CN104546118B - A kind of ablation apparatus for being treated to the endoceliac tissue with varying dimensions - Google Patents

A kind of ablation apparatus for being treated to the endoceliac tissue with varying dimensions Download PDF

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Publication number
CN104546118B
CN104546118B CN201410781722.5A CN201410781722A CN104546118B CN 104546118 B CN104546118 B CN 104546118B CN 201410781722 A CN201410781722 A CN 201410781722A CN 104546118 B CN104546118 B CN 104546118B
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ablation
ablation structure
expansion
electrode
conduit
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CN104546118A (en
Inventor
A·D·詹姆森
C·L·巴格利
H·K·赫斯泽尔
M·A·马圭尔
D·S·厄特利
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Nellcor Puritan Bennett LLC
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Nellcor Puritan Bennett LLC
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Priority claimed from US14/519,950 external-priority patent/US9743981B2/en
Priority claimed from US14/519,409 external-priority patent/US9763733B2/en
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Abstract

Describe method, system and the equipment for providing body cavity inner tissue treatment.System may include that conduit, the ablation structure of the expansion being connect with catheter distal portion including one or more longitudinal electrode sections and the ablation structure support element that is connect with ablation structure, ablation structure are configured to expand with expansion and be unfolded at least partly and shrink and roll with expansion.Ablation structure may include it is multiple separate wiring and/or be separately controlled longitudinal electrode, longitudinal electrode area, or both so that electrode or longitudinal electrode area optionally enable or selectively disable longitudinally in each.In some cases, one or more springs are connected to ablation structure, one or more of springs be configured to promote around expansion expansion or roll.In some cases, one or more protective elements are positioned along conduit.

Description

A kind of ablation for being treated to the endoceliac tissue with varying dimensions Equipment
Cross reference
This application requires on October 21st, 2014 submitting, entitled " to be set with the expansion electrodes of multiple longitudinal electrode sections Standby (UNFURLING ELECTRODE DEVICES WITH THE MULTIPLE LONGITUDINAL ELECTRODE SEGMENTS U.S. Patent application No.14/519) ", on October 21st, 409,2014 are submitting, entitled " with spring The U.S. Patent application No.14/ of expansion electrode equipment (UNFURLING ELECTRODE DEVICES WITH SPRING) " On October 21st, 519,950 and 2014 it is submitting, entitled " with protection element expansion electrode equipment The U.S. Patent application of (UNFURLING ELECTRODE DEVICES WITH THE PROTECTION ELEMENT) " No.14/520,028 equity and priority, each of which patent application require that on October 25th, 2013 is submitting, entitled " expansion electrode equipment (the UNFURLING ELECTRODE DEVICES WITH THE with multiple longitudinal electrode sections MULTIPLE LONGITUDINAL ELECTRODE SEGMENTS) " U.S. Provisional Application No.61/895,501,2013 years October 25 it is submitting, entitled " with spring expansion electrode equipment (UNFURLING ELECTRODE DEVICES WITH SPRING U.S. Provisional Application No.61/895) ", on October 25th, 514 and 2013 are submitting, entitled " with protection The expansion electrode equipment (UNFURLING ELECTRODE DEVICES WITH THE PROTECTION ELEMENT) of element " U.S. Provisional Application No.61,895,530 priority, their full content all things considered is incorporated herein by reference This.
Background technology
The cavity that human body has multiple inner body cavities or is located therein, the different piece of such as gastrointestinal tract are permitted in them There is liner or internal layer more.Body cavity may include remnants, rectum and the anus after such as esophagus, small intestine and large intestine, stomach, bariatric surgery Door.These liners can be easy to fall ill.In some cases, different ablation techniques have been utilized to prevent disease about liner It spreads to positioned at other neighbouring health tissues.
Inner body cavity about can have different sizes each other or about different patients.Therefore, it can utilize various sizes of Equipment adapts to these various sizes of chambers.However, this may include utilizing multiple equipment, such as the calibration of multiple scales and/or Therapeutic equipment, this be not so good as the equipment calibrated and treated come scale using single intubation more efficiently, more cost efficient or more Safety.
Can there are problems that another in target site of the treatment than therapeutic equipment surface area bigger.Traditional ablation method warp Include often that three or more reposition steps with therapeutic targets position.These repositionings action easily causes treatment precision Reduce, the excess in target site subprovince domain or insufficient ablation, or both can all cause.In addition, reposition operation with equipment Practical reposition in the relevant quantity for repositioning step and physical process is ad hoc.Lacking for the consistency can also subtract Less treat precision, treatment validity, or both all reduce.
Therefore there are above-mentioned and/or other shortcomings the system, apparatus and method for overcoming known system, equipment and method Demand.
Invention content
Describe method, system and the equipment for providing target site (such as endoceliac position) treatment.System It may include the expansion being connect with catheter distal portion, and the ablation structure support element being connect with ablation structure, ablation structure It is configured to roll and be unfolded at least partly around expansion with expansion expansion and contraction.Expansion may include non-suitable Ying Xing, compliance or highly compliant property sacculus.Ablation structure support element may include one or more longitudinal electrodes, longitudinal electrode Area, and/or longitudinal electrode region.In some embodiments, which may include one or more protective elements, described one A or multiple protective elements along conduit be located in ablation structure distal side, ablation structure nearside, or both have concurrently.
According to certain embodiments of the present invention, it provides for controlling the endoceliac tissue with varying dimensions The ablation apparatus for the treatment of.The ablation apparatus generally includes the expansion being connect with catheter distal portion, and including multiple longitudinal electricity The ablation structure of polar region.Ablation structure support element can connect ablation structure, and ablation structure and ablation structure support element can match It is set to and is expanded with expansion or shrink and be unfolded or roll at least partly around expansion.
In some embodiments, ablation apparatus further includes the one or more springs being connect with ablation structure support element, One or more of springs are configured to roll ablation structure support element at least partially about expansion.It is one or more of Spring may include one or more constant force springs.Ablation apparatus may also include one or more protective elements, fixed along conduit Position is to be at least distally from or close to ablation structure.
In some embodiments, the electrode district longitudinally in each of ablation apparatus is configured to be selectively enabled or disable.Often A longitudinal electrode area can be separately controlled or wiring.In some embodiments, longitudinal electrode area includes having different in width At least two longitudinal electrode areas.In some embodiments, which may include at least one bipolar electrode array.? In certain situations, expansion is sacculus, and sacculus can be compliance in some embodiments.
According to certain embodiments of the present invention, it provides and the endoceliac tissue with varying dimensions is treated Method.This method generally includes the ablation structure and expansion that connect with ablation structure support element being inserted into body cavity. Ablation structure and ablation structure support element can be configured to expand with expansion or shrink and opened up at least partly around expansion It opens or rolls.This method further includes expanding expansion ablation structure to be unfolded at least partly, to engage the circle of body cavity Circumference, and convey circumferential part of the energy across one or more of multiple longitudinal electrode areas of ablation structure to body cavity.
In some cases, conveying energy passes through one or more of multiple longitudinal electrode areas of ablation structure to body cavity Circumferential part include be selectively enabled electrode district longitudinally in each.This method may also include shrinkage expansion component to promote from body cavity Remove ablation structure.In some embodiments, one or more springs cause ablation structure with expansion shrink and at least Partly rolled around expansion.In some cases, one or more of springs may include one or more constant force springs.
In some embodiments, this method further includes in the ablation structure and expansion that will be connect with ablation structure support element Component is inserted into body cavity phase and utilizes one or more protective elements for at least distal portion or proximal portion of ablation structure.One In a little embodiments, this method further includes mobile one or more of protectiveness members after ablation structure is located in body cavity Part is far from ablation structure.In some cases, this method further includes each of multiple longitudinal electrode areas for ablation structure Impedance, and impedance determined by comparison are determined to determine one or more longitudinal electrode areas whether at least partly by electrode section Covering.
In some embodiments, the longitudinal electrode area of ablation structure includes at least two longitudinal electricity for having different in width Polar region.In some cases, ablation structure may include at least bipolar electrode array.In some embodiments, expansion can To be sacculus.
According to certain embodiments of the present invention, it provides for controlling the tissue in the body cavity with variable size The ablation apparatus for the treatment of.Ablation apparatus generally includes the expansion being connect with catheter distal portion and ablation structure, ablation structure It is configured to expand with expansion or shrinks and be unfolded or roll at least partly around expansion.Ablation apparatus further includes and disappears One or more springs of molten bonding structure connection, one or more of springs are configured to provide for active force so that ablation structure with Expansion is expanded or shrinks and be unfolded or roll around expansion.
In some embodiments, one or more of springs of ablation apparatus include one or more material strips, institute State longitudinal axis and ablation structure lateral connection of one or more material strips about ablation structure.In some cases, it melts One or more of springs of equipment include one or more material strips, to close to described the one of the free end of ablation structure The density of a or multiple material strips is less than the density of one or more of material strips of the free end far from ablation structure.And In other embodiment, one or more of springs of ablation apparatus include one or more material strips, to close to ablation The density of one or more of material strips of the installation end of the free end of structure and close ablation structure is less than in ablation structure Between one or more of material strips at portion density.One or more of material strips may include metal material or polymer Material.In some embodiments, one or more of material strips may include shape memory polymer material.
In some cases, one or more of springs of ablation apparatus include at least the first bullet with the first length Spring and second spring with the second length, the second length are different from the first length.First length can be more than the second length, and And free end positioning of the second spring with the second length far from ablation structure.
In some embodiments, one or more material strips of one or more of springs include one or more squares Shape material strips.In some cases, at least one of described rectangle material item rectangle material item include be configured to it is described at least At least one or more of one end opening of one rectangle material item.In some embodiments, in the material strips extremely Few material strips include at least tapered portion.And in other embodiments, at least one of described material strips material strips packet Include at least one or more of one end slit for being configured at least one material strips.
In some embodiments, the ablation structure of ablation apparatus includes multiple longitudinal electrode areas, the multiple longitudinal electricity Polar region is configured to be sequentially activated.In some embodiments, ablation structure includes multiple longitudinal electrode areas, the multiple vertical It is configured to be sequentially activated since the first region of neighbouring ablation structure free end to electrode district.It is other other In embodiment, ablation structure includes multiple longitudinal electrode areas, and electrode district is configured to be selectively enabled or disable longitudinally in each. Longitudinal electrode area may include at least two longitudinal electrode areas with different in width.In some cases, described that there are different width At least two longitudinal electrode areas of degree include the first longitudinal direction electrode district and second longitudinal direction electricity of the free end of neighbouring ablation structure Polar region, the wherein width of first longitudinal direction electrode district are more than the width of second longitudinal direction electrode district.
In some embodiments, the longitudinal electrode area of ablation apparatus includes at least three longitudinal electricity for having different in width Polar region, at least three longitudinal electrode areas with different in width include the first longitudinal direction electricity close to the free end of ablation structure The longitudinal electricity of third of polar region, the second longitudinal direction electrode district of neighbouring first longitudinal direction electrode district and the free end far from ablation structure Polar region.The width of first longitudinal direction electrode district is more than the width of second longitudinal direction electrode district, and the width of second longitudinal direction electrode district is big Width in third longitudinal electrode area.
In some embodiments, the ablation structure of ablation apparatus includes at least bipolar electrode array.In some embodiment party In formula, the expansion of ablation apparatus is sacculus.
