CN102892456A - Resector balloon system - Google Patents

Resector balloon system Download PDF

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Publication number
CN102892456A
CN102892456A CN2010800667693A CN201080066769A CN102892456A CN 102892456 A CN102892456 A CN 102892456A CN 2010800667693 A CN2010800667693 A CN 2010800667693A CN 201080066769 A CN201080066769 A CN 201080066769A CN 102892456 A CN102892456 A CN 102892456A
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China
Prior art keywords
air bag
pump
fluid
physiology
conduit
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Granted
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CN2010800667693A
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Chinese (zh)
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CN102892456B (en
Inventor
E·H·贡达伊
L·J·格朗斯
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SANOVAS LLC
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SANOVAS LLC
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10181Means for forcing inflation fluid into the balloon
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10184Means for controlling or monitoring inflation or deflation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1018Balloon inflating or inflation-control devices
    • A61M25/10184Means for controlling or monitoring inflation or deflation
    • A61M25/10185Valves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00863Fluid flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06Measuring instruments not otherwise provided for
    • A61B2090/064Measuring instruments not otherwise provided for for measuring force, pressure or mechanical tension
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/90Identification means for patients or instruments, e.g. tags
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1072Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/109Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

A resector balloon system is disclosed generally comprising a catheter with at least one balloon having an outer wall with a resecting, non-slip surface for resecting unwanted biological material, such as tissues or tumors, and a pump that supplies fluid thereto in pulsed fashion to repeatedly deflate and inflate said balloon. In certain embodiments, the pump includes a processor that controls the pulsed supply of fluid based on an established frequency or change in volume. In some embodiments, the system includes a keyed connector with which the pump identifies the balloon type, and in some cases, the system calculates intra-lumen diameters and densities. In some embodiments, the balloon portion of the catheter includes multiple balloon segments, which in some cases, are inflatable separately from one another.

Description

The resectoscope gas-bag system
Technical field
The present invention relates to excise the System and method for of undesired physiology's material, tissue growth and tumor in all in this way chambers on health of this undesired physiology's material.More specifically, the present invention relates to have the balloon catheter of removal surface, it operates with pulse mode, with minimal damage excision target material.
Background technology
Remove undesired and/or life-threatening physiology's material from the bodily cavity chamber interior, such as organ, blood vessel, joint combination and structure, hole and all kinds of health cavity, the operation that right and wrong are usually seen in such as the plurality of medical specialty of pulmonology, cardiology, urology, gynecology, gastroenterology, neurological, otolaryngology, plastic surgery and general surgery and subject.Therefore, taked various instruments and method to carry out these operations, these generally are known in the prior art.
One of most important factor is hemorrhage in such process.In current known a lot of surgical operations, prevalence hemorrhage and caused tissue is scratch, wound and the excision of invasion property and the result who removes technology.A lot of such technology are being emitted the blood vessel of wherein performing the operation or the danger of tube chamber perforation, cause surgeon and patient's severe complication.In addition, a lot of patient diseases are not simply by these surgical healings, because there is not the treatment form of intervention, minimally-invasive, these methods not effectively, safety and repeatable, and/or the instrument that adopts lacks safe, effective and repeatable that suitable observability, physiological measurements and/or necessary feedback guarantee to perform the operation.Therefore, need the treatment of newtype.
An instrument that generally uses in various types of medical operatings is the inflatable bladders conduit, has much dissimilarly, is used to carry out the function of various necessity.For example, these aerating gasbags be often used in control or stop hemorrhage, keep instrument to put in place or prevent or auxiliary other flow in the health chamber or mobile.For example, via be held in place with a lot of urological catheters of urethra sidewall contact, a lot of department of obstetrics and gynecology instruments are held in place via contacting with the fornix vaginae sidewall, air bag is often used in Bleeding control, aerating gasbag and sometimes is used to control and injects cystic duct and detect the adverse current of the contrast agent that cholelithiasis exists and recently, balloon catheter has been used to discharge congestion of nasal sinus in general surgery cholecystectomy process in the blood vessel.
An application-specific of such conduit is pulmonary carcinoma.In all types of cancers, pulmonary carcinoma has minimum survival rate because since in the death that causes of cancer more than 1st/3rd, caused by pulmonary carcinoma.Annual worldwide is diagnosed out and is surpassed 1,500,000 new patient.The common cause of the death of lung cancer patient is airway obstruction.In cancer patient, 1/3rd among all patients have just begun and are other 1/3rd long-term, main airway occurs and block, and this causes and suffocate, bleeds in a large number and infects.These complication are the most common causes of the death of lung cancer patient.
Use the intervention bronchoscopy to be used for quality of life that lung cancer therapy and caused airway obstruction increased the patient who stands chronic obstructive pulmonary disease (COPD) and survival rate and the obstructive relevant with cancer jointly ill.Therefore, the balloon catheter bronchoscope that has been used for routinely various endoscopies and flexible and rigidity is to be used for expansion, to stop blooding and as the intervention fixing device instrument is kept putting in place and preventing these instruments retreating under countercurrent pressure as filling.
Needs based on the treatment of aforesaid newtype for being used for removing the undesired physiology's material of health chamber, realized, can be further excise as the intervention instrument and remove such material-such as endolymph obturator and tumor and Endovascular Occlusion-in various application, such as pulmonology, cardiology, urology, gynecology, gastroenterology, neurological, otolaryngology and the general surgery of above-mentioned intervention medical speciality with the inflatable bladders conduit.Compare the method and apparatus (such as machinery, laser, electric cautery, cryotherapy etc.) of the other types that are used, use in this way that balloon catheter has presented simply, safety, highly effectively and not expensive Therapeutic Method.
Therefore, advised that the air bag of new classification is used for this purpose, such as disclosed among the european patent application No.EP 1,913 882 by the Karakoca application.This equipment has adopted the balloon catheter with hardened surface, and it can be inserted into the health chamber.After this equipment was inserted into, air bag was inflated, thereby and this air bag in chamber, move forward and backward veined surface and carry out at undesired physiology's material and strike off action.In this way, excised targeting substance.
Yet this particular instrument is limited by several inferior positions and shortcoming with the method for using it.One of sixty-four dollar question of this resectoscope air bag is, by striking off with the hardened surface that is positioned at the air bag outside, that is, by with air bag front and back and/or rotary moving, removes undesired physiology's material.This motion mechanism may cause scratch and wound.In addition, hardened surface adds that striking off action sometimes may lack necessary degree of accuracy and prevent complication such as the hemorrhage and structural perforation of affected anatomical structure.Further, on air bag needed moment of torsion and back and forth the amount of active force can cause equipment fault, particularly be attached to the conduit part at air bag.
Another inferior position of this resectoscope air bag is that its hardened surface is the discrete thin film that is positioned at the air bag outside.This thin film has the extension characteristics different from air bag, and adversely affects the performance of balloon catheter.May need before use at external this balloon catheter that checks in advance.Additionally, under the friction stree of operation, the tear-away and safety of further blocking or jeopardizing the health chamber that has wherein launched air bag of this air bag.
Another problem of this resectoscope air bag is that this air bag also lacks accuracy, and the size of its environment that is used provides physiologic measurement and the feedback that can help Results and effect because this air bag shortage is accurately measured wherein.For example, the surgeon have no idea to know the health chamber itself that affects (approach wherein obturator or away from wherein obturator) diameter.Similarly, the surgeon has no idea to know the cavity interior diameter that wherein has undesired tissue growth or tumor, and further, has no idea to regulate exactly when this tissue growth or tumor are cut this diameter over time.Owing to there is not mechanism to be used at different time point measurement chamber inner chamber body interior diameter, and specifically, measure this diameter as where time to time change, can not regulate suitably provides to the amount of pressure of air bag and prevents from by this complication and accelerate treating.
Be that with this device-dependent problem the doctor has no idea to measure two intraarticular spaces between articulation structure, soleplate or the surface.
Another relevant issues of this equipment are, the density that the surgeon has no idea to understand the health chamber is that the surgeon does not know the density of tissue growth or tumor itself yet near obturator or different from obturator.Owing to there is not the mechanism for the density of measuring chamber or obstruction, the pressure that possibly can't control suitably in the air bag is helped the surgery degree of accuracy, minimizes potential complication, is also accelerated operation.
