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WO2025080622A1 - Dispositif de suture préchargé pour intervention herniaire - Google Patents

Dispositif de suture préchargé pour intervention herniaire Download PDF

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Publication number
WO2025080622A1
WO2025080622A1 PCT/US2024/050438 US2024050438W WO2025080622A1 WO 2025080622 A1 WO2025080622 A1 WO 2025080622A1 US 2024050438 W US2024050438 W US 2024050438W WO 2025080622 A1 WO2025080622 A1 WO 2025080622A1
Authority
WO
WIPO (PCT)
Prior art keywords
preloaded
preloaded suture
suture
slider
wedge
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/US2024/050438
Other languages
English (en)
Inventor
Bradley T. PIERCE
Benjamin D. TABAK
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
United States Department of the Army
Original Assignee
United States Department of the Army
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 United States Department of the Army filed Critical United States Department of the Army
Publication of WO2025080622A1 publication Critical patent/WO2025080622A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0483—Hand-held instruments for holding sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0493—Protective devices for suturing, i.e. for protecting the patient's organs or the operator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B2017/06052—Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/06071—Needles, e.g. needle tip configurations with an abrupt angle formed between two adjacent sections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06066—Needles, e.g. needle tip configurations
    • A61B2017/061—Needles, e.g. needle tip configurations hollow or tubular

