Source: https://patents.google.com/patent/CN105377159B/en
Timestamp: 2020-01-22 05:09:11
Document Index: 483392966

Matched Legal Cases: ['art 164', 'art 190', 'art 190', 'arts 260', 'art 592', 'art 602', 'arts 600']

CN105377159B - medical system and method - Google Patents
medical system and method Download PDF
CN105377159B
CN105377159B CN201480032804.8A CN201480032804A CN105377159B CN 105377159 B CN105377159 B CN 105377159B CN 201480032804 A CN201480032804 A CN 201480032804A CN 105377159 B CN105377159 B CN 105377159B
CN201480032804.8A
CN105377159A (en
凯尔·克莱因
迈克尔·D·沃克
2013-04-08 Priority to US61/809,681 priority
2014-04-08 Application filed by 波士顿科学医学有限公司 filed Critical 波士顿科学医学有限公司
2016-03-02 Publication of CN105377159A publication Critical patent/CN105377159A/en
2018-06-12 Publication of CN105377159B publication Critical patent/CN105377159B/en
A kind of fluid management system for being used to use in cutting tissue operation, including controller.Pump is flowed into operate by controller and be configured to provide for flowing by the fluid of the position in flow path to patient body.Efflux pump is operated by controller and is configured to provide for the fluid outflow of the position by flow path in patient body.Motor can be set to drive excision equipment so as to the resection organization at this position.Controller, which is configured to activate in response to unlike signal, to be flowed into pump and efflux pump and sets algorithms of different to provide fault warning and ensure safety operation.
Medical system and method
The U.S. Provisional Application 61/809,681 submitted this application claims on April 8th, 2013 (acts on behalf of Reference Number No.41878- 722.101) priority, entire contents are incorporated herein by reference.
The present invention relates to surgical fluids manage System and method for, such as expand uterine cavity with allow excision with taking Go out the anomalous uterus tissue of such as fibroid and polyp.
Fibroid is the non-tumor formed in the wall in uterus.This fibroid is happened at the women people of big percentage In mouthful, some are research shows that up to all women of percentage 40 have fibroid.Fibroid can rise to the time Several centimetres of diameter and symptom can include menorrhalgia, reproductive dysfunction, pelvic pressure and pain.
A kind of current therapy of fibroid be hysteroscope excision or myomotomy, this be related to by hysteroscope together with The excision instrument for the service aisle being inserted through in hysteroscope enters uterus through uterine neck.It can be that mechanical tissue is cut to cut off instrument The electrosurgery excision equipment of cutter or such as cut ring.In U.S. Patent No. 7,226,459,6,032,673 and 5, 730,752 and US publication application 2009/0270898 in disclose mechanical cutting device.In U.S. Patent No. 5, Electrosurgical resection equipment is disclosed in 906,615.
In myomotomy or hysteroscope excision, expansion of the initial step including uterine cavity of this operation is used for being formed Assist the working space by uterus sem observation.In release conditions, uterine cavity collapses so that uterine wall contacts with each other.Fluid hose Reason system is for expanding uterus to provide offer working space, under sufficient pressure by logical in hysteroscope in working space Road applies fluid so that uterine cavity expansion or expansion.For expand the fluid in uterus be typically such as salting liquid or sugar based on The liquid aqueous solution of aqueous solution.
In some radio frequency electrosurgical resection operations, expansion fluid is the non-conducting water conducted for limitation of radio frequency electric current Solution.
Particularly interesting is that fluid management system normally gives stream under up to 100mmHg or higher pressure Body, the great risk that this cutting vessel that leads to expansion fluid and may be exposed in uterine cavity occupies.This undesirable fluid Intake is oozed in being referred to as, and may lead to serious complication and even death.For this reason, it has developed in hand The fluid management system of continuous monitoring Patient Fluid intake during art usually using capture, is collected and is weighed and flow through The complication system of the expansion fluid of uterine cavity.
Although hysteroscope excision may be effective in fibroid is removed, many commercially available instruments Diameter is too big and thus needs to anaesthetize in operating room environment.Traditional resectoscope requires cervical dilatation to about 9mm.It is desirable that The system with removing Human Leiomyma can be effectively cut off by minor diameter hysteroscope.
In the first aspect of the present invention, fibroid treatment system includes：Controller；Pump is flowed into, passes through controller It operates and is configured to provide for flowing by the fluid of flow path to patient uterine's chamber；Efflux pump is operated by controller And it is configured to provide for flowing out by fluid of the flow path from uterine cavity；And the motor driving operated by controller is cut Except equipment.Excision equipment includes elongated guide members, this elongated guide members is with the taking-up wherein with the diameter not less than 2.4mm Tissue takes out channel and the external bushing with the diameter no more than 3.8mm.In addition, this excision equipment is suitable for at least 2gm/ The rate of min removes Human Leiomyma.In a variant, controller can be structured as in response to the stream in the uterine cavity The signal actuating of body pressure is described to be flowed into pump and the efflux pump and keeps goal pressure as described above.It additionally, can be with The signal of Fluid pressure is provided by being connected to the pressure sensor of the passive flow scapus of uterine cavity unicom.In another modification In, as will be described further below, controller can be structured as in response to selected in the group that is formed from following parameters to A few parameter operates excision equipment, and the parameter includes flowing into pump speed, outflow pump speed and the Fluid pressure in uterine cavity Signal.
In the second aspect of the present invention, fluid management system includes controller.First pump by controller operate and It is configured to providing fluid inflow into the position in patient body.Second pump, which is operated and is configured to provide for also by controller, to be come From the position fluid outflow in patient body.Controller is configured to keep selected from the first pump speed, fluid rate of influx, the second pump Speed, at least one operating parameter with fluid discharge rate, and controller is configured to, if the first pump speed is more than predetermined grade Up to pre-selected time interval, then be provided with fluid loss alarm.
In the illustrative embodiments of second aspect, pre-selected time interval can be at least 1 second, at least 5 seconds or Person at least 10 seconds.Controller can be further configured for, if the first pump speed, which is more than predetermined grade, reaches pre-selected time interval, that Just go to activate at least one pump, and controller can be further configured for, if the first pump speed be more than predetermined grade reach with Pre-selected time interval, then the excision equipment for the energization being located in position is just made to go to activate.
In the third aspect of the present invention, fluid management system includes controller.Flow into pump by controller operate and It is adapted to provide for flowing by the fluid of the position in flow path to patient body.Efflux pump is operated and is fitted also by controller It is flowed out in providing the fluid by position of the flow path in patient body.Controller is configured to keep selected from the first pump Speed, fluid rate of influx, the second pump speed, at least one operating parameter with fluid discharge rate, and this controller is configured to, If for the calculating power for flowing into pump to be driven to reach pre-selected time interval more than predetermined grade, then be provided with obstructed flow police Report.
In the illustrative embodiments of the third aspect of the present invention, controller can be further configured for, if be used for The calculating power that driving flows into pump is more than that predetermined grade reaches pre-selected time interval, then at least one pump is just made to go to activate.Control Device processed can also be further configured for, if for driving the calculating power for flowing into pump more than predetermined grade up between pre-selected time Every, then the energization being located in position excision equipment is just made to go to activate.
In the fourth aspect of the present invention, fluid management system includes controller.First pump by controller operate and It is configured to providing fluid inflow into the position in patient body.Second pump by controller operate and be configured to from provide come It is flowed out from the fluid of the position in patient body.Controller is configured to keep selected from the first pump speed, fluid rate of influx, the second pump Speed, at least one operating parameter with fluid discharge rate, and this controller is further configured for, if to outflow pump motor Input voltage less than predetermined threshold voltage up to pre-selected time interval, be provided with obstructed flow alarm.
In the illustrative embodiments of the fourth aspect of the present invention, pre-selected time interval can be from 5 seconds to 120 second In the range of change.Controller can be further configured for, if reaching pre-selection less than predetermined grade to the input voltage for flowing into pump It fixes time interval, then at least one pump is made to go to activate, and controller can also be further configured for, if to pump motor is flowed into Voltage be more than predetermined grade reach pre-selected time interval, then the excision equipment for the energization being located in position is just made to go to cause It is dynamic.
In the fifth aspect of the present invention, fluid management system includes controller.Flow into pump by controller operate and It is configured to provide for flowing by the fluid of the position in flow path to patient body.Efflux pump also by controller operate and It is configured to provide for the fluid outflow of the position by flow path in patient body.Controller is configured to keep selected from first Pump speed, fluid rate of influx, the second pump speed, at least one operating parameter of fluid discharge rate, and this controller is into one Step is configured to, if the measurement electric current to efflux pump is more than that predetermined threshold voltage reaches pre-selected time interval, then be provided with hindering Plug flow moves alarm.
In the sixth aspect of the present invention, the fluid management system for cutting tissue operation includes controller.Flow into pump It is operated by controller and is configured to provide for flowing by the fluid of the position in flow path to patient body.Efflux pump The fluid for being operated by controller and being configured to provide for the position by flow path in patient body flows out.Also provide For the motor driving excision equipment of the resection organization at the position.Controller is configured in response in patient body The signal actuating of actual pressure at position flows into pump and efflux pump, is flowed out with providing corresponding fluid and flowing into fluid, so as to Goal pressure at this position is kept, and controller is further configured for, when detecting the actual pressure in this position When dropping to below predetermined threshold pressure grade, then motor driving excision equipment is just made to go to activate.
In the illustrative embodiments of the sixth aspect of the present invention, controller can be further configured for, if herein Actual pressure in position drops to below predetermined threshold pressure grade, then just goes the motor in motor driving excision equipment Actuating.Controller can be alternatively configured to, if the actual pressure in this position drop to predetermined threshold pressure grade with Under, then just make to go to activate at least one of motordriven tissue excision equipment cutting tissue electrode.Threshold pressure level It is 100mmHg either less, 50mmHg or less or 25mmHg or less.
In the seventh aspect of the present invention, include controller for the fluid management system of cutting tissue.Controller constructs For：(a) it is activated in response to the signal of the actual pressure in the position in patient body and flows into pump and efflux pump, thus to provide Corresponding fluid is flowed into flow out with fluid, so as to the goal pressure being maintained at the position；(b) it is detecting by the position In engaged target tissue resecting tool generate pre-selected interval in actual pressure predetermined increase after, tissue is connect It closes signal and is sent to controller；(c) it is detecting by then real in the pre-selected interval of resecting tool generation for organizing to detach After the predetermined reduction of border pressure, tissue separation signal is sent to controller；And (d) in response to tissue engagement signal or group Knit the operating parameter of separation Signal Regulation fluid management system.
In the illustrative embodiments of the seventh aspect of the present invention, controller, which can be further configured for flowing into, pumps cloth It puts in preparation state to provide the high rate of influx selected in response to tissue engagement signal.Controller can also be constructed further It pumps to provide selected high rate of influx to flow into response to tissue separation signal actuating.
Fig. 1 is inserted through the according to the present invention including hysteroscope and tissue ablation device of the service aisle of hysteroscope The plan view of component.
Fig. 2 is the fluid management system for expanding uterus and for assisting electrosurgery cutting tissue with taking out Schematic perspective view.
Fig. 3 is the viewgraph of cross-section of the axis of the hysteroscope of Fig. 4 of multiple channels being shown in which.
