WO2019092474A1 - Ensemble de guidage de suture - Google Patents

Ensemble de guidage de suture Download PDF

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Publication number
WO2019092474A1
WO2019092474A1 PCT/IB2017/056955 IB2017056955W WO2019092474A1 WO 2019092474 A1 WO2019092474 A1 WO 2019092474A1 IB 2017056955 W IB2017056955 W IB 2017056955W WO 2019092474 A1 WO2019092474 A1 WO 2019092474A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
suturing
guide assembly
suture
lumens
Prior art date
Application number
PCT/IB2017/056955
Other languages
English (en)
Inventor
Filippo Bastia
Original Assignee
Thd S.P.A.
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 Thd S.P.A. filed Critical Thd S.P.A.
Priority to PCT/IB2017/056955 priority Critical patent/WO2019092474A1/fr
Publication of WO2019092474A1 publication Critical patent/WO2019092474A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482Needle or suture guides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00349Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00637Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for sealing trocar wounds through abdominal wall
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/0057Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • A61B2017/00646Type of implements
    • A61B2017/00663Type of implements the implement being a suture
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0469Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
    • A61B2017/0472Multiple-needled, e.g. double-needled, instruments

Definitions

  • the present invention relates generally to suturing devices and methods, such as for the percutaneous closure of body lumens and tissues by means of sutures, and particularly to a suturing guide assembly that facilitates passing sutures and needles through tissues to create stitches.
  • suturing devices are known in the art that puncture the skin with needles and percutaneously deliver sutures to the site.
  • endoscopic procedures where access to the work site is not readily available, the surgeon must use auxiliary devices to be able to grasp the suture strands and pass them through desired tissue.
  • PCT/IB2016/054972 describes a multiple-needle suturing assembly, which can be used to close a tissue puncture site with suture thread, such as a puncture site through the wall of a body lumen, or a percutaneous vascular puncture site at the distal end of a tissue tract.
  • the assembly can achieve closure wholly within the tissue tract leading to a puncture site and can be manipulated entirely from the portion of the device lying outside of the tissue tract.
  • the assembly can be used in various medical procedures, such as but not limited to, laparoscopic procedures, endoscopic procedures, arthroscopic procedures, and the like.
  • the present invention seeks to provide a suturing guide assembly, as described in more detail further below.
  • the guide of the present invention may be used in endoscopic or laparoscopic procedures, such as but not limited to, laparoscopic port closure, intra-abdominal suturing, closure of peritoneum or intra-abdominal knot-tying, hernia mesh fixations and many other surgical procedures.
  • the guide may be used to form any complex suture pattern, by passing needles of a multiple-needle suturing tool through holes of the guide, puncturing the tissue with the needles, passing the suture up through the tissue and guide, repositioning the suturing tool through other holes of the guide and repeating the steps of puncturing and passing the sutures up through the tissue and guide.
  • the guide of the invention comprises a stem having groups of needle lumens for inserting therein needles of a multiple-needle suturing tool, each of the groups comprising at least two needle lumens, and each of said needle lumens comprising an entry opening, a passageway and an exit opening in which each of said passageways connects one of the entry openings with one of the exit openings.
  • the guide also comprises a platform positioned on top of the stem that comprises the entry openings and wherein the exit opening of at least a first lumen of each group is on a side of the stem.
  • the suturing guide assembly may include needle lumens of at least one of the groups that are parallel with respect to each other.
  • the suturing guide assembly may include entry openings of the groups of needle lumens that are collinear.
  • the suturing guide assembly may include entry openings of the groups of needle lumens that are not collinear, whereby an axis extending between the entry openings of one group of the needle lumens and an axis extending between the entry openings of another group of the needle lumens are not collinear.
  • the suturing guide assembly may include groups that share at least a second needle lumen.
