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WO2016125176A1 - A medical device for limiting tissue damage and uses thereof - Google Patents

A medical device for limiting tissue damage and uses thereof Download PDF

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Publication number
WO2016125176A1
WO2016125176A1 PCT/IL2016/050144 IL2016050144W WO2016125176A1 WO 2016125176 A1 WO2016125176 A1 WO 2016125176A1 IL 2016050144 W IL2016050144 W IL 2016050144W WO 2016125176 A1 WO2016125176 A1 WO 2016125176A1
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WO
WIPO (PCT)
Prior art keywords
limiter
tissue
medical device
contact
energy
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IL2016/050144
Other languages
French (fr)
Inventor
Orgad ROSENBLAT
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Tel HaShomer Medical Research Infrastructure and Services Ltd
Original Assignee
Tel HaShomer Medical Research Infrastructure and Services Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Tel HaShomer Medical Research Infrastructure and Services Ltd filed Critical Tel HaShomer Medical Research Infrastructure and Services Ltd
Publication of WO2016125176A1 publication Critical patent/WO2016125176A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320708—Curettes, e.g. hollow scraping instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3494—Trocars; Puncturing needles with safety means for protection against accidental cutting or pricking, e.g. limiting insertion depth, pressure sensors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/18—Inserters or removers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3209—Incision instruments
    • A61B17/3211—Surgical scalpels, knives; Accessories therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/064—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • A61B2090/065—Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension for measuring contact or contact pressure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0807—Indication means
    • A61B2090/0811—Indication means for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142—Wirelike structures, e.g. loops, rings, spirals
    • A61F6/144—Wirelike structures, e.g. loops, rings, spirals with T-configuration

Definitions

  • the present invention relates to medical devices, and uses thereof.
  • the present invention relates to medical tools that are configured to reduce the risk of perforation of a tissue during a medical procedure such as curettage, insertion of medical device/ s or application of medical treatment.
  • Curettes are surgical tools that can be used on a variety of tissue-types in a variety of medical practices for diagnostic or therapeutic purposes. Curettes are typically used for scraping away or for debridement of unwanted material, e.g., tissue. In medical terms this use is referred to as curettage. For example, curettes can be used for scraping away unwanted buildup, such as tarter, plaque and calculus that has accumulated on teeth; or for removing necrotic tissues, earwax or adenoids.
  • Curettes are also used in dilation and curettage (D&C) gynecological procedures, wherein the cervix is dilated and uterine contents and or its lining are removed via a curette or similar device.
  • D&Cs are common gynecological procedures and can be used as both a diagnostic and a therapeutic procedure. D&Cs may be used with patients who experience instances of abnormal uterine bleeding, with patients who have experienced a missed or incomplete miscarriage, or to prevent hemorrhage and infection as the result of a retained placenta post birth, particularly in instances of placenta accrete and other cases of a very adherent placenta.
  • curettage is performed for many other diagnostic, hemostatic and/or therapeutic procedures.
  • gingival curettage may be used to promote the generation of new connective tissue in the gums by removing soft tissue in the periodontal pocket.
  • Curettage may also be performed as a clinical procedure for treatment of benign bone tumors such as osteoid osteoma either in an open fashion or percutanously under imaging guidance.
  • curettage, such as tumescent suction curettage may be performed for the treatment of axillary hyperhidrosis to destroy and/or remove sweat glands.
  • Curettage during an adenoidectomy is a surgical treatment that consists in the removal of hypertrophied lymphatic tissue (Lushka's pharyngeal tonsil), which blocks the rhino pharynx, behind the nose.
  • Curettage with aspiration may be a component of the treatment for gastric cancers, particularly to preserve the spleen in a radical D2 gastrectomy, and curettage maybe a component of a treatment procedure of low-grade chondrosarcoma, for example in the course of intralesional surgery.
  • Curettage procedures involve a risk of perforation or scraping a subject's tissue beyond a desired limit.
  • curettage procedures used as part of a D&C have up to a 1% overall risk for perforation of a woman's uterus. While most perforations heal of their own accord, up to 50% of the perforations will require diagnostic or curative surgery. In such commonly performed procedures that involve curettage, a 1% risk of preventable iatrogenic complications is too high. (Ben-Baruch G. et al., (1980) Isr J Med Sci. 16(12):821-824.).
  • IUD Intrauterine Devices
  • the present invention provides a medical device comprising: a limiter and a tissue interaction member (TIM), wherein the limiter is configured to limit an amount of force and/or energy that can be applied by the tissue interaction member on a tissue.
  • the limiter comprises a spring.
  • the spring is a coiled spring.
  • the spring is a leaf spring.
  • the limiter comprises at least two concentric sleeves.
  • the limiter comprises a wire and the tissue interaction member comprises unit links.
  • the limiter comprises magnets, friction elements, elastic bands, bearings, or a combination thereof.
  • a limiter of this invention limits tissue penetration during a medical use.
  • a medical device of this invention further comprises a mechanism configured to override the limiter thereby removing limiter's limiting features, such as: the limit of the amount of force that can be applied by the medical device on the tissue or the penetration range/depth.
  • a medical device of this invention further comprises a regulator for regulating at least one property of the limiter.
  • the regulator is configured as a step-wise regulator.
  • regulator is configured as a variable regulator.
  • the regulating comprises setting a limit for the at least one regulating property of the regulator.
  • at least one regulating property comprises resistance thereby regulating the amount of the force that the medical device can apply on the tissue.
  • at least one regulating property comprises penetration range/depth, thereby the amount of penetration into the tissue.
  • the override mechanism overrides the regulator setting.
  • the force that can be applied by the tissue interaction member on a tissue is in an axial direction, or in other words, substantially perpendicular to a surface of the tissue.
  • the force is in a lateral direction, or in other words, substantially parallel to a surface of the tissue or substantially following a contour of a surface of the tissue.
  • the force is in multiple directions, with respect to the tissue, wherein interaction with the tissue in multiple directions is necessary to accomplish a use of the medical device.
  • a medical device of this invention further comprises a fail-safe mechanism configured for collapsing and/or retracting of the TIM to prevent the TIM from further force application and/or further contact with the tissue.
  • a medical device of this invention further comprises a feedback mechanism.
  • the feedback mechanism alerts a user of the medical device that the limit of the applied force has been reached and/or that the penetration has reached its limit range (measured in length).
  • the feedback mechanism alerts a user of the medical device that the applied force has reached a predetermined percentage out of the limit for the applied force.
  • the feedback mechanism alerts a user of the medical device that the penetration range has reached a predetermined percentage out of the limit for the range.
  • the feedback mechanism comprises a mechanical, auditory, haptic, sensory, visual mechanism, and/or any combination thereof.
  • a limiter of this invention is coupled to a tissue interaction member.
  • the limiter is coupled directly with the tissue interaction member.
  • the limiter is indirectly coupled with the tissue interaction member, via a coupling element.
  • the limiter and the tissue interaction member are comprised within a single unit.
  • a tissue interaction member is disposable. In another embodiment, a tissue interaction member is configured for multiple uses. In one embodiment, the limiter is disposable and in another embodiment the limiter is configured for multiple uses.
  • a tissue interaction member comprises at least a shaft having a distal end and a proximal end, wherein the distal end is the end that interacts with the tissue during a use of the medical device.
  • the shaft comprises a single unit. In another embodiment, the shaft comprises at least two units.
  • the medical device further comprises a handle.
  • the limiter is coupled to the handle.
  • the limiter is directly coupled to the handle.
  • the limiter is indirectly coupled to the handle, via a coupling element.
  • the handle is configured as a sleeve, or in other words as a cylindrical tube.
  • the limiter collapses when the limiter detects a resistance force greater than a predetermined limit setting. In one embodiment, a portion of the tissue interaction member collapses when the hmiter detects a resistance force greater than a predetermined limit setting. In one embodiment, the predetermined limit setting is set using the regulator. In one embodiment, the predetermined limit setting is adjustable. In one embodiment, the setting is adjusted by changing a tension in the limiter. In one embodiment, the limiter comprises a spring and the setting is adjusted by changing the tension in the spring.
  • a tension/compression can be configured therebetween and wherein the tension therebetween may be changed by altering the resistances (spring, friction, magnetic).
  • a limiter comprises unit links strung on a thread, the tension is changed by altering the looseness of the links on the thread.
  • a limiter's tension/compression is changed by altering the forces of a spring, magnets, friction elements, bearings, and any combination thereof.
  • the medical device is selected from a group comprising a curette, hysterometer, hysteroscope, applier of an intra uterine device (IUD).
  • a medical device of this invention is used for curettages.
  • the curettage is for diagnostic, hemostatic, gynecological, obstetrical, abortive, dental, adenoidectomy, plastic surgery or orthopedic purposes, or any combination thereof.
  • the medical device of this invention is a single use device.
  • the medical device comprises bio-degradable components.
  • this invention provides a method for preventing tissue damage using a medical device comprising a limiter and a tissue interaction member (TIM) as described herein, the method comprising the steps of:
  • the limiter is a resistance is set using a regulator comprised in the medical device.
  • the medical device is selected from a group comprising a curette, a hysterometer, an hysteroscope, an applier of an intra uterine device (IUD), scalpel and a cytoscope.
  • a limiter is regulated for at least one of: - halting further penetration into the tissue;
  • the tissue damage which is prevented comprises perforation of the tissue.
  • the tissue to be treated is selected from a group comprising: uterine tissue, cervical tissue, dental tissue, buccal cavity tissue, adenoidal tissue, bone tissue, muscle tissue, skin tissue and connective tissue, or any combination thereof.
  • the limit setting is selected from a group of pre-existing settings.
  • the method of this invention provides prevention of tissue damage during curettage, comprising the steps of
  • the resistance force limit is set using a regulator comprised in the medical device.
  • the medical device is a curette.
  • the limiter registers a resistance force equal to- or greater than- the set resistance force limit, the method comprises at least one of :
  • the tissue damage is perforation of the tissue.
  • the tissue is selected from a group comprising uterine tissue, cervical tissue, dental tissue, buccal cavity tissue, adenoidal tissue, bone tissue, muscle tissue, skin tissue and connective tissue, or any combination thereof.
  • the setting is selected from a group of pre-existing settings.
  • a tissue interaction member TIM
  • the preventive action is an alert to a user of the medical device.
  • the alert comprises as at least one of: visual indication, haptic indication, audio indication.
  • the applied energy is kinetic energy.
  • the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof.
  • the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch (changing from static friction to dynamic friction) and any combination thereof.
  • the medical device includes a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue.
  • the limiter further comprises a cylinder like member (CLM) configured to allow the shaft a motion along its longitudinal axis; and wherein the limiter is configured to at least partially transfer a force, which is applied to the CLM, towards the shaft.
  • CLM cylinder like member
  • the limiter further comprises at least one override element configured to allow the medical device to at least partially override the limiter, thereby avoid at least one of:
  • the medical device is at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, catheter, trocar, and retractors.
  • the limiter further comprises a regulating element, configured to adjust the limiter's initial properties.
  • the limiter comprises a coupling element configured to couple the limiter to device, the coupling element selected from a group consisting of: magnet/s, binding string/s, binding clip/s, adhesive element/s, vacuum container, and elastic sleeve.
  • the limiter comprises a tissue interaction member (TIM) in communication with a limiter, wherein the limiter is configured to provide a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue.
  • the predefined excessive contact relates to at least one of:
  • the medical device as defined above wherein the applied energy is kinetic energy
  • the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof.
  • the limiter comprises at least one selected from a group consisting of: coil spring/s, spiral springs, leaf spring/s, elastic bands, friction element/s, magmatic element/s and any combination thereof.
  • the preventive action is a collapse and/or retract of the TIM configured to prevent the TIM from further force application and/or fiirther contact with the tissue.
  • the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch (changing from static friction to dynamic friction) and any combination thereof.
  • the TIM comprises a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue.
  • the medical device further comprises a cylinder like member (CLM); wherein the shaft is configured to move along longitudinal axis of the CLM; and wherein the limiter is configured for communication between the shaft and the CLM to at least partially transfer a force, which is applied to the CLM, towards the shaft.
  • CLM cylinder like member
  • the medical device fiirther comprises at least one override element configured to at least partially override the limiter, thereby avoid at least one of:
  • the TIM comprises or in communication with at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, catheter, trocar, and retractors.
  • IUD intra uterine device
  • surgeons optically assisted surgical devices
  • the medical device as defined above further comprises a regulating element, configured to adjust the limiter's initial properties.
  • the regulating element is configured to determine at least one of: the predetermined force and the predetermined amount of contact.
  • preventive action comprises alerting a user of the medical device.
  • alerting comprises providing to the user at least one of: visual indication, haptic indication, audio indication.
  • the alerting comprises providing a measurement of the related force and/or the related amount of contact.
  • the preventive action comprises at least partially converting an applied energy, applied by a user and/or a robotic arm towards the tissue via the medical device or via the limiter, into a second form of energy, in order to control resulted contact.
  • the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction, heat energy, magnetic field energy and any combination thereof.
  • the preventive action comprises collapsing and/or retracting the TIM thereby preventing the TIM from further force application and/or further contact with the tissue.
  • IUD intra uterine device
  • microscopes optically assisted surgical devices
  • graspers graspers
  • tweezers and retractors.
  • the measurements include safety and efficacy parameters.
  • safety parameters include physical and/or mechanical damage of the tissue.
  • the damage is visual.
  • efficacy parameters are defined as the parameters to be achieved according to the common standards of the specific procedure.
  • the tested-configurations are selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof.
  • the selecting of the tested-configurations comprises selecting a different material for each tested-configuration.
  • the selecting of the tested-configuration comprises selecting dimensions for the limiter, fixed dimensions, dimensions within a range, or combinations thereof.
  • measurements of at least one effect comprise at least one of: procedure efficacy, tissue damage and a combination thereof.
  • the performing of the plurality of similar procedures is performed ex-vivo or on an artificial model.
  • the performing of the plurality of similar procedures is performed in a step up/ step down manner as with common known search algorithms.
  • the procedure is selected from: dilation, curettage, tissue removal, tumor removal, application of IUD, application of medical treatment, catheterization, and any procedure a skilled artisan would perform with a contact with a tissue.
  • the medical device is selected from: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, retractors, catheter, trocar and any device a skilled artisan would use for contact with a tissue.
  • IUD intra uterine device
  • hager scalpel
  • hysteroscope cystoscope optically assisted surgical devices
  • graspers graspers
  • tweezers retractors
  • catheter trocar and any device a skilled artisan would use for contact with a tissue.
  • the preventing comprising at least one of:
  • Figures 2A and 2B depict embodiments of a medical device of this invention comprising elements of a limiter and a tissue interaction member (TIM), and an embodiment of a safe use thereof;
  • Figures 3A-3D depict embodiments of a medical device of this invention showing embodiments further comprising a regulating element for the limiter;
  • Figures 4A-4B depict embodiments of a medical device of this invention showing embodiments further comprising a regulating and/or an override element for the limiter;
  • Figures 5A-5E depict additional embodiments of a medical device of this invention, comprising plurality of unit links;
  • Figure 6 depicts another embodiment of a medical device of this invention configured to respond to a range of horizontal motion or rotational motion of the TIM;
  • Figure 7 depicts yet another embodiment of a medical device of this invention, comprising a leaf spring, configured to respond to a range of horizontal motion or rotational motion of the TIM;
  • Figures 8A-8C depict another embodiment of this invention where the limiter is disposed within the sleeve handle, and where the handle is configured to be coupled to the medical device;
  • Figures 9A-9F depict embodiments of a limiter element comprised within double sleeves configured to be coupled to the medical device;
  • Figures 10A-10M depict embodiments of a limiter configured to halt the use of the medical device;
  • Figures 11A-1C depict embodiments of a limiter configured to be coupled to the medical device;
  • Figure 12 presents a schematic showing one embodiment of a method of use of a medical device of this invention.
  • Figure 13 presents another schematic showing yet another embodiment of a method of use of a medical device of this invention.
  • a "medical device” may refer to a curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, retractors, catheter, trocar and any device a skilled artisan would use for contact with a tissue.
  • IUD intra uterine device
  • hager scalpel
  • hysteroscope cystoscope optically assisted surgical devices
  • graspers graspers
  • tweezers retractors
  • catheter trocar and any device a skilled artisan would use for contact with a tissue.
  • curettage refers in some embodiment of the invention to a surgical scraping or cleaning of a tissue by means of a curette.
  • “Curettage” usually of the lining of a body cavity, may be used in some embodiments to clean it of foreign matter, to remove tumors or other growths or diseased tissue (as in the curetting out of diseased bone tissue in osteomyelitis), or to obtain a sample of tissue for diagnosis.
  • the term refers to the scraping of the wall of the uterus to obtain tissue for microscopic examination to determine the cause of abnormal uterine bleeding.
  • curettage may be performed with a medical device of this invention, which may have a tissue interaction member comprising the shape of a scoop or hoe, which may be scalpel-sized, and may have a blunt or sharp edge.
  • the term force refers in one embodiment to strength or energy exerted or brought to bear on a tissue by a medical device of this invention. Force exerted on a tissue may be used for medical procedures including treatment or diagnostic procedures, wherein even a reasonable force used may lead to a medical device penetrating a boundary beyond which it is not safe to penetrate. Similarly, excessive force may result in penetration of such a boundary. Penetration of such a boundary may cause damage to a tissue including bleeding. A force on a tissue by a medical device of this invention may be constant or variable, and may depend on the medical procedure.
  • the term "a boundary beyond which it is not safe to penetrate” as used herein refers in one embodiment to a boarder or limit or level of penetration of a tissue wherein further penetration might cause undesired damage or effect.
  • the term "resistance” as used herein, refers in one embodiment to an effort made to stop, prevent or reduce a force against something.
  • a tissue exerts a certain resistance against a force of a tissue interaction member of a medical device.
  • the resistance of a tissue to a force may be constant or differ dependent on the state of a tissue, the type of a tissue, multiple tissue types, e.g., tumor and healthy tissue within a region, or depth of a tissue interaction member within a tissue.
  • An ability of a practitioner to sense or feel the resistance of a tissue in response to a force being used during a procedure determines the practitioner's ability to prevent damage to the tissue. That is to stop, prevent, reduce or ameliorate a tissue interaction member of a medical device from having a negative or damaging effect on a tissue.
  • the term "damage” as used herein refers in one embodiment to causing excess bleeding, removing a larger part of tissue then intended, increasing the risk of excess scaring or adhesions, increasing the risk of infection, perforating a target organ or having a device reach tissues or spaces not intended, or any combination thereof.
  • the term “damage”, as used herein also refers to connecting two anatomical spaces not intended on being connected (for example, creating a "fistula"), diminishing structural strength of tissue or causing disruption to organ functionality, or any combination thereof of these outcomes and those listed above.
  • proximal refers to the side facing towards the user, a care giver, a physician, and/or a robotic arm.
  • distal refers to the side facing away from the user, a care giver, a physician, and/or a robotic arm. II Safety Curettes and Uses Thereof
  • Curettes are commonly used is in the gynecological procedure of dilation and curettage (D&C).
  • D&C dilation and curettage
  • a practitioner may place the tip of the curette near or at one of the uterine horns and subsequently pull the curette with a consistent and/or continuous motion to remove strips of endometrium.
  • the practitioner may also use the curette as a scrub brush.
  • the use of the curette as a scrub brush may facility the denuding of the endometrium until the basal layer is reached.
  • This systematic removal of tissue may continue until the point of a physical detection by the practitioner of a scratching or similar sensation.
  • a practitioner will continue until they hear the "uterine cry", i.e., a sound resulting from the sharp curette running over myometrium.
  • the myometrium may be sufficiently soft and delicate such that the uterine cry is not heard and/or the scratching is not felt by the practitioner.
  • a practitioner may damage the basal layer when excessive pressure is used, or if there is excess removal of tissue.
  • Damage and healing from damage caused by the misuse of a curette may result in a number of conditions for the woman, including secondary infertility.
  • a practitioner may fail to fully remove all of the endometrial tissue from the uterine cavity in an effort to prevent damage to the basal layer.
  • Curettage may, in some instances result in an injury to the patient. These injuries include the perforation of the uterus, particularly the fundus of the uterus. Uterine perforation may include damage to surrounding vessels and viscera. The chances of perforation may be exacerbated in instances where the endometrial cavity is larger, or the uterine wall is softer, such as during or immediately after pregnancy. Uterine perforation may increase in post-menopausal women due to issues such as endometrial atrophy and myometrial thinning. [0127] Uterine perforation, likely one of the most common and immediate complications of a D&C can result in sepsis or even hemorrhaging. The practitioner, in many instances might not even recognize that the uterus was perforated. Uterine perforation can be caused when a user such as a surgeon applies too much pressure to the tissue via the curette.
  • curettage may result in cervical injuries including trauma due to lacerations, which may result in extensive hemorrhaging. In some instances, curettage leads to an increased risk of infection.
