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WO2010041101A1 - Dispositif hémostatique pour procédures chirurgicales et d'urgence - Google Patents

Dispositif hémostatique pour procédures chirurgicales et d'urgence Download PDF

Info

Publication number
WO2010041101A1
WO2010041101A1 PCT/IB2008/054178 IB2008054178W WO2010041101A1 WO 2010041101 A1 WO2010041101 A1 WO 2010041101A1 IB 2008054178 W IB2008054178 W IB 2008054178W WO 2010041101 A1 WO2010041101 A1 WO 2010041101A1
Authority
WO
WIPO (PCT)
Prior art keywords
band
head
strap
haemostatic device
vessels
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.)
Ceased
Application number
PCT/IB2008/054178
Other languages
English (en)
Inventor
Fabrizio Dal Moro
Walter Artibani
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.)
Universita degli Studi di Padova
Original Assignee
Universita degli Studi di Padova
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 Universita degli Studi di Padova filed Critical Universita degli Studi di Padova
Priority to PCT/IB2008/054178 priority Critical patent/WO2010041101A1/fr
Publication of WO2010041101A1 publication Critical patent/WO2010041101A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12009—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
    • A61B17/12013—Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot for use in minimally invasive surgery, e.g. endoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/132—Tourniquets
    • A61B17/1322—Tourniquets comprising a flexible encircling member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00004—(bio)absorbable, (bio)resorbable or resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00893—Material properties pharmaceutically effective