Another relevant issues of this equipment are that this equipment has no idea to identify the type of the balloon catheter that is connected to pump.As a result of, this air bag can unexpectedly excessively be inflated, and therefore, this air bag can break.
Another inferior position of this resectoscope air bag is that structure single, monomer that this air bag comprises only this means and whole air bag can be inflated as a whole.This causes some deficiencies, comprising: can not measure the cavity interior diameter not existing together, comprise physiology's material of health chamber itself (approach/away from obturator) and obstruction; Can not accurately locate need maximum pressure part (a plurality of) thus excise exactly and methodically this obturator; Thereby can not clog the specific region Bleeding control; Thereby can not catch cut material draws out from the health chamber with it; Also have air bag to slide and mobile trend.
Another deficiency of this equipment is, this equipment can not be by according to desirably optimally being placed.For example, the integral diameter of this balloon catheter need to have rigidity or the soft endoscope of service aisle.Except the fact that such endoscope is difficult for obtaining, endoscope is independent cavity equipment.As a result of, can not use seal wire, by rigidity or soft endoscope or other with endoscope in rigidity or soft endoscope, they be guided to the health chamber.Similarly, this equipment does not have ability air bag is transmitted along catheter configurations is linear, and air bag is placed and repeatability and this can optimize.At last, this equipment does not comprise for the material that externally identifies its position (such as radiography material).Therefore, can not easily identify via outside imaging form (such as actinogram or ultra sonic imaging) position of air bag.Each of these shortcomings is so that can not like that accurately locate as desired this air bag.
Another inferior position of this resectoscope air bag is, have no idea for the doctor illumination light, non-thermoluminescence light and air bag be provided before, from air bag forward direction air bag hope, along the visual feedback of air bag side or air bag rear region, optimize Results and effect.
The further deficiency of this resectoscope air bag is derived from such fact: it is the single cavity equipment that near-end is blocked.As a result of, when air bag was inflated, it did not allow fluid (such as air or blood) to flow to near-end from distal end of catheter.This is very important in the intervention pulmonology is used, if the airway obstruction situation wherein occurs, suction is crucial.Similarly, in the intervention cardiology was used, it was important allowing the by-pass flow of blood in the operation of vessel segment (vesselsegment).
Another deficiency of this equipment is that it does not have the ability transmission can help to excise the low temperature agent of undesired physiology's material or the energy of various ways.As a result of, thereby can not provide the energy of low temperature agent or the various ways such as radio frequency, ultrasonic and electrosurgical energy to carry out melts, dry, burn, excise, divest and/or thereby tissue modification is optimized hemostasis and excision.
The further deficiency of these balloon catheters is, has no idea to provide medicine, support, physiology's material, nano-particle or the correlation technique of localization transmission to balloon surface.Therefore, the means of supply medical science, treatment and rehabilitation processing can not be provided with this equipment.
Therefore, desired is a kind of resectoscope gas-bag system, is used for removing physiology's material of not expecting, and does not cause the unnecessary damage for the health chamber that affects as the result who strikes off action who is used to excise this material.Also expectation is to have the resectoscope gas-bag system of controlled rate for inflating and exitting.Further expectation is, does not need to be fixed to the resectoscope gas-bag system of the discrete thin film of air bag outside.Also expectation is by endoscope, by endoscope or via actinogram or the manageable resectoscope gas-bag system of ultra sonic imaging.Also expectation is a kind of resectoscope gas-bag system, and this system can provide the physiology to feed back to determine wherein to have cavity interior diameter and the density of undesired physiology's material and be adjacent to or away from the type of the intraarticular spacing between the cavity interior diameter of the position of such material and density, two articulation structures and the balloon catheter that connects.Also expectation is a kind of resectoscope gas-bag system, and this system can also provide size and the performance metric that is structured in intravital balloon catheter.Further expectation is a kind of resectoscope gas-bag system, and it is indoor and can accurately locate the specific region that maximum inflation is provided that this system can be positioned bodily cavity best.Also expectation is a kind of resectoscope gas-bag system, and this system can provide light and visual ability, low temperature agent and various forms of energy to help surgical technic and deliver to anatomic points with medicine and relevant material.Further expectation is a kind of resectoscope gas-bag system, and this system allows fluid to flow to far-end from catheter proximal end.
Summary of the invention
Therefore, the object of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, this system does not need to strike off motion mechanism.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system does not adopt the separating film that is fixed to the air bag outside.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, this system provides the physiology to feed back, from these feedbacks, can determine wherein to have diameter in the cavity of these physiology's materials and contiguous and away from the health chamber of this material itself, and correspondingly scalable provides pressure and stream to air bag.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, this system provides the physiology to feed back, from this physiology feedback, can determine two intraarticular spaces between articulation structure, soleplate or the surface, and correspondingly scalable provides pressure and stream to air bag.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, this system provides the physiology to feed back, from these feedbacks, can determine wherein to have density in the cavity of these physiology's materials and contiguous and away from the health chamber of this material itself, and correspondingly scalable provides pressure and stream to air bag.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system can identify the type of the balloon catheter that is connected to pump.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and wherein this air bag partly has the different section that can be inflated independently.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system also has at least one additional via except the path for the fluid of inflating this air bag.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system can make this air bag be transmitted along this conduit.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, the outside imaging of this system supplymentary.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system provides bodily cavity indoor visual pattern.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system can transfer its energy to the target area.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system can be passed to the target area with the low temperature agent.
Another purpose of the present invention is to provide a kind of resectoscope conduit system be used to removing physiology's material of not expecting, and this system can be passed to the target area with medicine, support, nano-particle and similar substance.
In order to overcome the deficiencies in the prior art and to realize listed purpose and at least some in the advantage, the present invention includes the method with resectoscope gas-bag system excision physiology material, the method comprises to be inserted conduit in the health chamber with physiology's material of wanting cut, this conduit comprises at least one air bag that has with the outer wall of removal surface, by coming this airbag aeration so that the removal surface of air bag touches this physiology's material to accommodating fluid wherein, by with pulse mode fluid being provided to this air bag repeatedly this air bag to exit and inflate, thereby the venting of this repetition and inflation are so that this removal surface has excised this physiology's material.
In certain embodiments, the step of airbag aeration is comprised with electropneumatic pump accommodating fluid to this air bag, and this air bag is repeatedly exitted and the step of inflating is controlled by this electropneumatic pump based on the change in volume of setting up or frequency at least in part.In some cases, the method also comprises the airbag types that detects the conduit that is inserted into the health chamber, wherein control at least in part the step to airbag aeration based on detected airbag types, and under specific circumstances, air bag is repeatedly exitted and the step of inflating comprises density or the diameter in physiology's chamber of determining physiology's material, and regulate the amount that provides to the fluid of air bag based on determined density or diameter at least in part.
In certain embodiments, at least one air bag comprises a plurality of balloon segment, and the step of airbag aeration is comprised being independent of at least one balloon segment inflation of at least one other balloon segment.
The present invention also comprises the resectoscope gas-bag system, comprise the conduit with at least one air bag of tool outer wall, this outer wall comprises the removal surface for excision physiology material, comprise that also by to the pump of fluid to airbag aeration wherein is provided, wherein this pump provides fluid repeatedly air bag to exit and inflate with pulse mode at least one air bag.
In certain embodiments, in specific favourable embodiment, this pump is the electropneumatic pump.In certain embodiments, this pump comprises processor, and the pulse that this processor is controlled fluid based on the frequency of setting up provides, and in other embodiments, this pump comprises processor, and this processor is controlled the pulse supply of fluid based on the change in volume of setting up in the air bag.
In certain embodiments, the present invention also comprises the adapter that connects the conductive pipe to pump, and wherein this adapter is air bag sign adapter, uses this adapter, and this pump identifies this air bag.In certain embodiments, this adapter comprises air bag marking plate and key, and when conduit was connected to this pump, this marking plate of this bond orientation was so that this pump uses this marking plate to identify this air bag.In some cases, this pump electric light ground identifies this air bag by this marking plate, and in other cases, this pump motor tool ground identifies this air bag by this marking plate.In a particular embodiment, this pump comprises air bag profile data and the processor corresponding to air bag, and this processor flows to the fluid supply of air bag at least in part based on this air bag profile data control.The air bag profile data also can comprise the correction data for dissimilar tissues.
