阅读说明：本技术 具有传感器组件的冷冻球囊导管系统 (Freezing balloon catheter system with sensor module ) 是由 尤金·J·小荣格 基根·哈柏 里卡多·罗曼 于 2018-01-30 设计创作，主要内容包括：一种用于治疗体内病症的血管内导管系统包括导管轴、第一可膨胀球囊以及多个电极。第一可膨胀球囊被定位在导管轴的远端附近。第一可膨胀球囊在膨胀状态和基本收缩状态之间移动。在膨胀状态下,第一可膨胀球囊具有最大圆周。多个电极远离第一可膨胀球囊的最大圆周被附接到第一可膨胀球囊。在一些实施例中,多个电极被附接到第一可膨胀球囊的内表面。在各种实施例中,血管内导管系统还可包括两个或更多个柔性电路,当第一可膨胀球囊处于基本收缩状态时,两个或更多个柔性电路基本上彼此面对。(A kind of catheter in blood vessel system for treating internal illness includes catheter shaft, the first balloon-expandable and multiple electrodes.First balloon-expandable is positioned in the proximate distal ends of catheter shaft.First balloon-expandable moves between swelling state and basic contraction state.In the expanded state, the first balloon-expandable has largest circumference.Multiple electrodes are attached to the first balloon-expandable far from the largest circumference of the first balloon-expandable.In some embodiments, multiple electrodes are attached to the inner surface of the first balloon-expandable.In various embodiments, catheter in blood vessel system may also include two or more flexible circuits, and when the first balloon-expandable is in basic contraction state, two or more flexible circuits are substantially facing with each other.)

1. a kind of for treating the catheter in blood vessel system of internal illness, the catheter in blood vessel system includes:

Catheter shaft has and is selectively located the intracorporal axis distal end；

First balloon-expandable, is positioned in the proximate distal ends of the catheter shaft, and first balloon-expandable is configured as It is moved between swelling state and basic contraction state, first balloon-expandable has greatest circle under the swelling state Week；And

Multiple electrodes, are attached to first balloon-expandable, intracorporal physiological parameter described in the multiple electrode senses, The multiple electrode is positioned remote from the largest circumference of first balloon-expandable, so that being positioned in without electrode described In the largest circumference of first balloon-expandable.

2. catheter in blood vessel system according to claim 1, wherein first balloon-expandable has inner surface and phase Anti- outer surface, and wherein, the electrode is positioned on the inner surface of first balloon-expandable.

3. catheter in blood vessel system according to claim 1, wherein first balloon-expandable has inner surface and phase Anti- outer surface, and wherein, the electrode is positioned on the outer surface of first balloon-expandable.

4. catheter in blood vessel system according to claim 1 further includes be fixed to first balloon-expandable one A or multiple flexible circuits, and wherein, the electrode is coupled to described first via one or more of flexible circuits Balloon-expandable.

5. catheter in blood vessel system according to claim 4, wherein each of described flexible circuit is towards the maximum Circumference distal end is fixed to first balloon-expandable.

6. catheter in blood vessel system according to claim 4, wherein one or more of flexible circuits are positioned as far Largest circumference from first balloon-expandable.

7. catheter in blood vessel system according to claim 4, wherein at least two electrodes are positioned in one or more On each of a flexible circuit.

8. catheter in blood vessel system according to claim 7, wherein two electrodes on each flexible circuit form thermoelectricity It is even.

9. catheter in blood vessel system according to claim 7, wherein at least eight flexible circuits are positioned in described first On balloon-expandable.

10. catheter in blood vessel system according to claim 7, wherein at least 12 flexible circuits are positioned in described On first balloon-expandable.

11. catheter in blood vessel system according to claim 4, wherein when first balloon-expandable is in the base When this contraction state, balloon-expandable includes multiple ridges.

12. catheter in blood vessel system according to claim 11, wherein two flexible circuits are positioned in two adjacent Between ridge.

13. catheter in blood vessel system according to claim 12, wherein when first balloon-expandable is in the base When this contraction state, described two flexible circuits are substantially facing with each other.

It further include that be positioned in first inflatable ball intracapsular 14. catheter in blood vessel system according to claim 1 Second balloon-expandable.

15. catheter in blood vessel system according to claim 14, wherein second balloon-expandable have outer surface and Opposite inner surface, and wherein, the multiple electrode is positioned on the outer surface of second balloon-expandable.

16. catheter in blood vessel system according to claim 1 further includes guidewire lumen and seal wire, the seal wire is by least It is partially positioned in the guidewire lumen；Wherein first balloon-expandable is attached to the guidewire lumen.

