WO2017163119A1 - Dispositif de fixation chirurgicale - Google Patents

Dispositif de fixation chirurgicale Download PDF

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Publication number
WO2017163119A1
WO2017163119A1 PCT/IB2017/000278 IB2017000278W WO2017163119A1 WO 2017163119 A1 WO2017163119 A1 WO 2017163119A1 IB 2017000278 W IB2017000278 W IB 2017000278W WO 2017163119 A1 WO2017163119 A1 WO 2017163119A1
Authority
WO
WIPO (PCT)
Prior art keywords
fastener
shaft
tissue
driver member
delivery tip
Prior art date
Application number
PCT/IB2017/000278
Other languages
English (en)
Inventor
Arie Levy
Yehonatan LEVIN
Ofek Levin
Lena Levin
Original Assignee
Via 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 Via Surgical Ltd. filed Critical Via Surgical Ltd.
Priority to CA3018652A priority Critical patent/CA3018652C/fr
Priority to EP17769516.0A priority patent/EP3432807A4/fr
Priority to JP2018549557A priority patent/JP6931657B2/ja
Publication of WO2017163119A1 publication Critical patent/WO2017163119A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B17/0644—Surgical staples, i.e. penetrating the tissue penetrating the tissue, deformable to closed position
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • 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
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/064—Surgical staples, i.e. penetrating the tissue
    • A61B2017/0647—Surgical staples, i.e. penetrating the tissue having one single leg, e.g. tacks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/0004—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse
    • A61F2/0031—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra
    • A61F2/0036—Closure means for urethra or rectum, i.e. anti-incontinence devices or support slings against pelvic prolapse for constricting the lumen; Support slings for the urethra implantable
    • A61F2/0045—Support slings

Definitions

  • Surgical fastening devices surgical fasteners, and surgical methods of fastening a mesh to tissue.
  • Prolapse is a medical condition in which organs, such as the uterus, fall down or slip out of place.
  • pelvic organ prolapse involves a loosening of connective tissue that holds the uterus, allowing the uterus to descend into the vagina. It is estimated that half of all women older than 50 years may experience symptomatic prolapse. The health care impact of prolapse is likely to expand, based on an aging population. Surgical repair of prolapse has been one of the most common procedures performed in women over 70.
  • Laparoscopic sacrocolpopexy is a surgical technique for repairing pelvic organ prolapse in which a piece of a pre- shaped mesh is inserted into the abdomen and attached at one end to the vaginal tissue and at the other end to the back portion of the sacral promontory, thereby lifting the vagina and preventing the prolapse.
  • Attachment of the mesh to the vagina wall by suturing is challenging because it requires the insertion of the suture to a specific depth into the vaginal wall. The suture must provide a secure attachment, but should not pass through the vagina wall since that could cause serious complications.
  • the invention provides devices and methods for delivering surgical fasteners to a controlled, specific depth in tissue and locking the fasteners closed to provide a secure and reliable attachment.
  • Devices may be used to secure a mesh to tissue, and thus may be used in sacrocolpopexy procedures to treat prolapse conditions such as pelvic organ prolapse.
  • the surgical fastening device will automatically apply individual fasteners through the mesh and into the vaginal wall.
  • the suture is inserted into a fixed depth, minimizing risk of piercing through the vagina wall and providing a reliable attachment. Because the device locks the individual fasteners into closed loops, there is no need for knot tying and thus devices and methods of this disclosure reduce the time and skill required to perform such a procedure. Because the procedure can be performed more readily and quickly than by other methods, the procedure will be less expensive and thus more widely available.
  • Device of the invention will allow a greater number of people to be treated to alleviate suffering from prolapse conditions.
  • Surgical fastening devices and fasteners described herein provide benefits and advantages for surgical procedures such as laparoscopic sacrocolpopexy for pelvic organ prolapse (POP).
  • POP pelvic organ prolapse
  • a fastener can be wider than a shaft diameter, the fastener is not limited in the width to the 5 mm diameter of a laparoscopic instrument. Even for fasteners that will penetrate only to a shallow depth, they can be wide (e.g., wider than the penetration depth). The generous width contributes to reliably securing a mesh to tissue.