In certain embodiments, this pump comprises be used at least one sensor and the processor of making at least one measurement, and at least one measures and the air bag profile data is calculated the density of the physiology's material in the physiology chamber this processor based on this at least in part.In certain embodiments, this at least one sensor comprises that the sensor and determining of the pressure of the fluid of determining to export to air bag exports the sensor that flows of the fluid of air bag to, and in some cases, this pump is controlled to the fluid supply of air bag at least in part based on the density of calculating.
Similarly, in certain embodiments, this pump comprises be used at least one sensor and the processor of making at least one measurement, and at least one measures and the air bag profile data is calculated diameter in the physiology chamber this processor based on this at least in part.In certain embodiments, this at least one sensor comprises that the sensor and determining of the pressure of the fluid of determining to export to air bag exports the sensor that flows of the fluid of air bag to, and in some cases, this pump is controlled to the fluid supply of air bag at least in part based on the diameter that calculates.
In a particular embodiment, this system also comprises the adapter that connects the conductive pipe to this pump, wherein this adapter is air bag sign adapter, use this adapter, this pump identifies air bag, and this pump comprises the air bag profile data corresponding to this air bag, and this pump comprises processor, this processor is determined the variation of volume in desired frequency or the air bag at least in part based on these disposition of gasbag data, and this pump is controlled to the fluid supply of air bag at least in part based on determined frequency or change in volume.
In certain embodiments, this at least one air bag comprises a plurality of balloon segment, and conduit comprises a plurality of cavitys, and by these a plurality of cavitys, this pump accommodating fluid is to this balloon segment, so that pair at least one balloon segment inflation that separates with at least one other balloon segment of this pump.
In specific advantageous embodiment, this system comprises that also accommodating fluid is at least one external cavity of this at least one balloon segment and internal cavity.In certain embodiments, internal cavity comprises air or body fluid path, and in certain embodiments, at least one seal wire is placed in the internal cavity.In the specific embodiment in these embodiments, this system also comprises at least one passage that connects internal cavity and gasbag outer surface, is used for transmitting medical science or therapeutic agent to this physiology's chamber.In certain embodiments, this conduit comprises the imaging device hole, also comprises the fibre bundle that places in this conduit and withdraw from described hole, is used for checking this physiology's chamber.For multiple purpose, can use some cavitys.For example, put in place in case this conduit is inserted under the help of seal wire, it is visual then can to use internal cavity to be used for.
In a particular embodiment, this pump comprises vacuum source, uses this vacuum source, and by the passage in the internal chamber, this pump is discharged cut material from the health cavity.In certain embodiments, this pump comprises the vacuum source that fluid is discharged from air bag.
In certain embodiments, this system also comprises for the energy source of energy supply and is molded at least one lead-in wire that is used for energy is conducted to from energy source this physiology's chamber in the conduit.
In specific favourable embodiment, this fluid is air.In certain embodiments, this fluid is cryogen.
In specific advantageous embodiment, this system comprises the mesh that is molded in this conduit, and wherein removal surface comprises the texturizing surfaces that is positioned at gasbag ektexine that this mesh produces.In other embodiments, the outer wall of this air bag comprises a plurality of inflatable chamber that removal surface is provided.In other embodiment, this system also comprises the spring lead-in wire that is mounted to this gasbag ektexine, and wherein removal surface comprises this spring lead-in wire, and in some cases, and this system comprises that also being connected to this spring lead-in wire is used for providing energy to arrive wherein energy source.
In certain embodiments, this air bag has the first and second ends, and this system comprises also and is installed as at least one imaging labelling (marker) adjacent with at least one air bag end that in some cases, the imaging labelling comprises radiography ring (radio-opaque ring).
Description of drawings
Fig. 1 is according to the front of resectoscope gas-bag system of the present invention, part sketch map.
Fig. 2 A is front, the part sketch map of balloon catheter of the system of Fig. 1.
Fig. 2 B is end, the partial cross section diagram of air bag of inflation of the system of Fig. 2 A.
Fig. 2 C is the partial cross section diagram of air bag of venting of the system of Fig. 2 A.
Fig. 3 A is front, the part sketch map of balloon catheter that adopts Fig. 2 A of a plurality of balloon segment.
Fig. 3 B is the side view of air bag of the conduit of Fig. 3 A, and middle air bag is inflated.
Fig. 3 C is the side view of air bag of the conduit of Fig. 3 A, and middle air bag is deflated.
Fig. 3 D is the partial cross section figure of the balloon catheter of Fig. 3 A.
Fig. 3 E is the side view of air bag of the conduit of Fig. 3 A, and balloon segment is separated spatially.
Fig. 3 F is the partial cross section figure of the balloon catheter of Fig. 3 E.
Fig. 4 A is side, the part sketch map of balloon catheter with Fig. 1 of energy delivery assembly.
Fig. 4 B is side, the part sketch map of the balloon catheter of Fig. 4 A.
Fig. 5 is the side view of the balloon catheter of Fig. 1, has the spring lead-in wire that is mounted to air bag.
Fig. 6 A is side, the part sketch map of balloon catheter with Fig. 1 of imaging device.
Fig. 6 B is the end diagram of the imaging device of Fig. 6 A.
Fig. 7 A-F is the just side of the balloon catheter of operated Fig. 1, partial cross section figure in the health cavity.
Fig. 8 is the block diagram of pneumatic member that the pump of Fig. 1 is shown.
Fig. 9 is the block diagram of soft copy that the pump of Fig. 1 is shown.
Figure 10 A illustrates the front panel of the pump of Fig. 1.
Figure 10 B illustrates the graphical demonstration of the front panel of Figure 10 A.
Figure 10 C illustrates the front panel of remote controller of the pump of Figure 10 A.
Figure 11 A illustrates the front panel of the pump of Fig. 1.
Figure 11 B illustrates the rear board of the pump of Figure 11 A.
Figure 11 C illustrates the front panel of remote controller of the pump of Figure 11 A.
Figure 12 A-B is the flow chart of operation that the resectoscope gas-bag system of Fig. 1 is shown.
Figure 13 is the example of the typical curve of the moving time response of volume relative current before and after proofreading and correct.
The specific embodiment
Shown in Fig. 1 according to the basic module of an embodiment of resectoscope gas-bag system of the present invention.As used in this description, term " top ", " bottom ", " on ", " under ", " up ", " below ", " on ", " beneath ", " at the top ", " below ", " making progress ", " downwards ", " on ", the object mentioned when D score, 'fornt', 'back', " back ", " forward " and " backward " refer to orientation shown in the accompanying drawings, these orientations are for realizing that purpose of the present invention is not necessary.
This system 20 comprises fluid source (22), and such as the electropneumatic pump that has control in its front portion, doctor or assistant can control this system (and remote control unit) from these controls, and this will further describe hereinafter.Balloon catheter (24) is connected to pump (22), this pump (22) accommodating fluid, such as gas, liquid or its mixture to balloon catheter.Under specific circumstances, this pump (22) thus the supply cryogen further helps particular procedure, dry such as tumor.
As shown in Fig. 2 A-B, this balloon catheter (24) comprises the conduit (26) of being made and being had 1.8mm external diameter and about 1.2 to 3 meters length by polythene material.Be positioned at the flexible part (28) with about 5-10mm length of conduit (24) far-end as safety terminal (tip).As a result of, when the available opening of conduit (24) by the health cavity was inserted into, it will be crooked and can not pierce through cavity wall.
Air bag that rubber or other suitable materials are made part (30) be positioned near the far-end of conduit (24) or be positioned at other expectations, along conduit (24) preset distance part.Air bag (30) has various sizes and diameter, and this can be selected to be fit to use the application-specific of this equipment.Generally, such air bag can have 5,10,15,20,30 or the length and 2.5,5,10,15,20 of 50mm, 30 or the diameter of 50mm.Various variable air bag sizes allow balloon catheters (24) to be used for the health cavity of various diameters and size, such as having all types of tumor that will be treated and larger and less bronchus, hole and the blood vessel of tissue.This pump (22) provides the air of about 2 atmospheric pressure, thereby can be complete size with such airbag aeration, from 2.5mml to 50mml between.
