WO2017044120A1 - Dispositif de fermeture chirurgicale rapide - Google Patents

Dispositif de fermeture chirurgicale rapide Download PDF

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Publication number
WO2017044120A1
WO2017044120A1 PCT/US2015/049671 US2015049671W WO2017044120A1 WO 2017044120 A1 WO2017044120 A1 WO 2017044120A1 US 2015049671 W US2015049671 W US 2015049671W WO 2017044120 A1 WO2017044120 A1 WO 2017044120A1
Authority
WO
WIPO (PCT)
Prior art keywords
closure device
incision
injection
drug delivery
skin
Prior art date
Application number
PCT/US2015/049671
Other languages
English (en)
Inventor
Brian Beckey
Amir Belson
James J. Leary
Original Assignee
Zipline Medical, Inc.
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 Zipline Medical, Inc. filed Critical Zipline Medical, Inc.
Priority to PCT/US2015/049671 priority Critical patent/WO2017044120A1/fr
Publication of WO2017044120A1 publication Critical patent/WO2017044120A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491—Surgical glue applicators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00792—Plastic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B2017/081—Tissue approximator
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B17/085—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer
    • A61B2017/086—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound with adhesive layer having flexible threads, filaments, laces or wires, e.g. parallel threads, extending laterally from a strip, e.g. for tying to opposing threads extending from a similar strip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/08—Wound clamps or clips, i.e. not or only partly penetrating the tissue ; Devices for bringing together the edges of a wound
    • A61B2017/088—Sliding fasteners

