilitate the generation of working space when the effector is rotated by sweeping the surrounding tissue.
According to another embodiment, the effector additionally comprises at least one marker disposed along at least partially the outer circumference thereof. According to this embodiment, the marker (see numerical reference 50 in Fig. 22A) is adapted to help the user get an estimation of depth and maintaining said at least one effector substantially at the same orientation.
Reference is now made to Figs. 12-18 illustrating a second embodiment of the apparatus
200 of the present disclosure. According to this embodiment, the mechanical properties of tube 101 and effector 201 have been switched. In other word, according to this embodiment, effector
201 is stiffer than tube 101, such that when the effector 201 is within tube 101 (i.e., in the retracted configuration), the shape of the tube is substantially the same as the effector (namely, a generally linear shape); and, when the effector is extracted outside the tube 101 (the deployed configuration), the shape of the tube is a preformed shape (namely, a bent form).
According to this embodiment, the effector is stiffer than the tube, such that the bending resistance of said effector is higher by at least 25%.
According to one embodiment, said at least one tube is made of super elastic Nitinol and characterized by Young's modulus in the range of below 100 GPa.
According to one embodiment, said at least one effector is made of stainless steel and is characterized by Young's modulus in the range of above 150 GPa.
Fig. 12 illustrates the effector 201 (being substantially linear shaped) and tube 101 being in said preformed shape (as effector 201 is introduced into said tube). As seen from the Fig. tube 101 is bent in a two folded form (see numerical references (18 and 19). It is within the scope of the present disclosure where there can be n bending planes; the projection of 3D angle between said main longitudinal axis and the tip of said elongate tube, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees
Reference is now made to Figs. 13-18 illustrating the method of creating a working space within the peritoneal cavity according to said second embodiment.
In the first step (see Fig. 13) effector 201 is introduced into elongated tube 101; thereby transforming the shape thereof from said preformed shape (bent) to substantially the shape of the effector (namely, substantially linear).
Fig. 13 illustrates the introduction of tube 101 through the fat and muscle layer 91, reaching the peritoneum 92. Also illustrated in the Fig, is the tenting up 93 the interior of the abdominal wall (of the peritoneum) by means of tube 10 pressing thereon.
Once the maximum tenting is achieved, the stopper 30 is moved along the longitudinal axis of tube 101 so as to be in contact with the patient skin (near the entry point 95). Once the stopper is placed as close as possible to the patient’s skin (see Fig. 14), screw 31 is fastened to tube 101, thereby securing and fixating the position and orientation of tube 101 relative to said entry point 95.
Next, the effector 201 is at least partially extracted from tube 101 (by pulling backwards, towards the proximal direction, thereof); thereby, the tube assumes its pre-shaped configuration (e.g., a bent configuration), see Fig. 15.
Next the apparatus could be rotated along its main longitudinal axis thereby rotating the tube 101 as well. Such rotational movement generates a working space without penetrating the peritoneal (by a sweeping movement of the same).
Alternatively, in order to generate a greater working space, utilization of several bending/folding of the tube is enabled. According to this embodiment, the user can release screw 31 and pull the same proximally (see. Fig. 16). Next, tube 101 is pushed distally to the maximum available position (generated by the tenting) - see Fig. 17. Next, in Fig. 18, the effector can be further pushed back (proximally, see arrow), thereby enabling tube 101 to fold (bend) again (see first and second fold illustrated by numerical references 18 and 19). In this position, rotation of the tube along the main longitudinal axis of the effector 101 (or apparatus 200), will generate a greater working space.
Reference is now made to Figs. 19A-19C illustrating the cross-sectional area (top view) that is generated by the use of apparatus of the present disclosure.
Fig. 19A illustrates the cross-sectional area of the effector (or the tube, should the tube have a pre-shaped form, as disclosed in the second embodiment). Fig. 19B illustrates the cross-sectional area of the effector (or the tube, should the tube have a pre-shaped form, as disclosed in the second embodiment), when the same is in its pre shaped form (i.e., bent).
Fig. 19C illustrates the cross-sectional area of the effector (or the tube, should the tube have a pre-shaped form, as disclosed in the second embodiment), when the same is in its 2nd folded bending. As can be seen, the diameter of the cross-section area generated by the 2nd fold is about 1.4 times of the initial diameter (i.e., of the first fold).
