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WO2025052370A1 - Outil chirurgical et dispositif et méthode de passage de suture - Google Patents

Outil chirurgical et dispositif et méthode de passage de suture Download PDF

Info

Publication number
WO2025052370A1
WO2025052370A1 PCT/IL2023/050941 IL2023050941W WO2025052370A1 WO 2025052370 A1 WO2025052370 A1 WO 2025052370A1 IL 2023050941 W IL2023050941 W IL 2023050941W WO 2025052370 A1 WO2025052370 A1 WO 2025052370A1
Authority
WO
WIPO (PCT)
Prior art keywords
tool
suture
diameter
capture element
wire
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/IL2023/050941
Other languages
English (en)
Inventor
Arnon Mosaiuf
Mark Shahar
Daniel BILLIG
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.)
BONFIX Ltd
Original Assignee
BONFIX 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 BONFIX Ltd filed Critical BONFIX Ltd
Priority to PCT/IL2023/050941 priority Critical patent/WO2025052370A1/fr
Publication of WO2025052370A1 publication Critical patent/WO2025052370A1/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
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/84—Fasteners therefor or fasteners being internal fixation devices
    • A61B17/846—Nails or pins, i.e. anchors without movable parts, holding by friction only, with or without structured surface
    • A61B17/848—Kirschner wires, i.e. thin, long nails
    • 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
    • A61B17/0485—Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1775—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the foot or ankle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8897—Guide wires or guide pins
    • 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
    • A61B2017/00477—Coupling
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0409—Instruments for applying suture anchors
    • 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
    • A61B17/0401—Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors
    • A61B2017/0417—T-fasteners
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B2017/564—Methods for bone or joint treatment
    • A61B2017/565—Methods for bone or joint treatment for surgical correction of axial deviation, e.g. hallux valgus or genu valgus

