IL288770B1 - Apparatus and adapter for preparing medical devices to a medical procedure - Google Patents

Apparatus and adapter for preparing medical devices to a medical procedure

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Publication number
IL288770B1
IL288770B1 IL288770A IL28877021A IL288770B1 IL 288770 B1 IL288770 B1 IL 288770B1 IL 288770 A IL288770 A IL 288770A IL 28877021 A IL28877021 A IL 28877021A IL 288770 B1 IL288770 B1 IL 288770B1
Authority
IL
Israel
Prior art keywords
adapter
hollow cylinder
seal
distal
operational unit
Prior art date
Application number
IL288770A
Other languages
Hebrew (he)
Other versions
IL288770A (en
IL288770B2 (en
Inventor
Sagiv Adam
Perle Amir
Lam Amnon
Wolfson Shuki
Original Assignee
Plasmatica Ltd
Sagiv Adam
Perle Amir
Lam Amnon
Wolfson Shuki
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 Plasmatica Ltd, Sagiv Adam, Perle Amir, Lam Amnon, Wolfson Shuki filed Critical Plasmatica Ltd
Priority to IL288770A priority Critical patent/IL288770B2/en
Publication of IL288770A publication Critical patent/IL288770A/en
Priority to JP2023565439A priority patent/JP2024518772A/en
Priority to CA3216142A priority patent/CA3216142A1/en
Priority to AU2022260712A priority patent/AU2022260712A1/en
Priority to EP22791182.3A priority patent/EP4326349A2/en
Priority to PCT/IB2022/000240 priority patent/WO2022224040A2/en
Priority to US17/660,398 priority patent/US11896204B2/en
Priority to US17/660,396 priority patent/US11896203B2/en
Priority to IL307894A priority patent/IL307894A/en
Publication of IL288770B1 publication Critical patent/IL288770B1/en
Publication of IL288770B2 publication Critical patent/IL288770B2/en
Priority to US18/491,630 priority patent/US12070193B2/en
Priority to US18/405,934 priority patent/US20240138664A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/02Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
    • A61L2/14Plasma, i.e. ionised gases
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/00002Operational features of endoscopes
    • A61B1/00059Operational features of endoscopes provided with identification means for the endoscope
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/12Instruments 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
    • A61B1/127Instruments 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 with means for preventing fogging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00Instruments 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
    • A61B1/24Instruments 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 the mouth, i.e. stomatoscopes, e.g. with tongue depressors; Instruments for opening or keeping open the mouth
    • A61B1/247Instruments 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 the mouth, i.e. stomatoscopes, e.g. with tongue depressors; Instruments for opening or keeping open the mouth with means for viewing areas outside the direct line of sight, e.g. dentists' mirrors
    • A61B1/253Instruments 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 the mouth, i.e. stomatoscopes, e.g. with tongue depressors; Instruments for opening or keeping open the mouth with means for viewing areas outside the direct line of sight, e.g. dentists' mirrors with means for preventing fogging
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70Cleaning devices specially adapted for surgical instruments
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B1/00Optical elements characterised by the material of which they are made; Optical coatings for optical elements
    • G02B1/10Optical coatings produced by application to, or surface treatment of, optical elements
    • G02B1/18Coatings for keeping optical surfaces clean, e.g. hydrophobic or photo-catalytic films
    • GPHYSICS
    • G02OPTICS
    • G02BOPTICAL ELEMENTS, SYSTEMS OR APPARATUS
    • G02B27/00Optical systems or apparatus not provided for by any of the groups G02B1/00 - G02B26/00, G02B30/00
    • G02B27/0006Optical systems or apparatus not provided for by any of the groups G02B1/00 - G02B26/00, G02B30/00 with means to keep optical surfaces clean, e.g. by preventing or removing dirt, stains, contamination, condensation
    • GPHYSICS
    • G08SIGNALLING
    • G08CTRANSMISSION SYSTEMS FOR MEASURED VALUES, CONTROL OR SIMILAR SIGNALS
    • G08C17/00Arrangements for transmitting signals characterised by the use of a wireless electrical link
    • G08C17/02Arrangements for transmitting signals characterised by the use of a wireless electrical link using a radio link
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • HELECTRICITY
    • H01ELECTRIC ELEMENTS
    • H01JELECTRIC DISCHARGE TUBES OR DISCHARGE LAMPS
    • H01J37/00Discharge tubes with provision for introducing objects or material to be exposed to the discharge, e.g. for the purpose of examination or processing thereof
    • H01J37/32Gas-filled discharge tubes
    • H01J37/32009Arrangements for generation of plasma specially adapted for examination or treatment of objects, e.g. plasma sources
    • H01J37/32403Treating multiple sides of workpieces, e.g. 3D workpieces
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04LTRANSMISSION OF DIGITAL INFORMATION, e.g. TELEGRAPHIC COMMUNICATION
    • H04L67/00Network arrangements or protocols for supporting network services or applications
    • H04L67/01Protocols
    • H04L67/12Protocols specially adapted for proprietary or special-purpose networking environments, e.g. medical networks, sensor networks, networks in vehicles or remote metering networks
    • HELECTRICITY
    • H04ELECTRIC COMMUNICATION TECHNIQUE
    • H04WWIRELESS COMMUNICATION NETWORKS
    • H04W76/00Connection management
    • H04W76/10Connection setup
    • H04W76/11Allocation or use of connection identifiers
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05HPLASMA TECHNIQUE; PRODUCTION OF ACCELERATED ELECTRICALLY-CHARGED PARTICLES OR OF NEUTRONS; PRODUCTION OR ACCELERATION OF NEUTRAL MOLECULAR OR ATOMIC BEAMS
    • H05H1/00Generating plasma; Handling plasma
    • H05H1/24Generating plasma
    • H05H1/2406Generating plasma using dielectric barrier discharges, i.e. with a dielectric interposed between the electrodes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/70Cleaning devices specially adapted for surgical instruments
    • A61B2090/701Cleaning devices specially adapted for surgical instruments for flexible tubular instruments, e.g. endoscopes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/10Apparatus features
    • A61L2202/12Apparatus for isolating biocidal substances from the environment
    • A61L2202/122Chambers for sterilisation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2202/00Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
    • A61L2202/20Targets to be treated
    • A61L2202/24Medical instruments, e.g. endoscopes, catheters, sharps
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05HPLASMA TECHNIQUE; PRODUCTION OF ACCELERATED ELECTRICALLY-CHARGED PARTICLES OR OF NEUTRONS; PRODUCTION OR ACCELERATION OF NEUTRAL MOLECULAR OR ATOMIC BEAMS
    • H05H2245/00Applications of plasma devices
    • H05H2245/30Medical applications
    • HELECTRICITY
    • H05ELECTRIC TECHNIQUES NOT OTHERWISE PROVIDED FOR
    • H05HPLASMA TECHNIQUE; PRODUCTION OF ACCELERATED ELECTRICALLY-CHARGED PARTICLES OR OF NEUTRONS; PRODUCTION OR ACCELERATION OF NEUTRAL MOLECULAR OR ATOMIC BEAMS
    • H05H2245/00Applications of plasma devices
    • H05H2245/30Medical applications
    • H05H2245/36Sterilisation of objects, liquids, volumes or surfaces

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Medical Informatics (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Optics & Photonics (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Plasma & Fusion (AREA)
  • Pathology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biophysics (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Radiology & Medical Imaging (AREA)
  • General Physics & Mathematics (AREA)
  • Business, Economics & Management (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Epidemiology (AREA)
  • Signal Processing (AREA)
  • General Business, Economics & Management (AREA)
  • Chemical & Material Sciences (AREA)
  • Dentistry (AREA)
  • Spectroscopy & Molecular Physics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Computing Systems (AREA)
  • Analytical Chemistry (AREA)
  • Primary Health Care (AREA)
  • External Artificial Organs (AREA)

Description

APPARATUS AND ADAPTER FOR PREPARING MEDICAL DEVICES TO A MEDICAL PROCEDURE FIELD OF THE INVENTION The invention, in some embodiments, relates to the field of medical devices, such as endoscopes, having an optical element intended to be inserted into a patient’s body, and more particularly, but not exclusively, to methods and systems for preventing or minimizing accumulation of fog on the optical surface of the optical element during a medical procedure.
BACKGROUND OF THE INVENTION Endoscopes are widely used in medical procedures, for example in minimally invasive surgical procedures. Endoscopes include a vast range of scopes, for example bronchoscopes, colonoscopes, cystoscopes and laparoscopes. A laparoscope – as a specific example – comprises a rigid or relatively rigid rod or shaft having an optical element, possibly including an objective lens, at the distal segment, and an eyepiece and/or an integrated visual display at the proximal end. The scope may also be connected to a remote visual display device or a video camera to record surgical procedures. However, here, the term "endoscope" is intended to include any scope that has a distal segment configured to be inserted into a patient’s body and collect an image, and a proximal end configured to remain outside the patient’s body during the procedure Typically, the distal segment comprises an optical element such as a lens or a window or a bare end of an optical fiber or even a mirror (such as a dentist mirror for example, wherein the mirror part of the tool is inserted into the patient’s mouth, and the handle remains outside the patient’s body). Through the optical element, the scope enables viewing or collecting an image of the surrounding of the optical element, e.g. using a light-sensitive device such as a CCD. The optical element may be aimed to collect light from in front of the device (namely from a region coinciding with the longitudinal axis of the device), or the optical element may be slanted at an angle relative to the longitudinal axis, or may be facing perpendicular to the longitudinal axis of the device (as is demonstrated for example in some colonoscopies). The proximal end typically includes or is connected to a handle to be held by a medical practitioner, 30 possibly including user interface components such as switches, navigating sticks, touch screens and touch pads.
In a laparoscopic procedure, the patient's abdominal or pelvic cavity is accessed through one or two or more relatively small incisions (typically between about 3mm and about 15mm) and a laparoscope may be inserted through one of the incisions to allow the practitioner a view of the internal organs to be operated on. The abdomen may be inflated with a gas through the use of an insufflator – carbon dioxide is usually used for insufflation – to distend the abdominal space by elevating the abdominal wall above the internal organs and thereby create a sufficient working and viewing space for the surgeon.
The local environment within a patient's abdominal space is generally humid and warm compared to the laparoscope which is being inserted. Consequently, the optical element of the laparoscope tends to blur, e.g. due to fog, that is to say due to condensation of vapor on the surface of the optical element, or, for example, due to accumulation of droplets, e.g. blood droplets originating from surgical activity during the procedure.
International patent application publication number WO/2017/042806 discloses methods of immunizing an optical element of a medical device against fogging before or during a medical procedure, and related apparatuses and devices. The methods comprise applying plasma to the optical element prior to use, thereby rendering a surface of the optical element highly hydrophilic.
SUMMARY OF THE INVENTION Aspects of the invention, in some embodiments thereof, relate to systems and methods for treating an optical surface of a medical device for decreasing or preventing blur due to accumulation of droplets on the optical surface. More specifically, aspects of the invention, in some embodiments thereof, relate to methods and systems for treating the optical surface by plasma prior or during a medical procedure.