  • the suturing guide assembly may include a stem that has a channel connecting a second needle lumen of one group with a second needle lumen of another group from the entry opening to the exit opening.
  • the suturing guide assembly may include entry openings of the first needle lumens that are disposed on opposite sides with respect to the channel.
  • the suturing guide assembly may include the exit opening of at least a second needle lumens of each group that is on a base surface of the stem opposite to the platform.
  • the suturing guide assembly may include the channel that connects the second needle lumens.
  • the suturing guide assembly may include each group that consists of two needle lumens.
  • the suturing guide assembly may include an internal stopper arranged to abut against an internal portion of a suturing site.
  • the suturing guide assembly may include an external stopper arranged to abut against an external portion of a suturing site.
  • the suturing guide assembly may include a handle extending from the platform.
  • the suturing guide assembly may include the platform formed with teeth.
  • the suturing guide assembly may include an adjustable holder for receiving a portion of the suturing guide assembly.
  • FIGs. 1 and 2 are simplified pictorial illustrations of a suturing guide assembly, constructed and operative in accordance with a non-limiting embodiment of the present invention, with an internal stopper before and after deployment, respectively;
  • FIG. 2A is a simplified illustration of the underside of the suturing guide assembly, showing lower structure of the assembly that prevents suturing the guide assembly to the patient's tissue;
  • Figs. 3 and 4 are simplified pictorial illustrations of the suturing guide assembly with a holder that spaces the guide assembly from the suture site, respectively without and with a suturing tool placed in the guide;
  • Figs. 5A and 5B are simplified illustrations of a multiple-needle suturing tool described in PCT Patent Application PCT/IB2016/054972, and which may be used with the suturing guide assembly of the present invention.
  • Figs. 6-23 are simplified pictorial illustrations of using the suturing guide assembly with a suturing tool to make stitches with a suture and close a port.
  • FIG. 1 and 2 illustrate a suturing guide assembly 10, constructed and operative in accordance with a non- limiting embodiment of the present invention.
  • the suturing guide assembly 10 includes a stem 22 having groups "A" and “B” of needle lumens 12 for inserting therein multiple needles of a multiple-needle suturing tool, as described further below with reference to Figs. 5A-5B.
  • Each groups "A” and “B” comprises at least two needle lumens 12.
  • Each of the needle lumens 12 comprises an entry opening 14, a passageway 16 and an exit opening 18.
  • the suturing guide assembly 10 comprises a platform 20 positioned on top of the stem 22 where the entry openings 14 are formed.
  • Each of the passageways 16 connect one of the entry openings 14 with one of the exit openings 18.
  • the passageways 16 extends from a corresponding entry opening 14 through platform 20 and stem 22 and terminates in exit opening 18.
  • the exit opening 18 of at least a first lumen of each group is on a side of the stem 22.
  • the first lumen of each group has a passageway 16 that connects the entry opening 14 of platform 20 and terminates in the exit opening 18 formed on the side of the stem 22.
  • One group (designated group "A") of needle lumens 12 is used for the multiple needles of the suturing tool.
  • the group is a pair of needle lumens.
  • the needle lumens of at least one particular group are parallel with respect to each other for multiple-needle suturing tools in which all the needles are parallel with respect to each other (which is the case for a dual-needle suturing tool as in Figs. 5A-5B), and are not parallel for non-parallel multiple-needle suturing tools.
  • the suturing guide assembly 10 includes at least two groups of needle lumens, such as group "A" and group "B", for performing any desired stitch, such as but not limited to, cross, interweaved, complex stitches, etc.
  • group "A" and group "B” for performing any desired stitch, such as but not limited to, cross, interweaved, complex stitches, etc.
  • the entry openings 14 of the groups of needle lumens may be collinear, as in the case of group A and group C (indicated in broken lines in Fig. 2).
  • the entry openings 14 of the groups of needle lumens may be non- collinear.
  • an axis extending between the entry openings 14 of one group "B" of the needle lumens 12 and an axis extending between the entry openings 14 of another group "A" of needle lumens are not collinear.