17. catheter in blood vessel system according to claim 16 further includes controller and multiple conductors, each conductor is in institute It states and transmits electric signal between at least one of electrode and the controller, the electric signal is based on the physiological parameter.

18. catheter in blood vessel system according to claim 17, wherein the guidewire lumen has lumen distal, and Wherein, each conductor is routed to the control from least one of described electrode via the lumen distal of the guidewire lumen Device.

19. catheter in blood vessel system according to claim 1 further includes being positioned remote from first balloon-expandable Reference electrode pair, the reference electrode to formed sensing body a part temperature thermocouple.

20. catheter in blood vessel system according to claim 19, wherein reference electrode generates reference sensor output, and And wherein, two electrodes in the multiple electrode generate sensor output, the sensor output and the reference sensor Output is compared with the temperature of a part of the determination body.

21. a kind of for treating the catheter in blood vessel system of internal illness, the catheter in blood vessel system includes:

Catheter shaft has and is selectively located the intracorporal axis distal end；

First balloon-expandable, is positioned in the proximate distal ends of the catheter shaft, and first balloon-expandable is configured as It is moved between swelling state and basic contraction state；

Flexible circuit is attached to first balloon-expandable；And

Electrode pair is fixed to the flexible circuit, and the electrode is to the sensing intracorporal physiological parameter.

22. catheter in blood vessel system according to claim 21, wherein when first balloon-expandable is in described swollen When swollen state, first balloon-expandable has largest circumference, and wherein, and the flexible circuit is positioned remote from described The largest circumference of first balloon-expandable.

23. catheter in blood vessel system according to claim 21, wherein first balloon-expandable have inner surface and Opposite outer surface, and wherein, the flexible circuit is positioned on the inner surface of first balloon-expandable.

24. catheter in blood vessel system according to claim 21, wherein first balloon-expandable have inner surface and Opposite outer surface, and wherein, the flexible circuit is positioned on the outer surface of first balloon-expandable.

25. catheter in blood vessel system according to claim 21, further includes multiple flexible circuits, each flexible circuit is attached It is connected to first balloon-expandable, and further includes multiple electrodes pair, wherein at least one electrode is described more to being fixed to Each of a flexible circuit.

26. catheter in blood vessel system according to claim 25, wherein the multiple flexible circuit is with substantially radial side Formula is positioned on first balloon-expandable.

27. catheter in blood vessel system according to claim 25, wherein first balloon-expandable has greatest circle Week, and wherein, each of the multiple flexible circuit is positioned remote from the largest circumference of first balloon-expandable.

28. catheter in blood vessel system according to claim 25, wherein each electrode is to formation thermocouple.

29. catheter in blood vessel system according to claim 25, wherein at least eight flexible circuits are positioned in described On one balloon-expandable.

30. catheter in blood vessel system according to claim 25, wherein when first balloon-expandable is in the base When this contraction state, balloon-expandable includes multiple ridges.

31. catheter in blood vessel system according to claim 30, wherein two flexible circuits are positioned in two adjacent Between ridge.

32. catheter in blood vessel system according to claim 31, wherein when first balloon-expandable is in the base When this contraction state, described two flexible circuits are substantially facing with each other.

It further include that be positioned in first inflatable ball intracapsular 33. catheter in blood vessel system according to claim 21 The second balloon-expandable.

34. catheter in blood vessel system according to claim 33, wherein second balloon-expandable have outer surface and Opposite inner surface, and wherein, multiple electrodes are positioned on the outer surface of second balloon-expandable.

35. catheter in blood vessel system according to claim 21 further includes guidewire lumen and seal wire, the seal wire is by least It is partially positioned in the guidewire lumen；Wherein first balloon-expandable is attached to the guidewire lumen.

36. catheter in blood vessel system according to claim 35 further includes controller and multiple conductors, each conductor is in electricity Electric signal is transmitted between at least one of pole and the controller, the electric signal is based on the physiological parameter.

37. catheter in blood vessel system according to claim 36, wherein the guidewire lumen has lumen distal, and Wherein, each conductor is routed to the control from least one of described electrode via the lumen distal of the guidewire lumen Device.

38. catheter in blood vessel system according to claim 21 further includes being positioned remote from first inflatable ball The reference electrode pair of capsule, thermocouple of the reference electrode to the temperature of a part for forming sensing body.

39. the catheter in blood vessel system according to claim 38, wherein reference electrode generates reference sensor output, and And wherein, two electrodes in the multiple electrode generate sensor output, the sensor output and the reference sensor Output is compared with the temperature of a part of the determination body.