Definitions

  • a drug injection manifold 150 with sharpened drug injection needles 154 can be inserted into the cavity 1 10 between the first and second rails 1 12, 1 14 before adhering the surgical closure device 100.
  • the drug injection needles 154 will pierce the skin as the surgical closure device 100 is adhered to the skin.
  • the drug injection manifold 150 can be used to anesthetize the skin and surrounding tissue prior to making the incision.
  • the incision can be made just adjacent to the drug injection needles 154.
  • the drug injection manifold 150 can be also be used after closing the incision to control pain in the incision and surrounding tissue during healing.
  • the drug injection needles 154 and/or the catheters 153 may extend into the tissue such as 8 mm to 1 cm into the tissue.
  • the drug injection needles 154 and/or the catheters 153 may extend subdermally to deliver a drug, such as a painkiller, to the tissue near a surgical incision.
  • the drug injection needles 154 and/or the catheters 153 may extend into the tissue at the same depth or at a variety of different depths.
  • the needles 154 and/or the catheters 153 may have a range of lengths so that the drug(s) that will be delivered via the catheters 153 can reach different layers of the skin. In some
  • the drug injection manifolds 149, 150, 151 may be configured as described above in connection with FIGS. 4 and 5.
  • the drug injection manifolds 149, 150, 151 may be aligned with a mid or centerline of an individual adhesion patch as in FIGS. 1 lOA-1 10F, 1 1 lA-1 11H.
  • one or more of the drug injection manifolds 149, 150, 151 may be configured with more flexible plastic drug injection catheters 153 arranged coaxially around drug injection or tissue piercing needles 154.
  • These drug injection or tissue piercing needles 154 may have a solid core or a hollow core.
  • the drug injection or tissue piercing needles 154 may have a hollow core to remove tissue when larger puncture sites for the plastic drug injection catheters 154 are desired.
  • the sharpened drug injection or tissue piercing, needles 154 may be withdrawn, leaving only the plastic drug injection catheters 153 behind.
  • solid, sharpened stylets may be used in place of the drug injection needles 154 in this configuration of the device.
  • the drug injection or tissue piercing needles 154 may thus serve as a guide for the placement of the plurality of plastic drug injection catheters 153 into the tissue (FIGS. 1 lOA-110F, 11 1A- 11 1H).
  • the second and third drug injection manifolds 149, 151 may be attached to the first and second adhesion patches 102, 104 so that the drug injection needles 154 (and the optional catheters 153) are inserted into the patient's tissue at the same time as the surgical closure device 100 is applied to the skin.
  • This configuration allows the area to be anesthetized through the second and third drug injection manifolds 149, 151 prior to making the incision.
  • the first drug injection manifold 150 may be omitted in this configuration.
  • the device 100 may be configured to generate an electric field(s) adjacent the incision to facilitate tissue healing. As shown in FIGS.
  • the injection catheters 153 may be axially aligned to form a comb-like configuration with each of the first and second main tubes 152a, 152b. As described above and herein, an array or plurality of needles 154 in a comb-like configuration may pierce the first and second main tubes 152a, 152b so that the needles 154 are coaxial with and extend through the lumens of the catheters 153. As described above and herein, the catheters 153 and/or other components of the surgical closure device 100a and injection manifold 150 may be coated with various drug(s) or materials such as antiseptic or anticoagulation agents. The inner surfaces of the catheters 153 may be coated with an antiseptic agent or an anticoagulation agent such as heparin, for example.
  • the injection manifold 150 may be advanced through the surgical closure device 100a.
  • the surgical closure device 100a may be first appropriately aligned with and adhered to the skin of a subject before the injection manifold 150 is placed over the surgical closure device 100a and pressed down, advancing the needles 154 and the catheters 153 through the skin.
  • the needles 154 may have a hollow core to remove tissue so as to generate larger punctures or may have a solid core.
  • the needles 154 punctures the tissue to facilitate the advancement of the catheters 153 into the tissue as the catheters 153 may otherwise be too compliant to be advanced into the tissue on their own.
  • FIG. 9 is a perspective drawing of a one-piece surgical closure device 100 with dual binders 106, 107 and appendages 170, 171.
  • FIG. 10 is a perspective view from the underside of the surgical closure device 100 of FIG. 9 showing construction details of the ends of the device 100.
  • This embodiment takes the previous concept one step further by adding a second appendage 171 and a second rail extension 173 on the opposite end of the closure device 100 from the appendage 170 and the rail extension 172 shown in FIGS. 7 and 8.
  • the appendages 170, 171 may include gripping tabs 176 and may have perforations 174 to make them removable as shown in FIGS. 7 and 8.
  • the first adhesion patch 102 and the second adhesion patch 104 are joined together by the end portions 178 of the appendages 170, 171.
  • the central parting line 124 of the device stops short of the end portions 178.
  • the central parting line 124 can be easily opened with surgical retractors, as shown by dashed lines 125, while keeping the one-piece device intact.
  • the binders 106, 107 can be parked on the rail extensions 172, 173 of the appendages 170, 171 during the surgical procedure. Because the binders 106, 107 are already aligned with and mounted on the first rail 1 12 and the second rail 1 14, it is easier to close the surgical closure device 100 after completion of the surgical procedure.
  • the cutter blades 332 are arranged so that they will cut the skin in a mesh pattern around the incision so that it can expand to make up the skin deficit created by removing a portion of the skin and underlying tissue. The small cuts will heel more quickly and with less scarring than the large incision where a lesion has been removed.
  • the skin cutting device 330 is removed after the skin has been perforated.
  • FIG. 87 illustrates an optional incision template 590 that can be used with the surgical closure device 490 in FIGS. 81-86.
  • the incision template 590 fits over the surgical closure device 490 when it is in a closed or partially-open position.
  • a central slot 592 has downwardly-extending lips 594 that extend into the opening 493 to protect the first sleeve 496 and the second sleeve 498 from being cut when the incision is being made.
  • the incision template 590 is preferably made of a rigid or semi-rigid polymer or metal that will resist being cut by a scalpel or other cutting device.
  • the incision template 590 is also adaptable for use with other embodiments of the surgical closure device described herein.
  • FIG. 89 illustrates a variation of the fork-shaped binder 500 that serves a similar function to the partially-open section 506 of the fork-shaped binder 500 shown in FIG. 84.
  • This variation of the fork-shaped binder 500 has a gap 505 between the tines 502, 504 to apply a spreading force to the opening 493 in the surgical closure device 490 and to the skin underneath to facilitate making an incision through the opening 493.
  • the fork-shaped binder 500 may be shortened so that it only includes the closed section 506 and optionally, a tapered end section 507.
  • the drug injection manifold 520 may also include a contact adhesive and/or locking pins or other locking features to seal and secure the surgical closure device 490 in the closed position. The drug injection manifold 520 may be inserted while the wound is still open or after the surgical closure device 490 has been closed, as shown in FIG. 96.
  • first sleeve 626 and the second sleeve 628 are segmented to allow the first adhesion patch 622 and the second adhesion patch 624 to be very flexible so that it can be placed along a curving or irregular incision line on the patient.
  • the first adhesion patch 622 and the second adhesion patch 624 may be long enough to surround the entire circumference of the patient or multiple shorter adhesion patches 622, 624 may be adhered to the skin end-to-end along the intended incision lines.

