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WO2025064305A1 - Systèmes, dispositifs et procédés de nettoyage de laparoscopes - Google Patents

Systèmes, dispositifs et procédés de nettoyage de laparoscopes Download PDF

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Publication number
WO2025064305A1
WO2025064305A1 PCT/US2024/046590 US2024046590W WO2025064305A1 WO 2025064305 A1 WO2025064305 A1 WO 2025064305A1 US 2024046590 W US2024046590 W US 2024046590W WO 2025064305 A1 WO2025064305 A1 WO 2025064305A1
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WO
WIPO (PCT)
Prior art keywords
cleaning
cleaning liquid
cannula
distal end
passageway
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.)
Pending
Application number
PCT/US2024/046590
Other languages
English (en)
Inventor
Evan Langdale
Christopher L. Radl
Trevor Smith
Tahlia DETWEILER
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.)
Boehringer Technologies LP
Original Assignee
Boehringer Technologies LP
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 Boehringer Technologies LP filed Critical Boehringer Technologies LP
Publication of WO2025064305A1 publication Critical patent/WO2025064305A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00131—Accessories for endoscopes
    • A61B1/00135—Oversleeves mounted on the endoscope prior to insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/12—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements
    • A61B1/126—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor with cooling or rinsing arrangements provided with means for cleaning in-use
    • 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
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/313—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes
    • A61B1/3132—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor for introducing through surgical openings, e.g. laparoscopes for laparoscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • 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
    • A61B90/70—Cleaning devices specially adapted for surgical instruments
    • A61B2090/701—Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes

Definitions

  • Laparoscopic surgery was made popular in the 1990s due to its advantages of smaller incisions that lead to less pain and faster recovery and is now a common modality for minimally invasive surgery.
  • Using the laparoscope enables the surgeon to see inside the abdomen, thorax or other internal portion of the body of a patient by the introduction of the laparoscope’s image-receiving face through a cannula extending into the patient’s body.
  • one common problem with the use of a laparoscope during the surgery is obscured vision through the laparoscope, typically due to biological debris from the patient covering the image-receiving distal face of the laparoscope.
  • Typical reasons for the occlusion or impairment of laparoscope vision in order of pervasiveness are: (1) cautery causing fluids and debris to land on the laparoscope’s image-receiving face, e.g., its lens; (2) running the laparoscope into biological tissue such as blood, fat or muscle by accident; (3) running the laparoscope into biological tissue within the cannula valve: (4) fogging of the image-receiving face when it is Attorney Docket No.
  • the ClearifyTM Visualization System available from Medtronic includes a device that sits on the side table next to the patient and has a bath of an anti-fog solution (saline + isopropyl alcohol + surfactant) with a sponge at the bottom that is warmed by battery powered resistors. It also comes with a towel and a large swab-type tip that cleans the trocar valves as re-dirtying of the camera is very common during cleaning via the valves of the trocar.
  • Other laparoscope cleaning techniques which require removal of the laparoscope from within the body of the patient make use of an anti-fog solution and sponge, or gauze and saline.
  • Laparoscope lens occlusion can have multiple negative effects during surgery including the following. Cleaning the lens can disrupt the flow of the surgery and interrupt the focus of the surgeon. Moreover, cleaning the lens can take extra operative time, increasing surgical cost and the amount of time the patient is under anesthesia. Multiple cleanings are common when removing the camera of the laparoscope for cleaning as the camera can be re-dirtied on the trocar gaskets and fogging can occur.
  • One aspect of this invention is a system for cleaning the distal end of a laparoscope extending through a cannula into the body of a patient while the cannula is within the body of the patient.
  • the cannula has an elongated tubular section including a longitudinal passageway having a distal end.
  • the laparoscope has a distally located image-receiving face and is configured for location within the longitudinal passageway of the cannula.
  • the system comprises a cleaning device and an actuating assembly.
  • the cleaning device comprises a tubular sheath configured for introduction into the body of the patient and has a main passageway and a distal end.
  • the main passageway is configured for receipt of the elongated tubular section of the cannula wherein the distal end of the cannula is located and releasably held by the cleaning device at an operative position a predetermined distance proximally of the distal end of the tubular sheath and within the body of the patient.
  • the tubular sheath comprises a suction passageway extending to a point adjacent the distal end of the tubular sheath and a cleaning liquid passageway extending to a point adjacent the distal end of the tubular sheath.
  • the actuating assembly is configured to be coupled to the cleaning device and to a source of suction.
  • the actuating assembly comprises a first port configured to be coupled to the source of suction, a second port configured to be coupled to the cleaning device, and a third port configured to be coupled to the cleaning device and cleaning fluid source.
  • the actuator assembly is configured for operation in a first state, a second state, a third state, and a fourth state.
  • the actuator Attorney Docket No. B1272/20120 assembly when in the first state precludes the suction and the cleaning liquid to be delivered to the laparoscope.
  • the actuator assembly when in the second state causes a charge of cleaning liquid to be ejected though the third port into the cleaning liquid passageway and out of the distal end of the tubular sheath to wash the image-receiving face of the laparoscope and causes suction from the suction source to be applied through the suction passageway to the distal end of the tubular sheath to withdraw the charge of cleaning liquid and any biologic material or other debris from the image- receiving face of the laparoscope for collection.
  • the actuator assembly when in the third state causes the charge of cleaning liquid to stop being ejected into the cleaning liquid passageway and enables suction from the suction source to continue to be applied to the distal end of the tubular sheath to withdraw any cleaning liquid and any biologic material or other debris remaining on the image-receiving face of the laparoscope for collection.
  • the actuator assembly when in the fourth state causing another charge of cleaning liquid to be ready to be introduced into the cleaning device.
  • it additionally comprises a head configured for location outside the body of the patient when the elongated tubular section of the cannula is in the main passageway at the operative position.
  • the head comprises a suction connector port in fluid communication with a proximally located portion of the enclosed suction passageway and a cleaning liquid connector port in fluid communication with a proximately located portion of the enclosed cleaning liquid passageway.
  • the suction connector port of the cleaning device is connected to and in fluid communication with the second port of the actuator assembly, and wherein the cleaning liquid connector port is connected to and in fluid communication with the third port of the actuator assembly.
  • the cleaning device additionally comprises markers on an inner surface of the main passageway adjacent the distal end of the tubular sheath to facilitate the placement of the image-receiving face of the laparoscope to a desired position within the main passageway proximally of the distal end of the tubular sheath.
  • Attorney Docket No. B1272/20120 the actuating assembly comprises an actuator.
  • the actuator comprises the heretofore mentioned first, second, and third ports, a first chamber into which a charge of cleaning liquid is disposed when the actuator is in the first state. The first and second ports being isolated from each other in the first state.
  • the actuator when in the second state causes the charge of cleaning liquid to be ejected from the first chamber though the third port into the cleaning liquid passageway and out of the distal end of the tubular sheath to wash the image-receiving face of the laparoscope.
  • the first and second ports are coupled to each other in the second state whereupon suction from the suction source is applied from the first port to the second port and from there through the suction passageway to the distal end of the tubular sheath to withdraw the charge of cleaning liquid and any biologic material or other debris from the image-receiving face of the laparoscope through the second and first ports for collection.
  • the actuator when in the third state causes the charge of cleaning liquid to stop being ejected from the first chamber into the cleaning liquid passageway.
  • the first and second ports are coupled to each other in the third state whereupon suction from the suction source continues to be applied to the distal end of the tubular sheath to withdraw any cleaning liquid and any biologic material or other debris remaining on the image-receiving face of the laparoscope through the second and first ports for collection.
  • the actuator when in the fourth state causes another charge of cleaning liquid to be introduced into the first chamber from a source of cleaning liquid.
  • the actuator comprises a body having a bore located therein, a first piston within the bore and coupled to a cap located outside the body of the actuator.
  • the cap is configured to be depressed to cause the actuator to be in the second state wherein the first piston moves to reduce the volumetric capacity of the first chamber to cause the ejection of the charge of cleaning liquid from the first chamber into the cleaning device.
  • the actuator assembly additionally comprises a check valve.
  • the actuator additionally comprises a first compression spring to bias the cap against depression thereof and to bias the first chamber against reduction of its volumetric capacity, whereupon when the cap is depressed the cleaning liquid is ejected into the cleaning device, and when the cap is released the actuator is in the fourth state whereupon first compression Attorney Docket No. B1272/20120 spring causes the first chamber to increase in volumetric capacity and to be filled with a charge of cleaning liquid via the opening of the check valve.
  • the actuator additionally comprises a second chamber formed by a portion of the first piston and an inner surface of the bore.
  • the second chamber is moveable to either isolate the first port from the second port or to couple the first port to the second port.
  • Another aspect of this invention is a cleaning device for cleaning the distal end of a laparoscope extending through a cannula into the body of a patient while the cannula is within the body of the patient.