Reference is now made to Fig. 20 illustrating several views of a pre-shaped effector 20 of apparatus 100 (the first embodiment disclosed in Figs. 1-11) or the elongated tube 101 of apparatus 200 (the second embodiment disclosed in Figs. 12-19) where the folding is arc shaped bent in different directions. The Fig. illustrates a continuous, smooth bending radii to enable ease of straightening the same back when extracted.
The pre-shaped form could be n bending planes; the projection of 3D angle between said main longitudinal axis and the tip of said effector 20 (of the first embodiment) or tube 101 (of the second embodiment), regardless of said n bending planes in between, is B (for example Bl, B2, B3); where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees. Fig. 20 illustrates an embodiment where n is ‘endless’. Thus, there are endless number of bending planes.
Reference is now made to Fig. 21 illustrating another embodiment of the present disclosure in which the distal end (i.e. the tip) of the elongated tube additionally comprising at least one protruding member 16 disposed along the outer circumference of the tube’s tip. Such protruding member 16 is adapted, by sweeping the tissue, to facilitate the generation of working space when the effector is rotated by sweeping the surrounding tissue.
According to another embodiment, the tube additionally comprises at least one marker disposed along at least partially the outer circumference thereof. According to this embodiment, the marker is adapted to help the user get an estimation of depth and maintaining said at least one effector substantially at the same orientation.
Reference is now made to Figs. 22A-22D illustrating the markers (notches) embodiment. As can be seen in the Fig. 22A, the proximal end of effector 201 comprises a plurality of notches (markers) 50 along the circumference thereof.
Thus, according to this embodiment, once device 200 is introduced into the peritoneum cavity and the maximum tenting is obtained (under visual feedback; namely, the endoscope) - stopper 30 is moved to maintain the required position and the user marks it as reference for the next move (see Fig. 22B). In Fig. 22B, markers/notches 50 in the effector 201 mark the stopper’s 30 position and provide the user information on the depth of penetration.
Next, in Fig. 22C, the effector 201 is pulled out to the proximal end, thereby the tube is converted to the extended configuration and gets partially to its pre-shape (bent configuration). In Fig. 22cc, B denotes the 1st notch that appears when the effector is pulled out (distally). Next, in Fig. 22D, the stopper is released, moved proximally for one notch (see C in Fig. 22C), and the whole device is pushed distally into the peritoneal cavity as much as stopper allows. Next the effector is pulled out (proximally) another notch (see B). The final shape (double bending) of tube 101 is also evident in Fig. 22D.
The first embodiment (Figs. 1-11) presents less complexity to operate, whereas in the second embodiment (Figs. 12 -20) operational complexity increases in the first embodiment, tenting is essential to generate the needed working space by means of the effector introduced therewithin and its extended configuration (the bent pre-shaped form). The bent configuration may be a single-plane bending, two-plane or an endless (continuous) -plane bending (e.g., a spiral). In either case, the tube (outer element) generates the tenting, remaining in place and allowing the effector (the inner element) to reach its extended (bent) configuration.
The tube (the outer element) may be fixed by an operator (e.g. surgeon) in order to prevent further insertion, the effector (the inner element) may be pushed distally into the peritoneal cavity and the apparatus may be rotated in order to generate a working space (including inflating, etc.).
In the 2nd embodiment, the same element that introduces the tenting (the tube) is the element that eventually will reconfigure to the deployed configuration and bend. As described above, in the 2nd embodiment, device 200 is inserted in its retracted (straight) configuration until the desired tenting is generated. At this point the stopper is attached to the body (namely, to insertion point 95). This position (of the stopper relative to the tube) may also be used as a reference point for the next step in the procedure. This reference point is marked by the marker/notch on the tube. The next step is to pull the effector (the inner element) distally until a first marker/notch appears on the exposed section. This should serve as an indicator that the first bent of the tube has taken place tenting is halted.
Next, an operator may release the stopper and move it backwards by one notch (as appears on the tube). It should be noted that the interval between the notches is as close as possible to the size of a typical tent. The entire device may be inserted into the cavity until the stopper reaches the penetration point again (numerical ref. 95). It should be noted that an accidental pulling of the apparatus is not feasible due to its internal bending. Once tenting is re-generated, an operator may pull back the effector, at an additional one notch movement, until the tube’s configuration is at its desired configuration (e.g., full bending). Thus, while in the 2nd embodiment, the markers (notches) are essential, in the 1st embodiment, the markers are not mandatory.
According to another embodiment, a better suitable infrastructure for future robotic operation is provided as well as the facilitation of a simple, easy to expand to other indications procedure.