Minimally invasive surgery involves a variety of techniques to operate with less damage to the body compared to open surgery. Generally, minimally invasive surgery is associated with less pain, a shorter hospital stay and fewer complications. Laparoscopy — surgery done through one or more small incisions, using small tubes and tiny cameras and surgical instruments — was one of the first types of minimally invasive surgery. Another type of minimally invasive surgery is robotic surgery. It provides a magnified 3D view of the surgical site and helps the surgeon operate with precision, flexibility and control.
Experience shows that images collected by optical instruments inserted to the patient’s body tend to blur due to accumulation of fog on the surface of the optical element of the instrument. As discussed above, the local environment within the patient's body is generally humid and warm compared to ambient conditions. Consequently, the optical element of the instrument, following insertion to the body, tends to accumulate fog, that is to say to accumulate condensed vapor on the surface of the optical element.
One reason that condensation of vapor on an optical element might cause blur, is that the condensed liquid – e.g. water, possibly mixed with body fluids – condenses into droplets which distort the light rays passing through the droplets, thereby ruining the optical quality of the optical element. In other words, each droplet might function as a lens, focusing or diverging or generally distorting the light rays passing therethrough in uncontrolled manner. The total effect of the multitude of droplets on the optical element is thus generating an optically rough surface, thereby preventing obtaining a sharp image from light passing the optical element (or reflecting therefrom).
It is noted that some medical instruments intended for collecting images as described herein may operate outside the visible spectrum of light, namely with non-visible radiation, such as in the near infra-red (IR) spectrum, using optical elements. Such optical elements may suffer deterioration in optical quality due to accumulation of fog similarly to optical elements operating in the visible spectrum. Consequently, the teachings herein should be understood as applicable to optical elements and optical systems in the wide sense, including such that operate with non-visible light. It is further noted that accumulation of fog on a surface of an optical element may affect not only incoming light rays but may also divert or even absorb light rays extending out from an optical device, and may thus hinder the operation of light-emitting elements, too. Aspects of the invention thus relate to treating an optical element of a medical device, as detailed below, be it a light collecting device or a light emitting device or a combination of both.
There is thus provided, according to an aspect of some embodiments, a method of treating an optical to prevent it from fogging during use. According to some embodiments the optical element may be an optical element of a medical device that is inserted into the patient’s body during use, such as an endoscope. The method comprises increasing hydrophilicity of the optical surface of the optical element. In some embodiments the method comprises applying a plasma-generating electromagnetic field in close vicinity to the optical element, so as to cause such increase in hydrophilicity. The treatment process may be provided prior using the medical device in the medical procedure. According to some embodiments the method may be applied during the medical procedure as the medical device is removed from the patient’s body for treatment and consequently re-introduced to the patient’s body.
Increasing hydrophilicity of the optical surface is achieved by increasing the surface tension of the optical surface. As the surface tension of the treated surface increases and approaches the surface tension of water, the contact angle of water droplets on the optical surface decreases, and each droplet tends to spread on the surface and form a more flattened and less curved structure. Complete wetting is achieved by increasing the surface tension of the treated surface to above the surface tension of water, namely above 0.072N/m. When the surface tension of the treated surface is higher than the surface tension of water, water does not accumulate in droplets on the surface but rather wet the surface, having a contact angle of substantially 0 degrees. Thus, the method eliminates or at least significantly reduces blur due to fogging because condensation of moisture on the hydrophilic surface of the optical element results in a thin and even layer of fluid, thereby maintaining the optical quality of the optical element or at least limiting the degradation of the optical quality. Variations of fluid thickness on the optical element is reduced by the plasma treatment, and thereby variability in optical lengths associated with passing of light through the condensed fluid on the optical element is reduced as well.
The effects of plasma treatment on hydrophilicity of a treated surface are often temporary, so that hydrophilicity of a treated surface tends to decrease over time after the exposure to plasma ends. The method may thus further comprise using the optical element (or the device in which the optical element is installed) – namely exposing the optical element to moisture – soon after applying the plasma. "Soon after" means within 24 hours, preferably within 6 hours and even more preferably using the optical element within less than an hour after applying the plasma thereto. Moreover, other treatments or processes applied to the instrument’s surface after such plasma treatment – sterilization as one example – might decrease or eliminate altogether the effects of the plasma treatment. It is therefore most preferable to apply the method of increasing hydrophilicity according to the teachings herein immediately prior to the medical procedure itself, to apply it on a medical device that has already been sterilized, and carry it out under sterile conditions while maintaining the sterility of the medical device.
According to some embodiments of the current invention, plasma may be generated in a Dielectric Barrier Discharge (DBD) mode, to enhance uniformity of the plasma generating electric field in the vicinity of the optical element, and hence to enhance the quality of the plasma treatment. The "quality" of the plasma treatment herein denotes the level of hydrophilicity attained, and the duration of time during which the electric field is activated to obtain that hydrophilicity. In other words, a high-quality plasma treatment achieves a relatively high level of hydrophilicity (e.g. obtaining a surface tension close to, or even above that of water, namely close to or even above 0.072N/M on the treated surface) within a relatively short duration (e.g. of 5 minutes, or 1 minute or as short as 10 seconds or even as short as 5 seconds of activated electric field).
Plasma generation in a DBD mode may be effected, for example, by electrically isolating one of the electrodes used for applying the field. Such isolation may be realized by a dielectric layer that isolates the electrode from the gas in the region where plasma is generated; or a DBD mode may be effected, for example, by a dielectric layer positioned between two electrodes between which the plasma-generating field is applied o as to interrupt a line-of-sight therebetween. For example, according to some embodiments, a dentist’s mirror may be treated according to the teachings herein by placing the distal segment of the device including the mirror in a closed chamber, electrically connecting a cathode to the metallic handle and applying a RF high voltage to an electrode facing the mirror, which is electrically isolated from the gaseous medium around the mirror. According to other exemplary embodiments, an optical element made of a dielectric material such as glass or plastic and having no metallic parts in a vicinity thereof may be treated according to the teachings herein by being positioned in between two exposed electrodes used to apply the plasma-generating electric field, so that the optical element itself is used as a dielectric barrier by interrupting the line of sight between the electrodes.
Generating plasma in a DBD mode as described herein allows positioning the electrodes at a relatively short distance from one another and at a short distance from the treated surface, and applying a relatively strong field while maintaining the field relatively uniform in close vicinity to the treated surface of the optical element, thereby providing a high-quality plasma treatment to the treated surface ("relatively" here is used as compared to generating plasma not in a DBD mode).
To remove doubt it is noted that other modes of plasma generation, additionally or alternatively to DBD, may be also employed. For example, Inductively Coupled Plasma (ICP) may be employed to generate plasma in the vicinity of the optical element using magnetically induced fields. In some embodiments, ICP plasma may be generated using a single electrode shaped as an elongated, coiled conductor.
Medical devices having an optical element that may require plasma treatment as described herein, may have a variety of shapes and sizes. For example, laparoscopes have diameters in the range of 5-10mm and even beyond. In some laparoscopy procedures, two laparoscopes may be used, typically sequentially, during a single procedure applied to a single patient. For example, entering the abdominal cavity under vision is a known technique which may be performed with a direct vision trocar. A first laparoscope may be placed directly into the trocar sheath so that the trocar end can be seen and followed. As the trocar is pushed and advanced into the peritoneal cavity, each layer of the abdominal wall may be visualized and registered. Following insertion of the trocar, a second laparoscope may be inserted over the trocar to allow inspection of the procedure inside the abdominal cavity. When robotic surgery is employed, the second laparoscope, being part of the robot, is evidently different from the first, and may consequently have a different diameter. It is therefore advantageous that a system, an apparatus or a device for treating an endoscope prior to or during a medical procedure, would be compatible with medical devices intended for use in a same procedure, of various shapes and dimensions. Particularly, it is advantageous if endoscopes having distal segments of different diameters, may be treated according to the teachings herein in a single system, apparatus or device.
Medical devices that may require treatment according to the teachings herein vary greatly not only in dimensions but also in types. For example, some endoscopes – e.g. laparoscopes – are rigid, having a metallic sheath in the distal segment thereof. Other endoscopes – e.g. colonoscopes – are typically flexible, having a non-rigid distal segment, namely such that does not comprise a metallic tube enveloping the distal segment, thus their distal segment has a substantially dielectric surface. Yet some types of endoscopes exist in both rigid and flexible configurations. Further, endoscopes of various types may have distal segments with very different diameters. For example, pediatric colonoscopes have distal segments with outer diameters in the range of 11-12 mm. Adult colonoscopes are even wider, with an outer diameter of 12.8 mm. Cystoscopes are available in both flexible and rigid configurations, the rigid ones typically having metallic external sheaths. Distal segments’ diameters of flexible cystoscopes range between 14 F and 16.2 F (1F=0.33mm). Diameters of rigid cystoscopes vary between 6 F and 27 F whereas the most commonly used cystoscopes in adults have diameters ranging between 15 F and 25 F. Rigid bronchoscopes may have outside dimeters ranging from 8.2mm (size 6) for adolescents, down to 3.7mm (size 2.5) for premature infants. Arthroscopes sheaths (used for diagnosing and treating joint problems) have outer diameters ranging from 6mm and more, down to 2.5mm and even 1.9mm.
It is thus advantageous to have a system that requires only minor adaptations to allow the system treating a large variety of medical devices. It is further advantageous to have a method of treating a medical device according to the teachings herein, that may employ a system capable of providing such a treatment, requiring only minor adaptations to treat medical devices that are different from one another. For example, it is advantageous to have a system comprising a universal operational unit and an adapter – or a set of adapters – each configured to adapt the universal operational unit to treating a specific medical device or a specific type of medical devices or a group of medical devices used in a same procedure given to a single patient. Different adapters may be needed to treat different types of medical devices or treat devices that differ in some other parameter. It is noted that in the description herein, differences between medical devices may include – but are not necessarily limited to – differences in shape, in dimension and in mechanical structure and electrical properties. Difference in electrical properties may include for example having a distal segment that is electrically conducting (e.g. due to an enveloping metallic sheath) or alternatively a distal segment that is electrically insulating (having a dielectric material on the external surface). It may further be advantageous that such a universal operational unit could identify and / or certify an adapter in use, to adapt certain operational parameters to the specific adapter and / or to the medical device being treated with the adapter.
