EP2490600A1 - Appareil hémostatique circulaire et procédé d'utilisation associé - Google Patents

Appareil hémostatique circulaire et procédé d'utilisation associé

Info

Publication number
EP2490600A1
EP2490600A1 EP10771025A EP10771025A EP2490600A1 EP 2490600 A1 EP2490600 A1 EP 2490600A1 EP 10771025 A EP10771025 A EP 10771025A EP 10771025 A EP10771025 A EP 10771025A EP 2490600 A1 EP2490600 A1 EP 2490600A1
Authority
EP
European Patent Office
Prior art keywords
clamp portion
hemostatic apparatus
hemostatic
clamp
tissue
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.)
Withdrawn
Application number
EP10771025A
Other languages
German (de)
English (en)
Inventor
Alain Sezeur
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.)
Le Groupe Hospitalier Des Diaconesses Croix Saint-Simon
Universite Pierre et Marie Curie Paris 6
Original Assignee
Le Groupe Hospitalier Des Diaconesses Croix Saint-Simon
Universite Pierre et Marie Curie Paris 6
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 Le Groupe Hospitalier Des Diaconesses Croix Saint-Simon, Universite Pierre et Marie Curie Paris 6 filed Critical Le Groupe Hospitalier Des Diaconesses Croix Saint-Simon
Publication of EP2490600A1 publication Critical patent/EP2490600A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B17/1114Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/32053Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00491Surgical glue applicators
    • A61B2017/00504Tissue welding
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/32007Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B17/320092Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
    • A61B2017/320094Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw additional movable means performing clamping operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, 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
    • A61B90/03Automatic limiting or abutting means, e.g. for safety
    • A61B2090/033Abutting means, stops, e.g. abutting on tissue or skin
    • A61B2090/034Abutting means, stops, e.g. abutting on tissue or skin abutting on parts of the device itself