  • devices have a tip that is angled in relation to the tissue or the shaft of the device. This means that the device shaft need not point straight towards the target tissue surface and a fastener can be deployed somewhat towards the side of the tip of the shaft. This may be prove convenient in many procedures.
  • Devices may be used to apply fasteners into only a very small depth, which is important for several applications. Because the device contains a driver member that extends from a tissue- facing surface at an acute angle and curves back to the tissue facing surface, the penetration depth can be very shallow. The acute angle may preferably be between 5° and 60°.
  • the closed loop of the fastener can span a width across the tissue that is wide and therefore strong. In fact, the width can be wider than a diameter of the shaft of the device.
  • the very shallow penetration depth is important in applications such as laparoscopic sacrocolpopexy is which the fastener must provide a secure attachment without passing through the vagina wall.
  • fasteners disclosed herein have no sharp edges pointing into the tissue. Such sharp edges may otherwise irritate the nerves and tissue.
  • the disclosed fasteners, when closed, contain all points or barbs within a smooth bowl of material and present only smooth surfaces to the surrounding tissue.
  • the surgical fastening device includes a driver member that extends from a tissue-facing surface at an acute angle and curves back to the tissue facing surface.
  • the driver member is made of a super-elastic material such as Nitinol. Such a material is advantageous because it gives the driver member the strength and shape necessary to allow it to fasten the fastener in the shallow, broad, edge-free configuration useful and beneficial for procedure such as laparoscopic sacrocolpopexy.
  • the invention provides a surgical fastening device.
  • the device includes a body with a handle with a trigger extending therefrom; a shaft extending from the body; a delivery tip at a distal end of the shaft; a driver member disposed within the shaft; and a fastener held at the delivery tip.
  • the fastener has an extended body with a barbed end and a receiving end.
  • Operation of the trigger causes the driver member to: push the barbed end of the fastener out of a tissue-facing surface of the delivery tip, along a curved path and back to the tissue-facing surface, and into the receiving end, thereby forming the fastener into a closed fastener; release from the closed fastener; and retract back into the shaft and engage a second fastener.
  • a single driver member extends from the delivery tip to fasten the fastener.
  • the delivery tip may protrude from the shaft and present a tissue-facing surface with an exit port thereon.
  • the fastener is held at the delivery tip at least partially within a guide slot in spatial communication with the exit port.
  • the delivery tip is biased away from the shaft such that an axis of the shaft and the tissue-facing surface form an acute angle
  • the driver member comprises a shape-memory material that biases the driver member into a curved shape.
  • the driver member is constrained by the shaft into a straight shape.
  • the barbed end of the fastener includes one or more barbs and a pushable surface engaged with a distal tip of the driver member, e.g., disposed within a delivery slot that terminates at the exit port.
  • the receiving end of the fastener may define a bowl with an opening and a lip that overhangs the opening. The receiving end may be positioned for delivery within a distal end of the guide slot within the delivery tip.
  • the exit port encompasses the distal end of the delivery slot and is in spatial communication with a distal end of the guide slot. Operation of the trigger causes the driver member to: push the barbed end of the fastener out of the distal end of the delivery slot, along a curved path to the distal end of the guide slot, and into the receiving end of the fastener such that the one or more barbs are engaged with the lip of the bowl of receiving end, thereby forming the fastener into a closed fastener.
  • the shaft may have a length L of at least 15 cm and has a diameter D of less than 1 cm. In certain embodiments, L > 25 cm and D ⁇ 7 mm and H ⁇ D ⁇ W.
  • the delivery tip may be bendable towards the axis of the shaft.
  • the device may include additional fasteners disposed with the shaft, wherein each operation of the trigger delivers a single fastener and advances the additional fasteners towards the delivery tip.
  • a surgical fastener that includes an extended body, at least a portion of the extended body being flexibly deformable, the extended body terminating at a barbed end and a receiving end, wherein the receiving end defines a bowl with an opening and a lip that overhangs the opening. Bending the deformable portion of the extended body and inserting the barbed end into the receiving end locks the fastener in a closed loop.