40. a kind of for treating the catheter in blood vessel system of internal illness, the catheter in blood vessel system includes:

Catheter shaft has and is selectively located the intracorporal axis distal end；

First balloon-expandable, is positioned in the proximate distal ends of the catheter shaft, and first balloon-expandable is configured as It is moved between swelling state and basic contraction state, first balloon-expandable has inner surface and opposite outer surface； And

Multiple electrodes, intracorporal physiological parameter described in each electrode senses, the multiple electrode is attached to described first can be swollen The inner surface of swollen sacculus.

41. catheter in blood vessel system according to claim 40, wherein the electrode is via one or more flexible circuits It is coupled to first balloon-expandable.

42. catheter in blood vessel system according to claim 41, wherein at least one of flexible circuit flexible adhesive Agent is fixed to first balloon-expandable.

43. catheter in blood vessel system according to claim 41, wherein one or more of flexible circuits are positioned as Largest circumference far from first balloon-expandable.

44. catheter in blood vessel system according to claim 41, wherein at least two electrodes be positioned in it is one or On each of multiple flexible circuits.

45. catheter in blood vessel system according to claim 44, wherein two electrodes on each flexible circuit form heat Galvanic couple.

46. catheter in blood vessel system according to claim 44, wherein at least eight flexible circuits are positioned in described On one balloon-expandable.

47. catheter in blood vessel system according to claim 41, wherein when first balloon-expandable is in the base When this contraction state, balloon-expandable includes multiple ridges.

48. catheter in blood vessel system according to claim 47, wherein two flexible circuits are positioned in two adjacent Between ridge.

49. catheter in blood vessel system according to claim 48, wherein when first balloon-expandable is in the base When this contraction state, described two flexible circuits are substantially facing with each other.

It further include that be positioned in first inflatable ball intracapsular 50. catheter in blood vessel system according to claim 40 The second balloon-expandable.

51. catheter in blood vessel system according to claim 40 further includes guidewire lumen and seal wire, the seal wire is by least It is partially positioned in the guidewire lumen；Wherein first balloon-expandable is attached to the guidewire lumen.

52. catheter in blood vessel system according to claim 51 further includes controller and multiple conductors, each conductor is in electricity Electric signal is transmitted between at least one of pole and the controller, the electric signal is based on physiological parameter.

53. catheter in blood vessel system according to claim 52, wherein the guidewire lumen has lumen distal, and Wherein, each conductor is routed to the control from least one of described electrode via the lumen distal of the guidewire lumen Device.

54. catheter in blood vessel system according to claim 40 further includes being positioned remote from first inflatable ball The reference electrode pair of capsule, thermocouple of the reference electrode to the temperature of a part for foring sensing body.

55. catheter in blood vessel system according to claim 54, wherein reference electrode generates reference sensor output, and And wherein, two electrodes in the multiple electrode generate sensor output, the sensor output and the reference sensor Output is compared with the temperature of a part of the determination body.

56. a kind of for treating the catheter in blood vessel system of internal illness, the catheter in blood vessel system includes:

Catheter shaft has and is selectively located the intracorporal axis distal end；

First balloon-expandable, is positioned in the proximate distal ends of the catheter shaft, and first balloon-expandable is configured as It is moved between swelling state and basic contraction state；

Multiple electrodes sense intracorporal one or more physiological parameters；And

Two flexible circuits, couple the electrodes to first balloon-expandable, and each of described two flexible circuits are attached It is connected to first balloon-expandable, it is described two soft when first balloon-expandable is in the basic contraction state Property circuit is substantially facing with each other.

57. catheter in blood vessel system according to claim 56, wherein when first balloon-expandable is in described swollen When swollen state, first balloon-expandable has largest circumference, and wherein, and the flexible circuit is positioned remote from described The largest circumference of first balloon-expandable.

58. catheter in blood vessel system according to claim 56, wherein first balloon-expandable have inner surface and Opposite outer surface, and wherein, the flexible circuit is positioned on the inner surface of first balloon-expandable.

59. catheter in blood vessel system according to claim 56, wherein first balloon-expandable have inner surface and Opposite outer surface, and wherein, the flexible circuit is positioned on the outer surface of first balloon-expandable.

60. catheter in blood vessel system according to claim 56, further includes multiple flexible circuits, each flexible circuit is attached It is connected to first balloon-expandable, and further includes multiple electrodes pair, wherein at least one electrode is described more to being fixed to Each of a flexible circuit.

