WO2007083305A2 - Dispositif d’ouverture d’acces pour procedures chirurgicales - Google Patents

Dispositif d’ouverture d’acces pour procedures chirurgicales Download PDF

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Publication number
WO2007083305A2
WO2007083305A2 PCT/IL2007/000064 IL2007000064W WO2007083305A2 WO 2007083305 A2 WO2007083305 A2 WO 2007083305A2 IL 2007000064 W IL2007000064 W IL 2007000064W WO 2007083305 A2 WO2007083305 A2 WO 2007083305A2
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WO
WIPO (PCT)
Prior art keywords
retractor
surgical
frame
conformation
surgical retractor
Prior art date
Application number
PCT/IL2007/000064
Other languages
English (en)
Other versions
WO2007083305A3 (fr
Inventor
Shay Dubi
Tovy Sivan
Eran Hirszowicz
Original Assignee
Ez Surgical Ltd.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Ez Surgical Ltd. filed Critical Ez Surgical Ltd.
Publication of WO2007083305A2 publication Critical patent/WO2007083305A2/fr
Publication of WO2007083305A3 publication Critical patent/WO2007083305A3/fr

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3417Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421Cannulas
    • A61B17/3423Access ports, e.g. toroid shape introducers for instruments or hands
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00902Material properties transparent or translucent
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B2017/0212Cushions or pads, without holding arms, as tissue retainers, e.g. for retracting viscera

Definitions

  • the present invention relates to a surgical retraction instrument used to retain or hold back internal organs in the operative region during either open or minimally invasive endoscopic surgery.
  • Surgical procedures can be divided into two fundamental types, conventional (open) surgery and Minimally Invasive Surgery (MIS or endoscopic surgery) .
  • Conventional surgery generally involves a relatively large incision with direct visualization (e.g. with the "naked eye") of the area being operated upon.
  • Examples of conventional surgery include various types of heart and bowel surgery.
  • Endoscopic surgery involves indirect visualization of the operative field with a small camera or optic fibers. Endoscopic surgery is generally achieved by means of making multiple small incisions through which the camera and surgical instruments are inserted. The instruments perform their functions inside the body but are operated- by use of their handles outside the body. Examples of endoscopic surgery include endoscopic appendectomy and laparoscopic cholecystectomy. Endoscopic surgery can also be performed through existing, natural orifices (for example, prostate surgeries and gastrointestinal surgeries performed through the relevant natural orifices) .
  • Endoscopic surgery poses many additional problems for the surgeon, such as mastering of non-intuitive tools, performing the procedure at one place while looking in another direction and lack of immediate manual feedback.
  • An additional important obstacle is the tendency of certain' tissues or organs to invade the surgical workspace and occlude the visual field, such as small bowel loops descending into the pelvis while performing pelvic surgery and healthy tissues covering a tumor during resection.
  • An important case study for the importance of the surgical access window is laparoscopic cholecystectomy, which carries specific procedure-related complications due to the unique endoscopic procedure (A. Shamiyeh, W. Wayand: Laparoscopic cholecystectomy: early and late complications and their treatment. Langenbecks Arch Surg (200.4) 389:164-171.).
  • Biliary complications include Spillage of gallstones and biliary leaks, and are highly affected by the surgeon's experience (Sarli L, Pietra N, Costi R, Grattarola M (1999) Gallbladder perforation during laparoscopic cholecystectomy. World J Surg 23:1186-1190.).
  • the most serious lesion of this type is transection of the bile duct, which is usually a consequence of the inadequate exposure (E. M. Targarona, C. Marco, C. Balague', J. Rodriguez, E. Cugat, C. Hoyuela, E. Veloso, and M. Trias. How, when, and why bile duct injury occurs-.
  • Bowel injuries may occur during the insertion of the trocars and during dissection of the tissues. They often remain undetected during the operation and have been reported to occur in up to 0.87% of cases (Bishoff JT, Allaf ME, Kirkels W, Moore RG, Kavoussi LR, Schroder F (1999) Laparoscopic bowel injury: incidence and clinical presentation. J Urol 161:887- 890.)
  • a surgical assistant is usually required to use the tools for tissue retraction (The grasper is operated by a surgeon, focusing his attention and occupying at least one of his hands with a relatively unimportant task) , thus increasing the work-force needed for the procedure and the cost of the procedure
  • a novel type of tissue retractor which can be inserted into the body cavity while in a contracted or collapsed state (i.e. having a much smaller diameter than in the open conformation, and lacking the internal cavity of that conformation) , and then allowed to expand within the surrounding tissues to create a discrete workspace (surgical window) .