  • the barbed end comprises a pointed tip for piercing through tissue. When the fastener is locked in the closed loop, the pointed tip is confined within the bowl.
  • the closed loop may include: the barbed end confined within the bowl, a first portion of the extended body extending substantially straight from the bowl, a bent portion of the extended body at an end of the first portion, and a bowed portion of the extended body defining a curve between the barbed end and the bent portion.
  • the closed loop spans a width W from the barbed end confined within the bowl to the bent portion and the bowed portion is spaced apart from the first portion no greater than a depth H.
  • a depth H Preferably, 3 cm > W > H, H ⁇ 6 mm, or both.
  • the barbed end comprises one or more barbs and when the fastener is locked in the closed loop, the barbs are retained by the lip that overhangs the opening of the bowl. When the fastener is locked in the closed loop, the barbs are confined within the bowl.
  • the barbed end may include a pushable surface behind the pointed tip.
  • the invention provides a surgical fastener that includes an extended body, at least a portion of the extended body being flexibly deformable, the extended body terminating at a round end and a receiving end defining a loop.
  • the round end comprises a bulbous shape that requires the loop to elastically deform for the round end to pass through the loop.
  • the closed loop spans a width W from the barbed end confined within the bowl to the bent portion and the bowed portion is spaced apart from the first portion no greater than a depth H.
  • a depth H Preferably, 3 cm > W > H, H ⁇ 6 mm, or both.
  • the invention provides a surgical fastening device that includes a body with a handle extending therefrom; a trigger on the handle; a shaft extending from the body; a delivery tip at a distal end of the shaft, the delivery tip protruding from the shaft and presenting a tissue-facing surface with an exit port thereon, wherein the delivery tip is biased away from the shaft such that an axis of the shaft and the tissue-facing surface form an acute angle, wherein the delivery tip is bendable towards the axis of the shaft, and wherein the exit port includes a distal end of a delivery slot that carries a barbed end of a fastener positioned within the shaft and the exit port is in spatial communication with a distal portion of a guide channel that includes a receiving end of the fastener; a driver member disposed within the shaft, the driver member comprising a shape-memory material that biases the driver member into a curved shape, and wherein when the driver member is disposed within the shaft, the driver member is con
  • the invention provides a surgical method of attaching a mesh.
  • the method includes obtaining a surgical fastening device that includes a body with a handle with a trigger extending therefrom; a shaft extending from the body; a delivery tip at a distal end of the shaft; a driver member disposed within the shaft; and a fastener held at the delivery tip.
  • the fastener has an extended body with a barbed end and a receiving end.
  • the method includes operating the trigger to cause the driver member to: push the barbed end of the fastener out of the delivery tip, along a curved path, and into the receiving end, thereby forming the fastener into a closed fastener; release from the closed fastener; and retract back into the shaft and engage a second fastener.
  • the delivery tip protrudes from the shaft and presents a tissue-facing surface with an exit port thereon.
  • the fastener is held at the delivery tip at least partially within a delivery slot terminating at the exit port.
  • a distal end of the fastener is held within a distal end of a guide slot that extends through the shaft.
  • the delivery tip is biased away from the shaft such that an axis of the shaft and the tissue-facing surface form an acute angle and the driver member comprises a shape-memory material that biases the driver member into a curved shape.
  • the method includes constraining the driver member in a straight shape by having the driver member disposed within the shaft.
  • the barbed end of the fastener comprises one or more barbs and a pushable surface engaged with a distal tip of the driver member and the receiving end of the fastener defines a bowl with an opening and a lip that overhangs the opening.
  • the barbed end may be held by the delivery slot and the receiving end may be held by the guide slot (e.g., at the distal ends of the delivery and guide slots).
  • the method may include operating the trigger to cause the driver member to: push the barbed end of the fastener out of the distal end of the delivery slot, along a curved path to the distal end of the guide slot, and into the receiving end of the fastener such that the one or more barbs are engaged with the lip of the bowl of receiving end, thereby forming the fastener into a closed fastener.