Fig. 4 is the electrosurgical tissue excision equipment for showing the Fig. 1 of external bushing with moving back and forth neck bush and electrode arrangement Working end schematic side elevation.
Fig. 5 is the schematic perspective view of the working end of the neck bush for the Fig. 4 for showing its electrode edge.
Fig. 6 A are the schematic cross sections of the tissue reception window of a part for external bushing, interior radio frequency excision bushing and external bushing Figure.
Fig. 6 B are the schematic diagrames of the distal end part of the another embodiment of interior radio frequency excision bushing.
Fig. 7 A are the viewgraph of cross-section along the interior radio frequency excision bushing of the line 7A-7A of Fig. 6 B Fig. 6 B taken.
Fig. 7 B are another viewgraph of cross-section along the interior radio frequency excision bushing of the line 7B-7B of Fig. 6 B Fig. 6 B taken.
Fig. 8 is the schematic diagram of the distal end part of the another embodiment of interior radio frequency excision bushing.
Fig. 9 A are the viewgraph of cross-section along the radio frequency excision bushing of the line 9A-9A of Fig. 8 Fig. 8 taken.
Fig. 9 B are the viewgraph of cross-section along the radio frequency excision bushing of the line 9B-9B of Fig. 8 Fig. 8 taken.
Figure 10 A are the work for the tissue ablation device for moving back and forth Fig. 1 that radio frequency excision bushing is in non-extended position The stereogram at end.
Figure 10 B are to move back and forth standing for the tissue ablation device of Fig. 1 that radio frequency excision bushing is in partially extended position Body figure.
Figure 10 C are to move back and forth radio frequency excision bushing to be in across Fig. 1 in the fully extended position of tissue reception window The stereogram of tissue ablation device.
Figure 11 A are the works for the tissue ablation device for moving back and forth Figure 10 A that radio frequency excision bushing is in non-extended position Make the sectional view at end.
Figure 11 B are the cross sections for the working end for moving back and forth Figure 10 B that radio frequency excision bushing is in partially extended position View.
Figure 11 C are the cross sections for the working end for moving back and forth Figure 10 C that radio frequency excision bushing is in fully extended position View.
Figure 12 A are that the reciprocating motion radio frequency for the plasma excision for showing radiofrequency field and tissue in the first rf-mode is cut Except bushing is in the enlarged cross-sectional view of the working end of the tissue ablation device of Figure 11 B in partially extended position.
Figure 12 B are move back and forth that radio frequency excision bushing almost extends and show that radiofrequency field shows from Figure 12 the One rf-mode is switched to the enlarged cross-sectional view of the working end of Figure 11 C of the second rf-mode.
Figure 12 C are to move back and forth radio frequency excision bushing again almost to extend and show the outburst of constraint liquid volume Property vaporization with along proximal direction discharge excision tissue Figure 11 C working end enlarged cross-sectional view.
Figure 13 is to show that interior room protrudes the amplification stereogram of a part for the working end of Figure 12 C of element with flute shape.
Figure 14 is to show interior room and the viewgraph of cross-section of the working end of Figure 12 C of the modification of prominent element.
Figure 15 is the figure of the modification for the protrusion element for showing interior room and being configured to explosively vaporize the liquid volume of constraint The viewgraph of cross-section of the working end of 12C.
Figure 16 is the schematic diagram for the system removed for fibroid for including fluid management system.
Figure 17 is the schematic diagram of the fluid management system of Figure 16, the cutting tissue being such as generally described in Fig. 1-Figure 12 C To cut off and take out Human Leiomyma during the enlarged drawing of the working end of probe is in place.
Figure 18 is the schematic diagram of the pressure sensor component of the fluid management system of Figure 16-Figure 17.
Figure 19 is the cut-away illustration of the filter unit of the fluid management system of Figure 16-Figure 17.
Figure 20 is the endoscope used in diagnostic mode and the schematic diagram of fluid management system.
Figure 21 is endoscope and the fluid management system of Figure 20 together with as used in non-diagnostic or treatment mode The schematic diagram of the excision probe of component.
Fig. 1 shows group of the endoscope 50 together with the service aisle 102 for extending through endoscope including being used for hysteroscope Knit the component of extraction device 100.Endoscope or hysteroscope 50 are with the elongated shaft 105 for being connected to the diameter with 5mm to 7mm The endoscope of handle 104 or hysteroscope 50.Service aisle 102 therein can be circle, D shapes or any other appropriate Shape.Endoscope shaft 105 is further configured for that there is optical channel 106 and the fluid with being configured to couple thereunto to flow into source 120 or selectively one or more fluid streams of valve connector 110a, 110b unicom of negative pressure source 125 (Fig. 1-Fig. 2) Enter/flow pass 108a, 108b (Fig. 3).It is such as known fluid management in the art (Fig. 2) that fluid, which flows into source 120, The component of system 126, including fluid container 128 with fluid pumping is passed through the pump machanism 130 in hysteroscope 50 to uterine cavity. As that can see in fig. 2, fluid management system 126 further includes 125 (its of negative pressure source for being connected to tissue ablation device 100 It can include operation locular wall suction source).The handle 104 of endoscope includes diagonal extension 132, this diagonal extension tool There is the optical device that fiberscope camera 135 can be operatively connected thereto.Light source 136 is also connected in hysteroscope 50 Handle on light connector 138.The service aisle 102 of hysteroscope is configured for insertion into and operation cutting tissue and extraction device 100, such as to treat and remove Human Leiomyma.In one embodiment, axial direction of the hysteroscope axis 105 with 21cm is long Degree, and 0 ° of visual field or 15 ° to the 30 ° visuals field can be included.
Referring now still to Fig. 1, tissue ablation device 100 has the height for being configured to extend through the service aisle 102 in hysteroscope Spend elongated shaft assembly 140.The handle 142 of tissue ablation device 100 is suitable for the electrosurgery working end 145 of operation equipment.It is using In, for example, can rotationally and axially operating handle 142, target Human Leiomyma is cut off with orientation works end 145.Group Knitting excision equipment 100, there is the subsystem for being connected to its handle 142 to enable to electrosurgical resection destination organization.It such as will be under Face detailed description, radio-frequency signal generator or radio frequency source 150 be connected to controller 155 carried by working end 145 it is at least one Radio-frequency electrode.In an embodiment shown in FIG. 1, cable 156 is operably linked to handle 142 with negative pressure source 125 In connector 158.Radio frequency source 150 is connected to electrosurgery working end 145 by cable.Negative pressure source 125 and tissue extraction device Tissue in the shaft assembly 140 of 100 (Fig. 4) takes out 160 unicom of channel.
Fig. 1 also shows seal casinghousing 162, which carries the flexible sealing carried by hysteroscope handle 104 The axis 140 of tissue ablation device 100 is sealed in service aisle 102 by part 164, so as to prevent expansion fluid from leaving uterus Chamber.
In an embodiment as shown in Figure 1, the handle 142 of tissue ablation device 100 drives including motor 165, as described below to move back and forth the excision component of electrosurgery working end 145 or to move in other ways.Handle 142 selects Include to selecting property one or more actuating buttons 166 for activating this equipment.In another embodiment, foot can be utilized Switch is stepped on to operate this equipment.In one embodiment, this system includes switch or control mechanism to provide multiple reciprocal fortune Dynamic speed, such as 1Hz, 2Hz, 3Hz, 4Hz and up to 8Hz.In addition, the system can include cutting for mobile reciprocating motion Except bushing and the mechanism for cutting off bushing and being locked in non-extended position and extended position will be moved back and forth.In addition, the system It can include activating the single mechanism for moving back and forth stroke.
With reference to Fig. 1 and Fig. 4, electrosurgical tissue excision equipment has the elongated shaft assembly 140 extended around the longitudinal axis 168, carefully Long axis component 140 includes outside or first external bushing 170 wherein with channel or cavity 172, and channel or cavity 172 are contained in (and selectively rotate or vibrate) can be moved back and forth in cavity 172 with the second of resection organization or neck bush 175, such as It is known in the technical field of this tubulose cutting member.In one embodiment, the tissue reception window in external bushing 170 176 have axial length of the range between 10mm and 30mm and relative to the axis 168 of bushing with surround external bushing 170 from About 45 ° to 210 ° of radial angle extension.As will be described in detail below, external bushing 170 can include thin with neck bush 175 Wall stainless steel material and as opposite polarity electrode.Fig. 6 A to Fig. 8 show what is carried by external bushing 170 and neck bush 175 Insulating layer is to limit, control and/or prevent undesirable electric current from being flowed between the definite part of bushing.In an embodiment In, stainless steel external bushing 170 has the outer diameter of 3.6mm to 3.8mm, has the internal diameter of 3.38mm to 3.5mm, and with interior exhausted Edge layer (following), this bushing have the calibration internal diameter of about 3.175mm.In this embodiment, 175 tool of stainless steel inner lining set There is the outer diameter of about 3.05mm, there is the internal diameter of 2.84mm.Calibration of the neck bush 175 with about 3.12mm with external insulation layer Outer diameter in cavity 172 to move back and forth.The internal diameter of neck bush part is described below.Such as can finding in Fig. 4, neck bush 175 distal end 177 is included with the first polarity electricity that the distal resection electrode edge 180 of plasma can be generated around it Pole.Since electrode edge 180 later has the surface for being substantially less than comparative electrode or refurn electrode in tissue ablation process Product, therefore electrode edge 180 can also be described as active electrode.In an embodiment of Fig. 4, the exposure of external bushing 170 Surface includes the second polar electric pole 185, it is possible thereby to be described as refurn electrode because in use with active electrode The surface area of the functionality exposure at edge 180 is compared, this electrode surface has the surface area of substantially bigger.
In one aspect of the invention, neck bush or excision bushing 175 have inner tissue take out cavity 160, this interior group It knits and takes out cavity 160 with the first internal diameter and the second internal diameter suitable for rapidly electrosurgical resection tissue volume, and hereafter exist The tissue strips of excision are consistently taken out in the case of nonclogging by height slender cavity 160.Referring now to Fig. 5 and Fig. 6 A, It can be seen that neck bush 175 has the first diameter part for the remote area 192 that bushing 175 is extended to from handle 142 (Fig. 1) 190A, wherein tissue, which takes out cavity, is transitioned into smaller second diameter cavity 190B, the diameter of reduction is by offer resection electrode It is indicated at the B that the electrode spacer element 195 at edge 180 limits.The axial length C for reducing cross section cavity 190B can be from about 2mm to 20mm changes.In one embodiment, first diameter A is between 2.8mm and 2.9mm, and second reduces diameter B Between 2.4mm and 2.5mm.As shown in Figure 5, neck bush 175 can be electrical conductivity stainless steel, and reduce diameter electrode Part can also include the stainless steel electrode spacer element 195 in place by weldment 196 (Fig. 6 A) welding.Another In one alternative embodiment, electrode includes that neck bush 175 can be press-fitted into swedged electrode spacer element 195 Tungsten filament pipe in distal end 198.Fig. 5 and Fig. 6 A also show what is correspondingly carried by the first bushing 170 and the second bushing 175 Interface insulating layer 202 and 204.In fig. 6, external bushing 170 is with the thinwalled insulation material 200 of such as PFA or following another A kind of material makees liner.Similarly, neck bush 175 has external insulation layer 202.These coating materials can be smooth and electric exhausted Edge, it is rubbed with reducing in the reciprocatory movement of neck bush 175.