Definitions

  • the present invention is directed to a preloaded suture device.
  • the preloaded suture device may be used in pediatric hernia procedures.
  • a technique for laparoscopic meshless inguinal hernia repair was developed and accepted by the pediatric surgery community as a safe and viable technique. This technique involves loading an 18 gauge spinal needle with a Prolene suture, which is then positioned around the inguinal ring, whereby application of circumferential force applied by the suture closes the congenital defect.
  • an 18 gauge spinal needle is manually bent at a 30° angle to facilitate suture placement.
  • the suture needle is cut from the suture.
  • the remaining suture is then manually loaded in the spinal needle from the middle of the suture and forms a loop at the end of the 18 gauge needle.
  • the spinal needle must be removed, and a second suture is placed in the spinal needle via the same process. Having to manually prepare the materials while scrubbed not only increases the time and the cost of the operation, but also increases surgeon frustration and fatigue if there is difficulty preparation.
  • the device of the present invention is inexpensive, intuitive for the surgeon, and has the potential to decrease the cost of the operation while reducing the risks to the patient.
  • Bilateral inguinal hernias are a common occurrence so two devices may be used in one surgery if bilateral repair is indicated.
  • the invention provides in a first embodiment a preloaded suture device comprising a needle; a plunger having an internal return spring; and a body located at or near a top of the needle.
  • the body includes at least two separate sliding mechanisms or sliders, each slider holding an end or stem of a preloaded suture; and at least two wedge-shaped protrusions, each wedge-shaped protrusion extending upwardly from a bottom of a bottom of the body.
  • the invention provides in a second embodiment further to any of the previous embodiments a preloaded suture device in which each slider comprises a cutout or slot for holding an end or stem of a preloaded suture.
  • the invention provides in a third embodiment further to any of the previous embodiments a preloaded suture device in which each slider comprises a cutout or slot that is T-shaped.
  • the invention provides in a fourth embodiment further to any of the previous embodiments a preloaded suture device in which the at least two sliders are separate elements that are connectable.
  • the sliders may be independent of each other and constrained to travel in a vertical direction by rails incorporated into a top of the body.
  • the invention provides in a fifth embodiment further to any of the previous embodiments a preloaded suture device in which each slider has a curved surface.
  • the invention provides in a sixth embodiment further to any of the previous embodiments a preloaded suture device in which the body further includes a tube forming a central cavity acting as a guide for at least two preloaded sutures.
  • the invention provides in a seventh embodiment further to any of the previous embodiments a preloaded suture device in which each slider has a cutout or notch on a bottom thereof that engages with a respective wedge-shaped protrusion on the body.
  • the invention provides in an eighth embodiment further to any of the previous embodiments a preloaded suture device in which the plunger comprises a rotatable protrusion for pushing down each slider.
  • the invention provides in a ninth embodiment further to any of the previous embodiments a preloaded suture device in which each preloaded suture is in the form of a loop.
  • the invention provides in a tenth embodiment further to any of the previous embodiments a preloaded suture device in which the needle comprises an 18 gauge spinal needle having an angled tip through which each preloaded suture is dispensed.
  • the invention provides in an eleventh embodiment further to any of the previous embodiments a preloaded suture device for use in a pediatric hernia repair procedure or for use in the treatment of a pediatric hernia.
  • the invention provides in a first method embodiment a method comprising providing a preloaded suture device according to any one of the previous embodiments; pushing the plunger downwards, thereby pushing down a first slider so that its wedge-shaped cutout or notch impacts a first wedge-shaped protrusion, thereby releasing a first preloaded suture from the device; returning the plunger to its original position; and pushing the plunger downwards again, thereby pushing down a second slider so that its wedge-shaped cutout or notch impacts a second wedge-shaped protrusion, thereby releasing a second preloaded suture from the device.
  • the invention provides in a second method embodiment further to any of the previous method embodiments a method further comprising positioning the first released preloaded suture around the inguinal ring during a pediatric hernia repair procedure.
  • the invention provides in a third method embodiment further to any of the previous method embodiments a method further comprising snaring the second released preloaded suture with the first released preloaded suture and advancing the second released preloaded suture around the inguinal ring.
  • FIG. 1 shows a perspective view of a preloaded suture device according to an embodiment of the present invention with a needle cover.
  • FIG. 2 shows a cross-section view of a body located at or near a top of the preloaded suture device.
  • FIG. 3 shows an internal exploded view of the body of FIG. 2.
  • FIG. 4 is a perspective view of the sliders, wedge-shaped mechanisms, and wedge- shaped protrusions of the body of FIG. 2.
  • the present invention is directed to a preloaded suture device, for example, with at least two preloaded sutures.
  • the preloaded suture device may be used in pediatric hernia procedures.
  • references to “one embodiment”, “an embodiment”, or “in embodiments” mean that the feature being referred to is included in at least one embodiment of the invention. Moreover, separate references to “one embodiment”, “an embodiment”, or “embodiments” do not necessarily refer to the same embodiment; however, neither are such embodiments mutually exclusive, unless so stated, and except as will be readily apparent to those skilled in the art. Thus, the invention can include any variety of combinations and/or integrations of the embodiments described herein.
  • substantially As used herein “substantially”, “generally”, “about”, and other words of degree are relative modifiers intended to indicate permissible variation from the characteristic so modified (e.g., ⁇ 0.1 %, ⁇ 0.5%, ⁇ 1.0%, ⁇ 2%, ⁇ 5%, ⁇ 10%, ⁇ 20%). It is not intended to be limited to the absolute value or characteristic which it modifies but rather possessing more of the physical or functional characteristic than its opposite, and preferably, approaching or approximating such a physical or functional characteristic.
  • a suture device 5 comprises a needle 10.
  • the needle may be an angled 18 gauge spinal needle in which a lower end of the needle has an angle of about 10 to about 40°, for example 30°, with respect to a longitudinal axis of the spinal needle.
  • the suture device 5 may include an optional removable plastic mechanism 15 at a base, which also serves as a handle for a surgeon.
  • the needle 10 may have a removable cover 20.
  • the suture device 5 has a body 25 which may be located at or near a top of the needle 10.
  • the body 25 may comprise a top or upper section and a bottom or lower section that are connectable together. The top and bottom sections may be press fit together during or after manufacture, thereby securing internal structures in place.
  • a plunger 30 is located at a top of the body 25.
  • the body 25 and needle 10 are preloaded with at least two separate sutures 35, so that a surgeon can easily dispense each suture in the right anatomical position.
  • the preloaded sutures 35 may have a shape so that when dispensed from a bottom of the needle 10 they are in the form a loop.
  • the plunger 30 houses an internal return spring 40 and is located at a top of body 25. As discussed below, each click of the plunger 30 dispenses a suture 35 from the needle 10 and the plunger 30 returns or resets via the internal return spring 40 to its original position. After one preloaded suture is dispensed, it is possible to dispense a second or additional preloaded suture.
  • the body 25 of suture device 5 at least partially or fully houses a tube or structure 45 forming a central cavity configured as a guide for the preloaded sutures 35.
  • the body 25 has at least two separate sliding mechanisms or sliders 50.
  • the at least two sliders 50 may be separate elements that each have a curved surface.
  • the sliders 50 may be connectable together, for example, along their respective vertical lengths.
  • the sliders 50 are independent of each other and are constrained to travel in a vertical direction by rails 51 incorporated into a top of the body 25.
  • each slider 50 has a cutout or slot 60 which holds a preloaded suture 35 in place.
  • the cutout or slot 60 holds an end or a stem of a respective suture 35.
  • the cutout or slot may have a T-shape or any shape that is able to hold an end or stem of a suture 35.
  • each suture may be in the form of a loop, with the loop of the suture being in the needle, for example, near or within an angled section of the needle, and the ends of the suture being held in a slider.
  • one or more additional cutouts or slots may be provided on each slider.
  • a lower part of the body 25 may have two wedges or wedge-shaped protrusions 55 integral with and/or extending upwardly from a bottom of the body 25 and on opposite sides of the body 25.
  • Each wedge-shaped protrusion 55 engages with a wedge-shaped notch or slot 58 located on a bottom of a corresponding slider 50.
  • each slider 50 may be is separately pushed down by the plunger 30.
  • the plunger may have a protrusion 65 extending downwardly on one side thereof.
  • the protrusion 65 may be rotatable as the plunger 30 is pressed downward.
  • the protrusion 65 engages a first slider 50 with a first click or press of the plunger 30, rotates as the internal spring 40 and plunger 30 return to their original position, and then engages a second slider 50 with a second click or press of the plunger 30.
  • each slider 50 moves downward in turn, its respective preloaded suture 35 moves downward through needle 10.
  • the respective slider 50 via its wedge-shaped notch or slot 58, impacts the corresponding wedge or wedge-shaped protrusion 55.
  • the slider 50 e.g., its curved surface
  • This flexing allows the cutout or slot 60 to open enough to free the end or stem of the preloaded suture 35, thereby allowing the preloaded suture 35 to be released from the device 5.
  • the process is repeated for the second or additional preloaded suture.
  • a laparoscopic tool may be used to grab the loop of the first preloaded suture and hold it in place as the suture device is retracted, leaving the first suture in the correct position. The surgeon can then place the needle in the next desired anatomical position to eject the loop of the second preloaded suture from the device.
  • a stab incision was made in the right groin overlying the 12 o'clock position of the internal ring.
  • An 18 gauge spinal needle loaded with a looped 3-0 PROLENE® suture was inserted into the incision and directed laterally around the internal inguinal ring in a preperitoneal plane, and brought into the peritoneal cavity at the 6 o'clock position.
  • the looped suture was advanced through the spinal needle into the peritoneal cavity, and the spinal needle was removed from the incision.
  • the spinal needle was then re-loaded with a new looped 3-0 SURGIPROTM suture, inserted into the incision, and directed medially in a preperitoneal plane around the internal ring and into the peritoneal cavity at the 6 o'clock position.
  • the preloaded suture device according to the present invention would allow the surgeon to no longer have to manually reload the suture in the needle.
  • the first looped 3-0 PROLENE® suture was used to snare the second, and advance it circumferentially around the internal ring.
  • the looped Surgipro suture was exchanged for a looped 3-0 TI-CRONTM suture.
  • the abdominal insufflation was released and the hernia sac contents were evacuated with external pressure.
  • the TI-CRON suture was cut in half, and each thread was tied down to doubly ligate the internal ring. The hernia site was then re-inspected and found to be hemostatic and well-closed.
  • the Maryland instrument was then removed from the abdomen under direct laparoscopic vision.
  • the fascia at this site was closed with a 2-0 VICRYL® suture.
  • the umbilical trocar was removed and the abdomen was allowed to desufflate.
  • the umbilical fascia was closed with a 2- 0 VICRYL® suture in an interrupted fashion.
  • the skin was re-approximated with 4-0 BIOSYNTM suture.
  • the wounds were dressed skin glue. Steri- Strips were placed over the incisions.
  • the present invention is directed to a preloaded suture device.
  • the suture device may be preloaded with at least two sutures.
  • the preloaded suture device may be used in pediatric hernia procedures.