  • the method also includes placing the tissue-facing surface against tissue and pulling the trigger, causing the driver member to push the barbed end through a mesh and the tissue and into the receiving end of the fastener outside of the tissue such that the closed fastener spans a width W across a surface of the tissue and penetrates to a depth H within the tissue.
  • the shaft may have a length L of at least 15 cm and has a diameter D of less than 1.55 cm. In preferred embodiments of the method, L > 25 cm and D ⁇ 10 mm. Also, H ⁇ D ⁇ W.
  • the method may include bending the delivery tip towards the axis of the shaft (e.g., for insertion through a standard trocar or incision during minimally-invasive surgery).
  • Method may include delivering one or more additional fasteners from the shaft, by operating the trigger to deliver a single fastener and advance any remaining fasteners towards the delivery tip.
  • FIG. 1 shows a surgical fastening device
  • FIG. 2 shows a delivery tip of the device.
  • FIG. 3 shows a surgical fastener of the invention.
  • FIG. 4 shows the fastener formed into the closed loop.
  • FIG. 5 shows the fastener being held within the delivery tip.
  • FIG. 6 gives a detailed view of a barbed end of the fastener and a driver member.
  • FIG. 7 shows the driver member extended along a curved path.
  • FIG. 8 shows the driver member released from the closed fastener.
  • FIG. 9 shows the closed fastener released from a guide slot.
  • FIG. 10 shows the fastener formed into a closed loop.
  • FIG. 11 shows positioning the device against a surface of tissue.
  • FIG. 12 shows the driver member extended through the tissue.
  • FIG. 13 shows the closed loop holding a mesh to the tissue.
  • FIG. 14 shows a device loaded with multiple fasteners.
  • FIG. 15 is a profile of the delivery tip.
  • FIG. 16 shows the delivery tip bent.
  • FIG. 17 shows slits that may be included on the delivery tip.
  • FIG. 18 illustrates pelvic organ prolapse.
  • FIG. 19 diagrams a sacrocolpopexy procedure.
  • Devices and methods for delivering surgical fasteners to a specific depth in tissue and locking the fasteners to secure a mesh to tissue are useful for sacrocolpopexy procedures to treat prolapse conditions such as pelvic organ prolapse.
  • Devices of the invention generally have a body with a handle and an extended shaft dimensioned for minimally invasive surgery. That is, the shaft is preferably smaller in diameter than a standard trocar (e.g., may be ⁇ about 15.5 mm in diameter, preferably ⁇ 10 mm).
  • the shaft is preferably long enough to reach a surgical target, e.g., at least about 15 cm long, preferably at least 25 cm long.
  • the shaft terminates in a delivery tip that presents a tissue-facing surface at an acute angle to an axis of the shaft. Due to this arrangement, when a driver member extends from the shaft while the tissue-facing surface is held against a surface of target tissue, the driver member initially penetrates the tissue at an acute angle (e.g., between about 25° and 65°), which allows the fastener to be wide while limiting penetration depth, minimizing risk of piercing through the tissue (e.g., vagina wall) and providing a reliable attachment.
  • the fastener may be wider than a diameter of a shaft of the device, the fastener is not limited in the width to the diameter of a laparoscopic instrument.
  • the closed loop of the fastener can span a width across the tissue that is wide and therefore strong. In fact, the width can be wider than a diameter of the shaft of the device.
  • the fasteners preferably capture any point or barbs within a smooth bowl once fastened and thus have no sharp edges that would otherwise irritate the nerves and tissue.
  • the driver member is made of a super-elastic material such as Nitinol. Such a material is advantageous because it gives the driver member the strength and shape necessary to allow it to fasten the fastener in the shallow, broad, edge-free configuration useful and beneficial for procedure such as laparoscopic sacrocolpopexy.
  • FIG. 1 shows a surgical fastening device 101.
  • the device 101 includes a body 109 with a handle 113 with a trigger 117 extending therefrom; a shaft 103 extending from the body 109; and a delivery tip 201 at a distal end of the shaft.
