WO2021130699A1 - Dispositif chirurgical d'extraction de tissu contenu - Google Patents

Dispositif chirurgical d'extraction de tissu contenu Download PDF

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Publication number
WO2021130699A1
WO2021130699A1 PCT/IB2020/062402 IB2020062402W WO2021130699A1 WO 2021130699 A1 WO2021130699 A1 WO 2021130699A1 IB 2020062402 W IB2020062402 W IB 2020062402W WO 2021130699 A1 WO2021130699 A1 WO 2021130699A1
Authority
WO
WIPO (PCT)
Prior art keywords
cutting element
tissue
cutting
morcellator
tenaculum
Prior art date
Application number
PCT/IB2020/062402
Other languages
English (en)
Inventor
Gal MEISTER
Original Assignee
Heracure Medical Ltd.
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 Heracure Medical Ltd. filed Critical Heracure Medical Ltd.
Publication of WO2021130699A1 publication Critical patent/WO2021130699A1/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
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • 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
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A61B2017/320024—Morcellators, e.g. having a hollow cutting tube with an annular cutter for morcellating and removing tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • A61B2017/320028—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments with reciprocating movements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320072—Working tips with special features, e.g. extending parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/320068—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • A61B2017/320098—Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic with transverse or torsional motion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/007—Auxiliary appliance with irrigation system