In specific favourable embodiment, air bag (30) comprises imaging labelling (32), such as the radiography ring that is positioned at end or close end.。Thereby can select and place suitably such labelling to reflect each image mode relevant ripple of (such as, x-ray), thereby allow to use such mode to help the accurate location of air bag (30).
Referring to Fig. 2 B, show the cross section of air bag (30), flexible removal surface (34) is stamped in this air bag coating, and flexible removal surface for example can comprise the fiber mesh on the surface that is fixed to this air bag (30).In specific favourable embodiment, removal surface (34) comprises as the ingredient of air bag and the thick texturizing surfaces of about 0.2mm that is incorporated therein in the molding process process.In these cases, by meticulous, fiber mesh are attached to and make removal surface (34) in the bag material, this mesh is made by lycra, polyurethane, synthetic spring or other suitable materials.The cross point of mesh parts produces towards the outside, less knot or pit, creates microshock at tumor tissues (or with other cut physiology's materials) in this inflation/deflation cyclic process of describing hereinafter.In other embodiments, size (dimensional) surface texture or inflatable cave (sinus) in the surperficial substrate that is encapsulated in air bag (30) have been adopted.This dipping (impregnated) structure in the surperficial substrate of air bag can be imitated mesh-like structure, piece (bump), ridge etc.
Back referring to Fig. 2 A, balloon catheter (24) comprises that the Y of internal chamber branch (breakout) ties introducing, air by-pass, drug delivery or visual guiding that (40) help seal wire.The near-end of the internal cavity (42) behind Y knot (40) is eventually with Luer connector (44) termination.With band key connector (46) termination, band key connector (46) comprises key (48) and air bag marking plate (50) to external cavity at its near-end.
Y knot (40) is used for several purposes.At first, it brings to suitable connector with independent, the internal cavity (42) of conduit (24), such as above-mentioned Luer connector (44), thereby provide independently path, such as at the far-end of balloon catheter (24) and the two-way air flue between the near-end, this is important for application-specific (, bronchoscopy) when air bag is inflated.In addition, this Y knot (40) comprises that also the valve-off (not shown) is used for so that this air bag (30) stops venting.For example, this can be used to, thereby when requiring it to leave aerating gasbag and reach long period section treatment chronic hemorrhage.
As mentioned above, conduit (24) is terminated at near-end with the air bag marking plate (50) with key.The purpose of this adapter is detected catheter (24) and identify the particular type of employed balloon catheter electronically when conduit is inserted in the pump (22).This key (48) orientation connector (46) and marking plate (50) are so that can identify airbag types by pump (22) by using electric light or electromechanical means.
Can be characterized by the air bag (30) of each type of using with pump (22), and the air bag profile data is registered in the enquiry form.By identifying the type of the air bag (30) that is connected with pump (22), can search suitable profile data and be used for guaranteeing that suitable pressure, volume, flow and the sequential of manipulation balloon (30) are regulated safely and effectively.With suitable pressure and flow measurement (as described further below), the air bag profile data is comprised in the enquiry form, and it is approximate to allow to make suitable tissue density.This air bag profile data and by the cavity diameter and the tissue density that are similar to, and any user command, be used to regulate pump (22) is passed to air bag (30) thus air capacity realize inflation and the discharge quantity of expectation.
As shown in Fig. 2 C, it shows the cross section of the conduit (26) of the air bag (30) of venting and the far-end that removal surface (34) is positioned at.In a particular embodiment, the internal cavity (42) of conduit (26) is by the flexible part extension of catheter tip (28) and in distal openings.As mentioned above, in application-specific, such as bronchoscopy, this internal cavity (42) allows air to move freely from each end of air bag (30) when air bag is inflated as path two-wayly.In addition, this internal cavity (42) can be used as the exactly device of positioning gasbag conduit (24), because when the balloon catheter (24) with venting inserted in the health cavity, this internal cavity can be used as the guiding of seal wire (63).In other are used, such as when treating coronary heart disease, can provide the by-pass prot (not shown) of internal cavity and this internal cavity (42) after this to get clogged by the correct position after the near-end of air bag (30), thereby the branch's knot that is used for it be not necessary.
Use the external cavity (60) of conduit (26) to come by the hole (62) that is arranged in the conduit outer wall (64) air bag (30) to be inflated and venting.These external cavities get clogged at the far-end of air bag (30), thereby are intended to can not overflow for the air of inflation and venting.
In specific advantageous embodiment, as shown in Fig. 3 A-B, balloon catheter (24) comprises many bladder configurations (70) at its far-end.This structure can comprise, for example, and nearly balloon segment (72), center sleeve section (74) and balloon segment (76) far away.Near-end in conduit (24), Y knot (40) brings another cavity (78), and it provides fluid to the nearly balloon segment (72) of separating with center sleeve section (74) and balloon segment (76) far away.This additional cavity (78) is connected to and is similar to another band key adapter (80) that the band key connects (46).In this way, center sleeve section (74) is independent of air bag near and far away (72,76) and is inflated and exits.
Adopt in this way the balloon segment near and far away of separating to play different purposes.At first, can inflation balloon segment near and far away (72,76) reach a certain amount of, this amount is suitable for conduit (24) is stably remained on the whereabouts of organizing that will be removed, simultaneously circularly middle air bag (74) is inflated and exits to excise undesired physiology's material, as shown in Fig. 3 B-C.By doing like this, can prevent air bag (30) movable or migration and may causing for health cavity itself in operation process, this stands at chamber in the situation of very big return pressure and inserts requirement at balloon catheter to reach in the application of time period of prolongation be very important.In addition, by to air bag near and far away (72,76) inflation, can prevent that cut material from entering the health chamber, but, simply remove thereby can catch the tissue that is released.At last,, independently inflatable bubble or pit a plurality of by adopting in this way, can be more selectively and accurately clog the health chamber different piece, measure its cavity interior diameter and density, and the tissue that hinders of excision.
Fig. 3 D illustrates how to come these three air bags (72,74,76) inflation and venting with external cavity.As mentioned above, use internal cavity (42) to be used for air by-pass and/or seal wire guiding.Lower cavity (82) only has inflation/deflation hole (84) along conduit (24) length in the locational catheter wall at center sleeve (74) place, and upper chamber (86) only comprises inflation/deflation hole (88) in the position at air bag near and far away (72,76) place along catheter length.It should be noted that comprise additional cavity and place the inflation/deflation hole along conduit (24) length at correct position by further separate external cavity, balloon segment near and far away (72,76) also can be independent of each other and be inflated/exit.Similarly, also can add the additional balloon section, by increasing number of cavities and increasing stand-alone terminal at Y knot (40) near-end, the additional balloon section can be independent of each other similarly and be inflated.
Although to be illustrated as be adjacent one another are to balloon segment among Fig. 3 A-3C, in other embodiments, as shown in Fig. 3 E, different balloon segment can be separated each other spatially.Balloon segment can separatedly reach, for example, and about 1cm distance, but depend on application-specific, this interval can be greater or lesser.By separating in this way balloon segment, can in conduit, provide hole (90) to other cavitys (92).
As shown in Fig. 3 F, cavity (92) and hole (90) can be used to transmit, for example, and medical medicine.In this way, along with air bag near and far away (72,76) keeps being inflated and center sleeve excises undesired physiology's material (such as described further below), medicine is comprised in target location and distributes equably.Yet, it should be noted that in other embodiments, such as medicine, nano-particle etc. can be dispersed by a plurality of distal tip or by the mouth in the air bag sidewall.Therefore, can via systematically and/or through the practice the such medicine of release.
