WO2020183412A1 - Instrument chirurgical pour mesurer la tension entre deux tissus mous à suturer - Google Patents

Instrument chirurgical pour mesurer la tension entre deux tissus mous à suturer Download PDF

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Publication number
WO2020183412A1
WO2020183412A1 PCT/IB2020/052237 IB2020052237W WO2020183412A1 WO 2020183412 A1 WO2020183412 A1 WO 2020183412A1 IB 2020052237 W IB2020052237 W IB 2020052237W WO 2020183412 A1 WO2020183412 A1 WO 2020183412A1
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WO
WIPO (PCT)
Prior art keywords
surgical instrument
arms
holding
designed
arm
Prior art date
Application number
PCT/IB2020/052237
Other languages
English (en)
Inventor
Francesco Costa
Original Assignee
Istituto Ortopedico Rizzoli
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 Istituto Ortopedico Rizzoli filed Critical Istituto Ortopedico Rizzoli
Publication of WO2020183412A1 publication Critical patent/WO2020183412A1/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
    • A61B17/28—Surgical forceps
    • A61B17/2812—Surgical forceps with a single pivotal connection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension

Definitions

  • the present invention concerns a surgical instrument to measure the tension between two soft tissues to be sutured.
  • Surgical suture is a surgical procedure that allows the edges of a wound to be permanently held together, promoting the healing thereof.
  • surgical suture consists in the application of one or more stitches that keep the edges of the wound in contact; said stitches con consist of knotted suture threads applied by hand, metal staples applied by means of an automatic stapler, synthetic glues (cyanoacrylates) or biological glues (fibrin glue) applied by hand, or also particular sticking plasters (steri strips) applied by hand.
  • Surgical sutures can be subject to a postoperative complication called dehiscence represented by spontaneous re opening of the previously sutured wound; the dehiscence can be partial, and therefore affect one or some of the stitches, or complete, and therefore affect all the stitches.
  • dehiscence represented by spontaneous re opening of the previously sutured wound
  • a skin wound i.e. a superficial wound
  • possible dehiscence does not entail particularly serious risks for the patient's health, but can have significant aesthetic repercussions since wounds that heal by secondary intention (namely after re-opening) can be subject to hyperplastic scar formation process.
  • One of the main causes of dehiscence of a surgical suture is an excessive tension between the edges of the wound which are held together by the stitches (namely an excessive force necessary to hold the edges of the wound together) ; among other things, an excessive tension between the edges of the wound tends to induce local ischemia of the blood vessels, reducing the blood flow towards the wound and therefore delaying healing.
  • EP2011442A1 describes surgical forceps used to separate two adjacent bone segments and comprising both a position sensor to determine the distraction distance between the two bone segments and a force sensor to determine the distraction force that acts on the bone segments when the jaws are opened.
  • EP0998877A1 describes surgical forceps provided with two jaws and with a mechanism that fixes the jaws in order to grip the tissue while a measurement assembly determines the tension or the force applied on the tissue.
  • the patent application US2009188094A1 describes a system for manufacturing a pair of forceps provided with a loading cell configured to measure a compression force between the jaws of the forceps .
  • the patent application FR3056902A1 describes surgical forceps provided with two jaws hinged to one another, used to clamp a blood vessel; between the jaws a sleeve of elastic material can be arranged in different positions to modulate a clamping force that pushes the jaws towards a closed position and therefore adapt the clamping force to the characteristics of the blood vessel to be clamped.
  • the object of the present invention is to provide a surgical instrument able to measure the tension existing between the edges of a wound in a simple, rapid and precise manner, and which is, at the same time, easy and inexpensive to produce.
  • a surgical instrument is provided to measure the tension between two soft tissues to be sutured, according to what is established in the attached claims .
  • figure 1 is a perspective view of a surgical instrument, produced in accordance with the present invention, to measure the tension between two soft tissues to be sutured;
  • figure 2 is a plan view of the surgical instrument of figure 1;
  • figure 3 is a perspective view on an enlarged scale of a detail of the surgical instrument of figure 1 according to an alternative embodiment
  • figures 4 and 5 are two schematic plan views, on an enlarged scale, of a further detail of the surgical instrument of figure 1 according to two further embodiments.
  • the number 1 indicates overall a surgical instrument to measure the tension between two soft tissues to be sutured.
  • the surgical instrument 1 comprises two twin arms 2 which are hinged together to rotate relative to one another around a rotation axis 3 which is arranged in an intermediate position of said two arms 2.
  • the two arms 2 constitute a lever, the fulcrum of which is arranged at the hinge, i.e. at the rotation axis 3.