  • the cannula has an elongated tubular section including a longitudinal passageway and a distal end.
  • the laparoscope has a distally located image-receiving face and is configured for location within the longitudinal passageway of the cannula.
  • the cleaning device is configured for releasable securement to the cannula in an operative position and comprises a tubular sheath and a head.
  • the tubular sheath has a distal end and a main passageway surrounded by a sidewall.
  • the main passageway is configured for receipt of the elongated tubular section of the cannula wherein the distal end of the tubular sheath is located at the operative position a predetermined distance proximally of the distal end of the cannula and is releasably secured at the operative position.
  • the sidewall comprises an enclosed suction passageway extending longitudinally through the sidewall, an enclosed cleaning liquid passageway extending longitudinally through the sidewall, and an inlet located proximally of the distal end and extending through the sidewall from an outer Attorney Docket No. B1272/20120 surface of the sidewall to the main passageway.
  • the enclosed suction passageway has an interior suction port located adjacent the distal end of the tubular sheath.
  • the enclosed suction passageway is in fluid communication with the main passageway via the interior suction port.
  • the enclosed cleaning liquid passageway has an interior cleaning liquid port located adjacent the distal end of the tubular sheath.
  • the interior cleaning liquid port is in fluid communication with the main passageway via the liquid cleaning port.
  • the head is configured for location outside the body of the patient when the cannula is at the operative position.
  • the head comprises a first port configured to be coupled to the source of suction and in fluid communication with a proximally located portion of the enclosed suction passageway and a second port in fluid communication with a proximately located portion of the enclosed cleaning liquid passageway.
  • the image-receiving face extends at an angle to a longitudinal axis of the laparoscope, and wherein the interior cleaning liquid port extends at an acute angle to the longitudinal axis to produce a jet of cleaning fluid directed to the image-receiving face.
  • the sidewall of the tubular sheath comprises an inner sheath and an outer sheath.
  • the outer sheath extends over the inner sheath.
  • the inner sheath comprises an elongated suction channel extending longitudinally along an external surface of the inner sheath.
  • An elongated portion of an inner surface of the outer sheath is disposed directly over and seals the elongated suction channel to thereby form the enclosed suction passageway.
  • the inner sheath also comprises an elongated cleaning liquid channel extending longitudinally along an external surface of the inner sheath and an elongated portion of an inner surface of the outer sheath disposed directly over and sealing the elongated cleaning liquid channel to thereby form the enclosed cleaning liquid passageway.
  • it additionally comprises markers on an inner surface of the main passageway adjacent the distal end of the tubular sheath to facilitate the placement of Attorney Docket No. B1272/20120 the image-receiving face of the laparoscope to a desired position within the main passageway proximally of the distal end of the tubular sheath.
  • the cleaning device of this invention additionally comprises a head configured for location outside the body of the patient when the elongated tubular section of the cannula is in the main passageway at the operative position.
  • the head comprises a first connector port in fluid communication with a proximally located portion of the enclosed suction passageway and a second connector port in fluid communication with a proximately located portion of the enclosed cleaning liquid passageway.
  • the inner sheath comprises at least one window therein configured to enable the visualization of the cannula therethrough.
  • the outer sheath comprises at least one window configured to provide an electrical path through the at least one window of the outer sheath and through the at least one window of the inner sheath.
  • the cleaning device comprises a releasably securable assembly enabling the cleaning device and the cannula to be slid with respect to each other to the operative position and to be releasably secured in the operative position.
  • the releasably securable assembly comprises a cam surface configured for engagement by a portion of the cannula to enable the portion of the cannula to slide along the cam surface and to be releasably secured in place with respect to the cam surface when the cannula is at the operative position.
  • Another aspect of this invention is a method for cleaning the distal end of a laparoscope extending through a cannula into the body of a patient while the cannula is within the body of the patient.
  • the cannula has an elongated tubular section including a longitudinal passageway having a distal end.
  • the laparoscope has a distally located image-receiving face.
  • the method comprises providing a cleaning device comprising a tubular sheath having a main passageway and a distal end.
  • the Attorney Docket No. B1272/20120 tubular sheath of the cleaning device is mounted on the elongated tubular section of the cannula so that the elongated tubular section of the cannula is located within the main passageway with the distal end of the elongated tubular sheath being located a predetermined distance proximally of the distal end of the cannula and within the body of the patient.
  • the image-receiving face of the laparoscope is located within the elongated tubular section of the cannula, wherein the image receiving face is located proximally of the distal end of the cannula and within a portion of the main passageway contiguous with the distal end of the tubular sheath.
  • Cleaning liquid is delivered through the tubular sheath to produce a jet of cleaning liquid within the portion of the main passageway contiguous with the distal end of the tubular sheath to wash the image-receiving face of any debris located thereon.
  • the cleaning device includes a chamber for receiving a charge of cleaning liquid from a source of cleaning liquid so that the cleaning device is in a first state, and wherein the cleaning device is configured to be placed in a second state under control of a user of the cleaning device, whereupon the cleaning device delivers the cleaning liquid to the image-receiving face to wash the image-receiving face and also delivers the suction to the distal end of the tubular sheath to withdraw the cleaning liquid and any debris from the image-receiving face in response to actuation by a user of the cleaning device, and wherein the delivery can be maintained by the user of the cleaning device after delivery of the cleaning liquid to the liquid receiving face.
  • FIG. 1 is a schematic diagram of one exemplary embodiment of a system constructed in accordance with this invention for cleaning the distally located image- receiving end of a laparoscope without removing the laparoscope from a cannula extending into the body of a patient, with the system include a cleaning sheath device and a cleaner actuating assembly;
  • Attorney Docket No. B1272/20120 Fig. 2 is an enlarged isometric view of a cleaning sheath device forming one portion of the system of Fig.
  • Fig.3 is an isometric view of the cleaning sheath device of Figs.1 and 2
  • Fig.4 is an isometric view the cleaning sheath device of Fig.3 shown mounted on a conventional cannula
  • Fig.5 is an enlarged longitudinal sectional view taken along line 5 – 5 of Fig.
  • Fig.6 is an enlarged top plan view, partially in section, of the cleaning sheath device mounted on the cannula of Fig.4;
  • Fig.7 is an enlarged isometric view of a portion of the cleaning sheath device shown in Figs.1 – 6;
  • Fig. 8 is a greatly enlarged top plan view of the distal end of one component of the cleaning sheath device shown in Fig. 8;
  • Fig. 9 is an enlarged longitudinal sectional view of the distal end of cleaning sheath device, the cannula and the laparoscope taken along line 5 – 5 of Fig.2;
  • FIG. 10 is an enlarged isometric view of the distal end of the structure shown in Fig.9;
  • Fig.11 is an enlarged end view of the distally located image receiving face of a laparoscope like shown in Fig.9;
  • Fig.12 is an isometric view, similar to Fig. 10, but without one component of the cleaning sheath device being shown;
  • Fig.13 is a greatly enlarged longitudinal sectional view of the distally located portion of the components of Fig.2 taken along line 5 – 5 of Fig.2;
  • Fig.14A is a schematic diagram of the cleaning actuating assembly shown in Fig.1 during one step in the method of using the system to clean the laparoscope while it is place withing the body of a patient;
  • Fig.14A is a schematic diagram of the cleaning actuating assembly shown in Fig.1 during one step in the method of using the system to clean the laparoscope while it is place withing the body of a patient;
  • FIG. 14B is a schematic diagram, like Fig. 14A, but showing the cleaning actuating assembly at subsequent step in the method of using the system to clean the laparoscope while it is place withing the body of a patient;
  • Fig. 15 is an enlarged isometric view of the interior of the distal end of the cleaning device as viewed by the laparoscope extending into the cleaning device at it Attorney Docket No. B1272/20120 desired operative location to clean the distal end face of the laparoscope; Fig.
  • FIG. 16A is an isometric view of another and more preferred exemplary embodiment of a system constructed in accordance with this invention for cleaning the distally located image-receiving end of a laparoscope without removing the laparoscope from a cannula extending into the body of a patient, with the system include a cleaning sheath device and an actuating assembly including an actuator, associated check valves and tubing;
  • Fig.16B is another isometric view of the system shown in Fig.16A.
  • Fig.17 is an enlarged isometric view of a cleaning sheath device forming one portion of the system of Figs.16A and 16B shown mounted on a conventional cannula and with a portion of a conventional laparoscope extending into the cannula;
  • Fig.18 is a top plan view of the cleaning sheath device of Figs.16A, 16B and 17;
  • Fig.19 is a bottom plan view of the cleaning sheath device of Figs.16A, 16B and 17;
  • Fig.20 is a left side elevation view of the cleaning sheath device of Figs.16A, 16B and 17;
  • Fig.21 is a right side elevation view of the cleaning sheath of Figs.16A, 16B and 17;
  • Fig.22 is an enlarged top plan view of a portion of the cleaning sheath device shown within the broken line oval designated by the number 22 in Fig.