Insulating layer 200 and 202 described above can include smooth, hydrophobic or hydrophilic polymer materials.For example, this material Can include bio-compatible materials, such as PFA,Polytetrafluoroethylene (PTFE) (PTFE), FEP (ethylene fluorides-the third Alkene), polyethylene, polyamide, ECTFE (ethylene chlorine trifluoro-ethylene), ETFE, Kynoar, polyvinyl chloride or organosilicon.
Referring now to Fig. 6 B, neck bush 175 is shown in a schematic form together with being cut off by plasma electrode edge 180 Another modification of tissue volume.In this embodiment, such as in the other embodiment of the disclosure, radio frequency source is with selected behaviour Make parameter operation to generate plasma around the electrode edge 180 of electrode bushing 195 as known in the art.As a result, At electrode edge 180 generate plasma can cut off with the path P in ablation tissue 220, and suitable for excision uterus muscle Tumor tissue and other anomalous uterus tissues.In fig. 6b, the distal portions of excision bushing 175 include neighbouring electrode bushing 195 The ceramic lantern ring 222 of remote edge 180.Ceramic lantern ring 222 is used to plasma formation being limited to around remote electrode edge 180 And for further preventing polymer insulation layer of the plasma contact with damage on excision bushing 175 in surgical procedure 202.In one aspect of the invention, it is provided at electrode edge 180 by the path P that plasma is cut in tissue 220 There is the path P for melting width indicate with W, wherein this path width W is due to tissue vaporization comparatively wide.In path P The removal of tissue is substantially different from similar by the knife-edged blades edge cutting such as in a variety of prior art devices with vaporization The effect of tissue.Knife-edged blades edge can divide tissue (in the case where not burning), but apply mechanical force to tissue And the big cross section filler rod of cutting tissue can be prevented.In contrast, the plasma at electrode edge 180 can not exist Tissue vaporizes the path P in tissue in the case of applying any big active force, with the larger transversal of thus resection organization Face filler rod or band.In addition, plasma excision effect reduces and is contained in tissue and takes out tissue strips 225 in cavity 190B Cross section.Fig. 6 B are described into cavity 190B, since the evaporator tissue strips 225 of tissue have horizontal stroke more smaller than cavity Section.In addition, when tissue enters larger cross section cavity 190A, organizing 225 cross section causes around tissue strips 225 Even greater free space 196.As a result, by the cutting tissue of electrode edge 180, cavity is taken out from tissue together with cavity 160 smaller cross-sectional area (190B), which is transitioned into larger cross section (190A), can significantly decrease or eliminate continuous resection organization Band 225 and the possibility for blocking cavity.The prior art excision equipment for taking out cavity with this small diameter tissue usually has The problem of blocking in a organized way.
In another aspect of the present invention, it is connected to the proximal end that tissue takes out cavity 160 (referring to Fig. 1 and Fig. 4) Negative pressure source 225 also aid in air-breathing and tissue strips 225 be moved to the receipts outside the handle 142 of equipment along proximal direction Collect reservoir (not shown).
Fig. 7 A- Fig. 7 B show the change of the cavity diameter of the excision bushing 175 of Fig. 6 B.Fig. 8 shows excision bushing The distal end of the modification of 175', it is part to be configured with compared with aforesaid tubular electrode member 195 (Fig. 5 and Fig. 6 A) The electrode excision element 195' of tubulose.Fig. 9 A- Fig. 9 B again illustrate the reduction transverse cross-sectional area of the excision bushing 175' of Fig. 8 190B' and the tissue increased between transverse cross-sectional area 190A' take out the change of the cross section of cavity.As a result, no matter resection electrode Element 195' is tubulose or part tubular, this functionality all keeps identical.Prolonged in fig. 8 with working as only partially about bushing 175' It stretches so that a kind of modification when coordinating with the radial angle of resection electrode element 195' shows ceramic lantern ring 222'.In addition, Fig. 8 Deformation show ceramic lantern ring 222' have than 202 bigger of insulating layer outer diameter.As a result, due to the short axial of ceramic lantern ring 222' Interface insulating layer 200 interface and slip of the length against the inner surface of the cavity 172 around external bushing 170, therefore can reduce Friction.
Usually, one aspect of the present invention includes cutting tissue and extraction device (Figure 10 A- Figure 11 C), the tissue Excision includes the first Concentric lining and the second Concentric lining with axis, and wherein second (interior) bushing 175 with extraction device Cavity is taken out, and wherein the second bushing 175 is relative to the group in the first bushing 170 with extension tissue axially therein Reception window 176 is knitted to move with resection organization between extended position, and wherein tissue takes out cavity 160 axially non-extended With the first cross section and the second cross section.Second bushing 175 have be configured to the distal end at plasma electrode edge 180 with Excision is arranged in the tissue in the tissue reception window 176 of the first bushing 170.In addition, the distal end of the second bushing, and more Body, electrode edge 180 is configured to the Inferior turbinate hypertrophy in the comparatively wide path in tissue.Usually, tissue takes out and sets The standby tissue that is configured with takes out cavity 160, and tissue takes out cavity 160 and includes with the centre less than cavity 160 and close end The distal end part of the cross section of the reduction for the cross section divided.
In one aspect of the invention, with reference to Fig. 7 A- Fig. 7 B and Fig. 9 A- Fig. 9 B, tissue takes out cavity 160 in neighbour There is the cross-sectional area reduced in the cavity area 190A of nearly plasma excision tip or electrode edge 180, wherein described subtract Small cross section is smaller than the centre of tissue taking-up cavity and the cross-sectional area of proximal part 190B, is that tissue is taken out in cavity Between with the cross-sectional area of proximal part 190B 95%, 90%, 85% or 80%, and wherein tissue take out cavity axis 10cm, 20cm, 30cm or 40cm are at least to length.It is set for hysteroscope resection of uterine leiomyoma with the cutting tissue taken out In standby 100 embodiment (Fig. 1), the length of the shaft assembly 140 of tissue ablation device is 35cm.
Figure 10 A- Figure 10 C show the working end 145 of tissue ablation device 100, move back and forth excision bushing or neck bush 175 are in relative to the tissue reception window 176 in external bushing 170 in three different axial positions.In Figure 10 A, show Excision bushing 175 in retraction or non-extended position, wherein bushing 175 are located at the proximal end limit of its movement and prepare Advance far from extended position, the tissue for being located in window 176 and/or being drawn into window 176 is cut off with thus electrosurgery.Figure 10B, which is shown, to be distally moved and is advanced relative to tissue reception window 176 or is partially advanced to centre position.Figure 10 C are shown The excision bushing 175 of the distal limit of its movement is fully advanced and extends to, wherein plasma resection electrode 180 has prolonged Extend through the distal end 226 of tissue reception window 176, at this moment resection organization's band 225 cut off from tissue volume 220 and It is strapped in the cross section cavity area 190A of reduction.
0A- Figure 10 C and Figure 11 A- Figure 11 C referring now to fig. 1, another aspect of the present invention include being carried by multiple element Supply " tissue displacement " mechanism and proceed to excision bushing 175 cavity 160 in along proximal direction " displacement " with move Tissue strips 225, to therefore ensure that tissue does not block the cavity of neck bush 175.As in Figure 10 A and Figure 11 A- Figure 11 C As it can be seen that a mechanism of tissue displacement includes proximally prolonging from the distal tip 232 for being fixedly attached to external bushing 170 in enlarged drawing The protrusion element 230 stretched.Prominent element 230 is in the distal end room 240 limited by external bushing 170 and distal tip 232 in Mandrel 168 proximally extends.In an embodiment described in Figure 11 A, shaft-like protrudes element 230 in terms of the first function Include when cut off bushing 175 extend to its fully advance or extended position in when from excision bushing 175 small cross section cavity 190B proximally pushes the mechanical push rods of the tissue strips 225 of constraint.In in terms of the second function, in the distal end of bushing 170 Room 240 in portion is configured to fetter the volume of the salt expansion fluid 244 from working space, and wherein working end 145 shows There is the fluid 244 that radio-frequency electrode is further configured for vaporizing constraint explosively, to cut off and be arranged in excision bushing 175 Cavity 160 in tissue strips 225 on generate proximal end be directed toward power.This two functional elements and process (tissue displacement's machine Structure) a large amount of mechanical forces can be applied on the tissue strips 225 of constraint by vaporizing the liquid burst in room 240 And it can be used for moving tissue strips 225 along proximal direction in tissue takes out cavity 160.It has been found that and utilizes multiple work( The combination of energy element and processing can actually eliminate the possibility that tissue occlusion tissue takes out cavity 160.
More specifically, Figure 12 A- Figure 12 C sequentially illustrate the function aspect of mechanism of tissue displacement and are strapped in room The explosive vaporization of fluid in 240.In fig. 12, the excision of movement repeatedly being distally advanced is shown in centre position Bushing 175, wherein the plasma excision at resection electrode edge 180 is arranged in the tissue in the cavity 160 of excision bushing 175 Band 225.In Figure 12 A- Figure 12 C, it can be seen that this system with excision bushing 175 relative to tissue reception window 176 The first electrosurgical model corresponding with axial movement is moved back and forth with being operated in the second electrosurgical model.As used herein , term " electrosurgical model " represents which of two opposite polarity electrodes electrode is used as " active electrode " and which electrode As " refurn electrode ".Term " active electrode " is used with " refurn electrode " in this technical field according to the present invention, wherein Compared with refurn electrode, active electrode has small surface area, thus this makes RF energy density concentrate in this active electrode Around.In the working end 145 of Figure 10 A- Figure 11 C, resection electrode element 195 and its resection electrode edge 180 must include master Moving electrode concentrates on surrounding them will measure, so as to generate the plasma for cutting tissue.It is applied in Figure 12 A- Figure 12 B The stroke X of instruction is required for this high intensity at electrode edge 180, high energy plasma with resection organization.When interior excision bushing 175 across this first mode occurs for the axial length top of the stroke of excision bushing 175 inside during tissue reception window 176, at this time Whole outer surfaces of external bushing 170 are included in the refurn electrode indicated at 185.The first radio frequency mould is generally pointed out in Figure 12 A The electric field EF of formula.
Figure 12 B show the interior distal advancement portion for cutting off bushing 175 or extension completely across tissue reception window 176 Moment.At the same time, electrode bushing 195 and its electrode edge 180 are confined to what is limited by external bushing 170 and distal tip 232 In most of insulation wall room 240.At this moment, this system is configured to be switched to the second rf-mode, electric in the second rf-mode EF is from these switchings previously described in the first rf-mode.As that can see in Figure 12 B, in this second mode In, it is used as active electrode, and be exposed to room 240 with the inner surface area 250 of the restriction of the distal tip 232 of 240 interface of room Excision bushing 175 distal end part be used as refurn electrode.In this mode, occur around surface 250 very high Energy density, and this include electric field EF can explosive ground and immediately vaporization be strapped in the fluid 244 in room 240.Water steams The expansion of vapour can be significant and thus huge mechanical force and Fluid pressure can be applied on tissue strips 225, with In tissue takes out cavity 160 tissue strips are moved along proximal direction.Figure 12 C show the expansion stream being strapped in room 240 This explosive or dilatancy of body 244 vaporizes and further illustrates the cavity by tissue strips 225 from interior excision bushing 175 160 discharge along proximal direction.Figure 14 further illustrate excision bushing 175 extension motion range at active electrode with The relevant surface areas of refurn electrode is shown nonisulated remote compared with the surface 255 of the electrode bushing including refurn electrode again The surface area for holding end surface 250 is smaller.