Definitions

  • the present invention relates generally to a circular hemostatic apparatus and the method of use thereof.
  • the present invention allows for the treatment of internal or external hemorrhoids by the use of a circular hemostatic apparatus which performs circular fusing and cutting of the mucous membrane and the sub-mucous membrane of the lower rectum without the need for suturing or stapling, thereby reducing or alleviating the hemorrhoids which are fed by the veins of mucous membrane and sub-mucous membrane.
  • hemorrhoids are evidenced by the swelling and inflammation of veins in the rectum or anus. Hemorrhoids affect a large percentage of the population and can be very painful. There are many procedures available for the reduction and alleviation of the symptoms associated with hemorrhoids.
  • One disadvantage of many of the surgical methods is that the surgery is frequently performed below the dentate line inside of the anal canal, so that many nerve endings are affected and the patient is likely to feel significant pain from the surgery.
  • the LONGO method for surgically treating hemorrhoids is well known in the prior art and typically involves surgery above the dentate line thereby reducing the pain felt by the patient.
  • the apparatus involved for this method typically includes a circular anal dilator, an anal endoscopic suturer, a circular anal-rectum stapler and a thread eyelet. This procedure
  • CONFIRMATION COPY involves the forming of a pocket followed by suturing or stapling, thereby repositioning the anal canal tissue and reducing blood blow to the internal hemorrhoids. This procedure is advantageous in that it is performed above the dentate line inside the anal canal so that the user is less likely to feel significant pain.
  • suturing or stapling with the foreign bodies left in place within the user's body, is disadvantageous.
  • Figure 1 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention inserted into a patient whereby the cylindrical dilator raises the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue.
  • Figure 2 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention wherein the cylindrical portion of the clamp has been inserted to the cylindrical dilator and the tapered head portion of the clamp has been raised to an open position above the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue.
  • Figure 3 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention wherein the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue, has prolapsed into the central channel of the cylindrical portion of the clamp in response to a vacuum or depressurization within the clamp.
  • FIG 4 is a cross-sectional view of an embodiment of the hemostatic apparatus of the present invention wherein the tapered head portion of the clamp has closed against the cylindrical portion of the clamp thereby capturing the mucous membrane and submucous membrane, including the hemorrhoidal tissue.
  • the mucous membrane and the submucous membrane include the blood vessels which supply blood to the hemorrhoidal tissue.
  • Ultrasonic or electrical energy is thereafter applied to the circular cutting surface thereby severing the prolapsed mucous membrane and sub-mucous membrane and fusing the edges of the severed inner wall.
  • a circular blade may be provided from the interior wall of the cylindrical portion to sever the prolapsed tissue.
  • Figure 5 is a cross-sectional view of an alternative embodiment to that shown in Figure 2, showing a circular blade extending from the interior wall of the cylindrical portion of the clamp.
  • Figure 6 is a cross-sectional view of an alternative embodiment to that shown in Figure 2, including lateral apertures for the depressurization of the hollow center of the clamp.
  • hemostatic apparatus 10 includes an anal dilator 12, a cylindrical portion 14 of the hemostatic clamp and a tapered head portion 16 of the hemostatic clamp.
  • Anal dilator 12 includes a hollow cylindrical segment 20 for insertion into the anus of the patient, as well as a cylindrically flared lower portion 22 for limiting the insertion of anal dilator 12. Furthermore, as shown in Figure 1, the anal dilator 12 is used to lift the mucous membrane and the sub-mucous membrane, including the hemorrhoidal tissue, to an elevated position.
  • Cylindrical portion 14 of the hemostatic clamp is cylindrically shaped and hollow, with a central channel 26 formed therein.
  • Circular cutting surface 28 is formed on the top edge of cylindrical portion 14.
  • Retractable stops 29 are used to initially position the hemostatic clamp with respect to the anal dilator 12 (see Figure 1) and are then placed into a retracted position to allow the cylindrical portion 14 to be inserted into the anal dilator 12 (see Figures 2-4).
  • circular rubber seal 30 is positioned on the outer surface of the lower edge of cylindrical portion 14.
  • Cylindrical portion 14 of the hemostatic clamp further includes a lower cylindrical segment 31 of reduced diameter, which includes apertures 32 which communicate with vacuum device 33 for depressurizing central channel 26 so as to draw the hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane, into the interior of the cylindrical portion 14 of the hemostatic clamp.
  • apertures 32 may be positioned on cylindrical portion 14 of the hemostatic clamp 10.
  • Figure 6 shows an alternative embodiment wherein the apertures 32 for depressurizing central channel 26 can be formed laterally on the cylindrical portion 14. Additionally, a source of ultrasonic or electrical energy 34 to provide energy for the cutting process. The electrical energy may be applied with a modulated impedance.
  • Tapered head portion 16 of the hemostatic clamp includes a rounded, hemispheric or partially ovoid head 35 with a bottom surface 36 and an outwardly flared seal 38 extending around the periphery of bottom surface 36 to form a leak-proof or leak-resistant seal with respect to the hollow cylindrical segment 20 of the inner wall anal dilator 12 as shown in Figure 1.
  • Tapered head portion 16 is attached to rod 40 which extends through central channel 26 of cylindrical portion 14.
  • Rod 40 allows the tapered head portion 16 to move between a position wherein the hemostatic clamp is open as shown in Figure 2 and a position wherein the hemostatic clamp is closed as shown in Figure 4.
  • the tapered head portion 16 is sized so as to engage against circular cutting surface 28 of cylindrical portion 14 as shown in Figure 4.
  • Rod 40 is used to apply a force to tapered head portion 16 against circular cutting surface 28 and likewise to apply electrical or ultrasonic energy to effect the fusing and cutting of the prolapsed tissue engaged between tapered head portion 16 and circular cutting surface of cylindrical portion 14.
  • the physician or other medical staff In order to use hemostatic apparatus 10, the physician or other medical staff first inserts anal dilator 12 into the anus of the patient thereby raising the hemorrhoids as high as possible as shown in Figure 1.
  • the physician or other medical staff can look through the anal dilator 12 to assure themselves that the hemorrhoids are sufficiently elevated.
  • the retractable stops 29 are in place so that the tapered head portion 16 of the hemostatic clamp is inserted to the extent of the upper edge of the anal dilator 12 (outwardly flared seal 38 forming a leak-proof or leak-resistant configuration with respect to anal dilator 14) while cylindrical portion 14 is initially inserted into anal dilator 12 as likewise shown in Figure 1.
  • a sufficiently strong vacuum or depressurization is created in the central channel 26 of cylindrical portion 14 by vacuum device 33 thereby drawing the prolapsed hemorrhoidal tissue, or other mucous membrane or sub-mucous membrane, into central channel 26 as shown in Figure 3.
  • the tapered head portion 16 is then drawn downwardly so to be urged against the circular cutting surface 28 of cylindrical portion 14.
  • Ultrasonic energy or electrical energy with a modulated impedance is then applied by source 34 to the tapered head portion 16 and/or the circular cutting surface 28 thereby fusing the tissues immediately between the tapered head portion 16 and the circular cutting surface 28 and severing the tissues extending beyond the fused portion.
  • the two edges of the severed inner wall are placed side by side and then anastomosed.
  • hemostatis is assured by the circular cutting surface 28 thereby forming a circular fused area around the inner periphery of the anal canal.
  • circular blade 42 extending upwardly from the inner wall of cylindrical portion 14 may be provided in order to sever the tissues extending beyond the fused portion.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Heart & Thoracic Surgery (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 appareil hémostatique circulaire destiné à être utilisé dans le traitement des hémorroïdes. Le dispositif comprend un clamp comprenant une partie cylindrique creuse et une partie de tête conique. Le tissu hémorroïdaire prolabé, ou autre muqueuse ou sous-muqueuse est aspiré dans la partie cylindrique creuse par un vide, et la partie de tête conique est aspirée vers la partie cylindrique creuse pour capturer le tissu hémorroïdaire, ou autre muqueuse ou sous-muqueuse. Une énergie ultrasonore ou électrique est alors appliquée au clamp, formant ainsi une zone fusionnée circulaire de tissu et sectionnant le tissu qui s'étend au-delà de la zone fusionnée circulaire, en d'autres termes, les deux bords de la paroi interne sectionnée sont placés côte à côte puis anastomosés. Une lame circulaire peut être incluse pour sectionner le tissu.
EP10771025A 2009-10-23 2010-10-21 Appareil hémostatique circulaire et procédé d'utilisation associé Withdrawn EP2490600A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25426109P 2009-10-23 2009-10-23
PCT/EP2010/006431 WO2011047857A1 (fr) 2009-10-23 2010-10-21 Appareil hémostatique circulaire et procédé d'utilisation associé