Definitions

  • the present invention related generally to surgical instruments and particularly to a contained tissue extraction surgical system for use in minimally invasive surgical procedures.
  • Minimally invasive surgical procedures typically involve one or more small incisions that provide access to the relevant internal organ or tissue.
  • a trocar, cannula, flexible fulcrum or the like is placed into each incision, and all surgical steps are subsequently performed with instruments passed through or into the trocar(s).
  • Known morcellators typically include a rotating tube having a sharp distal cutting edge, which rotates within an outer stationary tube.
  • the morcellator is inserted through a cannula or trocar, or more commonly directly through the incision.
  • a grasping instrument tenaculum
  • the surgeon pulls the tissue to be severed up into the tube so that the rotating edge of the inner tube severs the grasped portion of tissue.
  • the surgeon can remove the large tissue mass in increments.
  • the present invention seeks to provide an improved surgical tissue morcellator or a contained tissue extraction device with a selective resection of specific tissue type based on their hardness or softness, as is described in detail below.
  • morcellator and tissue extraction device are used interchangeably.
  • a morcellator/tissue extraction device including a cutting element disposed at a distal end of a shaft, a rotatable helical tenaculum, disposed at a distal end of a tenaculum tube, and arranged for relative axial movement with respect to the shaft, so that the helical tenaculum is locatable distally beyond the cutting element and locatable proximal to the cutting element, a cutting actuator coupled to the shaft for moving the cutting element in order to cut tissue, a tenaculum actuator coupled to the tenaculum tube for moving the helical tenaculum, and a tissue sealing element disposed on a distal portion of an outer tube, the shaft and the tenaculum tube being disposed in the outer tube.
  • the cutting element may be a rotational cutting element or an oscillatory cutting element.
  • the cutting element may have a continuous and tapered cutting edge or may have a series of circumferentially spaced cutting teeth.
  • the tenaculum actuator may be configured to cause linear motion and axial motion of the helical tenaculum.
  • the tissue sealing element may flare outwards.
  • a morcellator including a cutting element disposed at a distal end of a shaft, a cutting actuator coupled to the shaft for moving the cutting element in order to cut tissue, wherein geometric features of the cutting element and operating characteristics of the cutting actuator are configured to selective cut specific tissue types, and a morcellating cutting member, proximal to the cutting element, operative to cut tissue that has been pre-cut by the cutting element.
  • An aspiration lumen within the device may be used to generate a low pressure zone around the cutting element, as opposed to the high-pressure zone in the insufflated abdominal/peritoneal cavity. This pressure difference prevents the morcellated tissue from escaping to the peritoneal cavity.
  • This feature of the device enables the surgeon to perform a contained resection of tissue mass/tissue extraction, while reducing the risk for spreading or dispersing cancerous tumors/sarcomas to adjacent normal tissues in the abdominal cavity or to other parts of a patient’s body.
  • a tissue sealing element is pressed against the tissue so that the tissue sealing element seals and prevents the insufflation gas in the peritoneal cavity from escaping through the device’s aspiration lumen thus maintaining a steady pressure in the abdominal/peritoneal cavity, as required for laparoscopic procedures.
  • This sealing also assists in preventing morcellated tissue from escaping to other parts of a patient’s body.
  • a selective cutting scheme can be generated to enable selective cutting of specific tissue types based on their hardness or other physical features behaviors.
  • a set of cutting elements or the cutting actuator may be used to selectively resect a particular tissue type, wherein if hardness is above a threshold, the cutting element is not capable to cut tissue.
  • a different set of cutting elements or cutting actuator may be used to selectively resect another tissue type, wherein if hardness is not above a threshold, the cutting element is not capable to cut tissue.
  • the system enables to distinguish between soft tissue and hard tissue mass based on physical features and selectively resects and removes the undesired tissue mass, fibroid, lesion, or tumor from a patient’s body.
  • a cutting element and actuators with a limited amplitude, frequency or unique geometrical shape and size may not be able to generate enough contact friction or resistance for cutting soft tissue. With hard, rigid tissue, the resistance force will be enough to generate a cut.
  • the medical device includes a cutting portion with blades that vibrates at a certain frequency (without limitation, in the range of 100-100,000 oscillations per minute, or in the ultrasonic range) for small and limited stroke distance or angle (without limitation, in the range of 0.05 mm-5mm).
  • a certain frequency without limitation, in the range of 100-100,000 oscillations per minute, or in the ultrasonic range
  • the tissue is flexible enough to deform without being cut. This is due to the limited/small amplitude of the cutting stroke/distance/angle exerted on the tissue. Due to the flexibility of the tissue, no solid resistance is generated on the cutting portion, making resection of the soft tissue impossible.
  • the invention provides a safer system for cutting hard tissue, fibroids, lesions or tumors while avoiding damage to the surrounding tissues.
  • Fig. 1 is a simplified pictorial illustration of a morcellator, constructed and operative in accordance with a non-limiting embodiment of the invention
  • Fig. 2 is a simplified pictorial illustration of a cutting element, helical (corkscrew) tenaculum and tissue sealing element of the morcellator, in accordance with a non limiting embodiment of the invention
  • Fig. 3 is a simplified cutaway illustration of the morcellator; and Figs. 4A, 4B and 4C are simplified pictorial illustrations of cutting elements of the morcellator.
  • Fig. 5 is a simplified pictorial illustration of an actuator to fold in or retract the tissue sealing element.
  • Fig. 6 A and 6B are simplified pictorial illustrations of different irrigation fluid exit ports.
  • Fig. 7 is a simplified flow chart illustration of methods to selectively resect tissue mass of a specific hardness/softness, in accordance with embodiments of the invention.
  • Figs. 8A and 8B are simplified pictorial and cutaway illustrations, respectively, of a morcellator that includes a cutting element for selective resection of tissue mass of specific softness or hardness, in accordance with a non-limiting embodiment of the invention.
  • Fig. 9 is a simplified pictorial illustration of the distal cutting element for selective resection of tissue mass of specific softness or hardness, and a proximal morcellating cutting member.
  • Fig. 10 is a simplified pictorial illustration of the distal cutting element for selective resection of tissue mass and the proximal morcellating cutting member, wherein in this version there is a side window which gives access to the tissue to be cut.
  • Fig. 11 is a simplified pictorial illustration of a morcellator that includes a morcellating cutting element with a movable side window, in accordance with a non limiting embodiment of the invention.
  • Fig. 12 is a simplified pictorial illustration of the morcellating cutting element with the movable side window, showing that the window may be provided with cutting elements with teeth.
  • Figs. 13 and 14 are simplified pictorial illustrations of the morcellator in which the side-facing window may be either open (Fig. 13) or closed (Fig. 14).
  • FIG. 1-3 illustrate a morcellator 10, constructed and operative in accordance with a non-limiting embodiment of the invention.
  • Morcellator 10 includes a cutting element 12 disposed at a distal end of a shaft 14 (all seen in Fig. 2), which is preferably, but not necessarily, hollow.