There is therefore provided, according to an aspect of the invention, an apparatus for preparing a medical device to a medical procedure. The medical device has a distal segment intended to be inserted to a patient’s body, whereas the distal segment has an optical member having an optical surface. The apparatus comprises an operational unit, an adapter detached from the operational unit and at least one electrode which may be comprised by the operational unit or by the adapter or (where there are more than one electrode) by both. The operational unit may comprise an EM power source and a housing comprising a slot configured to receive the adapter in the slot. The operational unit further comprises an adapter identifier, configured to receive an identification signal from a corresponding transponder, and a controller functionally associated with the adapter identifier. The adapter comprises a hollow cylinder extending between an opening and a distal end of the hollow cylinder, wherein the opening is dimensioned to allow insertion of the distal segment into the hollow cylinder. The term ‘hollow cylinder’ is used herein in a general sense meaning a receptable or a container and does not necessarily infer a circular cross-section. The adapter further comprises a seal positioned in the hollow cylinder and defining a distal portion of the hollow cylinder between the seal and the distal end of the hollow cylinder. The seal is dimensioned to sealingly fit an external circumference of the distal segment when the distal segment is inserted into the hollow cylinder. The adapter further comprises the transponder, being configured to transmit the identification signal identifying the adapter or a position thereof relative to the adapter identifier, when the adapter is in the slot. The apparatus is configured, when the distal segment is in the hollow cylinder of the adapter, the adapter is in the slot and the adapter identifier receives the identification signal from the transponder, to apply a plasma-generating EM field in the distal portion of the hollow cylinder by the at least one electrode, the electrode receiving EM power from the power source.
There is further provided, according to an aspect of the invention, an adapter for use with an operational unit for preparing a medical device as described above for a medical procedure, the adapter being detachable from the operational unit and from the medical device. The adapter comprises a hollow cylinder extending between an opening dimensioned and configured to receive the distal segment of the medical device and a distal end of the hollow cylinder. The adapter further comprises a seal positioned in the hollow cylinder and defining a distal portion of the hollow cylinder between the seal and the distal end of the hollow cylinder, the seal dimensioned to sealingly fit an external circumference of the distal segment when the distal segment is inserted into the hollow cylinder. And the adapter further comprises a transponder configured to transmit an identification signal identifying the adapter when the adapter is in the slot. In some embodiments the transponder stores information identifying the adapter. In some embodiments the transponder is configured to transmit the identification signal in response to a coded signal, thereby identifying the adapter.
There is yet further provided, according to an aspect of the invention, an adapter for use with an operational unit for preparing a medical device as described above for a medical procedure, the adapter being detachable from the operational unit and from the medical device. The adapter comprises a hollow cylinder extending between an opening dimensioned and configured to receive the distal segment of the medical device, and a distal end of the hollow cylinder. The adapter further comprises a seal positioned in the hollow cylinder and defining a distal portion of the hollow cylinder between the seal and the distal end of the hollow cylinder. The seal is dimensioned to sealingly fit distal segments having external circumferences in a range between a first circumference L and a second circumference greater than 1.5L. And the adapter further comprises an electrical feedthrough electrically connecting an external contact outside of the hollow cylinder to an electrical conductor inside the hollow cylinder in the distal portion thereof.
There is also provided, according to an aspect of the invention, a method of preparing at least a first medical device and a second medical device for a medical procedure carried out on a single patient. Each of the medical devices has a distal segment comprising an optical member. The circumference of the distal segment of one of the first and second medical devices is L and the circumference of the distal segment of the other medical device is greater than 1.2L. The method comprises providing a plasma chamber comprising at least one electrode electrically associated with a power source and configured for applying in the plasma chamber a plasma generating EM field. The plasma chamber also has an opening and a seal dimensioned and configured to receive the distal segment of each of the first and second medical devices in the opening. The method further comprises inserting the distal segment of the first medical device to the plasma chamber through the opening so that the seal and the distal end together seal the opening. The method further comprises supplying EM power from the power source to the at least one electrode, thereby applying a plasma generating EM field and generating plasma in the vicinity of the optical member. And the method further comprises repeating said steps of inserting the distal segment and supplying EM power for the second medical device.
And there is yet further provided, according to an aspect of the invention, an adaptive seal made of a flexible material. The seal is shaped as a combined outer tube and an inner annular ring extending radially along a wavy curve having at least one crest, between the outer tube and a central opening of the seal. The adaptive seal is thereby configured to sealingly fit to an external surface of a member positioned in the central opening and having a smooth circumference within a range between a first circumference L and a second circumference 1.5L. A smooth circumference herein means a convex curve outlining aa convex shape and having no corners or sharp edges.
Certain embodiments of the present invention may include some, all, or none of the above advantages. Further advantages may be readily apparent to those skilled in the art from the figures, descriptions, and claims included herein. Aspects and embodiments of the invention are further described in the specification hereinbelow and in the appended claims.
Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. In case of conflict, the patent specification, including definitions, governs. As used herein, the indefinite articles "a" and "an" mean "at least one" or "one or more" unless the context clearly dictates otherwise.
BRIEF DESCRIPTION OF THE FIGURES Some embodiments of the invention are described herein with reference to the accompanying figures. The description, together with the figures, makes apparent to a person having ordinary skill in the art how some embodiments may be practiced. The figures are for the purpose of illustrative description and no attempt is made to show structural details of an embodiment in more detail than is necessary for a fundamental understanding of the invention. For the sake of clarity, some objects depicted in the figures are not to scale.
In the Figures: FIG. 1A schematically depicts an embodiment of an apparatus, comprising an operational unit and an adapter, for preparing a medical device for a medical procedure according to the teachings herein; FIG. 1B schematically depicts a distal segment of a medical device such as an endoscope, the distal segment comprising an optical element suitable to be plasma-treated by the apparatus of FIG. 1A; FIG. 1C schematically depicts an embodiment of the apparatus of FIG. 1A inside a sterility cup, coverable with a cup cover; FIG. 2A schematically depicts an embodiment of an adapter of an apparatus for preparing a medical device for a medical procedure according to the teachings herein; FIG. 2B schematically depicts an embodiment of an adaptive vacuum seal accommodated by the adapter of FIG. 2A according to the teachings herein; FIG. 2C schematically depicts the adapter of FIG. 2A inside a slot of an operational unit and housing the distal segment of an endoscope in the hollow cylinder of the adapter; 30 FIG. 3A schematically depicts an electrode arrangement that can be employed to plasma-treat an optical element of a medical device that does not have a metallic surface at the distal segment thereof; FIG. 3B schematically depicts another electrode arrangement that can be employed to plasma-treat the optical element of the medical device depicted in FIG. 3A; FIG. 3C schematically depicts yet another electrode arrangement that can be employed to plasma-treat the optical element of the medical device depicted in FIG. 3A; FIG. 4 schematically depicts an embodiment of an apparatus comprising an operational unit and an adapter according to the teachings herein wherein the adapter comprises a transponder configured to transmit a signal certifying or validating the adapter or the adapter’s position for use with the operational unit; FIG. 5A schematically depicts an embodiment of an apparatus according to the teachings herein comprising an adapter wherein the transponder comprises a magnet; FIG. 5B schematically depicts an embodiment of an apparatus according to the teachings herein comprising an adapter wherein the transponder comprises a mirror; FIG. 5C schematically depicts an embodiment of an apparatus according to the teachings herein comprising an adapter wherein the transponder comprises a code sticker; FIG. 5D schematically depicts an embodiment of an apparatus according to the teachings herein comprising an adapter wherein the transponder comprises an RFID chip, and FIG. 5E schematically depicts an embodiment of an apparatus according to the teachings herein comprising an adapter wherein the transponder comprises a smart card.
DETAILED DESCRIPTION OF SOME EMBODIMENTS The principles, uses and implementations of the teachings herein may be better understood with reference to the accompanying description and figures. Upon perusal of the description and figures present herein, one skilled in the art is able to implement the teachings herein without undue effort or experimentation. In the figures, like reference numerals refer to like parts throughout.
Figure 1A schematically depicts an apparatus 100, according to an aspect of some embodiments, for preparing a medical device 200 such as an endoscope, to a medical procedure. Medical device 200 comprises a distal segment 210, schematically depicted also in Figure 1B. Distal segment 210 comprises an optical element 220 configured to enable collecting an image of the surroundings of the optical element. Optical element 220 may be in some embodiments a transparent sheet such as a window or a lens, of material such as glass or quartz, or plastic such as Perspex, thereby allowing light from the outside of the medical device 200 to be collected in the inside of medical device 200, e.g. by a light sensitive device (not shown here) such as a camera. According to some embodiments optical element 220 may be a mirror, reflecting light (rather than transferring light there through) towards a light collecting apparatus (not shown here) or a light sensitive device. Optical element 220 comprises an optical surface 222 which during a medical procedure may be exposed to moisture. Consequently, if not treated to prevent fogging, optical surface 222 may thereby become covered with fog, such fog being the result of accumulation of droplets on the optical surface 222, e.g. (but not limited to) due to condensation of vapor.
Apparatus 100 comprises an adapter 110 dimensioned to receive therein distal segment 210 of the medical device 200. Apparatus 100 further comprises an operational unit 1detached from adapter 110. Operational unit 120 comprises a slot 122 configured to receive therein distal segment 210 of medical device 200, whereas distal segment 210 is shrouded within adapter 110. In other words, for use, distal segment 210 of medical device 200 is inserted into adapter 110, and adapter 110, with distal segment 210 being shrouded therein, is inserted into slot 122. According to some embodiments adapter 110 is inserted into slot 122, and then distal segment 210 is inserted and advanced into adapter 110.
Operational unit 120 comprises an electric power source (not shown here). Operational unit 120 is further configured, when distal segment 210, shrouded within adapter 110, is positioned inside slot 122, and upon activation of the power source, to apply inside adapter 1inside slot 122 an electric field suitable for plasma generation proximal optical surface 222. In some embodiments operational unit 120 is energized from an external energy source e.g. from a wall outlet via a cable 130. In some embodiments the operational unit may be energized by an internal energy source such as a battery, for example a rechargeable battery.
According to some embodiments operational unit 120 may be fluidly associated with a gas pump and additionally or alternatively with a gas reservoir (neither one is shown here) via one or more gas tube(s) 132. The gas pump and the gas reservoir may be used to controllably evacuate, or to controllably flush with a preferred gas, respectively, a vicinity of the distal segment of the endoscope, to facilitate plasma ignition, as is further detailed and explained below. According to some embodiments, a preferred gas may be helium, argon or nitrogen. According to some embodiments, a gas pressure suitable for plasma ignition after evacuation may be below 0.1Atm. According to some embodiments, the vicinity of the distal segment of the endoscope may be pumped and evacuated and then flushed with a desired gas. According to some embodiments, the gas pump and / or the gas reservoir, as the case may be, may be optionally situated in the operational unit 120.
Operational unit 120 is configured to enable a user of apparatus 100 to operate and control the apparatus. Operational unit 120 may thus comprise command switches 134, such as physical or virtual switches. Operational unit 120 may further comprise indicators 136 for providing a user with required data and information for operating the apparatus, such as indication LEDs, displays and possibly an operating software for providing a user with operating and command screens to allow a user operate and command the apparatus.