  • Fig. 23 is an enlarged bottom plan view of a portion of the cleaning sheath shown within the broken line oval designated by the number 23 in Fig. 19, with the external sheath removed to show underlying features the internal sheath;
  • Fig. 24 is an enlarged left side elevation view of a portion of the cleaning sheath shown within the broken line oval designated by the number 24 in Fig.20, with the external sheath removed to show underlying features the internal sheath; Fig.
  • FIG. 25 is an enlarged right side elevation view of a portion of the cleaning sheath shown within the broken line oval designated by the number 25 in Fig.21, with the external sheath removed to show underlying features the internal sheath;
  • Fig. 26 is an enlarged front view of the cleaning sheath device of Figs. 16A, Attorney Docket No. B1272/20120 16B and 17;
  • Fig.27 is an enlarged back or rear view of the cleaning sheath device of Figs. 16A, 16B and 17;
  • Fig.28A is an isometric view of the cleaning sheath device of Figs.
  • FIG.28B is an enlarged isometric view of the distal end of the cleaning sheath device in the insertion state
  • Fig. 28C is an enlarged isometric view of the proximal end of the cleaning sheath device and cannula in the insertion state
  • Fig.29A is an isometric view of the cleaning sheath device of Figs.16A, 16B and 17 shown with a conventional cannula located in it what will be referred to as the sliding state
  • Fig.29B is an enlarged isometric view of the distal end of the cleaning sheath device in the sliding state
  • Fig.29A is an isometric view of the cleaning sheath device of Figs.16A, 16B and 17 shown with a conventional cannula located in it what will be referred to as the sliding state
  • Fig.29B is an enlarged isometric view of the distal end of the cleaning sheath device in the sliding state
  • Fig.29A is an isometric view of the cleaning
  • FIG. 29C is an enlarged isometric view of the proximal end of the cleaning sheath device and cannula in the sliding state
  • Fig.30A is an isometric view of the cleaning sheath device of Figs.16A, 16B and 17 shown with a conventional cannula located in it what will be referred to as the cleaning state
  • Fig.30B is an enlarged isometric view of the distal end of the cleaning sheath device in the cleaning state
  • Fig.30A is an isometric view of the cleaning sheath device of Figs.16A, 16B and 17 shown with a conventional cannula located in it what will be referred to as the cleaning state
  • Fig.30B is an enlarged isometric view of the distal end of the cleaning sheath device in the cleaning state
  • FIG. 30C is an enlarged isometric view of the proximal end of the cleaning sheath device and cannula in the cleaning state;
  • Fig.31 is an isometric view of the actuator of the actuator assembly;
  • Fig.32 is a reduced exploded isometric view of the actuator shown in Fig.31;
  • Fig.33 is a top plan view of the actuator shown in Fig.31;
  • Fig.34 is a longitudinal sectional view of the actuator taken along line 34 – 34 of Fig 33;
  • Fig. 35 is a longitudinal section view of the actuator shown connected to the check valves and the tubing sections making up the actuator assembly of the system shown in Figs.16A and 16B, wherein the actuator assembly is in what will be referred to as the flow neutral state;
  • Fig.31 is an isometric view of the actuator of the actuator assembly
  • Fig.32 is a reduced exploded isometric view of the actuator shown in Fig.31
  • Fig.33 is a top plan view
  • Fig. 36 is a longitudinal section view of the actuator shown connected to the Attorney Docket No. B1272/20120 check valves and the tubing sections making up the actuator assembly of the system shown in Figs.16A and 16B, wherein the actuator assembly is in what will be referred to as the flow depressing state;
  • Fig. 37 is a longitudinal section view of the actuator shown connected to the check valves and the tubing sections making up the actuator assembly of the system shown in Figs.16A and 16B, wherein the actuator assembly s in what will be referred to as the flow fully depressed state; and Fig.
  • “coupled” may also mean that two or more elements are not in direct contact with each other, yet still cooperate or interact with each other.
  • a phrase in the form “A/B” or in the form “A and/or B” means (A), (B), Attorney Docket No. B1272/20120 or (A and B).
  • a phrase in the form “at least one of A, B, and C” means (A), (B), (C), (A and B), (A and C), (B and C), or (A, B and C).
  • a phrase in the form “(A)B” means (B) or (AB) that is, A is an optional element.
  • Fig. 1A one exemplary embodiment of a system for cleaning the distal end of a laparoscope 10 extending through a cannula 20 into the body of a patient while the cannula is within the body of the patient so that it does not need to be removed for cleaning, thereby expediting the laparoscopic procedure.
  • the cannula typically will have been extended into the body of the patient via an obturator (not shown) and which is removed after the cannula has been so placed. At that point the laparoscope can be introduced through the cannula so that the image-receiving face of the laparoscope is within the operative field to give the surgeon a view of the operative field.
  • the system 1A basically comprises a cleaning device or instrument 100 and a cleaning actuating assembly 200, the details of each will be described later. However, before doing that the details of the construction of the laparoscope and the cannula will be described.
  • the laparoscope 10 and cannula 20 are each conventional devices, such as are available from various manufacturers and suppliers.
  • the laparoscope is an 8 mm Xi 30 laparoscope which forms a part of a conventional DaVinci Intuitive X/Xi robotic system.
  • the cannula is a conventional DaVinci 8 mm cannula forming a part of the DaVinci Intuitive X/Xi robotic system. It must be pointed out at this time that the subject invention is intended for use with any conventional laparoscope, whether manually operable or part of a robotic system, and can also be used with any type of cannula. Referring to Figs.
  • the exemplary laparoscope 10 basically comprises an elongated tubular body 10A terminating at a distal end face 10B.
  • the proximal end of the tubular body 10A is connected to structure (not shown) whose details need not be described since that structure is conventional and the subject Attorney Docket No. B1272/20120 invention doesn’t depend upon it.
  • the tubular body includes a longitudinally extending axis X (Figs. 5 and 13).
  • the distal end face 10B includes a planar central window 10C.
  • the planar end face 10B of the DaVinci Xi 30 laparoscope extends at an angle of 30 degrees to the longitudinal axis X.
  • a pair of laterally spaced-apart cameras 10D are located behind the central window 10C so that the central window serves as the image-receiving face of the laparoscope, with the two cameras providing the desired field of view.
  • a planar upper window 10E which serves as one light source.
  • a planar lower window 10F which also serves as another light source.
  • the upper and lower windows 10E and 10F, respectively, are coplanar and extend slightly distally of the plane of the central window 10C.
  • the light sources illuminate the field of view of the cameras 10D so that the user can view the anatomic structures within the operative field in which the laparoscope’s distal end is located.
  • the cannula 20 is best seen in Figs.
  • the tubular body 22 includes a distally located tubular section 26 (Fig. 2), an intermediate section 28, and a proximally located section 30.
  • the distally located section 26 has a central passageway 32 (Figs. 5 and 13) extending therethrough.
  • the inner diameter of the central passageway is slightly larger than the external diameter of the laparoscope, so that the laparoscope can freely fit therein, with the central longitudinal axis of the passageway 32 coincident with the central longitudinal axis X of the laparoscope so that the laparoscope can be slid longitudinally through the passageway and/or rotated about the central axis of the passageway.
  • the intermediate section 28 is conical in shape and flares outward to the proximally located cylindrical section 30.
  • the proximally located cylindrical section 30 includes a box-shaped portion 34 which projects outward therefrom.
  • the sealing section 24 is releasably securable to the body 22 and includes a gasket (not shown) to enable the tubular body 10A of the laparoscope to be extended through the cannula body 22 without any leakage of fluid through the interface between the gasket in the sealing section 24 and the exterior surface of the laparoscope’s tubular body 10A.
  • the cleaning device 100 basically comprises a sheath-like member configured to be mounted on the cannula with the laparoscope extending through the cannula. To that end, as best seen in Fig.
  • the cleaning device 100 basically comprises a distally Attorney Docket No. B1272/20120 located sheath section 102 and a head section 104.
  • the sheath section 102 is an elongated tubular member having a cylindrical sidewall 106, a distal end 108 and a proximal end 110.
  • the head section is a generally conically shaped member which is connected to the proximal end 110 of the sheath section.
  • a main passageway 112 extends the entire length of the sheath section from the distal end 108 to the proximal end 110.
  • the inner diameter of the main passageway 112 is approximately the same as outside diameter of the distal section 26 of the cannula so that the distal section of the cannula can be disposed therein with the distal end of the cannula located slightly proximally of the distal end of the sheath section.
  • the frictional engagement between the inner surface of the main passageway 112 of the cleaning device, and the exterior surface of the distal end section 26 of the cannula holds the cleaning device in place on the cannula. With the cleaning device being mounted on the cannula as just described it is in its operative position ready for use. The cleaning of the laparoscope’s image-receiving face will be described later.