Can use cavity (92) and hole (90) to transmit any amount of things and help to open chamber, circulation, air-breathing, the decomposition of breathing, helping blockage or be affected regional internal stimulus treatment, such things comprises air, aspirate, medicine, biomaterial, biological reagent, nano-particle, solution, stem cell and gene therapy and support (stent) and shelf (scaffold).Specifically, (pro-generative) medium and/or catalytic materials are progenesised in reparation, processing and treatment deployment and the implantation that can use this equipment to be used in target area, comprise biomaterial, nano-particle material and/or physiology's material, structure, support and similar equipment and medium, comprise, for example, bone morphogenetic protein, microcrystal nanometer granule, collagen, softening GUSUIPIAN, calcio structure, polyglycolic acid, polylactic acid and hyaluronic acid.Can be similarly dispose and implant the material of inertia, nonelastic and semihard with this equipment, such as, for example PEEK, pottery, cobalt chromium, titanium and rustless steel, and be used at anatomical structure, along anatomical structure and/or around this anatomical structure implantation enhancing structure, this enhancing structure can be configured then impregnated, compression, perhaps before and after inserting, fill with inert material, this inert material comprises, for example, polymethyl methacrylate, sclerotin, polyethylene, polypropylene, latex and PEEK.
In addition, in the some of them of these many balloon embodiment, above-mentioned imaging labelling (such as, developing ring) can be positioned at each balloon segment place or near each balloon segment, thereby helps the use of specific image mode to help the accurate location of air bag.
As shown in Fig. 4 A, in specific favourable embodiment, use the flexible conduit (100) with electric lead (103) and electrode (104) to transfer its energy to physiology's material place with processed expectation.As shown in Fig. 4 B, use access hole (106) that electrocautery electrode (104) is introduced into target location.Electrode (104) is molded in the flexible conduit (100), and is electrically connected to wire (103), and wire also is molded in the conduit (100) and is electrically insulated from each other.The far-end of wire (103) so be connected to be used to provide must energy (108) energy generation apparatus, such as, for example, suitable electrosurgery unit.
Electrode (104) is made by suitable spring metal, and this spring metal is straight, not excessive by access hole (106) when being pushed out in the inside cavity of conduit (26), and its original-shape rebounds.By locating to push and release conduit (100) at Y knot (40), dispose this electrode.Gradually air bag (30) is inflated desirably and exitted by rotary pneumatic ductus bursae (26), electrode (104) is placed on desired locations.It should be noted that one pole (electrode is remotely connected) and bipolar (two electrodes all are placed) all may be utilized.In this way, the energy of various forms and type, such as radio frequency and electrosurgery energy, thus can 360 ° mode be provided to carry out melt, burn, excision, cortex divests and/or tissue modification is optimized hemostasis and excision.Can make up similar energy delivery system and be used for ultrasonic transmission.
In specific advantageous embodiment, the present invention is along in the surface or surface in bladder configurations of bladder configurations, comprise also that insulant comes with insulation barrier so that this air bag with hot, ultrasonic and completely cut off by the relevant adverse effect of the multi-form energy of above-mentioned balloon catheter (24) transmission.Therefore, under energy transfer process (a plurality ofs') pressure, avoid becoming venting or damaged by other that air bag (30) is protected.
As shown in Figure 5, in a particular embodiment, in the cylinder mode, straight, steel spring line (110) are installed on the air bag (30).Wire termination is fixed to balloon catheter (24) at the near-end (112) of air bag (30), thereby they are not mobile with respect to conduit (26).In far-end (114), line (110) is fixing and extend into the passage that is arranged in the balloon catheter (26) to the distant place.Therefore, when air bag (30) when being inflated, spring wire (110) thus the shape by inflation stressed formation air bag (30).In this way, by so that the end of spring wire (110) completely cuts off each other and ties (40) by Y wire (103) being provided to the outside, another means that removal surface is set for air bag (30) are provided, and these means also can be used to provide one pole or bipolar electrode for electric cautery.
In certain embodiments, as shown in Fig. 6 A, be conducted through access hole (122) by imaging fiber light beam (120), or (124) are directed the imaging peripheral region.Near-end in balloon catheter (26), Y knot (40) provides path by port (126) and/or (128).As shown in Fig. 6 B, imaging fiber bundle (120) is made by the coherent fibre bundle (130) that is used for illumination and the coherent imaging fibre bundle (132) and the lens (not shown) that are positioned at core.Also can use two independently bundles, one is used for illumination and another is used for the imaging (not shown).Far-end in fibre bundle (120), imaging coherent optical-fiber be independent of the lighting fiber (not shown) and, the optical element (not shown) by suitable is interfaced to imaging sensor, such as CMOS or CCD.Similarly, lighting fiber is interfaced to the light source (not shown).Yet, it should be noted, also can adopt other light sources, such as light emitting diode.Be also to be noted that imaging sensor (nowadays at the 2mm obtainable CCD of size or CMOS) can be positioned at the terminal (not shown) of imaging catheter assembly, eliminated the needs for coherent imaging light, therefore increased picture quality and reduced cost.
By this way, the doctor can be provided illumination light, non-thermoluminescence light and for air bag (30) front, along the air bag both sides and/or the direct vision of air bag Background Region feedback.Imaging sensor and illumination optical device have ability by linear or rotatably by and/or be passed around air bag (30), thereby permission is visual for 360 ° of area for treatment.
The operation of air bag (30) can usually be described referring to Fig. 7 A-F.At first referring to Fig. 7 A, after endoscope, x ray and/or ultrasonic appearance test, select balloon catheter, and the equipment that is deflated is inserted into the position in the health cavity.This measure can be finished or as mentioned above by the service aisle that uses endoscope, along before be inserted into the wire of health and the internal cavity that the near-end of the seal wire of health outside inserts conduit finished.Conduit is connected to pump (its assembly and operation will be described in more detail below), at this moment, and the type of the definite balloon catheter that has been inserted into of this pump.
Then referring to Fig. 7 B, under about 2 atmospheric air pressures, come airbag aeration is reached the set time amount by pump (type of its known air bag that connects), and measure mobile (after the doctor presses inflation button on the pump).Then this pump calculates tissue density in tumor tissues and the initial approximation of openings of sizes, and shows that the result is used for being confirmed by the doctor.Along with this pump of operation, these data are by continuous updating and demonstration.
As shown in Fig. 7 C-D, when the pulse button on the pump is pressed, based on the parameter of user's input or the default parameters of selecting based on pump, air bag is deflated in a looping fashion and inflates, and parameter is based on the characteristic of specific air bag (its result as above-mentioned air bag marking plate is identified) and diameter that system makes and/or density measure.In this way, the pulse mode of pump is so that air bag is beated according to the change in volume in expected frequency and the air bag, and the periodicity that produces the air bag size repeats to increase and reduce.
Therefore, the removal surface of air bag repeatedly touches tissue growth, tumor or other undesired blockages and creates microshock on it.Along with air bag is deflated and inflates, removal surface creates with one heart just in time enough interference and fixes on undesired physiology's material, and compression stress excites and rubs, decompose and excision thereby promote compression stress to exhaust and wear and tear to draw it, thereby excise targeting physiology material in the not damaged mode.Damaged and remove along with organizing, air bag is inflated to larger initial diameter, and these steps repeat until all undesired organize cut.
Therebetween, pump is monitored gasbag pressure and air-flow constantly, and correspondingly upgrades graphical the demonstration, and is As described in detail below such.This points out to the doctor, and when the stop pulse pattern is also discharged the tissue that gets loose.
Referring to Fig. 7 E, in case tumor and/or tissue are damaged, air bag is deflated (by pressing the venting button on the pump), and air bag, passes the position of undesired tissue, further is inserted into the health chamber far.
As shown in Fig. 7 F, then air bag is again inflated (by pressing the inflation button on the pump) and is gently drawn to near-end, moves together the tissue and the fragment that get loose to can use tweezers or suction pump to remove point.In many bladder configurations, remove fragment by one of available cavity.
For example, optimizing 360 ° of cavitys decomposes blockages, minute unblocks, clean and an application-specific of fragment seizure relates to and in series uses four bubbles.At first, all four bubbles are inflated cavity divided and unblock.Then, bubble far away is fully inflated, and in bubble far away abandoned fully and in nearly bubble partly exitted.When balloon catheter is retracted, in nearly bubble preferably be inflated, the rotation of nearly bubble in the beginning, and therefore fragment by cut from cavity inner wall.In case in the far away and near bubble, fragment is captured in the middle of the bubble far away of fully inflation is retracted and is comprised in.