  • the purpose of the device of the invention is to widen the access area to the treatment site, to retract the surrounding tissues and to maintain the resultant size of the access area.
  • the structure of the device of the invention in outline form, in its fully expanded (open) conformation, consists of a tube-like structure open at both ends, the wall of the tube optionally comprising a plurality of vertically and/or horizontally disposed rods (or elements) and optionally comprising a membrane or other thin covering layer attached to said rods.
  • the retractor of the invention can anchor to the tissues surrounding the surgical window, and does not require any external anchoring outside the treated area, although such external anchoring may be used if desired.
  • the device of the invention thus prevents any unwanted protrusion of retracted tissues into the workspace, enables good access to the treated area and allows the surgeon to comfortably and safely work within the surgical window.
  • the retractor of the invention may be self expanding - i.e.
  • the retractor may be manually deformable, such that upon placement at the desired site, the operator pushes or bends outwards the relevant portions of the collapsed device into various different shapes and dimensions in order to achieve retraction of the relevant tissues.
  • the device may be constructed of a plastic or metal skeleton, which may be covered by a transparent membrane or covering, constructed by an appropriate polymer or other appropriate material.
  • the device of the invention may have the benefits of simplifying surgical procedures, saving surgeon time and improving patient safety.
  • the present invention is primarily directed to a surgical retractor capable of being manipulated from a closed conformation to an open conformation and vice versa, wherein said retractor in its open conformation comprises a tube-like frame, such that the inner face of said frame defines the outer boundary of an internal space, and wherein said internal space is essentially eliminated when said retractor is in its fully closed conformation.
  • the term 'tube-like frame' is intended to convey the meaning that the frame of the presently-disclosed device is a three- dimensional structure that forms the external boundary of an internal space. While the tube-like frame may, in a preferred group of embodiments have an outline shape that is generally cylindrical, it may also be conical, frusto-conical, spherical, elongated spheroid, flattened spheroid or any other suitable shape that defines an internal space that will provide a convenient surgical window. Similarly, the device of the present invention may be constructed with a variety of different cross-sectional shapes, including (but not limited to) circular, elliptical, irregular, rectangular or any other polygonal shape.
  • the cross-sectional shape is essentially pentagonal, the sides of said pentagon being curved, while the general three-dimensional shape is generally cylindrical and conforms to the shape of the structure generally known as a 'Chinese lantern'.
  • the dimensions of said retractor in its closed conformation render it suitable for endoscopic delivery (e.g. through a trocar).
  • the retractor frame is left uncovered, in other embodiments said frame is covered with a membrane.
  • a membrane will generally be constructed from one or more biocompatible elastomers and/or polymers.
  • the membrane is transparent.
  • the surgical retractor is capable of self-expanding from a closed conformation to an open conformation as a result of outwardly directed elastic forces generated within the frame and/or membrane.
  • This particular embodiment may be implemented by incorporating a restraining element (e.g. a clip, girdle or latch) into the retractor, the purpose of which is to .maintain the device in a fully closed, collapsed state.
  • a restraining element e.g. a clip, girdle or latch
  • the retractor Upon release of the restraining element (e.g. after the retractor has been delivered to its intended working site) , the retractor self-expands into its open position.
  • the retractor is capable of being manipulated from a closed conformation to an open conformation and vice versa by means of manual deformation of the frame (e.g. by the pulling and pushing of the frame and/or covering membrane in the required directions) .
  • the "plastic" deformation of the retractor into an open position may be used to cause said retractor to open either fully or partially, and in either a symmetrical or asymmetrical manner.
  • the frame of the retractor comprises a plurality of vertically and/or horizontally disposed elements (e.g. rods). These elements may be identical or similar to each other in shape and structure. Alternatively, the frame may comprise more than one type of vertically disposed element and/or more than one type of horizontally disposed element, each type being characterized by having different physical properties (e.g. resiliency, elasticity, rigidity etc.).
  • At least one type of vertically-disposed and/or horizontally-disposed element is represented by a wire spring such as a spring having a series of angled portions.
  • one or more of the vertically and/or horizontally disposed elements are constructed from a plurality of telescopic (or otherwise overlapping) segments.