Definitions

  • the present patent relates to haemostatic devices, and particularly concerns a new haemostatic device for use in all types of surgical procedure, and particularly in laparoscopic procedures.
  • mechanical haemostatic methods for instance, which may involve exerting a mechanical pressure, inserting stitches, or using a mechanical stapler or clips.
  • physical haemostatic methods such as the methods that involve the use of high temperatures, low temperatures, electricity, ultrasound, laser, radio frequencies, and so on.
  • the ideal haemostatic agent should have a powerful, rapid and reliable haemostatic effect; it should also be reabsorbable or, if it is non- reabsorbable, it should be completely inert; it should also be sterile and antibacterial, and practical to use.
  • haemostatic substances such as gels, colloids, adhesives, etc.
  • metal or plastic clips enables the use of energy to be avoided, but it is not unusual for such clips to prove incapable of assuring a reliable haemostasis, as seen in numerous cases in which clips have been used, and particularly when a kidney is harvested laparoscopically from a living donor. Moreover, the force with which the stems of the clips are closed can cause ischaemic damage due to compression of the nerve structures contained in the neurovascular bundle.
  • clips e.g. for renal artery closure, during laparoscopic nephrectomies can often prove scarcely reliable due to the risk of intraoperative or postoperative displacement of the clip.
  • vessels involved are atherosclerotic, i.e. they have become stiff and calcified, it can be hazardous to use a clip, which exerts a strong compressive force between only two stems, whereas it would be preferable to apply a gradual circumferential compression to bear, as is the case when a stitch is inserted.
  • haemostatic device has been studied and developed for use in various types of surgical procedure, and particularly in laparoscopy.
  • the main object of the present invention is to enable the tension applied around structures requiring haemostasis to be adjusted, while also assuring the utmost safety in use for the patient, since said device can withstand distinctly stronger forces than those potentially developing in the biological structures for which it is proposed.
  • Another object of the present invention is to enable a haemostatic control of neurovascular structures without the need to use energy that might damage the neural components that need to be preserved.
  • Another object of the present invention is to enable the rapid and reliable haemostatic control of large vessels, particularly during laparoscopic and robot-assisted laparoscopic procedures, but also in open surgical procedures.
  • Another advantage of the present invention lies in that it has a broad range of uses and can be applied to vessels or structures of various dimensions.
  • a further advantage of the present invention lies in that it is also suitable for use in radical prostatectomy procedures.
  • Another object of the present invention is to enable haemostatic control either from the outside or directly around a vessel in the event of extreme emergencies.
  • a further object of the present invention is to enable the temporary closure of large vessels in the event of vascular surgery.
  • Another advantage of the present invention lies in that it is very quick and easy to position, as well as being easy to remove and reposition.
  • the present invention is preferably made of an inert and antibacterial material, such as polyamide 6,6 - nylon.
  • Another characteristic of the present invention, that also represents a novelty in this field, is that the polymer of which the invention is made can be used as a drug-eluting medium, i.e. to release certain substances, such as haemostatic, chemotherapeutic or other kinds of substance, directly in situ.
  • the new haemostatic device for use in all kinds of surgical procedure, and particularly in laparoscopy, comprising at least one autostatic or self-locking strap, said strap in turn comprising a head combined with a serrated band, suitable for being flexed and inserted through a hole in said head, wherein at least one flexible tooth is contained inside said head, coinciding with said hole, to enable the insertion of said band in one direction and prevent it from accidentally sliding in the opposite direction.
  • Said strap may be designed to be of the non-reopening type, or of the reopening or removable type, also comprising an external tooth on a level with the heads that, when pressed, enables the band to be released and the strap to be opened.
  • Said device consequently comprises an adjustable closing mechanism, since said strap can easily be inserted during laparoscopic or robot-assisted laparoscopic procedures, and can be tightened around structures needing to be ligated, progressively adjusting the tension thereon, so as to obtain the necessary haemostatic control without causing any damage due to pressure on the structures involved, unlike the situation when clips of the known type are used.
  • said device can be used very effectively in applications for controlling haemostasis on a level with the prostatic stumps and the neurovascular bundles during laparoscopic or robot-assisted laparoscopic radical prostatectomy procedures.
  • the new device can also be used in other types of open, non-laparoscopic surgical procedures, however.
  • Said device can be made entirely or partially of a non-reabsorbable material, preferably poly amide 6,6 - nylon, and/or entirely or partially of various kinds of reabsorbable material.
  • the new device can also include at least one applicator and/or means for positioning and closing the strap.
  • said band and/or said head on the strap can comprise one or more grooves and/or cavities, and/or teeth for engaging with such means for positioning and closing the strap.
  • said means can comprise wires or linear probes that, inserted in said grooves, enable the operator to guide the positioning of the strap and to achieve the flexing of the band and the closing of the strap. Said procedure can be completed effectively both during laparoscopic procedures and in open surgery.
  • An advantage of the present invention lies in its considerable safety in use, which is greater than any haemostatic method using forms of energy, without carrying the related risk of damaging the adjacent structures; moreover, it affords a mechanical closure with a shape that makes it distinctly more stable than a closure achieved with any clip of known type.
  • the new invention is quick to position, so it is suitable for use both in open surgery and in laparoscopic procedures. It can also include the possibility to cut off the excess length of band after closing the strap.
  • Said strap can thus be adjusted, i.e. once in position, the tension can be progressively increased to improve haemostasis in the vessels that need to be closed, reducing the damage due to excessive compression on the nerve structures in the neurovascular bundle where the bleeding has to be controlled, while preserving the vitality of the nerves.
  • the pressure exerted by the strap's band when it is wrapped around the vessel is distributed around the circumference of the vessel in question, instead of pressing the vessel with just two stems, as in the case of using vascular staplers to temporarily close vessels.
  • the new haemostatic device is versatile and can also serve as a device for use in first aid, for the acute control of bleeding either from the outside or directly on an exposed vessel.
  • the device can be produced in various sizes and it can be of the non- removable or of the reopenable type; it can be made of a non-reabsorbable and/or a reabsorbable material.
  • Figures 1-5 show five different embodiments of the new haemostatic device, comprising at least one strap (F) of the self-locking type, with a head (T) attached to a band (N) that is serrated along all or part of at least one side.
  • Figure 6 shows a detail of the head (T") of the strap (F) made according to another possible embodiment.
  • FIG 7 schematically shows the method for using the new haemostatic device on vessels (Vl, V2).
  • the haemostatic device comprises at least one strap (F) of the autostatic and self-locking type, said strap (F) in turn comprising a head (T) substantially in the shape of a prism, truncated pyramid or cube, or preferably semi- spherical in shape, combined with a band (N) entirely or partially serrated on at least one side.
  • a strap (F) of the autostatic and self-locking type said strap (F) in turn comprising a head (T) substantially in the shape of a prism, truncated pyramid or cube, or preferably semi- spherical in shape, combined with a band (N) entirely or partially serrated on at least one side.
  • Said band (N) is made of a flexible material and can be inserted in a hole (Tl) passing through said head (T).
  • Said strap (F) is designed to be tied around structures or vessels (Vl, V2) needing to be ligated, progressively adjusting the tension in order to obtain the required haemostatic control without causing any damage due to excessive pressure on said vessels (Vl, V2).
  • said strap (F) comprises a head (T') preferably with a substantially semi-spherical or semi-cylindrical shape, with rounded rather than sharp edges, and with a substantially flat base (T3) suitable for facing towards said vessels (Vl, V2), and a band (N) with locking teeth (Dl) distributed along all or part of the inner side (Nl) of the band (N), i.e.
  • Said flexible teeth (T21) on the head (T') are located inside said hole (Tl), in a position corresponding to the position of the locking teeth (Dl) when said band (N) is flexed, inserted and passed through said head (T').
  • Said hole (Tl) in said head (T') is preferably made in the longitudinal direction, parallel to said band (N) when it is not flexed, i.e. between the wall (T5) of the head (T') to which said band (N) is attached and the opposite wall (T6), and wherein said flexible teeth (T21) are arranged on the underside of said hole (Tl).
  • said strap (F) when said band (N) is flexed and inserted in said head (T'), said strap (F), positioned so as to throttle one or more vessels (Vl, V2), substantially forms a ring, wherein said locking teeth (Dl) lie facing said flexible teeth (T21), which enable their insertion and passage in a single direction, towards the vessels (Vl, V2).
  • Said locking teeth (Dl) serves the purpose of assuring a greater friction and a better grip of the band (N) on the vessels (Vl, V2) to ensure a more stable positioning of the strap (F).
  • said band (N) comprises gripper teeth (DIl) distributed preferably in the stretch closest to said head (T') on the inner side (Nl) of the band (N), serving the purpose of ensuring that the band (N) grips the walls of the vessels (Vl,
  • said strap (F) comprises a head (T") substantially parallelepiped or cubic in shape, with preferably rounded corners and edges.
  • said strap (F) comprises a head (T'") of substantially semi-spherical shape, wherein said hole (Tl) provided in said head (T'") lies in a direction substantially crosswise to the direction of the band (N) when it is not flexed, i.e. said hole (Tl) is made between the bottom wall (T3) of said head (T'") and the opposite wall (T4).
  • the band (N) can thus be flexed, inserted and passed through said hole (Tl) so as to substantially form a ring of smaller radius.
  • said strap (F) comprises a head (T") with a base (T3) that is not flat and linear but concave, so as to substantially follow the curved trend of the flexed band (N).
  • Said head (T', T") can also be designed, as shown schematically in Figures 6 and 7, to comprise one or more extensions (A) in the vicinity of the hole (Tl) where the band (N) is inserted, wherein said extensions (A) serve the dual purpose of guiding the proper insertion of the band (N) inside the head
  • One or more grooves and/or cavities, and/or serrated surfaces can also be provided on said band (N), and preferably on said outer side (N2), i.e. on the side where there are no locking teeth (Dl 5 D2), and/or on said head (T), to engage with means, such as wires or probes, for the positioning and closing of the strap (F).