Reference is now made to Figs. 23 - 29 illustrating embodiment 300 of the present disclosure.
According to this embodiment, device 300, comprises a metal alloy (e.g., nitinol) elongated wire 302 having a pre-shaped configuration; reversibly insertable into the main tube 301.
The main tube 301 comprises, at its distal end 307 (illustrated in Figs. 25) at least one opening 306 with an internal anvil 308 (illustrated in Fig. 25) adapted to facilitate the elongated wire 302 to assume its configuration (as will be detailed below) through opening 306 as it departures tube 301 and into the body cavity.
As detailed in Fig. 25, portion (or one end) 302a of elongated wire 302 is threaded within tube 301 up to the distal most end 307 and encircle anvil 308 to revert back to the proximal end of device 300 (portion or the second end 302b of wire 302).
According to one embodiment, device 300 also comprises at least one opening 305 for introduction of inflating medium into the cavity. The inflating medium could be any fluid or gas selected from a group consisting of carbon dioxide, air and any combination thereof or liquid being saline.
Device 300 also comprises at least one element for advancing at least a portion of wire
302 (either 302a or 302b or both simultaneously) into tube 301 and out of tube 301 into the cavity. Such element is represented in the Figs. As 304. Optionally, element 304 is provided with stopping means 303 (e.g., clamping screw) to secure the position of element 304 and therefrom the position of a portion of wire 302 (either 302a or 302b). Thus, the operator can advance the disc -like element 304 (and thus, advance a portion of wire 302 (either 302a or 302b)) to any position desired and then tight the stop 303. When he wishes to change to position, the operator can loosen the stopping means, pull back the disc -like element 304 (and thus, a portion of wire 302 (either 302a or 302b)) to the desired position and the clamp the stop
303 etc. It is noted that the same process can be applied to pull out; i.e., element 304 can also be used for retracting wire 302 (either 302a or 302b)) by the end of process.lt should be further noted that although element 304 is represented in e.g., Fig. 23 as a clamping screw, any other advancement mechanism (e.g., a ratchet mechanism, an electric drive mechanism, see e.g., Fig. 29, and any combination thereof) is within the scope of the present disclosure.
Reference is now made to Fig. 23 which illustrates device 300 in the closed position, for example during storage. It is noted the tube 301 is designed such that the inner diameter thereof is adapted to prevent both portions of wire 302 (302a or 302b) from buckling when applying axial thrust force (linear movement into and out of the main tube 301).
Reference is now made to Fig. 24 illustrating device 300, when wire 302 is fully inserted into tube 301. In this configuration, element 304 is moved to the distalmost position thereof and the maximum wire 302 has protruded through opening 306. It is noted that element 304 can be moved back and forth as much times as needed; therefore it may reach same position several times.
It should be noted that element 304 could advance portion 302a or 302b or both simultaneously within tube 301 and out of tube 301 into the cavity. Such movement will determine the size of wire 302’s pre -shaped configuration.
Once wire 302 has exited opening 306 into the cavity it assumes it's pre-shaped configuration. As seen in Fig. 24, once wire 302 has exited opening 306 it conforms to its pre shaped configuration. In this case a semi-circular one, bent relatively to tube 301.
It should be noted the that the pre-shaped (of said wire) form could be any shape selected from circular, elliptic or any desirable shape.
Reference is now made to Fig. 25A illustrating opening 306 in the distal most end 307 of tube 301 and anvil 308. As seen in the Fig. 25A, wire 302 is looped around anvil 308 such that the proximal end of device 300 comprises the two portions (or two ends), 302a and 302b, of wire 302.
It is noted that the bottom-most part of the opening 306 includes a curved slope 310 facilitate the extraction of wire 302 to the body cavity by directing the same towards opening 306 (seen in Figs. 25C-25E).
Figs. 25B-25E illustrates a view of the distal most end 307 of tube 301. While Figs. 25B and 25E illustrates atop view, Figs. 25C-25D illustrates a side view.
Reference is now made to Figs. 26A-26B illustrating a closer view of wire 302 (Fig. 26A) and the distal end thereof (Fig. 26B), both in storage position.
Reference is now made to Fig. 27A illustrating the elongated wire 302 before insertion into tube 301 in its open (non-restricted) configuration; namely, its pre-shaped form. It should be noted the that the pre-shaped form of wire 302 could be any shape selected from circular, elliptic or any desirable shape.