  • Each arm 2 has a holding end 4 provided with a holding member 5 adapted to grip a corresponding soft tissue and an operating end 6 which is opposite the holding end 4 and is designed to be pressed by a surgeon's fingers.
  • each holding member 5 consists of (at least) one (skin) hook: in the embodiment illustrated in figures 1 and 2 each holding member 5 consists of a single-pronged hook, whereas in the embodiment illustrated in figure 3 a holding member 5 consists of a single-pronged hook while the other holding member 5 consists of a double-pronged hook.
  • Joseph hooks (or alternatively Gillies hooks) could be used, and in particular a holding member 5 consists of a single-pronged Joseph hook, while the other holding member 5 consists of a double-pronged Joseph hook (namely with two prongs) .
  • each holding member 5 is oriented parallel to the arms 2, while in the embodiment illustrated in figure 3 each holding member 5 is oriented perpendicular to the arms 2.
  • the two hooks that form the two holding members 5 are arranged on slightly different planes but parallel to the plane on which the arms 2 develop; whereas in the embodiment illustrated in figure 3, the hooks that form the two holding members 5 are arranged perpendicular to the arms 2 and also have the function of avoiding the rotation of the surgical instrument 1, stabilizing it in the measurement phase.
  • the holding members 5 are shaped differently from what is illustrated in the attached figures.
  • each operating end 6 of the surgical instrument 1 is provided with an eyelet 7 for a surgeon's finger. According to a different embodiment not illustrated, the operating ends 6 of the surgical instrument 1 are without the eyelets 7.
  • the surgical instrument 1 comprises a rack 8 which is designed to lock the two arms 2 in a closed position and has: a first part 9 integral to an arm 2 close to the operating end 6, and a second part 9 integral to a second arm 2 close to the operating end 6. According to a different embodiment not illustrated, the surgical instrument 1 is without the rack 8.
  • the surgical instrument 1 comprises a measuring device 10 which is interposed between the two arms 2 and is designed to measure a return force with which the two holding ends 4 tend to be moved away from one another; in other words, the measuring device 10 is designed to measure the return force which tends to spread the two holding ends 4.
  • the measuring device 10 is designed to generate a resisting torque that counters a return torque due to the return force (which tends to spread the two holding ends 4) .
  • the resisting torque generated by the measuring device 10 is at least equal to (in an ideal situation exactly equal, but in practice slightly higher than) the return torque due to the return force (which tends to spread the two arms 2) so as to keep the two arms 2 still (in a closed position illustrated in figures 1 and 2) in the absence of external interventions on the arms 2.
  • the resisting torque generated by the measuring device 10 is at least equal to (in an ideal situation exactly equal, but in practice slightly higher than) the return torque due to the return force (which tends to spread the two holding ends 4) so as to keep the two holding ends 4 still (in the closed situation illustrated in figures 1 and 2) in the absence of external interventions on the arms 2.
  • the measuring device 10 comprises an elastic element 11 which is designed to push or pull the two arms 2 towards one another to move the two holding ends 4 close to one another (or to move the two arms 2 towards the closed position illustrated in figures 1 and 2 ) .
  • the elastic element 11 consists of a ring of elastic material (for example made of silicone or another elastomer) which is arranged around both the arms 2.
  • the elastic element 11 consists of a spring, for example omega-shaped, possibly designed to generate a variable elastic force by modifying a calibration of the spring (for example rotating a screw which modifies the pre-compression of the spring) .
  • the elastic element 11 is movable to vary its distance from the rotation axis 3 and therefore, the elastic force generated by the elastic element 11 being equal, to vary the resisting torque generated by the measuring device 10 due to the variation in length of the arm (or of the distance from the rotation axis 3 of the application point of the elastic force generated by the elastic element 11) .
  • the resisting torque generated by the measuring device 10 is increased and vice versa.
  • each arm 2 is provided with a series of notches 12, each of which is designed to house on the inside the elastic element 11.
  • each notch is a small cavity (or a small recess) obtained on the edge of a corresponding arm 2 (for example with two cuts converging, thus usually forming a V shape) ; the elastic element 11 can be inserted inside two corresponding notches 11 obtained in the two arms 2 to take on a stable and predefined position.
  • the notches 12 are not present.
  • one arm 2 is provided with a graduated scale 13 which allows the position of the elastic element 11 to be measured, or allows the distance of the elastic element 11 from the rotation axis 3 to be measured (and therefore allows the resisting torque generated by the measuring device 10 to be measured indirectly) .