Landscapes

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

Abstract

La présente invention concerne un dispositif hémostatique conçu pour être utilisé dans des procédures chirurgicales de dives types, lequel dispositif présente la caractéristique de comprendre au moins une sangle (F) de type à auto-verrouillage pourvue de moyens de fermeture ajustables. La sangle (F) comprend au moins une tête (T) combinée avec au moins une bande (N) souple striée conçue pour être entourée autour d'un ou de plusieurs récipients (V1, V2) ou de structures du corps humain et pour être insérée dans au moins un orifice (T1) traversant la tête (T). Au moins une dent souple (T21, T22) ménagée sur la tête (T) et conçue pour entrer en prise avec les dents (D1, D11, D21) ménagées sur ladite bande (N), permettant l'insertion de la bande (N) dans un sens et l'empêchant de glisser dans le sens opposé.
PCT/IB2008/054178 2008-10-10 2008-10-10 Dispositif hémostatique pour procédures chirurgicales et d'urgence Ceased WO2010041101A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/054178 WO2010041101A1 (fr) 2008-10-10 2008-10-10 Dispositif hémostatique pour procédures chirurgicales et d'urgence

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/IB2008/054178 WO2010041101A1 (fr) 2008-10-10 2008-10-10 Dispositif hémostatique pour procédures chirurgicales et d'urgence

Publications (1)

Publication Number Publication Date
WO2010041101A1 true WO2010041101A1 (fr) 2010-04-15

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WO (1) WO2010041101A1 (fr)

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013185484A1 (fr) * 2012-06-14 2013-12-19 Min Yike Dispositif de fermeture de plaie sans suture pour une lumière dans un corps humain
JP2014515637A (ja) * 2011-03-15 2014-07-03 エシコン・エンド−サージェリィ・インコーポレイテッド 外科用締結器具
US9084644B2 (en) 2011-02-02 2015-07-21 DePuy Synthes Products, Inc. Bone fixation assembly
CN105054986A (zh) * 2015-08-17 2015-11-18 何定甫 脐带拉扎带
CN105054987A (zh) * 2015-08-17 2015-11-18 何定甫 脐带扎束装置
WO2016025666A1 (fr) * 2014-08-14 2016-02-18 Lifecell Corporation Matrices tissulaires et méthodes de traitement
US9474553B2 (en) 2013-01-25 2016-10-25 DePuy Synthes Products, Inc. Caps for implants, implant assemblies, and methods of use
US9585705B2 (en) 2012-03-28 2017-03-07 DePuy Synthes Products, Inc. Bone fixation member systems and methods of use
US9603646B2 (en) 2014-05-30 2017-03-28 DePuy Synthes Products, Inc. Bone fixation assembly
CN109700493A (zh) * 2017-10-25 2019-05-03 复旦大学附属华山医院 一种串珠状手术用阻断牵引装置
US10307237B2 (en) 2015-05-15 2019-06-04 Lifecell Corporation Tissue matrices and methods of treatment
US11298220B2 (en) 2019-05-03 2022-04-12 Lifecell Corporation Breast treatment device

