Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/11—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis
  • A61B17/1114—Surgical instruments, devices or methods for performing anastomosis; Buttons for anastomosis of the digestive tract, e.g. bowels or oesophagus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/3205—Excision instruments
  • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
  • A61B18/12—Surgical 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
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/00491—Surgical glue applicators
  • A61B2017/00504—Tissue welding
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
  • A61B2017/32007—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with suction or vacuum means
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B17/32—Surgical cutting instruments
  • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
  • A61B17/320092—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with additional movable means for clamping or cutting tissue, e.g. with a pivoting jaw
  • A61B2017/320094—Surgical 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
• • 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
  • A61B90/03—Automatic limiting or abutting means, e.g. for safety
  • A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
  • A61B2090/034—Abutting 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.

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• 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)

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• 2010
  • 2010-10-21 WO PCT/EP2010/006431 patent/WO2011047857A1/en active Application Filing
  • 2010-10-21 EP EP10771025A patent/EP2490600A1/de not_active Withdrawn

Non-Patent Citations (1)

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