  • Asherman's syndrome may result from damage caused by curettage.
  • Intrauterine adhesions may present themselves after curettage, particularly in instances of D&C for incomplete abortions. These intrauterine adhesions typically arise following trauma to the basal layer as a result of the curettage. The trauma can result in granular tissue healing on varied uterine surfaces. This granular tissue healing can result in tissue bridges. These bridges may be, in some instances, composed of dense connective tissues, and may harm the uterine cavity, resulting in abnormal bleeding and infertility.
  • D&C related to molar pregnancies can result in trophoblastic embolizations that can lead to fatal instances of cardiovascular collapse.
  • a medical device may result in damage to a tissue including causing excess bleeding, removing a larger part of tissue then intended , increasing the risk of excess scaring or adhesions, increasing risk of infection, perforating target organ, having a device reach tissues or spaces not intended, connecting two anatomical spaces not intended on being connected (a "fistula"), diminishing structural strength of tissue or causing disruption to organ functionality, or any combination thereof.
  • a tissue interaction member TIM
  • It is another object of the present invention to provide a new medical device comprising a tissue interaction member (TIM) in communication with a limiter, wherein the limiter is configured to provide a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue.
  • a tissue interaction member TIM
  • the limiter is configured to provide a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue.
  • the limiter is configured to selectively provide a preventive and/or precautionary action; - using the medical device for a medical procedure;
  • the predefined excessive contact relates to at least one of:
  • the preventive action is an alert to a user of the medical device.
  • the alert comprises as at least one of: visual indication, haptic indication, audio indication.
  • the alert comprises a measurement of the related force and/or the related amount of contact.
  • the preventive action is configured to at least partially convert an applied energy, applied by a user or by a robotic arm towards the tissue via the medical device or via the limiter, into second form of energy, in order to control the contact.
  • the applied energy is kinetic energy.
  • the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof.
  • the limiter comprises at least one element selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof.
  • the preventive action is a collapse and or retract of the TIM configured to prevent the TIM from further force application and/or further contact with the tissue.
  • the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch (changing from static friction to dynamic friction) and any combination thereof.
  • the medical device includes a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue.
  • the limiter or the medical device comprise a cylinder like member (CLM) configured to allow the shaft a motion along its longitudinal axis; and wherein the limiter is configured to at least partially transfer a force, which is applied to the CLM, towards the shaft.
  • the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm.
  • the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm.
  • the limiter or the medical device further comprising a placement rod or an extracting rod, configured to be pushed through the medical device or to be held while the medical device is withdrawn, and thereby to discharge a medical apparatus and/or to dispense a medical treatment, temporarily accommodated within the medical device
  • the preventive action is configured to avoid at least one incident selected from a group consisting of: tissue perforation, tissue puncture, tissue penetration, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
  • the limiter further comprises at least one override element configured to allow the medical device to at least partially override the limiter, thereby avoid at least one of:
  • the medical device is at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, catheter, trocar, and retractors.
  • the limiter or the medical device comprises a regulating element, configured to adjust the limiter's initial properties.
  • the regulating element is configured to determine at least one of a group consisting of: the predetermined force and the predetermined amount of contact.
  • the regulating or adjusting of the limiter allows using the medical device for at least one procedure selected from a group consisting of: dilation, curettage, tissue removal, tumor removal, application of 1UD, application of medical treatment, and catheterization
  • the limiter comprises a coupling element configured to couple the limiter to device, the coupling element selected from a group consisting of: magnet/s, binding string/s, binding clip/s, adhesive element/s, vacuum container, and elastic sleeve.
  • the limiter comprises an at least partially flexible string, attached to a handle, at the string's proximal end; and wherein the TIM comprises a plurality of links, connected by the string's distal end.
  • the present invention further provides a new method for determining configuration and/or properties of a limiter for a specific procedure; the limiter is coupled to a medical device and is configured to provide a preventive action and/or a precautionary action, responsive ly to a predefined excessive contact of the device with a tissue; the method comprising steps of:
  • the measurements include safety and efficacy parameters.
  • safety parameters include physical and/or mechanical damage of the tissue.
  • the damage is visual.
  • efficacy parameters are defined as the parameters to be achieved according to the common standards of the specific procedure.
  • the present invention further provides a new method for determining configuration of a limiter coupled to a medical device, wherein the limiter is for preventing an excessive contact of the device with a tissue, the method comprising the steps of:
  • the tested-configurations are selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof.
  • the selecting of the tested-configurations comprises selecting a different material for each tested-configuration.
  • the selecting of the tested-configuration comprises selecting dimensions for the limiter, fixed dimensions, dimensions within a range, or combinations thereof.
  • measurements of at least one effect comprise at least one of: procedure efficacy, tissue damage and a combination thereof.
  • the procedure is selected from: dilation, curettage, tissue removal, tumor removal, application of IUD, application of medical treatment, catheterization, and any procedure a skilled artisan would perform with a contact with a tissue.
  • the device is selected from: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, retractors, catheter, trocar and any device a skilled artisan would use for contact with a tissue.
  • the preventing comprising at least one of:
  • Figures 1A and IB depict outcomes of curettage use.
  • Figure 1A shows one embodiment of a curette procedure, where a curette (1000) scrapes a surface of a tissue (1004) without perforating the tissue.
  • Figure IB shows an embodiment of an unsafe curettage, where the tissue (1004) has been perforated by the curette (1000).
  • Figures 2A and 2B depict embodiments of a medical device of this invention comprising elements of a limiter (2012) and a tissue interaction member (TIM) (2002), and an embodiment of a safe use thereof.
  • Figure 2A shows an embodiment of a medical device (2000) comprising a handle (2014), the TIM (2002), a coiled spring limiter (2012) connected at one end (2023) to the TIM (2002) and at the other end (2024) to the handle (2014), a warning indicator (2010) accommodated within the handle and in communication with the TIM (2002) proximal end, where the distal end of the tissue interaction member (2008) has begun to scrape a surface (2004) of a tissue and the warning indicator (2010) is still hidden at the proximal end of the handle (2014).
  • Figure 2B shows an embodiment of a safe use of the medical device, where the distal end of the medical device (2008) has penetrated a tissue to a boundary beyond which it is unsafe to penetrate (2006).
  • the coiled spring limiter (2012) compresses, the warning indicator (2010) at least partially pops out of the proximal end of the handle and is visible (2016) to the user; accordingly, further penetration into the tissue may be halted.
  • Figures 3A and 3B depict embodiments of a medical device (3000) of this invention showing embodiments where a regulator (3020) may regulate the compression of a spring limiter (3012).
  • the spring limiter is connected at its distal end (3023) to the TIM (3002) and at its proximal end to handle (3014) via the regulator (3020).
  • the TIM is limited in its forward motion (towards its distal end), by a stopping element (3022).
  • Figures 3A and 3B demonstrate the adjusting of the spring limiter (3012) using the regulator (3020).
  • the spring is demonstrated to be less compressed than what is demonstrated in Figure 3B therefore in Figure 3A the spring is more flexible, and in Figure 3B the spring is less flexible.
  • FIGs 3C and 3D depict embodiments of a medical device of this invention where a regulator (3030) may regulate the compression of a spring limiter (3012), as demonstrated in Figure 3C and may regulate tension of the spring limiter (3012), as demonstrated in Figure 3D.
  • a regulator (3030) may regulate the compression of a spring limiter (3012), as demonstrated in Figure 3C and may regulate tension of the spring limiter (3012), as demonstrated in Figure 3D.
  • the proximal end of spring limiter (3034) is connected to the TIM (3002) and the spring limiter's distal end (3032) is connected to the handle (3014).
  • a regulating element (3030) is configured to gradually push the TIM (3002) forward (towards its distal end) and therefore compress the spring limiter to a specific length.
  • the proximal end of spring limiter (3038) is connected to the handle (3014) and the spring limiter's distal end (3036) is connected to the TIM (3002).
  • a regulating element (3030) is configured to gradually push the TIM (3002) forward (towards its distal end) and therefore stretch the spring limiter to a specific length.
  • the regulating element may be a screw (3030), located at the proximal end of the handle, or a sliding clip (not shown) configured to be pushed at several steps.
  • Figures 4A and 4B depict embodiments of a medical device (4000) of this invention comprising: a TIM (4002), a handle (4014) and a spring limiter (4012) connected therebetween.
  • the device further comprises an override element comprising: a pin (4022), connected to the handle (4014), and receptacle (4024) connected to the TIM (4002), the receptacle (4024) having at least one pitch (4030).
  • Figure 4A shows an embodiment where the override pin element (4022) may be inserted into the receptacle comprising wide registered pitches (slots) (4030), thereby compressing or stretching the spring limiter to a certain level and where the pitch (4030) of the TIM (4002) determines a limited pitch for the TIM.
  • the device (4000) further comprises a warning indicator (4010) configured to respond to a contact with the tissue interaction element (4002).
  • Figure 4B shows a similar embodiment where the override pin element (4022) may be inserted into a receptacle (4026) comprising plurality of narrow registered slots, thereby overriding the spring element, at any stage of contact between the TfM and the tissue, by pressing the pin is against the TIM.
  • Figures 5A-5E depict additional embodiments of a medical device (5000) of this invention.
  • Figure 5A shows a medical device where the limiter comprises an at least partially flexible string (5024), attached to a handle (5010), at the string's proximal end; and where the TIM comprises a plurality of unit links (5120), connected by the string's distal end.
  • the device (5000) further comprises a regulating element (5020), a screw or sliding-clip (not shown) configured to adjust the limiter's (5024) initial settings (tension) and thereby to determine the predetermined force and/or the predetermined amount of contact.
  • Figure 5B shows elements of the unit links (5120) strung along a thread (5024) under high tension (large arrows), where the unit links align and present a sharpened edge (5026) for scraping a tissue.
  • Figure 5C shows forces affecting the geometry of the TIM, where the shape and tension along the thread (low tension-small arrows) may affect the shape formed by the unit links and the point at which they collapse (long internal arrows).
  • Figure 5D shows the unit links (5120) of the TIM (5012) strung along a thread (5024), wherein the links are in contact with a tissue surface (5004,5006).
  • Figure 5E shows an embodiment of safe use of a medical device of this invention, wherein when the distal end of the TIM (5008) comprising unit links (5120) perceives a tension, due to an excessive contact with the tissue, beyond which further penetration is not safe (5006), the TIM then collapses and thereby prevents further penetration and/or contact with the tissue, e.g., prevents forward movement (large arrows) into the tissue.
  • Figure 6 depicts another embodiment of a medical device (6000) of this invention, comprising a TIM (6002), a handle (6014) and a spring limiter (6012) therebetween, where a coiled spring limiter (6012) may respond to a range of horizontal motion and/or rotational motion (rotation axis at 6030) of the tissue interaction member (TIM) (6002) at its distal end (6008).
  • the device (6000) further comprises warning indicators (6080) configured to pop out of the handle and indicate a boundary beyond which it is unsafe for the device to penetrate (6006).
  • Figure 7 depicts another embodiment of a medical device (7000) of this invention, configured to respond to horizontal motion and/or rotational motion (rotation axis at 7030) of the distal end of the TIM (7008).
  • the device comprising a TIM, a handle and a leaf spring limiter (7012) communicating therebetween.
  • the device (7000) further comprises a regulator (7020) that is configured slide along the spring leaf to adjust the length of the leaf spring limiter (7012) and thereby to determine its initial properties.
  • Figures 8A. 8B and 8C depict another embodiment of this invention (8000).
  • Figure 8A shows a sleeve handle (8014) coupled with a medical device (8002), wherein a limiting element (not shown) is disposed within the sleeve handle (8014) and where the limiting element (not shown) communicates between the sleeve handle (8014) and the medical device (8002).
  • Figure 8B shows the application of an energy and/or a force by a user or a robotic arm (not shown) to the handle (8014), according to some embodiments, the applied energy and/or force is being reduced when applied to the actual device (8002) and towards the tissue (8004,8006).
  • This energy and/or force reduction or limitation prevents a scraping/cutting distal edge of the device (8002) from penetrating a tissue beyond a safe border (8006).
  • the energy and/or force transference is gradually diminished as power is applied near the set limit, until the point where there is no transference of energy and/or force at all, which may prevent unwanted tissue damage.
  • Figure 8C demonstrates the coupling of such a sleeve (8014) with the known in the art curette device (8002).
  • Figures 9A-9F depicts embodiments of a limiter element comprised within a sleeve.
  • Figure 9A shows an embodiment of a double sleeve limiter (9000), comprising an inner sleeve (9014i) and an outer sleeve (9014o), which may in certain embodiments also be used as the handle, the limiter comprising two spring elements (9012). One end of the spring elements is attached to the inner surface of the outer sleeve (9013), while the other end of the spring elements is attached to the outer surface of the inner sleeve (9015) axially distant from the outer sleeve attachment site.
  • a tissue interaction member (TIM) may be attached to the inner sleeve (See Figure 9F).
  • FIG 9A shows the spring elements in an extended, no tension/compression configuration at which the inner sleeve (9014i) rests within the outer sleeve (9014o).
  • Figure 9B presents the double sleeve limiter (9000) of Figure 9 A wherein the spring elements (9012) are in a compressed configuration showing the inner sleeve (9014i) remaining in the same relative place, e.g., keeping a tissue interaction member from further penetrating a tissue, while the outer sleeve continues moving in the direction of the force (9030) applied by the user, which may occur in one embodiment after a tissue interaction member attached to the inner sleeve (9014i) encounters resistance and the outer sleeve continues in a forward movement, while the inner sleeve is halted in its forward progress.
  • the spring elements (9012) are in a compressed configuration showing the inner sleeve (9014i) remaining in the same relative place, e.g., keeping a tissue interaction member from further penetrating a tissue, while the outer sleeve continues moving in the direction of the force (9030) applied by the user, which may occur in one embodiment after a
  • Figure 9C shows another embodiment of a double sleeve limiter (9000), which in certain embodiments may also be used as the handle, comprising at four at least four spring elements at four different directions, up, down, left and right (9012).
  • One end of the spring elements is attached to the inner surface of the outer sleeve (9014o), while the other end of the spring elements is attached to the outer surface of the inner sleeve (9014i), wherein attachment sites are directly adjacent to one another.
  • more than four spring elements may be used, disposed in additional directions around the sleeve and/or along the longitudinal axis of the sleeve.
  • Figure 9D shows a cross-section view of the inner and outer sleeves (9014i,9014o) of Figure 9C, wherein there is no differential force experience between the different springs (9012).
  • Figure 9E shows a cross-section view of the inner and outer sleeves (9014i,9014o) of Figure 9C, wherein there is a differential force experienced in the direction of the arrow leading to a compressed spring element (9012-1) on the left side and an expanded spring element on the right side (9012-r).
  • Figure 9F shows an embodiment of a double sleeve limiter (9000), wherein the stippled areas (9050,9052) indicate potential location for attachment of a tissue interaction member.
  • stippled areas may be used to bind an existing medical device running through internal sleeve as described below.
  • Figures 10A-10M depict embodiments of a limiter configured to halt the use of the medical device (100).
  • Figure 10A demonstrates an embodiment of the medical device (100), where according to a non-limiting example, the demonstrated device is an IUD applicator for dispensing an IUD (140) into the uterus, when in the right position within the uterus, while avoiding its perforation, according to other embodiments (not shown) medical treatment/s may be dispensed instead of, or with, the IUD.
  • the device comprising:
  • TIM shown as a shaft (110), which temporarily accommodates the IUD in its distal portion;
  • a handle configured for the use of a care giver, having a cylinder form, wherein the handle is configured to accommodate the shaft's proximal portion, and allow the shaft to move along its longitudinal axis;
  • the limiter is a sliding clip: having a base (124) at proximal end configured to be pushed by the proximal end of the TIM, and at least one arm (127) which is at least partially flexible and comprising at least one stopping element (121) at its distal end; the stopping element (121) configured to be held by at least one holding element (131) located at inner side of the cylindrical like handle (130), while the force applied on the limiter via the shaft is less than the predetermined force Fmax.
  • Figure IOC and 10D demonstrate positions of the limiter, according to some embodiments of the invention.
  • Figure IOC demonstrate a resting position where the applied force on the tissue, transferred to the limiter via the shaft, is still under the predetermined force F ⁇ Fmax, and therefore the device can still be pushed towards the uterine.
  • Figure 10D demonstrate the collapse of the limiter, buy means that the applied force made the at least one at least partially flexible arm fold inward, and the limiter's stopping element (121) is therefore released from the handle's holding element (131), and the TIM (shaft 120) is now retract towards its proximal end.
  • the IUD may be applied even if limit is not been reached, according to the physician's decision. According to some embodiments, the IUD may be applied when an alert limit has been reached, according to the physician's decision.
  • Figure 10E discloses another embodiment for the limiter's (120) configuration, where a coil spring (125) communicates between the proximal end of the shaft (110) and the base of the limiter (124), for at least partially converting kinetic energy applied by the user via the handle into elastic strain energy.
  • a number of stopping elements (121) and/or a number of holding element (131) may provide the limiter with multiple stops.
  • each of the multiple stops may have a different Fmax.
  • by changing the limiter's material and/or geometry flexibility is modified and accordingly the Fmax and amount of sliding of the limiter, before final decoupling occurs.
  • Figures 10F, 10G-10J disclose another embodiment for the medical device (100), via several views.
  • the handle (131) comprises at least one override pin (132), configured to be pushed inward (150) and to be firmly attached to the body of the limiter (120), demonstrated herein according to a non-limiting example, at ring (122) of the limiter.
  • This override firm connection prevents the shaft from pushing the limiter towards the proximal end, even if F>Fmax.
  • Figure 10H demonstrates another embodiment for the limiter (120), comprising a wedge, at outer ring of the base (124) configured to spotted by the handle (130) proximal end, therefore prevents the limiter from motion towards it distal end.
  • Figures 10K-10M disclose another embodiment for the medical device (100).
  • the device (100) further comprises a placement rod (160) in communication with the proximal end of the IUD (141).
  • the placement rod (160) is configured to be inserted through the handle (130), the limiter (123) and within the shaft (110), and to hold an IUD (141) in place, while withdrawing the shaft (110), thereby place the IUD in the uterus.
  • the placement rod (160) comprises at least one rod-handle (161), at proximal end. Accursing to one embodiment the rod-handle (161) is at least partially flexible (164). According to another embodiment the rod-handle (161) comprises a spring (163). According to other embodiments the placement rod (160) may also be an extracting rod which may assist in dispensing medical treatment/s.
  • FIGS 11A-11C disclose several views of another embodiment of the invention.
  • a limiter (200) is provided for being coupled with a medical device (not shown) having a tissue interaction member (TIM) and/or configured for temporarily accommodating medical treatment s before its dispensing.
  • the limiter (200) is configured to a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue.
  • the limiter comprises: cylindrical tube (210) configured to be attached to any selected medical device existing in the art, at least one handle (230) connected to the cylindrical tube (210) via flexible/elastic leaf springs (220).
  • cylindrical tube (210) comprises at least one picking slot (240).
  • the user sense of the contact with the tissue is amplified, due to the response of the limiters at least partially flexible/elastic parts (220 and/or 230).
  • the at least one handle (230) may be pressed against the cylindrical tube (210) and into grooves (221) of the cylindrical tube (210), and thereby override the limiter.
  • Figure 1A presents an example of curettage using a medical device (1000), for example a curette, wherein a tissue interaction member of the device (1002) is in contact with superficial layers of a tissue without causing damage to the tissue.
  • Figure IB provides an example of a medical device perforating a tissue, possibly damage the tissue and causes internal bleeding in a subject.
  • a medical device of this invention comprises a limiter and a tissue interaction member, wherein the limiter is configured to limit an amount of force that can be applied by the tissue interaction member on a tissue.
  • a result of limiting an amount of force that can be applied by the tissue interaction member may be prevention of perforation of a tissue boundary beyond which it is not safe to penetrate.
  • Medical devices may be for single use or multiple uses, wherein a user would sanitize or sterilize a multiple use device between uses. Further, materials used for components of a device of this invention may be biodegradable.
  • a tissue interaction member may be configured to interact with a tissue.
  • a distal end of the tissue interaction member comprises the region of tissue interaction during use of the device.
  • the proximal end may in certain instances be used for holding a medical device directly, or in alternative embodiments, may be incorporated into a handle. When the proximal is used for holding the medical device, it is in effect a handle.
  • tissue interaction device may also be referred to as a "tool” or a "surgical tool”, wherein terms may be used interchangeably having all the same meanings and qualities.
  • a tissue interaction member comprises a shaft connecting the proximal and distal ends.
  • the shaft is a single unit that includes the distal and proximal ends.
  • the shaft comprises at least two sections.
  • the shaft may have one section for a user to grasp and one section for tissue interaction separated by a limiter of this invention.