Referring now still to Figure 12 A- Figure 12 C, it has been found that being arranged on radio frequency source 150 can be with structure with the single supply on controller 155 It makes and generates plasma at the electrode margins of excision 180 of electrode bushing 195 so as to resection organization in the first pattern for (i), and (ii) expansion fluid 244 of constraint is vaporized in a second mode explosively.Further, it is found that this system can be with range from every The appropriate reciprocating rate in second 0.5 period to 8 or 10 periods per second is automatically used for rf-mode switching.It is testing In, it has been found that tissue ablation device described above can block tissue in no tissue strips 225 and take out appointing for cavity 160 With from 2 gram/minutes to the excision of the rate of 8 gram/minutes and taking-up tissue in the case of what possibility.In one embodiment, Negative pressure source 125 can be connected to tissue extraction chamber 160, and tissue extraction power is applied to the tissue strips in this cavity.
Particularly advantageously, the fluid constraint room 240 limited by bushing 170 with distal tip 232 can be designed as having Selected volume, the electrode surface areas of exposure, length and geometry, so as to be applied to the expulsion force of resection organization's band 225 It optimizes.In one embodiment, the diameter of room is 3.175mm and length is 5.0mm, this considers prominent element 230, carries For the constraint fluid volume of about 0.040mL.In other modifications, the fluid volume range of constraint can from 0.004mL to 0.080mL。
In an example, constraint liquid volume of the room 240 with 0.040mL is together with 100% transfer efficiency, instantaneous vapour Change needing 103 joules liquid being heated to water vapour from room temperature.In operation, since joule is W*s, and this system with 3Hz is moved back and forth, therefore it is required that energy by the grade of whole 311W, be instantaneously transformed into vapor.It will be in phase conversion The corresponding theoretical expansion of 1700x occurs, this may immediately lead to up to 25,000psi (14.7psix1700), but by In loss of efficiency and non-instantaneous expansion, actual pressure may smaller.In any case, pressure be all it is a large amount of and The expulsion power that the tissue strips 22 for being enough to discharge capture take out the length of channel within the probe can be applied.
With reference to Figure 12 A, interior chamber 240, which can have from the axial length of about 0.5mm to 10mm, fetters range from about The liquid volume of 0.004mL to 0.010mL.In fig. 12 it is understood that the inner wall of room 240 has insulating layer 200, this Thus limit the electrode surface area 250 for being exposed to room 240.In one embodiment, distal tip 232 be stainless steel simultaneously And it is welded to external bushing 170.Column element 248 is welded to tip 232 or is machined as its feature.It protrudes in this embodiment Element 230 is non-conductive ceramic.Figure 13 shows the cross section of the prominent element 230 of ceramics, is flute shape, in a reality Applying tool in three corresponding axial notches 262 in mode in its surface, there are three flute champion parts 260.Any amount of flute shape Part, channel etc. are all possible, such as from 2 to about 20.The purpose of this design is the proximal end in prominent element 230 Place provides significant cross-sectional area to push tissue strips 225, and at the same time three grooves 262 allow the proximal end of water vapour The injection of direction is exposed to the tissue of groove 262 to impact.In one embodiment, the axial length D structures of prominent element 230 Make the outside for the reduction transverse cross-sectional area 190B for fully shifting electrode spacer element 195 onto will be organized.In another embodiment party In formula, the volume configuration of room 240 is provides the taking-up channel that is enough to be expanded into and at least occupy in equipment when explosive vaporization The 10% of 160 total length takes out at least the 20% of channel 160, takes out at least the 40% of channel 160, takes out channel 160 At least 60%, take out at least the 100% of at least 80% or taking-up channel 160 of channel 160.
As that can be understood by Figure 12 A to Figure 12 C, when excision bushing 175 non-prolongs along proximal direction or towards its When stretching position movement, the expansion fluid 244 in working space supplements the constraint fluid in room 240 again.As a result, when excision serves as a contrast Set 175 again along distal direction movement with resection organization when, interior chamber 240 is filled with fluid 244, then 244 quilt of fluid It accommodates again and explosive vaporization as described above is then applicable to when excision bushing 175 is closed tissue reception window 176. In another embodiment, can check valve be set in distal tip 232 to be moved through window 176 without fluid In the case of fluid is directly drawn into interior chamber 240.
Figure 15 shows another modification, wherein active electrode surface region 250 ' in a second mode is passed including having The protrusion element 230 in region and non-conductive regions 260 is led, this can have in the multiple discrete regions contacted with constraint fluid 244 The effect of RF energy transmission in each top allocation set in domain.This construction can be more efficiently vaporized in room 240 The fluid volume of constraint.In one embodiment, conductive regions 250 ' can be included in rosette or pad on column 248 Circle.In other modification (not shown), conductive regions 250 ' can be included in the ceramics for being fixed on 248 top of electrical conductivity column Hole, port or hole in material 260.
In another embodiment, radio frequency source 150 can be programmed for the stroke in Figure 12 A- Figure 12 C with controller 155 Energy is adjusted during X and stroke Y and is passed a parameter and passes through the plasma of electrode edge 180 to provide optimum capacity (i) Excision and (ii) are for the fluid that is fettered in explosive ground vaporizing chamber 240.In a variant, controller 155 can include Algorithm, this algorithm activate radio frequency source 150 to be penetrated when position is moved when excision bushing 175 is extended towards along distal direction Frequency energy is transmitted to working end, so as to resection organization, but when excision bushing 175 along proximal direction towards its non-extended position It is terminated when mobile to working end and transmits RF energy.The end that RF energy transmits in the proximal end stroke procedure of excision bushing 175 It only eliminates and is transmitted when 180 non-resection organization of electrode edge to the energy of electrode edge 180, this thus prevents working as and cut off The unnecessary heating to expansion fluid with that may occur during transmission RF energy during backward stroke forward of bushing.
Figure 16-Figure 18 shows what can be used when the tissue in treatment body cavity, space or latent space 502 (Figure 17) Fluid management system 500.Fluid management system 500 is schematically described in hysteroscope tissue ablation system 510, is suitable for profit With endoscope or hysteroscope 512 and tissue resection probe 515 similar to the above come cut off and take out fibroid or its Its anomalous uterus inner tissue.Figure 16 is described with handle 516 and including the external bushing 518 with working end 520 (Figure 17) The tissue resection probe 515 of extended element can be conducted through and extend through the ontology 523 of hysteroscope 512 and axis 524 Service aisle 522.Figure 16 also shows the handle for the tissue resection probe that controller and power supply are connected to by power supply cable 526 Motor 525 in 516.Figure 17 shows the working ends of the excision probe 515 in the uterine cavity of adjacent objects fibroid 530 520。
With reference to Figure 16-Figure 17, usually, fluid management system 500 includes：The fluid source of expansion fluid 244 or storage Device 535, controller with for provide be suitable for keep body space expansion fluid flow into fluid outflow pumping system and For filtering expansion fluid 244 that is being removed from body cavity and thereafter returning to fluid source 535.Restore and filtering fluid 244 It is advantageous using the supplement with fluid source 535, because:(i) closed circuit fluid management system can be with effectively measuring fluid Unfavourable balance is to ooze in thus monitoring and ensure patient safety；(ii) this system can be set and be operated in a manner of very timesaving； And (ii) this system can be compact and less costliness, the operation based on thereby assisting in and make consulting room is possible.
Fluid management system 500 (Figure 16) includes computer control system, and integrated control is integrated in rf control system In device 545 processed.Controller 545 is suitable for control the first peristaltic pump 546A and the second peristaltic pump 546B, so as in order to expand body cavity Purpose provides the inflow and outflow of the expansion fluid 244 of such as salting liquid from source 535.Here the first peristaltic pump can also claim Make to flow into pump or charge pump.Here the second peristaltic pump is also referred to as efflux pump or suction pump.Controller 545 is fitted with control algolithm In with taking out in operation controlling cavity pressure in such as the cutting tissue described in Figure 17.The reality shown in Figure 16-Figure 18 It applies in mode, the control of controller 545 flows into pump 546A to provide positive pressure at the outflow side 548 of pump (Figure 17), in order to provide logical Cross the inflow of the expansion fluid 244 of inflow line 550, this inflow line and the fluid stream in accessory 561 and hysteroscope 515 Dynamic channel 108a unicom.Flow channel 108a is shown described in embodiment and in fig. 3 above in front.Controller 545 further control efflux pump 546B, by negative pressure provide pump (Figure 17) inflow side 552 at outflow pipeline 555 with Outflow of the expansion fluid 244 from body cavity 502 is provided.As described above, the fluid in the working end 525 of excision probe 515 Explosive evaporation for proximally along excision bushing 175 taking-up channel 160 discharge tissue strips 225, this can with by pumping Negative pressure binding operation in the line 555 that 546B is provided.In operation, efflux pump 546B is also operated as in the second effuser pipeline portion Positive pressure is provided on the outflow side 556 of pump 546B divided in 555' so that the outflow of expansion fluid 244 pumping is passed through filtration system 540 And back to fluid source 535.
In a system embodiment, the operation of controller 545 is passes through the pressure signal control from pressure sensor 560 Pressure in cavity 502 processed, pressure sensor 560 are connected to and extend through the flow channel 108b of hysteroscope (referring to Figure 16) Accessory 562 in the hysteroscope 512 of unicom.In one embodiment, flow channel 108b has at least diameter of 1.0mm, Highly accurately to sense actual lumen pressure.In the commercially available fluid management system of the prior art, normally Pass through a variety of meters using the pump in the fluid inflow line by the way that back-pressure can be measured or the known flow rate of remote pressure sensor Calculate estimation cavity pressure.This prior art fluid management system be autonomous system and be suitable for use in diversified hysteroscope with Endoscope, wherein most do not have for the Moveable channel with pressure sensor unicom.For this reason, prior art stream Body management system is dependent on algorithm and calculating, only to estimate cavity pressure.
In one embodiment, as described in Figure 16, pressure sensor 560 be can freely use and can It removes ground and is connected to endoscope 512 and by the fluid channel 108b in endoscope and body cavity fluidly unicom.Pressure sensing Device 560 is operably linked to controller 545 by cable 564.Pressure sensor can be used in invasive monitoring of blood pressure Type biological compatible, piezo-resistive Si-sensor.For example, sensor can be available from Measurement Specialties.Ltd., 45738Northport Loop West, Fremont, the silicon of the product type 1620 of CA 94538 Piezoresistive pressure sensor.This Sensor Design is with the pressure sensor on ceramic substrate.It can sense Dielectric gel is arranged on element to provide electricity and fluid insulation.Sensor housing can have to be connected to endoscope 512 Female Luer connects.In addition, sensor body can have the pressure relief valve for redundancy overvoltage protection (not shown).