  • Non-collinear needle lumen groups are particularly useful in making cross stitches and other complex stitches.
  • the groups “A” and “B” share at least a second needle lumen 12 and the stem 22 has a channel 24 that connects a second needle lumen 12 of one group “A” with a second needle lumen 12 of another group “B” from the entry opening 14 to the exit opening 18.
  • the entry openings 14 of the first needle lumens 12 are disposed on opposite sides with respect to the channel 24.
  • Fig. 2A illustrates the underside of suturing guide assembly 10.
  • the assembly is formed with a base surface that prevents suturing the guide assembly to the patient's tissue.
  • the exit opening of at least a second needle lumen 12 of each group "A" is on the base surface of the stem 22 opposite to said platform 20.
  • the lower structure may include one or more openings 33 (near the internal stopper 26) and a cutout 35 formed inside stem 22 which extends from opening or openings 33.
  • the presence of the cutout and openings prevents the suture from accidentally tying the assembly to the tissue.
  • the suturing guide assembly 10 may include an internal stopper 26 arranged to abut against an internal portion of the suturing site, such as the internal wall of tissue (e.g., the abdominal wall, not shown) at the suturing site.
  • guide assembly 10 may include an external stopper 28 that can abut against an external portion of the suturing site (e.g., the skin).
  • the internal and external stoppers 26 and 28 have several advantages.
  • the stoppers may be mechanical (e.g., arms, flanges, wings, etc.) as shown in the figures, or they may be inflatable (e.g., balloon) as shown in broken lines in Fig. 2.
  • the mechanical stopper 26 may be deployed from a retracted position (Fig. 1 ) to a deployed position (Fig. 2) by an actuator, such as a spring-activated trigger, push-pull mechanism or any other suitable means.
  • the balloon may be inflated or deflated by a fluid source connected thereto.
  • a handle 30 may extend from platform 20, such as a pair of opposing finger grips.
  • Platform 20 may be formed with teeth 32, such as internal gear teeth, for incrementally rotating a device about the vertical axis 34 (Fig. 1 ) of guide assembly 10.
  • the inner part of platform 20 may be rotatable about axis 34, in which the finger grips of handle 30 ratchet with teeth 32.
  • the suturing tool or other surgical tool may engage teeth 32.
  • holder 36 may include a plurality of shelves 38. A portion of suturing guide assembly 10, such as the external stoppers 28, may be received in one of the shelves 38. In this manner, the user can select a desired penetration distance of stem 22 and exit openings 18 into the suture site.
  • a balloon may be used instead of holder 36 to achieve this effect, either added to guide assembly 10 or an integral part thereof.
  • the holder may be adjustable in another ways, such as a single shelf which is movable to a plurality of positions.
  • FIGs. 5A and 5B illustrate a multiple-needle suturing tool 40 described in PCT Patent Application PCT/IB2016/054972, and which may be used with the suturing guide assembly 10 of the present invention.
  • Suturing tool 40 includes a suture passing member 42, which is formed with a lumen 44.
  • a suture holding element 46 and a first needle 48 are disposed in lumen 44.
  • First needle 48 is formed with a sharp distal end 58 for puncturing tissue.
  • both first needle 48 and suture holding element 46 include suture receiving portions 60 and 62, respectively.
  • a second needle 64 includes a suture receiving portion 66 and a sharp distal end 68 for puncturing tissue.
  • a spacer element 70 may be provided for maintaining a space between suture passing member 42 and second needle 64.
  • Suturing tool 40 has a handle 63 and an actuator 65 for actuating the needles.
  • a suture 82 (Fig. 5B) is initially disposed in the suture receiving portions 60 and 62 of first needle 48 and suture holding element 46.
  • first and second needles 48 and 64 are first pushed through a tissue wall at a suture site 83 (indicated by broken lines in Fig. 5B).
  • a space is formed between first needle 48 and suture holding element 46, and second needle 64 is positioned opposite the space 86.
  • first needle 48 and/or the distal end of suture holding element 46 bend to a curved position and pass over the distal end of second needle 64.
  • suture receiving portion 60 and/or 62 of first needle 48 and/or suture holding element 46 moves adjacent the suture receiving portion 66 of second needle 64.
  • the movement of first needle 48 and suture holding element 46 from the deployed position back to the retracted position causes suture 82 to move against second needle 64 and become disengaged from the suture receiving portions 60 and 62 and to pass into the suture receiving portion 66 of second needle 64.