If any being necessary that these steps are repeated many times, until all undesired organizing all are removed.Generally, this operation will between 5-45 minute, be depended on the density of tumor or undesired tissue.
Hereinafter with the pump (22) of the operation of the above-mentioned resectoscope air bag of description control.Fig. 8 illustrates the Pneumatic assembly of pump and the block diagram of operation.This pump comprises air compressor (232) and head tank (233), such as Festo model C RVZS-0.1, and can achieve up to 10 atmospheric continuous.Air pressure in the groove (233) is constantly by microcontroller (254) monitoring, and this microcontroller general further describes in conjunction with the electronic component (Fig. 9) of pump hereinafter.When the groove pressure drop was lower than 4-5 atmospheric pressure, this microcontroller initialized compressor (232) via signal of telecommunication output (252) and operates.Select groove (233) thus size can not have in the situation of compressor operation, finish at least one operation (procedure).Air capacity in this microcontroller calculating and the display channel (233), this shows whether exist enough air to finish this operation to the user.Check valve (234) such as Festo model H-1/8-A/1, is positioned between compressor (232) and the groove (233), thereby prevents that compressed air return is in compressor (232).Yet, in another of pump (22) changes, do not comprise above-mentioned compressor and head tank, and from external source (such as air drain or operating room common visible operation locular wall) in air or the carbon dioxide of compression alternatively are provided.
Compressed gas from air groove (233) at first passes through pressure regulator (238), this actuator comes electric control via analog electrical output (0V-10V) signal (246) that microcontroller produces, thereby with accurate pressure air is provided to air bag, this pressure can be arranged and change by the doctor.Yet any pressure that is higher than the upper limit of employed specific air bag will produce caution signals.As mentioned above, depend on application, can use different balloon catheters, this can identify via the key adapter.Therefore, thus the pressure of dissimilar air bags, volume and flow behavior are comprised in the enquiry form operation of optimizing air bag and guarantee the performance that they are consistent.
Therefore, prescribe a time limit when pressure is set to be higher than on the air bag, incite somebody to action so that pump stops and producing warning for the detection of air-flow, and then the doctor must take specific action to come this situation of override.Similarly, if there is no gasbag pressure, the detection of air-flow also will produce warning, because this may mean that air bag is punctured.Be also to be noted that pump is inoperation also if conduit is not connected.In addition, the operation of air bag can be different from its normal operating when taking out from encapsulation for the first time, and before requiring to use in vivo, they are at first practised.Therefore, the setting of pump and preparatory function allow this inconsistent.
In specific favourable embodiment, vacuum source (239) such as Festo model VN-05-L-T3-PQ2-VQ2-R01-B, also is included in the pump, thus air bag unanimously mode exitted rapidly.This assembly also helps to obtain higher frequency in the burst mode operation process.Via electrical output signal (247), open and close vacuum source (239) by microcontroller.
Using two electromagnetic valves of being controlled by microprocessor---venting valve (240) and charging valve (241) are controlled inflation and the venting of air bag.By keep air pressure constant, use gasbag pressure from lookup table data, flow and time of the ON/OFF activity time section of bulk properties and by-pass valve control (240,241), it is big or small to obtain suitable airbag aeration.Respectively by the venting signal of telecommunication (248) and the inflation signal of telecommunication (249) (being produced by above-mentioned microcontroller), control venting valve (240) and charging valve (241).
Use the pressure regulator (242) of the input of groove (233), be positioned at actuator (238) output place pressure regulator (243) and be positioned at the pressure regulator (244) of air bag output place, continue to monitor air pressure by microcontroller.These pressure regulators, can for example be Festo model SDET-22T-D10-G14-U-M12, offer microcontroller and analog electrical signal (0V-10V) input (250,251,252) that is positioned at the proportional variation of pressure that these actuators (242,243,244) locate.Before being passed to air bag, gas flow is crossed by electric flowmeter (245) (such as Festo model SFET-F010-L-WQ6-B-K1) and filter (246).Effusion meter (245) provides analog electrical signal input (254) to microcontroller, and it has indicated the air flow that flows into air bag.
Pressure regulator (244) and effusion meter (245), and known air bag size provide necessary feedback to determine tumor size and resistance via tangential force and degree of depth resistance, therefrom make determining about the density of the diameter of cavity and tumor.Use these parameters, necessary suitable pressure made by microcontroller and sequential is regulated, maximize the effectiveness of air bag, physiology's tolerance for affect and impregnable zone is provided, and data point and the designator that is relevant to the interior anatomy of cavity and pathological specific dimensions and density feature is provided, help the doctor to determine safely and the transmission treatment.
In this way, thus air pressure strictly monitored and maintained 2 atmospheric pressure and avoided balloon rupture.Electronically and under software control, higher air input pressure (up to 10 atmospheric pressure) is reduced and is adjusted to 2 atmospheric pressure.Yet, via operator commands, under specific circumstances, can increase or reduce the pressure that is passed to air bag.
In certain embodiments, also adopt one or more temperature sensors, before low temperature and/or heat treatment mode apply, apply in and apply after, intravital tissue, tumor, thin film or other cavity inner tissues and/or equipment (no matter being organic or inorganic) are made lasting physiology's temperature reading.In certain embodiments, this system for or body in low temperature or the Equipment for Heating Processing degree of depth making lasting temperature reading and evaluate temperature, rate of temperature change and thrust the energy of cavity inner tissue, thereby help control low temperature or the distribution of heat treatment mode and/or the control of application, thereby optimizing tissue is revised and/or is cut.
Fig. 9 illustrates the assembly of electronic component of pump (22) and the block diagram of operation.This microcontroller (254) is risc processor and the cardia that is positioned at electronic component.What be connected to microcontroller (254) by the suitable signal of telecommunication is general static state, dynamically and flash memories (255), question blank (256) and be used for interface (257) with external device communication for firmware and data.Can come by USB (universal serial bus) (USB) (258) programming, upgrade, diagnose and/or control with this interface.Also can set up the interface for Long-distance Control handheld unit (278) that hereinafter further describes by interface circuit (257).In addition, pump comprises real-time date time integrated circuit (not shown).
Use the control of digital simulation (D is to A) transducer that the pressure regulator of air pressure to air bag is provided.D produces and the proportional analog electrical signal (269) from 0V to 10V of desired pressure to A transducer (268).The pressure signal (251) of the pressure signal (250) that a series of analog digitals (A is to D) transducers (270) allow microcontrollers (254) to read compressed air groove (233) to locate, output place of pressure regulator (238), the pressure signal (252) of air bag output place and to the air-flow (254) of air bag.
Allow microcontroller (254) with control signal (253) control compressor (232) (ON/OFF(opening/closing) with the in addition a series of numeral output of suitable interface circuit (275)), with control signal (247) control vacuum source (239) (ON/OFF), inflate electromagnetic valve (241) with control signal (248) control pressure-releasing electromagnetic valve (240) (opening/closing) with control signal (249) control.
A series of input circuits (276) are connected to the switch that is positioned on pump (22) front panel, thus input user control, and this will further describe hereinafter.In addition, display driving circuit (277) is interfaced to the front panel LCD display with microcontroller (254), also will be described below.
As shown in Figure 10 A, in a particular embodiment, pump (22) comprises that along the form of the bottom of graphical LCD display panel (264) and side be the user control button of soft keyboard (263).It is upper and depend on the pattern of pump and change that the function of control knob (263) is displayed on LCD panel (264).Can use button (263) to input the pattern of setting, show setting, call collected data or increase/reduce frequency and pressure.Except soft key function, graphical LCD display (264) has also shown setting, pressure, frequency and slamp value, warning, other information such as event, data and elapsed time of pump and has performed the operation and collect any other useful information of surgical data for the doctor, as shown in Figure 10 B.