Definitions

  • the present invention relates to a surgical device, system and method. More particularly, the present invention relates to a tool and suture catching device and a tool and suture catching and passing system useful in surgical environments, including orthopedic surgery.
  • U.S. Pat. No. 9,138,223 teaches another drill pin for suture passing where the pin is provided with a wire loop or suture loop which attaches to a suture that may be threaded through a graft.
  • U.S. Pat. No. 8,425,554 describes a device used in bunion repair which includes a suture passing K-wire which has a portion or “guide pin” with a first diameter and terminating in a sharp tip and an adjacent second portion “behind” the guide pin in the direction of drilling and having a smaller diameter than the first diameter and terminating in an eyelet at the end opposite the sharp tip.
  • a medical device suitable for use in these and other methods comprises: an elongated support configured to be passed through a bore in a bone; and a capture element attached at one end of the elongated support having an outside diameter adapted to be passed through the bore and an interior space adapted to receive and grasp a wire or implant having a smaller diameter than a diameter of the interior space of the capture element.
  • the capture element is a coil spring which has an internal diameter that is reduced when rotated to grip an opposing wire or tool.
  • the elongated support is a first Kirschner wire, or drill bit, adapted to be removed from the bore in the bone before completion of a surgical procedure; and the device further comprises a second tool attached to the first Kirschner wire, or drill bit, by the capture element.
  • a method for fixing an elongated element between two or more bones may comprise: drilling bores in first and second bones and passing a first tool having a first diameter in a first direction through at least one of the bores; attaching a second tool having a second diameter smaller than the first diameter to the first tool with a capture element; adjusting the capture element to grip the first or second tool; pulling the second tool attached to the first tool by the capture element in a direction opposite the first direction through at least one of the bores; and releasing the grip of the capture element.
  • the capture element is a coil spring
  • adjusting the capture element to grip the second tool consists of rotating the coil spring in one direction to reduce the inside diameter of the spring and releasing the grip consists of rotating the coil spring in the opposite direction to increase the inside diameter of the spring.
  • the capture element may be attached to the first tool and may be manipulated to grip the second tool having a smaller diameter.
  • the capture element may also be attached to the smaller diameter tool and may be manipulated to grip the larger diameter tool, provided the outer diameter of the capture element is small enough to be pulled through at least one of the bores.
  • the method further comprises: providing a suture passer having a connector at a first end thereof adapted to receive the second tool in frictional engagement and an aperture at a second end thereof adapted to receive a suture; inserting the second-diameter wire into the connector of the suture passer so that the wire is frictionally engaged; and guiding a suture attached to the second end of the suture passer opposite the first end through at least one of the aligned bores in the first and second bones in a second direction opposite the first direction. (In embodiments, this is a direction from the first metatarsal toward the second metatarsal.)
  • the suture passaer may be provided with a tubular connector in which a tool can be inserted and frictionally engaged.
  • an elongated support for example a 1.7 mm Kirschner wire (“K-wire”)
  • K-wire Kirschner wire
  • a capture element attached at one end of the elongated support has an outside diameter that fits in the bore and an interior space adapted to receive and grasp an elongated member having a smaller diameter (for example, a 1.2 mm K- wire) which can then be pulled through the bore(s).
  • the interior space of the capture element may be described as having a smaller diameter than a tool, wire, implant or anchor that the capture element grips if the capture element can be adjusted to have a smaller diameter.
  • the wire having a capture element thereon may be provided separately or in a kit for performing methods according to the invention, the kit may include a suture passer having a tubular connector at a first end thereof adapted to receive the second tool in frictional engagement and having an aperture at an end opposite the tubular connector configured for attachment to a suture.
  • an implant or anchor is secured at one end of the suture, wherein an end of the suture opposite said implant or anchor is configured to be attached to an aperture in the suture passer.
  • the second tool may then be used to manipulate the suture into place in the bore(s) by pulling the suture through the bore(s).
  • FIG. 1 is schematic view of a surgical tool catching device according to embodiments of the invention.
  • FIG. 2 depicts passing a first tool having a capture element at one end thereof passed in a first direction through the bores using a drill and an aiming tool according to an embodiment of the invention.
  • FIG. 3 depicts a larger diameter wire positioned within aligned bores in adjacent bones with a capture element attached thereto and accessible on a lateral side of the second metatarsal according to embodiments of the invention.
  • FIG. 4 depicts a smaller diameter wire pulled through aligned bores in two bones by an attachment to a larger wire via a capture element.
  • FIG. 5 depicts a suture passing device according to embodiments of the invention.
  • FIG. 6 depicts drilling over a smaller diameter wire from the medial side of the first metatarsal using a step-down drill.
  • FIG. 7 depicts an embodiment of the invention wherein a capture element is provided on a smaller diameter wire and adapted to capture an element having a larger diameter.
  • FIG. 8 depicts an embodiment of the invention wherein a capture element on a first tool is adapted to grip an implant or anchor.
  • a method may recite steps performed when a device is manufactured in addition to steps performed when the device is used in surgery, such as when a capture element is fixed to an elongated support.
  • the description refers to “wires,” which refers to any flexible elongated support.
  • the wires may be Kirschner wires (hereinafter “K-wires”) but the term “wire” is not limited to such embodiments.
  • K-wires Kirschner wires
  • a “surgical tool” as used herein is any device (including an elongated element adapted to be passed through a bore in a bone) that may be used to manipulate another object in a surgical environment.
  • the description refers to first and second “tools,” which in embodiments may be wires or K-wires.
  • the device, systems and methods according to embodiments of the invention may be described in connection with a surgical technique for correction of bunion deformity in which an incision is made on the medial side of the first metatarsal followed by an incision on the lateral side of the second metatarsal. The bunion is thereafter shaved and the angle between the first and second metatarsal is corrected with a reduction clamp.
  • An anchor is provided in the first metatarsal and a stabilizing element is installed between the first and second metatarsal secured by a second anchor in the second metatarsal.
  • a drilling position on the second metatarsal is made with a marking and aiming tool for the entry point of a stabilizing pin (commonly, a K-wire).
  • the tool is used to guide the drilling of a K-wire through the first and second metatarsals forming aligned bores in both bones.
  • drilling is performed from the medial side of the first metatarsal over the installed wire.
  • a step down drill is used, adapted to form bores having different diameters in the first and second metatarsal, respectively.
  • An anchor is thereafter introduced into the bore in the first metatarsal and a stabilizing element is installed between the two bones.
  • One aspect of the invention in the context of the above-described surgical procedure, involves using a capture element on the first tool to grasp a smaller wire and pull the smaller wire through the aligned bores and then perform drilling with the step down drill over the smaller wire.
  • a device comprises an elongated support configured to be passed through a bore in a bone.
  • An elongated support may be a wire or a plastic tube that may be attached to a drill bit and having a diameter that allows the elongated support to pass through a bore formed by the drill bit.
  • Supported or attached at one end of the elongated support is a capture element having a diameter adapted to receive a smaller- diameter second elongated member, wire or suture.
  • the capture element is a coil spring which may be attached to the support element by crimping, ultrasonic welding, bonding or other method.
  • a coil spring has an internal diameter that is reduced when rotated to grip the wire having the smaller diameter and may be rotated in the opposite direction to release the wire.
  • Other mechanisms to capture the smaller-diameter member include, for example, a mesh which narrows as it is lengthened and pulled.
  • a button click system may also be adapted to attach to the first tool to capture a smaller diameter tool.
  • one end of elongated element 20 having a first diameter may be provided with grasping element 22.
  • grasping element is a coil spring, which may be rotated to reduce its inside diameter and grip a second tool and rotated in the opposite direction to increase the inside diameter of the spring and release the second tool.
  • Attachment of the grasping element to elongated element 20 may be made by any known method, such as by crimping, ultrasonic welding or bonding.
  • Grasping element 22 has an opening 28 configured to receive smaller diameter elongated element 24 (for example a 1.2 mm K-wire).
  • Arrows 26 show rotation of second elongated element 24 to grip and release the grip of grasping element 22 around smaller diameter element 24.
  • rotating the spring in one direction may loosen an opening area 28 where a pointed end of a K-wire maybe inserted.
  • Rotating the spring in an opposite direction may tighten spring 22 along its entire length around a portion of the smaller diameter element 24.
  • a grasping element may be made of a mesh that tightens as it lengthens, or other securing mechanisms may be employed that attach such as by clipping or pinning the smaller diameter element in grasping element 22.
  • FIG. 2 depicts elongated element 20 installed through an aligned bore in two bones using an aiming and guiding tool 30 and drill 32.
  • the drill may be detached, leaving a proximal grasping element 22 available to receive a smaller diameter elongated element 24.
  • smaller diameter wire 24 is shown pulled through aligned bores in the bones in direction of arrow 40 by force applied to wire 20 and via grasping element 22.
  • FIG. 6 depicts a step-down drill bit 62 having aperture 52 at one end thereof which may attach to a surgical suture.
  • An implant or anchor (not shown) may be attached to the suture and adapted to fit in a recess on the medial side of the first metatarsal.
  • a connector 54 may be provided adapted to receive the second tool in frictional engagement, for example using a conical and slightly resilient opening in a tubular connector 54.
  • wire 24 may be used to guide the suture and the attached implant or anchor into place.
  • capture element 28 may grasp implant or anchor 29 which may then be guided into place with tool 20.