According to the embodiment of the present invention, it provides for being treated to the endoceliac tissue with variable size Ablation apparatus.The ablation apparatus generally includes the ablation structure being connect with conduit, and the ablation structure includes being located in along conduit One or more protective elements in ablation structure distal side, one or more protectiveness that ablation structure nearside is located in along conduit Element or the one or more protective elements positioned along above-mentioned the two.In some embodiments, ablation structure includes rolling Bipolar electrode array.
In some cases, one or more of protective elements include be configured to protection ablation structure one or more One or more cones at a edge.Each of one or more of cones can have the circumference of the ablation structure than contraction Big basic circumference.In addition, one or more of cones can be configured to it is separate when ablation structure is disposed to engage tissue Ablation structure moves.In some embodiments, ablation apparatus, which may also include, is configured to promote about described in ablation structure movement One or more tethers of one or more cones.
In some cases, one or more of protective elements are configured at least be deployed into body cavity or from body cavity Prevent ablation structure along catheter expansion during removal.One or more of protective elements are configured at least be deployed into body Chamber destroys the surface of body cavity from prevention ablation structure during body cavity removal.
In some embodiments, one or more of protective elements include one or more sides with ablation structure One or more buffers of edge connection.One or more of buffers inwardly hang on the edge of ablation structure towards conduit It hangs down.
According to each embodiment, one or more of protective elements of ablation structure nearside include being connect with conduit Protruding block.The protruding block can be configured to prevent ablation structure swollen to nearside along conduit during being inserted into or being deployed into body cavity It is swollen.
In each embodiment, ablation apparatus further includes the expansion being connect with conduit, wherein the ablation structure It is rolled around expansion.In these embodiments, one or more of protective elements in ablation structure distal side include expanding The agglomerate portion of component is opened, the agglomerate portion is configured to the agglomerate when expansion is not expanded, so that the diameter in agglomerate portion is super Cross the diameter for the ablation structure rolled.The agglomerate portion of expansion can be configured to prevent ablation structure edge during removing from body cavity Conduit distad expands.
In some cases, one or more of protective elements include being located in ablation structure distal side about conduit First protective element, and it is located in about conduit the second protective element of ablation structure nearside.
According to certain embodiments of the present invention, it provides and the tissue in the body cavity with varying dimensions is treated Method.This method generally includes the ablation structure connecting with conduit being inserted into body cavity.One or more protective elements can edge Conduit is located at least distal side or the nearside of ablation structure.This method further includes expanding expansion to be unfolded at least partly Ablation structure, to engage body cavity.Protective element may include being configured to the one of one or more edges of protection ablation structure A or multiple cones.In some cases, this method further includes making one or more when disposing ablation structure to engage body cavity Cone is shifted far from ablation structure.This method further includes utilizing the one or more systems being connect with one or more protective elements Rope, to promote to move one or more protective elements about ablation structure.
In some cases, one or more protective elements are configured to prevent ablation structure during being deployed into body cavity Along catheter expansion.In some embodiments, one or more protective elements include one or more sides with ablation structure One or more buffers of edge connection.One or more of buffers can on the edge of ablation structure inwardly conduit Pendency.
According to each embodiment, what one or more protective elements of ablation structure nearside may include connecting with conduit Protruding block.The protruding block can be configured to that ablation structure is prevented to expand to nearside along conduit during disposing or being inserted into body cavity.
In some cases, one or more protective elements in ablation structure distal side may include the agglomerate of expansion Portion, the agglomerate portion are configured to the agglomerate when expansion is not expanded, so that the diameter in agglomerate portion is more than the ablation rolled The diameter of structure.The agglomerate portion of expansion can be configured to prevent ablation structure distad swollen along conduit during removing from body cavity It is swollen.
In some embodiments, one or more of protective elements include the first protective element, about leading Pipe is located in ablation structure distal side and the second protective element, and ablation structure nearside is located in about conduit.
Front has quite widely summarized the feature and technical advantage of embodiment according to the present invention, it is therefore intended that can be with More fully understand subsequent detailed description.Other feature and advantage are described below.Be easy using disclosed thought and Particular instance is basic to be used for executing the identical purpose of the present invention as changing or designing other structures.These equivalent constructions without departing from The spirit and scope of the appended claims.Be considered as those of the characteristic of thought disclosed herein feature, whether about Their mechanism or operating method, together with related advantage will when considered in conjunction with the drawings from being described below it is more preferable geographical Solution.Each attached drawing is merely provided for illustrating and describes purpose, and not as the restriction to claim boundary.
Description of the drawings
By referring to following accompanying drawings it will be recognized that the property of each embodiment and advantage are further understood.In the accompanying drawings, Similar component or feature can reference markers having the same.In addition, all parts of same type can be by reference marker Afterwards plus dash and distinguishes the second label of similar component and distinguish.When during only the first reference marker is for specification, retouch It states suitable for any one similar component with identical first reference marker and without considering the second reference marker.
Figure 1A is for conveying treatment to the schematic diagram of the system in target treatment region comprising according to each embodiment The component of configuration.
Figure 1B is the schematic diagram of a particular implementation of the system shown in Figure 1A.
Fig. 1 C are the power supply of the system shown in Figure 1A and Figure 1B and the schematic diagram of switching mechanism.
Fig. 2 is the partial schematic diagram of upper digestive tract in human body.
Fig. 3 A are in esophagus in rolling/the schematic diagram of the ablation apparatus of collapsed mode.
Fig. 3 B are the schematic diagrames of the ablation apparatus in expansion/expansion mode in esophagus.
Fig. 4 is in rolling/the perspective view of the ablation apparatus of collapsed mode, the longitudinal electrode areas with multiple wiring respectively Connection.
Fig. 5 is the perspective view of the ablation apparatus in expansion/expansion mode, the longitudinal electrode area with multiple wiring respectively Connection.
Fig. 6 is the perspective view of the partially unfolded ablation apparatus of Fig. 5.
Fig. 7 is the perspective view of the partially unfolded distal portion of the ablation apparatus of Fig. 2, with single spring and same width Multiple longitudinal electrode areas.
Fig. 8 is the perspective view of the partially unfolded distal portion of the ablation apparatus of Fig. 2, with single spring and uniform narrow width Multiple longitudinal electrode areas of degree.
Fig. 9 is the perspective view of the partially unfolded distal portion of the ablation apparatus of Fig. 2, with single spring and is sequentially reduced Multiple variable-length longitudinal electrodes area of width.
Figure 10 A are that the ablation structure of the ablation apparatus of Fig. 2 is in the sectional top view of expansion/expansion mode, with office The electrode district and completely overlapped electrode district of portion's overlapping.
Figure 10 B are that the ablation structure of the ablation apparatus of Fig. 2 is in the sectional top view of expansion/expansion mode, with complete The folded electrode district of full weight.
Figure 11 is the sectional view of the lineation electrode area array pattern of the ablation apparatus of Fig. 2.
Figure 12 is the schematic diagram of the electrode pattern of the ablation apparatus of Fig. 2.
Figure 13 is the sectional view of the ablation structure of the ablation apparatus of Fig. 2.
Figure 14 is the plan view of the ablation structure of the ablation apparatus of Fig. 2, the spring with variable-length.
Figure 15 is the plan view of the fluting spring of the ablation structure of Figure 15.
Figure 16 A are the plan views of the volute spring of the ablation structure of Figure 15.
Figure 16 B are the plan views of the ablation structure of the ablation apparatus of Fig. 2, with volute spring.
Figure 17 is the plan view of the metal spring of the ablation structure of Figure 15, and metal spring includes pin hole.
Figure 18 is the plan view of the ablation structure of the ablation apparatus of Fig. 2, has the variable-length metal spring with pin hole.
Figure 19 A are that the ablation apparatus of Fig. 4 is in and rolls/the perspective view of collapsed mode, with the anti-guard circle of nearside and distal side Bore element.
Figure 19 B are that the ablation apparatus of Fig. 5 is in the perspective view of expansion/expansion mode, with the anti-guard circle of nearside and distal side Bore element.
Figure 20 A are that the ablation apparatus of Fig. 4 is in and rolls/the perspective view of collapsed mode, with distal protection buffer Element.
Figure 20 B are that the ablation apparatus of Fig. 5 is in the perspective view of expansion/expansion mode, with distal protection buffer Element.
Figure 21 is that the ablation apparatus of Figure 20 B is in the perspective view of expansion/expansion mode, the anti-guard circle in distal side with tether Bore element.
Figure 22 is that the ablation apparatus of Figure 20 B is in the perspective view of expansion mode, the nearside with tether and distal side protection Cone element.
Figure 23 A are that the ablation apparatus of Fig. 4 is in and rolls/the perspective view of collapsed mode, with nearside protrusion block element.
Figure 23 B are that the ablation apparatus of Fig. 5 is in the perspective view of expansion/expansion mode, with nearside protrusion block element.
Figure 24 is that the ablation apparatus of Fig. 4 is in and rolls/the perspective view of collapsed mode.
Figure 25 is to illustrate to be used to provide treatment to the flow chart of the method in target site region according to each embodiment.
Figure 26 is to illustrate to be used to provide treatment to the flow chart of the method in target site region according to each embodiment.
Figure 27 is illustrated according to each embodiment using the expansion including one or more protective elements to carry For treating to the flow chart of the method in target site region.
Figure 28 is to illustrate to use the expansion for including one or more movable protective elements according to each embodiment To provide treatment to the flow chart of the method in target site region.
Figure 29 is to illustrate to be used to provide treatment to the flow chart of the method in target site region according to each embodiment.
Figure 30 is to illustrate to use the expansion offer for including one or more protective elements according to each embodiment It treats to the flow chart of the method in target site region.
Figure 31 is illustrated according to each embodiment using the expansion including one or more protective elements to carry For treating to the flow chart of the method in target site region.
Figure 32 is to illustrate to use the expansion for including the movable protective element of one or more tethers according to each embodiment Component is to provide treatment to the flow chart of the method in target site region.
Specific implementation mode
It describes for providing treatment to method, system and the equipment of target site (such as chamber position).System can Including expansion, expansion can be connected to the distal portion of conduit.Ablation structure can be wound around expansion, to expand structure The body cavity of the engageable variable size of expansion of part.
The ablation structure support element for being connected to ablation structure can be positioned on the distal end of conduit.Ablation structure may include flexible electrical Road, the expansion that flexible circuit can be arranged around it are rolled and are unfolded.The various aspects of flexible circuit can be integrated with conventional Circuit is similar with microelectronic device.Flexible circuit may include the multiple separately wiring for being parallel to axis alignment or being separately controlled Longitudinal electrode, longitudinal electrode area, or both, ablation structure around the axis roll configuration and expansion configuration between convert.
Ablation structure may include the longitudinal electrode of variable-width, variable-width longitudinal electrode area, or both.Longitudinally in each Electrode or longitudinal electrode area optionally enable or selectively disable.For the purpose of this application, electrode or electrode are enabled Area has identical meanings with active electrode or electrode district.In some cases, ablation structure includes electrod-array, such as, citing For, bipolar electrode array.
Ablation structure support element can be connected to one or more springs.Spring can be made of a variety of materials, and such as, citing comes It says, metal material or polymer material.Spring is alterable about the position density of ablation structure support element, to weaken one or Grasping effect at multiple ablation structure positions.Spring density can be for example, by including fluting spring, volute spring, and/or can Become the structure of length spring to change.