  • the graduated scale 13 could also comprise a colouring to indicate the different zones: for example a green colour to indicate the zones corresponding to a reduced tension (and therefore perfectly compatible with a surgical suture without the addition of extra soft tissue) and a red colour to indicate the zones corresponding to a high tension (and therefore not compatible with a surgical suture without the addition of extra soft tissue) .
  • the surgical instrument 1 comprises an alignment indicator 14 that visually indicates when the holding members 5 are aligned with one another (or are in a position that determines an alignment between the soft tissues gripped by the holding members 5) .
  • the alignment indicator 14 comprises two reference elements 15 that can be seen by looking at the surgical instrument 1 from above and are arranged at the holding ends 4 of the two arms 2: the alignment of the two reference elements 15 (which can be clearly and easily seen by looking at the surgical instrument 1 from above) indicates that the holding members 5 are aligned with one another (or are in a position that determines an alignment between the soft tissues gripped by the holding members 5) .
  • each arm 2 has an appendage that projects in a cantilever fashion from the holding end 4 of the arm 2, protrudes towards the other arm 2 and supports the corresponding reference element 15; obviously the two appendages supporting the reference elements 15 are arranged at different heights so as to at least partially overlap over the alignment position.
  • a reference element 15 consists of a through opening (not necessarily of circular shape) through which the other reference element 15 can be seen consisting of a dot (or alternatively any other type of graphic symbol); in particular, figure 4a illustrates a condition of non-alignment of the two reference elements 15 while figure 4b illustrates a condition of alignment of the two reference elements 15.
  • both the reference elements 15 consist of a line (or alternatively any other type of graphic symbol); in particular, figure 5a illustrates a condition of non-alignment of the two reference elements 15, while figure 5b illustrates an condition of alignment of the two reference elements 15.
  • the two arms 2 can be (slightly) closed also beyond the alignment position indicated by the alignment indicator 14, namely the alignment position indicated by the alignment indicator 14 does not represent the maximum closure possible of the two arms 2, so that starting from the alignment position indicated by the alignment indicator 14 the two arms can be rotated in both directions.
  • the surgical instrument 1 described above can be used to measure the tension existing between two soft tissues to be sutured; in particular the soft tissues in which the surgical instrument 1 described above can be applied are the skin tissue, the tendon tissue and the muscular tissue.
  • the operation of the surgical instrument 1 is described below with reference to the suture of a skin wound presenting two edges to be brought together.
  • the surgeon uses the surgical instrument 1 to measure in an instrumental and therefore objective manner the tension of the wound, namely the force necessary to keep the two edges of the wound close together: according to the tension of the wound, the surgeon decides the most appropriate closure technique (for example with or without the use of grafts or flaps) and the type of mechanical aid to be used for the suture (for example the type and diameter of the suture thread, metal staples, glues%) .
  • the surgeon applies the two holding members 5 (namely the hooks) to the two edges of the wound, namely with the two holding members 5 (i.e. with the hooks) the surgeon grips the two edges of the wound to be sutured.
  • the surgeon closes the surgical instrument 1 until the rack clicks; this step allows for checking whether the elasticity of the soft tissues to be sutured allows the two edges of the wound to be brought close together (namely, it allows a closure rim of the wound to be attained) by applying the closure force that can be generated by the surgeon's fingers acting on the surgical instrument 1.
  • the elastic element 11 is in a neutral position (illustrated in figures 1 and 2) in the area of the rotation axis 3, namely the elastic element 11 does not generate any resisting torque since the arm is nil relative to the rotation axis 3.
  • the surgeon moves the elastic element 11 from the neutral position (illustrated in figures 1 and 2) at the rotation axis 3 to one of the pairs of notches 13, thus moving the elastic element 11 away from the rotation axis 3; once the elastic element 11 is arranged in one of the pairs of notches 13, the surgeon opens the rack 8 and checks whether the surgical instrument 1 tends to open (namely if the resisting torque generated by the elastic element 11 is lower than the return torque due to the tension of the wound which tends to re-open the edges of the wound previously brought together) , whether the surgical instrument 1 tends to close (namely if the resisting torque generated by the elastic element 11 is higher than the return torque due to the tension of the wound) , or whether the surgical instrument 1 is in mechanical equilibrium (namely whether the resisting torque generated by the elastic element 11 is substantially equal to the return torque due to the tension of the wound) .
  • the surgeon seeks the condition in which the surgical instrument 1 is in mechanical equilibrium or, more probably, seeks the two limits of the mechanical equilibrium (namely seeks the two adjacent pairs of notches 13 between which the mechanical equilibrium is found, namely a pair of notches 13 closer to the rotation axis 3 for which the surgical instrument 1 tends to open and an adjacent pair of notches 13 farther from the rotation axis 3 for which the surgical instrument 1 tends to close) .