According to some embodiments operational unit 120 is required to be portable, so it can be freely moved and positioned in any required location in the operation room. In other words operational unit 120 is required to be operable while being disconnected from any other object, particularly from a fixed object such as a wall outlet. In such embodiments, operational unit 120 may be energized by an internal battery, and in some embodiments, which require gas pumping or flushing, operational unit 120 may comprise a gas pump and/or a gas reservoir (neither are shown here). Embodiments of operational unit 120 wherein the operational unit is portable as described herein, may be void of cable 130 and of gas tube(s) 132, or the cable and the gas tube(s) may be out of use.
Figure 1C schematically depicts an apparatus 100a comprising an operational unit 120a which is portable as described above. Apparatus 100a further comprises a sterility cup 150 and an adapter 110 comprising a cup cover 152 configured to close sterility cup 150. Sterility cup 150 and cup cover 152 are intended to provide a sterile environment for treating the medical device, prior or during a medical operation, while using operational unit 120a which may be non-sterile. sterility cup 150, cup cover 152 and adapter 110a may be dispensable, disposable or replaceable parts, being configured to be used during a single medical procedure carried out on a single patient. According to some embodiments, the adapter functions as a sterility barrier between the medical device which should be kept clear of contamination, and the operational unit, which may be exposed to contamination and is considered non-sterile.
For use, the sterility cup 150, cup cover 152 and adapter 110 may be supplied in one or more sterile packages which are opened in a sterile environment prior to activating the apparatus. Operational unit 120 may then be inserted into sterility cup 150 as is depicted in Figure 1C. Further, adapter 110 may be attached to cup cover 152 as is depicted in Figure 1C. Additionally or alternatively, adapter 110 and cup cover 152 may be supplied being attached together as depicted in the Figure. By inserting the adapter to the slot 122, while closing the sterility cup 150 with the cup cover 152, sterile environment may be provided in the surroundings outside of the cup. In other words, sterility cup 150, closed by cup cover 152, functions as a microbially sealed case enclosing the operational unit there within and preventing spreading contamination originating from the operational unit outside the cup. Furthermore, the medical device’ distal segment 210 may be inserted into the sterile adapter 110, for treatment.
According to some embodiments, inserting the distal segment 210 to the adapter activates the operational unit, as is further detailed and explained below. In some embodiments, the user may turn on the operational unit using a physical switch, prior to closing the cup with the cup cover, thereby switching the operational unit into a ‘standby’ state. Then, inserting the distal segment into the adapter, may activate the operational unit to perform plasma treatment. In some embodiments the cup cover 152, and optionally the sterility cup 150, are transparent so the user may see the operational indicators 136 and monitor the progress of the treatment.
Figures 2A and 2C schematically depict in a cross-sectional view, an embodiment of an adapter 300 according to an aspect of the invention. Adapter 300 is particularly suitable for use with a medical device such as an endoscope 400, depicted schematically inside a hollow cylinder 312 of adapter 300 in Figure 2C whereas adapter 300 is inside a slot 422 of an operational unit 420. Endoscope 400 comprises a distal segment 402 and an electrically conducting surface – e.g. a metallic surface 404 – at distal segment 402, proximal an optical element 406. Optical element 406 further comprises an optical surface 408, which may be subject to plasma treatment as described herein.
Adapter 300 is configured to provide a sterile environment to a medical device inserted thereto, hence it is microbially sealed to external contaminants. In other words, adapter 300 is configured to prevent penetration of contaminants from the surroundings of the adapter – e.g. from the operational unit – through the walls of the hollow cylinder to the inside thereof, when the adapter is in the slot of the operational unit. Further, adapter 300 is configured to provide a confined space which is gas sealed when the medical device is inserted into the hollow cylinder of the adapter. The confined space which is gas-sealed may be fluidly associated, via one or more pumping openings, to a gas pump, thereby enabling pumping the confined space. Furthermore, adapter 300 is configured as a disposable part intended for use during one operational procedure to a single patient. Accordingly, adapter 300 is configured to be manufactured and assembled at a low cost, as is detailed further below.
Drawing attention to Figure 2A, hollow cylinder 312 is made substantially of a dielectric material, and extends between a cylinder proximal opening 314 and a cylinder distal end 316. Adapter 300 further comprises an adaptive vacuum seal 320 depicted schematically also in Figure 2B. Adaptive vacuum seal 320 is positioned inside hollow cylinder 312 and adapted to fit an external dimension (e.g. an external circumference) of endoscopes such as endoscope 400 so as to allow insertion of the endoscope into adapter 300 using a slight force, e.g. by hand, as is known in the art. Accordingly, adaptive vacuum seal 320 is configured to hold a pressure difference (or gas concentration difference) between a distal portion 302 of hollow cylinder 312 and an outside 304 of adapter 300 when endoscope 400 is positioned inside adapter 300.
Adaptive vacuum seal 320 is constructed of a seal outer ring 322 shaped as a short cylinder, and a seal inner ring 324 extending radially between seal outer ring 322 and a seal central opening 328 of the adaptive vacuum seal 320, along a wavy curve having at least one crest 326. Adaptive vacuum seal 320 may be formed of a flexible material such as rubber or silicone and may therefore fit an external circumference of endoscopes (or other devices) within a range of circumferences. In other words, adaptive vacuum seal 320 may seal against a first medical device, having a first circumference, inserted into hollow cylinder 312 and through central opening 328, and also against a second medical device, having a second circumference different from the first circumference, inserted through central opening 328 after the first device is removed from the adapter. According to some embodiments, the ratio between the two circumferences may be at least 1.5. Accordingly, if the first and second medical devices have circular cross-sections, then adaptive vacuum seal 320 may vacuum seal against the first and second medical devices even if their cross-sectional diameters have a ratio of at least 150%. Further, adaptive vacuum seal 320 may vacuum seal against a devise having a non-circular cross-section.
Adapter 300 further comprises feedthroughs 330a and 330b arranged on hollow cylinder 312 along the cylinder’s longitudinal axis and configured to establish an electrical connection between the outside 304 of adapter 300 and an inside 306 of the hollow cylinder.
Feedthroughs 330 are constructed of a metallic outer ring 332 (that is, metallic rings 332a and 332b respectively) shaped as a short cylinder and two opposing flexible metallic stripes 3extending inwards from the metallic ring and slanted at an angle relative to the plane of the metallic ring. Feedthroughs 330 may be made of a flexible metal, preferably inert and medically approved, for example stainless steel.
To allow low-cost manufacturing, hollow cylinder 312 is constructed of four segments – a proximal segment 340, a first middle segment 342, a second middle segment 344 and a cylinder distal segment 346, which are made of a dielectric material or dielectric materials, and configured to be sealingly assembled together during manufacturing as is explained below.
When the segments are separated, an O-ring 360a is positioned in a corresponding groove in proximal segment 340 and an O-ring 360b is positioned in a corresponding groove in first middle segment 342. Feedthrough 330a may then be appended by sliding the metallic outer ring 332a over the O-ring 360a while adjusting the metallic stripes 334a into corresponding proximal segment slits 348 in proximal segment 340. The proximal segment and the first middle segment may then be assembled together in a snap-fit manner by sliding the first middle segment into the metallic outer ring 332a while adjusting first protrusions 350 of first middle segment 342 into corresponding proximal depressions 352 in proximal segment 340. When assembled together, O-rings 360a and 360b, between the proximal segment and the metallic outer ring 332a and between the first middle segment 342 and the metallic outer ring 332a, respectively, seal the gap between the two segments, and particularly prevent the penetration of contaminants, through the gap, from the outside 304 into the hollow cylinder 312.
Second middle segment 344 may be assembled with first middle segment 342 in a similar snap-fit manner, as second protrusions 354 of first middle segment 342 are adjusted into corresponding second depressions 356 in second middle segment 344. The gap between second middle segment 344 and first middle segment 342 is sealed by O-rings 360c and 360d, between the first middle segment and the metallic outer ring 332b and between the second middle segment 344 and the metallic outer ring 332b, respectively. The metallic stripes 334b of feedthrough 330b are adjusted into corresponding first slits 358 in first middle segment 342.
Cylinder distal segment 346 may also be assembled with second middle segment 344 using a snap-fit manner, as second protrusions 362 are engaged into distal segment depressions 364. O-ring 366 seals the gap between second middle segment 344 and cylinder distal segment 346. When second middle segment 344 and cylinder distal segment 346 are assembled together, outer ring 322 of adaptive vacuum seal 320 is held tight between opposing grooves of second middle segment 344 and cylinder distal segment 346 so that inserting a medical device into central opening 328 or extracting a medical device therefrom does not displace the adaptive vacuum seal from position.
Adapter 300 comprises pumping opening 368 in cylinder distal segment 346, allowing pumping gas through the pumping openings from distal portion 302. Openings 368 are equipped with a unidirectional valve 370 allowing extracting gas from the distal portion 3through the pumping openings, but preventing penetration of gas through the pumping openings into the distal portion. Thus, unidirectional valve 370 allows pumping gas from the distal portion while preventing penetration of contamination into the hollow cylinder through the pumping openings.
Figure 3C schematically depicts adapter 300 positioned inside slot 422 of operational unit 420, wherein endoscope 400 is inside the hollow cylinder 312 of the adapter. Endoscope 400 is advanced in the hollow cylinder until distal segment 402 contacts fins 372 of the adapter. Thus fins 372 are employed as a stopper for the advancement of the endoscope into the adapter, so as to determine a proper position of the endoscope during plasma generation.
During insertion of endoscope 400 into the adapter, the endoscope is advanced through central opening 328 of adaptive vacuum seal 320. The edges of the inner ring 324 around the central opening sealingly contact the metallic surface 404 of the endoscope, thus allowing pumping air from the distal portion 302 while maintaining a pressure difference across the adaptive vacuum seal. In some embodiments adapter 300 comprises a stabilizer 374 positioned near opening 314 of the hollow cylinder and configured to stabilize the endoscope in a center position of the hollow cylinder during insertion into the hollow cylinder and during the endoscope’s residing in the adapter. Stabilizer 374 is configured as an annular ring of a soft and flexible material, e.g, soft silicone or a sponge, and is configured to allow insertion of endoscopes having different diameters into the hollow cylinder. Stabilizer 374 should not necessarily seal against the walls of the endoscope, but rather maintain the endoscope stabilized along the longitudinal (symmetry) axis of the hollow cylinder so as to prevent deviations of the endoscope from the center of the adaptive vacuum seal 320 during insertion or during residence of the endoscope therein, so as to prevent air leaks through an accidental gap between the adaptive vacuum seal 320 and the endoscope.
Operational unit 420 comprises a pumping channel 424 fluidly associated with a vacuum pump (not shown here) of the operational unit. Channel 424 is fluidly associated to pumping openings 368 via unidirectional valve 370, thus enabling pumping air from the distal portion 302, to enable or to facilitate generating plasma therein. An external seal 380 positioned on the external wall of the hollow cylinder, preferably near the distal end 316 of hollow cylinder 312, seals against the walls of the slot 312 thereby preventing air leaks from the outside 3via the slot 312 into the channel 424 and thus allowing pumping air from the distal portion.