  • the surgical retractor further comprises a plurality of connection elements attached to the proximal end of the vertically disposed elements, wherein said connection elements are suitable for connecting pulling wires to said vertically disposed elements, such that said wires may be used to externally control the diameter of said retractor.
  • This control mechanism will be described in more detail hereinbelow, with reference to the figures.
  • the present invention also encompasses several different forms of frame (in addition to the frame comprising a plurality of longitudinal and horizontal elements that was disclosed hereinabove) .
  • the frame has a helical structure that is constructed from one or more lengths of wires that are elastically-deformable.
  • the frame comprises a basal ring to which is attached a plurality of elastic arms extending longitudinally and radially therefrom.
  • the elastic arms may be constructed in any suitable manner, but in one preferred embodiment they are constructed from wires formed into an inverted 'U' shape. This is, however, just one non-limiting example, many other shapes also being possible, all of which fall within the scope of the present invention.
  • the frame may be constructed from one or more elements that overlap in a circumferential plane, thereby permitting the diameter of said retractor to be altered by means of manipulating the degree of overlap between said overlapping elements .
  • the frame has a circular cross-sectional shape, and is constructed of a plurality of longitudinally-disposed elements, the three dimensional form of said frame being frusto-conical or conical.
  • the present invention is also directed to a method for retracting tissues and/or organs during an open surgical procedure comprising the steps of: providing a surgical retractor as disclosed hereinabove, inserting said retractor in its closed conformation through the external layers of the surgical incision, positioning said retractor at the desired operating location, manipulating said retractor from its closed conformation to an open conformation, such that the required tissues and/organs are displaced from the operating location, thereby providing clear visual and instrumental access to said operating location through the internal space of said retractor.
  • the present invention also provides a method for retracting tissues and/or organs during an endoscopic surgical procedure (e.g.
  • a laparoscopic procedure comprising the steps of: insertion of one or more trocars through the external tissues overlying the operating site, • providing a surgical retractor of the type disclosed hereinabove, delivering said retractor in its closed conformation through one of said trocars, positioning said retractor at the desired operating location, manipulating said retractor from its closed conformation to an open conformation, such that the required tissues and/organs are displaced from the operating location, thereby providing clear visual and instrumental access to said operating location through the internal space of said retractor.
  • the step of manipulating said retractor from its closed conformation to an open conformation may comprise the release of a restraining element, thereby permitting the self-expansion of said retractor.
  • the step of manipulating said retractor from its closed conformation to an open conformation may comprise the manual manipulation of the frame and/or membrane of said retractor.
  • said method may further comprise the steps of providing external anchoring means and using said means to anchor the retractor to tissues and/or organs located outside of the operating location.
  • Fig. 1 schematically illustrates an exemplary embodiment of the invention
  • FIG. 2 schematically illustrates another exemplary embodiment of the invention
  • FIG. 3A schematically illustrates another exemplary embodiment of the invention and Fig. 3B schematically illustrates the invention in use during cranial surgery ;
  • Fig. 4 schematically illustrates the invention in use during laparoscopic surgery
  • FIG. 5A schematically illustrates another exemplary embodiment of the invention and Fig. 5B schematically illustrates the invention in use during surgery;
  • FIG. 6 is a photograph of the exemplary embodiment of the invention illustrated in figure 3A;
  • Fig. 7A schematically illustrates an external manipulator of an exemplary embodiment of the invention and Fig. 7B schematically illustrates an exemplary mechanism of the external manipulator;
  • Fig. 8A schematically illustrates another exemplary mechanism of the external manipulator of the invention in a closed position and Fig. 8B illustrates the mechanism of the external manipulator of the invention in an open position ;
  • Fig. 9A schematically illustrates another exemplary embodiment of the' invention and Fig. 9B schematically illustrates the invention in use during surgery;
  • Fig. 1OA and 1OB schematically illustrate another exemplary embodiment of the invention;
  • Fig. HA schematically illustrates a view from above of another exemplary embodiment of the invention and Fig. HB schematically illustrates the embodiment of HA from a lateral view;
  • Fig. 12A schematically illustrates another exemplary embodiment of the invention in a closed position
  • Fig. 12B schematically illustrates another exemplary embodiment of the invention in a partially-expanded position
  • Fig.l2C schematically illustrates the embodiment of 12A in an open position
  • Figs. 13A and 13B illustrate a further umbrella-shaped embodiment of the present invention in its closed (Fig. 13A) and fully open (Fig. 13B) positions; and Fig. 14 is a flowchart demonstrating the steps of an endoscopic surgical procedure performed with the device of the invention.