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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

Un dispositif de suture préchargé comprend une aiguille ; un piston ayant un ressort de rappel interne ; et un corps situé au niveau ou à proximité d'une partie supérieure de l'aiguille. Le corps comprend au moins deux mécanismes coulissants ou coulisseaux séparés, chaque coulisseau maintenant une extrémité ou une tige d'une suture préchargée ; et au moins deux saillies en forme de coin, chaque saillie en forme de coin s'étendant vers le haut à partir d'une partie inférieure du corps.
PCT/US2024/050438 2023-10-12 2024-10-09 Dispositif de suture préchargé pour intervention herniaire Pending WO2025080622A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363543743P 2023-10-12 2023-10-12
US63/543,743 2023-10-12

Publications (1)

Publication Number Publication Date
WO2025080622A1 true WO2025080622A1 (fr) 2025-04-17

Family

ID=95396411

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/050438 Pending WO2025080622A1 (fr) 2023-10-12 2024-10-09 Dispositif de suture préchargé pour intervention herniaire

Country Status (1)

Country Link
WO (1) WO2025080622A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001067963A2 (fr) * 2000-03-13 2001-09-20 Sutura, Inc. Dispositif et procede de suture
US20110270282A1 (en) * 2008-10-29 2011-11-03 Norbert Lemke Surgical suture positioning system for closing an opening inside a tissue wall
US20120191109A1 (en) * 2011-01-24 2012-07-26 Brian Rockrohr Wound closure device using t-shaped tag
US11229427B2 (en) * 2011-08-04 2022-01-25 Suture Ease, Inc. Dual insufflation and wound closure devices and methods
US11284897B2 (en) * 2013-08-02 2022-03-29 Covidien Lp Devices, systems, and methods for wound closure

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001067963A2 (fr) * 2000-03-13 2001-09-20 Sutura, Inc. Dispositif et procede de suture
US20110270282A1 (en) * 2008-10-29 2011-11-03 Norbert Lemke Surgical suture positioning system for closing an opening inside a tissue wall
US20120191109A1 (en) * 2011-01-24 2012-07-26 Brian Rockrohr Wound closure device using t-shaped tag
US11229427B2 (en) * 2011-08-04 2022-01-25 Suture Ease, Inc. Dual insufflation and wound closure devices and methods
US11284897B2 (en) * 2013-08-02 2022-03-29 Covidien Lp Devices, systems, and methods for wound closure

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