  • the cleaning device 100 is configured so that the image-receiving face 10B of the laparoscope can be positioned within the cleaning device at a desired cleaning position. That cleaning position is shown in Fig. 10 and will be described later.
  • the sidewall 106 of the cleaning device 100 is formed of two sheaths (to be described later) and includes an enclosed cleaning liquid passageway 114 which extends from the proximal end of the section 102 to a terminal distal point which is also located slightly proximally, e.g., 13 mm, from the distal end of the sheath section 102. As best seen in Figs.
  • the 8 and 9 pair of internal ports 116 is located at the terminal distal point of the enclosed cleaning liquid passageway 114.
  • the internal ports are each circular bores of small diameter, e.g., approximately 1 mm and extend at an acute angle to the longitudinal axis, that angel may be from approximately 30 degrees to approximately 70 degrees. In the embodiment shown the angle is approximately 70 degrees to the axis X.
  • the internal ports 116 provide fluid communication between the enclosed liquid passageway 114 in the sidewall 106 and the main passageway 112 about which the sidewall extends.
  • the size, number, shape, and angle of the ports 116 is merely exemplary Attorney Docket No. B1272/20120 of various ports that can be used in the cleaning device of this invention to form the cleaning liquid jets depending upon the particular laparoscope to be cleaned.
  • the sidewall 106 of the cleaning device 100 also includes two longitudinally extending enclosed suction passageways 118 and 120 (Fig.
  • a pair of internal slots or ports 122 is located at the terminal distal point of each of the enclosed suction passageways 118 and 120.
  • the internal slots or ports provide fluid communication between the enclosed suction passageways 118 and 120 in the sidewall 106 and the main passageway 112 about which the sidewall extends.
  • the sidewall 106 is composed of two elongated tubes or sheaths, namely, an inner sheath 124 and an outer sheath 126.
  • the inner sheath 124 is in the form of a tube which is integral with the head section 104.
  • the outer sheath 126 is in the form of a heat shrinkable sleeve or tube which is heat shrunk about the outer peripheral surface of the inner sheath and which cooperates with longitudinally extending grooves or channels in the outer surface of the inner sheath to form the heretofore identified enclosed channels 114, 118 and 120.
  • the inner sheath 124 includes a longitudinally extending cleaning liquid channel 114A (Figs.6 - 8) in the outer surface of the inner sheath.
  • the channel 114A extends from the proximal end of the sheath section 102 to the terminal distal point of the cleaning liquid channel 114.
  • the heat shrinkable sleeve of the outer sheath 126 when the heat shrinkable sleeve of the outer sheath 126 is heat shrunk about the inner sheath 124 it seals off or encloses the top of the channel 114A, thereby forming the enclosed cleaning liquid channel 114.
  • the inner sheath 124 includes two longitudinally extending suction channels 118A and 120A (Figs. 6 - 8) which extend side-by-slide from the proximal end of the sheath section 102 to the terminal distal point of the enclosed suction passageways 118 and 120, respectively. Accordingly, when the heat shrinkable sleeve of the outer sheath 126 is heat shrunk about the inner sheath 124 it Attorney Docket No.
  • B1272/20120 seals off or encloses the tops of the channels 118A and 120A, thereby forming the enclosed suction channels 118 and 120, respectively.
  • the proximal end of the enclosed cleaning liquid passageway 114 is in fluid communication with a passageway or manifold 128 extending through a portion of the conically shaped head 104.
  • the manifold 128 terminates at an external barbed fitting or connector 132, which is configured to have a section of flexible tubing (to be described later) from the actuation assembly 200 connected thereto.
  • the proximal ends of the enclosed suction passageways 118 and 120 are in fluid communication with another passageway or manifold (not shown) extending through a portion of the conically shaped head 104. That other manifold terminates at an external barbed connector 130, which is configured to have a section of flexible tubing (to be described later) from the actuation assembly 200 connected thereto.
  • an external barbed connector 130 which is configured to have a section of flexible tubing (to be described later) from the actuation assembly 200 connected thereto.
  • inlet port 134 extends through the sidewall 106 approximately diametrically opposite to the ports 116 and 122.
  • the inlet port 134 is composed of a linear shaped elongated slot in the outer sheath 126 and a corresponding shaped slot in the underlying inner sheath 124 and which is coincident with the slot in the outer sheath.
  • the longitudinal axis of the elongated slots which form the inlet port 134 extend at approximately the same angle to the longitudinal axis X as the angle at which the image-receiving face 10B of the laparoscope is oriented, e.g., 30 degrees. Accordingly, as will be described later when the laparoscope is at the desired cleaning position, such as shown in Fig. 10, the inlet port 134 will be immediately adjacent that image-receiving face 10B.
  • the port 134 enables biological material and debris in the operative field contiguous with the distal end of the cleaning device 100 to be drawn into the main passageway where it will mix with the cleaning liquid ejected from the cleaning liquid ports 116 washing the image-receiving face 10B.
  • the laparoscope 10 has two degrees of freedom that must be adjusted to initiate effective cleaning of its image- receiving face with respect to the cannula and cleaning device, namely, rotation about the laparoscope’s longitudinal axis X and longitudinal displacement along that axis.
  • the cleaning device 100 preferably includes plural guide markers or hash marks.
  • Those Attorney Docket No. B1272/20120 guide markers or hash marks can be be printed, embossed, cut or applied with an adhesive backed printed sheet on the inner surface of the main passageway 112 of the cleaning device adjacent the distal end thereof.
  • the guide markers or hash marks are made up of embossments or shallow grooves which form of a longitudinally extending mark line 136 and two transversely extending mark lines 138 and 140.
  • the two transversely extending mark lines 138 and 140 perpendicularly intersect the longitudinally extending mark line 136.
  • the guide markers are located between the suction ports 122 and the inlet port 134. Accordingly, when the user of the subject invention is positioning the laparoscope to the desired cleaning position, he/she will move/orient the laparoscope so that it is longitudinally aligned with the longitudinally extending mark line 136, with its image-receiving face 10B being located between the transverse mark lines 138 and 140.
  • guide markers as just described are merely exemplary of various visual guides or hash marks that can be provided to facilitate proper location of the laparoscope for cleaning. Thus, the design of the hash marks can take several forms.
  • the head of 104 of the cleaning device includes a pair of spaced apart parallel elongated alignment tabs 142.
  • the alignment tabs are configured to engage the proximal cylindrical section 28 of the cannula, with the box-like projection 34 of the cannula being located between the alignment tabs like shown in Figs. 4 and 5, whereupon the cleaning device 100 will be deemed to be in its operative position ready for use to clean the laparoscope.
  • the releasable securement of the cleaning device on the cannula to attach it rigidly to the cannula during use so that it does not come off or move to inhibit proper use of the DaVinci robotic surgical system (or any other robotic or manual system) is achieved by a releasable locking feature of the cleaning device 100.
  • locking feature is provided by a tight fit of the main passageway 112 of the cleaning device on the tubular section 102 of the cannula 20, utilizing friction to keep the cleaning device immobilized.
  • the alignment tabs engaging the proximal section of the cannula on both sides of the box-like structure 34 serve to prevent rotation. If desired, an additional releasably securable locking Attorney Docket No.
  • the cleaning actuating assembly 200 is configured for coupling to the cleaning device 100 in the operative position to provide a cleaning liquid from a cleaning liquid source, whereupon when the cleaning actuating assembly is actuated the cleaning liquid will be sprayed under high pressure on the image-receiving face of the laparoscope as an abrasive to dislodge and stuck biological debris therefrom.
  • the cleaning liquid may be the following substances: common hospital saline, anti-fog solution, sterile water, or another liquid that is safe for surgical use.
  • the cleaning actuating assembly 200 also provides the suction used by the cleaning device 100 to remove the cleaning fluid and biological debris during and after cleaning. To that end, the cleaning actuating assembly 200 is configured to be releasably connected to a source of negative pressure or vacuum, such as hospital suction line or a portable suction system, to provide the necessary suction for the proper operation of the cleaning device.
  • the cleaning actuating assembly 200 basically comprises a control switch 144, a dispenser 146, Y-connectors 148 and 150, check valves 152, 154, and 156, and plural sections of flexible tubing (to be described later).
  • the control switch 144 is a five-way switch (whose details will be described shortly), such as Model: s17112400wm0528 available from Unique Bargains. While that particular embodiment of the control switch 144 has proved effective in a laboratory to demonstrate the operability of the cleaning actuating assembly, it would not be suitable for clinical use on a patient.
  • dispenser 146 basically comprises a pneumatic cylinder 158, a cleaning liquid cylinder 160, a piston assembly 162 and a gasket 186.
  • the liquid cylinder 160 includes a first chamber 164 and a fourth chamber 166.
  • the first chamber forms the cleaning liquid holding chamber.
  • the pneumatic cylinder 158 includes a second chamber 168 and a third chamber 170.
  • the second chamber forms a suction chamber.
  • the gasket is interposed between the pneumatic cylinder 158 and Attorney Docket No.