One or more protective elements can be located in ablation structure distal side and/or ablation structure nearside along conduit.It can slide The circular cone protective element of dynamic movement can be positioned so that the edge that they cover ablation structure support element, to be inserted into and move Except period prevents from scraping body cavity or prevents ablation supporting piece structure expansion.The distal end of tether arrangements can mount to circular cone protectiveness member Part prevents from hindering to roll and be unfolded so that can move protective element after expansion deployment to remove cone Conversion.In some cases, it is connected to ablation less than the flexible distal protective cushion device element for the ablation structure perimeter rolled The longitudinal edge in structure distal-lateral portion.The ablation structure rolled including protective cushion device element can be similar to the normal of endoscope See tubular form.In addition, conduit may include that protruding block, protruding block are located in ablation structure nearside, it is configured to insert in ablation structure Prevent ablation structure along catheter expansion during entering body cavity.In addition, expansion may include the part in ablation structure distal side, Agglomerate when expansion is unexpanded, so that the expansion material of agglomerate prevents during removing ablation structure from body cavity Ablation structure is along catheter expansion.
A referring to Fig.1 is shown according to each embodiment for conveying treatment to the general-purpose system in target treatment region 100.System 100 can be designed to provide treatment to internal targeting regions, such as organ walls or chamber in the digestive tract.System 100 It may include power supply 105, conduit 115 and expansion 120.Expansion 120 is generally configured to support ablation structure 160, Ablation structure 160 can be used for providing treatment to target treatment position.System 100 can be by being located in body by guide assembly 165 It is interior and operated by expansion 120 on guide assembly 165, so that expansion 120 can transport to internal Target treatment position.Power supply 105 then can be used for supplying electric power to the ablation structure 160 being placed in expansion 120, to So that treatment can be applied to target treatment position.
Expansion 120 can be expandable devices, can by using auxiliary expanding mechanism shrink or it is unexpanded Switch between configuration and expansion configuration.Suitable expansion 120 includes but not limited to sacculus, compliant balloon, has taper Sacculus, the bladder of geometry, etc..In some embodiments, power supply 105 is configured to for example by being assisted in internal combustion Expanding mechanism come make expansion 120 expand.Collapsed configuration usually can be inserted into body cavity in expansion 120 and be removed from body cavity When use.When expansion 120 obtain it is expected ablation locations when, expansion 120 can such as by from deflated state (that is, receive Contracting configuration) it is expanded to basic swelling state (that is, expansion configuration) and expands.
Expansion 120 can be configured to support ablation structure 160.In some embodiments, ablation structure 160 is treatment Or diagnostor, such as ablation, ablation energy can be provided to target treatment region.Some ablation structures 160 can design To make them be in direct contact with target treatment region, including ablation structure 160 pressed against to target site.
Expansion 120 can be connected to conduit 115, so that expansion 120 can pass through the body passage of such as esophagus And it is manipulated at target treatment region.Conduit 115 can be connected to power supply/bloating plant 105 at 115 proximal end 145 of conduit. Expansion 120 can be positioned between the distal end 140 of conduit 115 and a part 150 for conduit 115.In some embodiments, Conduit 115 includes opening 175, and opening 175 is configured to allow entering and leaving for guide assembly 165, so that 115 phase of conduit Guide assembly 165 is slideably moved.Guide assembly inlet point 175 can be usually located at the outside of conduit 115 and close to electricity Source 105.
Power supply 105 can provide electrical power to the ablation structure 160 being placed in expansion 120.In some embodiments, electric Power is provided to ablation structure 160 from power supply 105 via one or more transmission lines 170, and transmission line 170 is in power supply 105 and ablation Extend between structure 160 and is contained in the channel of conduit 115.
Figure 1B illustrates system 100-a, can be the reality of the system 100 shown in figure 1A according to each embodiment Example.System 100-a may include generator 105-a, hand-held air compressor 112, the guiding group with distal end 166 and proximal end 167 Part 165, conduit 115, expansion 120, ablation structure 160, and/or the ablation structure support element being connect with ablation member 120 180。
Expansion 120 may include that sacculus, ablation structure support element 180 may be supported on the sacculus.Expansion 120 Can be the flexible material that can be bent or fold, expansion is in expansion usually with the elongate cylinder for including rounded distal Shape.Expansion 120 can be tapered at its proximal end, and is connect with conduit 115 near the part of conduit 115 150.
Arrange that ablation structure 160, ablation structure 160 are configured to provide for controlling in the part on the surface of expansion 120 It treats to target treatment region.Ablation structure 160 may include single electrode, and the single electrode includes multiple electrodes area or horizontal each other To a series of electrodes 169 for the longitudinal axis for adjoining and being parallel to ablation structure 160 and expansion 120.One or more electricity Pole 169 can be that staggeredly, wherein approximately half of electrode extends from the first bus, and approximately half of electrode is total from second Line extends.First bus or the second bus can be connected to positive terminal, and another of the first bus or the second bus can It is connected to negative terminal or ground terminal, and then bipolar electrode configuration is provided.It is one or more when being connected to power supply 105-a Electrode 169 can provide ablation energy to target treatment region.
Expansion 120 can be connected to the part 150 close to distal end 140 of conduit 115.Ablation structure support element 180 can It is rolled with the excircle at least partially about expansion 120, so that when expansion 120 is expanded, ablation structure branch Support member 180 is suitable for changing perimeter, and ablation structure 160 maintains the constant electrode density of each unit area.One group of transmission line 170-a passes through the channel of conduit 115 to extend to ablation structure 160 from power supply 105-a.From power supply 105-a and/or from being configured to The switching printed circuit board in other one or more channels of driving carrys out control area activation.
C referring now to fig. 1 diagrammatically illustrates the power supply 105-b according to each embodiment.Power supply 105-b can be The example of the power supply 105 or 105-a of A or 1B descriptions referring to Fig.1.In general, power supply 105-b may include power switching mechanism 190, power switching mechanism 190 is configured to open and close longitudinal electrode area, therefore controls treatment site energy at least partly Measure sequence, time setting and the duration of conveying.For example, power switching mechanism 190 may include RF producing element 181, RF producing element 181 is configured to transmit RF energy in one or more output channels 186 to power switching element 192, wherein RF energy 198 is then re-routed to multiple longitudinal electrode areas by the power switching element 192.In some implementations, electric power is cut Converting mechanism 190 is the external component for being communicatively connected to power supply 105-b and conduit 115.In other situations, power switching mechanism 190 are integrated to and/or are connected to conduit 115.In some cases, the combiner of conduit 115 and switching mechanism 190 is single The disposable unit used.
In some cases, the quantity in the longitudinal electrode area of the restriction of ablation structure 160 is less than or equal to by power supply 105-b The quantity of the RF channel 186 of support, wherein the longitudinal electrode area each limited is connected to single RF channel 186.In the configuration, Switching mechanism 190 is communicatively coupled the path management module 183 integrated with power supply 105-b.Path management module 183 may include Microprocessor 184 and memory 182.Switching mechanism 190 may also comprise microprocessor 195 and memory 194.Path management module 183 bootable switching mechanisms 190 enable or disable and one or more according to the one or more algorithms stored in memory 182 The associated RF channel of electrode district 186.In some cases, the ablation parameter of such as impedance can be communicated to electricity by switching mechanism 190 Source 105-b determines for algorithm.
In certain implementations, the quantity of the electrode district of restriction is more than the quantity by the power supply 105-b RF channels 186 supported. For example, RF producing element 181 can support maximum 3 channels RF 186, wherein ablation structure 160 to may include 6 (for example, see Fig. 1) The electrode district of a wiring respectively.In these cases, RF producing element 181 can be configured to only upload in an output channel 186 Defeated RF energy is to power switching element 192, and wherein the power switching element 192 then re-routes RF energy to multiple longitudinal electrodes Area.Alternatively, RF producing element 181 can be configured to transmit RF energy in multiple output channels 186 to reversed multiplexer 191, wherein the reversed multiplexer 191 is for example by re-routing the shared return of bipolar DC system come the number of extended channel 197 Amount.
Additionally, or alternatively, power supply 105-b can be configured on one or more channels 186 simultaneously or with limit Determine sequential delivery RF energy.In some embodiments, switching mechanism 190 by block from the transmission of RF producing element 181 come Open or close RF output channels 186.Switching mechanism 190 may include power switching element 192, such as, for example, metal oxygen Compound semiconductcor field effect electric transistor or relay.In some cases, isolation element 193 is located in power switching element 192 Between logic element or microprocessor 195 and memory 194.In some cases, path management module 183 is by longitudinal electrode Area's activation sequence is communicated to power switching element 192, and power switching element 192 blocks or allowed according to the sequence received RF is transmitted, and to the activation of energy conveying, time setting at control and 186 relevant longitudinal electrode area of RF channel and is continued Time.Additionally, or alternatively, switching mechanism 190 can be based at least partially on the algorithm stored in memory 194 and determine Independently of the longitudinal electrode area activation sequence of power supply 105-b.
In some cases, other signals that 190 monitoring current of switching mechanism and/or interpretation are communicated from power supply 105-b with Partly determine when to open or close channel.In addition, or alternatively, power supply 105-b can pass through one-way or bi-directional communication Channel 185 controls the switching behavior of switching mechanism 190, and the channel 185 connects power logic element 184 and switching mechanism Logic element 195.In certain implementations, power supply 105-b can be received from switching mechanism 190 to be fed back, such as, for example, receive To switching command and/or perform the confirmation of guided switching behavior.Communication between logic element 184,195 can execute Set communication protocol, such as, for example, I2C or SPI.
Ablation of tissue can lead to the variation of impedance for the non-ablation tissue of the tissue contrast.Such as identical and/or not Same therapentic part region, probe sensor is by by the impedance in therapentic part region and previous impedance data comparison, can be used for Determine the ablation condition in circumference therapentic part region.The data are subsequently used in selection for one or more longitudinal electrodes region State of activation and/or activation the duration.It will be appreciated by persons skilled in the art that can lead to outside power supply 105-b Believe connection one or more computer equipments on execute these and other automatically select algorithm.For example, other computers are soft Region and/or overlapped electrodes section that part (such as image analysis software) can be used for previously having melted are identified as a part for algorithm, The activation in algorithm management related electrode region and/or energy convey distribution curve.
Referring now to Fig. 2, certain diseases can cause stomach or intestinal contents from 212 reflux of stomach to esophagus 214, such as arrow A and B institute Show.Although the origin cause of formation of these problems is variation, reflux can lead to secondary disease, such as Barrett esophagus, this need with Protopathy --- treat independent and very different treatment needed for such as disease of lower esophageal sphincter 216.Barrett esophagus It is inflammatory lesion, wherein entering lower esophagus from the hydrochloric acid in gastric juice of stomach and duodenal regurgitation, bile acid and enzyme, this is caused to esophageal mucosa Damage.When such reflux sufficiently frequently occurs, which can occur to esophageal epithelial 218.At some In situation, which leads to the change of squamous cell, and it is the specific columnar epithelial cell of higher 220 so that them is changed.Mucosal epithelium Metaplasia lesion from squamous cell to columnar cell is referred to as Barrett esophagus.Although some columnar cells are benign, and its His columnar cell can lead to gland cancer.