The front panel of pump (22) comprises that venting button (259), inflation button (260) and pulse button (261) change the pattern of operating pumps (22).Front panel also comprises On/Off switch (265) and emergency stop push button (266), and it is by closing charging valve (241) and opening venting valve (240) and start the air-flow that vacuum source (239) stops to air bag.Also be included in and be one or more key socket (a plurality of) (267) of the above-mentioned band key adapter (a plurality of) of balloon catheter on the front panel of pump (22).
In a particular embodiment, the front panel of pump (22) also comprises the interface (210) of handheld remote controller (278), as previously mentioned.This handheld remote controller (278) is illustrated among Figure 10 C, can be positioned at aseptic place, but and hardwired ground, or wirelessly, be connected to pump (22) with the communication technology that is easy to obtain (such as infrared or radio frequency (that is, bluetooth)).Similar with the front panel of pump (22), remote controllers (278) have three push-in type buttons (259,260,261) and are used for venting, inflation and pulse control.Remote controllers (278) also have (ready) lamp (262) of awaiting orders, and represent the suitable order that is ready to receive.
As shown in Figure 11 A-C, in another variation of pump (22), do not comprise compressor, compressed air groove and vacuum source.Namely use the vacuum source can be quickly to air bag deflation, the elasticity of fiber mesh and latex balloon also will produce sufficient frequency makes it useful.As shown in Figure 11 A, the front panel of this equipment comprises that pump On/Off switch (215), airbag types selector knob (216), air bag out connector (217), balloon inflation/deflation speed select push-in type press button (218) and the speed L(low), among the M() and H(high) indicator LED(219).As shown in Figure 11 B, rear board comprises the input of VAC power supply (220), pressure control handle (221), compressed air input connector (222) and Long-distance Control adapter (223).The gasbag pressure scale is positioned at the top of this unit.
The operation of this system will be described referring to Figure 12 A-B.Initialization step comprises setting and operational diagnostics test on all intrawares, intraware comprises pressure transducer, effusion meter, electromagnetic valve etc., and show any warning, if perhaps do not detect problem, then to the user display system indication (step 300) of awaiting orders.
After initializing, pump opens the venting valve and cuts out charging valve and guarantee do not have air pressure and flow (step 302) in output place to balloon catheter.Then this system reads interior groove pressure (step 304).If pressure too low (decision box 306), this system will show available air volume and wait for that the user confirms to start compressor (step 308).Alternatively, if inner compressor is unavailable, will reads the air pressure of porch and show that warning connects the external compression air.
Then this system with display message and etc. balloon catheter to be connected.When air bag is connected, detects (step 310) and confirm airbag types (step 312) to user's display message by electric light or electro-mechanical devices.If the user has confirmed (decision box 314), then system will confirm that this air bag should tested (step 316) to user's display message, and if the user confirm (decision box 318), then test this air bag and check in advance (step 320).Then this system will be to user's display message (step 322), and in case receive affirmation (decision box 324) from the user, will be from front panel, remote controllers or serial line interface scan command (step 326).Before system's operation and in the process of while wait command, receive the Rapid degassing that emergency stop command will cause air bag.
Each " inflation " order (order 330) will be based on the airbag types that connects to airbag aeration recruitment (step 332).Reach the scheduled volume time valve of exitting simultaneously and keep closing by opening charging valve, finish this cumulative inflation.In this way, this air bag is inflated and reaches the desired size of user.Alternatively, push down and keep inflating button will be in a continuous manner to airbag aeration.
When inflation, the flow velocity of measurement gas (ml/sec) (step 332).After closing this charging valve, record cavity pressure, and make volume V approximate (step 334) based on desirable air law (V=nRT/P) and enquiry form.Herein, it is that gas constant, n are number of moles of gas that T is assumed to be at 310 ° of K constant (can record body temperature and also input this equation), R, proportional with the flow velocity that records, and P is the pressure that records.Along with the inflation of each increase, V is recalculated, and shows that relative volume changes (V2-V1) (step 336).From air bag sign, known air bag shape, and use data from question blank, also calculate and shown the relative variation (D2-D1) of air bag diameter.As shown in Figure 13, graphically form illustrates the relatively mobile time characteristic data of general volume.The typical characteristics performance curve (400) of air bag is converted into (translated to) actual linear properties (401).
Similarly, by open abandon valve reach the setting-up time section simultaneously charging valve keep closing, each " venting " order (ordering 340) is progressively to air bag exit (step 342).
When pump received " pulse " order (order 350), based on parameters, this air bag was inflated with pulse mode and is exitted (step 352, decision box 354, step 356, decision box 358), and this comprises that inflation is preferential.In pulse mode, this aspect of inflation/deflation circulation can be set as required.The priority that this pump has variation (dilatation) based on volume or a frequency is controlled the feature of this function.Because air pressure is maintained at constant value (that is, 2 atmospheric pressure), cost will change the time of airbag aeration to the expectation size owing to different sizes and the volume of airbag types.Therefore, in the preferential situation of dilatation, employed specific air bag is calculated and arranges minimum and maximum frequency, thus the dilatation of maximization between inflation and deflated state.In the preferential situation of frequency, calculate and arrange minimum and maximum dilatation for specific air bag, thus the frequency of maximization inflation/deflation circulation.
Be each inflation/deflation cycle calculations dilatation and/or frequency, and update displayed correspondingly.If in this pulse mode process, " inflation " button is pressed, and when air bag was in the inflated condition, this pulse mode was stopped.Similarly, if in this pulse mode process, " venting " button is pressed, and when air bag was in the deflated state, this pulse mode was stopped.
Change arranges frequency and/or dilatation if the user is intended for pulse mode, can finish this measure (order 360, step 362-364) by pressing the up/down soft key that is positioned on the LCD display floater.The user also can press the soft key input state that is positioned on the display floater and demonstration (order 370, step 372-374) is set.This comprise that screen arranges and the input initialization data to system, and in operation process, show the data of accumulating.
It should be noted that in all states of the operation of pump, vacuum source is opened and closed to realize exitting faster and higher inflation/deflation circulation.
It should be noted that although sometimes with reference to using tumor and tissue to describe described embodiment, native system also can be used in other application.Similarly, although described the present invention with reference to impulse interference wave machine described herein braking, such action is not uniqueness.That is, as required, except pulse, can adopt the action of other mechanism, such as the Linear-moving along the air bag of conduit, and rotate.In plaque excision in ENT for example uses and the situation of mucosa resection, useful especially during such motion.
Can usefully adopt another example of said system to be, with the minimal damage mode recover joint space, highly with function in the reparation of decompression in compression joint.The decompression air bag comprises the wider anatomy joint size that various shape and size are found in solving and copy in human and other body of mammals, comprises spine, knee, shoulder, buttocks, ankle, elbow, wrist, hands, finger, foot, toe, jaw, rib, clavicle and relevant joint.The application in this field will be the method for minimal damage, adopt intervertebral to process distance piece, comprise unique shape, size bladder configurations, when being inflated, have the ability of processing the joint between the decompress(ion) cone.Under endoscope, actinogram and/or ultrasonic visualization, via less otch and/or via the line guiding, this bladder configurations can be inserted into.Then, this air bag distance piece can be inflated to provide the necessary decompress(ion) of processing (interspinous process) between cone.As a result of, use current material and the frequent appreciable stress shielding of method and failure mode to be alleviated.This method is widely used in a lot of joints in human body and the body of mammals.
Said system can be used to the minimal damage therapeutic intervention of little joint fusion (Facet Joint fusion).Via in endoscope/or the line guiding then inflation of cryptoscope under visual, imitate the air bag of unique dimensions shape of the articular surface in little joint to be used to little joint.Thereby the mesh surface of the grinding of air bag with one heart and is rapidly produced little grinding on the articular cartilage by pulse, and the energy of then ablating is applied to the conduction ridge (conductive ridge) on the outer surface of air bag top, causes the decompress(ion) of articular surface and decorticates.By airbag aeration being created compression and/or clogging any hemorrhagely via applying electrosurgical energy, electrosurgical energy is transmitted via the conduction ridge that is positioned at air bag outer surface top.Then, air bag be rotated further decorticate and so that joint space broaden.Then air bag is deflated, and then along venting conduit and/or seal wire inertia implant, nail or other bone conduction things and bone is promoted implant to be inserted into to close to create in the bond space to intervene to cooperate and promote to merge.The little key of configuration that repeatedly also comprises of this operation substitutes implant.This operation has wider application in the broad range of joint fusion and crucial substitute.