  • the present invention is directed to a method and apparatus for improving the surgical window during open and endoscopic surgical procedures by using a tissue retraction device that may be inserted into the surgical treatment area in a contracted state, the device is then expanded within the treatment site, inducing radial forces on the surrounding tissue.
  • the aforementioned forces both anchor the device in place and prevent external tissues from penetrating into the surgical window and interfering with the surgeons ' view of the treatment site or access into the site.
  • the device is self expanding, utilizing a spring-like mechanism.
  • the device is not self expanding, but is in a "plastic" state, thus requiring external forces in order to expand the device.
  • Exemplary materials for construction of the device of the invention are biocompatible polymers and metals, as will be described hereinbelow.
  • the device comprises a skeleton, which may be covered by a transparent membrane or thin covering or webbing.
  • exemplary materials for construction of the covering of the device of the invention are elastomers and polymers such as silicon and polyurethane .
  • Fig. 1 is a schematic diagram illustrating a perspective view of an exemplary embodiment of the device 10 of the invention, having a tubular formation with exemplary longitudinal rods 50 and exemplary horizontal rods 40, forming a plurality of slots parallel to the longitudinal axis of the device. Opening 30 is approximated to the tissue which is to be treated, and opening 20 is the access plane through which the surgeon can insert the surgical tools into the surgical working space, within the device 10.
  • Rods 50 and 40 are flexible, thus allowing contraction of the device for insertion through a small aperture (for example a trocar in endoscopic surgery) and allowing expansion of the device within the surgical working space after its insertion.
  • An advantage of the elastic embodiment is the ability for self expansion of the device within the body tissue, thus allowing a self-anchoring tissue retraction device.
  • a self expanding device may exert predetermined forces on the tissues, thus reducing the risk of tissue damage.
  • the rods are in a "plastic" state, i.e. require external force for movement and will stay in the new position after they are moved.
  • An advantage of a "plastic" embodiment is that the surgeon may move and tightly control the 3D form of the device, and constantly change its size and structure according to the needs during the procedure .
  • the device 10 may be constructed from a single type of material, or, from a plurality of different types of materials.
  • the device may be constructed from a single type of material, or, from a plurality of different types of materials, exhibiting the physicochemical property and behavior of elasticity, whereby the device, in general, and, the at least one elastic component, in particular, are self-expandable.
  • such material is selected from the group consisting of a pure metal, a metal alloy, plastic, polymer and combinations thereof.
  • Exemplary pure metals are tungsten, platinum, and, titanium.
  • Exemplary metal alloys are nitinol, and, stainless steel.
  • the device may be designed, configured, and constructed, by starting with a single, unitary, preferably metal, tube, followed by removing, for example, by laser cutting, selected material from the tube, until only the desired geometry, shape, and dimensions, remain.
  • the device of the invention may be constructed by bending a wire or multiple wires into the desired shape. Industrial bending machinery may be used to bend the wire into the desired .shape, and the wires may be connected by welding, in the case that multiple wires are used, suitable metal wires may be obtained, for example, from Allvac Inc., Monroe, NC.
  • the device 10 of the invention may be covered by a membrane or web or similar thin covering that partially or completely envelopes the body of the device.
  • This covering has the advantage of preventing tissue from penetrating into the surgical area through the slots of the device.
  • the covering is transparent, allowing the surgeon to view the retracted tissues, thereby improving the safety of the procedure. This is a significant advantage over currently used retractors, which are most commonly made of metal and prevent view of the retracted tissues (thus bleeding or perforation may occur and not be noticed by the surgeon.).
  • Exemplary materials for a transparent covering are polyurethane, silicone and other polymers and elastomers.
  • An exemplary method for preparing the covering is as follows:
  • the surface is prepared in order to enable good adhesion between the polymer and the surface of the device by surface treatment or another primer; - the device is covered with a thin sheath (webbing) of the covering polymer by means of a dipping method.
  • the covering of the device may additionally be used as a means for detection of bleeding from the retracted tissues. This may be achieved by adding to the cover a material that will signalize and emphasize bleeding. Exemplary materials that can be added are fluoroscopic materials, or other coloring materials, that will visually shine when directly contacting with blood.
  • the device 10 of the invention may contain several means for improving the view of the surgical are, and the access to the area.