Publications (1)

Publication Number Publication Date
EP2490600A1 true EP2490600A1 (fr) 2012-08-29

Family

ID=43126909

Family Applications (1)

Application Number Title Priority Date Filing Date
EP10771025A Withdrawn EP2490600A1 (fr) 2009-10-23 2010-10-21 Appareil hémostatique circulaire et procédé d'utilisation associé

Country Status (2)

Country Link
EP (1) EP2490600A1 (fr)
WO (1) WO2011047857A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9907600B2 (en) * 2013-11-15 2018-03-06 Ethicon Llc Ultrasonic anastomosis instrument with piezoelectric sealing head
CN103989498B (zh) * 2014-04-29 2017-02-15 中国人民解放军第三军医大学第二附属医院 肛肠pph手术用引导缝合器
CN110393562B (zh) * 2019-07-23 2020-08-25 上海市宝山区仁和医院 痔吻合器及痔吻合器套件

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5197649A (en) * 1991-10-29 1993-03-30 The Trustees Of Columbia University In The City Of New York Gastrointestinal endoscoptic stapler
US6142933A (en) * 1998-11-23 2000-11-07 Ethicon Endo-Surgery, Inc. Anoscope for hemorrhoidal surgery

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2011047857A1 *

Also Published As

Publication number Publication date
WO2011047857A1 (fr) 2011-04-28

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