  • a shaft of a tissue interaction member connecting the distal and proximal ends, directly or indirectly, may be hollow, solid, flexible, malleable or rigid, or any combination thereof.
  • the limiter in this embodiment is a leaf spring (7012) connecting the two halves, wherein tension may be set using a regulator (7020) in contact with the leaf spring.
  • the distal end (7008) of the tissue interaction member may be moved in a back and forth motion (see arrows) that could scrap laterally a surface of a tissue or could be forced axially into a tissue to scoop out a section of tissue, e.g., tumor material.
  • the distal end may in certain embodiments be shaped as a loop, scoop, gouge, spoon or blade, or other configuration as required by a use of the medical device.
  • the region of the distal end for tissue interaction comprises an edge.
  • the edge may be beveled, sharp, blunt, serrated, smooth, rigid, malleable or flexible, or any combination thereof or otherwise finished such that the finishing is configured to facilitate the use of the tissue interaction member for one or more uses.
  • the distal end may be disposable or for multipurpose use.
  • a tissue interaction member, or a section thereof, may in certain embodiments be made of metal or plastic or a composite.
  • the outer surface of a tissue interaction member may be surfaced with an antimicrobial, antibacterial or antifungal coating.
  • a tissue interaction member and a handle if present are made of the same materials.
  • a tissue interaction member and a handle, if present, are made of different materials.
  • a tissue interaction member with our without a handle may be configured to be autoclavable or otherwise sanitized for use in medical, therapeutic or other procedures.
  • a tissue interaction member may itself be autoclavable or able to be sanitized using means known in the art.
  • components within a handle may be configured to be autoclavable or otherwise sterilized.
  • a handle may be sealed such that it is autoclavable.
  • a medical device of this invention further comprises a handle.
  • a handle may be a component of the tissue interaction membrane or in another embodiment may be coupled permanently to tissue interaction member.
  • a handle may be a component of a limiter or, in another embodiment, may be coupled permanently to a limiter. Coupling of a handle to a limiter and/or a tissue interaction member may be direct or indirect, permanent or impermanent. Further, in certain embodiments a handle may be couple to both a limiter and a tissue interaction member.
  • a handle may be configured to be removable from tissue interaction member and/or limiter.
  • a handle may have a locking mechanism or other mechanism configured to maintain a coupling between a handle and a tissue interaction member or a limiter.
  • a handle may have a smooth surface, alternatively in another embodiment, the handle may have bumps and/or indentations and/or other surface structures.
  • the bumps and/or indentations and/or other surface structures may be configured to provide grip.
  • a grip may include indentation that may house a control means for use in operating surgical tool.
  • a handle may be a sleeve.
  • a handle may include an exit hole or space in the proximal end of the handle (the end closest to the user's hand.
  • a tissue interaction member is disposable. In another embodiment, a tissue interaction member is for multiple uses, wherein the member is sterilized between uses. [0195] A tissue interaction member of this invention may be configured for diagnostic, therapeutic or other uses.
  • a tissue interaction member may be configured for use in gynecological procedures. In one embodiment a tissue interaction member may be configured for use in dental procedures. In another embodiment, a tissue interaction member may be configured for use in laproscopic procedures. In yet another embodiment, a tissue interaction member may be configured for use in otolaryngo logical procedures. In still another embodiment, a tissue interaction member may be configured for use in procedures involving a subject's bone or skin. In a further embodiment, a tissue interaction member may be configured for one or a plurality of medical or therapeutic procedures. [0197] In one embodiment, a tissue interaction member is selected from a group comprising a curette, a hysterometer, a hystero scope and a cytoscope.
  • a tissue interaction member is brought into contact with a tissue surface and through use to a boundary within the tissue beyond which it is not safe to proceed further, for example so as not to penetrate a tissue to cause damage or bleeding.
  • a tissue which may be contacted by a tissue interaction member of this invention, may include uterine tissue, cervical tissue, dental tissue, buccal cavity tissue, adenoidal tissue, bone tissue, muscle tissue, skin tissue, bladder tissue or connective tissue, or any combination thereof.
  • a limiter of this invention is selected from a group comprising a spring, wherein the spring may be a spring, tension spring, a torsion spring or a leaf spring; a set of at least two concentric sleeves; unit links, magnets, a bearing, or a friction element, or any combination thereof.
  • the function of a limiter is to limit tissue penetration during a medical use. By limiting tissue penetration a user of a device of this invention comprising a limiter may avoid, prevent, and/or lessen tissue damage to a subject.
  • FIGS 2A and 2B present an embodiment of a medical device of this invention and a safe use thereof.
  • the device of Figure 2A (2000) comprises a tissue interaction member (2002) and a spring limiter (2012), wherein the tissue interaction member and spring limiter are encased in a handle (2014).
  • the tissue interaction member comprises a feedback warning indicator (2016) at its proximal end (2010), which may emerge an opening comprised in the handle in order to alert a user that a set resistance has been reached.
  • the handle further comprises an indentation providing a place for finger or thumb support.
  • Figures 5A-5C show an alternate embodiment of a device of this invention, wherein Figure 5 A shows a limiter (5012) comprised of unit links (5120) strung along a thread (5024) and wherein the limiter itself comprises the distal end (5008) of a tissue interaction member (5002).
  • the tension of the limiter may be set using a screw regulator (5020) around which the thread may be wound, wherein the screw is located within the proximal end (5010) of the handle.
  • the double headed arrow shows that the screw may be adjusted (turned) in order to tighten or loosen the thread.
  • a thread comprises a cable able to be adjusted in order to adjust the tension between the unit links.
  • FIG. 5B is a close-up showing a section of the unit links (5120 indicates a single unit link), which comprise the limiter and are comprised within the tissue interaction member, under high tension.
  • the block arrows indicate a tension on the thread (5024) thereby maintaining the unit links in a set geometry providing a rigid edge (5026) which may be used in a method of this invention to scrape or cut a tissue.
  • Figure 5C is another close-up showing a section of the device, for instance a curette comprising a limiter comprising unit links under low tension (small arrows) of the thread (5024) leading to a deformation (long arrows) of the limiter/tissue interaction member.
  • a limiter may be configured such that it will limit and/or inhibit a practitioner's ability to exert a force.
  • the force may be predetermined.
  • the force may, in some embodiments of the invention, be determinable in advance prior to using surgical tool. In some embodiments the force may first be determined by trial and error.
  • the inhibition and or limitation of the exertion of a predetermined force may be configured such that undesired damage of tissue is less likely as a result of a practitioner's use of a medical device.
  • the inhibition and or limitation of the exertion of a force, which has not been predetermined may be configured such that undesired damage of tissue is still less likely to occur as a result of a practitioner's use of a medical device.
  • the force may be a range of forces.
  • a force may be in a single direction, for example in an axial direction substantially perpendicular to a surface of a tissue surface or, in another embodiment, a force may be in a lateral direction, substantially parallel to a surface of a tissue or substantially following a contour of a surface of a tissue.
  • a force may be in multiple directions if necessary to accomplish the use of the medical device, for example curettage over a broad surface or lateral scraping.
  • FIG. 6 shows an embodiment of a medical device (6000) and use thereof for scraping in a lateral direction (see arrows at the distal end (6008) of tissue interaction member (6002), following the contour of a surface of the tissue (6004).
  • a spring limiter 6012
  • the tension/release of the spring are in the same direction as the movement of the tissue interaction member along the surface of the tissue (see arrows).
  • the feedback warning indicator 6080
  • a thumb or finger indentation is represented at 6018.
  • a portion of the shaft exits the handle of the device, providing feedback to the user.
  • the force exerted by a user via medical device that exceeds a predetermined force may be sufficient for the tissue interaction portion of a device to pass through the entirety of a tissue or just a portion of a tissue. In this way, the interaction of the device with the tissue may be harmful to tissue.
  • a medical device of this invention further comprises a regulator for regulating at least one property of the limiter, for instance a property of force.
  • regulating a limiter's properties comprises a step-wise regulation, for example a step-wise regulation of force.
  • regulating a limiter's properties comprises a variable regulation, for example a variable regulation of force. In this way a practitioner may set a limiter's properties based on the need for a particular medical use.
  • a force that may be applied by a tissue interaction member is a resistance from the tissue to which the force is being applied.
  • a regulator of this invention may in certain embodiments be able to detect a tissue resistance opposing the force of a tissue interaction member.
  • a limit may be set for at least one property of a regulator.
  • a limit may be set as to the resistance a regulator detects, such that upon detection of the resistance limit a regulator regulates a limiter such that the amount of force that a medical device can apply to a tissue is limited.
  • a limiter and a regulator comprise the same unit.
  • a regulator and limiter comprise individual units that may be functionally and/or structurally linked.
  • Figures 3A and 3B show one embodiment of a regulator of this invention, wherein a medical device comprises a spring limiter (3012) coupled to a regulator (3020).
  • the regulator may be adjusted so that the spring is under less tension (Figure 3 A) or more tension ( Figure 3B) by essentially extending or compressing the spring by way of movement of the regulator, as indicated by the double headed arrow.
  • a limiter may provide resistance via one or more of the following: bearings, friction elements, magnets, tension springs, torsion springs, leaf springs or concentric sleeves and/or other components.
  • the one or more of the above mentioned components may be configured to be operating either in parallel and/or series.
  • a limiter may collapse when a resistance greater than a predetermined setting is felt. Collapse of a limiter may result in the inability to continue use of a device. In one embodiment, a portion of the tissue interaction member collapses when a limiter detects resistance greater than a predetermined setting. Collapse of a tissue interaction member may result in the inability to continue use of a device. Collapse of a limiter and/or tissue interaction member may inhibit or reduce a force, for example a force promoting a tissue interaction member deeper into a tissue.
  • Figure 5D presents an embodiment of a medical device and method of use thereof of this invention, wherein the tissue interaction member (5002) comprising a limiter (5012) comprising unit links (5120), wherein the distal edge (5008) is brought into contact with a tissue surface (5004) -note direction of arrows.
  • Figure 5E presents an embodiment of a limiter (5012) responding to a resistance detected in response to the force of forward motion, that is greater than a predetermined setting by collapsing and deforming in order to limit continue penetration into a tissue past a safe boundary (5006).
  • a predetermined setting is set using a regulator.
  • a predetermined setting is adjustable.
  • the setting may be adjusted by changing a tension in a limiter, for example changing a tension in a spring, or changing or altering the looseness of unit links on a thread, or changing the type of thread to have more or less stiffness, or changing the resistance between concentric sleeves, or altering the forces, e.g., attractive/repulsive forces, between magnets, or changing the amount of friction between friction elements, or changing the ability of a bearing to move.
  • a medical device further comprises an override mechanism that overrides a regulatory setting. This may enable a practitioner to make decisions based on need and/or experience in order that a medical procedure may be carried out successfully, wherein the limitation of a limiter needs to be overridden.
  • a shaft of a surgical tool includes a series of notches, slots or indentations.
  • a notched shaft may be a component continuous with a tissue interaction member.
  • a notched shaft may be a component continuous with a tissue interaction member.
  • a notched unit that is configured to interface with a pin is couple to a shaft of a tissue interaction member.
  • a pin may be configured to be an override for a limiter of this invention.
  • the notches or indentations may be spaced regularly, irregularly, at exactly the width for pin entry or wider that the pin or any combination thereof. The differences in notch distribution and/or width allow for an override mechanism to be more or less exact, enabling an override at only a single point (width exact for pin) or providing a range that can be overridden (width wider than needed for pin entry).
  • a pin may be mechanically disengaged from a notched shaft by a user.
  • the removal of a pin from a notched shaft may allow the user to override the limiter by allowing, in some embodiments of the invention, tissue interface member to move independent of the limitations employed by the limiter.
  • Figure 4A shows an override mechanism (4022 and 4024) having wide slots (4024) and a pin (4022) that may be inserted into the slots to set a broad predetermined limit point or removed to override a setting, as shown by the double headed arrow.
  • Figure 4B shows an override mechanism (4022 and 4024) having narrow slots (4026) and a pin (4022) that may be inserted into the slots to allow override at any stage of the procedure, as shown by the double headed arrow.
  • a medical device further comprises a feedback mechanism.
  • a feedback mechanism represents return information based on the input, e.g., force on a tissue, and thus is a part of the output of a medical device of this invention and part of the output of a method of use of a medical device of this invention.
  • a feedback may provide a self-corrective action or may transmit evaluative or corrective information about a medical procedure in process. For instance, in one embodiment a feedback mechanism alerts a user of the medical device that the limit of applied force has been reached. In one embodiment, a feedback mechanism alerts a user that the force is within a predetermined percentage of the limit. For a non- limiting, a feedback mechanism may alert a user that the force is within 10%, 20% 30% 40% 50% or any chosen percentage of the limit.
  • a feedback mechanism comprises a mechanical, auditory or visual mechanism, or any combination thereof.
  • a feedback mechanism may comprise a warning indicator that emerges from a medical device when a limit is reached, or a light that shines or changes colors upon reaching a limit, or a sound that is emitted upon reaching a limit, or any combination thereof.
  • a shaft may be a component or, or may be directly or indirectly linked with, a tissue interaction member. The shaft may be configured such that when it exits a handle it provides a visual cue to the user that excessive force that exceeds a predetermined level of force has been applied on a tissue using the device.
  • the shaft may be configured to provide a visual cue prior to the boundary beyond which a tool should not penetrate.
  • a shaft may be colored such that when the shaft exits the handle, the user is sees the proximal end of the shaft. There may be a range of colors indicating distance to the boundary beyond which the tool should not penetrate.
  • the proximal end of a shaft may have text applied to it, such that when the shaft exits the handle, the user is likely to see the text on the proximal end of the shaft.
  • a text message may provide a warning to the user that excessive force has been applied.
  • the proximal end of the shaft may light up or may produce an audible sound when it exits handle.
  • the proximal end of the shaft may use another means to alert that the use of excessive force above a predetermined amount of force has been applied.
  • a user may be warned and receive feedback by emergence of a proximal end and/or other components when the user is approaching a force that may be excessive.
  • there may be multiple warnings to a user wherein the warnings may change as the nature of the force becomes such that it is more likely to harm tissue.
  • feedback may be provided by informing a user of the use of excessive force by a means other than shaft.
  • This means may include a haptic response, an audible response, a visual response, and/or a combination of responses.
  • excessive force by the user can result in a haptic and/or force feedback response, for example through handle.
  • the haptic response may be commensurate with the degree of excessive force above a predetermined amount of force, as applied by the user. For examples a vibration signal wherein the vibration rate changes based on the proximity of the tool with the boundary beyond which the tool should not penetrate.
  • a user may be warned of excessive use of force, or that the user is approaching excessive use of force by methods as described herein and above.
  • the excessive use of force applied by a user may cause a limiter to act as a fail-safe.
  • a limiter acts as a fail-safe, the surgical tool may fail and may become inoperable, thereby halting or reducing a force and/or further progress into a tissue.
  • the inoperability of a surgical tool may be permanent or temporary.
  • a medical device further comprises a fail-safe mechanism.
  • a fail-safe mechanism in a medical device of this invention, the device provides a safeguard that prevents continuing a procedure that may damage a tissue. For instance, even if a practitioner of a device fails to see or heed the warnings of a feedback warning indicator of a medical device and continues to exert force on a tissue with the device, a fail-safe mechanism could inhibit or reduce the force automatically.
  • a surgical tool may include a fail-safe mechanism, wherein the fail-safe mechanism may result in the bending or collapsing of all or part of a surgical tool when a user exerts an amount of pressure above a predetermined threshold wherein that threshold is designed to limit the ability of the user to damage the surface of tissue.
  • a limiter may collapse when a set resistance is detected.
  • a limiter is configurable to bend, twist, deform or otherwise change the shape of a shaped end and/or shaft in response to the application of an amount of force in excess of a predetermined force, as applied by a user on tissue.
  • a tissue interaction member may collapse when a set resistance is detected.
  • a tissue interaction member is configurable to bend, twist, deform or otherwise change the shape of a shaped end and/or shaft in response to the application of an amount of force in excess of a predetermined force, as applied by a user on tissue.
  • the bending, twisting or otherwise changing of shape of a component of a medical device e.g., a limiter or tissue interaction member is configured to prevent the further application of force by the user.
  • the changing of shape of shaped end is reversible.
  • a shaped end and/ or shaft cannot revert to its original shape.
  • a limiter comprises a spring that may be configured such that the spring's tension, stiffness, resistance and/or other characteristics are adjustable by a user.
  • a spring may be configured such that the spring's tension stiffness, resistance and/or other characteristics are not adjustable by the user.
  • a spring may be configured to provide a single stage or multi-stage variable resistance.
  • a spring may be coupled to shaft.
  • a shaft may be configured to sit within a handle.
  • a limiter comprises unit links strung on a thread that may be configured such that the unit's links and thread's tension, stiffness, resistance and/or other characteristics are adjustable by a user.
  • unit links may be configured such that the unit links and/or thread tension stiffness, resistance and/or other characteristics are not adjustable by the user.
  • Unit links may be configured to provide a single stage or multi-stage variable resistance.
  • a thread linking the unit links comprises a metal thread (a wire), a plastic thread, a nylon thread, a synthetic thread or a cotton thread, or any other long thin line of material.
  • a thread of this invention may be coated or uncoated. For instance, a thread may be covered with plastic, rubber, metal, or any other suitable material.
  • a thread may be flexible or inflexible providing a range of flexibility and tension.
  • unit links may be coupled to shaft.
  • a shaft may be configured to sit within a handle.
  • a limiter may in some embodiments of the invention, be connected to cable.
  • the thread stringing unit links may act as a cable that may be attached to a medical device at a point away from tissue interaction region. Changes in cable length and/or tension could be used to adjust tension and arrangement of the unit links. Or a cable could be connected to a spring to adjust tension.
  • a cable may be situated within a hollow of a tissue interaction member.
  • a cable may run along the external surface of tissue interaction member.
  • a cable may be a thread, a tether or other coupling device.
  • a cable may be made of one or a combination of materials. The materials may include metal, plastic, a polymer, and/or other materials.
  • a cable may run through the length of tissue interaction member and into a handle.
  • a cable may be coupled to a limiter control device.
  • Limiter control device may be couple to the exterior of handle.
  • a limiter control device may be at a distal end of a handle.
  • a limiter comprises a magnets or concentric sleeves or friction elements or bearings that may be configured such that the magnets or sleeves or friction elements or bearings create a tension, stiffness, resistance and/or other characteristics are adjustable by a user.
  • magnets or concentric sleeves or friction elements or bearings may be configured such that the tension, stiffness, resistance and/or other characteristics are not adjustable by the user.
  • Magnets or sleeves or friction elements or bearings may be configured to provide a single stage or multi-stage variable resistance.
  • magnets or sleeves or friction elements or bearings may be coupled to shaft.
  • a shaft may be configured to sit within a handle.
  • a limiter may be coupled to a tissue interaction member.
  • a limiter may be coupled to handle, wherein these embodiments are not exclusion, e.g., the tissue interaction member may also be the handle. Coupling may be direct or indirect.
  • a limiter is coupled directly to a tissue interaction member.
  • a limiter is coupled indirectly to a tissue interaction member.
  • a limiter and a tissue interaction member are all one unit.
  • a limiter may be coupled, or may be in communication with, other components of surgical tool.
  • a limiter may be coupled, or may be in communication with, other components not directly coupled to surgical tool, for example, external monitors, external processors, external memory, and/or other external components. Coupling may be direct or through a wireless means.
  • a limiter may be coupled directly to a distal end of tissue interaction member.
  • a limiter may be incorporated within a distal end of a tissue interaction member.
  • a limiter is configured to automatically or semi automatically limit the amount of force that can be exerted by a user on a tissue via surgical tool and tissue interaction member.
  • a limiter of this invention may be configured to be contained partially or wholly within a handle or within a tissue interaction member. Alternatively, in one embodiment a limiter of this invention may be attached to an independent medical device.
  • An example of a limiter being attached to an independent medical device may be a sleeve configured to be coupled or attachable to a surgical tool ( Figures 8 A and 8B; Figures 9A- 9F), wherein the sleeve comprises a limiter, for example spring limiters (9012).
  • a surgical tool may be a curette.
  • the sleeve may be configured to serve as a handle for surgical tool.
  • a sleeve may be configured to cover from, 5%-95%, 10% to 70%, 20%-60%, or less than 50% of a surgical tool.
  • a sleeve comprising a limiter that could be attached to an independent medical device may include a double sleeve wherein the inner sleeve is wide enough to fit over the medical device, wherein the sleeves are connected by a spring (e.g., end of the spring is connected to the inner side of the outer sleeve and the other end of the spring is connected to the outer surface of the inner sleeve) and the force is limited in an axial direction between the sleeves.
  • a spring e.g., end of the spring is connected to the inner side of the outer sleeve and the other end of the spring is connected to the outer surface of the inner sleeve
  • multiple springs connect the inner and outer sleeves and the force is limited in multiple directions. Placement of the springs and tension of the springs used effects the range and directions of forces that may be limited.