  • the device of the present invention further comprises means for suction of fluids from the surgical area (not shown) .
  • An exemplary suction means can be achieved by connecting one or more suction tubes alongside the longitudinal aspect of the device, to allow suction of fluids from the surgical area.
  • the device further comprises means for illuminating the surgical area, for example by connecting fiber-optics alongside the device, or implementing LED light sources within the device.
  • Exemplary dimensions of the device of the invention are as follows. Longitudinal length is in the range of between about 2 cm to about 15 cm, preferably, about 5 cm. Horizontal length (diameter) , when in extended position, is in the range of between about 2 cm to about 20 cm, preferably, about 10 cm. When the device is to be used for endoscopic delivery (e.g. through a trocar) the diameter of the fully closed (i.e. collapsed) device will be approximately 5-8 mm.
  • the general depth or thickness of the material of the device is in the range of between about 0.01 mm (10 microns) to about 5.0 mm (5000 microns), preferably, about 0.3 mm (300 microns).
  • FIG. 2 is a schematic diagram illustrating a perspective view of an exemplary embodiment of the device of the invention in which there is more than one type of longitudinal rod.
  • longitudinal rods 50 have a different resiliency and a different ' structure than longitudinal rods 60.
  • longitudinal rods 60 are made of wire springs, wherein each wire is bent such that it contains one or more angled portions, each angled portion comprising either a rightward- directed or a leftward-directed apex.
  • FIG. 3A is a schematic diagram illustrating a perspective view of an exemplary embodiment of the device of the invention in which there is more than one type of horizontal rod.
  • horizontal rods 40 have a different resiliency and a different structure than horizontal rods 70.
  • FIG. 3B is a schematic diagram illustrating a perspective view of the exemplary embodiment of the device of FIG. 3A in use during an open surgical procedure. Opening 20 is the access plane through which the surgeon can insert the surgical tools into the surgical working space, within the device, and opening 30 is approximated to the tissue which is to be treated. In the example shown, the device is used for cranial surgery, showing the cut-down cranial bone 100.
  • FIG. 4 is a schematic diagram illustrating a perspective view of the exemplary embodiment of the device of FIG. 3A in use during endoscopic surgical procedure. Opening 20 is the access plane through which the surgeon can insert the surgical tools into . the surgical working space, within the device, and opening 30 is approximated to the tissue which is to be treated. In the example shown, the device is used for Laparoscopic surgery, showing gastrointestinal tissues 110 that are retracted by the device from the surgical area.
  • FIG. 5A is a schematic diagram illustrating a perspective view of an exemplary embodiment of the device of the invention in which the longitudinal length of the device can be altered in-situ, by manipulating the overlap between the different telescoping segments that are used to construct longitudinal rod 80.
  • longitudinal rods 80 can be inserted into the surgical area in a contracted state (maximal overlap between the elements) and enlarged in-situ by the surgeon by simple elongation (thus reducing the overlap between the elements) .
  • a similar mechanism can be used for horizontal expansion of the device (not shown in the figures) .
  • FIG. 5B is a schematic diagram illustrating a perspective view of the exemplary embodiment of the device of FIG. 5A in use during a surgical procedure.
  • FIG. 6 is a photograph of an exemplary embodiment of the device of FIG. 3A.
  • the device is approximated to a standard ballpoint pen, in order to illustrate exemplary dimensions.
  • the exemplary device shown is made of two types of longitudinal rods, interconnected by horizontally oriented wires that enable shifting the device position from retracted to expanded (open) .
  • Step l The device will be cut to its final shape from a tube with a diameter that matches the final product desired diameter.
  • Step 2 Heat treatment and electropolish as described above.
  • ⁇ Manufacturing approach IV o
  • the device will be made by weaving dense and flexible mesh wires.
  • Potential raw materials for this approach are stainless steel - 316L, 316LVM, PH17-4, Nitinol (nickel titanium alloy) , Polymer / plastic material cast over a metal wire mesh.
  • the device can be made of plastic, elastomeric or polymeric materials.
  • an appropriate mould can be manufactured according to the required design.
  • injection molding can be used, which involves heating & injecting plastic material under pressure into a closed metal mould tool. The molten plastic cools & hardens into the shape inside the mould tool, which then opens to allow the moldings to be removed.
  • FIG. 7A is a schematic diagram illustrating a perspective view of an exemplary embodiment of the device of the invention in which the length (diameter) of the access planes can be altered in-situ, by manipulating an external expansion mechanism attached to longitudinal rods 50.