As that can be understood by Figure 16 and Figure 17, pressure sensor 560 is attached to endoscope 512 so as to extending through Endoscope shaft is to the fluid channel unicom of body cavity.The fluid channel or sensor passage 108b used by pressure sensor 560 is only Stand on the fluid channel 108a being flowed into for expansion fluid in body cavity.There is no the feelings that fluid flows in sensor passage 108b Under condition, then the fluid in channel 108b forms static incompressible flow scapus, and when endoceliac pressure change, static state can not Compression fluid column changes pressure.When 1mm or bigger is in the cross section of sensor passage, pressure and body cavity in pressure channel column Interior pressure is equal.Pressure sensor 560 can directly measure endoceliac pressure as a result,.Schematically show in figure 18 In another modification gone out, pressure sensor 560 as shown in Figure 16 can be included with extending from single fluid channel 108b To two independent sensing element 560' and 560 " of the fluid interface in sensor 560.Sensing element 560' and 560 " passes through Pressure signal is sent to controller 545 (Figure 18) by cable 564' and 564 ".Start in operation or during operation, then Controller can be structured as monitoring or compare the pressure signal from independent sensing elements 560' and 560 ".If two sensors Pressure signal each other not within the predefined range, then controller 545 can provide sensor fault alarm and/or termination or Adjust any ongoing operation of fluid management system or excision equipment.
Figure 17 diagrammatically illustrates the fluid management system 500 in operation.Uterine cavity 502 is possible space and needs It expands to allow uterus sem observation.Selected pressure can be set in controller 545, such as via touch screen 565, doctor passes through Experience understands this and is suitable for expansion cavity 502 and/or performs operation.In one embodiment, selected pressure can be 0mmHg with Any pressure between 150mmHg.In a system embodiment, flow into pump 546A and may be operative to variable speed pump, It activates to provide the up to flow velocity of 850ml/min by the first pipeline or inflow line 550.In this embodiment, it flows out Pumping 546B can be with a fixed speed operation with the fluid in mobile second line or outflow pipeline 555.In use, controller 545 It can increase, be reduced or kept at the expansion in uterine cavity 502 to select matching or non-matching speed pump operation 546A and 546B The volume of Zhang Liuti 244.The pump rate of pump 546A and efflux pump 546B is flowed by independently controlling as a result, can be responded It is realized in the signal of the practical cavity pressure provided by sensor 560 and keeps endoceliac selected setting pressure.
In a system embodiment, as shown in Figure 17 and Figure 19, fluid management system 500 includes filter unit Or system 540, filter unit or system 540 can include being suitable for the strip of tissue that capture has cut off and taken out from body cavity 502 With 225 first filter or tissue filter for trapping 570.Second filter or molecular filter 575 are normally hollow fibres Dimensional filter device surmounts first filter 570 and sets, and wherein molecular filter 575 is suitable for blood and other body materials from expansion Zhang Liuti 244 is removed.Particularly, molecular filter 575 can remove red blood cell, hemoglobin, particulate matter from expansion fluid 244 Matter, protein, bacterium, virus etc. so that this endoscopic observation of body cavity will not be by this any blood constitutent or other pollutions Object and it is fuzzy or shielded.As that can be understood by Figure 16-Figure 19, efflux pump 546B provides phase in its outflow side 556 For being flowed into the positive pressure of the fluid in filter element 540, so that expansion fluid 244 is moved through first with bulk medium 570 and second filter 575 of filter, and in the circulating cycle fluid source 535 is flow to time.
With reference to Figure 19, in embodiments, first filter 570 includes container part or small with removable cap 577 Bottle 576.Expansion fluid 244 and the inflow of bulk medium flow through line segments 555 and enter arrangement by accessory 578 In net capsule or perforation structure 580 in the interior room 582 of bottle 576.The range of the pore size of perforation structure 580 can be from about 200 microns to 10 microns.It can be from about 400 microns to 20 microns in the cavity diameter of 575 doughnut 585 of the second filter. Usually, the pore size of the perforation structure 580 in first filter 570 is less than the doughnut in the second filter 575 The diameter of 585 cavity.In one embodiment, the pore size of perforation structure 580 is 100 microns, and in molecular filtration The cavity size of doughnut 585 in device 575 is 200 microns.In one embodiment, molecular filter 575 is available from 07661 kidney DSU filters of Nephros, Inc., 41Grand Ave., River Edge, NJ.In a variant, it filters Device 575 is configured with doughnut, this doughnut has the calibration molecular wt pole less than 50kDa, 30kDa or 20kDa It limits (NMWL).
In another aspect of the present invention, since fluid flowing is cycle, molecular filter 575 is configured to Filter the expansion fluid of large volume.In addition, molecular filter 575 is configured to the potentially large number of volume of filtering expansion fluid, expansion Fluid may be by the pollution of blood, the blood product that will be mixed with fluid etc..In one embodiment, molecular filter 575 have at least 0.6m2、0.8m2、1.0m2、1.2m2And 1.4m2Membrane surface product, wherein membrane surface product be defined to molecule The total surface area of the cavity of doughnut 585 in filter 575.In another aspect of the present invention, the method for fluid management It can include expansion body plenum and keep expansion fluid to be up to the flow velocity of 850ml/min disengaging body plenum and hereafter By the filtration system 540 that at least 20ml, 40ml or 60ml blood can be removed from expansion fluid 244.
With reference to Figure 19, it can be seen that filter unit 540 includes the dismountable connection between different fluid flowing pipeline, with Filter is allowed to couple with the quick of flowline with going to couple.More specifically, the stream extended from tissue resection probe 515 Dynamic pipeline 555 has the coupling part 592 for being connected to the inlet fitting 578 in first filter 546A.Media filter 546A There is the connecting portion of outlet accessory 596b being connected in first filter 542A with the fluid line line segments 555' of 546B Divide 596a.The outflow end of flowline 555' has the connector for the inlet fitting 598b for being connected to the second filter 546B 598a.The return flowing pipeline 600 of medium the second filter 546B and fluid source 535, which has, to be connected in the second filter 546B Outlet accessory 602b coupling part 602a.In one embodiment, at least one check-valves 605 is arranged on flow path In, flow path medium for example can be in the filter in pipeline 555 ', connector 596a, 598a or accessory 596b, 598b 546A、546B.In Figure 19, the arrival end 608 of 605 and second filter 546B of check-valves is integrated.In use, system Operation is by a large amount of Fluid pressures in the inside for leading to the second filter, and check-valves 605 allows for example when completion tissue is cut Except operation and doctor or nurse are desirable to biopsy purpose by bottle 576 therein and tissue strips 225 therein When being transmitted at different location, make first filter in the case where no pressure is detached from and fluid media (medium) can be discharged into environment It goes to couple.Usually, such as check-valves 605 can be set at one or more of flowline 555 and 555' position Check valve, to prevent pressure from flowing back into excision equipment 515 by line 555.For example, such as by Figure 19 (referring also to Figure 20-figure 21) the check valve 605' of such as float trap of the dotted line instruction in can be arranged on the one or more of pipeline 555 or accessory 578 In position.Float trap 605 " can also be positioned adjacent in the pipeline 550 of saline source 535.
In an aspect, fluid management system includes：First fluid pipeline 550, be configured to by expansion fluid 224 from Fluid source 535 moves to body plenum；Second fluid pipeline 555,555' and 560 are configured to transport fluid from body plenum It is sent to first filter 570 and is then transported to the second filter 575 and then returnes to fluid source 535；Efflux pump, It is operably linked to second fluid pipeline；And at least one check-valves 605, the first mistake of medium in second fluid pipeline 570 and second filter 575 of filter.
In one embodiment, the controller 545 of fluid management system 500 is configured to calculate fluid unfavourable balance, this fluid Unfavourable balance is measured as in the medical procedure removed in such as fibroid, be transmitted to the fluid volume of body plenum 502 with from Difference between the fluid volume that body plenum regains (referring to Figure 16-Figure 19).Fluid management in the videoendoscopic surgery of uterus Method includes providing the expansion fluid source 535 (Figure 17) with predetermined volume, and the fluid (for example, salt) from source 535 is passed through First flowline or inflow line 550 are introduced into uterine cavity and by the second flowline or outflow pipeline 555 from chamber It is introduced into filter unit 540 and returns to fluid source 535 by the other parts 600 of the second flowline, wherein the The internal volume when the predetermined volume from source 535 removes of flow line and the second flowline and filter unit is equal to 2.5 liters or less.Then operation instruction can include that only single 3 can be used in any fibroid or polyp remove operation The requirement of salt bag is risen, this will then may insure to ooze in salt to never exceed 2.5 liters.In this modification, the predetermined volume in source 535 can To be 3.0 liters, such as in 3 liters of salt bags of standard, and built-in system volume can be at least 0.5 liter.
Figure 20 and Figure 21 is the fluid management system of the radiofrequency tissue excision probe 515 and the above-mentioned type about the above-mentioned type The schematic diagram of 500 integrated operation.Usually, controller 545, radio-frequency signal generator 670 are suitable for carrying with fluid management system 500 Controlled flow for the expansion fluid for passing in and out body cavity 502, while goal pressure is kept in body cavity, at the same time flowed with fluid The RF energy for being transmitted to excision probe is simultaneously provided.In a system embodiment, this system can be passed through with whole Three kinds of different modes that controller 545 controls operate：(i) for the diagnostic mode of hysteroscopy；(ii) it is cut for tissue Except the excision treatment mode with taking-up；And (iii) and the solidification treatment pattern for tissue coagulation.
With reference to Figure 20, in diagnostic mode, flow into or charge pump 546A, outflow or suction pump 546B and pressure sensor 560 and monitoring system all activated.In one embodiment, the touch screen 565 on controller 545 has graphical user Interface (GUI), graphic user interface have the fluid control devices (Figure 16) that can be adjusted by doctor.Flowing into pump 546A can be with It is switcheded on/off by touching the pump button of the inflow on GUI.Target cavity pressure can be set on touch screen 565, such as from 0 To 150mmHg or more (Figure 16).
In operating method as shown in Figure 20, doctor sets target cavity pressure and then actuating stream on GUI Enter to pump 546A, this causes the flow of expansion fluid 244 to enter body cavity 502 with endoscope 512 by inflow or fill up line 550 In.In one embodiment, the inflow pump 546A in diagnostic mode can be activated on touch screen 565.In diagnostic mode, Controller 545 is configured to not activate efflux pump 546B until obtaining setting pressure or with over-pressed situation.As a result, at one In modification, then efflux pump 546A will be operated with fixed rate and then can be in response to the signal tune from pressure sensor It throttles into pump speed, so that pressure stability is near target cavity pressure.The practical cavity pressure measured by pressure sensor 560 It may be displayed on controller GUI (Figure 16).
In order to stablize endoceliac Fluid pressure, controller 545 includes being configured to the pressure control of feedback control loop Algorithm.Controller microprocessor reads the cavity pressure set point and reality based on the signal from pressure sensor 560 Chamber pressure.In response to this two parameters, which is based on general proportional integration (PI) control algolithm and calculates increment value signal. Increment size is sent to digital-to-analog converter and is supplied to driving and flows into the amplidyne generator of pump 536A.Controller algorithm Then the speed of (perfusion) pump 546A is flowed by adjusting minimizes the difference between setting pressure and actual pressure.