  • first needle 48 and suture holding element 46 are fully retracted and the tool is pulled back to the near side of the suture site 83. Afterwards, the suture 82 may be secured to form a stitch.
  • FIGs. 6-23 illustrate using the suturing guide assembly 10 with suturing tool 40 to make stitches with suture 82, in accordance with a non-limiting embodiment of the present invention.
  • suture 82 is held in suture holding element 46 and first needle 48 of suturing tool 40, whose needles 48 and 64 have not yet been inserted in the needle lumens 12 of suturing guide assembly 10.
  • Figs. 7 and 8 (Fig. 8 is a close-up of Fig. 7), the needles 48 and 64 have been inserted in the needle lumens 12 of suturing guide assembly 10.
  • Fig. 9 the needles 48 and 64 have passed through stem 22.
  • the needles and part of the suture 82 are now on the inner side of tissue (not shown) to be sutured, while the suturing guide assembly is on the outer side of the suture site (in particular the platform 20 is on the outer side of the suture site).
  • Figs. 1 1 and 12 (Fig. 12 is a close-up of Fig. 1 1 ), the distal ends of first needle 48 and suture holding element 46 bend to a curved position and pass over the distal end of second needle 64. The suture 82 is held in first needle 48 and suture holding element 46.
  • first needle 48 and suture holding element 46 are retracted from the deployed position back to the retracted position.
  • the movement of first needle 48 and suture holding element 46 from the deployed position back to the retracted position causes suture 82 to move against second needle 64 and become disengaged from the suture receiving portions of first needle 48 and suture holding element 46 and to pass into the suture receiving portion of second needle 64.
  • Figs. 14 and 15 (Fig. 15 is a close-up of Fig. 14), after the suture 82 has been received in second needle 64, the needles and suture holding element 46 are fully retracted and the suturing tool is pulled back to the near side of the suture site and out of the needle lumens 12 of the guide assembly. In this way, the suture 82 is in the first and second lumen 12 of the group ("A" or "B" depending on which is choose to start the suturing operation).
  • the suture 82 is moved from the entry opening 14 of one of the first needle lumen 12 of one group (for example group "A") via channel 24 to the entry opening 14 of another first needle lumen 12 of another group (for example group "B").
  • Figs. 17 and 18 (Fig. 18 is a close-up of Fig. 1 7), the suturing tool has been rotated and now the suture holding element 46 is on the left (in the sense of the drawing) and grasps the suture 82. The suturing tool is then re-inserted into the guide assembly, as seen in Fig. 19.
  • the needles 48 and 64 have passed through stem 22.
  • the needles are now on the inner side of tissue (not shown) to be sutured, while the suturing guide assembly is on the outer side of the suture site.
  • Figs. 20 and 21 (Fig. 21 is a close-up of Fig. 20), the distal ends of first needle 48 and suture holding element 46 bend to a curved position and pass over the distal end of second needle 64. The suture 82 is held in first needle 48 and suture holding element 46.
  • first needle 48 and suture holding element 46 are retracted from the deployed position back to the retracted position. Once again, the movement of first needle 48 and suture holding element 46 from the deployed position back to the retracted position causes suture 82 to move against second needle 64 and become disengaged from the suture receiving portions of first needle 48 and suture holding element 46 and to pass into the suture receiving portion of second needle 64.
  • Fig. 23 after the suture 82 has been received in second needle 64, the needles and suture holding element 46 are fully retracted and the suturing tool is pulled back to the near side of the suture site and out of the needle lumens 12 of the guide assembly.
  • the suture 82 exits different entry openings of the needle lumens 12.
  • the two ends of the suture may now be pulled, which tightens the tissues at the port site, and the stitch may be tied to close the port.
  • more elaborate stitches may also be made with the guide assembly, such as cross-stitches, which may be done by using two perpendicular sets of needle lumens or by turning the assembly 90° before tightening the first pass of the suture and inserting the suture once again
  • the suturing guide assembly 10 is advantageously useful to access to the work site during endoscopic procedures (in particular, in laparoscopic procedures).
  • the suturing guide assembly 10 can be used by a surgeon to grasp the suture strands and pass them through desired tissue.