  • the piston assembly 162 comprises a first piston head 172, a second piston head 174 and a connecting shaft 176 connecting the two piston heads.
  • the connecting shaft 176 passes through an opening in the gasket 186, with the portion of the gasket contiguous with the opening forming a fluid tight interface between the gasket and the connecting shaft.
  • the first piston head is in the liquid cylinder and isolates the first chamber from the fourth chamber of the liquid cylinder.
  • the second piston head 174 is in the pneumatic cylinder and isolates the second chamber from the third chamber of the pneumatic cylinder.
  • the piston assembly 162 is slidably mounted within the liquid dispenser so that it can be slid from left to right and right to left and as shown in Figs.14A and 14B.
  • the normal or quiescent state of the actuating assembly 200 is shown in Fig. 14A and is the state in which the first chamber 164 of the liquid cylinder is charged with a predetermined volume of cleaning liquid, i.e., the maximum volume of the first chamber, so that the user of the cleaning device 100 can, when desired, clean the viewing face of the laparoscope.
  • the cleaning liquid charging action is accomplished as follows.
  • Negative pressure from a negative pressure source is coupled by a section of flexible tubing through a cleaning liquid/debris collecting bag, cannister or bottle (not shown) which is interposed between the negative pressure source and the five-way switch 144.
  • the state of the switch 144 is shown diagrammatically in Fig. 14A. In that state the vent 182 to the atmosphere is closed as indicated by the bold X in Fig. 14A.
  • the negative pressure (suction) is coupled through the switch 144 to a section of flexible tubing 178B and from there to the second chamber 168 of the pneumatic cylinder.
  • the first chamber includes a port connected via a section of flexible tubing 178C one port of the Y-connector 148.
  • a second port of the Y- connector 148 is connected via a section of flexible tubing 178D to one side of the check valve 152.
  • the other side of the check valve 152 is connected to a source of cleaning liquid, e.g., a bag, a cannister, bottle, syringe, etc.
  • the third port of the Y-connector 148 is connected to one side of the check valve 154.
  • the other side of the check valve 154 is connected to a section flexible tubing 178G to the liquid inlet port 132 of the cleaning device 100.
  • the fourth chamber 166 includes a vent to the ambient atmosphere. Accordingly, when the piston assembly is pulled to the left by the suction applied to the second chamber 168 of the pneumatic cylinder any air in the fourth chamber will vent to the ambient atmosphere.
  • the movement of the first piston head 172 to the left results in the increase in the volume of the first chamber 164, whereupon cleaning liquid from the cleaning liquid source passes through the tubing section 178F, the check valve 152, through the Y- connector 184 and out through the tubing section 178C into the first chamber 164, thereby filling or charging that chamber.
  • the check valve 154 is closed so that the cleaning liquid entering the Y-connector 148 from the cleaning liquid source is blocked from passing into the tubing section 178G and from there into the liquid input port of the cleaning device.
  • the check valve 154 may be a pop-off type of check valve which requires a predetermined pressure to open, so that it doesn’t leak.
  • the 5-way switch 144 includes a vent 180 to the ambient atmosphere.
  • the vent 180 is coupled through the switch 144 to a section of flexible tubing 178H and from there to one port of the Y-connector 150. From there the air at ambient pressure passes to a second port of the Y-connector 150 and from there to a section of tubing 178I into the third chamber 170.
  • the third port of the Y- connector 150 is connected to a tubing section 178J, which is connected to one side of the check valve 156.
  • the check valve 156 is closed at this time and is also preferably a pop-off check valve.
  • the ambient air pressure which is applied to the Y-connector 150 and hence to the flexible tubing section 178J is precluded from passing through the check valve 156 to the flexible tubing section 178K connected to the suction input port 130 of the cleaning device.
  • air or any insufflation gas which is within the operative space into which the laparoscope is extended is precluded from venting to the ambient atmosphere.
  • This action is important to ensure that slight positive pressure, e.g., 2 psi, is maintained within the operative space, since loss of that positive pressure could impede the laparoscopic surgical procedure from being accomplished.
  • the user e.g., the surgeon
  • the five-way switch 144 includes a manually activatable momentary button 144A which is configured when depressed to initiate operation of the cleaning of the laparoscope since the liquid cylinder will have been charged with the cleaning liquid.
  • Manually depressing the button 144A by the user, e.g., surgeon causes the switch 144 to be in the state shown therein, wherein the vent 180 of the switch 144 closes, as shown by the bold X in Fig.14B, and the vent 182 of the switch 144 opens.
  • the opening of vent 182 enables air at atmospheric pressure to pass through the switch and the section of flexible tubing 178B to the second chamber 168 of the pneumatic cylinder.
  • suction from the source of negative pressure is coupled through the switch 144 to the section of flexible tubing 178H to the first port of the Y-connector 150 and from there to the second port of the Y-connector, whereupon suction is applied via the flexible tubing section 178I to the third chamber 170 of the pneumatic cylinder. That suction causes the second piston head 174 to be drawn or slid to the right as shown in Fig.
  • the liquid flows through the manifold 128 into the proximal end of the liquid carrying passageway 114, from whence it flows out of the two liquid ports 116 as bursts or jets of the cleaning liquid.
  • the bursts or jets of cleaning liquid is directed by those ports at an angle of approximately seventy degrees to the image-receiving face of the laparoscope to wash it.
  • some of the ejected cleaning liquid may ricochet off of the inner surface of the passageway 112 and back into engagement with the image-receiving surface, thereby enhancing the washing operation.
  • the suction in flexible tubing section 178H is coupled via the third port of the Y-connector 150 to the section of flexible tubing 178J and from there to one side of the check valve 156, whereupon that check valve opens. Accordingly, suction is provided via the section of flexible tubing 178K to the suction input port 130 of the cleaning device. From there the suction passes through the associated manifold in the head 104 to the proximal ends of the side-by- side enclosed suction passageways 118 and 120 in the sidewall of the tubular section 102.
  • That suction is transmitted to the suction slots 122 at the distal end of those passageways, whereupon any cleaning liquid and debris within the distal end of the cleaning device is carried into those passageways and back through the cleaning device and out of the suction port 130 into the flexible tubing section 178K. From there the cleaning liquid and debris passes through the actuating assembly into the section of flexible tubing 178A. From there the cleaning liquid and debris flows into a collection receptacle, e.g., a cleaning liquid/debris collecting bag, cannister, bottle or other hollow collector (not shown) which is interposed between the tubing section 178A and the source of suction, where it is collected and thus prevented from entering the source of suction.
  • a collection receptacle e.g., a cleaning liquid/debris collecting bag, cannister, bottle or other hollow collector (not shown) which is interposed between the tubing section 178A and the source of suction, where it is collected and thus prevented from entering the source of suction.
  • FIG.16A and 16B there is shown a more preferred exemplary embodiment of a system 1B constructed in accordance with this invention for cleaning the distally located image-receiving end of a laparoscope without removing the laparoscope from a cannula extending into the body of a patient.
  • the system 1B is similar in many respects to the system 1A in that it includes a cleaning device or instrument 300, an actuating assembly 400 and a shipping mandrel 16 which will be placed inside of the cleaning device 300 for shipping purposes to maintain the size and shape of the cleaning device in transit and sterilization. This part may or may not be needed in future iterations of this system, with different sterilization methods.
  • the cleaning device 300 will be described in detail later.
  • the actuating assembly 400 is coupled to the cleaning device 300 to control the operation thereof. It basically includes an actuator 202, a first section 204 of flexible tubing, a second section 206 of flexible tubing, a Y-connector 208, a third section 210 of flexible tubing, a fourth section 212 of flexible tubing, a fifth section 214 of flexible tubing, a first check valve 216, a second check valve 218, a pinch clamp 218, and conventional flexible tubing connectors 220.
  • Attorney Docket No. B1272/20120 The details of the actuator will be described later.
  • the actuator includes a first barbed connector forming a first port 222 of the actuator, a second barbed connector forming a second port 224 of the actuator, and a third connector 226 (Figs 31 – 38) forming a third port of the actuator.
  • the first port can also be referred to as the suction input port of the actuator since it is configured to be coupled to one end of the tubing section 206.
  • the opposite end of the tubing section 222 is in the form of a coupling or connector 226 which is configured to be connected to a collection receptacle, which in turn is configured to be connected to a suction supply, e.g., a standalone suction pump and cannister or the suction line of a hospital or some other medical facility where the laparoscopic procedure using the subject system 1B will be accomplished.
  • the collection receptable can be of the type discussed with reference to system 1A.
  • the second port 224 can also be referred to as the suction outlet port of the actuator. It is configured to be coupled to one end of the flexible tubing 206 section, the other end of which is connected to the suction port 130 of the cleaning device, whereupon suction provided from the actuator is delivered to the cleaning device.