In one embodiment, this system further includes actuator and algorithm, in order to provide for rinsing body cavity 502 Rapid fluid is flowed into flow out, such as can be the actuating button 672 on floor push component 675 with fluid.It rinses herein In method, outflow (suction is raised) pump 546B is activated to provide increased outflow grade, and then pressure algorithm adjusts inflow (filling Note) pump speed to be maintained at the goal pressure in cavity.As a result, in diagnostic mode, this system can be activated so that body cavity Flowed in and out with fluid rapidly concordant, while controller algorithm keeps cavity pressure as described above.Pass through system and body The flow velocity of chamber can be set in advance in 100ml/min or bigger, such as 200ml/min or 300ml/min.In another implementation In mode, doctor can select the fast flow rate from 200ml/min to 800ml/min on the touchscreen.
With reference to Figure 21, in for the non-diagnostic of resection organization or treatment excision model, controller 545 passes RF energy The bipolar electrode for being sent to probe 515 (referring to Figure 12 A- Figure 12 C) is arranged with resection organization and also activates two pumps to provide such as The upper fluid is flowed into flow out with fluid.In order to be operated with excision model, doctor can using touch screen 565 (Figure 16) come into Enter non-diagnostic (treatment) pattern of operation.The first pedal 677a on floor push 675 can be used for excision model as a result, Actuating system is with resection organization.The actuating of first pedal 677a simultaneously leads to controller：(i) efflux pump is activated with fixed speed 546B is in order to provide the outflow under 400ml/min to 850ml/min rates；(ii) it activates described flow into and pumps 564A, have It controls with the rotary speed adjusted to keep the goal pressure in body cavity by controller 545 as described above；(iii) by DC electricity Pressure is transmitted to the motor 525 of excision probe 515, so that excision bushing 175 moves back and forth；And RF energy is transmitted to by (iv) Cut off the bipolar electrode arrangement of probe 515.In one embodiment, radio-frequency signal generator 670 will be lied prostrate with controller 545 from 5-20 Special variable DC voltage, 200 watts of peak RF power and 240 volts of the peak RF voltage under 148kHz frequencies The motor 525 of excision probe is provided.
In excision model, the pressure algorithm of controller is operated with dynamic flow situation, wherein the expansion from body cavity 502 Zhang Liuti 244 changes, because this is by can be with depending on the rate of cutting tissue and the tissue strips of excision 225 and fluid 244 It is moved through taking out the speed of channel 160.Cavity pressure with above-mentioned similar fashion by being grasped when system is operated with diagnostic mode The backfeed loop of work is maintained at setting pressure.The tissue strips 225 of excision are moved through system as described above and pass through stream Go out pipeline 555 to take out from body cavity and probe.As that can see in figure 21, the outflow of fluid by resection organization, blood and Other body fluid are carried in first filter 570 and then in the second filters 575.When doctor is discharged in the first pedal During pressure on 677a, then cut off probe 515 and go to activate and only flow into 546A in cavity pressure as described above is controlled Holding is worked.
In coagulation mode, controller 545 and the bipolar electrode of controller algorithm actuated probe 515 are arranged, to condense group It knits and intermittently activates fluid flowing function as described above in addition.Motor 525 in probe handle is not activated, and Excision bushing 175 is located in the centre position in the window 517 in external bushing 518 (referring to Figure 12 A).Bushing 175 is cut off in window Centre position in 517 is each default location for occurring to terminate to the DC current of probe motor 525.
In order to start to operate under solidification model, it is assumed that doctor has been previously selected operation using touch screen 565 Non-diagnostic (treatment) pattern.Then doctor can be actuated at the second pedal 677b on floor push 675 so that coagulation of tissues. Activating the second pedal 677b simultaneously leads to controller：(i) bipolar electrode that RF energy is transmitted to excision probe 515 is arranged； And (ii) intermittently actuating flows into pump 546A and efflux pump 546B, to cause to follow when keeping cavity pressure as described above Circulation body flows.In one embodiment, double pumping is operated up to 1 after the consecutive intervals of RF energy transmission are more than 10 seconds To 8 seconds.Fluid flow rate can be from 100ml/min to 600ml/min.In addition, doctor makes RF energy transmission eventually every time When only, inflow pump 546A and efflux pump 546B can be made to activate 1 second to 10 seconds.Due to RF energy application, in solidification model Intermittent cyclic flowing be suitable for assisting observation with further preventing the heating of expansion fluid 244 in body cavity 502.In an implementation In mode, radio-frequency signal generator 670 provides bipolar radio frequency output with controller 545, so as under 110 watts of peak RF power And it is solidified under 200 volts of 148kHz frequencies of crest voltage.
In an operating system in any diagnosis or treatment mode, it is more than in target cavity that controller 545, which has in this pressure, Set the overvoltage protection algorithm in pressure situation.In one embodiment, if surpassed in pre-selected time interval cavity pressure Setting pressure is crossed with predetermined quantity, then controller 545 can activate outflow under pump rate more higher than inflow pump 546A 546B is pumped below the fluid pressure drop to setting pressure of the measurement in cavity.Selectively, controller 545 can make stream Enter to pump 546A to be slowed or stopped until chamber pressure drops to goal gradient.In a variant, if the pressure measured is more than It sets pressure 5mmHg and reaches and be more than 1 second, 2 seconds or 5 seconds, then pump or multiple pumps can be activated to reduce cavity pressure.
It is set in the form of such as the pressure relief valve 680 described in Figure 18 for another mechanism of overvoltage protection.One In a modification, the housing 682 of 680 connecting sensor 560 of pressure relief valve and with the fluid channel 108b' in sensor 560 Unicom, the fluid drainage by sensor body to be allowed to be discharged with pressure.Pressure relief valve 680 can be more than 100mmHg Appropriate pressure, such as released stress under 100mmHg, 125Hg, 150Hg or another predetermined pressure.As a result, if intracavitary pressure Power is more than target greatest level, then controller 545 is stopped simultaneously by the pressure release mechanism based on adjusting pump offer algorithm Return the backup form (Figure 18) that valve 680 provides pressure release.In addition, the system, which can be included in, is connected to the primary of endoscope Manual pressure relief valve 688 in property accessory 712 is for additional Safety Redundancy (Figure 20).
In another aspect of the present invention, the actual pressure that controller 545 includes being suitable in treatment position drops to The excision equipment of energization is made to remove the algorithm of actuating in situation below predetermined threshold level.Controller 545 is equipped with to come in position From the continuous actual pressure signal of pressure sensor assembly 560.In a variant, if actual pressure in this position Drop to below permissible threshold pressure level, then controller algorithm can make driving move back and forth or rotate excision component Motor automatically goes to activate.As shown in Figure 16-Figure 17, in another modification, controller algorithm can make to be transmitted to cut Except the RF energy of the working end of equipment 515 goes to activate.In this modification, wherein RF energy transmission is gone to activate, this algorithm The lasting movement of bushing 175 can be allowed to cut off to select interval, and then can simultaneously be increased in cavity pressure grade More than to predetermined threshold or when this pressure is more than that threshold levels activated radio frequency again later up to the selected interval of such as 1 to 10 seconds. In another modification, controller algorithm can be such that motor driving is passed with radio frequency when pressure drops to below threshold pressure level Send to actuating.Threshold pressure level in this algorithm can be any predetermined pressure, for example, 100mmHg or less, 50mmHg Or less or 25mmHg or less.In a variant, threshold pressure level is set in 15mmHg.
The present invention be related to treat tissue with directly detection body space in pressure one side in, method packet It includes：(i) into body space or potential body space, at least one system unit is configured to provide for expansion fluid 244 to space Inflow and fluid from the outflow in this space, at least one component includes electrosurgical tissue and cuts off probe；(ii) pressure is provided Sensor is connected at least one component for the actual pressure being configured to measure in this space；(iii) pressure in space is detected Power and the adjusting of the pressure in response to detecting inflow and discharge rate, to realize or keep pressure set-point in space； And (iv) operates the electrosurgical probe with resection organization with the first radio frequency parameter.Can probe be operated with the second radio frequency parameter With solidified structure.The step of adjusting rate of influx can provide the inflow between 0ml/min and 800ml/min.Pressure set-point It can be between 30mmHg and 200Hg.As described above, by being connected to the flow channel flowed into carrying expansion fluid with outflow The sensor of the independent fluid pathways of separation realizes the step of detection pressure.
Usually, fibroid treatment system according to the present invention includes：Controller；Pump is flowed into, passes through controller It operates and is configured to provide for flowing by the fluid of the uterine cavity of flow path to patient；Efflux pump is grasped by controller Make and be configured to provide for flowing out by the fluid of flow path to uterine cavity；And motor driving excision equipment, pass through institute State controller operation.Excision equipment includes elongated guide members, this elongated guide members is straight not less than 2.4mm with diameter in it The tissue of diameter takes out channel (190A, 190B in Fig. 6 A) and the external bushing 170 with the diameter no more than 3.8mm.Excision Equipment is suitable for removing Human Leiomyma with the rate of at least 2gm/min.In this modification, controller as described above can construct Pump and efflux pump are flowed into for the signal actuating in response to the Fluid pressure in uterine cavity and keep goal pressure.More specifically It says, the signal of Fluid pressure can be provided by being connected to the pressure sensor of the passive flow scapus of uterine cavity unicom.Another In one modification, as will be described further below, controller can be structured as in response to from the group that parameters described below is formed At least one parameter of selection operates the excision equipment, and the parameter includes in such as pump speed, outflow pump speed and uterine cavity Fluid pressure signal.In another aspect of the present invention, fluid management system 500 is set with cooperation electrosurgery probe Be set to including：Pump 546A is flowed into, is configured to provide the inflow of expansion fluid in the position in patient body；Control system System, is configured to operator's selection at least first and second flow control mode, and wherein first flow control model constructs To be used for resection organization pump is flowed into provide the first peak value rate of influx with operation, and wherein second flow control model constructs It pumps to provide the second peak value rate of influx to be used for tissue coagulation and operating inflow.Normally, the first peak value rate of influx is big In the second peak value rate of influx.In a variant, the first peak value inflow is 1,000ml/min, 800ml/min, 600ml/min Or 500ml/min.Fluid management and treatment system include being configured to operator and select pressure set-point at this position Control system.As described above, fluid management system is configured to operation with controller flows into pump and efflux pump, to provide expansion fluid Outflow from this position, so that pressure set-point is realized or kept in first and second flow control mode.
With reference to Figure 16-Figure 21, fluid management system 500 of the invention includes flowing into pump 546A, is configured to flow expansion The inflow of body 244 is provided into position in patient body；And efflux pump 546B, it is configured to provide for coming the fluid of position since then Outflow and controller 545, be configured to operator's selection at least first flow control model, second flow control model With third flow control mode, wherein in the case of with the interval outflow with pre-selected time interval, first flow controls Schema construction is for diagnoses and treatment and provides the up to rate of influx of 800ml/min, wherein second flow control model structure It makes to be used for cutting tissue operation and providing the up to rate of influx of 1,0ml/min, and wherein third flow control mode It is configured to tissue coagulation and the rate of influx for being up to 800ml/min is provided.