  • Longitudinal rods 50 and horizontal rods 40 of the device are shown.
  • Connection elements 200 are used to connect pulling wires 210 to each proximal end of the longitudinal rods.
  • Mechanism 220 can be used to employ forces on wires 210, thus enabling expansion or contraction of the device.
  • the device can be inserted into the surgical area in a contracted state and enlarged in-situ by 1 the surgeon by a simple maneuver of mechanism 220.
  • FIG. 7B is a schematic diagram illustrating an enlarged view of an exemplary mechanism 220 for expanding and contracting the device, in which the forces are achieved by a helical screw mechanism.
  • FIG. 8 is another schematic diagram illustrating a view from above of a different embodiment of the device in which the length (diameter) of the access planes can be altered in-situ, by manipulating an external expansion mechanism.
  • Connection elements 200 are used to connect pulling wires 210 to each proximal end of the longitudinal rods (shown here from above) .
  • the mechanism exemplified here for expansion or contraction of the device is similar to a camera shutter (or diaphragm) , utilizing twisting motions for expansion and contraction of the device.
  • FIG 8A illustrates a contracted state of the device
  • FIG.8B illustrates an expanded state.
  • FIG. 9A is a schematic diagram illustrating a perspective view of another exemplary embodiment of the device of the invention, in which the device is constructed by one or more wires having an essentially tubular elastic form and in which the longitudinal length of the device can be altered in-situ, by releasing additional wire length through wire-grasper 230.
  • FIG. 9B is a schematic diagram illustrating a perspective view of the exemplary embodiment of the device of FIG. 9A in use during a surgical procedure .
  • FIG. 1OA and 1OB illustrate perspective views of additional exemplary embodiments of the device of FIG. 9, in which the device is constructed by one or more wires having an essentially tubular elastic form, but in which the longitudinal length of the device is pre-determined during the manufacturing process, and not determined in-situ.
  • Fig. 1OA illustrates a device with an essentially constant diameter
  • FIG.1OB illustrates two devices with irregular diameters .
  • FIGS. HA and HB are schematic diagrams illustrating a two-dimensional planar view from above, and a perspective view, respectively, of an additional embodiment of the device 300 of the invention.
  • the device is designed and constructed as an integral single elastic component, featuring a plurality of, for example four, elastic arms or extensions 310, longitudinally and radially extending from, for example, a single optional elastic lower basal section or ring formation 320, which is preferably self-expanding.
  • the lower end regions of the elastic arms or extensions of the device are integral and continuous with each other, by way of optional elastic lower basal section or ring formation 320.
  • the device is actually of conical geometry, shape, and, form, as particularly shown in FIG.
  • FIG. HA particularly illustrates elastic as an inverse U shape, having a generally symmetrical pattern, however, other non-symmetrical and cut-out patterns may be designed.
  • FIG. HB illustrates an optional covering, preferable transparent, which may be utilized in this design, similar to the covering previously described.
  • FIG. 12 is a schematic diagram illustrating a perspective view of an additional exemplary embodiment of the device of the invention in which the length (diameter) of the access planes can be altered in- situ, by manipulating the overlap between the elements of the device.
  • FIG. 12A illustrates such a device that is constructed with one element 400, overlapping on itself.
  • FIG. 12B illustrates such a device that is constructed with two elements 410 and 420, in which the overlap between the elements determines the horizontal diameter of the device.
  • the device can be inserted into the surgical area in a contracted state (maximal overlap between the elements) and enlarged in-situ by the surgeon by simple elongation (thus reducing the overlap between the elements) .
  • the device can additionally utilize more than two elements (not shown in the figures).
  • FIG. 12C is a schematic diagram illustrating a perspective view of the exemplary embodiment of the device of FIG. 12A and 12B, in a fully expanded state.
  • the retractor of the present invention is constructed as an umbrella-shaped device 500.
  • the device comprises a frame comprising a series of rod-like structures 510 which, in the fully open state, radiate outwards in a distal direction, thereby forming a structure having a conical or frusto-conical shape.
  • the rods are affixed at their proximal ends to a common basal element 520, said element having a diameter that is sufficiently small to allow delivery of the device in its closed (collapsed) state through a trocar or other type of endoscopic port.
  • the intervals e.g.