  • One leg of the Y-connector 208 is connected to a connector forming the third port 226 of the actuator. Another leg of the Y-connector connected by a suitable connector to one end of the flexible tubing section 210. The opposite end of the flexible tubing section 210 is connected to the check valve 216. That check valve is configured to be connected to a source of cleaning liquid, e.g., saline, like that used in system 1A by a flexible tubing section 210A (figs. 35 – 38). Another leg of the Y-connector connected by a connector 220 to one end of the flexible tubing section 212. The opposite end of the flexible tubing section 212 is connected to the check valve 218.
  • a source of cleaning liquid e.g., saline
  • That check valve is connected to one end of the flexible tubing section 214.
  • the opposite end of the flexible tubing section 214 is connected to the barbed connector 132 of the cleaning device 300, which barbed connector serves as the inlet port for the cleaning liquid.
  • the pinch clamp 206 is mounted on the flexible tubing section 206 to isolate the source of suction from the system 1B when desired, e.g., in the event of the emergency where suction is not automatically turned off by the operation of the actuator, thus evacuating abdominal insufflation (pneumoperitoneum).
  • the cleaning device 300 differs from the cleaning device 100 is some respects but is similar in construction and operation in many other respects.
  • the actuating assembly 400 also differs from the actuating assembly 200 in many respects but operates in a somewhat similar manner as will be described in detail later.
  • the inner sheath 324 is similar to the inner sheath 124 except that it includes three rectangularly shaped windows 302, 304 and 306 (Figs.23, 24 and 25) and three sloped ridges 308, 310 and 312.
  • the three sloped ridges 308, 310 and 310 are provided to enhance the securement of the heat shrunk outer sheath 126 onto the inner sheath 124, e.g., they provide additional grip to prevent slippage of the outer sheath on the inner sheath.
  • the midsection of the outer sheath 126 includes three circular windows 314, 316 and 318 which are located over the windows 302, 304 and 306 of the inner sheath, respectively.
  • the windows of the inner sheath are provided to enable the user of the system 1B to visualize insertion markers, e.g., laser-marked lines, on the side of the cannula to know how far to insert the trocar for robotic use since the material making up the inner sheath, e.g., polycarbonate, nylon or polyethylene, of the cleaning instrument is opaque.
  • the user can see the markers on the laparoscope through the windows of the inner sheath 124 and through the windows of the outer sheath 126.
  • the windows of both sheaths also provide a conductive path for electricity to minimize the chance of injury to internal organs or tissue of the patient with the use of a plastic cannula with monopolar energy.
  • the cleaning device 300 includes markers to allow the user of the subject invention to position or “drive” the laparoscope’s image- receiving face to the correct position for optimal cleaning. However, those markers are slightly different than the markers of the cleaning device 100. As can be seen in Figs.22, 24, 29B, and 30B the markers are in the form of two generally T-shaped cuts 136A and 136B. The central legs of the two T-shaped cuts are axially aligned and extend parallel to the central longitudinal axis X of the cleaning device to define a longitudinally extending mark line similar to mark line 136 of the cleaning device 100.
  • the head portions of the T-shaped cuts are disposed opposite each other and extend perpendicular to the longitudinal axis X to form two transversely extending mark lines similar to mark lines 138 and 140 of the cleaning device 100.
  • the guide Attorney Docket No. B1272/20120 markers are located between the suction ports 122 and the inlet port 134. Accordingly, when the user of the subject invention is positioning the laparoscope to the desired cleaning position, the user will move/orient the laparoscope so that it is longitudinally aligned with the longitudinally extending mark line, with its image-receiving face 10B being located between the transverse mark lines.
  • the head 104 of the cleaning device 300 is similar to the head 104 of the cleaning device 100 in that it includes the heretofore identified barbed connectors 130 and 132, which serve as the suction and cleaning liquid ports, respectively.
  • the barbed connecter 132 of the cleaning device 300 is smaller in size than the connector 132 of the cleaning device 100.
  • Other portions of the head 104 of the cleaning device 300 differ considerably.
  • the head 104 does not include the pair of spaced apart parallel elongated alignment tabs 142 for releasably securing the cleaning device onto the cannula in the operative position.
  • the cleaning device 300 includes a hollow body 320 configured for receipt of the proximally located section 30 of the cannula.
  • a recess or slot 322 is located in the hollow body and extends parallel to the longitudinal central axis X.
  • the slot 322 includes a bottom edge 324 which forms a stop (to be described later).
  • the proximal portion of the body is in the form of a wall 326 whose proximal edge includes a helical ramp 328 extending about the central axis X and which terminates in a hook-like portion 330.
  • the helical ramp 328 terminates in a slight depression or recess 328A having a generally flat bottom surface.
  • the proximal end of the hook-like portion includes an inner surface 332.
  • the actuator assembly 400 will be described shortly. Before doing that a brief discussion of the changes of the actuator assembly 400 from the actuator assembly 200 is in order.
  • the actuator assembly is like the actuator assembly 200 shown in Figs. 1, 14 A and 14B in that it controls suction coming from the cleaning device 100 and cleaning liquid, e.g., saline, going to the cleaning device 100.
  • the actuator is configured to operate manually as a momentary switch to express or eject the cleaning liquid with the force of the user’s hand.
  • system 1B includes a Y-connector 208 which is comparable in function to the Y-connector 148 of the system 1A. It also has check valves 216 and 218 comparable to check valves 152 and 154 of the system 1A.
  • the cleaning device 300 also has a pneumatic Attorney Docket No. B1272/20120 and cleaning cylinder, but the cylinders are of the same diameter and share one continuous outer wall of the actuator’s body and has the same amount of chambers.
  • the inner cylinders no longer have a rigid connecting shaft. They are two separate bodies.
  • the first chamber works the same, as a pump with two check valves. As it goes up it takes cleaning liquid from the cleaning liquid source and pushes it to the cleaning device.
  • the actuator assembly 400 largely differs at this point from the actuator assembly 200.
  • the five-way valve is now integrated into the pistons.
  • the actuator includes an integral body 230 formed of a rigid plastic such as polycarbonate, nylon or polyethylene.
  • the body includes a tubular section 232 whose intermediate portion is in the form of the two heretofore identified ports 222 and 224.
  • a central bore 234 (Fig.34) extends from the proximal end of the tubular section to a point adjacent the distal end of the tubular section.
  • the distal end of the tubular section is in the form of a conventional threaded connector 236 (e.g., a male luer lock), which forms the heretofore identified third port 226 of the actuator.
  • the proximal end of the body 230 is in the form of a outwardly projecting handle 238.
  • An internal passageway or channel 240 extends from the suction input port 222 to the central bore 234.
  • An internal passageway or channel 242 extends from the suction outlet port 224 to the central bore 234.
  • Other components of the actuator are located within the central bore 234. Those components are best seen in Figs. 32 and 34.
  • the proximal piston 244 serves to control the application of suction to the cleaning device, and thus may also be referred to as the suction piston. It is formed of a rigid plastic such as nylon, polyethylene or polycarbonate and includes three annular recesses 254 in which respective O-rings 252A, 252B, and 252C are located to form fluid-tight seals between the portions of the piston at which they are located and the inner surface of the central bore 234 thereby forming a chamber 288 (to be described later) therebetween.
  • the proximal end of the central bore 234 is closed off by a cap 256 formed of rigid plastic such as nylon, polyethylene or polycarbonate.
  • the cap 256 is secured to the handle 238 by a pair of socket head flat screws 258 (Fig. 32) extending through threaded holes 260 in the cap and into internally threaded holes 262 in the handle 238.
  • Attorney Docket No. B1272/20120 The cap 256 includes a central hole 264 through which the proximal end of the proximal piston 244 extends.
  • the distal piston 246 serves to control the application of the cleaning liquid to the cleaning device, and thus may also be referred to as the cleaning liquid piston.
  • the distal piston is fluted, i.e., includes a plurality of longitudinally extending grooves 246A equidistantly spaced about the periphery of the distal piston.
  • the grooves 246A are provided for the purpose of allowing for venting through holes 290 if it is required for the pistons to move independently and removing risk of pressure forming, discussed later.
  • the distal plunger 248 is a resilient member formed of a soft rubber or rubber- like material such as isoprene, silicone, or Buna-N rubber and is mounted on the distal end face of the distal piston.
  • the distal piston includes a projecting flange 266 which fits tightly within a correspondingly shaped recess in the distally located face of the distal plunger 238.
  • the portion of central passageway 234 located distally of the distal plunger forms a chamber 268 (Fig.32) for holding the cleaning liquid.
  • the bottom 270 of the central bore 234 includes an annular recess 272 contiguous with the inner surface of the central bore.
  • the distal spring 250 is a helical compression spring formed of stainless steel such as 302 or 316 SS and is interposed between the bottom of the annular recess 272 and the front or distal face of the distal plunger 248.