Referring now still to Figure 16-Figure 21, fluid management corresponding with the present invention includes being configured in patient body with excision system Position in enter with perform operation elongated member, this system unit include endoscope, tissue resection probe, fluid source and pipe Group flows into pump and efflux pump and controller, is configured to provide for passing through the first passage in component from fluid source wherein flowing into pump To the inflow of the fluid of this position, wherein efflux pump is configured to provide for coming the fluid by second channel in component of position since then Outflow, and wherein controller is configured to simultaneously be controlled at least one operation mode and probe and flows in and out pump, with The pressure set-point for providing and keeping operator to select in this position.
This system further includes the disposable pressure sensor for being removably coupled to system unit, and in a modification In, this pressure sensor is operably linked to the third channel in the system normally in endoscope.In another modification In, pressure sensor is operably linked to pipe group.Normally, above-mentioned first passage is in endoscope shaft 524, and second is logical Road is in tissue resection probe 515.
In another aspect of the present invention, with reference to Figure 20-Figure 21, fluid management system includes fluid source 535, normally It is salt bag, has Packed outflow port 702；And inflow line pipe 550, there is the company for including at least one barb feature End 705 is connect, barb latent structure is allows the connecting pin 705 to proceed in outflow port 702 and prevent outflow port 702, but prevent the connecting pin 705 from being exited from outflow port 702.
In another aspect of the present invention, fluid management system 500 (Figure 16-Figure 17) is including controller algorithm, when this Controller algorithm is arranged in diagnosis or treatment procedure and in diagnosis or treatment procedure in use, this controller algorithm is suitable for Notable fluid leakage or loss in detection system.This leakage can include the fluid loss from anywhere in fluid path, Such as around in flowing in or out pipeline (550,555) or by endoscope 512 (referring to Figure 17) elongated shaft 524 At the connector of canal of uterine cervix.
In order to determine leakage or fluid loss, controller algorithm constantly monitors the electricity for flowing into pump or charge pump 546A The input voltage of machine, wherein this input voltage are directly corresponding to pump speed and thus corresponding with fluid rate of influx.This algorithm Further constantly monitor the input voltage of efflux pump or the motor of suction pump 546B, this directly with fluid discharge rate phase It should.Herein during continuous monitoring, if algorithm determines to flow into pump motor to be more than the input voltage of predetermined threshold voltage class (such as rate) operates, then just starts timer.Threshold voltage level be setting pressure, practical cavity pressure and its at this moment Function with the operation mode (diagnostic mode, excision model etc.) in operation.In each operation mode, the input of efflux pump Voltage (discharge rate) is different to meet the target of each pattern.For variant pattern and corresponding discharge rate, profit Undesirable fluid loss is determined whether there is with different threshold voltages, rate of influx and time interval.In another change In type, controller algorithm, which can utilize, makes perfusion electric moter voltage and the relevant linear adaptation curve detection system in elapsed time interval In leakage or fluid loss, with send leakage or fluid loss signal.This type algorithm can allow to detect it quickly The middle operation mode for flowing into pump motor and operating at the higher speeds, the fluid loss such as in excision model.In other words, exist Wherein in the higher situation of loss late, fluid loss can be detected earlier.When can collect test data to measure leap Between the fluid loss under different motor speeds that is spaced this linear adaptation curve is unfolded.
If timer is more than pre-selected time interval, the input voltage for flowing into pump motor during this period is more than predetermined voltage Threshold value, then controller will show notice alarm and/or sound or visual alert to indicate leakage or fluid loss.It is grasped in system In any one of operation mode, be also based on the severity of fluid rate of influx, i.e., based on to the input voltage for flowing into pump motor, Change the length at pre-selected interval.When rate of influx increases to more than calibration rate of influx in any pattern, flowed reducing Bulk diffusion alarm or the pervious time interval of warning.In a variant, predetermined voltage threshold grade can be at least 25ml/ The rate of influx of min, at least 50ml/min or at least 100ml/min are corresponding, and pre-selected time interval can be at least 1 Second, at least 5 seconds or at least 10 seconds.
In another aspect of the present invention, controller 545 includes the intrusion pipe or stream that are suitable in detection inflow line 550 The algorithm of kink or blocking in pipe is raised in the suction for going out pipeline 555.For outflow pipeline 550 or flow out pipeline 555 flexible pipe and Speech kink is possible, this may keep not noticed by doctor and medical staff provisionally.If inflow line 550 is turned round Knot, then the reduction that the fluid into treatment position flows into will lead to the pressure loss in this position and working space may collapse It falls into.Kink in pipeline 555 is flowed out may cause the undesirable Fluid pressure in treatment position to increase.
In order to rapidly detect the kink in the loading line 550 on the positive pressure side for flowing into pump 564A, if driving flows into pump The power that calculates of motor is more than the predetermined value across pre-selected time interval, then controller algorithm is adapted to provide for kink pipe police Report.This predetermined value depends on motor, gearbox, pump head and scheduled pressure limit.The upper of dual pumping system can such as be passed through Face description understands that the pressure on positive pressure side of the power of motor to flowing into pump 564A is directly corresponding.When flow into the pressure in pipe by Kink or blocking in pipe and when increasing, the hydraulic load in the pump roller from pipe will increase, and load is transmitted to inflow by this Pump motor.This increase of load on motor and then the increase for leading to require the electric current for being driven with target velocity pump motor.Control Device 545 processed include no matter load during use of the fluid management system in its various modes for keep pump speed (and Corresponding flow velocity) in the algorithm of predetermined grade.Performance number is measured by controller algorithm, and at preset limit, algorithm can be with (i) alarm of display obstruction fluid flowing, this can be related to kink pipe or blocking in flow path or filter 575； (ii) information or alarm that display molecular filter 575 may block；Or the information of filter 575 is replaced in (iii) display. This algorithm can also be in use by making pump 546A, 546B go actuating and/or by making any tissue ablation device 515 Power actuating is gone to interfere this program.
Fluid management system 500 further includes to detect in the outflow pipeline 555 on the suction side of efflux pump 546B Kink or the controller algorithm blocked.Kink detection is realized by monitoring the electric moter voltage of two pump motors.If with excision Pattern or diagnostic mode operate this system, then and algorithm is first checked for whether in an open state to determine efflux pump 546B, and And then check the voltage for being applied to and flowing into pump 546A.If the motor of pump 546A is flowed into the electricity below predetermined threshold level Press operation, then start timer.It is cutting off with during diagnostic mode, pump is flowed into based on desired input electric moter voltage selection The predetermined voltage threshold of motor.It is 250 millis cutting off with the usual fluid discharge rate from uterine cavity during diagnostic mode Liter/min to 500 ml/mins, it is desirable that the minimum electric moter voltage on pump motor is flowed into inputs the flowing speed to keep pressure Rate.If the outflow due to the kink in pipeline 555 is flowed out from uterine cavity is reduced or is stopped, then practical cavity pressure It will remain in relative quiescent grade.In this static case, the input voltage for flowing into pump motor will be in predetermined threshold input voltage Hereinafter, and thus it will start probe timer of twisting together.When the pre-selected time that timer overruns from 5 seconds to 120 second Every when, this algorithm be adapted to provide for kink pipe alarm.In addition, this algorithm can be in use by making pump 546A, 546B go to cause It moves and/or by making the power to any excision equipment 515 that actuating be gone to interfere this program.
Fluid management system 500 further includes the pipe for detecting the outflow pipeline 555 on the positive pressure side of efflux pump 546B In kink controller algorithm.If the current of electric of the measurement on the motor of driving efflux pump 546B is more than predetermined etc. Grade, then this kink in controller algorithm detection outflow pipeline 555.Predetermined grade again depends on motor, gearbox, pump Head and the predetermined pressure limit.Pressure on positive pressure side of the current of electric to pumping 546B is directly corresponding.Due to the pressure in pipe Increase (due to pipe kink or plugged sereen), the hydraulic load in the pump roller from pipe increases, this passes load It is sent to motor.The increase of this load to motor to increase for carrying out the electric current of driving motor with target velocity and flow rate. As previously described, controller 545 is included in fluid management system makes pump speed be maintained at predetermined during the use of multiple patterns The algorithm of grade.Kink probe algorithm is measured as a result, drives outflow under the predetermined current limit across pre-selected time interval The electric current of pump motor, the algorithm can (i) display kink pipe alarm；(ii) display molecular filter 575 block information or Alarm；Or the information of filter 575 is replaced in (iii) display.In addition, the algorithm can be in response to the torsion in detection flow path Knot pipe is blocked by the way that pump (546A, 546B) is made to go actuating and/or by the power to any excision equipment 515 in use Actuating is gone automatically to interfere this operation.
In another aspect of the present invention, controller 545 is included in keeps goal-setting using feedback control loop It is suitable for further control and the algorithm of the Fluid pressure in optimization position in the cutting tissue interval procedure of pressure.Feedback control is returned Road monitors the actual pressure in this position, and then adjusted using controller algorithm including the use of pressure sensor 560 Flow into the speed of pump 546A and efflux pump 546B (Figure 21).More specifically, the institute in doctor is utilized such as Figure 16-Figure 17 and Figure 21 When the tissue ablation device 515 shown starts cutting tissue, it will block at least partly with the tissue volume of window 517 (Figure 21) interface This window and thus make to start to slow down by the outflow of the fluid of the taking-up channel 160 in neck bush 175.Due to the reduction of outflow, The actual pressure indicated in this position is increased from pressure sensor 560 to the signal of controller 545, then this is being previously described Algorithm under the input voltage that will cause to flow into pump motor reduce thus to slow down fluid rate of influx.If reduce outflow Situation continues the first pre-selected time interval, then controller algorithm will identify excision equipment resection organization and engage tissue Signal is sent to controller.Then or behind the second pre-selected time interval, this algorithm will cause controller 545 to make efflux pump electric The input voltage of machine (and fluid discharge rate) is reduced to relatively low electricity from high voltage grade (for example, 15 to 30 volt ranges) It presses (for example, 5 to 12 volt ranges), is placed in " preparation " state and at the same time ground flows into pump.In this preparation state, If pass through the unexpected reduction of actual pressure of 560 signal designation of pressure sensor in this position, then this algorithm will cause Maximum voltage (for example, 30 volts, substitute nominal voltage), which is transmitted to, flows into pump motor thus maximum fluid to be caused to be flowed into this In position.When this pressure reduces suddenly, then algorithm will organize separation signal to be sent to controller, this is with as described above most Big voltage actuation flows into pump.In usual operational scenario, calibration flows into pump voltage can be in 10 to 20 volt ranges.This pressure The purpose for keeping algorithm is when the window 517 in excision equipment removes tissue excision equipment operation simultaneously or works as histotomy It is removed by taking out channel 160, when this leads to the quick increase of outflow then, it is contemplated that the unexpected of pressure in this position subtracts It is small.The outflow pump voltage for then proceeding to reduce also reduces discharge rate, and " preparation " state for flowing into pump is ensured when generation When unexpected tissue removes situation (tissue detaches signal), flow into pump 546A with its maximum voltage and rate of influx activated with Match or more than discharge rate, then this will prevent any decline of the actual pressure in position here.Maximum rate of influx is with reducing Discharge rate will be continued until that target set pressure is kept up to the pre-selected interval changed from 0.1 second to 10 second.