  • the trigger 117 is operably engaged with a driver member that extends through shaft 103. Any suitable engagement may be used.
  • the trigger may present a curved, geared surface within the body 109.
  • the curved geared surface may engage a geared slot wheel (through any optional stepper gears that increase or decrease a magnitude of rotation imparted when the trigger 117 is squeezed to rotate about a pivot).
  • the geared slot wheel within handle 109 may include an eccentric slot and a proximal end of the driver member may have a pin engaged into the slot. Squeezing the trigger causes the slot wheel to rotate. The eccentric slot pushes the pin in a direction that includes displacement parallel to an axis of the shaft 103. The displacement of the pin pushes the driver member in a direction distal along shaft 103 and then pull the driver member back in a proximal direction. Thus, squeezing the trigger 117 causes the driver member to translate along the shaft outwards and back to deliver a fastener as described below.
  • a suitable geared trigger with slot wheel and pin that may be modified for use with the invention is shown in U.S. Pat. 8,535,339 (e.g., see FIG. 14 and accompanying text), incorporated by reference.
  • FIG. 2 shows the delivery tip 201.
  • the delivery tip 201 includes an extension 205 protruding from the shaft 103 and presenting a tissue-facing surface 207 with an exit port 221 in spatial communication with a guide slot 215.
  • the exit port 221 is proximal to the axis of the shaft and include a distal end of a delivery slot 225.
  • the guide slot 215 extends from within the shaft 103 and curve through the extension 205 and terminates at a release port 209.
  • the delivery slot 225 opens into the exit port 221, which allows a driver member to be pushed outwards from the shaft and through the exit port 221.
  • the delivery tip 201 is biased away from the shaft 103 such that an axis of the shaft and the tissue-facing surface 207 form an acute angle.
  • the guide slot 215 holds an end of a fastener 301 therein.
  • FIG. 3 shows the surgical fastener 301.
  • the fastener 301 includes an extended body 321, at least a portion 319 of the extended body 321 being flexibly deformable.
  • the extended body 321 terminates at a barbed end 305 and a receiving end 339.
  • the receiving end 339 defines a bowl 327 with an opening and a lip 333 that overhangs the opening.
  • the barbed end 305 may include a pointed tip 341 for piercing through tissue.
  • the barbed end 305 of the fastener 301 has one or more barbs 311.
  • the barbed end 305 includes one or more pushable surfaces 317 behind the pointed tip 341.
  • FIG. 4 shows the fastener 301 formed into the closed loop 401.
  • the pointed tip 341 is confined within the bowl.
  • the closed loop 401 includes the barbed end 305 confined within the bowl 327, a first portion 415 of the extended body 321 extending substantially straight from the bowl 327, a bent portion 411 of the extended body 321 at an end of the first portion 415, and a bowed portion 407 of the extended body 321 defining a curve between the barbed end 305 and the bent portion 411.
  • the barbs are confined within the bowl 327.
  • the barbs 311 are retained by the lip 333 that overhangs the opening of the bowl 327.
  • FIG. 5 shows the fastener 301 being held within the delivery tip 201.
  • a driver member 601 is disposed within the shaft 103, in which the driver member 601 is channeled and guided by a delivery slot 225 that extends within the shaft 103. It can be seen that the receiving end 339 of the fastener 301 is held within the guide slot 225.
  • the barbed end 305 of the fastener 301 is held by the delivery slot 225.
  • the pushable surface 317 on the barbed end 305 is oriented to engage with a distal tip 611 of the driver member 601.
  • the exit port 221 defines a space through which the driver member 601 can push the barbed end 305 of the fastener 301 out of the shaft 103.
  • the guide slot 215 holds the receiving end 339 of the fastener 301 and the delivery slot 225 holds the barbed end 305 of the fastener 301.
  • the receiving end 339 is held in place during operation of the device 101 to prevent its retraction back into the shaft 103 due to tension at the fastener.
  • the guide slot 215 is open at a release port 209 on a distal end of the guide slot 215 in order to facilitate release of the closed fastener 401 from the device once the fastener is delivered and locked.