It should be understood that above-mentioned is illustrative and non-limiting, and those skilled in the art can make a lot of apparent changes without departing from the spirit of the invention.Therefore, should mainly make reference to claims, rather than above-mentioned description, determine scope of the present invention.

Claims (38)

1. method with resectoscope gas-bag system excision physiology material, described method comprises:
Conduit is inserted in the health cavity with physiology's material of wanting cut, and described conduit comprises at least one air bag, and described air bag has the outer wall with removal surface;
By to wherein providing fluid to come described airbag aeration, thereby the described removal surface of described air bag contacts described physiology's material; With
By providing fluid to come repeatedly described air bag deflation and inflation with pulse mode to described air bag, thereby the venting of described repetition and inflation are so that described removal surface excises described physiology's material.
2. the method for claim 1 is characterized in that:
The step of described airbag aeration comprised with electropneumatic pump provide fluid to described air bag; With
Based on the change in volume of setting up or frequency, control the described step that described air bag is repeatedly exitted and inflated by described electropneumatic pump at least in part.
3. method as claimed in claim 2 is characterized in that, also comprises detecting the airbag types that is inserted into the described conduit in the described health cavity, wherein at least in part based on the step of the airbag types control of monitoring to described airbag aeration.
4. method as claimed in claim 2 is characterized in that, described air bag is repeatedly exitted and the described step of inflating comprises:
Determine the density of described physiology's material or the diameter in described physiology's chamber; With
Based on determined density or diameter, regulating provides to the amount of the fluid of described air bag at least in part.
5. the method for claim 1 is characterized in that, described at least one air bag comprises a plurality of balloon segment, and the step of described airbag aeration is comprised: be independent of at least one other balloon segment ground at least one balloon segment inflation.
6. resectoscope gas-bag system comprises:
Conduit, described conduit has outer wall, and described outer wall comprises the removal surface for excision physiology material; With
Pump, described pump is by providing fluid to described air bag to come described airbag aeration;
Thereby wherein said pump provides fluid repeatedly to described air bag deflation and inflation with pulse mode to described at least one air bag.
7. system as claimed in claim 6 is characterized in that, described pump comprises the electropneumatic pump.
8. system as claimed in claim 6 is characterized in that, described pump comprises processor, and described processor is controlled the pulse supply of fluid based on the frequency of setting up.
9. system as claimed in claim 6 is characterized in that, described pump comprises processor, and described processor is controlled the pulse supply of fluid based on the variation of volume in the described air bag of setting up.
10. system as claimed in claim 6 is characterized in that, also comprises adapter, and described adapter is connected to described pump with described conduit, and wherein said adapter is air bag sign adapter, uses described adapter, and described pump identifies described air bag.
11. system as claimed in claim 10 is characterized in that, described adapter comprises:
The air bag marking plate; With
Key, when described conduit is connected to described pump, thereby the described pump of the described marking plate of described bond orientation identifies described air bag with described marking plate.
12. system as claimed in claim 11 is characterized in that, described pump is the described air bag of electric light ground sign from described marking plate.
13. system as claimed in claim 11 is characterized in that, described pump is the described air bag of electromechanical ground sign from described marking plate.
14. system as claimed in claim 10 is characterized in that, described pump comprises:
Air bag profile data corresponding to described air bag; With
Processor, described processor are based in part on described air bag profile data control to described air bag accommodating fluid.
15. system as claimed in claim 14 is characterized in that, described pump comprises:
Be used for making at least one sensor of at least one measurement; With
Processor, described processor at least in part based on described at least one measure and described air bag profile data is calculated the density of the described physiology's material in described physiology's chamber.
16. system as claimed in claim 15 is characterized in that, described at least one sensor comprises the sensor of the pressure of determining to export to described air bag, and determines to export to the sensor that flows of the fluid of described air bag.
17. system as claimed in claim 15 is characterized in that, described pump is supplied with to the fluid of described air bag based on the density control of calculating at least in part.
18. system as claimed in claim 14 is characterized in that, described pump comprises:
Be used for making at least one sensor of at least one measurement; With
Processor, described processor at least in part based on described at least one measure and described air bag profile data is calculated diameter in described physiology's chamber.
19. system as claimed in claim 18 is characterized in that, described at least one sensor comprises the sensor of the pressure of determining to export to described air bag, and determines to export to the sensor of the fluid flow of described air bag.
20. system as claimed in claim 18 is characterized in that, described pump is supplied with to the fluid of described air bag based on the diameter control that calculates at least in part.
21. system as claimed in claim 6 is characterized in that, also comprises the adapter that described conduit is connected to described pump, wherein:
Described adapter is air bag sign adapter, uses described adapter, and described pump identifies described air bag;
Described pump comprises the air bag profile data corresponding to described air bag;
Described pump comprises processor, and described processor is determined change in volume in expected frequency or the described air bag based on described air bag profile data at least in part; And
Described pump is controlled to the fluid of described air bag based on determined frequency or change in volume at least in part and is supplied with.
22. system as claimed in claim 6 is characterized in that:
Described at least one air bag comprises a plurality of balloon segment;
And
Described conduit comprises a plurality of cavitys, and by described cavity, described pump provides fluid to described balloon segment, thereby described pump and at least one other described balloon segment are discretely at least one described balloon segment inflation.
23. system as claimed in claim 6 is characterized in that, also comprises:
Be used for providing to described at least one balloon segment at least one external cavity of fluid; With
Internal cavity.
24. system as claimed in claim 23 is characterized in that, described internal cavity comprises the fluid passage.
25. system as claimed in claim 23 is characterized in that, also comprises at least one seal wire that places described internal cavity.
26. system as claimed in claim 23 is characterized in that, also comprises at least one passage that connects described internal cavity and described gasbag outer surface, is used for transmitting medical science or therapeutic agent to described physiology's chamber.
27. system as claimed in claim 23 is characterized in that, described conduit comprises the imaging device hole, also comprises the fibre bundle that places in the described conduit and withdraw from described hole, is used for checking described physiology's chamber.
28. system as claimed in claim 23 is characterized in that, also comprises:
Be used for providing the energy source of energy; With
Be overmolded at least one lead-in wire in the described conduit, be used for energy is guided to described physiology's chamber from described energy source.
29. system as claimed in claim 23, it is characterized in that, also comprise at least one passage, the outer surface that connects described internal cavity and described air bag, wherein said pump comprises vacuum source, use described vacuum source, the material under described pump will excise is discharged by described passage and described internal cavity from described health chamber.
30. system as claimed in claim 6 is characterized in that, also comprises the mesh that is molded in the described conduit, wherein said removal surface comprises the texturizing surfaces that is positioned at described gasbag ektexine that described mesh produces.
31. system as claimed in claim 6 is characterized in that, the outer wall of described air bag comprises a plurality of inflatable chamber that described removal surface is provided.
32. system as claimed in claim 6 is characterized in that, also comprises a plurality of spring wires that are mounted to described gasbag ektexine, wherein said removal surface comprises described spring wire.
33. system as claimed in claim 32 is characterized in that, comprises that also being connected to described spring wire is used for providing the energy source of energy to it.
34. system as claimed in claim 6 is characterized in that, described air bag has the first and second ends, also comprises being installed near at least one imaging labelling at least one end in two ends of described air bag.
35. system as claimed in claim 34 is characterized in that, described at least one imaging labelling comprises the radiography ring.
36. system as claimed in claim 6 is characterized in that, described fluid is cryogen.
37. system as claimed in claim 6 is characterized in that, described fluid is gas.
38. system as claimed in claim 6 is characterized in that, described pump also comprises the vacuum source that described fluid is discharged from described air bag.
CN201080066769.3A 2010-05-13 2010-05-13 Resectoscope gas-bag system Expired - Fee Related CN102892456B (en)

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CN102892456B (en) 2016-01-13
CA2797861C (en) 2015-02-24

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