  • a sleeve may be configured to interface with surgical tool such that a limiter can convert energy applied by a user of surgical tool.
  • Figures 9A and 9B show the limiter before ( Figure 9A) and after ( Figure 9B) an application of a force.
  • Figure 9B demonstrates the convention of kinetic energy to spring potential energy, and therefore the inner sleeve (9014-i) remains in place while the outer sleeve (9014o) continues in a forward motion to the extent the spring elements (9012); direction of the force is shown by arrow at Figure 9B. It is shown that the limiter halts a tissue interaction member from penetrating further into a tissue.
  • a sleeve limiter impedes forward progress of a tissue interaction member and potential penetration of a tissue.
  • Figure 9A shows a configuration when the threshold of excessive force has not yet been met and the sleeves rest one within the other.
  • the embodiment of a sleeve limiter shown in Figures 9A-9B may be effective to prevent tissue damage for axial forces parallel to the long axis of the sleeves.
  • Figures 9C-9E shows another embodiment, wherein the double sleeve limiter may be effective to prevent tissue damage for forces applied in multiple direction (See multiple arrows in Figure 9C).
  • Figure 9E shows the results of one embodiment wherein the force applied is in a side-ways (transverse) direction wherein the resultant force compresses one spring limiter (9012-1) and expands another spring limiter (9012-r).
  • a sleeve (8014) may be configured such that when it is coupled with surgical tool, limiter can limit the use of excess force by a user of surgical tool on tissue (note a large force exerted at the site of the sleeve results in a much smaller force at the point of the distal end of a tissue interaction member (8002) on a tissue surface (8004) such that a boundary beyond which damage may occur (8006) is not penetrated.
  • a sleeve is attached to an independent medical device.
  • Figure 9F shows an embodiment of attachments sites (9050; 9052).
  • attachment could be anywhere along the length of an inner sleeve that allows for the translation of forces presented in Figure 8B.
  • the attachment may be through the use of clamps, use of an adhesive mechanism for example an adhesive tape, through the use of cable ties, use of any known mechanism in the art, or any combination thereof.
  • a limiter is further coupled to a user interface, wherein the user interface is coupled to surgical tool.
  • a user interface may be positioned on a handle of a surgical tool.
  • a user interface may be mechanical, electrical or a combination of mechanical and electrical components.
  • a user interface may be a button, a switch, a knob, a ring, a screw, a barb, a slider, a wheel, a touch screen or other component.
  • User interface may be configured to control or partially control limiter.
  • a user interface is configured to override the function of limiter. In some embodiments of the invention, interface is configured to vary the function of limiter.
  • a user interface is a wheel, wherein the wheel may be coupled to a handle and/or a limiter.
  • a user using a surgical tool may, in some examples, turn the wheel clockwise and/or counterclockwise to alter the characteristics of limiter. In some examples, turning a wheel may result in changing a tension, for example, of a spring.
  • Curettage may be for diagnostic, hemostatic, gynecological, obstetrical, abortive, dental, adenoidectomy, plastic surgery, or orthopedic purposes or any combination thereof.
  • FIGS. 2A and 2B show one embodiment of a method of use, wherein the distal end of a tissue interaction member (2008) may be in contact with the tissue surface (2004) for use for example scrapping a surface.
  • the feedback warning indictor (2016) emerges from the handle alerting the user that a set tissue resistance has been met. Note that along with the alert the limiter spring (2012) compresses. Similar representations of safe methods are represented in Figures 5E and 8B.
  • this invention provides a method for preventing tissue damage using a medical device comprising a limiter and a tissue interaction member, the components of which have been described in details above.
  • the steps of a method for preventing tissue damage include selecting a device based on need, setting a resistance limit for the limiter, and using the medical device wherein penetration of a portion of the tissue interaction member into a tissue is limited by the limiter, thereby achieving a safe method of use.
  • a limiter detects or registers a resistance equal to or greater than a set resistance limit further penetration into a tissue may be reduced or halted altogether. The user is alerted that a limit has been detected. The reduction or elimination of further penetration may therefore be user initiated.
  • the device may collapse when a limit is reached, for example a limiter or tissue interaction unit may collapse preventing continuation of an application of force. By halting or reducing progress of a tissue interaction member of a device perforation and/or damage to a tissue to prevented or reduced.
  • this invention provides a method of preventing or reducing tissue damage during curettage.
  • An initial step (400) is selecting the medical device based on a medical need. If the device selected does not comprise a limiter of this invention, a limiter may be added (402) prior to use. Choice of a limiter may depend on direction of forces needed for a medical procedure and/or an amount of force needed and/or the resistance a tissue may present to a medical device.
  • a resistance limit may be set, for instance using a regulator comprised in the medical device.
  • the device is used by a skilled practitioner for its intended purpose (405) with the knowledge that a particular resistance limit has been set and the practitioner may receive a warning or the device may become inoperable, when the limit is detected (410).
  • a procedure may be completed prior to penetrating a tissue to an unsafe depth, no further action occurs (408).
  • a use alert limit has been reached (410) there are multiple possible outcomes including by not limited to, (1) a user may override the limiter and continue use (414); (2) a user may halt use based on the information received thereby preventing possible perforation of a tissue; or (3) a limiter may collapse or deform halting use and preventing possible perforation of a tissue.
  • a limiter is selected according to its requirements of the required medical procedure, e.g. selecting at least one limit type (301): force, contact range (measured in length and/or length percentage), any contact with a tissue.
  • a configuration is selected for the limiter (302), according to its limit type and according to the required medical procedure.
  • the limiter is either a part of the medical device (303), or an independent device, which requires a coupling to a medical device of a choice (304).
  • a regulating process is conducted (305) to adjust initial properties of the limiter, and/or the selected limit.
  • performing of the medical procedure comprises manual and/or automatic usage of the medical device (306).
  • an initial contact or a predetermined contact range with the tissue, measured in length and/or in percentage from a set length limit, is alerted (313).
  • an examination for a completion of the procedure (314) is identified (310) by the care giver, physician, or the robotic control, and accordingly the performance of the procedure may be halted (312).
  • the limiter may be overridden (307), to allow a user a limit free use of the medical device.
  • the limiter is responsive to a predetermined limit (308), and accordingly at least one preventive action is performed, selected from a group consisting of: user alert (310), convert at least part of the kinetic energy (311), and halt the medical procedure (312).
  • user alert 310
  • convert at least part of the kinetic energy 311
  • halt the medical procedure 312.
  • the term "comprise” or grammatical forms thereof refers to the inclusion of the indicated elements, such as the limiter or tissue interaction member of this invention, as well as inclusion of other elements, such as regulator(s), override mechanisms, material coatings, etc.
  • the term “consisting essentially of” refers to a device, whose only essential elements are the indicated elements, however, other elements or limitations be included which are for quality or identification purposes of a device, but are not involved directly in the use of the device.
  • the term “consisting essentially of may refer to elements, which exert an effect via a mechanism distinct from that of the indicated essential element for ensuring safety, for instance a type of coating on a handle which may aid a user holding the tool but does not directly influence the safety elements presented herein above.
  • the term “consisting” refers to a device, which includes the elements and limitations as described herein.
  • the terms “a” or “one” or “an” refer to at least one.
  • the phrase “two or more” may be of any denomination, which will suit a particular purpose.
  • "about” may comprise a deviance from the indicated term of + 1 %, or in some embodiments, - 1 %, or in some embodiments, ⁇ 2.5 %, or in some embodiments, ⁇ 5 %, or in some embodiments, ⁇ 7.5 %, or in some embodiments, ⁇ 10 %, or in some embodiments, ⁇ 15 %, or in some embodiments, ⁇ 20 %, or in some embodiments, ⁇ 25 %.

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Abstract

A limiter configured to be coupled to a medical device and methods thereof The limiter is configured to provide a preventive action and/or a precautionary action, responsively to a predefined excessive contact of the medical device with a tissue. According to some embodiments, the preventative action is at least one selected from: an alert to a user, energy conversion in order to control the contact, and prevention of the medical device from further force application and/or further contact with the tissue.

Description

A MEDICAL DEVICE FOR LIMITING TISSUE DAMAGE AND USES THEREOF
FIELD OF THE INVENTION
[01] The present invention relates to medical devices, and uses thereof. In particular the present invention relates to medical tools that are configured to reduce the risk of perforation of a tissue during a medical procedure such as curettage, insertion of medical device/ s or application of medical treatment.
BACKGROUND OF THE INVENTION
[02] In the following described is a non-limiting example of a Curette and its uses, order to explain the need for protective medical devices. Curettes are surgical tools that can be used on a variety of tissue-types in a variety of medical practices for diagnostic or therapeutic purposes. Curettes are typically used for scraping away or for debridement of unwanted material, e.g., tissue. In medical terms this use is referred to as curettage. For example, curettes can be used for scraping away unwanted buildup, such as tarter, plaque and calculus that has accumulated on teeth; or for removing necrotic tissues, earwax or adenoids.
[03] Curettes are also used in dilation and curettage (D&C) gynecological procedures, wherein the cervix is dilated and uterine contents and or its lining are removed via a curette or similar device. D&Cs are common gynecological procedures and can be used as both a diagnostic and a therapeutic procedure. D&Cs may be used with patients who experience instances of abnormal uterine bleeding, with patients who have experienced a missed or incomplete miscarriage, or to prevent hemorrhage and infection as the result of a retained placenta post birth, particularly in instances of placenta accrete and other cases of a very adherent placenta.
[04] In addition, curettage is performed for many other diagnostic, hemostatic and/or therapeutic procedures. For instance, gingival curettage may be used to promote the generation of new connective tissue in the gums by removing soft tissue in the periodontal pocket. Curettage may also be performed as a clinical procedure for treatment of benign bone tumors such as osteoid osteoma either in an open fashion or percutanously under imaging guidance. Further, curettage, such as tumescent suction curettage may be performed for the treatment of axillary hyperhidrosis to destroy and/or remove sweat glands. Curettage during an adenoidectomy is a surgical treatment that consists in the removal of hypertrophied lymphatic tissue (Lushka's pharyngeal tonsil), which blocks the rhino pharynx, behind the nose.
[05] Curettage with aspiration may be a component of the treatment for gastric cancers, particularly to preserve the spleen in a radical D2 gastrectomy, and curettage maybe a component of a treatment procedure of low-grade chondrosarcoma, for example in the course of intralesional surgery.
[06] As with many medical procedures, each of these procedures involves certain risks. Curettage procedures involve a risk of perforation or scraping a subject's tissue beyond a desired limit. For instance, curettage procedures used as part of a D&C have up to a 1% overall risk for perforation of a woman's uterus. While most perforations heal of their own accord, up to 50% of the perforations will require diagnostic or curative surgery. In such commonly performed procedures that involve curettage, a 1% risk of preventable iatrogenic complications is too high. (Ben-Baruch G. et al., (1980) Isr J Med Sci. 16(12):821-824.).
[07] Another medical procedure having a risk of perforation is the insertion Intrauterine Devices (IUD). Uterine perforation, which is more likely to occur during insertion of the medical device, ranges from 0.1 to 0.3 percent.
[08] Accordingly, there exists a need for an improved medical device and/or a need to improve current medical devices, and the methods thereof, in order to reduce patient risk during any of these procedures.
SUMMARY OF THE INVENTION [09] In one embodiment, the present invention provides a medical device comprising: a limiter and a tissue interaction member (TIM), wherein the limiter is configured to limit an amount of force and/or energy that can be applied by the tissue interaction member on a tissue. In one embodiment, the limiter comprises a spring. In one embodiment, the spring is a coiled spring. In another embodiment, the spring is a leaf spring. In one embodiment, the limiter comprises at least two concentric sleeves. In another embodiment, the limiter comprises a wire and the tissue interaction member comprises unit links. In yet another embodiment, the limiter comprises magnets, friction elements, elastic bands, bearings, or a combination thereof.
[010] In one embodiment, a limiter of this invention limits tissue penetration during a medical use.
[Oi l] In one embodiment, a medical device of this invention further comprises a mechanism configured to override the limiter thereby removing limiter's limiting features, such as: the limit of the amount of force that can be applied by the medical device on the tissue or the penetration range/depth.
[012] In one embodiment, a medical device of this invention further comprises a regulator for regulating at least one property of the limiter. In one embodiment, the regulator is configured as a step-wise regulator. In one embodiment, regulator is configured as a variable regulator. In one embodiment, the regulating comprises setting a limit for the at least one regulating property of the regulator. In one embodiment, at least one regulating property comprises resistance thereby regulating the amount of the force that the medical device can apply on the tissue. In one embodiment at least one regulating property comprises penetration range/depth, thereby the amount of penetration into the tissue. In one embodiment, the override mechanism overrides the regulator setting. [013] In one embodiment, the force that can be applied by the tissue interaction member on a tissue is in an axial direction, or in other words, substantially perpendicular to a surface of the tissue. In another embodiment, the force is in a lateral direction, or in other words, substantially parallel to a surface of the tissue or substantially following a contour of a surface of the tissue. In one embodiment, the force is in multiple directions, with respect to the tissue, wherein interaction with the tissue in multiple directions is necessary to accomplish a use of the medical device.
[014] In one embodiment, a medical device of this invention further comprises a fail-safe mechanism configured for collapsing and/or retracting of the TIM to prevent the TIM from further force application and/or further contact with the tissue.
[015] In one embodiment, a medical device of this invention further comprises a feedback mechanism. In one embodiment, the feedback mechanism alerts a user of the medical device that the limit of the applied force has been reached and/or that the penetration has reached its limit range (measured in length). In one embodiment, the feedback mechanism alerts a user of the medical device that the applied force has reached a predetermined percentage out of the limit for the applied force. In one embodiment, the feedback mechanism alerts a user of the medical device that the penetration range has reached a predetermined percentage out of the limit for the range. In another embodiment, the feedback mechanism comprises a mechanical, auditory, haptic, sensory, visual mechanism, and/or any combination thereof.
[016] In one embodiment, a limiter of this invention is coupled to a tissue interaction member. In one embodiment, the limiter is coupled directly with the tissue interaction member. In another embodiment, the limiter is indirectly coupled with the tissue interaction member, via a coupling element. In one embodiment, the limiter and the tissue interaction member are comprised within a single unit.
[017] In one embodiment, a tissue interaction member is disposable. In another embodiment, a tissue interaction member is configured for multiple uses. In one embodiment, the limiter is disposable and in another embodiment the limiter is configured for multiple uses.
[018] In one embodiment, a tissue interaction member comprises at least a shaft having a distal end and a proximal end, wherein the distal end is the end that interacts with the tissue during a use of the medical device. In one embodiment, the shaft comprises a single unit. In another embodiment, the shaft comprises at least two units.
[019] In one embodiment of this invention, the medical device further comprises a handle. In one embodiment, the limiter is coupled to the handle. In one embodiment, the limiter is directly coupled to the handle. In another embodiment, the limiter is indirectly coupled to the handle, via a coupling element. In one embodiment, the handle is configured as a sleeve, or in other words as a cylindrical tube.
[020] In one embodiment of a device of this invention the limiter collapses when the limiter detects a resistance force greater than a predetermined limit setting. In one embodiment, a portion of the tissue interaction member collapses when the hmiter detects a resistance force greater than a predetermined limit setting. In one embodiment, the predetermined limit setting is set using the regulator. In one embodiment, the predetermined limit setting is adjustable. In one embodiment, the setting is adjusted by changing a tension in the limiter. In one embodiment, the limiter comprises a spring and the setting is adjusted by changing the tension in the spring. In another embodiment, when a limiter comprises at least two concentric sleeves, a tension/compression can be configured therebetween and wherein the tension therebetween may be changed by altering the resistances (spring, friction, magnetic). In yet another embodiment, when a limiter comprises unit links strung on a thread, the tension is changed by altering the looseness of the links on the thread. In a further embodiment when a limiter's tension/compression is changed by altering the forces of a spring, magnets, friction elements, bearings, and any combination thereof. [021] In one embodiment of this invention, the medical device is selected from a group comprising a curette, hysterometer, hysteroscope, applier of an intra uterine device (IUD). Scalpel, applier of a medical treatment, applier of an intra uterine device (TUD), hager, scalpel, cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, catheter, trocars, retractors, cystoscope, and any device a skilled artisan would use for contact with a tissue. [022] In one embodiment, a medical device of this invention is used for curettages. In one embodiment, the curettage is for diagnostic, hemostatic, gynecological, obstetrical, abortive, dental, adenoidectomy, plastic surgery or orthopedic purposes, or any combination thereof.
[023] In one embodiment, the medical device of this invention is a single use device. In one embodiment, the medical device comprises bio-degradable components. [024] In one embodiment this invention provides a method for preventing tissue damage using a medical device comprising a limiter and a tissue interaction member (TIM) as described herein, the method comprising the steps of:
- selecting the a device or a tissue interaction member;
- adding/coupling a limiter if one not comprised;
- setting a limit for the limiter, if not predetermined; and
- using the medical device;
wherein penetration, of the distal end of the tissue interaction member into the tissue, is limited by the limiter. In one embodiment, the limit is a resistance is set using a regulator comprised in the medical device. [025] In one embodiment, the medical device is selected from a group comprising a curette, a hysterometer, an hysteroscope, an applier of an intra uterine device (IUD), scalpel and a cytoscope.
[026] In one embodiment of the method, a limiter is regulated for at least one of: - halting further penetration into the tissue;
- preventing perforation of a tissue; and
- alerting a user of the medical device that the limit has been reached.
[027] In one embodiment of the method of this invention, the tissue damage which is prevented comprises perforation of the tissue. In one embodiment, the tissue to be treated is selected from a group comprising: uterine tissue, cervical tissue, dental tissue, buccal cavity tissue, adenoidal tissue, bone tissue, muscle tissue, skin tissue and connective tissue, or any combination thereof.
[028] In one embodiment of the method of this invention, the limit setting is selected from a group of pre-existing settings.
[029] In one embodiment, the method of this invention provides prevention of tissue damage during curettage, comprising the steps of
- selecting a medical device comprising a limiter and a tissue interaction member as described herein;
- setting a resistance limit for the limiter; and
- using the medical device;
wherein penetration of a portion of the tissue interaction member into the tissue is limited by the limiter.
[030] In one embodiment of the method of this invention, the resistance force limit is set using a regulator comprised in the medical device. In one embodiment, the medical device is a curette.
[031] In one embodiment of the method of this invention, the limiter registers a resistance force equal to- or greater than- the set resistance force limit, the method comprises at least one of :
- halting further penetration into tissue;
- preventing perforation of a tissue; and
- alerting a user of said device, that the force limit has been reached;
[032] In one embodiment, the tissue damage is perforation of the tissue. In one embodiment, the tissue is selected from a group comprising uterine tissue, cervical tissue, dental tissue, buccal cavity tissue, adenoidal tissue, bone tissue, muscle tissue, skin tissue and connective tissue, or any combination thereof. In one embodiment of a method of this invention, the setting is selected from a group of pre-existing settings.
[033] It is one object of the present invention to provide a new limiter for a medical device, the medical device having a tissue interaction member (TIM), wherein the limiter is configured to be coupled with the medical device and to provide a preventive action and/or a precautionary action, responsively to a predefined excessive contact of the TIM with a tissue.
[034] It is another object of the present invention to provide the limiter as defined above, wherein the predefined excessive contact relates to at least one of:
- a predetermined force applied by the medical device to the tissue;
- a predetermined amount of contact with the tissue; and
- any contact with the tissue.
[035] It is another object of the present invention to provide the limiter as defined above, wherein the preventive action is an alert to a user of the medical device. [036] It is another object of the present invention to provide the limiter as defined above, wherein the alert comprises as at least one of: visual indication, haptic indication, audio indication.
[037] It is another object of the present invention to provide the limiter as defined above, wherein the alert comprises a measurement of the related force and/or the related amount of contact.
[038] It is another object of the present invention to provide the limiter as defined above, wherein the preventive action is configured to at least partially convert an applied energy, applied by a user and/or a robotic arm towards the tissue via the medical device or via the limiter, into a second form of energy, in order to control resulted contact. [039] It is another object of the present invention to provide the limiter as defined above, wherein the applied energy is kinetic energy. [040] It is another object of the present invention to provide the limiter as defined above, wherein the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof. [041] It is another object of the present invention to provide the limiter as defined above, wherein the limiter comprises at least one selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof.
[042] It is another object of the present invention to provide the limiter as defined above, wherein the preventive action is a collapse and/or retract of the TIM configured to prevent the TIM from further force application and/or further contact with the tissue.
[043] It is another object of the present invention to provide the limiter as defined above, wherein the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch (changing from static friction to dynamic friction) and any combination thereof.