  • the decoding table is obtained experimentally in a laboratory and associates with each pair of notches 13 a corresponding tension value of the wound (namely the force that tends to move away the two holding members 5 secured to the two edges of the wound) ; obviously, the decoding table is set according to the characteristics of the elastic element 11 which could also be chosen from several elastic elements 11 available: in order to measure higher wound tensions (typically in the case of larger wounds), thicker elastic elements 11 are used (which therefore, given the same deformation, generate higher elastic forces), whereas to measure lower wound tensions (typically in the case of smaller wounds) thinner elastic elements 11 are used (which therefore, given the same deformation, generate lower elastic forces) .
  • the surgeon does not determine an exact measurement of the wound tension, namely he does not determine a lower tension value and a higher tension value from which the exact measurement of the wound tension is found, but confines himself/herself to checking that the wound tension is lower (it does not matter how much lower) than an upper limit value which indicates the limit beyond which the surgical suture in the absence of a soft tissue graft is at (high) risk of dehiscence.
  • the shape of the arms 2 (in particular at the zones provided with the notches 12) can be modified (for example by moving the two notches 12 of each pair of notches 12 away or closer together) to try to make more linear (and therefore more intuitive) the experimental law which links the position of the elastic element 11 (at each pair of notches 12) to the force that tends to move the two holding members 5 away.
  • the operation of the surgical instrument 1 is somehow analogous to the operation of the traditional steelyard balance: in the steelyard the balancing weight is moved until reaching equilibrium and the position of the balancing weight at equilibrium is an index of the weight to be measured, whereas in the surgical instrument 1 the elastic element 11 (analogous to the balancing weight) is moved until reaching equilibrium and the position of the elastic element 11 at equilibrium is an index of the wound tension to be measured.
  • the surgical instrument 1 is derived from the Klemmer haemostatic forceps; according to a different embodiment not illustrated, the surgical instrument 1 is derived from the Pean haemostatic forceps or from another type of haemostatic forceps; according to a different embodiment not illustrated, the surgical instrument 1 could be derived from the Castroviejo compass (embodiment preferred when the elastic element 11 consists of an omega-shaped spring) or another type of surgical instrument .
  • the measuring device 10 comprises a movable elastic element 11.
  • the measuring device 10 comprises a loading cell (or another sensor designed to measure the force) which is designed to measure the resisting force (namely the force necessary to generate the resisting torque that opposes the return torque due to the tension of the wound which tends to re-open the edges of the wound previously brought together) ;
  • the loading cell could be integrated in the rack 8 (for example interposed between a part 9 of the rack 8 and the corresponding arm 2) to measure the force to which the rack 8 is subjected to keep the two arms 2 (or the two holding members 5) closed.
  • the surgical instrument 1 could be provided with a screen that displays the measurement carried out by the loading cell or the loading cell could communicate its reading in radiofrequency (for example using the Bluetooth® communication standard) to an external device (for example a mobile phone or a tablet computer) .
  • an external device for example a mobile phone or a tablet computer
  • the surgical instrument 1 described above has numerous advantages .
  • the surgical instrument 1 described above allows quantitative measurement of the tension created when two soft tissues to be sutured are brought together (for example two edges of a skin wound) ; consequently, the surgical instrument 1 described above provides the surgeon with instrumental and objective numerical data that guide him in choosing the best wound closure strategy, since the tension that is created by bringing together two soft tissues to be sutured is inversely correlated to the probability of rapid and prompt healing (or is directly correlated to the probability of complications) .
  • the surgical instrument 1 described above derives directly from a well-known and widely used surgical instrument, therefore its use is immediate and intuitive for any surgeon by referring to standard handling practices in surgical routine.
  • the surgical instrument 1 described above is completely compatible with intraoperative use, since it can be fully sterilized at high temperature.
  • the surgical instrument 1 described above has an extremely limited production cost which, among other things, also allows the surgical instrument 1 described above to be produced as a single-use (namely disposable) device; in fact, the surgical instrument 1 described above can be obtained from a simply produced standard surgical instrument 1 with minimum modifications and with the addition of a small number of commercially available parts.