Operational unit 420 further comprises an anode 430, electrically associated, e.g via a HV cable 432, with a RF high voltage (HV) power source (not shown here). Anode 430 is annular, being arranged around the longitudinal axis of the slot, that is to say around the longitudinal axis of hollow cylinder 312 and opposite the distal portion 302 of the hollow cylinder, when the adapter is inserted to the slot. Operational unit 420 further comprises electrical contracts 434 and 436, configured to electrically contact the metallic outer rings 332a and 332b, respectively, of feedthroughs 330a and 330b of the adapter. Electrical contacts 4and 436 may be electrically associated, via HV cables 440 and 442 respectively, to electrical circuitry of the operational unit. In some embodiments electrical contact 434 may be electrically associated to the RF HV power source, so that when the RF HV power source is activated, a RF high voltage is applied between anode 430 and electrical contact 434. In some embodiments electrical contact 434 is fixedly connected to a ground potential.
When the distal segment of the endoscope is in the hollow cylinder as detailed above, flexible stripes 334a and 334b electrically contact the metallic surface 404, so that when the RF HV power source is activated, a plasma generating HV is applied between the anode and the metallic surface 404. The plasma generating EM field may generate plasma in the vicinity of the optical element 406. It is noted that the dielectric walls of the cylinder distal segment 346 are positioned between the anode and the metallic surface 404 of the endoscope, hence plasma is activated in the distal portion 302 in a Dielectric Breakdown Discharge (DBD) mode of operation. It is further noted that fins 372 may be employed to focus and unify the plasma onto the optical surface 408.
In some embodiments the electrical connection formed by the metallic surface between flexible stripes 334a and 334b, as the endoscope is inserted into the hollow cylinder (and when the adapter is in the slot of the operational unit) may be employed for automatic activation of the HV power source. For example, in embodiments wherein electrical contact 434 is fixedly connected to a ground potential as described above, electrical contact 436 may be electrically associated with a controller (not shown here) of the operational unit, wherein the controller may consequently control activating or deactivating the RF HV source. Insertion of the endoscope into the hollow cylinder may force a ground potential at electrical contact 436 to command the controller activating the RF HV power source thereby generating plasma in the vicinity of the distal segment of the endoscope. Plasma may so be generated for a pre- determined time duration required for a proper plasma treatment as is dictated by the controller, and, alternatively of additionally, plasma may be generated until the endoscope is removed from the hollow cylinder and ground potential ceases at electrical contact 436.
Figures 3A, 3B and 3C depict schematically various electrode arrangements that can be employed to treat a medical device 450 having, on a distal segment 452 thereof an optical element 454 having an optical surface 456 that may be treated against accumulation of fog. For the sake of simplicity the distal segment 452 is depicted as an elongated member, however this should not be construed as limiting and the teachings herein may apply to medical devices having other shapes and dimensions. Medical device 450 is different from medical device 4of Figure 2C in that medical device 450 does not have a metallic surface at the distal segment 452 thereof, in other words the surface of the distal segment is not electrically conducting. Figures 3A, 3B and 3C depict apparatuses 508, 538 and 568, respectively. In the Figures, medical device 450 is inserted in adapters 510, 540 and 570, respectively, wherein the adapters are positioned in corresponding slots 530, 560 and 590 of operational units 512, 542 and 572, respectively, substantially as described above.
In Figure 3A, an annular electrode 514 is comprised by adapter 510, and a second electrode 516 is comprised by the operational unit 512. Electric connections of the electrodes to a power source (not shown here) are implied, and are not explicitly shown. Annular electrode 514 may be made flexible to tightly contact the surface of the distal segment of the medical device, or it may be dimensioned to allow a gap between the electrode and the medical device. The second electrode 516 is shaped as a plate, however other shapes are readily contemplated. In some embodiments the second electrode may be annular, having a ring-like shape. In some embodiments the second electrode may be pointed, having a tip pointing towards the adapter, to amplify the field and focus the field in the vicinity of the center of the optical surface. Because the distal segment of the endoscope does not have a conducting surrface, a plasma generating electric field is applied between the electrodes, in other words the geometry of the electrodes and the distance between the electrodes are dominant in determining the field. Plasma is generated in the vicinity of the optical surface 456 in a DBD mode, due to a dielectric barrier formed by the distal end 518 of the hollow cylinder. Vacuum seals 520 and 522, between the distal segment and the hollow cylinder of the adapter, and between the adapter and the slot of the operational unit, respectively, assist in maintaining vacuum in the distal portion 524 of the hollow cylinder, substantially as explained above regarding Figure 2C. Pumping the distal portion is made possible via channels 526 of the operational unit and via pumping openings 528 in the adapter.
In Figure 3B, an annular electrode 544 and a second electrode 546 are comprised by adapter 540. As in Figure 3A, electric connections of the electrodes to a power source (not shown here) are implied. Annular electrode 544 and second electrode 546 may be shaped similarly to annular electrode 514 and second electrode 516, respectively, in Figure 3A, and according the description above. Plasma is generated in the vicinity of the optical surface 4in a DBD mode, due to a dielectric barrier formed by the distal end 548 of the hollow cylinder. Also, vacuum seals 550 and 552 and pumping arrangements are substantially similar to the corresponding seals and pumping method described above to Figure 3A. In operation, the electrode arrangement of Figure 3B is advantageous over that of Figure 3A in that both the annular electrode 544 and second electrode 546 are comprised by the adapter 540, hence the plasma generating electric field applied between the electrodes is more accurately determined and is less subject to in consistencies or uncertainty involving the relative position of the adapter in the slot. A disadvantage of the arrangement in Figure 3B is that the adapter 5might be more expensive relative to adapter 510 of Figure 3A, due to the inclusion of the second electrode 546 in the adapter.
The electrodes arrangement in Figure 3C is different from that of Figure 3B in that an annular electrode 574 in an adapter 570 is located outside the hollow cylinder of the adapter 570 and not inside hollow cylinder as in Figure 3B. Also, a second electrode 576 comprised by the adapter 570, is not separated from the optical element 454 of the endoscope by a dielectric layer as in Figure 3B. Thus, in the arrangement of Figure 3C, plasma is generated in a DBD mode due to the dielectric layer of the walls of the adapter 570 next to the annular electrode 574.
According to an aspect of the invention, it would be advantageous to certify an adapter housing a medical device therein, for activating plasma, prior to such plasma activation and/or during such plasma activation. For example, it may be necessary or at least advantageous to certify that an adapter is properly positioned in the slot of an operational unit, to ensure proper plasma activation inside the adapter. For example it may be advantageous to prevent the generation of high-voltage (intended to induce a plasma-generating EM field or to generate plasma or to maintain plasma inside the adapter), if the adapter in absent from the slot or misplaced in the slot. Such prevention of high-voltage generation may be needed to prevent accidental electrification of a user or undesired arcing, or other undesired results of unsuccessful delivery of the plasma generating field to the adapter. According to some embodiments accurate positioning of the adapter inside the slot may be necessary to ensure suitable coupling of the electric voltage generated by the operational unit to the adapter. For example, it may be necessary or at least desired to ensure electric contact of the RF power supply in the operational unit with electrodes of the adapter. In some embodiments such accurate positioning of the adapter in the slot may be necessary to ensure suitable and proper impedance matching between the adapter and the HV generator. According to some embodiments, it is necessary or at least desirable to ensure that plasma is actually being generated inside the adapter, to validate the plasma treatment and to prevent mistaken use of a medical device that did not undergo plasma treatment.
According to some embodiments it may be necessary, or at least desirable, to associate and apply a particular plasma treatment protocol to a particular type of medical device, by identifying the adapter used with the medical device. In other words, different types of medical devices may undergo plasma treatment in different adapters, wherein each type of medical device may be identified by an identification component embedded in the corresponding adapter. When the adapter is positioned in the slot of the operational unit, the operational unit may identify the type of the medical device by recognizing the identification component of the adapter, thereby preventing applying plasma according to a wrong protocol, and ensuring applying plasma according to a correct and suitable protocol.
Thus, according to an aspect of the invention, an apparatus for plasma treatment of a medical device is provided comprising an operational unit and an adapter (detachable from the operational unit). The apparatus further comprises an adapter certification system comprising a field transponder attached to one of the operational unit and the adapter, and a receiver, attached to the other of the operational unit and the adapter. A signal transmitted from the field transponder may be received by the receiver, thereby certifying the identity of the adapter or the position thereof relative to the operational unit. According to some embodiments the certification system further comprises a transmitter positioned also on the other one of the operational unit and an adapter. According to some embodiments, the transmitter may transmit a transmitted signal to which the field transponder may respond with a response signal which is received by the receiver. The field transponder may be passive (such as a reflector) or may be active (powered by an energy source).
Figure 4 schematically depicts an embodiment of an apparatus 600 for plasma treatment of a medical device 602 – e.g. endoscope – having an optical element 604 with an optical surface 606 at a distal segment 608 thereof. The optical surface may require treatment as described above prior to using the medical device in a medical procedure. Apparatus 6comprises an operational unit 610 and an adapter 620 detachable from the operational unit. Adapter 620 contains therein the distal segment 608 in hollow cylinder 630. The operational unit comprises a slot 640 configured to receive adapter 620 therein. It is noted that in some embodiments medical device 602 may have a non-cylindrical or a non-symmetric shape (at least near the optical element) and the hollow cylinder may have a corresponding non-cylindrical or a non-symmetrical shape, allowing the insertion of the medical device into the hollow cylinder in a single orientation. Yet the external shape of the adapter, as well as the shape of the slot, may be symmetrical, to allow various adapters, corresponding to different types of medical devices, be used with the operational unit. In such cases it may be desired to certify the orientation of the adapter inside the slot.
According to some embodiments hollow cylinder 630 may be sealed by the medical device 602 inserted thereto, substantially as escribed above, thereby being configured to maintain in a distal portion thereof vacuum or an atmosphere that is markedly different in pressure and composition from ambient atmosphere (i.e. air). Hollow cylinder 630 may be fluidly associated with a vacuum pump or a gas reservoir 612 of the operational unit via pumping openings 632 in the adapter, to allow pumping the distal portion 634 of the hollow cylinder or flush the hollow cylinder with gas as described above. According to some embodiments, hollow cylinder 630 is not gas-sealed, but only microbially sealed. Apparatus 600 further comprises electrodes 660, comprised by the operational unit and electrodes 662, comprised by the adapter. Operational unit 610 further comprises a power source 6electrically associated with the electrodes 660 and configured to generate electric power – e.g. power at a high voltage and high frequency – suitable to employ the electrodes 660 to induce a plasma-generating electric field in hollow cylinder 630 in the vicinity of optical surface 606.