[044] It is another object of the present invention to provide the limiter as defined above, wherein the medical device includes a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue. [045] It is another object of the present invention to provide the limiter as defined above, wherein the limiter further comprises a cylinder like member (CLM) configured to allow the shaft a motion along its longitudinal axis; and wherein the limiter is configured to at least partially transfer a force, which is applied to the CLM, towards the shaft.
[046] It is another object of the present invention to provide the limiter as defined above, wherein the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm.
[047] It is another object of the present invention to provide the limiter as defined above, wherein the preventive action is configured to avoid at least one incident selected from a group consisting of: tissue perforation, tissue puncture, tissue penetration, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
[048] It is another object of the present invention to provide the limiter as defined above, wherein the limiter further comprises at least one override element configured to allow the medical device to at least partially override the limiter, thereby avoid at least one of:
- the alert;
- the energy conversion; and
- the prevention of the TIM from further force application and/or further contact with the tissue. [049] It is another object of the present invention to provide the limiter as defined above, wherein the medical device is at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, catheter, trocar, and retractors. [050] It is another object of the present invention to provide the limiter as defined above, wherein the limiter further comprises a regulating element, configured to adjust the limiter's initial properties.
[051] It is another object of the present invention to provide the limiter as defined above, wherein the regulating element is configured to determine at least one of: the predetermined force and the predetermined amount of contact.
[052] It is another object of the present invention to provide the limiter as defined above, wherein the limiter comprises a coupling element configured to couple the limiter to device, the coupling element selected from a group consisting of: magnet/s, binding string/s, binding clip/s, adhesive element/s, vacuum container, and elastic sleeve. [053] It is one object of the present invention to provide a new medical device comprising a tissue interaction member (TIM) in communication with a limiter, wherein the limiter is configured to provide a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue. [054] It is another object of the present invention to provide the medical device as defined above, wherein the predefined excessive contact relates to at least one of:
- a predetermined force applied by the medical device to the tissue;
- a predetermined amount of contact with the tissue; and
- any contact with the tissue.
[055] It is another object of the present invention to provide the medical device as defined above, wherein the preventive action is an alert to a user of the medical device.
[056] It is another object of the present invention to provide the medical device as defined above, wherein the alert comprises as at least one of: visual indication, haptic indication, audio indication.
[057] It is another object of the present invention to provide the medical device as defined above, wherein the alert comprises a measurement of the related force and/or the related amount of contact.
[058] It is another object of the present invention to provide the medical device as defined above, wherein the preventive action is configured to at least partially convert an applied energy, applied by a user and/or a robotic arm towards the tissue via the medical device, into a second form of energy, in order to control resulted contact.
[059] It is another object of the present invention to provide the medical device as defined above, wherein the applied energy is kinetic energy [060] It is another object of the present invention to provide the medical device as defined above, wherein the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof.
[061] It is another object of the present invention to provide the medical device as defined above, wherein the limiter comprises at least one selected from a group consisting of: coil spring/s, spiral springs, leaf spring/s, elastic bands, friction element/s, magmatic element/s and any combination thereof. [062] It is another object of the present invention to provide the medical device as defined above, wherein the preventive action is a collapse and/or retract of the TIM configured to prevent the TIM from further force application and/or fiirther contact with the tissue.
[063] It is another object of the present invention to provide the medical device as defined above, wherein the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch (changing from static friction to dynamic friction) and any combination thereof.
[064] It is another object of the present invention to provide the medical device as defined above, wherein the TIM comprises a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue.
[065] It is another object of the present invention to provide the medical device as defined above, wherein the medical device further comprises a cylinder like member (CLM); wherein the shaft is configured to move along longitudinal axis of the CLM; and wherein the limiter is configured for communication between the shaft and the CLM to at least partially transfer a force, which is applied to the CLM, towards the shaft.
[066] It is another object of the present invention to provide the medical device as defined above, wherein the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm.
[067] It is another object of the present invention to provide the medical device as defined above, wherein the preventive action is configured to avoid at least one incident selected from a group consisting of: tissue perforation, tissue penetration, tissue puncture, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
[068] It is another object of the present invention to provide the medical device as defined above, wherein the medical device fiirther comprises at least one override element configured to at least partially override the limiter, thereby avoid at least one of:
- the alert;
- the energy conversion; and - the prevention of the TIM from further force application and/or further contact with the tissue.
[069] It is another object of the present invention to provide the medical device as defined above, wherein the TIM comprises or in communication with at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, catheter, trocar, and retractors.
[070] It is another object of the present invention to provide the medical device as defined above, further comprises a regulating element, configured to adjust the limiter's initial properties. [071] It is another object of the present invention to provide the medical device as defined above, wherein the regulating element is configured to determine at least one of: the predetermined force and the predetermined amount of contact.
[072] It is another object of the present invention to provide the medical device as defined above, further comprises a coupling element configured to couple the limiter to the TIM, the coupling element selected from a group consisting of: magnet/s, binding string/s, binding clip/s, adhesive element/s, vacuum container, and elastic sleeve.
[073] It is another object of the present invention to provide the medical device as defined above, wherein the limiter comprises an at least partially flexible string, attached to a handle, at the string's proximal end; and wherein the TIM comprises a plurality of links, connected by the string's distal end.
[074] It is another object of the present invention to provide the medical device as defined above, further comprising a placement rod or an extracting rod, configured to be pushed through the medical device or to be held while the medical device is withdrawn, and thereby to discharge a medical apparatus and/or to dispense a medical treatment, temporarily accommodated within the medical device.
[075] It is one object of the present invention to a new method for using a medical device having a tissue interaction member (TIM), comprising steps of: - providing the medical device with a limiter, wherein the limiter is configured to selectively provide a preventive and/or precautionary action;
- using the medical device for a medical procedure; and
- responsively to a predefined excessive contact of the medical device with a tissue, providing the preventative action.
[076] It is another object of the present invention to provide the method as defined above, wherein the predefined excessive contact relates to at least one of:
- a predetermined force applied by the medical device to the tissue;
- a predetermined amount of contact with the tissue; and
- any contact with the tissue.
- any contact with the tissue.
[077] It is another object of the present invention to provide the method as defined above, wherein preventive action comprises alerting a user of the medical device.
[078] It is another object of the present invention to provide the method as defined above, wherein the alerting comprises providing to the user at least one of: visual indication, haptic indication, audio indication.
[079] It is another object of the present invention to provide the method as defined above, wherein the alerting comprises providing a measurement of the related force and/or the related amount of contact. [080] It is another object of the present invention to provide the method as defined above, wherein the preventive action comprises at least partially converting an applied energy, applied by a user and/or a robotic arm towards the tissue via the medical device or via the limiter, into a second form of energy, in order to control resulted contact.
[081] It is another object of the present invention to provide the method as defined above, wherein the applied energy is kinetic energy
[082] It is another object of the present invention to provide the method as defined above, wherein the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction, heat energy, magnetic field energy and any combination thereof. [083] It is another object of the present invention to provide the method as defined above, wherein the preventive action comprises collapsing and/or retracting the TIM thereby preventing the TIM from further force application and/or further contact with the tissue.
[084] It is another object of the present invention to provide the method as defined above, wherein the preventive action comprises avoiding at least one incident selected from a group consisting of: tissue perforation, tissue penetration, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
[085] It is another object of the present invention to provide the method as defined above, further comprising at least partially overriding the limiter, thereby avoiding at least one of:
- the alerting;
- the energy conversion;
- the preventing of the TIM from further force application and/or further contact with the tissue.
[086] It is another object of the present invention to provide the method as defined above, further comprising selecting the TIM from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, and retractors.
[087] It is another object of the present invention to provide the method as defined above, further comprising adjusting the limiter's initial settings and thereby determining the predetermined force and/or to the predetermined amount of contact.
[088] It is another object of the present invention to provide the method as defined above, wherein the adjusting is configured to determine at least one of: the predetermined force and the predetermined amount of contact.
[089] It is another object of the present invention to provide the method as defined above, wherein the adjusting of the limiter allows using the medical device for at least one procedure selected from a group consisting of: dilation, curettage, tissue removal, tumor removal, application of IUD, application of medical treatment, and catheterization.
[090] It is another object of the present invention to provide a new method for determining configuration and/or properties of a limiter for a specific procedure; the limiter is coupled to a medical device and is configured to provide a preventive action and/or a precautionary action, responsively to a predefined excessive contact of the medical device with a tissue; the method comprising steps of:
- selecting a model of the tissue that can potentially be damaged by the procedure;
- performing plurality of similar procedures, using the medical device;
- using a different configuration and/or different properties for the limiter, for every predetermined number of procedures of the plurality of procedures;
- collecting measurements of effects of the medical device on the tissue and/or procedure efficacy, for each individual procedure of the plurality of procedures; and
- comparing the collected measurements therebetween and comparing the measurements with prior knowledge, in regards to a tissue effect and/or a similar procedure efficacy, to determine best configuration and/or best properties of the limiter for the procedure.
[091] According to some embodiments the measurements include safety and efficacy parameters. According to some embodiments, safety parameters include physical and/or mechanical damage of the tissue. According to some embodiments, the damage is visual. According to some embodiments the efficacy parameters are defined as the parameters to be achieved according to the common standards of the specific procedure.
[092] It is another object of the present invention to provide a new method for determining configuration of a limiter coupled to a medical device, wherein the limiter is for preventing an excessive contact of the medical device with a tissue, the method comprising the steps of:
- selecting the medical device;
- selecting a procedure using the medical device;
- selecting at least two tested-configurations for the limiter;
- performing a plurality of procedures similar to the selected procedure;
- collecting measurements of at least one effect of the medical device on the tissue for each individual procedure; and
- comparing at least one of: the collected measurements with prior knowledge in regards to a tissue effect, and efficacy of each of the tested-configurations on the selected procedure; — responsively to required tissue safety, required procedure efficacy or a combination thereof, selecting a configuration for the limiter out of the at least two tested- configurations.
[093] According to some embodiments, the tested-configurations are selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof. According to some embodiments, the selecting of the tested-configurations comprises selecting a different material for each tested-configuration. According to some embodiments, the selecting of the tested-configuration comprises selecting dimensions for the limiter, fixed dimensions, dimensions within a range, or combinations thereof. According to some embodiments, measurements of at least one effect comprise at least one of: procedure efficacy, tissue damage and a combination thereof. According to some embodiments, the performing of the plurality of similar procedures is performed ex-vivo or on an artificial model. According to some embodiments, the performing of the plurality of similar procedures is performed in a step up/ step down manner as with common known search algorithms.
[094] According to some embodiments, the procedure is selected from: dilation, curettage, tissue removal, tumor removal, application of IUD, application of medical treatment, catheterization, and any procedure a skilled artisan would perform with a contact with a tissue.
[095] According to some embodiments, the medical device is selected from: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, retractors, catheter, trocar and any device a skilled artisan would use for contact with a tissue.
[096] According to some embodiments, the preventing comprising at least one of:
- alerting a user of the medical device;
- at least partially converting an applied energy into a second form of energy to control the applied contact, wherein said applied energy is applied by a user and or a robotic arm towards the tissue via the medical device or via the limiter;
- a collapsing of and/or a retracting of the medical device, thereby avoiding the medical device from further force application and/or further contact with the tissue; or a combination thereof. BRIEF DESCRIPTION OF THE DRAWINGS
[097] In the figures, identical and similar structures, elements or parts thereof that appear in more than one figure are generally labeled with the same or similar references in the figures in which they appear. Dimensions of components and features shown in the figures are chosen primarily for convenience and clarity of presentation and are not necessarily to scale. The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying drawings in which: [098] Figures 1A and IB depict a use of a curette, and where Figure IB depicts perforation of tissue by a curette;
[099] Figures 2A and 2B depict embodiments of a medical device of this invention comprising elements of a limiter and a tissue interaction member (TIM), and an embodiment of a safe use thereof; [0100] Figures 3A-3D depict embodiments of a medical device of this invention showing embodiments further comprising a regulating element for the limiter;
[0101] Figures 4A-4B depict embodiments of a medical device of this invention showing embodiments further comprising a regulating and/or an override element for the limiter;
[0102] Figures 5A-5E depict additional embodiments of a medical device of this invention, comprising plurality of unit links;
[0103] Figure 6 depicts another embodiment of a medical device of this invention configured to respond to a range of horizontal motion or rotational motion of the TIM;
[0104] Figure 7 depicts yet another embodiment of a medical device of this invention, comprising a leaf spring, configured to respond to a range of horizontal motion or rotational motion of the TIM; [0105] Figures 8A-8C depict another embodiment of this invention where the limiter is disposed within the sleeve handle, and where the handle is configured to be coupled to the medical device; [0106] Figures 9A-9F depict embodiments of a limiter element comprised within double sleeves configured to be coupled to the medical device;
[0107] Figures 10A-10M depict embodiments of a limiter configured to halt the use of the medical device; [0108] Figures 11A-1C depict embodiments of a limiter configured to be coupled to the medical device;
[0109] Figure 12 presents a schematic showing one embodiment of a method of use of a medical device of this invention; and
[0110] Figure 13 presents another schematic showing yet another embodiment of a method of use of a medical device of this invention.
[0111] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.
DETAILED DESCRIPTION OF THE INVENTION
[0112] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the invention. However, it will be understood by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.
[0113] The following description is presented to enable one of ordinary skill in the art to make and use the invention as provided in the context of a particular application and its requirements. Various modifications to the described embodiments will be apparent to those with skill in the art, and the general principles defined herein may be applied to other embodiments. Therefore, the present invention is not intended to be limited to the particular embodiments shown and described, but is to be accorded the widest scope consistent with the principles and novel features herein disclosed. In other instances, well-known methods, procedures, and components have not been described in detail so as not to obscure the present invention.
/. Exemplary Definitions of Terms Used Herein
[0114] Before explaining at least one embodiment of the present invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting. [0115] The term "medical device" as used herein, refers in some embodiments of the invention to a surgical tool used in a number of different medical procedures involving an interaction between the medical device and superficial layers of a tissue. For example, in certain embodiments a "medical device" may refer to a curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, retractors, catheter, trocar and any device a skilled artisan would use for contact with a tissue.
[0116] The term "curettage" as used herein, refers in some embodiment of the invention to a surgical scraping or cleaning of a tissue by means of a curette. "Curettage", usually of the lining of a body cavity, may be used in some embodiments to clean it of foreign matter, to remove tumors or other growths or diseased tissue (as in the curetting out of diseased bone tissue in osteomyelitis), or to obtain a sample of tissue for diagnosis. In one embodiment, the term refers to the scraping of the wall of the uterus to obtain tissue for microscopic examination to determine the cause of abnormal uterine bleeding. As described herein, curettage may be performed with a medical device of this invention, which may have a tissue interaction member comprising the shape of a scoop or hoe, which may be scalpel-sized, and may have a blunt or sharp edge.
[0117] The term force" as used herein, refers in one embodiment to strength or energy exerted or brought to bear on a tissue by a medical device of this invention. Force exerted on a tissue may be used for medical procedures including treatment or diagnostic procedures, wherein even a reasonable force used may lead to a medical device penetrating a boundary beyond which it is not safe to penetrate. Similarly, excessive force may result in penetration of such a boundary. Penetration of such a boundary may cause damage to a tissue including bleeding. A force on a tissue by a medical device of this invention may be constant or variable, and may depend on the medical procedure. [0118] The term "a boundary beyond which it is not safe to penetrate" as used herein, refers in one embodiment to a boarder or limit or level of penetration of a tissue wherein further penetration might cause undesired damage or effect.
[0119] The term "resistance" as used herein, refers in one embodiment to an effort made to stop, prevent or reduce a force against something. For instance a tissue exerts a certain resistance against a force of a tissue interaction member of a medical device. The resistance of a tissue to a force may be constant or differ dependent on the state of a tissue, the type of a tissue, multiple tissue types, e.g., tumor and healthy tissue within a region, or depth of a tissue interaction member within a tissue. An ability of a practitioner to sense or feel the resistance of a tissue in response to a force being used during a procedure determines the practitioner's ability to prevent damage to the tissue. That is to stop, prevent, reduce or ameliorate a tissue interaction member of a medical device from having a negative or damaging effect on a tissue.
[0120] The term "damage" as used herein, refers in one embodiment to causing excess bleeding, removing a larger part of tissue then intended, increasing the risk of excess scaring or adhesions, increasing the risk of infection, perforating a target organ or having a device reach tissues or spaces not intended, or any combination thereof. The term "damage", as used herein also refers to connecting two anatomical spaces not intended on being connected (for example, creating a "fistula"), diminishing structural strength of tissue or causing disruption to organ functionality, or any combination thereof of these outcomes and those listed above.
[0121] The term "proximal" as used herein, refers to the side facing towards the user, a care giver, a physician, and/or a robotic arm.
[0122] The term "distal" as used herein, refers to the side facing away from the user, a care giver, a physician, and/or a robotic arm. II Safety Curettes and Uses Thereof
[0123] Curettes are commonly used is in the gynecological procedure of dilation and curettage (D&C). In some examples, a practitioner may place the tip of the curette near or at one of the uterine horns and subsequently pull the curette with a consistent and/or continuous motion to remove strips of endometrium. In some examples, the practitioner may also use the curette as a scrub brush. The use of the curette as a scrub brush may facility the denuding of the endometrium until the basal layer is reached.
[0124] This systematic removal of tissue, for example, by scrubbing, may continue until the point of a physical detection by the practitioner of a scratching or similar sensation. In some examples, a practitioner will continue until they hear the "uterine cry", i.e., a sound resulting from the sharp curette running over myometrium. In some examples such as delayed postpartum bleeding, the myometrium may be sufficiently soft and delicate such that the uterine cry is not heard and/or the scratching is not felt by the practitioner. In these instances, a practitioner may damage the basal layer when excessive pressure is used, or if there is excess removal of tissue. [0125] Damage and healing from damage caused by the misuse of a curette may result in a number of conditions for the woman, including secondary infertility. In some examples, a practitioner may fail to fully remove all of the endometrial tissue from the uterine cavity in an effort to prevent damage to the basal layer.
[0126] Curettage may, in some instances result in an injury to the patient. These injuries include the perforation of the uterus, particularly the fundus of the uterus. Uterine perforation may include damage to surrounding vessels and viscera. The chances of perforation may be exacerbated in instances where the endometrial cavity is larger, or the uterine wall is softer, such as during or immediately after pregnancy. Uterine perforation may increase in post-menopausal women due to issues such as endometrial atrophy and myometrial thinning. [0127] Uterine perforation, likely one of the most common and immediate complications of a D&C can result in sepsis or even hemorrhaging. The practitioner, in many instances might not even recognize that the uterus was perforated. Uterine perforation can be caused when a user such as a surgeon applies too much pressure to the tissue via the curette.
[0128] In addition to uterine injury, curettage may result in cervical injuries including trauma due to lacerations, which may result in extensive hemorrhaging. In some instances, curettage leads to an increased risk of infection.
[0129] Asherman's syndrome may result from damage caused by curettage. Intrauterine adhesions may present themselves after curettage, particularly in instances of D&C for incomplete abortions. These intrauterine adhesions typically arise following trauma to the basal layer as a result of the curettage. The trauma can result in granular tissue healing on varied uterine surfaces. This granular tissue healing can result in tissue bridges. These bridges may be, in some instances, composed of dense connective tissues, and may harm the uterine cavity, resulting in abnormal bleeding and infertility. [0130] In some instances, D&C related to molar pregnancies can result in trophoblastic embolizations that can lead to fatal instances of cardiovascular collapse.
[0131] Additionally, use of a medical device may result in damage to a tissue including causing excess bleeding, removing a larger part of tissue then intended , increasing the risk of excess scaring or adhesions, increasing risk of infection, perforating target organ, having a device reach tissues or spaces not intended, connecting two anatomical spaces not intended on being connected (a "fistula"), diminishing structural strength of tissue or causing disruption to organ functionality, or any combination thereof.
[0132] It is one object of the present invention to provide a new limiter for a medical device, the medical device having a tissue interaction member (TIM), wherein the limiter is configured to be coupled with the medical device and to provide a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue.
[0133] It is another object of the present invention to provide a new medical device comprising a tissue interaction member (TIM) in communication with a limiter, wherein the limiter is configured to provide a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue.
[0134] It is another object of the present invention to provide a new method for using a medical device having a tissue interaction member (TIM), comprising steps of:
providing the medical device with a limiter, wherein the limiter is configured to selectively provide a preventive and/or precautionary action; - using the medical device for a medical procedure; and
- responsively to a predefined excessive contact of the medical device with a tissue, providing the preventative action.
[01 5] According to some embodiments, the predefined excessive contact relates to at least one of:
- a predetermined force applied by the medical device to the tissue;
- a predetermined amount of contact with the tissue; and
- any contact with the tissue.
[0136] According to some embodiments, the preventive action is an alert to a user of the medical device. According to some embodiments, the alert comprises as at least one of: visual indication, haptic indication, audio indication. According to some embodiments, the alert comprises a measurement of the related force and/or the related amount of contact.