In some embodiments, described method, system and device configuration are to treat esophagus by ablation of tissue The columnar epithelium at selected position.Term " ablation " is here used for referring to the pyrolytic damage to tissue, causes tissue or cell Necrosis.It will be understood by those skilled in the art that desired therapeutic effect of some treatment procedures with insufficient ablation, such as, For example, tissue can be applied to ensure the certain level of the cyto-architectural expectancy changes of tissue disturbance or damage, Rather than tissue necrosis.In some cases, it is imitated using a variety of different energy delivery devices to generate the treatment of tissue shallow-layer Fruit, and the intact of deeper function is protected, this will be described below.
By using in a suitable level of energy (such as RF energy) to complete mucous membrane tissue or submucosa tissue It melts and retains muscle layer tissue substantially, to realize cell or tissue necrosis.It can be using the ablation come from infected esophagus 214 Part removes columnar growth 220.
Referring now to Fig. 3 A and Fig. 3 B, expansion 120 can be inserted into vivo, such as including guide assembly in various ways 165 placements, endoscope placement, surgical operation or by other means.Expansion 120 can be the expansion of Figure 1A and/or Figure 1B Open the example of component 120.Referring now to Fig. 3 A, according to each embodiment, expansion 120 is shown as collapsed configuration.Expansion Component 120 is configurable to convert between expansion configuration shown in the collapsed configuration shown in and Fig. 3 B.In expansion configures, expand Opening at least one size of component 120 can increase.In each embodiment, expansion configuration is significantly more than collapsed configuration, and Allow 160 contact treatment surface of ablation structure, such as columnar epithelial cell 220-a and/or 220-b.Ablation structure 160 can be Endoceliac therapentic part is delivered to when contraction state.Little profile configuration is permissible to simply access therapentic part without causing The uncomfortable or complication of patient.When using endoscope (not shown), the part 150 of conduit 115 can be fixed on the outside of endoscope Position.Alternatively, endoscope can be used for visualizing the path that expansion 120 should follow during placement.Guiding The distal end 166 of component 165 can along endoscope outer side positioning and endoscope removal after remain within the body cavity.Guide assembly 165 Proximal end 167 is can be plugged into (for example, see Figure 1B) in the distal end 140 of conduit 115, and conduit 115 follows 165 institute of guide assembly Determining path is inserted into esophagus.
Ablation structure 160 can be provided and be connected to expansion 120, and positioned close to the part 150 of conduit 115. In some cases, expansion 120 is bound to the part 150 of conduit 115.Ablation structure 160 may include one or more electricity Pole 169.One or more electrodes 169 may be arranged to have equal or varying width multiple longitudinal electrode areas 161,162.Institute It states one or more electrodes 169 and can be connected to power supply 105 (referring for example to Figure 1A), power supply 105 is configured to one or more electricity Pole and/or longitudinal electrode area 161,162 are suitable for providing predetermined tissue depth the horizontal energy supply of ablation of tissue.
In some embodiments, ablation structure 160 includes flexible unaugmentable liner.For example, ablation structure 160 can Including thin, rectangle sheets of polymer material, such as polyimides, polyester or other flexible thermoplastics or thermosetting polymer are thin Film.Ablation structure 160 may also include polymer overmold material or other non-conducting materials.In addition, liner may include that electrical isolation is poly- Object is closed, wherein the conductive material of such as copper deposits on the surface so that electrode pattern can etch on the material to form electricity Pole array.
Ablation structure 160 can directly contact be operated with tissue site wall.This can be by connecting ablation structure 160 It is realized to expansion 120, expansion 120 has to follow the shape of chamber size in the therapentic part of esophagus under such as human body The configuration of shape expansion.Ablation structure 160 can be positioned so that energy and be evenly applied to it is expected the inner periphery of the chamber for the treatment of.This can To be realized by the way that expansion 120 with collapsed configuration is located in therapentic part first, wherein ablation structure 160 is around expansion structure Part 120 is rolled.Once the equipment advances to proper site, expansion 120 can be expanded, to by ablation structure 160 from volume The state of rising is converted to unfolded state, to the inner wall of engagement cavity.
With reference to Fig. 3 B, the inner wall of the equably engagement cavity of ablation structure 160, wherein one or more electrode districts 161,162 tool There is constant density, so that energy can be evenly applied to esophagus or all or part circle of other tissue site inner cavities Week.Expansion 120 can be for example including sacculus, and such as compliant balloon and/or the sacculus with taper geometry, sacculus exist Expansion configuration is expanded to when expansion.
In some embodiments, as the expansion of expansion 120 and ablation structure 160 are unfolded, other electrode or The exposure below the overlapping portion of ablation structure 160 181 of electrode district 163.One or more longitudinal electrodes 169 and/or longitudinal electrode The selective enabling in area 161,163 allows the total surface region of ablation structure 160 to be divided, to adapt to certain power of power supply Limitation, and suitable energy density is provided in turn to tissue.The deployable circumference for being more than expansion component 120 of ablation structure 160 Arc length distance realizes seamless circumferential ablation so that when expansion 120 is expanded for the body cavity of various sizes.
Ablation structure 160 can be positioned, and energy is applied to the inner periphery of body cavity therapentic part.This can be by first will Expansion 120 is positioned with collapsed configuration and is realized to therapentic part.Once ablation structure 160 advances to suitable therapy section Position, expansion 120 can be expanded, and ablation structure 160 is promoted to engage the inner wall of body cavity.It then can be by selectively opening Desired treatment energy is delivered to tissue with one or more longitudinal electrodes and/or longitudinal electrode area 161,162,163.? In some situations, all longitudinal electrodes and/or longitudinal electrode area 161,162,163 sequentially enable, from close to ablation structure 160 free edge or the longitudinal electrode of overlapping edge 181 and/or longitudinal electrode area 161 start.Full masking longitudinal electrode and/ Or the detection in longitudinal electrode area can stop other longitudinal electrodes and/or longitudinal electrode area that energy is delivered in the sequence, this is Because other longitudinal electrodes and/or longitudinal electrode area are not contacted with bodily cavity tissue.
In some embodiments, ablation structure 160 conveys various types of energy, including but not limited to radio frequency energy Amount, microwave energy, ultrasonic energy, resistance heating energy, chemical energy, heating liquid energy, optical energy are (including but unlimited In ultraviolet light, visible light, infrared ray, collimation or non-collimated, relevant or incoherent or other luminous energy) etc..
Referring now to Fig. 4, show that the conveying that is used for according to the collapsed configuration of each embodiment is treated to target treatment The distal portion of the general-purpose system 400 in region.System 400 can be the system 100 that A or 1B is described referring to Fig.1 or the reality of 100-a Example, and may include conduit 115, the expansion being connect with conduit 115 120 and the ablation knot rolled around expansion 120 Structure 160.In order to engage the inner surface for the body cavity for being more than 120 contracted diameter of expansion, expansion 120 can expand (example Such as, referring to Fig. 5) until applying desired pressure on cavity wall.Expansion 120 can be expanded so that being applied to the pressure of body cavity Power is less than the pressure that can lead to damage (such as tearing or puncture chamber).Although the exposed surface area of ablation structure 160 is with expansion Component 120 is expanded and is increased, and the electrode or electrode district individually or sequentially enabled can maintain the perseverance on 160 surface of ablation structure Fixed electrode density.The energy (including but not limited to RF signals) for being delivered to electrode or electrode district provides in each region accurate group Knit the uniform treatment of depth.After having been carried out treatment, expansion 120 can be shunk and system is removed from body cavity.
In some embodiments, ablation structure 160 includes big single electrode, is divided into uniform or variable-width phase Adjacent longitudinal electrode area 161,162, adjacent longitudinal electrode area 161,162 are configured to reduce ablation areas overlapping degree and therefore subtract Few degree excessively melted.Longitudinal electrode area 161,162 can by power supply 105 (for example, see Figure 1A) and longitudinal electrode area 161, The plurality of transmission lines 170 extended between 162 is selectively enabled.Ablation structure 160 may include the electrode array etched on its surface Row 163, and can be arranged between the distal end of expansion 120 404 and proximal end 402.
Referring now to Fig. 5, the system 400 configured according to each embodiment, with reference to the expansion of Fig. 4 descriptions is shown.When When expansion 120 is inflated or expands, ablation structure 160 is unfolded, and exposes electrode 504,506.The longitudinal direction of ablation structure 160 Electrode 502,504,506 can be more by extending between power supply 105 (for example, see Figure 1A) and longitudinal electrode 502,504,506 Transmission lines 170 are selectively enabled.For example, isolation transmission line 170-a, 170-b, 170-c can respectively be wired to electrode or Electrode district 502,504,506.These lines can respectively with the pyrocondensation pipe insulation along 115 whole length of conduit.Every line can be whole The mini connector plug or switching printed circuit board controller of power supply 105 are terminated in, which is configured to leading to except power supply 105 Transmission channel is also driven except road.Under in such a configuration, electric power is optionally delivered to one or more electrodes or electrode district, from And allows to give along the specific region of ablation structure 160 and treat.Switching printed circuit board may include on conduit 115, The outside of power supply 105 or in power supply 105.
In some embodiments, ablation structure 160 is configured so as to be located at 160 free end 181 of ablation structure One or more longitudinal electrodes or longitudinal electrode section have than closer to remaining longitudinal direction of 160 binding end (not shown) of ablation structure The width of electrode or longitudinal electrode section bigger.When the chamber size (such as in the situation of esophagus be about 16mm) of expectable minimum When, it can be used as being located in one or more near 160 free end 181 of ablation structure corresponding to the arc length of the minimum dimension circumference A wider longitudinal electrode or the width in longitudinal electrode area.For example, if maximum cavity dimension is 37mm, one or more electrodes it is total Arc length may be calculated 37*pi=116mm.In the situation of the single electrode with multiple longitudinal electrode areas, it is equal to minimum The electrode zone of the arc length (16*pi=50mm) of chamber size can be configured to each two electrode zones with 25mm width.Its Remaining region may include one group narrow width electrode region, for example, 7 electrode zones of each 10mm.With use one group of fixed width Region is compared, this can lead to the reduction of overall area quantity, and the potential region of ablation structure overlapping is continued to provide narrow width Region.
Referring now to Fig. 6, show according to each embodiment for convey treat it is general to target treatment position System 600 is in the distal portion of collapsed configuration.System 600 can be referring to Fig.1 A, 1B, 4 or 5 description system 100,100-a, Or 400 example, and may include conduit 115, the expansion being connect with conduit 115 120 and ablation structure 160.Ablation knot Structure 160 is shown as the partially unfolded configuration to show the bottom side of ablation structure 160.Ablation structure 160 can connect ablation structure support Part 180, ablation structure support element 180 combine or are attached to expansion 120.For example, the first end 612 of ablation structure 160 can In conjunction with or be attached to expansion 120.Along the contact area between the first end 612 and expansion 120 of ablation structure 160 Whole length or partial-length can implement to bond.In some cases, occur when expansion 120 is in expansion configuration viscous It is attached.The inner surface of ablation structure 160 may include the spring 602,604,606,608 of four variable-widths, they are from ablation structure The first edge 612 of 160 combination extends vertically, and perpendicular to the longitudinal axis of expansion 120, is configured so that part The free end 181 of spring density towards ablation structure 160 linearly increases.Ablation structure 160 may include single electrode, single electrode segmentation For the longitudinal sections 502,504,506,610 with one or more variable-widths.The free edge 181 of neighbouring ablation structure 160 Longitudinal electrode section 502 can have more than other longitudinal electrode sections 504,506,610 width.Longitudinally in each electrode section 502, It 504,506,610 can be by being isolated with the wiring construction for other longitudinal electrode sections 170-a, 170-b, 170-c, 170-d Wiring construction and be connected to power supply 105 (for example, see Figure 1A).