Operational unit 610 further comprises a transmitter 650 configured to transmit a signal towards adapter 620. According to some embodiments, transmitter 650 is configured to transmit the signal towards adapter 620 when adapter 620 is proximal to slot 640 or inside slot 640. Operational unit 610 further comprises a receiver 652 configured to receive from adapter 620 a response signal, namely a reflected or transmitted signal respective to the transmitted signal transmitted from transmitter 650. Adapter 620 comprises a field transponder 654, configured to reflect or to transmit the response signal, in response to the signal transmitted from transmitter 650. The signal transmitted towards the adapter and/or from the adapter towards receiver 652 may be wireless (e.g. an electromagnetic signal such as a RF signal or an optical signal) or may be wired using electrical contacts, as is exemplified herein below.
According to some embodiments transmitter 650 is a directional transmitter, configured to transmit along a predetermined direction, and field transponder 654 is localized. In such embodiments only when adapter is suitably positioned in a well-defined position – for example in slot 640 whereas field transponder 654 is positioned in the direction of the transmitted signal from transmitter 650 – that transponder 654 responds with a response signal. According to some embodiments field transponder 654 is passive, thereby passively reflecting a portion of the transmitted signal. According to some embodiments field transponder 654 is active thereby actively transmitting a response signal (which may be different in frequency or have a stronger intensity compared to the transmitted signal from transmitter 650).
According to some embodiments transmitter 650 is not necessary, and active field transponder 654 may be configured to actively transmit a certifying signal which certifies the identity of adapter 620 or the validity thereof or the position thereof when received by receiver 654. According to some such embodiments, active field transponder 654 may include a light source, or a directed light source such as a laser or a LED, configured to be directed towards received 652 in the operational unit when the adapter is suitably positioned in the slot. According to some embodiments active field transponder 654 may transmit a coded RF signal which may be received by receiver 652 when the adapter is suitably positioned in the slot. According to some embodiments, active field transponder 654 may be energized by a portable energy source such as a battery which is comprised by the adapter. According to some embodiments active field transponder 654 may be energized – through electric wires and/or wirelessly through induction or otherwise by radiation – by an energy source of the operational unit. According to some embodiments electric contacts on the adapter and on the slot of the operational unit may come into mutual electric contact when the adapter is inserted into the slot, so as to close an electric circuit that allows activation (energizing) active field transponder 654. According to some embodiments an interaction between transmitter 650 and transponder 654 is mutual and not directional, as for example a magnetic force occurring between two magnets.
According to some embodiments operational unit 610 may further comprise a controller 670 functionally associated with receiver 652 and optionally associated with transmitter 650. According to some embodiments the controller may receive an output from receiver 6indicating receiving a response signal from field transponder 654. According to some embodiments the controller may be functionally associated with power source 644, to control power source 644 to generate power when a valid response signal is received in receiver 652, and not to generate power when a response signal is not received in receiver 652.
According to some embodiments, transmitter 650, receiver 652 and field transponder 654 may be shielded, e.g. by an electromagnetic shield (not shown here), to prevent interference of the plasma excitation field with their operation. Each of the transmitter, the receiver and the field transponder may be shielded or not According specifics of the embodiment involved. Such shielding may be required or not depending on several considerations including whether or not interference from the plasma excitation field impairs the operation of the transmitter, the receiver or the field transponder.
Figures 5A – 5E schematically exemplify some embodiments of corresponding apparatuses configured for certifying an adapter having a field transponder according to the teachings herein. Figure 5A schematically depicts an embodiment of an apparatus 600a comprising an operational unit 610a and an adapter 620a. Apparatus 600a exemplifies certifying a correct positioning and / or orientation of the adapter in a slot 640a of the operational unit, employing wireless interaction between a transmitter and a transponder, wherein any one, or both, may be passive, embodied by two magnets. Operational unit 610a comprises a ferromagnet 650a positioned near slot 640a and mechanically associated with a switch 652a. Ferromagnet 650 a may be a magnetic slab or an electromagnet being energized constantly or towards a validity test of the adapter. Adapter 620a comprises a ferromagnetic slab 654a (e.g. a slab of iron or a magnet). When adapter 620a is inserted into slot 640a, a magnetic fource between ferromagnet 650a and ferromagnetic slab 654a may displace ferromagnet 650a or otherwise cause switch 652a to close a circuit thereby certifying that adapter 620a is suitably positioned in slot 640a. Switch 652a may be functionally associated with a controller 670a, the controller being configured to control the activation of power source 644a (or otherwise control the application of a plasma-generating EM field in the adapter) as described above, according the state (open or close) of switch 652a. According to various embodiments, both ferromagnet 650a and ferromagnetic slab 654a are magnets; or ferromagnet 650a is a magnet whereas ferromagnetic slab 654a is not a magnet; or ferromagnetic slab 654a is a magnet whereas ferromagnet 650a is not a magnet.
Figure 5B schematically depicts an embodiment of an apparatus 600b comprising an operational unit 610b and an adapter 620b, exemplifying certifying a correct positioning and / or orientation of the adapter in a slot 640b of the operational unit, employing wireless interaction between a directional transmitter, a passive transponder and a receiver. Operational unit 610b comprises a light source 650b such as a LED or a focused beam source such as a laser. Light produced by light source 650b is directed towards adapter 620b, possibly through a window or an opening (not shown here) in slot 640b. When adapter 620b is suitably positioned inside slot 640b, the light beam produced by the light source is reflected from a reflector 654b (such as a mirror) accommodated on adapter 620b, towards a light detector 652b in operational unit 610b. A detection signal from the light detector may then certify the position of adapter 620b and / or the orientation thereof, inside slot 640b. The detection signal may thereby be used to allow (e.g. by a controller 670b) activation of plasma in the adapter. According to some embodiments, the operational unit does not include a light source whereas the adapter comprises a light source (not shown here), for example a directional light source, energized by a battery (not shown here). The light source on the adapter may be configured to direct light towards a light detector of the operational unit, thereby certifying that the adapter is properly positioned in the slot of the operational unit.
Figure 5C schematically depicts an embodiment of an apparatus 600c allowing certifying the validity and / or the positioning and / or orientation of a related adapter 620c or the position thereof in slot 640c, without a transmitter. Adapter 620c comprises a code sticker 654c whereas an operational unit 610c comprises an optical reader 652c configured to read – possibly through a window or an opening (not shown here) of a slot 640c – a code on the code sticker 654c when adapter 620c is suitably positioned inside the slot. Such reading may be accomplished, in some embodiments, using a laser beam as is known in the art. In some embodiments such reading is accomplished without a dedicated light source using ambient light. The code on the code sticker may be decoded by the code reader and a corresponding validation signal may be sent to a controller 670c of the operational unit 610c. Additionally or alternatively, the code on the code sticker may be decoded by the controller (e.g. by way of receiving an image of the code sticker and employing an image analysis algorithm). The code read from the code sticker may be used to validate an identity of the adapter, for example for the purpose of certifying employment of a correct treatment protocol suitable for the specific medical device in the adapter.
Figure 5D exemplifies an embodiment of an apparatus 600d allowing certifying the validity of a related adapter 620d. An operational unit 610d comprises an RFID reader 650d functionally associated with a controller 670d, whereas adapter 620d comprises an RFID chip 654d. In some embodiments RFID chip 654d may be activated by radiation received from the RFID reader 650d, rendering the RFID chip substantially independent of a dedicated energy source and responsive from any location around the RFID reader where the received energy is sufficient to activate the RFID chip. According to some embodiments, RFID chip 654d may be activated by a portable energy source of the adapter such as a battery thereby being independent of an energy source external to the adapter. In some embodiments the RFID chip may be energized by an energy source of the operational unit e.g. via electrical contacts or wirelessly, only when the adapter is properly positioned in the slot. When adapter 620d is in the vicinity of operational unit 610d, RFID reader 650d may identify RFID chip 654d, thereby identifying the type of adapter 620d, and, possibly, certifying the adequacy of a plasma activation protocol to the type of medical device inside the adapter. In some embodiments the RFID chip may be configured to register a mere activation of the RFID chip or a transmission of validation response signal towards the RFID reader, thereby enabling monitoring instances of activation or instances of use of the adapter.
Figure 5E exemplifies an embodiment of an apparatus 600e allowing certifying the validity of a related adapter 620e and the adapter’s position in a slot 640e of an operational unit 610e. Adapter 620e comprises a smart card 654e (a Universal Integrated Circuit Card (UICC), e.g. a Subscriber Identification Module (SIM)), and operational unit 610e comprises a card reader 650e functionally associated with a controller 670e. When adapter 620e is in slot 640e, smart card 654e may be read by a card reader 650e to certify the adequate position of the adapter in the slot and/or to identify the adapter 620e as explained above. To read the smart card, the card reader contacts the smart card, hence accurate positioning of the adapter in the slot is required to validate the adapter and/or the activation of the operational unit. Identification of the adapter may be employed to identify the type of the adapter among several types of adapters, and additionally or alternatively to identify the specific adapter in use. Identification of the adapter may be employed to approve and allow – or to prevent – a plasma treatment protocol according to the type of adapter, and / or to approve and allow – or to prevent – the use of a specific adapter during a specific event of using the apparatus.
There is therefore provided, according to an aspect of the invention, an apparatus (100, 100a, 508, 538, 568, 600, 600a, 600b, 600c, 600d, 600e) for preparing a medical device (200, 400, 450, 602) to a medical procedure. The medical device has a distal segment (210, 402, 452, 608) intended to be inserted to a patient’s body, whereas the distal segment comprises an optical member (220, 406, 454, 604) having an optical surface (222, 408, 456, 606). It should be understood that, generally, each of the medical devices may be treated by each of the apparatuses, unless explicitly dictated otherwise by the description (for example medical device 450 may not be treated by adapter 300 of Figure 2A, which is explicitly configured to be used with a medical device having a metallic surface at the distal segment thereof).
The apparatus comprises an operational unit (120, 120a, 420, 512, 542, 572, 610,610a, 610b, 610c, 610d, 610e), an adapter (110, 110a, 300, 510, 540, 570, 620, 620a, 620b, 620c, 620d, 620e) detached from the operational unit and at least one electrode (430, 516, 546, 576, 660, 660a, 660b, 660c, 660d, 660e) which may be comprised by the operational unit (anode 430) or by the adapter (in adapters 540 and 570) or by both (in apparatuses 508, 600, 600a, 600b, 600c, 600d, 600e). The operational unit may comprise an EM power source (644) and a housing comprising a slot (122, 122a, 422, 530, 560,590, 640, 640a, 640, 640b, 640c, 640d, 640e) configured to receive the adapter in the slot. The operational unit further comprises an adapter identifier (652, 650a, 652b, 652c, 650d, 650e), configured to receive an identification signal from a corresponding transponder (654, 654a, 654b, 654c, 654d, 654e), and a controller (670) functionally associated with the adapter identifier.