Another method such as the operation fluid management system described in Figure 16-Figure 21 and radio frequency excision probe includes： (i) position in patient body is entered by the working end of the distal end of endoscope and electrosurgery probe；(ii) it will penetrate Frequency energy is transmitted to working end to apply energy to the tissue in this position；(iii) it is simultaneously operated fluid management system The fluid outflow that the fluid that this position flies selected rate flowed into and came position since then is provided；(iv) it detects in operation The change of the signal of the electrical parameter of probe and in response to detecting the change, switches at least one of the fluid management system Operating parameter.Normally, electrical parameter can include at least one in the class of impedance, power grade, voltage class and current class It is a.The operating parameter for the fluid management system that can be adjusted includes the fluid rate of influx to this position, passes through from this position Unite flow pass fluid outflow rate, with the positive pressure grade of fluid feed channel unicom, with fluid outlet passage unicom At least one of rate of negative pressure grade, the goal pressure set point at this position and any of the above-described change.Another In one modification, it is the pressure for determining to obtain Fluid pressure at this position that at least one operating parameter, which can include for operative configuration, The algorithm of power sensor-based system.In the above-mentioned methods, the energy of application may be adapted to ablation and resection organization or solidified structure.
Although some embodiments of the present invention are described in detail above, it should be understood that this description is only used for Description above the purpose and the present invention of description is exhaustive.Particularly unique feature of the present invention is shown in some drawings And other feature is not shown, and this is just for the sake of convenient, and can be with another according to any feature of the present invention With reference to.Multiple modifications for the personnel with ordinary skill in this field with optionally will be apparent.This is alternative It is intended to be included in the scope of the claims with modification.The special characteristic being present in dependent claims can be combined and be fallen Enter in the scope of the present invention.The present invention is also comprising embodiment, like dependent claims are another with reference to other independent claims Selection of land is written in multiple dependent claims forms.
1. a curing hysteromyoma treatment system, including：
Pump is flowed into, is operated by the controller and is configured to fluid be made to be flowed into patient uterine's chamber by flow path；
Efflux pump is operated by the controller and is configured to push fluid out uterine cavity by flow path；
Motor drives excision equipment, is operated by the controller, and the equipment includes elongated guide members, the elongate guide With (i), the tissue of its interior diameter with not less than 2.4mm takes out the outer diameter of channel and (ii) no more than 3.8mm to part, makes The equipment is obtained to be suitable for removing Human Leiomyma with the rate of at least 2gm/min；
Pressure sensor, including being passed with the first sensing element and second for extending to the fluid interface in the pressure sensor Sensing unit, wherein, pressure signal is sent to controller by first sensing element and the second sensing element so that the control Device is configured as monitoring or the pressure signal, and if pressure signal each other not within the predefined range, controller The alarm and/or termination of offer sensor fault or any ongoing operation for adjusting the system；
Wherein, the controller is configured in response to the signal actuating inflow pump of the Fluid pressure in the uterine cavity and institute Efflux pump is stated to keep goal pressure therein；And
Wherein, the controller is configured to provide fluid loss signal, at least one ginseng in response at least one parameter Number is selected from the signal for flowing into pump speed, outflow pump speed and the Fluid pressure in the uterine cavity.
2. fibroid treatment system according to claim 1, wherein, the controller is configured in response at least one Parameter operates the excision equipment, at least one parameter be selected from flow into pump speed, outflow pump speed in the uterine cavity The signal of Fluid pressure.
3. fibroid treatment system according to claim 1, wherein, the letter of the Fluid pressure in the uterine cavity Number by be connected to and the pressure sensor of the passive flow scapus of the uterine cavity unicom provide.
4. a kind of fluid management system, including：
First pump, is operated by the controller and is configured to that fluid is made to be flowed into the position in patient body；
Second pump, is operated by the controller and is configured to push fluid out the position in patient body；
Wherein, the controller is configured to provide for selected from the first pump speed, the second pump speed and the goal pressure in the position At least one operating parameter；And
Wherein, the controller is configured to, if first pump speed is provided with more than predetermined grade up to pre-selected time interval Fluid loss alarm.
5. fluid management system according to claim 4, wherein, when being operated in cutting off operation mode, described first Pump speed provides the fluid loss alarm under the first predetermined grade, and when being operated with non-ablated operation mode, and described first Pump speed provides the fluid loss alarm under the second predetermined grade.
6. fluid management system according to claim 5, wherein, the pre-selected time interval is at least 1 second.
7. fluid management system according to claim 5, wherein, the pre-selected time interval is at least 5 seconds.
8. fluid management system according to claim 5, wherein, the pre-selected time interval is at least 10 seconds.
9. fluid management system according to claim 5, wherein, if the controller is further configured for described first Pump speed is more than that the predetermined grade reaches the pre-selected time interval, then just goes to activate at least one pump.
10. fluid management system according to claim 5, wherein, if the controller is further configured for described One pump speed is more than that the predetermined grade reaches the pre-selected time interval, then makes to be located in the excision equipment of the energization in position It goes to activate.
11. a kind of fluid management system, including：
Pump is flowed into, is operated by the controller and suitable for fluid being made to be flowed into the position in patient body by flow path It puts；And
Efflux pump is operated by the controller and suitable for described in being pushed fluid out in patient body by flow path Position；
Wherein described controller is configured to provide for selected from the first pump speed, the second pump speed and the goal pressure in the position At least one operating parameter；And
Wherein described controller is configured to, if being more than predetermined grade up to pre-selected for driving the calculating power for flowing into pump Time interval, then be provided with obstructed flow alarm.
12. fluid management system according to claim 11, wherein, the controller is further configured for, if be used for It is more than that the predetermined grade reaches the pre-selected time interval to drive the calculating power for flowing into pump, then makes at least one A pump goes to activate.
13. fluid management system according to claim 11, wherein, the controller is further configured for, if be used for It is more than that the predetermined grade reaches the pre-selected time interval to drive the calculating power for flowing into pump, then just makes to be located in institute The excision equipment of energization during rheme is put goes to activate.
14. a kind of fluid management system, including：
Wherein, the controller is configured to, if reaching the stream less than predetermined threshold voltage to the input voltage for flowing into pump motor Go out the pre-selected time interval of pump operation, then be provided with obstructed flow alarm.
15. fluid management system according to claim 14, wherein, the pre-selected time interval ranging from from 5 seconds By 120 seconds.
16. fluid management system according to claim 14, wherein, the controller is further configured for, if to institute It states the input voltage for flowing into and pumping and drops to the predetermined grade to assign the pre-selected time interval, then just make at least One pump goes to activate.
17. fluid management system according to claim 14, the controller is further configured for, if to the inflow The voltage of pump motor is more than that the predetermined grade reaches the pre-selected time interval, then just makes to be located in logical in the position The excision equipment of electricity goes to activate.
18. a kind of fluid management system, including：
Pump is flowed into, is operated by the controller and is configured to fluid be made to be flowed into patient body by flow path Position；
Efflux pump is operated by the controller and is configured to push fluid out the institute in patient body by flow path Rheme is put；
Wherein, the controller is configured to keep selected from the first pump speed, fluid rate of influx, the second pump speed and fluid outflow At least one operating parameter of rate；And
Wherein, the controller is further configured for, if the measurement electric current to the efflux pump is reached more than predetermined threshold voltage Pre-selected time interval, then be provided with obstructed flow alarm.
19. a kind of fluid management system for cutting tissue operation, including：
Efflux pump is operated by the controller and is configured to push fluid out the institute in patient body by flow path Rheme is put；And
Motor drives excision equipment, is used to cut off the tissue at the position；
Wherein, the controller is configured to activate stream in response to the signal of the actual pressure at the position in patient body Enter pump and efflux pump, flowed out with providing corresponding fluid and flowing into fluid, so as to the goal pressure being maintained at the position；With And
Wherein, the controller is configured to, when detecting that the actual pressure in the position drops to predetermined threshold pressure When below grade, the motor driving excision equipment is made to go to activate.
20. fluid management system according to claim 19, wherein, the controller is further configured for, if in institute Actual pressure during rheme is put drops to below predetermined threshold pressure grade, then just goes the motor of the driving excision equipment Actuating.
21. fluid management system according to claim 19, wherein, the controller is further configured for, if described Actual pressure in position drops to below predetermined threshold pressure grade, then at least one cutting tissue electrode is made to go to activate.
22. fluid management system according to claim 19, wherein, the threshold pressure level is 100mmHg or more It is few.
23. fluid management system according to claim 19, wherein, the threshold pressure level is 50mmHg or more It is few.
24. fluid management system according to claim 19, wherein, the threshold pressure level is 25mmHg or more It is few.
25. a kind of fluid management system for cutting tissue, including：
Controller is configured to：
(a) it is activated in response to the signal of the actual pressure in the position in patient body and flows into pump and efflux pump, thus to provide Corresponding fluid is flowed into flow out with fluid, so as to the goal pressure being maintained at the position；
(b) the predetermined stable pressure in the pre-selected interval that resecting tool engaged target tissue generates in detecting by the position After power state, tissue engagement signal is sent to the controller；
(c) it is detecting by subsequent resecting tool and the predetermined change for organizing to detach actual pressure in the pre-selected interval of generation After change, tissue separation signal is sent to the controller；And
(d) operating parameter of fluid management system described in Signal Regulation is detached in response to tissue engagement signal or tissue,
Pressure sensor, including being passed with the first sensing element and second for extending to the fluid interface in the pressure sensor Sensing unit, wherein, pressure signal is sent to controller by first sensing element and the second sensing element so that the control Device is configured as monitoring or the pressure signal, and if pressure signal each other not within the predefined range, controller The alarm and/or termination of offer sensor fault or any ongoing operation for adjusting the system.
26. fluid management system according to claim 25, wherein, the controller is further configured for the inflow Pump is arranged in preparation state to provide the selected high rate of influx in response to organizing engagement signal.
27. fluid management system according to claim 25, wherein, the controller is further configured in response to tissue Engagement signal reduces the inflow pump speed.
28. fluid management system according to claim 25, wherein, the controller is further configured in response to tissue Separation signal actuating is described to flow into pump to provide selected high rate of influx.
CN201480032804.8A 2013-04-08 2014-04-08 medical system and method CN105377159B (en)
US61/809,681 2013-04-08
CN201810190132.3A CN108720909A (en) 2013-04-08 2014-04-08 medical system and method
CN201810190132.3A Division CN108720909A (en) 2013-04-08 2014-04-08 medical system and method
CN105377159A CN105377159A (en) 2016-03-02
CN105377159B true CN105377159B (en) 2018-06-12
CN201480032804.8A CN105377159B (en) 2013-04-08 2014-04-08 medical system and method
CN (2) CN105377159B (en)
CA (2) CA2908862C (en)
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Effective date of registration: 20170714
Applicant after: Boston Scient Scimed Inc.
Applicant before: ARQOS SURGICAL INC.