  • a rotatable helical (corkscrew) tenaculum 16 is arranged for relative axial movement with respect to shaft 14, so that helical tenaculum 16 may be advanced distally beyond cutting element 12 (in the direction of arrow 17 in Fig. 2) and also retracted (in the direction of arrow 19 in Fig. 2) to be positioned proximal to cutting element 12.
  • Tenaculum 16 may be disposed at a distal end of a tenaculum tube 18 which is movable over shaft 14.
  • a cutting actuator 20, coupled to shaft 14, is provided for moving cutting element 12 (e.g., rotational or oscillatory motion) in order to cut tissue.
  • a tenaculum actuator 21, coupled to tube 18, is provided for moving (e.g., in translation and rotation, with or without a ratchet mechanism 27) the helical tenaculum 16, as is now explained.
  • the actuators 20 and 21 may be housed in a housing 22, which may be provided with a handle 24 (Fig. 1).
  • cutting element 12 is a rotational cutting element that rotates 360°.
  • cutting actuator 20 may be a rotary motor.
  • cutting element 12 is an oscillatory cutting element.
  • cutting actuator 20 may be an oscillatory or vibrational actuator with a rotational oscillation which may be in the range of, without limitation, ⁇ 50°.
  • the cutting element may have a continuous and tapered cutting edge 13.
  • the cutting element may have a series of circumferentially spaced cutting teeth (e.g., trapezoidal shaped teeth) 23.
  • the tenaculum actuator 21 may include two actuator portions, one for causing linear motion and the other for causing rotational motion. The invention is not limited to this, and one actuator may be used for both linear and rotational motion. Suitable examples for tenaculum actuator 21 include, without limitation, linear actuators, solenoids, control motors, gear motors, and more. Alternatively, tenaculum actuator 21 may be a manual actuator, such as a dial that the user can turn and also slide for both rotational and translational motion of the tenaculum 16. The tenaculum actuator 21 may be located inside a housing 25.
  • the shaft 14 and tube 18 may be disposed in an outer tube 26.
  • a tissue sealing element 28 may be disposed on a distal portion of outer tube 26.
  • the tissue sealing element 28 flares outwards (e.g., funnel shaped, bell shaped, trumpet-horn shaped, leaf shaped elements, v-shaped or cylinder- shaped sealing elements).
  • shaft 14 may be stationary, whereas tenaculum tube 18 and outer tube 26 may be axially movable.
  • outer tube 26 may be stationary, whereas shaft 14 and tenaculum tube 18 may be axially movable.
  • tenaculum tube 18 may be stationary, whereas shaft 14 and outer tube 26 may be axially movable.
  • shaft 14, tenaculum tube 18 and outer tube 26 may all be axially movable.
  • tissue extracting device 10 may include an aspiration port 40, connected to a suction source (not shown), for drawing and removing tissue that has been morcellated by the cutting element.
  • the cut tissue is aspirated by the suction source to an external collector for removal of the undesired tissue mass, fibroid or lesion, and if required, for future histopathology of the removed tissue.
  • the aspiration source creates a low pressure zone 34 inside a high pressure zone 36; this high pressure zone may be created by pressurized insufflation gas (usually carbon dioxide) that is introduced in a cavity, such as the abdominal/peritoneal cavity, of the patient.
  • the tissue sealing element 28 may be pressed against target tissue 38 (Fig.
  • tissue sealing element 28 prevents the insufflation gas in the peritoneal cavity from escaping through the device’s aspiration lumen 40 (Fig. 3) that may cause to a pressure loss that affects the pneumoperitoneum, required for laparoscopic procedure.
  • the sealing also assists in preventing morcellated tissue from escaping to other parts of the patient’s body, thereby providing important safety to the patient, as in a laparoscopic or open abdominal procedure.
  • morcellator 10 may include a proximal irrigation inlet port 30 (connected to an irrigation fluid source, not shown) and a distal irrigation exit port 32, which may direct the irrigation fluid axially along or parallel to tenaculum tube 18 (Figs. 6A-6B); the fluid flow may be sealed by a fluid sealing element 31.
  • the irrigation fluid path may be internal to the shaft 14 as shown in Fig. 6 A or external to the shaft 14 as shown in Fig. 6B.
  • the irrigation fluid path along with an aspiration source connected to aspiration lumen 40 help produce the required aspiration effect on the morcellated tissue and help decrease friction during evacuation of the morcellated tissue until it reaches a remote jar or a tissue trap.
  • tissue sealing element 28 seals and prevents morcellated tissue from escaping to other parts of the patient’s body. As seen in Fig. 5, tissue sealing element 28 may be folded or retracted into outer lumen 26 by means of an actuator 29, for removing or inserting the device through a trocar hole.
  • Fig. 6A shows another way, but not limited to, for directing the irrigation fluid outside the shaft 14 and aspiration lumen 40.
  • FIG. 7 a system methodology to selectively resect tissue mass of specific softness or hardness is presented.
  • a morcellator that includes cutting elements for such selective resection of tissue mass of specific softness or hardness is now described with reference to Figs. 8A-9.
  • the morcellator of Figs. 8A and 8B is constructed similarly to the morcellator of Figs. 1-3, with like elements being designated by like numerals.
  • morcellator of Figs. 8A and 8B there are no tenaculum 16 and outer tube 26, but it may include tissue sealing element 28 (not shown in Figs. 8A and 8B).
  • This embodiment of the morcellator includes the distal cutting element 12 which may be an oscillatory cutting element, as described above.
  • the distal cutting element 12 which may be an oscillatory cutting element, as described above.
  • parameters that define the oscillation movement of the cutting element 12 e.g., amplitude, speed, frequency
  • a selective cutting scheme can be generated to enable selective cutting of specific tissue types based on their hardness or other physical features behaviors. For example, if tissue hardness is above a threshold, the cutting element 12 and its cutting actuator cannot cut the tissue.
  • a different cutting element 12 or cutting actuator may be used to selectively resect another tissue type, wherein if hardness is not above a threshold, the cutting element 12 is not capable to cut the tissue. Accordingly, the device can distinguish between soft tissue and hard tissue mass based on physical features and can selectively resect and remove the undesired tissue mass, fibroid, lesion, or tumor from a patient’s body.
  • a morcellating cutting member 41 proximal to cutting element 12, that chops, dices, morcellates or otherwise cuts the selected tissue that has been pre-cut by cutting element 12.
  • Cutting member 41 may rotate by means of a rotatable shaft 42 which may be coupled to a rotating actuator (not shown).
  • the resected tissue may be evacuated using suction to a distal tissue collecting vessel, as described above.
  • irrigating fluid may flow through one or more channels 43 and openings 44.
  • Fig. 10 illustrates another version with the distal cutting element 12 for selective resection of tissue mass and the proximal morcellating cutting member 41, wherein in this version there is a side window 45 which gives access to the tissue to be cut.
  • Figs. 11 and 12 illustrate another version of the morcellator that includes the morcellating cutting member 41.
  • the side window 45 is formed on a movable outer tube 47, which is coupled to an actuator 48 which moves outer tube 47 in rotation and/or axial translation. In this manner, side window 45 is movable to modify access to the tissue to be cut.
  • the movable side window 45 may be provided with cutting elements 46, such as teeth.
  • FIGs. 13 and 14 illustrate another version of the morcellator that includes the morcellating cutting member 41.
  • side-facing window 45 may be either open (Fig. 13) or closed (Fig. 14).
  • cutting element 12 and side-facing window 45 are arranged for relative motion with respect to each other. Accordingly, cutting element 12 may be moved axially (by moving its shaft) and window 45 may be stationary; alternatively, cutting element may not move axially and window 45 may be moved axially by moving tube 47; alternatively, both cutting element 12 and window 45 may be moved axially. In this manner, window 45 is locatable to be either distal or proximal to cutting element 12.