  • the guide slot 215 is characterized by having a narrow width along the tissue-facing surface 207 in order to hold the receiving end 339 during its advance along the slot 215.
  • the device 101 includes a spring-loaded mechanism in the operation handle in order to facilitate faster application which can be necessary for better penetration through tissue.
  • FIG. 6 gives a detailed view of the barbed end 305 of the fastener 301 and the distal tip 611 of the driver member 601.
  • the pushable surface 317 includes a recess defined to receive the distal tip 611.
  • the driver member 601 may also include a thinner extension portion 607 to fully engage with the pushable surface 317 on the barbed end 305 of the fastener 301.
  • the barbed end 305 of the fastener 301 has barbs and a pushable surface 317 engaged with a distal tip 611 of the driver member 601 (in FIG. 6, the pushable surface 317 and the distal tip 611 are spaced apart to aid visualization, but one will readily appreciate that the distal tip 611 engages the pushable surface 317).
  • FIG. 6-10 illustrate operation of the surgical fastening device 101 in response to one operation of the trigger 117.
  • Pulling the trigger 117 causes the driver member 601 to push the barbed end 305 of the fastener out of the delivery slot 225 on the delivery tip 201, along a curved path, and into the receiving end 339, thereby forming the fastener into a closed fastener 401, release from the closed fastener 401, and retract back into the shaft 103 and engage a second fastener.
  • FIG. 7 shows the driver member 601 extended along a curved path, pushing the barbed end 305 of the fastener 301 into the receiving end 339.
  • the driver member 601 includes a shape-memory material that biases the driver member 601 into a curved shape as seen in FIG. 7.
  • the driver member 601 is constrained by the delivery slot 225 in the shaft 103 into a straight shape.
  • FIG. 8 shows the driver member 601 released from the closed fastener 401.
  • operation of the trigger 117 has caused the driver member 601 to push the barbed end 305 of the fastener 301 out of the exit port 221 on the delivery tip 201, along a curved path and into the receiving end 339 held within the guide slot 215, such that the one or more barbs 311 are engaged with the lip 333 of the bowl 327 of receiving end 339, thereby forming the fastener 301 into a closed fastener 401.
  • FIG. 9 shows the closed fastener 401 released through the release port 209 as the driver member 601 retracts back into the shaft 103 and engage a second fastener.
  • An important feature of the surgical fastening device 101 is the control over delivery depth and the fastening strength that are afforded by the particular dimensional relationships of the fastener 301 and the device 101. Placing the tissue-facing surface 207 against tissue and pulling the trigger 117 causes the driver member 601 to push the barbed end through the tissue and into the receiving end 339 of the fastener back on the outside of the tissue, forming the fastener 301 into the closed loop 401.
  • FIG. 10 shows a fastener 301 formed into the closed loop 401 with the delivery tip 201 still in place against tissue 505.
  • the device 101 has been used to fasten a mesh 511 to the tissue 505.
  • the shaft 103 is positioned such that the tissue-facing surface 207 of the delivery tip 201 faces the mesh 511 and a surface of the tissue 505.
  • the closed fastener 401 spans a width W across a surface of the tissue and penetrates to a depth H within the tissue. Because the delivery tip 201 is biased away from the shaft 103 such that an axis of the shaft 103 and the tissue facing surface 207 form an acute angle, A, the shaft 103 forms the angle A with the surface of the tissue 505.
  • the shaft is dimensioned for minimally-invasive surgery and has a length L of at least 15 cm and has a diameter D of less than 1 cm. More preferably, L > 25 cm and D ⁇ 7 mm. Most preferably, H ⁇ D ⁇ W.
  • FIGS. 11-13 show operation of the device 101.
  • FIG. 11 shows positioning the tissue-facing surface 207 against a surface of tissue 505, and specifically against a mesh 511 to be fastened to the tissue.
  • FIG. 12 shows the driver member 601 extended through the tissue 505 to form the fastener 301 into the closed loop 401.
  • FIG. 13 shows the closed loop 401 holding the tissue 511 to the tissue 505.