Abstract

La présente invention concerne un dispositif de fermeture chirurgicale ou de fermeture de plaie qui fait intervenir une fermeture à glissière pour fermer rapidement une incision chirurgicale ou une plaie par un accolement précis des côtés de l'incision. Les dispositifs de fermeture chirurgicale sont configurés pour des incisions linéaires, des incisions de forme spéciale, telles que celles utilisées pour la biopsie en coin ou la biopsie-exérèse, et des incisions longues, telles que celles utilisées pour la laparotomie ou l'élimination chirurgicale de peau superflue. Le dispositif de fermeture chirurgicale peut être appliqué sur la peau du patient avant de pratiquer une incision, et est ensuite utilisé pour fermer l'incision.
PCT/US2015/049671 2015-09-11 2015-09-11 Dispositif de fermeture chirurgicale rapide WO2017044120A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2015/049671 WO2017044120A1 (fr) 2015-09-11 2015-09-11 Dispositif de fermeture chirurgicale rapide

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2015/049671 WO2017044120A1 (fr) 2015-09-11 2015-09-11 Dispositif de fermeture chirurgicale rapide

Publications (1)

Publication Number Publication Date
WO2017044120A1 true WO2017044120A1 (fr) 2017-03-16

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2015/049671 WO2017044120A1 (fr) 2015-09-11 2015-09-11 Dispositif de fermeture chirurgicale rapide

Country Status (1)

Country Link
WO (1) WO2017044120A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10010710B2 (en) 2009-09-17 2018-07-03 Zipline Medical, Inc. Rapid closing surgical closure device
US10123800B2 (en) 2011-11-01 2018-11-13 Zipline Medical, Inc. Surgical incision and closure apparatus with integrated force distribution
US10123801B2 (en) 2011-11-01 2018-11-13 Zipline Medical, Inc. Means to prevent wound dressings from adhering to closure device
US10456136B2 (en) 2011-11-01 2019-10-29 Zipline Medical, Inc. Surgical incision and closure apparatus
US10888269B2 (en) 2014-01-05 2021-01-12 Zipline Medical, Inc. Instrumented wound closure device
US10918332B2 (en) 2016-10-31 2021-02-16 Zipline Medical, Inc. Systems and methods for monitoring physical therapy of the knee and other joints
US11051988B2 (en) 2010-06-14 2021-07-06 Zipline Medical, Inc. Methods and apparatus for inhibiting scar formation
EP4285875A1 (fr) * 2022-06-02 2023-12-06 Caranx Medical SAS Dispositif et procédé de partitionnement d'un tissu interne
US11849415B2 (en) 2018-07-27 2023-12-19 Mclaren Applied Technologies Limited Time synchronisation
US11898874B2 (en) 2019-10-18 2024-02-13 Mclaren Applied Technologies Limited Gyroscope bias estimation