Landscapes

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

Abstract

Un outil chirurgical et un dispositif et une méthode de passage de suture fournissent un élément de capture sur un outil allongé qui peut être inséré dans un alésage dans un os et qui peut être utilisé pour capturer un second outil et le tirer à travers l'alésage. Le second outil peut être fixé à une suture à l'aide d'un passeur de suture spécialement configuré pour manipuler une suture dans l'alésage. Le système et la méthode ont une large applicabilité chirurgicale, y compris dans la réparation de déformation.
PCT/IL2023/050941 2023-09-04 2023-09-04 Outil chirurgical et dispositif et méthode de passage de suture Pending WO2025052370A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IL2023/050941 WO2025052370A1 (fr) 2023-09-04 2023-09-04 Outil chirurgical et dispositif et méthode de passage de suture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IL2023/050941 WO2025052370A1 (fr) 2023-09-04 2023-09-04 Outil chirurgical et dispositif et méthode de passage de suture

Publications (1)

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WO2025052370A1 true WO2025052370A1 (fr) 2025-03-13

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Country Status (1)

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8652141B2 (en) * 2010-01-21 2014-02-18 Tarsus Medical Inc. Methods and devices for treating hallux valgus
US9345514B2 (en) * 2010-08-29 2016-05-24 Bonfix Ltd. Orthopedic implant for treatment of bone deformities
US9750551B1 (en) * 2014-02-26 2017-09-05 Donald Nichols Bunion repair method and tool assembly
US10143469B2 (en) * 2008-12-16 2018-12-04 Arthrex, Inc. Suture passing K-wire

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10143469B2 (en) * 2008-12-16 2018-12-04 Arthrex, Inc. Suture passing K-wire
US8652141B2 (en) * 2010-01-21 2014-02-18 Tarsus Medical Inc. Methods and devices for treating hallux valgus
US9345514B2 (en) * 2010-08-29 2016-05-24 Bonfix Ltd. Orthopedic implant for treatment of bone deformities
US9750551B1 (en) * 2014-02-26 2017-09-05 Donald Nichols Bunion repair method and tool assembly

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