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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)
  • Cardiology (AREA)
  • Surgical Instruments (AREA)

Abstract

L'invention concerne un ensemble de guidage de suture (10) comprenant une tige (22) ayant des groupes (A, B) de lumières d'aiguille (12) pour y insérer des aiguilles (48, 64) d'un outil de suture (40) à aiguilles multiples, chacun des groupes comprenant au moins deux lumières d'aiguille (12), et chacune des lumières d'aiguille (12) comprenant une ouverture d'entrée (14), un passage (16) et une ouverture de sortie (18) dans laquelle chacun desdits passages (16) relie l'une des ouvertures d'entrée (14) à l'une des ouvertures de sortie (18). L'ensemble de guidage de suture (10) comprend une plateforme (20) positionnée sur le dessus de la tige (22), les ouvertures d'entrée (14) étant formées sur la plateforme (20). L'ouverture de sortie (18) d'au moins une première lumière de chaque groupe se trouve d'un côté de ladite tige (22).
PCT/IB2017/056955 2017-11-07 2017-11-07 Ensemble de guidage de suture WO2019092474A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2017/056955 WO2019092474A1 (fr) 2017-11-07 2017-11-07 Ensemble de guidage de suture

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2017/056955 WO2019092474A1 (fr) 2017-11-07 2017-11-07 Ensemble de guidage de suture

Publications (1)

Publication Number Publication Date
WO2019092474A1 true WO2019092474A1 (fr) 2019-05-16

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2017/056955 WO2019092474A1 (fr) 2017-11-07 2017-11-07 Ensemble de guidage de suture

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WO (1) WO2019092474A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006111955A2 (fr) * 2005-04-19 2006-10-26 Vladimir Shpaichler Dispositif de suture de plaies et d'hemostase dans la paroi thoracique ou abdominale, principalement au cours d'operations endoscopiques
WO2012106555A2 (fr) * 2011-02-02 2012-08-09 Filiciotto Sam Systèmes chirurgicaux et procédés associés
US20120265223A1 (en) * 2005-04-19 2012-10-18 Vladimir Shpaichler Device for Wound Suturing and Hemostasis in the Thoracic and The Abdominal Wall Mainly in Endoscopic Operations
CA2928615A1 (fr) * 2014-10-01 2017-11-03 Brainchild Surgical Devices Llc Dispositif de suture et methode

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006111955A2 (fr) * 2005-04-19 2006-10-26 Vladimir Shpaichler Dispositif de suture de plaies et d'hemostase dans la paroi thoracique ou abdominale, principalement au cours d'operations endoscopiques
US20120265223A1 (en) * 2005-04-19 2012-10-18 Vladimir Shpaichler Device for Wound Suturing and Hemostasis in the Thoracic and The Abdominal Wall Mainly in Endoscopic Operations
WO2012106555A2 (fr) * 2011-02-02 2012-08-09 Filiciotto Sam Systèmes chirurgicaux et procédés associés
CA2928615A1 (fr) * 2014-10-01 2017-11-03 Brainchild Surgical Devices Llc Dispositif de suture et methode

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