  • the closed loop 401 includes the barbed end 305 confined within the bowl 327, a first portion 415 of the extended body 321 extending substantially straight from the bowl 327, a bent portion 411 of the extended body 321 at an end of the first portion 415, and a bowed portion 407 of the extended body 321 defining a curve extending through the tissue 505 between the barbed end 305 and the bent portion 411.
  • the closed fastener 401 preferably spans a width W from the barbed end 305 confined within the bowl 327 to the bent portion 411 and the bowed portion 407 is preferably spaced apart from the first portion 415 no greater than a depth H. In preferred embodiments, 3 cm > W > H. Additionally or alternatively, it may be preferable that H ⁇ 6 mm.
  • pulling the trigger 117 causes the device 101 to form the fastener into a closed fastener 401, release from the closed fastener 401, and retract back into the shaft 103 and engage a second fastener.
  • FIG. 14 shows a device 101 loaded with the fastener 301, a second fastener 399, and three additional fasteners 1401 disposed with the shaft. Visible within shaft 103 are the delivery slot 225 extending to the exit port 221 and also the guide slot 215 extending to the release port 209. Each fastener 301 is held within the shaft 103 in an open configuration, with the receiving end held in the guide slot 215 and the barbed end 205 held in the delivery slot 225.
  • the device 101 may be loaded with any suitable number of the fasteners 301. Each operation of the trigger delivers a single fastener and advances the additional fasteners towards the delivery tip.
  • the delivery tip 201 may be bendable towards the axis of the shaft 103, i.e., so that the extended shaft may most easily pass through a standard surgical trocar.
  • FIG. 15 is a profile of the delivery tip 201. It can be seen that the delivery tip 201 is biased away from the shaft 103 such that an axis X of the shaft 103 and the tissue-facing surface 207 form an acute angle. It may be preferable to be able to deform the delivery tip 201, e.g., for ease of insertion of the shaft 103 through a standard surgical trocar.
  • FIG. 16 shows the delivery tip 201 bent towards the axis X.
  • FIG. 17 shows a compression slit 1701 and an expansion slit 1709 that may be included so that the delivery tip 201 may be more readily bent towards the axis X of the shaft 103.
  • the axis X is an idealized geometrical concept defined by the generally cylindrical nature of the shaft 103 and that there need not be any tangible shaft axis.
  • the axis X is referred to so that one may comprehend the configuration of the delivery tip 201.
  • the disclosure includes a surgical fastening device 101 that includes a body 109 with a handle 113 extending therefrom; a trigger 117 on the handle; a shaft 013 extending from the body; a delivery tip 201 at a distal end of the shaft 103, the delivery tip 201 protruding from the shaft 103 and presenting a tissue-facing surface 207 with an exit port 221 and a guide slot 215, wherein the delivery tip 201 is biased away from the shaft 103 such that an axis of the shaft 103 and the tissue-facing surface 207 form an acute angle, wherein the delivery tip 201 is bendable towards the axis of the shaft 103, and wherein the exit port 221 includes an end of a delivery slot 225; a driver member 601 disposed within the shaft 103, the driver member 601 comprising a shape-memory material that biases the driver member 601 into a curved shape, wherein when the driver member 601 is disposed within the shaft 103, the driver pushing
  • FIG. 18 illustrates pelvic organ prolapse. As reported in Swift, 2000, Am J Obstet Gynecol 183(2):277-85 (incorporated by reference), approximately half of all women older than 50 years complain of symptomatic prolapse.
  • Laparoscopic sacrocolpopexy is a surgical technique for repairing pelvic organ prolapse.
  • FIG. 19 diagrams the sacrocolpopexy procedure.
  • a piece of a pre- shaped mesh is inserted into the abdomen and attached to the vaginal wall, then, the other end of the mesh is attached to the back portion of the pelvic (sacral promontory) therefore, lifting the vagina and preventing the prolapse.
  • Attachment of the mesh to the vagina wall by suturing is challenging because it require the insertion of the suture to a specific depth into the vaginal wall.
  • the suture must provide a secure attachment, but should not pass through the vagina wall since that may cause serious complications.