In some embodiments, ablation structure 160 includes big single electrode, and big single electrode is divided into uniform width Adjacent longitudinal electrode area, the adjacent longitudinal electrode area of uniform width are configured to mitigate the overlapping degree of ablation areas and therefore mitigate The degree excessively melted.When not knowing the chamber of minimum dimension, such as when ablation system is for various different body cavitys, this is uniform Width configuration is useful.Referring now to Fig. 7, show according to each embodiment for conveying treatment to target treatment portion The general-purpose system 700 of position is in the distal portion of collapsed configuration.System 700 can be the system of A, 1B or 4-6 description referring to Fig.1 100, the example of 100-a, 400 or 600, and may include conduit 115, the expansion being connect with conduit 115 120 and disappear Molten bonding structure 160.Ablation structure 160 is shown as the partially unfolded configuration to show the bottom side of ablation structure 160.Ablation structure 160 can Ablation structure support element 180 is connected, ablation structure support element 180 combines or be attached to expansion 120 along jointing edge 722. The bottom side of ablation structure 160 may include that single spring 720, single spring 720 are vertical from the combination side 722 of ablation structure 160 Start to extend in the longitudinal axis of expansion 120.Single electrode can be divided into longitudinal region 702 with uniform width, 704,706,708,710,712,714,716,718.Longitudinally in each electrode zone 702,704,706,708,710,712,714, It 716,718 can be by the wiring construction be isolated with the wiring construction of other longitudinal electrode sections 170-a, 170-b, 170-c, 170-d The wiring constructions of isolation (other be not shown) and be connected to power supply 105 (for example, see Figure 1A).
In some embodiments, ablation structure 160 includes big single electrode, and big single electrode is divided into uniform narrow width Spend, be, for example, less than 10mm width adjacent longitudinal electrode area, adjacent longitudinal electrode area be configured to mitigate ablation areas overlapping journey It spends and therefore mitigates the degree excessively melted in the region that there is overlapping.Referring now to Fig. 8, show according to each embodiment party The distal portion for being in collapsed configuration to the general-purpose system 800 at target treatment position for conveying treatment of formula.System 800 can be Referring to Fig.1 A, 1B or 4-7 description system 100,100-a, 400,600 or 700 example, and may include conduit 115, with The expansion 120 and ablation structure 160 that conduit 115 connects.Ablation structure 160 is shown as the partially unfolded configuration, to show Go out the bottom side of ablation structure 160.Ablation structure 160 can connect ablation structure support element 180, and ablation structure support element 180 is along knot It closes side 812 and combines or be attached to expansion 120.The bottom side of ablation structure 160 may include single spring 820, single spring 820 extend since the combination side 812 of ablation structure 160 is perpendicular to the longitudinal axis of expansion 120.Single electrode can divide It is segmented into the longitudinal region 802,804,806,808,810 with uniform width.Longitudinally in each electrode zone 802,804,806, It 808,810 can be by the wiring construction be isolated with the wiring construction of other longitudinal electrode sections 170-a, 170-b, 170-c, 170-d The wiring constructions of isolation (other be not shown) and be connected to power supply 105 (for example, see Figure 1A).
In some embodiments, ablation structure 160 includes big single electrode, and big single electrode, which is divided into, to be had and can broaden The adjacent longitudinal electrode area of degree, adjacent longitudinal electrode area are configured to mitigate ablation areas overlapping degree and therefore mitigate excessively ablation Degree.Referring now to Fig. 9, show according to each embodiment for conveying treatment to the general system at target treatment position System 900 is in the distal portion of collapsed configuration.System 900 can be the system 100 that A, 1B or 4-8 are described referring to Fig.1,100- A, 400,600,700 or 800 example, and may include conduit 115, the expansion being connect with conduit 115 120 and ablation Structure 160.Ablation structure 160 is shown as the partially unfolded configuration to show the bottom side of ablation structure 160.Ablation structure 160 can connect Ablation structure support element 180 is connect, ablation structure support element 180 combines or be attached to expansion 120 along combination side 914.Ablation The bottom side of structure 160 may include a spring 916, and a spring 916 is from the combination side 914 of ablation structure 160 perpendicular to expansion The longitudinal axis for opening component 120 starts to extend.Single electrode can be divided into longitudinal region 902 with variable-width, 904, 906,908,910,912.The adjacent longitudinal electrode area 912 extended since the free edge 181 of ablation structure 160 is on the width It is linear to reduce until reaching minimum widith, such as, for example, 10mm.All follow-up adjacent longitudinal electrode areas 902,904, 906,908,910 can have the width equal to minimum widith.Electrode section 902,904,906,908,910,912 can longitudinally in each Pass through wiring construction (other isolation being isolated with the wiring construction of other longitudinal electrode sections 170-a, 170-b, 170-c, 170-d Wiring construction be not shown) and be connected to power supply 105 (for example, see Figure 1A).
0A and Figure 10 B referring now to fig. 1 show ablation structure 160 and expansion 120 according to each embodiment Sectional view.Ablation structure 160 can be the example in conjunction with the ablation structure 160 of the description of Figure 1A, 1B, 4 and/or 5.As indicated, Ablation structure 160 can be attached to expansion 120 at first end 1012 (adherency is not shown).The free end of ablation structure 160 181 can roll around expansion 120, one or many to be overlapped binding end 1012.As expansion 120 is expanded, ablation Structure 160 is unfolded and further exposes previously to be ablated to other electrodes or electrode that the overlapping portion 181 of structure 160 is covered Area.
At any given swell diameter, one or more electrodes or electrode district can be contacted with treatment tissue area, and One or more electrode sections can be contacted with the insulating cell of ablation structure 160 or ablation structure support element 180.Electrode trace can lead to Cross such as conductive material of brine, mucus or tissue coagulation bridge joint.In no mitigation structure or program, these material meetings It is contacted with the insulating cell of ablation structure 160.This can will be used for tissue when using single electrode and/or when circumferential orientation zone of ablation The energy for the treatment of is discharged, to reduce predetermined power conveying and reduce density/ablation of tissue less than threshold level in turn Depth.In some embodiments, longitudinally in each electrode or longitudinal electrode area be independent control, independent wiring, or both have concurrently, So that electrode or longitudinal electrode area be not by by ablation structure covering and/or by the conduction of such as liquid or tissue longitudinally in each The present or absent influence of the electrode district of coating substance.The gross energy for being delivered to electrode longitudinally in each or longitudinal electrode area can The ablation parameter (such as, for example, with the parameter that ablation catheter system is used together) developed according to this field is based on vertical It is calculated to electrode or the gross activity surface area in longitudinal electrode area.
The free end 181 of usual ablation structure 160 is completely or partially overlapped one or more longitudinal electrodes area.Work as electrode Section 1006 is only partially exposed (that is, the overlapping portion 181 for being partly ablated to structure 160 covers) (as shown in Figure 10 A) and therefore When only partially being contacted with tissue treatment area, energy 1002 can transport to treatment region, and energy 1004 can transport to ablation and tie The liner of structure 160, this can cause energy conveying distribution curve to deviate from expected energy conveying distribution curve, thus will be excessive Energy is delivered to treatment tissue area.Configure longitudinal electrode or longitudinal electrode section so that longitudinal electrode that innermost part is exposed or The width in longitudinal electrode area is no more than the predetermined percentage for the treatment of region perimeter (such as, for example, about 20%), this can mitigate The effect.
Various methods can be used and (such as scheme with the longitudinal electrode of part masking or longitudinal electrode area to limit excessive be delivered to The electrode district 1006 of 10A) contact tissue treatment area energy degree.Path management module can wrap (for example, with reference to Fig. 1 C) Computer instruction is included, computer instruction is configured to from the longitudinal electrode or longitudinal electrode close to 160 free edge 181 of ablation structure Area 1008 starts sequentially to enable each adjacent longitudinal electrode or longitudinal electrode area.Computer instruction can also be set to execute resistance Anti- measurement and calculating, so that degree of ablation can be controlled in real time.The longitudinal electrode locally covered or longitudinal electrode area 1006 Can usually have impedance more higher than non-obstructing longitudinal electrode or longitudinal electrode area (area 1010 shown in such as 10B).It is enabling Longitudinally in each before electrode or longitudinal electrode area, the impedance in electrode or longitudinal electrode area can be obtained with first proparea longitudinally in each resistance Anti- measurement comparison.The detection of more high impedance can be partially enclosed (for example, 1006 of Figure 10 A) or completely enclosed (for example, figure The 1007 of 10B) electrode or electrode district instruction.Computer instruction can also be set to reduce ablation time and/or reduce defeated Send the low-voltage to the determining partially completely closed electrode of the detection by higher starting impedance or electrode district 1006,1007. Computer instruction can also be set and detect first partly or completely totally enclosed electrode or electrode district 1006,1007 to terminate in The sequence starting of electrode or electrode district 1014,1016 later.Longitudinal electrode or longitudinal electrode area are not covered in addition to having to be more than Outside the starting impedance of 1010 impedances, enclosed-electrode or electrode district 1006,1007 are usually subjected to comparison and do not cover longitudinal electrode or vertical Increased impedance rate of change for electrode district 1010.Impedance rate of change during computer instruction can be set melting with The impedance rate of change formerly melted from same patient or previous patient compares, and the detection of wherein higher impedance rate of change refers to Show that the electrode currently enabled or electrode district may be what part was covered.Computer instruction can also be set to reduce ablation time And/or reduce the voltage for being delivered to enclosed-electrode or electrode district.
1A to Figure 11 C referring now to fig. 1, therapy section in length that electrode pattern can be based on position to be treated, oesophagus situation At position under mucous membrane and mucous membrane depth and other factors and change.Electrode pattern 1102-1208 can be the electrode of Fig. 4 and Fig. 5 The example of electrode pattern included by array 163.Electrod-array pattern can be made of specific electrode member, specific electrode member Part can be with various deployment arrangements, such as, for example, circumferential orientation or portrait orientation.Electrode member is the conduction of electrod-array Element.In some cases, electrode member is aligned in parallel with each other.The density of electrode member can influence the depth of ablation. Longitudinal electrode or longitudinal electrode area pattern can be across one or more electrodes in an axial direction or horizontal direction alignment, or are formed as line Property or non-linear parallel matrix or a series of bipolar pair or monopolar electrodes.One or more different patterns can be connected to ablation structure 160 each position.For example, as shown in figures 11A to 11c, electrod-array may include bipolar axially staggered finger electrode 1102, the pattern with the unipolar rectangular 1104 of 1mm spacing or six bipolar rings 1106 with 2mm spacing.It can use Other suitable RF electrode patterns, the pattern shown by including but not limited to Figure 12 A- Figure 12 D.Pattern can be for example including having The bipolar axially staggered finger electrode 1202 of 0.3mm spacing, the monopole band 1204 with 0.3mm spacing, with 0.3mm spacing Bipolar ring 1208, and/or corrugated electrode 1206 with 0.2548mm spacing.