  • a portion of the frame, close to its distal end, is covered with a plastic or fabric membrane 540, the primary purpose of which is to prevent entry of adjacent organs and tissues (e.g. the intestinal loops 550) from entering into the surgical window.
  • a plastic or fabric membrane 540 the primary purpose of which is to prevent entry of adjacent organs and tissues (e.g. the intestinal loops 550) from entering into the surgical window.
  • the device In use, the device is inserted into the body cavity in its contracted or collapsed state, as shown in FIG. 13A, through a port 560, and allowed to expand (by virtue of the elastic forces inherent in the structure of the frame) within the surrounding tissues, as illustrated in FIG. 13B, thereby creating a discrete workspace (the surgical window) within the internal space that is bounded externally by the umbrella- shaped frame.
  • a metal ring (not shown) distally from its initial position (surrounding the rod-like structures at their proximal ends) to the distal end of the frame, thereby causing the umbrella-shaped device to adopt its closed (or collapsed) conformation.
  • it is possible to close the device by having the operator pull it through the port entry (e.g. trocar) thereby forcing the umbrella-shaped device into its closed position. The device will then have a sufficiently small diameter to permit it to be withdrawn from the patient's body through the insertion port.
  • the flowchart of Fig. 14 demonstrates the steps of an interventional procedure performed with the device of the invention. In this -example an endoscopic procedure is presented.
  • the procedure starts with insertion of trocars to provide access for the surgical tools.
  • the device of the invention can then be inserted through the trocars in a contracted state, delivered into the surgical area, and expanded to retract adjacent tissues and allow access to the surgical window.
  • the surgeon decides if a clear surgical window has been achieved. If not, the device of the invention may be re-contracted, and re-expanded in an improved location. After a clear view has been established, the surgical procedure may be performed, with maximal convenience and safety.
  • the device of the invention may be re-contracted and removed from the body, through a trocar.

Abstract

La présente invention concerne principalement un écarteur chirurgical qui peut être changé d’une conformation fermée en conformation ouverte et vice versa, sachant que ledit écarteur comprend dans sa conformation ouverte un cadre semblable à un tube, tel que la face interne dudit cadre définit la limite externe d’un espace interne et sachant que ledit espace interne est essentiellement éliminé lorsque ledit rétracteur est dans sa conformation fermée. L’invention concerne aussi des procédés d’écartement de tissus et/ou d’organes lors de procédures chirurgicales utilisant l’écarteur mentionné ci-dessus.
PCT/IL2007/000064 2006-01-17 2007-01-17 Dispositif d’ouverture d’acces pour procedures chirurgicales WO2007083305A2 (fr)

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WO2010014707A1 (fr) 2008-07-30 2010-02-04 Cornell University Procédé et appareil pour renforcer et aplatir la paroi latérale d'une lumière corporelle ou d'une cavité corporelle, de manière à fournir une exposition tridimensionnelle d'une liaison ou anomalie dans la lumière corporelle ou la cavité corporelle, et/ou pour stabiliser un instrument par rapport à celle-ci
GB2467960A (en) * 2009-02-23 2010-08-25 Neosurgical Ltd Laparoscopic surgical retraction device with expanding element and anchor arrangement
WO2011026124A1 (fr) * 2009-08-31 2011-03-03 Applied Medical Resources Corporation Système d'accès chirurgical multifonctionnel
JP2016137218A (ja) * 2015-01-29 2016-08-04 独立行政法人国立病院機構 開創器
JP2018083114A (ja) * 2009-07-21 2018-05-31 アプライド メディカル リソーシーズ コーポレイション 手術用アクセスデバイス
EP3461423A1 (fr) * 2011-05-10 2019-04-03 Applied Medical Resources Corporation Écarteur de plaies
US10507017B2 (en) 2002-06-05 2019-12-17 Applied Medical Resources Corporation Wound retractor
US10575840B2 (en) 2015-10-07 2020-03-03 Applied Medical Resources Corporation Wound retractor with multi-segment outer ring