Abstract

L'invention concerne un dispositif de morcellement/extraction de tissu contenu (10) qui comprend un élément de coupe (12) disposé à une extrémité distale d'un arbre (14). Un actionneur de coupe (20) est couplé à l'arbre (14) pour déplacer l'élément de coupe (12) afin de couper un tissu. Des caractéristiques géométriques de l'élément de coupe (12) et des caractéristiques de fonctionnement de l'actionneur de coupe (20) sont configurées pour des types de tissu spécifiques coupés sélectifs. Un élément de coupe par morcellement (41), proximal audit élément de coupe (12), est conçu pour couper un tissu qui a été pré-coupé par l'élément de coupe (12).
PCT/IB2020/062402 2019-12-23 2020-12-23 Dispositif chirurgical d'extraction de tissu contenu WO2021130699A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962952641P 2019-12-23 2019-12-23
US62/952,641 2019-12-23

Publications (1)

Publication Number Publication Date
WO2021130699A1 true WO2021130699A1 (fr) 2021-07-01

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080255597A1 (en) * 2007-04-12 2008-10-16 Applied Medical Resources Corporation Method and apparatus for tissue morcellation
US20110160740A1 (en) * 2009-12-28 2011-06-30 Acclarent, Inc. Tissue Removal in The Paranasal Sinus and Nasal Cavity
WO2017160940A1 (fr) * 2016-03-17 2017-09-21 DePuy Synthes Products, Inc. Dispositifs d'ablation de tissu
EP3508149A1 (fr) * 2016-08-30 2019-07-10 Terumo Kabushiki Kaisha Dispositif médical et méthode thérapeutique
WO2019239338A2 (fr) * 2018-06-13 2019-12-19 Heracure Medical Ltd. Résection et détection sélectives de masse tissulaire

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080255597A1 (en) * 2007-04-12 2008-10-16 Applied Medical Resources Corporation Method and apparatus for tissue morcellation
US20110160740A1 (en) * 2009-12-28 2011-06-30 Acclarent, Inc. Tissue Removal in The Paranasal Sinus and Nasal Cavity
WO2017160940A1 (fr) * 2016-03-17 2017-09-21 DePuy Synthes Products, Inc. Dispositifs d'ablation de tissu
EP3508149A1 (fr) * 2016-08-30 2019-07-10 Terumo Kabushiki Kaisha Dispositif médical et méthode thérapeutique
WO2019239338A2 (fr) * 2018-06-13 2019-12-19 Heracure Medical Ltd. Résection et détection sélectives de masse tissulaire

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