Operator controls treatment depth by selecting suitable treatment parameter, this will be retouched in example illustrated herein It states.The parameter that can influence treatment depth is the density of electrode member.With electrode member spacing reduce, when RF energy with When double pole mode conveys on the electrode, the treatment depth of influenced tissue is also reduced.Very close electrode member spacing can limit The Ohmic heating of electric current and generation for shallow depth, damage and heating to make submucosa minimize.For using RF Energy carries out the treatment of esophageal tissue, it may be desirable to which the interval having between adjacent electrode elements is no more than (i) 3mm, (ii) 2mm, (iii) 1mm, (iv) 0.5mm, (v) 0.3mm, (vi) 0.1mm, etc..
In each embodiment, the interval between the size and electrode member of electrode, which is chosen to be, can carry out controllable depth Degree ablation.United States Patent (USP) No.6,551,310 (Ganz etc.), 7,150,745 (Stern etc.), 7,344,535 (Stern etc.), 7,530,979 (Ganz etc.), 7,993,336 (Jackson etc.), 8,012,149 (Jackson etc.), 8,192,426 (Stern Deng), the electrode configuration described in 8,439,908 (Utley etc.) and 8,398,631 (Ganz etc.) for controllable depth ablation Example, their full content all things considered is included herein by reference.In each embodiment, power generator And/or path management module is configured to apply to control energy by using ablation structure 160 (for example, see Fig. 1 C), with reality The ablation of tissue of existing controllable depth.
Although being described according to the electrod-array melted for RF, it will be appreciated by persons skilled in the art that Ablation structure suitable for being used together with embodiment as described herein can be configured to give the treatment or diagnosis of other forms. For example, techniques as described above can be used to form the antenna for microwave ablation.In another example, operating member may include covering Cover the sensor element of expansible support element equipment.Monopole RF configurations can be additionally used in some embodiments.Some embodiments It is configured using bipolar RF.
In each embodiment, ablation structure as described herein is ablation apparatus, and in some embodiments, institute The ablation structure of description is RF ablation apparatus.In each embodiment, ablation structure as described herein is configured to heat and disappears Melt.In some embodiments, ablation structure as described herein is configured to through resistance heating or conduction come circumference group It knits.The embodiment of ablation structure as described herein can be configured to that surrounding tissue is treated or diagnosed by other mode.
In each embodiment, ablation structure as described herein is configured to the ablation of abnormal structure in esophagus.? In some situations, ablation structure as described herein is configured to the ablation of abnormal structure in esophageal sphincter.In certain realities Shi Zhong, ablation structure as described herein be configured in the case where not damaging the mucous membrane of lower layer carry out Barrett esophagus and/ Or the ablation organized before cancer in epithelial tissue.In some embodiments, ablation structure as described herein is configured to various Road body cavity and organ, including but not limited to stomach and intestine (GI) (for example, esophagus or duodenum), alimentary canal, digestive system (for example, Bile duct), cardiovascular system, internal system (for example, pancreas) and respiratory system.
In each embodiment, ablation structure as described herein is configured to ablation tissue to predetermined depth.At some In situation, ablation structure as described herein is configured to submucous tissue of the ablation mucous membrane tissue without damaging lower layer.Certain In situation, ablation structure as described herein is configured to muscle layer of the ablation mucous membrane tissue without damaging lower layer.In some implementations, Ablation structure as described herein is configured to not extend over esophageal mucosa to a suitable level of energy of tissue application to realize The depth of ablation of lower layer.In some embodiments, ablation structure as described herein is configured to control depth of ablation to upper Skin tissue.In some cases, ablation structure as described herein is configured to epidermis ablation.For example, ablation structure is each Embodiment is configurable to cauterise tissue surface.In some cases, ablation structure as described herein is configured to convey and fill Divide energy to initiate the regeneration in such as mucous layer.
Each factor, such as power and treatment time can be based on by controlling depth of ablation.In each embodiment, power supply with The enough energy and grace time amount of ablation tissue to predetermined depth activate longitudinal electrode or longitudinal electrode area.Illustrative In embodiment, power supply to convey between about 1 coke/square centimeter and about 50 cokes/square centimeter, about 10 cokes/square centimeter peace treaty Between 40 cokes/square centimeter, between about 15 cokes/square centimeter and about 105 cokes/square centimeter, about 25 cokes/square centimeter peace treaty Between 105 cokes/square centimeter, between about 30 cokes/square centimeter and about 105 cokes/square centimeter, about 35 cokes/square centimeter peace treaty Sufficient energy needed for energy between 105 cokes/square centimeter or between about 40 cokes/square centimeter and about 105 cokes/square centimeter Amount and time span activate one or more longitudinal electrodes or longitudinal electrode area.In some embodiments using other The energy of per unit area.
In each embodiment, power supply 105-a can be configured to (for example, see Figure 1B) conveying about 10 watts/square centimeter and Between about 50 watts/square centimeter, between about 10 watts/square centimeter and about 40 watts/square centimeter, about 10 watt/square centimeter peace treaties Between 30 watts/square centimeter, between about 15 watts/square centimeter and about 30 watts/square centimeter or about 15 watt/square centimeter peace treaties Energy between 40 watts/square centimeter.In some embodiments using the energy of other per unit areas.
In some cases, power supply 105-a be configured to activation longitudinal electrode or longitudinal electrode area about 10ms and about 5 minutes it Between, between about 100ms and about 1 minute, between about 100ms and about 30 second, between about 10ms and about 1 second, about 100ms and about 1 second Between or about 300ms and about 800ms between.In some embodiments, power generator is configured to active electrode less than 1 Second is less than 500ms or is less than 300ms.In some implementations, power configuration be convey about 40 watts/square centimeter energy about The duration of 300ms to about 800ms.In some embodiments, power configuration is to convey about 12 cokes/square centimeter to about 15 The duration of the energy of coke/square centimeter about 300ms to about 800ms.In some embodiments using other per units The energy and time quantum of area.
In some cases, ablation structure support element 180 is rolled around the longitudinal axis spiral of expansion 120.Electrode figure Case can across pad it is in an axial direction or laterally aligned, formed linearly or nonlinearly parallel array or it is a series of it is bipolar to or other conjunction Suitable pattern.Referring now to fig. 13, show according to the expansion 120 of each embodiment, ablation structure support element 180, with And the sectional view of ablation structure 160.In some embodiments, ablation structure support element 180 includes flexible nondistensible lining Pad.For example, liner may include thin, rectangle sheet of polymeric material, such as polyimides, polyester or other flexible thermoplastics or heat Solidity thin polymer film, polymer overmold material or other non-conducting materials.Liner may also include electric insulating copolymer, wherein The conductive material deposition of such as copper is on the surface.Ablation structure 160 can be formed by metal layer 1310, and metal layer 1310, which can be used, appoints What known technology (such as using the etching of mask) is etched to include electrode pattern.
One or more constant force springs 1304,1306 can be attached to flexible liner 1302 by application adhesive 1308. Polytetrafluoroethylene film in a lateral erosion and can be adhered to the spring side of ablation structure 160.Entire ablation structure 160 can be laminated Match to reduce conversion to expansion for rolling transition period reduction friction between configuration and expansion configuration for thin slice Set required pressure.Other methods construction ablation structure 160 and ablation structure support element 180 can also be utilized.In some situations In, ablation structure support element 180 includes the shape-memory polymer spring made of polymeric thermoplastic material, for example, citing comes It says, amorphous thermoplastic's polyetherimide or the organic polymer thermoplastic material for coming autohemagglutination aryl ketone race.Entire lamination ablation Structural support 180 can be heat-treated to realize stable final spiral structure.In an alternate embodiment, gold can be used Belong to spring, such as spring made of surgical operation stainless steel.Metal spring is configured so that with coil before being laminated can To keep stable spiral structure.
Referring now to fig. 14 to 17, it shows and the various knots that spring density locally reduces is used for according to each embodiment Structure.Referring now to fig. 14, the spring 1402,1404,1406,1408 of four variable-lengths is connected to ablation structure support element 180 Inner insulative surface.Ablation structure support element 180 can be the ablation structure support element 180 of Figure 1B, 6,7,8,9, and/or 13 Example.The spring 1402,1404,1406,1408 of variable-length is arranged so that the remote of one or more springs 1404,1406 End 1410,1412 and the free end 181 of ablation structure support element 180 are not attached to.In some embodiments, one group of four bullet Spring include equal length two longer springs 1402,1408, a spring 1406 of short length and length be less than it is longer The length of spring 1402,1408 but more than shorter spring 1406 length a spring 1404.Ablation structure support element 180 Spring density near free end 181 can be the half of spring density near binding end 1415.In some cases, spring is close Degree is linear from the binding end 1415 of ablation structure support element 180 to free end 181 to be reduced.The freedom of ablation structure support element 180 Spring density at or near end 181 can be directly related with the grasping degree of presentation, wherein grasping refers to ablation structure support element 180 The trend that is returned towards initial spring radius of free end 181.
Referring now to fig. 15 to Figure 17, it can be by reducing the materials of the one or more positions along one or more springs It measures to obtain the reduction of local spring density.Spring 1506,1602,1702 can be with reference to described by Fig. 6-9, and/or 13-14 One or more springs example.For example, referring to Figure 15, slit 1504 may include the distal portion in spring 1506, to Reduce grasping force of the spring 1506 at or near slit area 1504.6A referring to Fig.1, in some cases, by making spring 1602 distal portions 1604 are tapered to realize local spring density reduction.It can also be moved from spring by the technology of such as punching Except material.Referring to Fig.1 7, in some cases, one or more is gone out at or near the distal end of one or more springs 1702 Hole 1704.One or more of these technologies (that is, variable-width spring, volute spring, fluting spring and punching spring) It can combine and enable to realize specific local spring density.
6B referring now to fig. 1, in some embodiments, multiple polymer springs 1600-a, 1600-b (each have Have tapered portion) it attaches to the electrical isolation inner surface of ablation structure support element 180.Ablation structure support element 180 can be Figure 1B, 6, the example of 7,8, and/or 9 ablation structure support element 180.Spring 1600-a, 1600-b can be arranged so that first group Spring 1600-a is aligned adjacent to each other and 181 free end of end abutment ablation structure support element of tapered portion 1606, and Second group of spring 1600-b is aligned and pacifies with the end abutment ablation structure support element 1610 of tapered portion 1608 adjacent to each other Fill end.In some cases, the end of the non-tapered spring portion 1612 of first group of spring 1600-a and second group of spring 1600-b Non-tapered portion 1614 end combine.In some embodiments, wherein the position 1616 that non-tapered end combines is in ablation At or near the middle part of structural support 180.Bullet near 180 free end 181 of ablation structure support element and installation end 1610 Spring density is respectively less than the half of spring density at or near 180 middle part 1616 of ablation structure support element.In some cases, bullet Spring density linearly reduces on the free end of ablation structure support element 181 181 and the direction of installation end 1610.In certain embodiment party In formula, the tapered portion 1608 of each spring 1600-b, which is tapered to, to be limited density and extends to ablation structure support with the restriction density The installation end 1610 of part 180.The free end 181 of ablation structure support element 180 and the spring density at or near installation end 1610 It can be directly related with the grasping degree of presentation.