[0137] According to some embodiments, the preventive action is configured to at least partially convert an applied energy, applied by a user or by a robotic arm towards the tissue via the medical device or via the limiter, into second form of energy, in order to control the contact. According to some embodiments, the applied energy is kinetic energy. According to some embodiments, the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof. [0138] According to some embodiments, the limiter comprises at least one element selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof.
[0139] According to some embodiments, the preventive action is a collapse and or retract of the TIM configured to prevent the TIM from further force application and/or further contact with the tissue.
[0140] According to some embodiments, the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch (changing from static friction to dynamic friction) and any combination thereof. [0141] According to some embodiments, the medical device includes a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue.
[0142] According to some embodiments, the limiter or the medical device comprise a cylinder like member (CLM) configured to allow the shaft a motion along its longitudinal axis; and wherein the limiter is configured to at least partially transfer a force, which is applied to the CLM, towards the shaft. According to some embodiments, the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm. According to some embodiments, the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm.
[0143] According to some embodiments, the limiter or the medical device further comprising a placement rod or an extracting rod, configured to be pushed through the medical device or to be held while the medical device is withdrawn, and thereby to discharge a medical apparatus and/or to dispense a medical treatment, temporarily accommodated within the medical device
[0144] According to some embodiments, the preventive action is configured to avoid at least one incident selected from a group consisting of: tissue perforation, tissue puncture, tissue penetration, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
[0145] According to some embodiments, the limiter further comprises at least one override element configured to allow the medical device to at least partially override the limiter, thereby avoid at least one of:
- the alert;
- the energy conversion; and
- the prevention of the TIM from further force application and/or further contact with the tissue.
[0146] According to some embodiments, the medical device is at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, catheter, trocar, and retractors. [0147] According to some embodiments, the limiter or the medical device comprises a regulating element, configured to adjust the limiter's initial properties. According to some embodiments, the regulating element is configured to determine at least one of a group consisting of: the predetermined force and the predetermined amount of contact. [0148] According to some embodiments, the regulating or adjusting of the limiter allows using the medical device for at least one procedure selected from a group consisting of: dilation, curettage, tissue removal, tumor removal, application of 1UD, application of medical treatment, and catheterization
[0149] According to some embodiments, the limiter comprises a coupling element configured to couple the limiter to device, the coupling element selected from a group consisting of: magnet/s, binding string/s, binding clip/s, adhesive element/s, vacuum container, and elastic sleeve.
[0150] According to some embodiments, the limiter comprises an at least partially flexible string, attached to a handle, at the string's proximal end; and wherein the TIM comprises a plurality of links, connected by the string's distal end. [0151] The present invention further provides a new method for determining configuration and/or properties of a limiter for a specific procedure; the limiter is coupled to a medical device and is configured to provide a preventive action and/or a precautionary action, responsive ly to a predefined excessive contact of the device with a tissue; the method comprising steps of:
- selecting a model of the tissue that can potentially be damaged by the procedure;
- performing plurality of similar procedures, using the medical device;
- using a different configuration and/or different properties for the limiter, for every predetermined number of procedures of the plurality of procedures;
- collecting measurements of effects of the device on the tissue and/or procedure efficacy, for each individual procedure of the plurality of procedures; and
- comparing the collected measurements therebetween and comparing the measurements with prior knowledge, in regards to a tissue effect and/or a similar procedure efficacy, to determine best configuration and/or best properties of the limiter for the procedure.
[0152] According to some embodiments the measurements include safety and efficacy parameters. According to some embodiments, safety parameters include physical and/or mechanical damage of the tissue. According to some embodiments, the damage is visual. According to some embodiments the efficacy parameters are defined as the parameters to be achieved according to the common standards of the specific procedure.
[0153] The present invention further provides a new method for determining configuration of a limiter coupled to a medical device, wherein the limiter is for preventing an excessive contact of the device with a tissue, the method comprising the steps of:
— selecting the medical device;
— selecting a procedure using the medical device;
— selecting at least two tested-configurations for the limiter;
— performing a plurality of procedures similar to the selected procedure;
— collecting measurements of at least one effect of the device on the tissue for each individual procedure; and
— comparing at least one of: the collected measurements with prior knowledge in regards to a tissue effect, and efficacy of each of the tested-configurations on the selected procedure;
— responsively to required tissue safety, required procedure efficacy or a combination thereof, selecting a configuration for the limiter out of the at least two tested- configurations.
[0154] According to some embodiments, the tested-configurations are selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof. According to some embodiments, the selecting of the tested-configurations comprises selecting a different material for each tested-configuration. According to some embodiments, the selecting of the tested-configuration comprises selecting dimensions for the limiter, fixed dimensions, dimensions within a range, or combinations thereof. According to some embodiments, measurements of at least one effect comprise at least one of: procedure efficacy, tissue damage and a combination thereof.
[0155] According to some embodiments, the procedure is selected from: dilation, curettage, tissue removal, tumor removal, application of IUD, application of medical treatment, catheterization, and any procedure a skilled artisan would perform with a contact with a tissue. [0156] According to some embodiments, the device is selected from: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices (scopes), graspers, tweezers, retractors, catheter, trocar and any device a skilled artisan would use for contact with a tissue.
[0157] According to some embodiments, the preventing comprising at least one of:
- alerting a user of the medical device;
- at least partially converting an applied energy into a second form of energy to control applied contact, wherein said applied energy is applied by a user and/or a robotic arm towards the tissue via the device or via the limiter;
[0158] a collapsing of and/or a retracting of the device, thereby avoiding the device from further force application and/or further contact with the tissue; or a combination thereof.
[0159] Reference is now made to the figures. Figures 1A and IB depict outcomes of curettage use. Figure 1A shows one embodiment of a curette procedure, where a curette (1000) scrapes a surface of a tissue (1004) without perforating the tissue. Figure IB shows an embodiment of an unsafe curettage, where the tissue (1004) has been perforated by the curette (1000).
[0160] Figures 2A and 2B depict embodiments of a medical device of this invention comprising elements of a limiter (2012) and a tissue interaction member (TIM) (2002), and an embodiment of a safe use thereof. Figure 2A shows an embodiment of a medical device (2000) comprising a handle (2014), the TIM (2002), a coiled spring limiter (2012) connected at one end (2023) to the TIM (2002) and at the other end (2024) to the handle (2014), a warning indicator (2010) accommodated within the handle and in communication with the TIM (2002) proximal end, where the distal end of the tissue interaction member (2008) has begun to scrape a surface (2004) of a tissue and the warning indicator (2010) is still hidden at the proximal end of the handle (2014). Figure 2B shows an embodiment of a safe use of the medical device, where the distal end of the medical device (2008) has penetrated a tissue to a boundary beyond which it is unsafe to penetrate (2006). At this point, the coiled spring limiter (2012) compresses, the warning indicator (2010) at least partially pops out of the proximal end of the handle and is visible (2016) to the user; accordingly, further penetration into the tissue may be halted.
[0161] Figures 3A and 3B depict embodiments of a medical device (3000) of this invention showing embodiments where a regulator (3020) may regulate the compression of a spring limiter (3012). The spring limiter is connected at its distal end (3023) to the TIM (3002) and at its proximal end to handle (3014) via the regulator (3020). In order to allow the compression adjustment, the TIM is limited in its forward motion (towards its distal end), by a stopping element (3022). Figures 3A and 3B demonstrate the adjusting of the spring limiter (3012) using the regulator (3020). In Figure 3A the spring is demonstrated to be less compressed than what is demonstrated in Figure 3B therefore in Figure 3A the spring is more flexible, and in Figure 3B the spring is less flexible.
[0162] Figures 3C and 3D depict embodiments of a medical device of this invention where a regulator (3030) may regulate the compression of a spring limiter (3012), as demonstrated in Figure 3C and may regulate tension of the spring limiter (3012), as demonstrated in Figure 3D. According to one embodiment, shown in Figure 3C, the proximal end of spring limiter (3034) is connected to the TIM (3002) and the spring limiter's distal end (3032) is connected to the handle (3014). A regulating element (3030) is configured to gradually push the TIM (3002) forward (towards its distal end) and therefore compress the spring limiter to a specific length. According to another embodiment, shown in Figure 3D, the proximal end of spring limiter (3038) is connected to the handle (3014) and the spring limiter's distal end (3036) is connected to the TIM (3002). A regulating element (3030) is configured to gradually push the TIM (3002) forward (towards its distal end) and therefore stretch the spring limiter to a specific length. According to one embodiment the regulating element may be a screw (3030), located at the proximal end of the handle, or a sliding clip (not shown) configured to be pushed at several steps.
[0163] Figures 4A and 4B depict embodiments of a medical device (4000) of this invention comprising: a TIM (4002), a handle (4014) and a spring limiter (4012) connected therebetween. The device further comprises an override element comprising: a pin (4022), connected to the handle (4014), and receptacle (4024) connected to the TIM (4002), the receptacle (4024) having at least one pitch (4030). Figure 4A shows an embodiment where the override pin element (4022) may be inserted into the receptacle comprising wide registered pitches (slots) (4030), thereby compressing or stretching the spring limiter to a certain level and where the pitch (4030) of the TIM (4002) determines a limited pitch for the TIM. The device (4000) further comprises a warning indicator (4010) configured to respond to a contact with the tissue interaction element (4002). Figure 4B shows a similar embodiment where the override pin element (4022) may be inserted into a receptacle (4026) comprising plurality of narrow registered slots, thereby overriding the spring element, at any stage of contact between the TfM and the tissue, by pressing the pin is against the TIM.
[0164] Figures 5A-5E depict additional embodiments of a medical device (5000) of this invention. Figure 5A shows a medical device where the limiter comprises an at least partially flexible string (5024), attached to a handle (5010), at the string's proximal end; and where the TIM comprises a plurality of unit links (5120), connected by the string's distal end. According to some embodiments, the device (5000) further comprises a regulating element (5020), a screw or sliding-clip (not shown) configured to adjust the limiter's (5024) initial settings (tension) and thereby to determine the predetermined force and/or the predetermined amount of contact. Figure 5B shows elements of the unit links (5120) strung along a thread (5024) under high tension (large arrows), where the unit links align and present a sharpened edge (5026) for scraping a tissue. Figure 5C shows forces affecting the geometry of the TIM, where the shape and tension along the thread (low tension-small arrows) may affect the shape formed by the unit links and the point at which they collapse (long internal arrows). Figure 5D shows the unit links (5120) of the TIM (5012) strung along a thread (5024), wherein the links are in contact with a tissue surface (5004,5006). Figure 5E shows an embodiment of safe use of a medical device of this invention, wherein when the distal end of the TIM (5008) comprising unit links (5120) perceives a tension, due to an excessive contact with the tissue, beyond which further penetration is not safe (5006), the TIM then collapses and thereby prevents further penetration and/or contact with the tissue, e.g., prevents forward movement (large arrows) into the tissue.
[0165] Figure 6 depicts another embodiment of a medical device (6000) of this invention, comprising a TIM (6002), a handle (6014) and a spring limiter (6012) therebetween, where a coiled spring limiter (6012) may respond to a range of horizontal motion and/or rotational motion (rotation axis at 6030) of the tissue interaction member (TIM) (6002) at its distal end (6008). According to some of the embodiments, the device (6000) further comprises warning indicators (6080) configured to pop out of the handle and indicate a boundary beyond which it is unsafe for the device to penetrate (6006).
[0166] Figure 7 depicts another embodiment of a medical device (7000) of this invention, configured to respond to horizontal motion and/or rotational motion (rotation axis at 7030) of the distal end of the TIM (7008). The device comprising a TIM, a handle and a leaf spring limiter (7012) communicating therebetween. According to some embodiments, the device (7000) further comprises a regulator (7020) that is configured slide along the spring leaf to adjust the length of the leaf spring limiter (7012) and thereby to determine its initial properties.
[0167] Figures 8A. 8B and 8C depict another embodiment of this invention (8000). Figure 8A shows a sleeve handle (8014) coupled with a medical device (8002), wherein a limiting element (not shown) is disposed within the sleeve handle (8014) and where the limiting element (not shown) communicates between the sleeve handle (8014) and the medical device (8002). Figure 8B shows the application of an energy and/or a force by a user or a robotic arm (not shown) to the handle (8014), according to some embodiments, the applied energy and/or force is being reduced when applied to the actual device (8002) and towards the tissue (8004,8006). This energy and/or force reduction or limitation, in some embodiments, prevents a scraping/cutting distal edge of the device (8002) from penetrating a tissue beyond a safe border (8006). According to embodiments the energy and/or force transference is gradually diminished as power is applied near the set limit, until the point where there is no transference of energy and/or force at all, which may prevent unwanted tissue damage. Figure 8C demonstrates the coupling of such a sleeve (8014) with the known in the art curette device (8002). [0168] Figures 9A-9F depicts embodiments of a limiter element comprised within a sleeve. Figure 9A shows an embodiment of a double sleeve limiter (9000), comprising an inner sleeve (9014i) and an outer sleeve (9014o), which may in certain embodiments also be used as the handle, the limiter comprising two spring elements (9012). One end of the spring elements is attached to the inner surface of the outer sleeve (9013), while the other end of the spring elements is attached to the outer surface of the inner sleeve (9015) axially distant from the outer sleeve attachment site. In one embodiment, a tissue interaction member (TIM) may be attached to the inner sleeve (See Figure 9F). At rest, without excess pressure experienced by the tissue interaction member the sleeves are as shown in Figure 9A, wherein a tissue interaction member would extend from the right-hand side of the inner sleeve (9020). Figure 9 A shows the spring elements in an extended, no tension/compression configuration at which the inner sleeve (9014i) rests within the outer sleeve (9014o).
[0169] Figure 9B presents the double sleeve limiter (9000) of Figure 9 A wherein the spring elements (9012) are in a compressed configuration showing the inner sleeve (9014i) remaining in the same relative place, e.g., keeping a tissue interaction member from further penetrating a tissue, while the outer sleeve continues moving in the direction of the force (9030) applied by the user, which may occur in one embodiment after a tissue interaction member attached to the inner sleeve (9014i) encounters resistance and the outer sleeve continues in a forward movement, while the inner sleeve is halted in its forward progress.
[0170] Figure 9C shows another embodiment of a double sleeve limiter (9000), which in certain embodiments may also be used as the handle, comprising at four at least four spring elements at four different directions, up, down, left and right (9012). One end of the spring elements is attached to the inner surface of the outer sleeve (9014o), while the other end of the spring elements is attached to the outer surface of the inner sleeve (9014i), wherein attachment sites are directly adjacent to one another. According to some embodiments, more than four spring elements may be used, disposed in additional directions around the sleeve and/or along the longitudinal axis of the sleeve.
[0171] Figure 9D shows a cross-section view of the inner and outer sleeves (9014i,9014o) of Figure 9C, wherein there is no differential force experience between the different springs (9012).
[0172] Figure 9E shows a cross-section view of the inner and outer sleeves (9014i,9014o) of Figure 9C, wherein there is a differential force experienced in the direction of the arrow leading to a compressed spring element (9012-1) on the left side and an expanded spring element on the right side (9012-r).
[0173] Figure 9F shows an embodiment of a double sleeve limiter (9000), wherein the stippled areas (9050,9052) indicate potential location for attachment of a tissue interaction member. In another embodiment, stippled areas may be used to bind an existing medical device running through internal sleeve as described below.
[0174] Figures 10A-10M depict embodiments of a limiter configured to halt the use of the medical device (100). Figure 10A demonstrates an embodiment of the medical device (100), where according to a non-limiting example, the demonstrated device is an IUD applicator for dispensing an IUD (140) into the uterus, when in the right position within the uterus, while avoiding its perforation, according to other embodiments (not shown) medical treatment/s may be dispensed instead of, or with, the IUD. The device comprising:
- a TIM shown as a shaft (110), which temporarily accommodates the IUD in its distal portion;
- a handle (130) configured for the use of a care giver, having a cylinder form, wherein the handle is configured to accommodate the shaft's proximal portion, and allow the shaft to move along its longitudinal axis;
- a limiter (120) configured to communicate between the shaft and the handle, wherein the limiter is configured to prevent of the TIM from further force application and/or further contact with the tissue, responsive to a predetermined force Fmax applied thereof. [0175] According to one embodiment, as demonstrated in Figure lOB, the limiter is a sliding clip: having a base (124) at proximal end configured to be pushed by the proximal end of the TIM, and at least one arm (127) which is at least partially flexible and comprising at least one stopping element (121) at its distal end; the stopping element (121) configured to be held by at least one holding element (131) located at inner side of the cylindrical like handle (130), while the force applied on the limiter via the shaft is less than the predetermined force Fmax.
[0176] Figure IOC and 10D demonstrate positions of the limiter, according to some embodiments of the invention. Figure IOC demonstrate a resting position where the applied force on the tissue, transferred to the limiter via the shaft, is still under the predetermined force F<Fmax, and therefore the device can still be pushed towards the uterine. Figure 10D demonstrate the collapse of the limiter, buy means that the applied force made the at least one at least partially flexible arm fold inward, and the limiter's stopping element (121) is therefore released from the handle's holding element (131), and the TIM (shaft 120) is now retract towards its proximal end. In such a posture the device may no longer be pushed against the tissue, procedure is halted and damage/perforation is prevented at this setting and according to the physician's decision the IUD may be applied. According to some embodiments, the IUD may be applied even if limit is not been reached, according to the physician's decision. According to some embodiments, the IUD may be applied when an alert limit has been reached, according to the physician's decision.
[0177] Figure 10E discloses another embodiment for the limiter's (120) configuration, where a coil spring (125) communicates between the proximal end of the shaft (110) and the base of the limiter (124), for at least partially converting kinetic energy applied by the user via the handle into elastic strain energy. According to some embodiments a number of stopping elements (121) and/or a number of holding element (131) may provide the limiter with multiple stops. According to some embodiments, each of the multiple stops may have a different Fmax. According to some embodiments, by changing the limiter's material and/or geometry, flexibility is modified and accordingly the Fmax and amount of sliding of the limiter, before final decoupling occurs. [0178] Figures 10F, 10G-10J disclose another embodiment for the medical device (100), via several views. According to some embodiments the handle (131) comprises at least one override pin (132), configured to be pushed inward (150) and to be firmly attached to the body of the limiter (120), demonstrated herein according to a non-limiting example, at ring (122) of the limiter. This override firm connection prevents the shaft from pushing the limiter towards the proximal end, even if F>Fmax.
[0179] Figure 10H demonstrates another embodiment for the limiter (120), comprising a wedge, at outer ring of the base (124) configured to spotted by the handle (130) proximal end, therefore prevents the limiter from motion towards it distal end. [0180] Figures 10K-10M disclose another embodiment for the medical device (100). According to some embodiments the device (100) further comprises a placement rod (160) in communication with the proximal end of the IUD (141). The placement rod (160) is configured to be inserted through the handle (130), the limiter (123) and within the shaft (110), and to hold an IUD (141) in place, while withdrawing the shaft (110), thereby place the IUD in the uterus. [0181] According to one embodiment the placement rod (160) comprises at least one rod-handle (161), at proximal end. Accursing to one embodiment the rod-handle (161) is at least partially flexible (164). According to another embodiment the rod-handle (161) comprises a spring (163). According to other embodiments the placement rod (160) may also be an extracting rod which may assist in dispensing medical treatment/s.
[0182] Figures 11A-11C disclose several views of another embodiment of the invention. According to some embodiments a limiter (200) is provided for being coupled with a medical device (not shown) having a tissue interaction member (TIM) and/or configured for temporarily accommodating medical treatment s before its dispensing. The limiter (200) is configured to a preventive and/or precautionary action, responsively to a predefined excessive contact of the TIM with a tissue. According to some embodiments the limiter comprises: cylindrical tube (210) configured to be attached to any selected medical device existing in the art, at least one handle (230) connected to the cylindrical tube (210) via flexible/elastic leaf springs (220). According to some embodiments cylindrical tube (210) comprises at least one picking slot (240). According to some embodiments, when using the limiter (200) the user sense of the contact with the tissue is amplified, due to the response of the limiters at least partially flexible/elastic parts (220 and/or 230). According to some embodiments the at least one handle (230) may be pressed against the cylindrical tube (210) and into grooves (221) of the cylindrical tube (210), and thereby override the limiter.
[0183] Further reference is made to Figure 1A which presents an example of curettage using a medical device (1000), for example a curette, wherein a tissue interaction member of the device (1002) is in contact with superficial layers of a tissue without causing damage to the tissue. In contrast, Figure IB provides an example of a medical device perforating a tissue, possibly damage the tissue and causes internal bleeding in a subject.
[0184] In one embodiment a medical device of this invention comprises a limiter and a tissue interaction member, wherein the limiter is configured to limit an amount of force that can be applied by the tissue interaction member on a tissue. A result of limiting an amount of force that can be applied by the tissue interaction member may be prevention of perforation of a tissue boundary beyond which it is not safe to penetrate.