Abstract

L'invention concerne un instrument chirurgical (1) pour mesurer la tension entre deux tissus mous à suturer. L'instrument chirurgical (1) comporte deux bras (2) qui sont articulés ensemble de manière à tourner ensemble autour d'un axe de rotation (3). Chaque bras (2) présente une extrémité de maintien (4) qui est pourvue d'un élément de maintien (5) conçu pour saisir un tissu mou correspondant, et une extrémité de commande (6) qui est située en regard de l'extrémité de maintien (4) et est conçue pour être pressée par les doigts d'un chirurgien. L'instrument chirurgical (1) présente un dispositif de mesure (10) qui est interposé entre les deux bras (2) et est conçu pour mesurer une force de rappel avec laquelle les deux extrémités de maintien (4) tendent à s'écarter l'une de l'autre.
PCT/IB2020/052237 2019-03-12 2020-03-12 Instrument chirurgical pour mesurer la tension entre deux tissus mous à suturer WO2020183412A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102019000003571 2019-03-12
IT102019000003571A IT201900003571A1 (it) 2019-03-12 2019-03-12 Strumento chirurgico per misurare la tensione tra due tessuti molli da suturare

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Publication Number Publication Date
WO2020183412A1 true WO2020183412A1 (fr) 2020-09-17

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PCT/IB2020/052237 WO2020183412A1 (fr) 2019-03-12 2020-03-12 Instrument chirurgical pour mesurer la tension entre deux tissus mous à suturer

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IT (1) IT201900003571A1 (fr)
WO (1) WO2020183412A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023084002A1 (fr) * 2021-11-11 2023-05-19 Freie Universität Berlin Instrument pour mesurer la tension d'une plaie

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0998877A1 (fr) * 1998-11-06 2000-05-10 JOHNSON & JOHNSON PROFESSIONAL Inc. Jauge de mesure de la tension tissulaire utilisée dans la chirurgie du genou
US20060122592A1 (en) * 1997-03-05 2006-06-08 Treat Michael R Ringed forceps
US20080132893A1 (en) * 2006-11-08 2008-06-05 Gyrus Group Plc Electrosurgical system
EP2011442A1 (fr) * 2007-07-02 2009-01-07 Berner Fachhochschule, Technik und Informatik (TI) Pinces pour séparer deux segments d'os adjacents
US20090188094A1 (en) * 2008-01-28 2009-07-30 Tyco Healthcare Group Lp System and Method for Manufacturing a Medical Instrument
US20110009899A1 (en) * 2009-05-13 2011-01-13 Joseph Ezhil Rajan Picha Muthu Tension transducing forceps
FR3056902A1 (fr) * 2016-10-02 2018-04-06 Xavier Renard Pince medicale

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060122592A1 (en) * 1997-03-05 2006-06-08 Treat Michael R Ringed forceps
EP0998877A1 (fr) * 1998-11-06 2000-05-10 JOHNSON & JOHNSON PROFESSIONAL Inc. Jauge de mesure de la tension tissulaire utilisée dans la chirurgie du genou
US20080132893A1 (en) * 2006-11-08 2008-06-05 Gyrus Group Plc Electrosurgical system
EP2011442A1 (fr) * 2007-07-02 2009-01-07 Berner Fachhochschule, Technik und Informatik (TI) Pinces pour séparer deux segments d'os adjacents
US20090188094A1 (en) * 2008-01-28 2009-07-30 Tyco Healthcare Group Lp System and Method for Manufacturing a Medical Instrument
US20110009899A1 (en) * 2009-05-13 2011-01-13 Joseph Ezhil Rajan Picha Muthu Tension transducing forceps
FR3056902A1 (fr) * 2016-10-02 2018-04-06 Xavier Renard Pince medicale

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023084002A1 (fr) * 2021-11-11 2023-05-19 Freie Universität Berlin Instrument pour mesurer la tension d'une plaie

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