Referring now to fig. 18, show the ablation structure support element 180 according to each embodiment comprising metal elastic Spring 1802,1804,1806.Three metal springs 1802,1804,1806 shown are each free in ablation structure support element 180 Spring far-end near edge 181 may include hole 1814,1816,1818.Metal spring 1802,1804,1806 can be figure 6 602,604,606,608, the 720 of Fig. 7, the 820 of Fig. 8, the 916 of Fig. 9, the 1304 of Figure 13,1305, and/or Figure 14's 1402, in 1404,1406,1408 one or more springs example.Fixed pin 1808,1810,1812 may pass through spring eye 1814,1816,1818, and can each have the shaft perimeter less than spring eye 1814,1816,1818, and in some feelings More than the outside perimeter of the internal circumference of spring eye 1814,1816,1818 in shape.Fixed pin 1808,1810,1812 may pass through bullet Spring hole 1814,1816,1818 is so that ablation structure support element 180 can be stretched as flat, configuration during lamination process.The journey Sequence is generally not used for the shape-memory polymer spring being heat-treated after laminating.
9A and Figure 19 B referring now to fig. 1 are shown according to each embodiment for conveying treatment to target treatment portion The general-purpose system 1900 of position is in collapsed configuration (Figure 19 A) and the distal portion in expansion configuration (Figure 19 B).System 1900 can be with It is the system 100 that A, 1B or 4-9 are described referring to Fig.1, the example of 100-a, 400,600,700,800 or 900, and may include leading Pipe 115, the expansion 120 being connect with conduit 115 (only being shown in Figure 19 B) and ablation structure 160.Circular cone protectiveness member Part 1902,1904 can be positioned along conduit 115 at the transverse edge 1906,1908 of ablation structure 160.Conical structure 1902, 1904 can for example be made of flexible smooth polymeric, such as high density polyethylene (HDPE).The larger open of conical structure 1902,1904 1910,1912 towards ablation structure 160 transverse edge 1906,1908 position.The larger diameter end of conical structure 1902,1904 1910, the perimeter at 1912 can be more than the perimeter for the ablation structure 160 shunk, so that the entire edge of ablation structure 160 1906, it 1908 may be inserted into the larger open 1910,1912 of conical structure 1902,1904, therefore prevent to melt during removing Chamber is scraped during the expansion and/or insertion of structure 160.The smaller diameter end 1914 of conical structure 1904 can have remoter than conduit 115 The slightly larger inner periphery of the excircle of side 140 so that conical structure 1904 along conduit 115 distal portion 140 slideably It is mobile.In some embodiments, the smaller diameter end 1916 of conical structure 1902 has the outer of the part 150 less than conduit 115 The inner periphery of circumference, so that conical structure 1902 can not be slidably moved along the part of conduit 115 150.Referring now to Figure 19 B show that the general-purpose system 1900 for conveying treatment to target treatment position according to each embodiment is in and expand Open the distal portion of configuration.Conical structure 1904 can be far from 160 light exercise of ablation structure, so that the response of ablation structure 160 is expanded It opens the expansion of component 120 and is unfolded in the case where not hindered by conical structure 1902,1904.
0A and Figure 20 B referring now to Fig. 2 are shown according to each embodiment for conveying treatment to target treatment portion The general-purpose system 2000 of position is in collapsed configuration (Figure 20 A) and the distal portion in expansion configuration (Figure 20 B).System 2000 can be with Be referring to Fig.1 A, 1B, 4-9 or 19 description system 100,100-a, 400,600,700,800,900 or 1900 example, And it may include conduit 115, the expansion being connect with conduit 115 120 and ablation structure 160.Buffer overhung structure 2002 The part at the distal-lateral edge 2004 of ablation structure 160 can be bound to.Buffer overhung structure 2002 can be by high flexibility Material is made, so that the structure will not significantly hinder ablation structure 160 to be unfolded in response to the expansion of expansion 120. Buffer overhung structure 2002 can be made of arch portion 2008 and multiple adjacent trapezoidal structures 2006, and arch portion 2008 is tied with ablation The surface co-planar of structure 160 and the surface for being bound to ablation structure 160, and multiple adjacent trapezoidal structures 2006 are from arch portion 2008 The distal portion 140 for being radially orientated conduit 115 extends vertically.The arc length of arch portion 2008 can make the edge of ablation structure 160 2004, which have enough parts to be covered with during removal, prevents from expanding and/or prevents from scraping chamber during insertion.
Referring now to Fig. 21, show according to each embodiment for convey treat it is general to target treatment position System 2100 is in the distal portion of expansion configuration.System 2100 can be the system that A, 1B, 4-9,19 or 20 describe referring to Fig.1 100, the example of 100-a, 400,600,700,800,900,1900 or 2000, and may include conduit 115, connect with conduit 115 The expansion 120 and ablation structure 160 connect.In some embodiments, tether arrangements 2102 are inside conduit 115 Extend in length all or in part, come out across distal portion 140, the distal end 2106 of wherein rope 2102 is connected to distal side slidably The protective element 1904-a of movement.Circular cone protective element 1904-a can be circular cone protectiveness described in 9 referring to Fig.1 The example of element 1904.The proximal end 2110 of tether arrangements 2102 extends about out opening 165 in 115 proximal portion 145 of conduit, from And it enables the operator to manipulate rope 2102 and controls the repositioning of the protective element 1904-a slidably moved.
Referring now to Fig. 22, show according to each embodiment for convey treat it is general to target treatment position System 2200 is in the distal portion of expansion configuration.System 2200 can be the system of A, 1B, 4-9 or 19-21 description referring to Fig.1 100, the example of 100-a, 400,600,700,800,900,1900,2000 or 2100, and may include conduit 115 and conduit The expansion 120 and ablation structure 160 of 115 connections.In some embodiments, tether arrangements 2202 are close in conduit 115 Extend in length all or in part outside side, the distal end 2204 of wherein rope 2202 is connected to the guarantor that nearside slidably moves Shield property element 1902-a.Circular cone protective element 1902-a can be circular cone protective element 1902 described in 9 referring to Fig.1 Example.Tether arrangements 2202 can for example be led by installing to one or more loop configuration 2206 of conduit 115 to be fixed to Pipe 115, the wherein inner periphery of the loop configuration 2206 are more bigger than the circumference of tether arrangements 2202, to allow tether arrangements 2202 The sliding freely in one or more rings 2206.Operator can be at 115 proximal portion of conduit, 145 (not shown) close to tether The distal end 2204 of structure 2202, so that operator can manipulate rope 2202 and control the protective element slidably moved The repositioning of 1902-a.
With reference to Figure 23 A, show according to each embodiment for conveying treatment to the general system at target treatment position System 2300 is in the distal portion for shrinking/rolling configuration.System 2300 can be that A, 1B, 4-9 or 19-22 are described referring to Fig.1 System 100,100-a, 400,600,700,800,900,1900,2000,2100 or 2200 example, and may include conduit 115, the expansion 120 and ablation structure 160 being connect with conduit 115.As indicated, in some embodiments, protruding block 2305 are connected to conduit 115 and are positioned about in the proximal end of expansion 120 2310.Protruding block 2305 can be by any suitable Polymeric material is made and can be adhered or be otherwise attached to conduit 115.Protruding block 2305 can be configured in ablation structure 160 Ablation structure 160 is prevented to be expanded along the nearside of conduit 115 during being inserted into the body cavity of such as esophagus.Therefore, protruding block 2305 Height can be sufficiently large so that when expansion 120 be in shrink or when unexpanded configuration protruding block 2305 compared to ablation Structure 160 is further far from conduit 115.Protruding block 2305 can be the example of protective element described in 9-22 referring to Fig.1. With reference to Figure 23 B, show that expansion 120 that Figure 23 A according to each embodiment are illustrated and ablation structure 160 are in Expansion/expansion configuration.
With reference to Figure 24, show according to each embodiment for conveying treatment to the general-purpose system at target treatment position 2400 in the distal portion for shrinking/rolling configuration.System 2400 can be the system of A, 1B, 4-9 or 19-23 description referring to Fig.1 100, the example of 100-a, 400,600,700,800,900,1900,2000,2100,2200 or 2300, and may include conduit 115, the expansion 120 and ablation structure 160 being connect with conduit 115.As indicated, expansion 120 may include agglomerate portion 2405, agglomerate portion 2405 is located near the distal end portion 140 of conduit 115.The agglomerate portion 2405 of expansion 120 can be configured to Expansion of the ablation structure 160 along conduit 115 in a distal direction is prevented when removing ablation structure 160 from body cavity.Therefore, gather Regiment headquarters 2405 can be configured to the average diameter than the diameter bigger in unexpanded or collapsed configuration ablation structure 160. Agglomerate portion 2405 can be the example of protective element described in 9-22 referring to Fig.1.
Expansion 120 can be changed in various ways to generate agglomerate portion 2405.For example, expansion 120 can design To have precipitous cone angle on the distal end of expansion 120.The precipitous cone angle will make the distal portion of expansion 120 unexpanded Shi Jutuan, to form agglomerate portion 2405.10008 additionally or alternatively, expansion 120 can include multilayer material in proximate distal ends Material, to form agglomerate portion 2405.Therefore, the distal portion of expansion 120 is thicker compared to the rest part of expansion 120.Expand The multilayer of component 120 can heat be merged or can be combined by adhesive or fixed mechanical component.
For example, in each embodiment, expansion 120 is the sacculus formed by two step blow-molding process.It was blow molded The first step of journey may include forming the first sacculus, then cut off the distal end of sacculus.The cutting portion can then form the second sacculus Shi Tianjia is returned in sacculus mould.Particularly, which is placed in the mold, so that cutting portion weight when the second sacculus is formed The distal portion of folded second sacculus.By the way that the cutting portion of the first sacculus is Chong Die with the distal portion of the second sacculus, the second sacculus it is remote Side will be thicker than the rest part of balloon material.Therefore, it is reduced or when unexpanded state when sacculus is in, distal portion will be due to Excessive material and form agglomerate portion 2405.It should be understood that cone angle and expansion by changing 120 distal portion of expansion The size of the quantity and thickness of layers of additional materials near 120 distal portion of component, agglomerate portion 2405 can customize.
With reference to Figure 25, show according to each embodiment, using each embodiment described herein system and/or The universal method 2500 of equipment.For example, 2500 utilisation system 100 of method, power supply 105, hand-held compressor 112, expansion 120, ablation structure 160, ablation structure support element 180, protective element 1902,1904,2002, and/or other equipment and/or Each embodiment of component executes.At module 2505, the ablation structure 160 that is connect with ablation structure support element 180 and Expansion 120 can be plugged into body cavity.The ablation structure 160 being connect with ablation structure support element 180 combines and can respond The expansion of expansion 120 and be unfolded, and rolled in response to the contraction of expansion 120.Guiding elements 165 can be used so that Expansion 120 can transmit on guide assembly 165, to which ablation structure 160 is delivered to endoceliac target treatment area.
At module 2510, expansion 120 is expansible so that the ablation structure being connect with ablation structure support element 180 160 are unfolded and engage the circumferential part of body cavity in combination.In some cases, expansion 120 includes compliant balloon.At some In embodiment, power supply 105 and/or hand-held compressor 112 can be used for expanding the expansion 120.
In module 2515, energy is conveyed to the first part of body cavity circumference treatment region by ablation structure 160.In some realities It applies in mode, ablation structure 160 includes two or more longitudinal electrodes or the longitudinal electrode area of variable-width.In some embodiment party In formula, ablation structure 160 includes the two or more longitudinal electrodes or vertical for being configured to be selectively enabled or selectively disable To electrode district.In some cases, ablation structure 160 includes bipolar electrode array.