[0185] Medical devices may be for single use or multiple uses, wherein a user would sanitize or sterilize a multiple use device between uses. Further, materials used for components of a device of this invention may be biodegradable.
[0186] In one embodiment, a tissue interaction member may be configured to interact with a tissue. In one embodiment, a distal end of the tissue interaction member comprises the region of tissue interaction during use of the device. The proximal end may in certain instances be used for holding a medical device directly, or in alternative embodiments, may be incorporated into a handle. When the proximal is used for holding the medical device, it is in effect a handle. As used herein, the term "tissue interaction device" may also be referred to as a "tool" or a "surgical tool", wherein terms may be used interchangeably having all the same meanings and qualities.
[0187] In one embodiment, a tissue interaction member comprises a shaft connecting the proximal and distal ends. In one embodiment, the shaft is a single unit that includes the distal and proximal ends. In another embodiment, the shaft comprises at least two sections. For example, the shaft may have one section for a user to grasp and one section for tissue interaction separated by a limiter of this invention. A shaft of a tissue interaction member connecting the distal and proximal ends, directly or indirectly, may be hollow, solid, flexible, malleable or rigid, or any combination thereof. [0188] Further reference is now made to Figure 7, which shows an embodiment of a medical device of this invention having a shaft comprising at least two sections (see left and right halves of 7002). Further, the limiter in this embodiment is a leaf spring (7012) connecting the two halves, wherein tension may be set using a regulator (7020) in contact with the leaf spring. In this embodiment, the distal end (7008) of the tissue interaction member may be moved in a back and forth motion (see arrows) that could scrap laterally a surface of a tissue or could be forced axially into a tissue to scoop out a section of tissue, e.g., tumor material.
[0189] The distal end may in certain embodiments be shaped as a loop, scoop, gouge, spoon or blade, or other configuration as required by a use of the medical device. In certain embodiments, the region of the distal end for tissue interaction comprises an edge. The edge may be beveled, sharp, blunt, serrated, smooth, rigid, malleable or flexible, or any combination thereof or otherwise finished such that the finishing is configured to facilitate the use of the tissue interaction member for one or more uses. Further, the distal end may be disposable or for multipurpose use.
[0190] A tissue interaction member, or a section thereof, may in certain embodiments be made of metal or plastic or a composite. The outer surface of a tissue interaction member may be surfaced with an antimicrobial, antibacterial or antifungal coating. In some embodiments of the invention, a tissue interaction member and a handle if present are made of the same materials. In some embodiments of the invention, a tissue interaction member and a handle, if present, are made of different materials. A tissue interaction member with our without a handle, may be configured to be autoclavable or otherwise sanitized for use in medical, therapeutic or other procedures. Alternatively, a tissue interaction member may itself be autoclavable or able to be sanitized using means known in the art. In addition, components within a handle may be configured to be autoclavable or otherwise sterilized. In some embodiments of the invention, a handle may be sealed such that it is autoclavable.
[0191] In one embodiment, a medical device of this invention further comprises a handle. In one embodiment, a handle may be a component of the tissue interaction membrane or in another embodiment may be coupled permanently to tissue interaction member. In one embodiment, a handle may be a component of a limiter or, in another embodiment, may be coupled permanently to a limiter. Coupling of a handle to a limiter and/or a tissue interaction member may be direct or indirect, permanent or impermanent. Further, in certain embodiments a handle may be couple to both a limiter and a tissue interaction member. A handle may be configured to be removable from tissue interaction member and/or limiter. In addition, a handle may have a locking mechanism or other mechanism configured to maintain a coupling between a handle and a tissue interaction member or a limiter.
[0192] In one embodiment, a handle may have a smooth surface, alternatively in another embodiment, the handle may have bumps and/or indentations and/or other surface structures. The bumps and/or indentations and/or other surface structures may be configured to provide grip. A grip may include indentation that may house a control means for use in operating surgical tool. In one embodiment, a handle may be a sleeve.
[0193] A handle may include an exit hole or space in the proximal end of the handle (the end closest to the user's hand.
[0194] In one embodiment, a tissue interaction member is disposable. In another embodiment, a tissue interaction member is for multiple uses, wherein the member is sterilized between uses. [0195] A tissue interaction member of this invention may be configured for diagnostic, therapeutic or other uses.
[0196] In certain embodiments, a tissue interaction member may be configured for use in gynecological procedures. In one embodiment a tissue interaction member may be configured for use in dental procedures. In another embodiment, a tissue interaction member may be configured for use in laproscopic procedures. In yet another embodiment, a tissue interaction member may be configured for use in otolaryngo logical procedures. In still another embodiment, a tissue interaction member may be configured for use in procedures involving a subject's bone or skin. In a further embodiment, a tissue interaction member may be configured for one or a plurality of medical or therapeutic procedures. [0197] In one embodiment, a tissue interaction member is selected from a group comprising a curette, a hysterometer, a hystero scope and a cytoscope.
[0198] In certain embodiments, a tissue interaction member is brought into contact with a tissue surface and through use to a boundary within the tissue beyond which it is not safe to proceed further, for example so as not to penetrate a tissue to cause damage or bleeding. In one embodiment, a tissue, which may be contacted by a tissue interaction member of this invention, may include uterine tissue, cervical tissue, dental tissue, buccal cavity tissue, adenoidal tissue, bone tissue, muscle tissue, skin tissue, bladder tissue or connective tissue, or any combination thereof.
[0199] In one embodiment, a limiter of this invention is selected from a group comprising a spring, wherein the spring may be a spring, tension spring, a torsion spring or a leaf spring; a set of at least two concentric sleeves; unit links, magnets, a bearing, or a friction element, or any combination thereof. In certain embodiments, the function of a limiter is to limit tissue penetration during a medical use. By limiting tissue penetration a user of a device of this invention comprising a limiter may avoid, prevent, and/or lessen tissue damage to a subject.
[0200] Further reference is made to Figures 2A and 2B, which present an embodiment of a medical device of this invention and a safe use thereof. The device of Figure 2A (2000) comprises a tissue interaction member (2002) and a spring limiter (2012), wherein the tissue interaction member and spring limiter are encased in a handle (2014). The tissue interaction member comprises a feedback warning indicator (2016) at its proximal end (2010), which may emerge an opening comprised in the handle in order to alert a user that a set resistance has been reached. The handle further comprises an indentation providing a place for finger or thumb support.
[0201] Further reference is made to Figures 5A-5C which show an alternate embodiment of a device of this invention, wherein Figure 5 A shows a limiter (5012) comprised of unit links (5120) strung along a thread (5024) and wherein the limiter itself comprises the distal end (5008) of a tissue interaction member (5002). Further, the tension of the limiter may be set using a screw regulator (5020) around which the thread may be wound, wherein the screw is located within the proximal end (5010) of the handle. The double headed arrow shows that the screw may be adjusted (turned) in order to tighten or loosen the thread. In one embodiment, a thread comprises a cable able to be adjusted in order to adjust the tension between the unit links. In the embodiment drawn, the thread is attached to a spring attached to the screw. In an alternate embodiment, a thread could be directly connected to the screw. Figure 5B is a close-up showing a section of the unit links (5120 indicates a single unit link), which comprise the limiter and are comprised within the tissue interaction member, under high tension. The block arrows indicate a tension on the thread (5024) thereby maintaining the unit links in a set geometry providing a rigid edge (5026) which may be used in a method of this invention to scrape or cut a tissue. Figure 5C is another close-up showing a section of the device, for instance a curette comprising a limiter comprising unit links under low tension (small arrows) of the thread (5024) leading to a deformation (long arrows) of the limiter/tissue interaction member.
[0202] In one embodiment, a limiter may be configured such that it will limit and/or inhibit a practitioner's ability to exert a force. The force may be predetermined. The force may, in some embodiments of the invention, be determinable in advance prior to using surgical tool. In some embodiments the force may first be determined by trial and error. The inhibition and or limitation of the exertion of a predetermined force may be configured such that undesired damage of tissue is less likely as a result of a practitioner's use of a medical device. In alternate embodiments, the inhibition and or limitation of the exertion of a force, which has not been predetermined, may be configured such that undesired damage of tissue is still less likely to occur as a result of a practitioner's use of a medical device. In one embodiment, the force may be a range of forces.
[0203] In one embodiment, a force may be in a single direction, for example in an axial direction substantially perpendicular to a surface of a tissue surface or, in another embodiment, a force may be in a lateral direction, substantially parallel to a surface of a tissue or substantially following a contour of a surface of a tissue. Thus, a practitioner skilled in the art could recognize that a force may be in multiple directions if necessary to accomplish the use of the medical device, for example curettage over a broad surface or lateral scraping.
[0204] Further reference is now made to Figure 6, showing an embodiment of a medical device (6000) and use thereof for scraping in a lateral direction (see arrows at the distal end (6008) of tissue interaction member (6002), following the contour of a surface of the tissue (6004). In this embodiment, a spring limiter (6012) is positioned so that the tension/release of the spring are in the same direction as the movement of the tissue interaction member along the surface of the tissue (see arrows). At a point of excess resistance detected by the limiter spring the feedback warning indicator (6080) would emerge from the handle (6014) of the device. A thumb or finger indentation is represented at 6018. [0205] In some embodiments of the invention, when a force is exerted by a user via a medical device that exceeds a predetermined force, a portion of the shaft exits the handle of the device, providing feedback to the user. The force exerted by a user via medical device that exceeds a predetermined force, may be sufficient for the tissue interaction portion of a device to pass through the entirety of a tissue or just a portion of a tissue. In this way, the interaction of the device with the tissue may be harmful to tissue.
[0206] In some embodiments of the invention, there may be other sensors coupled to or in communication with surgical tool.
[0207] In one embodiment, a medical device of this invention further comprises a regulator for regulating at least one property of the limiter, for instance a property of force. In one embodiment, regulating a limiter's properties comprises a step-wise regulation, for example a step-wise regulation of force. In one embodiment, regulating a limiter's properties comprises a variable regulation, for example a variable regulation of force. In this way a practitioner may set a limiter's properties based on the need for a particular medical use.
[0208] Opposing a force that may be applied by a tissue interaction member is a resistance from the tissue to which the force is being applied. A regulator of this invention may in certain embodiments be able to detect a tissue resistance opposing the force of a tissue interaction member. In one embodiment, a limit may be set for at least one property of a regulator. For example, a limit may be set as to the resistance a regulator detects, such that upon detection of the resistance limit a regulator regulates a limiter such that the amount of force that a medical device can apply to a tissue is limited. In one embodiment a limiter and a regulator comprise the same unit. In another embodiment, a regulator and limiter comprise individual units that may be functionally and/or structurally linked.
[0209] Further reference is now made to Figures 3A and 3B, which show one embodiment of a regulator of this invention, wherein a medical device comprises a spring limiter (3012) coupled to a regulator (3020). The regulator may be adjusted so that the spring is under less tension (Figure 3 A) or more tension (Figure 3B) by essentially extending or compressing the spring by way of movement of the regulator, as indicated by the double headed arrow.
[0210] In some embodiments of the invention, a limiter may provide resistance via one or more of the following: bearings, friction elements, magnets, tension springs, torsion springs, leaf springs or concentric sleeves and/or other components. The one or more of the above mentioned components may be configured to be operating either in parallel and/or series.
[0211] In one embodiment, a limiter may collapse when a resistance greater than a predetermined setting is felt. Collapse of a limiter may result in the inability to continue use of a device. In one embodiment, a portion of the tissue interaction member collapses when a limiter detects resistance greater than a predetermined setting. Collapse of a tissue interaction member may result in the inability to continue use of a device. Collapse of a limiter and/or tissue interaction member may inhibit or reduce a force, for example a force promoting a tissue interaction member deeper into a tissue. [0212] Further reference is now made to Figures 5D and 5E. Figure 5D presents an embodiment of a medical device and method of use thereof of this invention, wherein the tissue interaction member (5002) comprising a limiter (5012) comprising unit links (5120), wherein the distal edge (5008) is brought into contact with a tissue surface (5004) -note direction of arrows. Figure 5E presents an embodiment of a limiter (5012) responding to a resistance detected in response to the force of forward motion, that is greater than a predetermined setting by collapsing and deforming in order to limit continue penetration into a tissue past a safe boundary (5006).
[0213] In one embodiment a predetermined setting is set using a regulator. In one embodiment a predetermined setting is adjustable. In one embodiment, the setting may be adjusted by changing a tension in a limiter, for example changing a tension in a spring, or changing or altering the looseness of unit links on a thread, or changing the type of thread to have more or less stiffness, or changing the resistance between concentric sleeves, or altering the forces, e.g., attractive/repulsive forces, between magnets, or changing the amount of friction between friction elements, or changing the ability of a bearing to move..
[0214] In one embodiment a medical device further comprises an override mechanism that overrides a regulatory setting. This may enable a practitioner to make decisions based on need and/or experience in order that a medical procedure may be carried out successfully, wherein the limitation of a limiter needs to be overridden.
[0215] In certain embodiments, a shaft of a surgical tool includes a series of notches, slots or indentations. A notched shaft may be a component continuous with a tissue interaction member. In one embodiment, a notched shaft may be a component continuous with a tissue interaction member. In another embodiment, a notched unit that is configured to interface with a pin, is couple to a shaft of a tissue interaction member. A pin may be configured to be an override for a limiter of this invention. The notches or indentations may be spaced regularly, irregularly, at exactly the width for pin entry or wider that the pin or any combination thereof. The differences in notch distribution and/or width allow for an override mechanism to be more or less exact, enabling an override at only a single point (width exact for pin) or providing a range that can be overridden (width wider than needed for pin entry).
[0216] In some embodiments of the invention, a pin may be mechanically disengaged from a notched shaft by a user. The removal of a pin from a notched shaft may allow the user to override the limiter by allowing, in some embodiments of the invention, tissue interface member to move independent of the limitations employed by the limiter.
[0217] Further reference is now made to Figures 4 A and 4B which depict embodiments of an override mechanism. Figure 4A shows an override mechanism (4022 and 4024) having wide slots (4024) and a pin (4022) that may be inserted into the slots to set a broad predetermined limit point or removed to override a setting, as shown by the double headed arrow. Similarly, Figure 4B shows an override mechanism (4022 and 4024) having narrow slots (4026) and a pin (4022) that may be inserted into the slots to allow override at any stage of the procedure, as shown by the double headed arrow. [0218] In one embodiment, a medical device further comprises a feedback mechanism. A feedback mechanism represents return information based on the input, e.g., force on a tissue, and thus is a part of the output of a medical device of this invention and part of the output of a method of use of a medical device of this invention. A feedback may provide a self-corrective action or may transmit evaluative or corrective information about a medical procedure in process. For instance, in one embodiment a feedback mechanism alerts a user of the medical device that the limit of applied force has been reached. In one embodiment, a feedback mechanism alerts a user that the force is within a predetermined percentage of the limit. For a non- limiting, a feedback mechanism may alert a user that the force is within 10%, 20% 30% 40% 50% or any chosen percentage of the limit. [0219] In one embodiment, a feedback mechanism comprises a mechanical, auditory or visual mechanism, or any combination thereof. For example, a feedback mechanism may comprise a warning indicator that emerges from a medical device when a limit is reached, or a light that shines or changes colors upon reaching a limit, or a sound that is emitted upon reaching a limit, or any combination thereof. [0220] In one embodiment, a shaft may be a component or, or may be directly or indirectly linked with, a tissue interaction member. The shaft may be configured such that when it exits a handle it provides a visual cue to the user that excessive force that exceeds a predetermined level of force has been applied on a tissue using the device. In one embodiment, the shaft may be configured to provide a visual cue prior to the boundary beyond which a tool should not penetrate. In some embodiments of the invention, a shaft may be colored such that when the shaft exits the handle, the user is sees the proximal end of the shaft. There may be a range of colors indicating distance to the boundary beyond which the tool should not penetrate. The proximal end of a shaft may have text applied to it, such that when the shaft exits the handle, the user is likely to see the text on the proximal end of the shaft. In some embodiments, a text message may provide a warning to the user that excessive force has been applied. In some embodiments, the proximal end of the shaft may light up or may produce an audible sound when it exits handle. In some embodiments of the invention, the proximal end of the shaft may use another means to alert that the use of excessive force above a predetermined amount of force has been applied.
[0221] In some embodiments of the invention, a user may be warned and receive feedback by emergence of a proximal end and/or other components when the user is approaching a force that may be excessive. In some embodiments of the invention, there may be multiple warnings to a user, wherein the warnings may change as the nature of the force becomes such that it is more likely to harm tissue.
[0222] In some embodiments of the invention, feedback may be provided by informing a user of the use of excessive force by a means other than shaft. This means may include a haptic response, an audible response, a visual response, and/or a combination of responses.
[0223] In some embodiments of the invention, excessive force by the user can result in a haptic and/or force feedback response, for example through handle. In some embodiments of the invention, the haptic response may be commensurate with the degree of excessive force above a predetermined amount of force, as applied by the user. For examples a vibration signal wherein the vibration rate changes based on the proximity of the tool with the boundary beyond which the tool should not penetrate.
[0224] In some embodiments of the invention, a user may be warned of excessive use of force, or that the user is approaching excessive use of force by methods as described herein and above. [0225] In some embodiments of the invention, the excessive use of force applied by a user may cause a limiter to act as a fail-safe. When a limiter acts as a fail-safe, the surgical tool may fail and may become inoperable, thereby halting or reducing a force and/or further progress into a tissue. The inoperability of a surgical tool may be permanent or temporary.
[0226] In one embodiment a medical device further comprises a fail-safe mechanism. By incorporating a fail-safe mechanism in a medical device of this invention, the device provides a safeguard that prevents continuing a procedure that may damage a tissue. For instance, even if a practitioner of a device fails to see or heed the warnings of a feedback warning indicator of a medical device and continues to exert force on a tissue with the device, a fail-safe mechanism could inhibit or reduce the force automatically. [0227] In some embodiments of the invention, a surgical tool may include a fail-safe mechanism, wherein the fail-safe mechanism may result in the bending or collapsing of all or part of a surgical tool when a user exerts an amount of pressure above a predetermined threshold wherein that threshold is designed to limit the ability of the user to damage the surface of tissue.
[0228] In one embodiment, a limiter may collapse when a set resistance is detected. In one embodiment, a limiter is configurable to bend, twist, deform or otherwise change the shape of a shaped end and/or shaft in response to the application of an amount of force in excess of a predetermined force, as applied by a user on tissue. In one embodiment, a tissue interaction member may collapse when a set resistance is detected. In one embodiment, a tissue interaction member is configurable to bend, twist, deform or otherwise change the shape of a shaped end and/or shaft in response to the application of an amount of force in excess of a predetermined force, as applied by a user on tissue. These different possibilities may in some embodiments, occur concurrently.
[0229] In some embodiments of the invention, the bending, twisting or otherwise changing of shape of a component of a medical device, e.g., a limiter or tissue interaction member is configured to prevent the further application of force by the user. In some embodiments of the invention, the changing of shape of shaped end is reversible. In some embodiments of the invention, a shaped end and/ or shaft cannot revert to its original shape.
[0230] In one embodiment, a limiter comprises a spring that may be configured such that the spring's tension, stiffness, resistance and/or other characteristics are adjustable by a user. Alternatively, in another embodiment, a spring may be configured such that the spring's tension stiffness, resistance and/or other characteristics are not adjustable by the user. A spring may be configured to provide a single stage or multi-stage variable resistance.
[0231] In some embodiments of the invention, a spring may be coupled to shaft. In some embodiments, a shaft may be configured to sit within a handle.
[0232] Similarly, in one embodiment, a limiter comprises unit links strung on a thread that may be configured such that the unit's links and thread's tension, stiffness, resistance and/or other characteristics are adjustable by a user. Alternatively, in another embodiment, unit links may be configured such that the unit links and/or thread tension stiffness, resistance and/or other characteristics are not adjustable by the user. Unit links may be configured to provide a single stage or multi-stage variable resistance. In one embodiment, a thread linking the unit links comprises a metal thread (a wire), a plastic thread, a nylon thread, a synthetic thread or a cotton thread, or any other long thin line of material. A thread of this invention may be coated or uncoated. For instance, a thread may be covered with plastic, rubber, metal, or any other suitable material. A thread may be flexible or inflexible providing a range of flexibility and tension.
[0233] In some embodiments of the invention, unit links may be coupled to shaft. In some embodiments, a shaft may be configured to sit within a handle.
[0234] A limiter, may in some embodiments of the invention, be connected to cable. For example the thread stringing unit links may act as a cable that may be attached to a medical device at a point away from tissue interaction region. Changes in cable length and/or tension could be used to adjust tension and arrangement of the unit links. Or a cable could be connected to a spring to adjust tension.