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1984001805A1 (fr) * 1982-11-01 1984-05-10 Allan M Parham Assemblage de vannes medicales a robinet d'arret
US5306236A (en) * 1993-02-18 1994-04-26 Vickers Plc Needle electrode for use with hypodermic syringe attachment
US5725507A (en) * 1994-03-04 1998-03-10 Mentor Corporation Self-sealing injection sites and plugs
US20030120198A1 (en) * 2001-11-13 2003-06-26 Becton, Dickinson And Compan, A New Jersey Corporation Spray dry process for applying anticoagulant on a syringe barrel
US20080103550A1 (en) * 2006-10-30 2008-05-01 Stuart Wenzel Multiple electrode wound healing patch
WO2011043786A1 (fr) * 2009-09-17 2011-04-14 Zipline Medical, Inc. Dispositif de fermeture chirurgicale rapide
US20130281981A1 (en) * 2010-09-21 2013-10-24 Israel SHAMIR LEBOVITZ Multi-directional needle

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1984001805A1 (fr) * 1982-11-01 1984-05-10 Allan M Parham Assemblage de vannes medicales a robinet d'arret
US5306236A (en) * 1993-02-18 1994-04-26 Vickers Plc Needle electrode for use with hypodermic syringe attachment
US5725507A (en) * 1994-03-04 1998-03-10 Mentor Corporation Self-sealing injection sites and plugs
US20030120198A1 (en) * 2001-11-13 2003-06-26 Becton, Dickinson And Compan, A New Jersey Corporation Spray dry process for applying anticoagulant on a syringe barrel
US20080103550A1 (en) * 2006-10-30 2008-05-01 Stuart Wenzel Multiple electrode wound healing patch
WO2011043786A1 (fr) * 2009-09-17 2011-04-14 Zipline Medical, Inc. Dispositif de fermeture chirurgicale rapide
US20130281981A1 (en) * 2010-09-21 2013-10-24 Israel SHAMIR LEBOVITZ Multi-directional needle

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10159825B2 (en) 2009-09-17 2018-12-25 Zipline Medical, Inc. Rapid closing surgical closure device
US10010710B2 (en) 2009-09-17 2018-07-03 Zipline Medical, Inc. Rapid closing surgical closure device
US11051988B2 (en) 2010-06-14 2021-07-06 Zipline Medical, Inc. Methods and apparatus for inhibiting scar formation
US11439395B2 (en) 2011-11-01 2022-09-13 Zipline Medical, Inc. Surgical incision and closure apparatus
US10123800B2 (en) 2011-11-01 2018-11-13 Zipline Medical, Inc. Surgical incision and closure apparatus with integrated force distribution
US10123801B2 (en) 2011-11-01 2018-11-13 Zipline Medical, Inc. Means to prevent wound dressings from adhering to closure device
US10456136B2 (en) 2011-11-01 2019-10-29 Zipline Medical, Inc. Surgical incision and closure apparatus
US10888269B2 (en) 2014-01-05 2021-01-12 Zipline Medical, Inc. Instrumented wound closure device
US11844625B2 (en) 2014-01-05 2023-12-19 Zipline Medical, Inc. Instrumented wound closure device
US11033270B2 (en) 2015-08-07 2021-06-15 Zipline Medical, Inc. Means to prevent wound dressings from adhering to closure device
US10918332B2 (en) 2016-10-31 2021-02-16 Zipline Medical, Inc. Systems and methods for monitoring physical therapy of the knee and other joints
US11337649B2 (en) 2016-10-31 2022-05-24 Zipline Medical, Inc. Systems and methods for monitoring physical therapy of the knee and other joints
US11849415B2 (en) 2018-07-27 2023-12-19 Mclaren Applied Technologies Limited Time synchronisation
US11898874B2 (en) 2019-10-18 2024-02-13 Mclaren Applied Technologies Limited Gyroscope bias estimation
EP4285875A1 (fr) * 2022-06-02 2023-12-06 Caranx Medical SAS Dispositif et procédé de partitionnement d'un tissu interne

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