With reference to Figure 26, show according to each embodiment, using each embodiment described herein system and/or The universal method 2600 of equipment.Method 2600 can be the example with reference to the method 2500 of Figure 25 descriptions.For example, module 2605, 2610 and 2615 can be the example of the method described in the module 2505,2510 and 2515 of method 2500.In addition, in mould At block 2620, expansion 120 is collapsible, so that connection ablation structure support element 180 (it includes one or more springs) Ablation structure 160 roll in combination and be detached from the circumferential part of body cavity.For example, 2600 utilisation system 100 of method, power supply 105, Hand-held compressor 112, expansion 120, ablation structure 160, ablation structure support element 180, spring 1506,1602,1702, Protective element 1902,1904,2002, and/or other equipment and/or each embodiment of component execute.In some feelings In shape, expansion 120 includes compliant balloon.In some embodiments, vacuum is for fully shrinkage expansion component 120.In some cases, one or more springs include constant force spring.
With reference to Figure 27, show according to each embodiment, using each embodiment described herein system and/or The universal method 2700 of equipment.Method 2700 can be the example with reference to the method 2500 of Figure 25 descriptions.For example, module 2705, 2710 and 2715 can be the example of the method described in the module 2505,2510 and 2515 of method 2500.In addition, in mould At block 2720, it can be utilized during the ablation structure being connect with ablation structure support element 180 and expansion 120 are inserted into body cavity One or more protective elements.For example, 2700 utilisation system 100 of method, power supply 105, hand-held compressor 112, expansion structure Part 120, ablation structure 160, ablation structure support element 180, spring 1506,1602,1702, protective element 1902,1904, 2002, and/or other equipment and/or each embodiment of component execute.One or more protective elements can be positioned on The distal portion of ablation structure 160, proximal portion, or both.These protective elements may include such as conical structure, buffer shape knot The agglomerate portion 2405 of structure, the protruding block 2305 being connect with conduit 115 or expansion 120, each of which are positioned so that inserting The expansion that ablation structure 160 is prevented during entering and/or the leading edge for preventing ablation structure scrape body lumen wall.In some of this method In embodiment, one or more protective elements remove after ablation structure positioning from ablation structure.
With reference to Figure 28, show according to each embodiment, using each embodiment described herein system and/or The universal method 2800 of equipment.Method 2800 can be the example with reference to the method 2500 of Figure 25 descriptions.For example, module 2805, 2810 and 2815 can be the example of the method described in the module 2505,2510 and 2515 of method 2500.In addition, in mould At block 2820, after ablation structure 160 is located in body cavity, one or more protective elements can be from the cross of ablation structure 160 It is distally moved to edge.For example, 2800 utilisation system 100 of method, power supply 105, hand-held compressor 112, expansion 120, ablation structure 160, ablation structure support element 180, spring 1506,1602,1702, protective element 1902,1904, rope 2102,2202, and/or other equipment and/or each embodiment of component execute.After positioning ablation structure 160, move It is without hindrance in combination that dynamic one or more protective element promotes the ablation structure 160 being connect with ablation structure support element 180 Expansion, and continue to prevent the expansion of ablation structure 160 simultaneously during insertion and/or the leading edge of ablation structure 160 is prevented to scrape Rub body cavity wall.
With reference to Figure 29, show according to each embodiment, using each embodiment described herein system and/or The universal method 2900 of equipment.Method 2900 can be the example with reference to the method 2500 of Figure 25 descriptions.For example, module 2905, 2910 and 2915 can be the example of the method described in the module 2505,2510 and 2515 of method 2500.In addition, in mould It, can be for electrode or longitudinal electrode area determine impedance level longitudinally in each at block 2920.For example, 2900 utilisation system of method 100, power supply 105, hand-held compressor 112, expansion 120, ablation structure 160, ablation structure support element 180, spring 1506,1602,1702, each embodiment of protective element 1902,1904,2002, and/or other equipment and/or component To execute.In some cases, before enabling given longitudinal electrode or longitudinal electrode area, sequentially measure, from by The longitudinal electrode of nearly ablation structure free edge or longitudinal electrode area start.In another embodiment, it is surveyed during ablation Measure impedance rate of change.In some cases, in module 2925, by current longitudinal electrode in electrode or electrode region sequence or longitudinal electricity The starting impedance of polar region and that previously longitudinal electrode or longitudinal electrode area had previously obtained in the sequence for electrode or electrode district Beginning impedance level is compared.In some cases, the impedance in current longitudinal electrode or longitudinal electrode area will be directed to during ablation Change rate is compared with for the impedance rate of change previously obtained from current patents and/or previous patient.
With reference to Figure 30, show according to each embodiment, using each embodiment described herein system and/or The universal method 3000 of equipment.For example, 3000 utilisation system 100 of method, expansion 120, ablation structure 160, ablation knot Structure support element 180, protective element 1902,1904,2002, and/or other equipment and/or each embodiment of component are held Row.In module 3005, the ablation structure 160 and expansion 120 that are connect with ablation structure support element 180 are inserted into body cavity It is interior.One or more protective elements can be positioned on the distal portion of ablation structure 160, proximal portion, or both.These protectiveness member Part may include such as conical structure, pendency buffer shape structure, the protruding block 2305 being connect with conduit 115 or expansion 120 Agglomerate portion 2405, each of which is positioned so as to prevent the expansion of ablation structure 160 during insertion and/or prevents ablation The leading edge of structure 160 scrapes body lumen wall.In some cases, ablation structure 160 includes the bipolar electrode array rolled.
In module 3010, expansion 120 is expansible, so that the ablation structure being connect with ablation structure support element 180 160 are unfolded and engage the circumferential part of body cavity in combination.In some cases, expansion 120 includes compliant balloon.At some In embodiment, power supply 105 and/or hand-held compressor 112 are for expanding the expansion 120.
With reference to Figure 31, show according to each embodiment, using each embodiment described herein system and/or The universal method 3100 of equipment.Method 3100 can be the example with reference to the method 3000 of Figure 30 descriptions.For example, module 3105 It can be the example of method described in the module 3005 and 3010 of method 3000 with 3110.In addition, in module 3115, After ablation structure is located in body cavity from, one or more protective elements can ablation structure 160 transverse edge to remote Side displacement.For example, 3100 utilisation system 100 of method, expansion 120, ablation structure 160, ablation structure support element 180, Protective element 1902,1904 and/or other equipment and/or each embodiment of component execute.By ablation structure Mobile one or more protective elements promote 160 groups of ablation structure being connect with ablation structure support element 180 after 160 positioning Without hindrance expansion is closed, and continues to prevent the expansion of ablation structure 160 simultaneously during insertion and/or prevents ablation structure 160 Leading edge scrape body lumen wall.
With reference to Figure 32, show according to each embodiment, using each embodiment described herein system and/or The universal method 3200 of equipment.Method 3200 can be the example with reference to the method 3000 of Figure 30 descriptions.For example, module 3205 It can be the example of method described in the module 3005 and 3010 of method 3000 with 3210.In addition, in module 3215, one A or multiple protective elements carry out phase by using the one or more tether arrangements for being connected to one or more protective elements Ablation structure 160 is moved.For example, 3200 utilisation system 100 of method, expansion 120, ablation structure 160, ablation knot Structure support element 180, protective element 1902,1904, each reality of rope 2102,2202, and/or other equipment and/or component Mode is applied to execute.In some embodiments, length of the tether arrangements from protective element along conduit upwardly extends, so that Operator can manipulate rope and control the repositioning of one or more protective elements.
Foregoing description provides example, and is not intended to be limited to the range of each embodiment, applicability or configuration.Phase Instead, these descriptions and/or attached drawing provide the adaptability for executing each embodiment for those skilled in the art and describe.? It can various changes can be made in the function and arrangement of element.
Therefore, suitable various programs or component can be omitted, substitute or be added to each embodiment.For example, it will be appreciated that , these methods can be different from described sequence and execute, and can add, omit or combine each step.Equally, It can be incorporated into each other embodiment with element in terms of described in certain embodiments.It should also be appreciated that It is that subsequent system, method and equipment can respectively or jointly the component as larger system, wherein other programs are possible Meeting is preferential or changes their application.
The foregoing description of particular implementation is presented for illustrating and describe purpose.They are not intended to as exhaustion Property or limit the invention to disclosed precise forms, and it is apparent that many modifications can be made according to the above instruction And variation.Embodiment is chosen and described to illustrate the principle and its practical application of different embodiments, so that this field Technical staff utilizes the different embodiments with various change, these variations are suitable for desired special-purpose.Purpose is each The range of a embodiment is determined by the appended claims and its equivalent.

Claims (7)

1. a kind of ablation apparatus for being treated to the endoceliac tissue with varying dimensions, the ablation apparatus packet It includes:
Conduit;
Expansion is connect with the distal portion of conduit;
Ablation structure comprising multiple longitudinal electrode areas, the electrode district longitudinally in each in the multiple longitudinal electrode area are separated Ground controls and wiring, to which the electrode district longitudinally in each in the multiple longitudinal electrode area can be selectively enabled or prohibit With;And
Ablation structure support element, connect with ablation structure, wherein ablation structure and ablation structure support element are configured to expansion Component is expanded or shrinks and be unfolded or roll at least partly around expansion;
It is characterized in that, ablation apparatus further includes one or more springs, one or more of springs are supported with ablation structure Part connect and be configured to provide for active force so that ablation structure with expansion shrink and rolled around expansion, it is one Or multiple springs include one or more material strips, one or more of material strips are lateral about the longitudinal axis of ablation structure Ground is connected to ablation structure, and at least one of one or more of material strips material strips include at least tapered portion so that lean on The density of at least one material strips of the free end of nearly ablation structure support element is less than oneself far from ablation structure support element By the density at least one material strips held.
2. ablation apparatus according to claim 1, wherein one or more of springs include one or more constant pressure bullets Spring.
3. ablation apparatus according to claim 1, further includes:
One or more protective elements are located at least ablation structure distal side or nearside along conduit.
4. ablation apparatus according to claim 1, wherein the multiple longitudinal electrode area includes having different in width extremely Shao Liangge longitudinal electrodes area.
5. ablation apparatus according to claim 1, wherein expansion includes sacculus.
6. ablation apparatus according to claim 5, wherein sacculus includes compliant balloon.
7. ablation apparatus according to claim 1, wherein ablation structure includes at least one bipolar electrode array.
CN201410781722.5A 2013-10-25 2014-10-24 A kind of ablation apparatus for being treated to the endoceliac tissue with varying dimensions Active CN104546118B (en)

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
US201361895514P 2013-10-25 2013-10-25
US201361895530P 2013-10-25 2013-10-25
US201361895501P 2013-10-25 2013-10-25
US61/895,501 2013-10-25
US61/895,530 2013-10-25
US61/895,514 2013-10-25
US14/519,950 US9743981B2 (en) 2013-10-25 2014-10-21 Unfurling electrode devices with spring
US14/519,409 2014-10-21
US14/519,409 US9763733B2 (en) 2013-10-25 2014-10-21 Unfurling electrode devices with the multiple longitudinal electrode segments
US14/520,028 US9918789B2 (en) 2013-10-25 2014-10-21 Unfurling electrode devices with the protection element
US14/519,950 2014-10-21
US14/520,028 2014-10-21

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