[0235] In one embodiment, a cable may be situated within a hollow of a tissue interaction member. In one embodiment, a cable may run along the external surface of tissue interaction member. A cable may be a thread, a tether or other coupling device. A cable may be made of one or a combination of materials. The materials may include metal, plastic, a polymer, and/or other materials.
[0236] In one embodiment, a cable may run through the length of tissue interaction member and into a handle. In one embodiment, a cable may be coupled to a limiter control device. Limiter control device may be couple to the exterior of handle. In one embodiment, a limiter control device may be at a distal end of a handle.
[0237] Similarly, in one embodiment, a limiter comprises a magnets or concentric sleeves or friction elements or bearings that may be configured such that the magnets or sleeves or friction elements or bearings create a tension, stiffness, resistance and/or other characteristics are adjustable by a user. Alternatively, in another embodiment, magnets or concentric sleeves or friction elements or bearings may be configured such that the tension, stiffness, resistance and/or other characteristics are not adjustable by the user. Magnets or sleeves or friction elements or bearings may be configured to provide a single stage or multi-stage variable resistance. [0238] In some embodiments of the invention, magnets or sleeves or friction elements or bearings may be coupled to shaft. In some embodiments, a shaft may be configured to sit within a handle.
[0239] In one embodiment, a limiter may be coupled to a tissue interaction member. In one embodiment a limiter may be coupled to handle, wherein these embodiments are not exclusion, e.g., the tissue interaction member may also be the handle. Coupling may be direct or indirect. In one embodiment, a limiter is coupled directly to a tissue interaction member. In another embodiment, a limiter is coupled indirectly to a tissue interaction member. In one embodiment, a limiter and a tissue interaction member are all one unit.
[0240] A limiter may be coupled, or may be in communication with, other components of surgical tool. Alternatively, a limiter may be coupled, or may be in communication with, other components not directly coupled to surgical tool, for example, external monitors, external processors, external memory, and/or other external components. Coupling may be direct or through a wireless means. In one embodiment, a limiter may be coupled directly to a distal end of tissue interaction member. In one embodiment, a limiter may be incorporated within a distal end of a tissue interaction member.
[0241] In certain embodiments, a limiter is configured to automatically or semi automatically limit the amount of force that can be exerted by a user on a tissue via surgical tool and tissue interaction member. A limiter of this invention may be configured to be contained partially or wholly within a handle or within a tissue interaction member. Alternatively, in one embodiment a limiter of this invention may be attached to an independent medical device.
[0242] An example of a limiter being attached to an independent medical device may be a sleeve configured to be coupled or attachable to a surgical tool (Figures 8 A and 8B; Figures 9A- 9F), wherein the sleeve comprises a limiter, for example spring limiters (9012). In one embodiment, a surgical tool may be a curette. The sleeve may be configured to serve as a handle for surgical tool. A sleeve may be configured to cover from, 5%-95%, 10% to 70%, 20%-60%, or less than 50% of a surgical tool.
[0243] embodiment a sleeve comprising a limiter that could be attached to an independent medical device may include a double sleeve wherein the inner sleeve is wide enough to fit over the medical device, wherein the sleeves are connected by a spring (e.g., end of the spring is connected to the inner side of the outer sleeve and the other end of the spring is connected to the outer surface of the inner sleeve) and the force is limited in an axial direction between the sleeves. In other embodiment, multiple springs connect the inner and outer sleeves and the force is limited in multiple directions. Placement of the springs and tension of the springs used effects the range and directions of forces that may be limited.
[0244] A sleeve may be configured to interface with surgical tool such that a limiter can convert energy applied by a user of surgical tool. For example, Figures 9A and 9B show the limiter before (Figure 9A) and after (Figure 9B) an application of a force. Figure 9B demonstrates the convention of kinetic energy to spring potential energy, and therefore the inner sleeve (9014-i) remains in place while the outer sleeve (9014o) continues in a forward motion to the extent the spring elements (9012); direction of the force is shown by arrow at Figure 9B. It is shown that the limiter halts a tissue interaction member from penetrating further into a tissue. In one embodiment, a sleeve limiter impedes forward progress of a tissue interaction member and potential penetration of a tissue. Figure 9A shows a configuration when the threshold of excessive force has not yet been met and the sleeves rest one within the other. The embodiment of a sleeve limiter shown in Figures 9A-9B may be effective to prevent tissue damage for axial forces parallel to the long axis of the sleeves. Figures 9C-9E shows another embodiment, wherein the double sleeve limiter may be effective to prevent tissue damage for forces applied in multiple direction (See multiple arrows in Figure 9C). Figure 9E shows the results of one embodiment wherein the force applied is in a side-ways (transverse) direction wherein the resultant force compresses one spring limiter (9012-1) and expands another spring limiter (9012-r).
[0245] Further reference to Figure 8B shows that a sleeve (8014) may be configured such that when it is coupled with surgical tool, limiter can limit the use of excess force by a user of surgical tool on tissue (note a large force exerted at the site of the sleeve results in a much smaller force at the point of the distal end of a tissue interaction member (8002) on a tissue surface (8004) such that a boundary beyond which damage may occur (8006) is not penetrated.
[0246] In one embodiment, a sleeve is attached to an independent medical device. Figure 9F shows an embodiment of attachments sites (9050; 9052). Alternatively, attachment could be anywhere along the length of an inner sleeve that allows for the translation of forces presented in Figure 8B. The attachment may be through the use of clamps, use of an adhesive mechanism for example an adhesive tape, through the use of cable ties, use of any known mechanism in the art, or any combination thereof.
[0247] In some embodiments of the invention, a limiter is further coupled to a user interface, wherein the user interface is coupled to surgical tool. A user interface may be positioned on a handle of a surgical tool. A user interface may be mechanical, electrical or a combination of mechanical and electrical components. A user interface may be a button, a switch, a knob, a ring, a screw, a barb, a slider, a wheel, a touch screen or other component. User interface may be configured to control or partially control limiter.
[0248] In some embodiments of the invention a user interface is configured to override the function of limiter. In some embodiments of the invention, interface is configured to vary the function of limiter.
[0249] In some embodiments of the invention, a user interface is a wheel, wherein the wheel may be coupled to a handle and/or a limiter. A user using a surgical tool may, in some examples, turn the wheel clockwise and/or counterclockwise to alter the characteristics of limiter. In some examples, turning a wheel may result in changing a tension, for example, of a spring.
[0250] Medical devices of this invention describe in all or any of the embodiments presented above, may be used for method of curettage. Curettage may be for diagnostic, hemostatic, gynecological, obstetrical, abortive, dental, adenoidectomy, plastic surgery, or orthopedic purposes or any combination thereof.
[0251 ] Medical devices of this invention have been designed with safety as a prominent feature. Methods are provided for prevention a device of this invention from penetrating a tissue to a boundary beyond which it is not safe to penetrate. Figures 2A and 2B show one embodiment of a method of use, wherein the distal end of a tissue interaction member (2008) may be in contact with the tissue surface (2004) for use for example scrapping a surface. In Figure 2B, at the point that the distal end (2008) reaches the boundary (2006) beyond which it is safe to penetrate, the feedback warning indictor (2016) emerges from the handle alerting the user that a set tissue resistance has been met. Note that along with the alert the limiter spring (2012) compresses. Similar representations of safe methods are represented in Figures 5E and 8B. [0252] In one embodiment, this invention provides a method for preventing tissue damage using a medical device comprising a limiter and a tissue interaction member, the components of which have been described in details above. The steps of a method for preventing tissue damage include selecting a device based on need, setting a resistance limit for the limiter, and using the medical device wherein penetration of a portion of the tissue interaction member into a tissue is limited by the limiter, thereby achieving a safe method of use.
[0253] During a method of use, when a limiter detects or registers a resistance equal to or greater than a set resistance limit further penetration into a tissue may be reduced or halted altogether. The user is alerted that a limit has been detected. The reduction or elimination of further penetration may therefore be user initiated. Alternatively, the device may collapse when a limit is reached, for example a limiter or tissue interaction unit may collapse preventing continuation of an application of force. By halting or reducing progress of a tissue interaction member of a device perforation and/or damage to a tissue to prevented or reduced.
[0254] In one embodiment, this invention provides a method of preventing or reducing tissue damage during curettage. [0255] Reference is now made to Figure 12, which provides a schematic method showing a number of embodiments of a method of this invention. An initial step (400) is selecting the medical device based on a medical need. If the device selected does not comprise a limiter of this invention, a limiter may be added (402) prior to use. Choice of a limiter may depend on direction of forces needed for a medical procedure and/or an amount of force needed and/or the resistance a tissue may present to a medical device. At step (404) a resistance limit may be set, for instance using a regulator comprised in the medical device. Next the device is used by a skilled practitioner for its intended purpose (405) with the knowledge that a particular resistance limit has been set and the practitioner may receive a warning or the device may become inoperable, when the limit is detected (410). In one embodiment, a procedure may be completed prior to penetrating a tissue to an unsafe depth, no further action occurs (408). Alternatively if a use alert limit has been reached (410) there are multiple possible outcomes including by not limited to, (1) a user may override the limiter and continue use (414); (2) a user may halt use based on the information received thereby preventing possible perforation of a tissue; or (3) a limiter may collapse or deform halting use and preventing possible perforation of a tissue.
[0256] Reference is now made to Figure 13, which provides another schematic description for methods of use according to some embodiments of the invention. According to some embodiments, a limiter is selected according to its requirements of the required medical procedure, e.g. selecting at least one limit type (301): force, contact range (measured in length and/or length percentage), any contact with a tissue. According to some embodiments a configuration is selected for the limiter (302), according to its limit type and according to the required medical procedure. According to some embodiments, the limiter is either a part of the medical device (303), or an independent device, which requires a coupling to a medical device of a choice (304). According to some embodiments, a regulating process is conducted (305) to adjust initial properties of the limiter, and/or the selected limit. According to some embodiments, performing of the medical procedure comprises manual and/or automatic usage of the medical device (306). According to some embodiments, an initial contact or a predetermined contact range with the tissue, measured in length and/or in percentage from a set length limit, is alerted (313). According to some embodiments, an examination for a completion of the procedure (314) is identified (310) by the care giver, physician, or the robotic control, and accordingly the performance of the procedure may be halted (312). According to some embodiments, the limiter may be overridden (307), to allow a user a limit free use of the medical device. According to some preferred embodiments, the limiter is responsive to a predetermined limit (308), and accordingly at least one preventive action is performed, selected from a group consisting of: user alert (310), convert at least part of the kinetic energy (311), and halt the medical procedure (312). [0257] In some embodiments, the term "comprise" or grammatical forms thereof, refers to the inclusion of the indicated elements, such as the limiter or tissue interaction member of this invention, as well as inclusion of other elements, such as regulator(s), override mechanisms, material coatings, etc. In some embodiments, the term "consisting essentially of refers to a device, whose only essential elements are the indicated elements, however, other elements or limitations be included which are for quality or identification purposes of a device, but are not involved directly in the use of the device. In some embodiments, the term "consisting essentially of may refer to elements, which exert an effect via a mechanism distinct from that of the indicated essential element for ensuring safety, for instance a type of coating on a handle which may aid a user holding the tool but does not directly influence the safety elements presented herein above. In some embodiments, the term "consisting" refers to a device, which includes the elements and limitations as described herein.
[0258] In one embodiment, the terms "a" or "one" or "an" refer to at least one. In one embodiment the phrase "two or more" may be of any denomination, which will suit a particular purpose. In one embodiment, "about" may comprise a deviance from the indicated term of + 1 %, or in some embodiments, - 1 %, or in some embodiments, ± 2.5 %, or in some embodiments, ± 5 %, or in some embodiments, ± 7.5 %, or in some embodiments, ± 10 %, or in some embodiments, ± 15 %, or in some embodiments, ± 20 %, or in some embodiments, ± 25 %.
[0259] While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.

Claims

WHAT IS CLAIMED:
1. A limiter for a medical device, the medical device having a tissue interaction member (TIM), wherein the limiter is configured to be coupled with the medical device and to provide a preventive action, responsively to a predefined excessive contact of the TIM with a tissue.
2. The limiter of claim 1, wherein the predefined excessive contact relates to at least one of:
- a predetermined force applied by the medical device to the tissue;
- a predetermined amount of contact with the tissue; and
- any contact with the tissue.
3. The limiter of claim 1, wherein the preventive action is an alert to a user of the medical device.
4. The limiter of claim 3, wherein the alert comprises as at least one of: visual indication, haptic indication, audio indication.
5. The limiter of claims 2 and 3, wherein the alert comprises a measurement of the related force and/or the related amount of contact.
6. The limiter of claim 1, wherein the preventive action is configured to at least partially convert an applied energy, applied by a user and/or a robotic arm towards the tissue via the medical device or via the limiter, into a second form of energy.
7. The limiter of claim 6, wherein the applied energy is kinetic energy.
8. The limiter of claim 6, wherein the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof.
9. The limiter of claim 1, wherein the limiter comprises at least one selected from a group consisting of: coil spring/s, spirals spring/s, leaf spring/s, elastic band/s, friction element/s, magmatic element/s and any combination thereof.
10. The limiter of claim 1, wherein the preventive action is a collapse and/or retract of the TIM configured to prevent the TIM from further force application and/or further contact with the tissue.
11. The limiter of claim 10, wherein the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch and any combination thereof.
12. The limiter of claim 1, wherein the medical device includes a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue.
13. The limiter of claim 12, wherein the limiter further comprises a cylinder like member (CLM) configured to allow the shaft a motion along its longitudinal axis; and wherein the limiter is configured to at least partially transfer a force, which is applied to the CLM, towards the shaft.
14. The limiter of claim 13, wherein the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm.
15. The limiter of claim 1, wherein the preventive action is configured to avoid at least one incident selected from a group consisting of: tissue perforation, tissue puncture, tissue penetration, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
16. The limiter of claims 3, 6 and 10, wherein the limiter further comprises at least one override element configured to allow the medical device to at least partially override the limiter, thereby avoid at least one of:
- the alert;
- the energy conversion; and
- the prevention of the TIM from further force application and/or further contact with the tissue.
17. The limiter of claim 1, wherein the medical device is at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hystero scope cysto scope, optically assisted surgical devices, scopes, graspers, tweezers, catheter, trocar, and retractors.
18. The limiter of claim 1, wherein the limiter further comprises a regulating element, configured to adjust the limiter's initial properties.
19. The limiter of claims 2 and 18, wherein the regulating element is configured to determine at least one of: the predetermined force and the predetermined amount of contact.
20. The limiter of claim 1, wherein the limiter comprises a coupling element configured to couple the limiter to device, the coupling element selected from a group consisting of: magnet/s, binding string/s, binding clip/s, adhesive element/s, vacuum container, and elastic sleeve.
21. A medical device comprising a tissue interaction member (TIM) in communication with a limiter, wherein the limiter is configured to provide a preventive action, responsively to a predefined excessive contact of the TIM with a tissue.
22. The medical device of claim 21, wherein the predefined excessive contact relates to at least one of:
- a predetermined force applied by the medical device to the tissue;
- a predetermined amount of contact with the tissue; and
- any contact with the tissue.
23. The medical device of claim 21, wherein the preventive action is an alert to a user of the medical device.
24. The medical device of claim 23, wherein the alert comprises as at least one of: visual indication, haptic indication, audio indication.
25. The medical device of claims 22 and 23, wherein the alert comprises a measurement of the related force and/or the related amount of contact.
26. The medical device of claim 21, wherein the preventive action is configured to at least partially convert an applied energy, applied by a user and/or a robotic arm towards the tissue via the medical device, into a second form of energy.
27. The medical device of claim 26, wherein the applied energy is kinetic energy
28. The medical device of claim 26, wherein the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof.
29. The medical device of claim 21, wherein the limiter comprises at least one selected from a group consisting of: coil spring/s, spiral springs, leaf spring/s, elastic bands, friction element/ s, magmatic element/ s and any combination thereof.
30. The medical device of claim 21, wherein the preventive action is a collapse and or retract of the TIM configured to prevent the TIM from further force application and/or further contact with the tissue.
31. The medical device of claim 30, wherein the limiter comprises at least one selected from a group consisting of: buckling element/s, buckling spring/s, sliding clip/s, friction clutch and any combination thereof.
32. The medical device of claim 21, wherein the TIM comprises a shaft having a proximal end and a distal end; the shaft's distal end is configured for the contact with the tissue, or in communication with another member which is configured for the contact with the tissue.
33. The medical device of claim 32, wherein the medical device further comprises a cylinder like member (CLM); wherein the shaft is configured to move along longitudinal axis of the CLM; and wherein the limiter is configured for communication between the shaft and the CLM to at least partially transfer a force, which is applied to the CLM, towards the shaft.
34. The medical device of claim 32, wherein the CLM is configured as a handle for a user and/or configured to be in communication with a robotic arm.
35. The medical device of claim 21, wherein the preventive action is configured to avoid at least one incident selected from a group consisting of: tissue perforation, tissue penetration, tissue puncture, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
36. The medical device of claims 23, 26 and 30, wherein the medical device further comprises at least one override element configured to at least partially override the limiter, thereby avoid at least one of:
- the alert;
- the energy conversion; and
- the prevention of the TIM from further force application and or further contact with the tissue.
37. The medical device of claim 21, wherein the TIM comprises or in communication with at least one selected from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices, scopes, graspers, tweezers, catheter, trocar, and retractors.
38. The medical device of claim 21, further comprises a regulating element, configured to adjust the limiter's initial properties.
39. The medical device of claims 22 and 38, wherein the regulating element is configured to determine at least one of: the predetermined force and the predetermined amount of contact.
40. The medical device of claim 21, further comprises a coupling element configured to couple the limiter to the TIM, the coupling element selected from a group consisting of: magnet/s, binding string/s, binding clip/s, adhesive element/s, vacuum container, and elastic sleeve.
41. The medical device of claim 30, wherein the limiter comprises an at least partially flexible string, attached to a handle, at the string's proximal end; and wherein the TIM comprises a plurality of links, connected by the string's distal end.
42. The medical device of claim 21, further comprising an extracting rod, configured to be pushed through the medical device or to be held while the medical device is withdrawn, and thereby to discharge a medical apparatus and/or to dispense a medical treatment, temporarily accommodated within the medical device.
43. A method for using a medical device having a tissue interaction member (TIM), comprising steps of:
- providing the medical device with a limiter, wherein the limiter is configured to selectively provide a preventive action;
- using the device for a medical procedure; and
- responsively to a predefined excessive contact of the medical device with a tissue, providing the preventative action.
44. The method of claim 43, wherein the predefined excessive contact relates to at least one of:
- a predetermined force applied by the medical device to the tissue;
- a predetermined amount of contact with the tissue; and
- any contact with the tissue.
45. The method of claim 43, wherein preventive action comprises alerting a user of the medical device.
46. The method of claim 45, wherein the alerting comprises providing to the user at least one of: visual indication, haptic indication, audio indication.
47. The method of claims 44 and 45, wherein the alerting comprises providing a measurement of the related force and/or the related amount of contact.
48. The method of claim 43, wherein the preventive action comprises at least partially converting an applied energy, applied by a user and/or a robotic arm towards the tissue via the medical device or via the limiter, into a second form of energy.
49. The method of claim 48, wherein the applied energy is kinetic energy
50. The limiter of claim 48, wherein the second form of energy is selected from a group consisting of: elastic strain energy, plastic strain energy, friction energy, heat energy, magnetic field energy and any combination thereof.
51. The method of claim 43, wherein the preventive action comprises collapsing and/or retracting the TIM thereby preventing the TIM from further force application and/or further contact with the tissue.
52. The method of claim 18, wherein the preventive action comprises avoiding at least one incident selected from a group consisting of: tissue perforation, tissue penetration, undesired tissue damage, excess scraping, deep incision, and damage to the medical device.
53. The method of claims 45, 48 and 51, further comprising at least partially overriding the limiter, thereby avoiding at least one of:
- the alerting;
- the energy conversion;
- the preventing of the TIM from further force application and/or further contact with the tissue.
54. The method of claim 43, further comprising selecting the TIM from a group consisting of: curette, hysterometer, applier of a medical treatment, applier of an intra uterine device (IUD), hager, scalpel, hysteroscope cystoscope, optically assisted surgical devices, scopes, graspers, tweezers, and retractors.
55. The method of claim 43, further comprising adjusting the limiter's initial settings and thereby determining the predetermined force and/or to the predetermined amount of contact.
56. The method of claims 44 and 55, wherein the adjusting is configured to determine at least one of: the predetermined force and the predetermined amount of contact.
57. The method of claim 55, wherein the adjusting of the limiter allows using the medical device for at least one procedure selected from a group consisting of: dilation, curettage, tissue removal, tumor removal, application of IUD, application of medical treatment, and catheterization.
PCT/IL2016/050144 2015-02-08 2016-02-08 A medical device for limiting tissue damage and uses thereof Ceased WO2016125176A1 (en)

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