The adapter comprises a hollow cylinder (312, 510, 540, 570, 630, 630a, 630b, 630c, 630d, 630e), extending between an opening (114 in adapter 110, 114a in adapter 110a, 314) and a distal end (316, 518, 548, 578) of the hollow cylinder (the opening is not explicitly shown in Figures 3A-3C, 4, and 5A-5E and the cylinder distal end is not explicitly enumerated in Figures 4 and 5A-5E). The opening is dimensioned to allow insertion of the distal segment into the hollow cylinder. The adapter comprises a seal (320, 520, 550, 580, 664, 664a, 664b, 664c, 664d, 664e) positioned in the hollow cylinder and defining a distal portion (302, 524, 554, 584, 634) of the hollow cylinder between the seal and the distal end of the hollow cylinder. The seal is dimensioned to sealingly fit an external circumference of the distal segment when the distal segment is inserted into the hollow cylinder. The adapter further comprises the transponder, being configured to transmit the identification signal identifying the adapter or a position thereof relative to the adapter identifier, when the adapter is in the slot. The apparatus is configured, when the distal segment is in the hollow cylinder of the adapter, the adapter is in the slot and the adapter identifier receives the identification signal from the transponder, to apply a plasma-generating EM field in the distal portion of the hollow cylinder by the at least one electrode, the electrode receiving EM power from the power source.
It should be understood that identification systems comprising an adapter identifier of the operational unit and a transponder of the adapter, which are depicted explicitly and explained in detail in apparatuses 600 and 600a-600e, may be employed and used in all apparatuses of the invention including apparatuses 100, 508, 538 and 568.
In some embodiments the transponder comprises at least one selected from the group consisting of a magnet (654a), a mirror (654b), a light source, an optical filter, a code sticker (654c), a RFID chip (654d) and a smart card (654e).
In some embodiments the seal is a microbial seal (320, 520, 550, 580, 664, 664a, 664b, 664c, 664d, 664e). In some embodiments the seal is a vacuum seal (320, 520, 664, 664a, 664b, 664c, 664d, 664e).
In some embodiments the seal (320, 664, 664a, 664b, 664c, 664d, 664e) ) is configured to sealingly fit the distal segment along a non-circular circumference. In some embodiments the seal (320) is configured to sealingly fit distal segments having various circumferences. In some embodiments the seal (320) is configured to sealingly fit distal segments having circular circumferences in a range between a first circumference L and a second circumference greater than 1.5L.
In some embodiments the adapter (312) further comprises an external vacuum seal (380) positioned along an external circumference of the adapter and configured to seal a gap between the adapter and an inner wall of the slot (422) of the operational unit (420), when the adapter is inserted into the slot.
In some embodiments the adapter (300, 510, 540, 570, 620, 620a, 620b, 620c, 620d, 620e) further comprises a pumping opening (368, 528, 558, 588, 632, 632a, 632b, 632c, 632d, 632e) on the distal portion of the hollow cylinder, configured for enabling pumping gas from the distal portion of the hollow cylinder or flowing gas thereto (e.g. apparatuses 538, 568).
In some embodiments the operational unit (610, 610a, 610b, 610c, 610d, 610e) further comprises a pump (612, 612a, 612b, 612c, 612d, 612e) configured to pump gas from the distal portion (634, 634a, 634b, 634c, 634d, 634e) of the hollow cylinder, via the pumping opening, when the adapter is in the slot.
In some embodiments the operational unit further comprises a gas port configured to fluidly associate a gas reservoir or a gas pump, external to the operational unit, to the pumping opening of the hollow cylinder, when the adapter is in the slot.
In some embodiments the pumping opening (368) is equipped with a microbial barrier configured for preventing penetration of contamination into the hollow cylinder through the venting opening during use. In some embodiments the microbial barrier is a sterility filter. In some embodiments wherein the microbial barrier is a unidirectional valve (370).
In some embodiments the operational unit (120a) further comprises a rechargeable battery.
In some embodiments the apparatus (100a) further comprising a sterility container (150) detached from the operational unit (120a) and from the adapter (110a), having a container opening (160) and being dimensioned to house the operational unit there inside when the adapter (110a) is in the slot (122a). In some embodiments the adapter further comprises a sterility screen (152) having a screen opening coinciding with said opening of the hollow cylinder (114a), the sterility screen being dimensioned and configured to fit and close the container opening (160) when the adapter is in the slot.
In some embodiments the at least one electrode (544, 546, 574, 576) is comprised by the adapter (540, 570). In some embodiments the at least one electrode (430) is comprised by the operational unit (420).
In some embodiments the adapter (300) comprises an electrical feedthrough (330a, 330b) electrically connecting an external contact (332a, 332b) on the outside of the adapter with an electrical contact (334a, 334b) on the inside (306) of the hollow cylinder, the electrical contact being configured to contact the distal segment (402) when the distal segment is received inside the hollow cylinder.
In some embodiments the plasma generating field is applied between the at least one electrode (430) and a metallic surface (404) on the distal end (402), the metallic surface being in contact with the electrical contact (434a, 434b) of the adapter (300).
There is further provided, according to an aspect of the invention, an adapter (110, 110a, 300, 510, 540, 570, 620, 620a, 620b, 620c, 620d, 620e) for use with an operational unit (120, 120a, 420, 512, 542, 572, 610,610a, 610b, 610c, 610d, 610e) for preparing a medical device as described above for a medical procedure, the adapter being detachable from the operational unit and from the medical device. The adapter comprises a hollow cylinder extending between an opening dimensioned and configured to receive the distal segment of the medical device and a distal end of the hollow cylinder. The adapter further comprises a seal (320, 520, 550, 580, 664, 664a, 664b, 664c, 664d, 664e) positioned in the hollow cylinder and defining a distal portion (302, 524, 554, 584, 634) of the hollow cylinder between the seal and the distal end of the hollow cylinder, the seal dimensioned to sealingly fit an external circumference of the distal segment when the distal segment is inserted into the hollow cylinder. And the adapter further comprises a transponder (654, 654a, 654b, 654c, 654d, 654e) configured to transmit an identification signal identifying the adapter when the adapter is in the slot.
In some embodiments the transponder (654c, 654d, 654e) stores information identifying the adapter. In some embodiments the transponder (654d, 654e) is configured to transmit the identification signal in response to a coded signal, thereby identifying the adapter.
In some embodiments the adapter (300, 620, 620a, 620b, 620c, 620d, 620e) further comprises an electrical feedthrough (330) electrically connecting an external contact (332) on the outside of the adapter to an electrical conductor (334, 622a, 622b, 622c, 622d, 622e) on the inside of the hollow cylinder.
In some embodiments the electrical conductor (334) is configured as an electrical contact (334a, 334b) configured to contact an external surface (404) of the distal segment of the medical device when the distal segment is received in the hollow cylinder. In some embodiments the electrical conductor is configured as an electrode (622a, 622b, 622c, 622d, 622e).
In some embodiments the adapter further comprises a stopper (372) configured to limit advancement of the distal segment of the medical device into the hollow cylinder. In some embodiments the stopper is employed as a dielectric barrier between the first electrode and the second electrode, thereby assisting in focusing plasma towards the optical member of the medical device, during use.
In some embodiments the adapter further comprises a hollow stabilizer (374) positioned near the opening (314) and configured to receive the distal segment of the medical device there through and adapted to fit an external circumference of the medical device to thereby stabilize the medical device in the hollow cylinder.
In some embodiments the adapter (110a) further comprises a rigid sterility screen (152) having a screen opening coinciding with the opening (114a) of the hollow cylinder.
In some embodiments the seal (320, 664, 664a, 664b, 664c, 664d, 664e) is configured to sealingly fit the distal segment along a non-circular circumference. In some embodiments the seal (320) is configured to sealingly fit distal segments having various circumferences. In some embodiments the seal (320) is configured to sealingly fit distal segments having circular circumferences in a range between a first circumference L and a second circumference greater than 1.5L.
In some embodiments the adapter (300, 510, 540, 570, 620, 620a, 620b, 620c, 620d, 620e) further comprises a pumping opening (368, 528, 558, 588, 632, 632a, 632b, 632c, 632d, 632e) at the distal portion of the hollow cylinder enabling pumping gas from – or flowing gas into – the inside of the hollow cylinder through the pumping opening when the distal segment of the medical device is inside the adapter. In some embodiments the adapter (300) further comprises a sterility barrier fluidly associated with said distal opening and configured for preventing penetration of contamination from the outside of the adapter to the inside of the hollow cylinder through the distal opening. In some embodiments the sterility barrier is a unidirectional valve (370). In some embodiments the sterility barrier is a sterility filter.
In some embodiments the adapter (300) further comprises an external vacuum seal (380) positioned along an external circumference of the adapter and configured to seal a gap between the adapter and an inner wall of a slot of said apparatus, when the adapter is inserted into the slot.
There is yet further provided, according to an aspect of the invention, an adapter (300) for use with an operational unit (420) for preparing a medical device (400) as described above for a medical procedure, the adapter being detachable from the operational unit and from the medical device. The adapter comprises a hollow cylinder (312) extending between an opening (314) dimensioned and configured to receive the distal segment of the medical device, and a distal end (316) of the hollow cylinder. The adapter further comprises a seal (320) positioned in the hollow cylinder and defining a distal portion (302) of the hollow cylinder between the seal and the distal end of the hollow cylinder. The seal is dimensioned to sealingly fit distal segments having external circumferences in a range between a first circumference L and a second circumference greater than 1.5L. And the adapter further comprises an electrical feedthrough (330a, 330b) electrically connecting an external contact (332a, 332b) outside of the hollow cylinder to an electrical conductor (334a, 334b) inside the hollow cylinder.
There is also provided, according to an aspect of the invention, a method of preparing at least a first medical device and a second medical device for a medical procedure carried out on a single patient. Each of the medical devices has a distal segment comprising an optical member. The circumference of the distal segment of one of the first and second medical devices is L and the circumference of the distal segment of the other medical device is greater than 1.2L. The method comprises providing a plasma chamber (distal portion 302 of adapter 3when the adapter is in the slot 422) comprising at least one electrode (430) electrically associated with a power source and configured for applying in the plasma chamber a plasma generating EM field. The plasma chamber also has an opening (314) and a seal (320) dimensioned and configured to receive the distal segment of each of the first and second medical devices in the opening through the seal. The method further comprises inserting the distal segment of the first medical device to the plasma chamber through the opening so that the seal and the distal end together seal the opening. The method further comprises supplying EM power from the power source to the at least one electrode, thereby applying a plasma generating EM field and generating plasma in the vicinity of the optical member. And the method further comprises repeating said steps of inserting the distal segment and supplying EM power for the second medical device. In some embodiments the medical devices are endoscopes, one having a distal member with a diameter D and the other having a distal member with a diameter 2D.
And there is yet further provided, according to an aspect of the invention, an adaptive seal (320) made of a flexible material. The seal is shaped as a combined outer tube (322) and an inner annular ring (324) extending radially along a wavy curve having at least one crest (326), between the outer tube and a central opening (328) of the seal. The adaptive seal is thereby configured to sealingly fit to an external surface of a member positioned in the central opening and having a smooth circumference within a range between a first circumference L and a second circumference 1.5L. A smooth circumference herein means a convex curve outlining aa convex shape and having no corners or sharp edges.