  • the distal spring serves to bias the plunger 248 and the components located within the central bore proximally of the plunger, i.e., the distal piston 246, the proximal piston 244, and the O-rings 252A, 252B, and 252C in the proximal direction for reasons to be described later.
  • a tapered passageway 274 (Fig. 32) extends along the central longitudinal axis X of the actuator from the bottom 270 of the chamber 268 to the threaded connector 236.
  • the passageway 274 serves to enable the filling of the cleaning liquid chamber 268 with a charge of cleaning liquid (e.g., saline) and the ejection of the charge of the cleaning liquid into the cleaning device 300 during use of the system 1B as will also be described later.
  • the filling of the cleaning liquid chamber and the ejection of the charge of cleaning liquid therefrom is under manual control of the user of the actuator.
  • the proximal end of the proximal piston is in the form of an elongated shaft 276 Attorney Docket No. B1272/20120 which extends through the opening 264 of the cap and terminates in a socket 278 in the underside of the thumb cap 280 at the proximal end of the shaft 276.
  • the thumb cap is configured to be pressed down by the thumb of the user of the actuator, while the user’s fingers are held under the handle 238 to manually operate the actuator, as will also be described later.
  • the actuator includes a second helical compression spring 282 which is formed of stainless steel such as 302 or 316 SS.
  • the proximal end of the compression spring 282 is located within an annular recess 284 in the underside of the thumb cap 280 and surrounding the socket 278.
  • the distal end of the compression spring 282 is located within an annular recess 286 in the proximal end face of the cap 256.
  • the thumb cap 280 is formed of a rigid plastic such as nylon, polyethylene or polycarbonate and serves to bias the proximal piston and the thumb cap 280 in the proximal direction, during operation of the actuator as will also be described later.
  • a rigid plastic such as nylon, polyethylene or polycarbonate
  • the portion of the proximal piston located between the proximally located O-ring 254A, the intermediately located O-ring 254B, and the inner surface of the central bore 234 located between those O-rings forms a second chamber 288.
  • That chamber can be referred to as a bridging chamber and serves to either isolate the channel 240 and its associated inlet suction port 222 from the channel 242 and its associated outlet suction port 224 during one phase in the use of the actuator and to enable fluid communication between those channels to provide suction to the cleaning device during another phase in the use of the actuator as will also be described later.
  • the tubular section 232 of the actuator body includes three vent holes 290 at equidistant spacing around the periphery of the tubular section (although only one of which vent holes can be seen in the figures). As best seen in Fig.
  • vent holes are located between the distal and proximal pistons when the actuator is in its flow fully depressed state to be described later so the suction can turn off in the event that the system 1B runs out of cleaning fluid. If the system included only a single integral piston for both suction and cleaning liquid, and the system ran out of cleaning liquid that piston would not be able to return due to suction in the distal chamber. However, with the separate piston design of the actuator 300, if the system runs out of cleaning liquid, the suction piston can return irrespective of the fluid piston position. Operation of the system 1B will now be described.
  • the cleaning instrument 300 and the cannula 20 to be used e.g., a da Vinci intuitive cleaning cannula (but Attorney Docket No.
  • B1272/20120 could be any cannula robotic or otherwise) are typically assembled on a back table in the operatory prior to use in the surgery by a nurse or other surgical assistant.
  • the tubular distal end portion 22 of the cannula 20 is introduced into the main passageway 112 of the cleaning instrument 300 and slid in the distal direction so that the box-shaped portion 34 of the cannula 20 enters a rectangular shaped slot or recess 322 in the cleaning instrument.
  • the cannula and cleaning instrument are continued to be slid together until the distal end of the box-shaped portion 34 engages the distal- most portion of the recess which acts as a stop 324 as shown clearly in Figs. 17.
  • the cleaning device and the cannula extending into it will be in what can be referred to as the “insertion state” ready to be inserted into the body of the patient.
  • the cannula will be releasably secured in the insertion state by the tight fit of the main passageway 112 of the cleaning device on the tubular section 102 of the cannula as discussed above with reference to system 1A.
  • the insertion state which is shown in Fig. 28A and 28C
  • the distal end of the cannula will be located at a desired position, i.e., approximately flush with the distal end of the cleaning instrument as shown in Fig. 28B.
  • This position is intended for insertion of the cannula through the abdominal wall and into the abdominal cavity with the use of an obturator, whereupon the cleaning instrument 300 can be said to be in its normal or quiescent state.
  • the user e.g., the surgeon, can then extend the image-receiving face of the laparoscope through the cannula 20 so that it is outside the distal end 108 of the cleaning device 300, and then can orient that combination of components so that the image-receiving face 10B is oriented in the direction that the surgeon wishes to view.
  • the cleaning device and the cannula must be moved into what will be referred to as the “sliding state”.
  • the cleaning instrument is pushed forward (distally) with respect to the cannula until the cleaning instrument is located at a position for cleaning the Attorney Docket No. B1272/20120 image-receiving face 10B of the laparoscope.
  • the cleaning state When the cleaning instrument has been extended to the cleaning position the cannula and instrument will be in what can be referred to as the “cleaning state”.
  • the extension or pushing of the cleaning instrument with respect to the cannula in the sliding state is shown in Fig. 29A and 29C and is achieved by grasping the cannula seal 24 and rotating it clockwise about the longitudinal axis X of the cannula. That action causes a surface 24A of the cannula seal 24 (Figs.
  • That action causes the hook shaped portion 330 to flex slightly thereby releasably trapping or snap-fitting the portion of cannula seal between the surfaces 24A and 24B between the surfaces 332328A.
  • the flat recess 328A, the surface 332 of the hook-like portion 330, and the portion of the cannula seal 24 between surfaces 24A and 24B cooperate to form a detent or locking mechanism releasably holding the cleaning device in its cleaning state.
  • the distal end of the cleaning device will be located a predetermined distance, e.g., approximately 18 mm distally, of the distal end of the cannula as shown in Fig.30B.
  • the cleaning instrument In that position the cleaning instrument is in its operative position wherein the ports 116 and 122 of the cleaning instrument are fully exposed and located immediately proximally of the distal end of the cannula so that the image-receiving face of the cannula is in position to be cleaned by the jets of cleaning liquid ejected through ports 116 as described earlier. It should be noted at this juncture that other releasably securable locking mechanisms can be used in lieu of the components described above to releasably secure the cleaning device on the cannula at the operative position.
  • releasably securable locking mechanisms are as follows: rubber material to increase friction and decrease sliding, a toggle switch to turn or off a retention mechanism, a hose clamp type mechanism that could tighten around the shaft of the cannula.
  • Figs. 35 – 38 the operation of the actuator 202 to clean the Attorney Docket No. B1272/20120 image-receiving face of the laparoscope will now be described.
  • Fig. 35 shows the system 1B wherein the actuator 202 of actuating assembly 400 is in its flow neutral state connected to the cleaning device 300.
  • the actuator 202 with its suction inlet port 222 is connected to tubing section 206, with the opposite end of that tubing section being connected via a connector 220 to a receptable (not shown) for collection of the liquid and debris from the patient.
  • the receptacle is itself connected to a source of suction, e.g., a hospital’s suction line or a standalone suction pump and canister.
  • the suction outlet port 224 of the actuator 202 is connected to the tubing section 204, whose opposite end is connected to the suction port 130 of the cleaning device 300.
  • the port 226 of the actuator is connected to a first leg of the Y-connector 236.
  • a second leg of the Y-connector 106 is connected to tubing section 210, whose opposite end is connected to the check valve 216.
  • the check valve 216 is connected via another section of flexible tubing (not shown) to the source of cleaning liquid (not shown).
  • the third leg of the Y-connector 236 is connected to the tubing section 212, whose opposite end is connected to the check valve 218.
  • the check valve 218 is connected to the tubing section 214 whose opposite end is connected to the liquid inlet port 132 of the cleaning device. In the flow neutral state, the cleaning liquid chamber will have been filled with a charge of cleaning liquid.
  • the channel 240 will be in fluid communication with the bridging chamber 288.
  • the channel 242 will be isolated from the bridging chamber by the O-ring 252A.
  • the check valve 216 which is in the path from the source of cleaning liquid, will be closed so that no cleaning liquid will flow into the cleaning liquid chamber from the cleaning liquid source during the flow neutral state.
  • the check valve 218, which is in the path carrying cleaning liquid to the tubing section 214 and from there to the cleaning device 300 will be closed, so that no cleaning fluid will be delivered to the cleaning device.
  • the user will place their thumb on the thumb cap 280, while their fingers are under the handle 238, whereupon the thumb cap is depressed to cause the actuator to be in its flow depressing state shown in Fig. 36
  • the depression of the thumb-cap will move the proximal piston 240 downward (distally) against the bias provided by the springs 282 and 250. That action will move (slide) the distal piston 266 with the distal plunger 238 downward, Attorney Docket No. B1272/20120 whereupon the volumetric capacity of the cleaning liquid chamber 268 will be reduced to cause the cleaning liquid to start to be ejected from the cleaning liquid chamber.