According to another embodiment of the present disclosure, prevention of buckling of wire 302 (302a or 302b) when pushed forward within tube 301 is enabled. As discussed above, one way to prevent such buckling is by furnishing tube 301’s inner diameter to match the diameter of both 302a or 302b; and thus, will not enable buckling of wire 302.
According to another embodiment, the two portions of wire 302 (302a and 302b) are e.g., crimped or trapped together to form a rigid guide rod (e.g., made of stainless steel) 311.
Such use can be advantageous for a couple of reasons: first, it will prevent the buckling of the portion 302a and 302b of wire 302; secondly, it will facilitate the use of robotic propulsion.
Such use of rod 311 could be in mechanical communication by means of e.g., ratchet, cog wheel, serrated rod, and any other equivalent mechanism with a drum (which is connected to an axial motor) to convert rotational movement to linear movement.
Reference is now made to Figs. 28A-28B illustrating side and upper views of device 300 when wire 302 is fully extracted from opening 306 of the distalmost end 307 of device 300.
As seen in Fig. 28A, reference A represents the tendency of wire 302 to spread laterally (due to its pre-shaping thermal treatment) to achieve lateral stiffness. Thus, once at least a portion of wire 302 is extracted out of opening 306 into the body cavity, wire 302 assumes its pre-shaping - the lateral spread.
As seen in Fig. 28B, reference B represents an arch that allows a portion of wire to pass over anvil 308 while being pushed forward towards the distal end of tube 301.
Reference C represents an arch that provides wire 302 with lateral inclination (bending) rather than axial progression and to better fit with the cavity shape.
Reference is now made to Figs. 29 illustrating another example of element 304. According to this embodiment utilizing electric propulsion for advancing portion 302a or 302b of wire 302.
According to this embodiment, portions 302a and 302b will be wrapped around a drum connected to an axial motor. Rotation in one direction will result in advancing either portions 302a and/or 302b; while rotation in the second direction will result in pulling either portions 302a and/or 302b back. According to one embodiment, the drum and motor will be affixed to the tube 301.According to another embodiment of the present disclosure, wire 302 can be used to ablate (and thereby to dissect) the tissue (e.g., by means of RF energy). According to another embodiment, wire 302 could be coated or lubricated with any desirable coating or lubrication to, e.g., decrease the friction of the same relative to tube 301; or portion 302a relatively to portion 302b.
According to one embodiment, said coating or said is biocompatible.
It is appreciated that certain features of the disclosure, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the disclosure, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination or as suitable in any other described embodiment of the disclosure. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
Although the disclosure has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

Claims

1. An apparatus for forming a working space in a body cavity, during a laparoscopic surgery, said apparatus comprising: a. at least one elongated tube having a distal end and comprising at least one opening and a proximal end interconnected along a main longitudinal axis; said distal end adapted to being inserted into a cavity; b. at least one effector co-axially, at least partially, housed within said at least one elongated tube, such that said at least one effector is reciprocally moved within said at least one elongated tube along said main longitudinal axis; said at least one effector is characterized by at least one preformed shape, and at least two configurations: a deployed configuration, in which said at least one effector protrudes at least partially out of said at least one opening in said distal end of said at least one elongated tube; and, a retracted configuration, in which said at least one effector is housed within said at least one elongated tube; wherein, when said at least one effector is in said retracted configuration, the shape of said effector is substantially the same as said at least one elongated tube; and, when said at least one effector is in said deployed configuration, the shape of said effector is said preformed shape.
2. The apparatus according to claim 1, for use to generate a working space in the preperitoneal cavity during a totally extraperitoneal (TEP) hernia repair procedure.
3. The apparatus according to claim 2, wherein said working space is generated in the preperitoneal cavity without penetrating the peritoneum.
4. The apparatus according to claim 1, wherein when said at least one effector is in said deployed configuration and in said preformed shape, said at least one effector is adapted to articulate at an angle A with respect to said main longitudinal axis; where A is the projection of 3D angle between said main longitudinal axis and said effector, as said effector emerges out of said tube; and wherein A may be in the range of 0 to 360 degrees.
5. The apparatus according to claim 1, wherein rotational movement of said at least one elongated tube along said main longitudinal axis results in rotational movement of said at least one effector which results in said generation of said working space in the preperitoneal cavity.
6. The apparatus according to claim 1, wherein said at least one elongated tube is stiffer than said at least one effector, such that the bending resistance of said elongated tube is higher by at least 25%.
7. The apparatus according to claim 1, wherein said at least one elongated tube is characterized by Young's modulus in the range of above 150 GPa.