  • the mesh may be attached using a method of attaching a mesh according to this disclosure.
  • the method includes obtaining a surgical fastening device that includes a body with a handle with a trigger extending therefrom; a shaft extending from the body; a delivery tip at a distal end of the shaft; a driver member disposed within the shaft; and a fastener held at the delivery tip.
  • the fastener has an extended body with a barbed end and a receiving end.
  • the method includes operating the trigger to cause the driver member to: push the barbed end of the fastener out of the delivery tip, along a curved path, and into the receiving end, thereby forming the fastener into a closed fastener; release from the closed fastener; and retract back into the shaft and engage a second fastener.
  • the delivery tip protrudes from the shaft and presents a tissue-facing surface that presents an exit port.
  • the fastener is held at the delivery tip at least partially within a guide slot.
  • the delivery tip is biased away from the shaft such that an axis of the shaft and the tissue-facing surface form an acute angle and the driver member comprises a shape-memory material that biases the driver member into a curved shape.
  • the method includes constraining the driver member in a straight shape by having the driver member disposed within the shaft within a delivery slot.
  • the barbed end of the fastener comprises one or more barbs and a pushable surface engaged with a distal tip of the driver member and the receiving end of the fastener defines a bowl with an opening and a lip that overhangs the opening. It may be that the exit port encompasses an end of the delivery slot.
  • the method may include operating the trigger to cause the driver member to: push the barbed end of the fastener out of the distal end of the delivery slot, along a curved path to the distal end of the guide slot, and into the receiving end of the fastener such that the one or more barbs are engaged with the lip of the bowl of receiving end, thereby forming the fastener into a closed fastener.
  • the method also includes placing the tissue-facing surface against tissue and pulling the trigger, causing the driver member to push the barbed end through the tissue and into the receiving end of the fastener outside of the tissue such that the closed fastener spans a width W across a surface of the tissue and penetrates to a depth H within the tissue.
  • the shaft may have a length L of at least 15 cm and has a diameter D of less than 1 cm. In preferred embodiments of the method, L > 25 cm and D ⁇ 7 mm. Also, H ⁇ D ⁇ W.
  • the method may include bending the delivery tip towards the axis of the shaft (e.g., for insertion through a standard trocar or incision during minimally-invasive surgery). Method may include delivering one or more additional fasteners from the shaft, by operating the trigger to deliver a single fastener and advance any remaining fasteners towards the delivery tip.

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

Abstract

L'invention concerne des dispositifs et des procédés permettant la pose d'attaches chirurgicales à une profondeur spécifique et commandée dans un tissu et le verrouillage des attaches en position fermée pour assurer une fixation solide et fiable. Les dispositifs comprennent un corps doté d'une poignée présentant une détente s'étendant à partir de cette dernière; une tige s'étendant à partir du corps; une pointe de pose sur une extrémité distale de la tige; un élément d'entraînement disposé à l'intérieur de la tige; et une attache maintenue sur la pointe de pose. L'attache est insérée à une profondeur fixe et se verrouille en une boucle fermée.
PCT/IB2017/000278 2016-03-24 2017-03-10 Dispositif de fixation chirurgicale WO2017163119A1 (fr)

Priority Applications (3)

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CA3018652A CA3018652C (fr) 2016-03-24 2017-03-10 Dispositif de fixation chirurgicale
EP17769516.0A EP3432807A4 (fr) 2016-03-24 2017-03-10 Dispositif de fixation chirurgicale
JP2018549557A JP6931657B2 (ja) 2016-03-24 2017-03-10 外科用締結デバイス

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US201662312597P 2016-03-24 2016-03-24
US62/312,597 2016-03-24

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JP (1) JP6931657B2 (fr)
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Also Published As

Publication number Publication date
EP3432807A1 (fr) 2019-01-30
JP2019511298A (ja) 2019-04-25
CA3018652A1 (fr) 2017-09-28
JP6931657B2 (ja) 2021-09-08
CA3018652C (fr) 2019-11-05
EP3432807A4 (fr) 2019-11-13

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