  • That ejected cleaning liquid will flow through the passageway 274, the port 226, the Y-connector 208, the tubing section 212, the check valve 218 (which will now open) to the tubing section 214 and from there to the liquid input port 132 of the cleaning device. From that port the cleaning liquid will flow as described above with reference to system 1A to exit the ports 116 in liquid jets to wash the image-receiving face of the laparoscope. Moreover, the movement of the proximal piston distally will bring the bridging chamber 288 into fluid communication with the channel 242, whereupon suction from the suction source will be brought to the suction outlet port 224, from whence it will flow through the tubing section 204 to the suction input port 130 of the cleaning device.
  • the suction applied to the port 130 will be carried through the cleaning device as described above with respect to system 1A to withdraw the cleaning liquid and any biologic material or other debris washed from the image- receiving face of the laparoscope out of the cleaning device 300. That removed liquid/debris will flow from the through the tubing section 204 into the port 224 and its communicating channel 242 into the bridging chamber 288. From the bridging chamber the liquid/debris will flow through the channel 240 and its communicating port 222 into the tubing section 206, from whence it will be carried to the collection receptacle (not shown). Continued downward pressing of the thumb-cap will move the proximal piston, the distal piston, and the distal plunger to its bottom-most position like shown in Fig.
  • the actuator can be said to be in its flow fully depressed state.
  • the cleaning liquid chamber will be at its smallest volumetric capacity, whereupon the charge of cleaning liquid will have been ejected from the cleaning chamber 268.
  • the check valve 218 will close, thereby preventing any further delivery of cleaning liquid which may still be in the cleaning liquid chamber from being delivered to the cleaning device 300.
  • suction will continue to flow through the actuator to carry any further liquid/debris from the cleaning device to the collection receptacle.
  • the user can hold the thumb cap down as long as desired to withdraw as much liquid/debris from the site as necessary or desirable. Once that has occurred the user Attorney Docket No. B1272/20120 can release the pressure on the thumb cap, whereupon the bias provided by the springs 250 and 282 will carry the distal plunger 248, the distal piston 246, and the proximal piston 244 upward (in the proximal direction) like shown in Fig. 38, whereupon the volumetric capacity of the liquid chamber will begin to increase and the actuator will be in its flow returning state. In that state suction will still be applied to the cleaning device via the bridging chamber.
  • the increase in the volumetric capacity of the liquid chamber will result in negative pressure in that chamber, which negative pressure is conveyed to the check valve 218 via the passageway274, the port 226, the Y-connector 208 and the tubing section 212. That negative pressure will cause the check valve 218 to close, thereby halting the flow of cleaning liquid to the cleaning device.
  • the actuator When the distal plunger 238, the distal piston 266, and the proximal piston 244 have moved to their maximum proximal position, the actuator will have returned to the flow neutral position like shown in Fig.35, whereupon the liquid chamber will be fully filled with a fresh charge of cleaning liquid, and the suction input port 222 will again be isolated from the suction output port 224 by the position of the bridging chamber 288.
  • the subject invention provides various clinical advantages over the prior art. They are: (1) reduced operative time due to better visibility and reduced time for each cleaning; (2) reduced risk of adverse event due to better visibility; (3) reduced stress on surgeons operating around obscured vision; and (4) increased surgeon autonomy and decreased reliance on surgical staff.
  • the subject invention has the Attorney Docket No.
  • actuating assembly components may be integrated into a single structure which could be mounted on the cleaning device or may merely be coupled to it and to the source of negative pressure and the source of the cleaning liquid by flexible tubing or other suitable conduits.
  • the cleaning device may be formed as an integral or one- piece unit, such as by 3-D printing, instead of being composed of an inner sheath and an outer sheath heat shrunk or otherwise tightly disposed about the inner sheath.
  • the cleaning device of this invention may include some other type of detent or locking mechanism to releasably lock it in place on the cannula to prevent accidental displacement or disconnection therefrom.
  • the markers or hash marks on the inner surface of the inner sleeve of the cleaning device of this invention which serve as the guides for proper positioning of the cleaning sheath device on the cannula may take different forms than those shown and described. For example, they may constitute printed indicia in lieu of embossments shown, or may constitute adhesively secured markers.
  • the marker or hash marks may be a plurality of lines in both longitudinal and radial directions to give the surgeon a range of cleaning locations and to accommodate laparoscopes with multiple cameras for right and left eye vision.
  • the amount of cleaning liquid per cleaning (or button press) can be limited to a discrete increment (e.g., 1 ml, 2 ml, 3 ml, 4 ml, 5 ml, etc.).
  • the embodiments of the cleaning device of subject invention as described above makes use of two suction channels and one cleaning liquid channel, it can make use of any number of suction channels and cleaning liquid channels, if desired.
  • the pistons and chambers of the actuator assemblies may need to be of dissimilar cross section.
  • a larger pneumatic cylinder to increase the mechanical advantage of the vacuum, creating more pressure in the liquid chamber than the pneumatic chamber may be desirable.
  • the device may be designed to have a gap between the proximal and distal pistons such that suction can be turned on first before saline is dispensed.
  • the actuation of the system 1A can be controlled from the console by the surgeon, either by vacuum/pneumatic switches, electronic switches, or solenoids.
  • the solenoids and/or switches at the console can be controlled by wireless transmission either via radio frequency, Bluetooth, Wi-Fi, or some other means of communication.
  • a cleaning device of this invention can be actuated by an automated mechanism by the laparoscope retracting into the cannula or device.
  • the actuation may be carried out through multiple possible methods including: an electro-mechanical switch that turns on when the laparoscope is retracted, a photogate sensor that turns on when the laparoscope is retracted, or an electric circuit that determines conductivity along the laparoscope to detect if laparoscope is retracted. All these mechanisms would activate solenoids or switches or thumb caps that control the suction and vacuum as described above. Without further elaboration the foregoing will so fully illustrate our invention that others may, by applying current or future knowledge, adopt the same for use under various conditions of service.

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Abstract

Sont divulgués des systèmes, des dispositifs et un procédé de nettoyage de l'extrémité distale de réception d'images d'un laparoscope s'étendant à travers une canule dans le corps d'un patient. Les systèmes comprennent un dispositif de nettoyage et un ensemble d'actionnement. Le dispositif de nettoyage comprend une gaine tubulaire ayant un passage principal pour la réception de la canule, un passage de liquide de nettoyage et un passage d'aspiration. L'ensemble d'actionnement est conçu pour distribuer une charge de liquide de nettoyage à travers le passage de liquide de nettoyage pour former un jet de liquide de nettoyage afin de laver l'extrémité distale du laparoscope. L'aspiration est fournie par l'ensemble d'actionnement à travers le passage d'aspiration jusqu'à un orifice adjacent à l'extrémité distale du laparoscope pour retirer le liquide de nettoyage et tout débris de l'extrémité distale du laparoscope. L'ensemble d'actionnement peut maintenir une aspiration à l'extrémité distale du laparoscope même après la fin du jet de liquide de nettoyage.
PCT/US2024/046590 2023-09-18 2024-09-13 Systèmes, dispositifs et procédés de nettoyage de laparoscopes Pending WO2025064305A1 (fr)

Applications Claiming Priority (4)

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US202363538931P 2023-09-18 2023-09-18
US63/538,931 2023-09-18
US202418882269A 2024-09-11 2024-09-11
US18/882,269 2024-09-11

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20140316327A1 (en) * 2011-05-18 2014-10-23 Solodex Llc Continuous anesthesia nerve conduction apparatus, system and method thereof
US20170245885A1 (en) * 2016-02-25 2017-08-31 Indian Wells Medical, Inc. Steerable endoluminal punch
US20200178767A1 (en) * 2015-07-21 2020-06-11 GI Scientific, LLC Endoscope accessory and medical device kit
US20210085167A1 (en) * 2014-12-12 2021-03-25 Medix3d LLC Scope Cleaning Device Configured to Be Removably Connected to a Surgical Tool
US20230054233A1 (en) * 2005-06-30 2023-02-23 Intuitive Surgical Operations, Inc. Surgical instrument with robotic and manual actuation features

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230054233A1 (en) * 2005-06-30 2023-02-23 Intuitive Surgical Operations, Inc. Surgical instrument with robotic and manual actuation features
US20140316327A1 (en) * 2011-05-18 2014-10-23 Solodex Llc Continuous anesthesia nerve conduction apparatus, system and method thereof
US20210085167A1 (en) * 2014-12-12 2021-03-25 Medix3d LLC Scope Cleaning Device Configured to Be Removably Connected to a Surgical Tool
US20200178767A1 (en) * 2015-07-21 2020-06-11 GI Scientific, LLC Endoscope accessory and medical device kit
US20170245885A1 (en) * 2016-02-25 2017-08-31 Indian Wells Medical, Inc. Steerable endoluminal punch

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