8. The apparatus according to claim 1, wherein said at least one effector is characterized by Young's modulus in the range of below 100 GPa.
9. The apparatus according to claim 1, wherein at least one of said at least one effector, or said at least one tube, or any combination thereof is made of a material selected from a group consisting of stainless steel, nitinol and any combination thereof.
10. The apparatus according to claim 1, wherein said at least one effector is characterized by a blunt tip.
11. The apparatus according to claim 1, wherein said apparatus additionally comprises at least one locking element.
12. The apparatus according to claim 11, wherein said at least one locking element is adapted to secure said at least one elongated tube in position and orientation within said peritoneal cavity.
13. The apparatus according to claim 1 , wherein said at least one effector comprises at least one aperture along the body thereof; and said at least one aperture being in fluid communication with at least one source of fluid.
14. The apparatus according to claim 13, wherein said at least one aperture is adapted to enable at least one fluid to enter said preperitoneal cavity and insufflate the same.
15. The apparatus according to claim 13 or 14, wherein said fluid is selected from a group consisting of carbon dioxide, air, nitrogen, saline and any combination thereof.
16. The apparatus according to claim 1 , wherein said at least one effector is made of at least one super elastic material.
17. The apparatus according to claim 16, wherein said super elastic material is nickel- titanium (NiTi).
18. The apparatus according to claim 1 , wherein said at least one effector is made of at least one shape memory material selected from a group consisting of copper-aluminum-nickel, nickel-titanium (NiTi), alloying zinc, copper, gold and iron, any polymer-based SMM and any combination thereof.
19. The apparatus according to claim 1, wherein said at least one effector additionally comprises at least one protruding member disposed along at least partially the outer circumference of said at least one effector.
20. The apparatus according to claim 19, wherein said at least one protruding member is adapted, when said at least one effector is rotated, to facilitate the generation of said working space within said preperitoneal cavity.
21. The apparatus according to claim 20, wherein said at least one protruding member, when rotated, is adapted to sweep the surrounding tissue facilitating the generation of said working space within said preperitoneal cavity.
22. The apparatus according to claim 1, wherein said at least one effector additionally comprises at least one marker disposed along at least partially the outer circumference thereof, adapted to estimate depth and maintain said at least one effector substantially at the same orientation.
23. The apparatus according to claim 1, wherein said pre-shaped form of said at least one effector is n bending planes; further wherein the projection of 3D angle between said main longitudinal axis and the tip of said effector, regardless of said n bending planes, is B; where n is an integer equals to or higher than 1; B is in the range of 0 to 360 degrees.
24. The apparatus according to claim 1, wherein said at least one effector is an elongated wire.
25. The apparatus according to claim 1, wherein said preformed shape of said wire is selected from a group consisting of circular, elliptical and any combination thereof.
PCT/IL2022/050674 2021-06-24 2022-06-22 Peritoneal separation apparatus WO2022269614A1 (en)

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US63/214,564 2021-06-24

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Citations (5)

* Cited by examiner, † Cited by third party
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US5460169A (en) * 1990-03-20 1995-10-24 Mouret; Philippe Instrument for implementing medical or surgical operations by laparoscopy or coelioscopy
US5823945A (en) * 1991-05-29 1998-10-20 Origin Medsystems, Inc. Endoscopic inflatable retraction device with additional inflatable chamber
US20110046441A1 (en) * 2003-01-15 2011-02-24 Usgi Medical, Inc. Endoluminal tool deployment system
US9592042B2 (en) * 2010-04-13 2017-03-14 Central Manchester University Hospitals Nhs Foundation Trust Surgical device and methods
US20190254646A1 (en) * 2011-08-04 2019-08-22 Suture Ease, Inc. Dual insufflation and wound closure devices and methods

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5460169A (en) * 1990-03-20 1995-10-24 Mouret; Philippe Instrument for implementing medical or surgical operations by laparoscopy or coelioscopy
US5823945A (en) * 1991-05-29 1998-10-20 Origin Medsystems, Inc. Endoscopic inflatable retraction device with additional inflatable chamber
US20110046441A1 (en) * 2003-01-15 2011-02-24 Usgi Medical, Inc. Endoluminal tool deployment system
US9592042B2 (en) * 2010-04-13 2017-03-14 Central Manchester University Hospitals Nhs Foundation Trust Surgical device and methods
US20190254646A1 (en) * 2011-08-04 2019-08-22 Suture Ease, Inc. Dual insufflation and wound closure devices and methods

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