In some embodiments the outer tube is a circular cylinder. In some embodiments the flexible material is silicone. In some embodiments the flexible material has a hardness of between 25 to 90 Shore. In some embodiments the inner annular ring extends radially along a wavy curve having at least two or at least three crests.
And there is yet further provided, according to an aspect of the invention, a method of sealing a tube using a member inserted into the tube. The method comprises providing adaptive seal 320; disposing the adaptive seal in the tube (e.g. hollow cylinder 312) to be sealed so that the outer tube (322) of the seal coincides with the inner wall of the tube; tightening the adaptive seal to the tube using at least one smaller tube (an edge of second middle segment 344) inserted into the outer tube of the seal, so a gap between the tube and the smaller tube is sealed. The method further comprises inserting the member to the central opening of the adaptive seal. In some embodiments the smaller tube is a ring.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub- combination or as suitable in any other described embodiment of the invention. No feature described in the context of an embodiment is to be considered an essential feature of that embodiment, unless explicitly specified as such.
Although steps of methods according to some embodiments may be described in a specific sequence, methods of the invention may comprise some or all of the described steps carried out in a different order. A method of the invention may comprise all of the steps described or only a few of the described steps. No particular step in a disclosed method is to be considered an essential step of that method, unless explicitly specified as such.
Although the invention is described in conjunction with specific embodiments thereof, it is evident that numerous alternatives, modifications and variations that are apparent to those skilled in the art may exist. Accordingly, the invention embraces all such alternatives, modifications and variations that fall within the scope of the appended claims. It is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth herein. Other embodiments may be practiced, and an embodiment may be carried out in various ways.
The phraseology and terminology employed herein are for descriptive purpose and should not be regarded as limiting. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the invention. Section headings are used herein to ease understanding of the specification and should not be construed as necessarily limiting.

Claims (39)

34 288770/ CLAIMS
1. An apparatus for preparing a medical device to a medical procedure, the medical device having a distal segment intended to be inserted to a patient’s body, the distal segment having an optical member having an optical surface, the apparatus comprising an operational unit, an adapter detached from the operational unit and at least one electrode, wherein the operational unit comprises: an EM power source; a housing comprising a slot configured to receive the adapter in the slot, an adapter identifier configured to receive an identification signal from a corresponding transponder, and a controller functionally associated with the adapter identifier, and the adapter comprises: a hollow cylinder extending between an opening and a distal end of the hollow cylinder, the opening being dimensioned to allow insertion of the distal segment into the hollow cylinder, the hollow cylinder comprising a seal defining a distal portion of the hollow cylinder between the seal and the distal end of the hollow cylinder, the seal being dimensioned to sealingly fit an external circumference of the distal segment when the distal segment is inserted into the hollow cylinder, and the transponder, being configured to transmit the identification signal identifying the adapter or a position thereof relative to the adapter identifier, when the adapter is in the slot, wherein the apparatus is configured, when the distal segment is in the hollow cylinder of the adapter, the adapter is in the slot and the adapter identifier receives the identification signal from the transponder, to apply a plasma-generating EM field in the distal portion of the hollow cylinder by the at least one electrode, the electrode receiving EM power from the power source. 35 288770/
2. The apparatus of claim 1 wherein the transponder comprises at least one selected from the group consisting of a magnet, a mirror, a light source, an optical filter, a code sticker, a RFID chip and a smart card.
3. The apparatus of claim 1 wherein the seal is a microbial seal.
4. The apparatus of claim 1 wherein the seal is a vacuum seal.
5. The apparatus of claim 1 wherein the seal is configured to sealingly fit the distal segment along a non-circular circumference.
6. The apparatus of claim 1 wherein the seal is configured to sealingly fit distal segments having various circumferences.
7. The apparatus of claim 6 wherein the seal is configured to sealingly fit distal segments having circular circumferences in a range between a first circumference L and a second circumference greater than 1.5L.
8. The apparatus of claim 1, wherein the adapter further comprises an external vacuum seal positioned along an external circumference of the adapter and configured to seal a gap between the adapter and an inner wall of the slot of the operational unit, when the adapter is inserted into the slot.
9. The apparatus of claim 1 wherein the adapter further comprises a pumping opening on the distal portion of the hollow cylinder, configured for enabling pumping gas from the distal portion of the hollow cylinder or flowing gas thereto.
10. The apparatus of claim 9 wherein the operational unit further comprises a pump configured to pump gas from the distal portion of the hollow cylinder, via the pumping opening, when the adapter is in the slot.
11. The apparatus of claim 9 wherein the operational unit further comprises a gas port configured to fluidly associate a gas reservoir or a gas pump, external to the operational unit, to the pumping opening of the hollow cylinder, when the adapter is in the slot.
12. The apparatus of claim 9 wherein the pumping opening is equipped with a microbial barrier configured for preventing penetration of contamination into the hollow cylinder through the pumping opening during use.
13. The apparatus of claim 12 wherein the microbial barrier is a sterility filter.
14. The apparatus of claim 12 wherein the microbial barrier is a unidirectional valve. 30 36 288770/
15. The apparatus of claim 1 wherein the operational unit further comprises a rechargeable battery.
16. The apparatus of claim 1 further comprising a sterility container detached from the operational unit and from the adapter, having a container opening and being dimensioned to house the operational unit there inside when the adapter is in the slot.
17. The apparatus of claim 16 wherein the adapter further comprises a sterility screen having a screen opening coinciding with said opening of the hollow cylinder, the sterility screen being dimensioned and configured to fit and close the container opening when the adapter is in the slot.
18. The apparatus of claim 1 wherein the at least one electrode is comprised by the adapter.
19. The apparatus of claim 1 wherein the at least one electrode is comprised by the operational unit.
20. The apparatus of claim 1 wherein the adapter comprises an electrical feedthrough electrically connecting an external contact on the outside of the adapter with an electrical contact on the inside of the hollow cylinder, the electrical contact being configured to contact the distal segment when the distal segment is received inside the hollow cylinder.
21. The apparatus of claim 20 wherein the plasma generating field is applied between the at least one electrode and a metallic surface on the distal end, the metallic surface being in contact with the electrical contact of the adapter.
22. An adapter for use with an operational unit for preparing a medical device for a medical procedure, the medical device having a distal segment intended to be inserted to a patient’s body and comprising an optical member, the adapter being detachable from the operational unit and from the medical device, the adapter comprising: a hollow cylinder extending between an opening dimensioned and configured to receive the distal segment of the medical device, and a distal end of the hollow cylinder, a seal positioned in the hollow cylinder and defining a distal portion of the hollow cylinder between the seal and the distal end of the hollow cylinder, the seal dimensioned to sealingly fit an external circumference of the distal segment when the distal segment is inserted into the hollow cylinder, and 37 288770/ a transponder configured to transmit an identification signal identifying the adapter when the adapter is in a slot.
23. The adapter of claim 22, wherein the transponder stores information identifying the adapter.
24. The adapter of claim 22, wherein the transponder is configured to transmit the identification signal in response to a coded signal, thereby identifying the adapter.
25. The adapter of claim 22, further comprising an electrical feedthrough electrically connecting an external contact on the outside of the adapter to an electrical conductor on the inside of the hollow cylinder.
26. The adapter of claim 25 wherein the electrical conductor is configured as an electrical contact configured to contact an external surface of the distal segment of the medical device when the distal segment is received in the hollow cylinder.
27. The adapter of claim 25 wherein the electrical conductor is configured as an electrode.
28. The adapter of claim 22,further comprising a stopper configured to limit advancement of the distal segment of the medical device into the hollow cylinder.
29. The adapter of claim 28 wherein the stopper is employed as a dielectric barrier between the first electrode and the second electrode, thereby assisting in focusing plasma towards the optical member of the medical device, during use.
30. The adapter of claim 22 further comprising a hollow stabilizer positioned near the opening, configured to receive the distal segment of the medical device there through and adapted to fit an external circumference of the medical device to thereby stabilize the medical device in the hollow cylinder.
31. The adapter of claim 22 further comprising a rigid sterility screen having a screen opening coinciding with said opening of the hollow cylinder.
32. The adapter of claim 22 wherein the seal is configured to sealingly fit the distal segment along a non-circular circumference.
33. The adapter of claim 22 wherein the seal is configured to sealingly fit distal segments having various circumferences. 38 288770/
34. The adapter of claim 33 wherein the seal is configured to sealingly fit distal segments having circular circumferences in a range between a first circumference L and a second circumference greater than 1.5L.
35. The adapter of claim 22 further comprising a pumping opening at the distal portion of the hollow cylinder enabling pumping gas from the inside of the hollow cylinder through the pumping opening when the distal segment of the medical device is inside the adapter.
36. The adapter of claim 35 further comprising a sterility barrier fluidly associated with said distal opening and configured for preventing penetration of contamination from the outside of the adapter to the inside of the hollow cylinder through the distal opening.
37. The adapter of claim 36 wherein the sterility barrier is a unidirectional valve.
38. The adapter of claim 36 wherein the sterility barrier is a sterility filter.
39. The adapter of claim 22 further comprising an external vacuum seal positioned along an external circumference of the adapter and configured to seal a gap between the adapter and an inner wall of a slot of said apparatus, when the adapter is inserted into the slot. Webb+Co. Patent Attorneys 20
IL288770A 2015-09-07 2021-12-07 Apparatus and adapter for preparing medical devices to a medical procedure IL288770B2 (en)

Priority Applications (11)

Application Number Priority Date Filing Date Title
IL288770A IL288770B2 (en) 2021-12-07 2021-12-07 Apparatus and adapter for preparing medical devices to a medical procedure
IL307894A IL307894A (en) 2021-04-22 2022-04-22 Methods and systems for providing plasma treatments to optical surfaces
EP22791182.3A EP4326349A2 (en) 2021-04-22 2022-04-22 Methods and systems for providing plasma treatments to optical surfaces
CA3216142A CA3216142A1 (en) 2021-04-22 2022-04-22 Methods and systems for providing plasma treatments to optical surfaces
AU2022260712A AU2022260712A1 (en) 2021-04-22 2022-04-22 Methods and systems for providing plasma treatments to optical surfaces
JP2023565439A JP2024518772A (en) 2021-04-22 2022-04-22 Method and system for providing plasma treatment to optical surfaces - Patents.com
PCT/IB2022/000240 WO2022224040A2 (en) 2021-04-22 2022-04-22 Methods and systems for providing plasma treatments to optical surfaces
US17/660,398 US11896204B2 (en) 2015-09-07 2022-04-22 Methods and systems for providing plasma treatments to optical surfaces
US17/660,396 US11896203B2 (en) 2015-09-07 2022-04-22 Methods and systems for providing plasma treatments to optical surfaces
US18/491,630 US12070193B2 (en) 2021-04-22 2023-10-20 Multiple pumps for reducing pressure for plasma treatment
US18/405,934 US20240138664A1 (en) 2015-09-07 2024-01-05 Methods and systems for providing plasma treatments to optical surfaces

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