IT201900014196A1 (it) * 2019-08-08 2021-02-08 Gardelli Manuela dispositivo medico del tipo retrattore autostatico atraumatico per chirurgia ricostruttiva del seno
US10952768B2 (en) 2014-08-15 2021-03-23 Applied Medical Resources Corporation Natural orifice surgery system

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US10507017B2 (en) 2002-06-05 2019-12-17 Applied Medical Resources Corporation Wound retractor
US8764630B2 (en) 2008-05-19 2014-07-01 Olympus Medical Systems Corp. Endoscopic surgical procedure and surgical apparatus
EP2123227A1 (fr) * 2008-05-19 2009-11-25 Olympus Medical Systems Corporation Procédure chirurgicale endoscopique et appareil chirurgical
EP2318085A4 (fr) * 2008-07-30 2017-01-11 Cornell University Procédé et appareil pour renforcer et aplatir la paroi latérale d'une lumière corporelle ou d'une cavité corporelle, de manière à fournir une exposition tridimensionnelle d'une liaison ou anomalie dans la lumière corporelle ou la cavité corporelle, et/ou pour stabiliser un instrument par rapport à celle-ci
EP2318085A1 (fr) 2008-07-30 2011-05-11 Cornell University Procédé et appareil pour renforcer et aplatir la paroi latérale d'une lumière corporelle ou d'une cavité corporelle, de manière à fournir une exposition tridimensionnelle d'une liaison ou anomalie dans la lumière corporelle ou la cavité corporelle, et/ou pour stabiliser un instrument par rapport à celle-ci
WO2010014707A1 (fr) 2008-07-30 2010-02-04 Cornell University Procédé et appareil pour renforcer et aplatir la paroi latérale d'une lumière corporelle ou d'une cavité corporelle, de manière à fournir une exposition tridimensionnelle d'une liaison ou anomalie dans la lumière corporelle ou la cavité corporelle, et/ou pour stabiliser un instrument par rapport à celle-ci
US9649100B2 (en) 2008-07-30 2017-05-16 Cornell University Method and apparatus for straightening and flattening the side wall of a body lumen or body cavity so as to provide three dimensional exposure of a lesion or abnormality within the body lumen or body cavity, and/or for stabilizing an instrument relative to the same
GB2467960A (en) * 2009-02-23 2010-08-25 Neosurgical Ltd Laparoscopic surgical retraction device with expanding element and anchor arrangement
JP2018083114A (ja) * 2009-07-21 2018-05-31 アプライド メディカル リソーシーズ コーポレイション 手術用アクセスデバイス
WO2011026124A1 (fr) * 2009-08-31 2011-03-03 Applied Medical Resources Corporation Système d'accès chirurgical multifonctionnel
US11510695B2 (en) 2009-08-31 2022-11-29 Applied Medical Resources Corporation Multifunctional surgical access system
US9717522B2 (en) 2009-08-31 2017-08-01 Applied Medical Resources Corporation Multi-functional surgical access system
US9743954B2 (en) 2009-08-31 2017-08-29 Applied Medical Resources Corporation Multifunctional surgical access system
EP3461423A1 (fr) * 2011-05-10 2019-04-03 Applied Medical Resources Corporation Écarteur de plaies
KR102480917B1 (ko) 2011-05-10 2022-12-23 어플라이드 메디컬 리소시스 코포레이션 창상 견인기
JP2020179200A (ja) * 2011-05-10 2020-11-05 アプライド メディカル リソーシーズ コーポレイション 開創器
KR20220104074A (ko) * 2011-05-10 2022-07-25 어플라이드 메디컬 리소시스 코포레이션 창상 견인기
US10952768B2 (en) 2014-08-15 2021-03-23 Applied Medical Resources Corporation Natural orifice surgery system
US11583316B2 (en) 2014-08-15 2023-02-21 Applied Medical Resources Corporation Natural orifice surgery system
JP2016137218A (ja) * 2015-01-29 2016-08-04 独立行政法人国立病院機構 開創器
US10335132B2 (en) 2015-01-29 2019-07-02 National Hospital Organization Retractor
WO2016121169A1 (fr) * 2015-01-29 2016-08-04 独立行政法人国立病院機構 Écarteur
US10575840B2 (en) 2015-10-07 2020-03-03 Applied Medical Resources Corporation Wound retractor with multi-segment outer ring
US11602338B2 (en) 2015-10-07 2023-03-14 Applied Medical Resources Corporation Wound retractor with multi-segment outer ring
WO2021024285A1 (fr) 2019-08-08 2021-02-11 Deco Med Srl Dispositif médical, de type écarteur à crémaillère non traumatique, pour chirurgie reconstructrice du sein
IT201900014196A1 (it) * 2019-08-08 2021-02-08 Gardelli Manuela dispositivo medico del tipo retrattore autostatico atraumatico per chirurgia ricostruttiva del seno

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