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4955913A (en) * 1985-03-28 1990-09-11 Robinson Walter C Surgical tie
US5250049A (en) * 1992-01-10 1993-10-05 Michael Roger H Bone and tissue connectors
US5269803A (en) * 1992-04-10 1993-12-14 Gtr Patent, Inc. Hemostasis pressure pad band
DE4228909A1 (de) * 1992-08-28 1994-03-10 Ethicon Gmbh Endoskopisches Instrument zur Applizierung von Ligaturbindern und Ligaturbinder
WO2002003869A1 (fr) * 2000-07-06 2002-01-17 Inzign Pte Ltd. Systeme d'occlusion du cordon ombilical
US20040089313A1 (en) * 1998-02-19 2004-05-13 Curon Medical, Inc. Systems and methods for treating obesity and other gastrointestinal conditions
EP1982659A2 (fr) * 2007-04-20 2008-10-22 O'Neil, Terence Procédé et appareil pour limiter le flux sanguin
WO2008146185A1 (fr) * 2007-05-27 2008-12-04 Simon Christian Hede Moyens de serrage pour une chirurgie orthopédique

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4955913A (en) * 1985-03-28 1990-09-11 Robinson Walter C Surgical tie
US5250049A (en) * 1992-01-10 1993-10-05 Michael Roger H Bone and tissue connectors
US5269803A (en) * 1992-04-10 1993-12-14 Gtr Patent, Inc. Hemostasis pressure pad band
DE4228909A1 (de) * 1992-08-28 1994-03-10 Ethicon Gmbh Endoskopisches Instrument zur Applizierung von Ligaturbindern und Ligaturbinder
US20040089313A1 (en) * 1998-02-19 2004-05-13 Curon Medical, Inc. Systems and methods for treating obesity and other gastrointestinal conditions
WO2002003869A1 (fr) * 2000-07-06 2002-01-17 Inzign Pte Ltd. Systeme d'occlusion du cordon ombilical
EP1982659A2 (fr) * 2007-04-20 2008-10-22 O'Neil, Terence Procédé et appareil pour limiter le flux sanguin
WO2008146185A1 (fr) * 2007-05-27 2008-12-04 Simon Christian Hede Moyens de serrage pour une chirurgie orthopédique

Cited By (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9084644B2 (en) 2011-02-02 2015-07-21 DePuy Synthes Products, Inc. Bone fixation assembly
US9084645B2 (en) 2011-02-02 2015-07-21 DePuy Synthes Products, Inc. Bone fixation assembly
US10307196B2 (en) 2011-02-02 2019-06-04 DePuy Synthes Products, Inc. Bone fixation assembly
JP2014515637A (ja) * 2011-03-15 2014-07-03 エシコン・エンド−サージェリィ・インコーポレイテッド 外科用締結器具
US9585705B2 (en) 2012-03-28 2017-03-07 DePuy Synthes Products, Inc. Bone fixation member systems and methods of use
WO2013185484A1 (fr) * 2012-06-14 2013-12-19 Min Yike Dispositif de fermeture de plaie sans suture pour une lumière dans un corps humain
US9474553B2 (en) 2013-01-25 2016-10-25 DePuy Synthes Products, Inc. Caps for implants, implant assemblies, and methods of use
US9603646B2 (en) 2014-05-30 2017-03-28 DePuy Synthes Products, Inc. Bone fixation assembly
AU2019283924B2 (en) * 2014-08-14 2021-01-21 Lifecell Corporation Tissue matrices and methods of treatment
EP3662940A1 (fr) * 2014-08-14 2020-06-10 LifeCell Corporation Matrices tissulaires et méthodes de traitement
WO2016025666A1 (fr) * 2014-08-14 2016-02-18 Lifecell Corporation Matrices tissulaires et méthodes de traitement
AU2015301688B2 (en) * 2014-08-14 2019-10-10 Lifecell Corporation Tissue matrices and methods of treatment
US10307237B2 (en) 2015-05-15 2019-06-04 Lifecell Corporation Tissue matrices and methods of treatment
CN105054987A (zh) * 2015-08-17 2015-11-18 何定甫 脐带扎束装置
CN105054986A (zh) * 2015-08-17 2015-11-18 何定甫 脐带拉扎带
CN109700493A (zh) * 2017-10-25 2019-05-03 复旦大学附属华山医院 一种串珠状手术用阻断牵引装置
US11298220B2 (en) 2019-05-03 2022-04-12 Lifecell Corporation Breast treatment device

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