61. catheter in blood vessel system according to claim 60, wherein the multiple flexible circuit is with substantially radial side Formula is positioned on first balloon-expandable.

62. catheter in blood vessel system according to claim 60, wherein at least eight flexible circuits are positioned in described On one balloon-expandable.

63. catheter in blood vessel system according to claim 60, wherein when first balloon-expandable is in the base When this contraction state, balloon-expandable includes multiple ridges.

64. catheter in blood vessel system according to claim 63, wherein two flexible circuits are positioned in two adjacent Between ridge.

It further include that be positioned in first inflatable ball intracapsular 65. catheter in blood vessel system according to claim 56 The second balloon-expandable.

66. catheter in blood vessel system according to claim 65, wherein second balloon-expandable have outer surface and Opposite inner surface, and wherein, the flexible circuit is positioned on the outer surface of second balloon-expandable.

67. catheter in blood vessel system according to claim 56 further includes guidewire lumen and seal wire, the seal wire is by least It is partially positioned in the guidewire lumen；Wherein first balloon-expandable is attached to the guidewire lumen.

68. catheter in blood vessel system according to claim 67 further includes controller and multiple conductors, each conductor is in electricity The electric signal based on physiological parameter is transmitted between at least one of pole and the controller.

69. catheter in blood vessel system according to claim 68, wherein the guidewire lumen has lumen distal, and Wherein, each conductor is routed to the control from least one of described electrode via the lumen distal of the guidewire lumen Device.

70. catheter in blood vessel system according to claim 56 further includes being positioned remote from first inflatable ball The reference electrode pair of capsule, thermocouple of the reference electrode to the temperature of a part for foring sensing body.

71. catheter in blood vessel system according to claim 70, wherein reference electrode generates reference sensor output, and And wherein, two electrodes in the multiple electrode generate sensor output, the sensor output and the reference sensor Output is compared with the temperature of a part of the determination body.

Background technique

Arrhythmia cordis is related to the exception of heart electrical conduction, and the main reason for be apoplexy, heart disease and sudden cardiac death. The therapeutic choice of patient with arrhythmia cordis includes the catheter ablation of drug, implantable device and heart tissue.

Catheter ablation is related to the tissue delivery ablation energy into heart, different from the normal conductive mode of heart to prevent The abnormal electrical activity of the depolarising cardiac myocyte of step.Pass through the trouble tip of energy delivery catheter being positioned adjacent in heart Diseased tissues or destination organization execute the operation.The energy delivery component of system is usually located at the distalmost end of conduit (from operator Farthest) at or near part, and it is usually located at the tip of device.Various forms of energy are used to melt the heart group of illness It knits.These may include radio frequency (RF), freezing, ultrasound and laser energy etc..The tip of conduit is positioned adjacent to illing tissue, Energy is delivered at this time causes the tissue of ablation that cannot conduct electric signal to generate tissue necrosis.The dosage of the energy delivered It is the key factor for increasing a possibility that tissue through treating cannot permanently conduct.Meanwhile slim and frahile collateral tissue (is such as eaten Nervus phrenicus around road, bronchus and zone of ablation) it is likely to be broken and may cause undesirable complication.Therefore, it operates Person must balance the energy of delivering treatment level subtly to realize expected tissue necrosis, while excessive energy being avoided to cause Collateral tissue damage.

Auricular fibrillation (AF) is one of the most common arrhythmia cordis using catheter ablation treatment.In the early stage of disease (paroxysmal AF), therapeutic strategy include from atrium sinistrum chamber isolation pulmonary vein.Recently, using referred to as " sacculus cold therapy " conduit The technology of operative treatment AF has increased.To a certain extent, when this is derived from ease for use, the shorter operation of sacculus cold therapy Between and improved patient's result.Although having the advantages that these, but still need to improve further to improve patient's result and more preferable Ground promotes to monitor the real-time physiological of tissue to be executed reversible " ice mapping " and permanent tissue and disappears most preferably to titrate energy Both melt.

There are still the unsatisfied demands to following distensible tissue ablation device, are capable of providing effective treatment Ablation energy and reliable physiological moniyoting, with the treatment results for improving the delivering to ablation energy to realize improvement.It also needs to subtract The excessive power of collateral tissue damage is caused to deliver less.The device should be monitored based on real-time physiological ideally to control treatment energy The amount of amount is delivered to the amount of the ablation energy of tissue in specified target location to control.This should include based on to tissue ginseng The real time inquiring of (temperature, device contact force, localised blood pressure etc.) is counted to adjust the mode of ablation energy output.

In addition, to following device, there are unsatisfied demands: it can be with seamless integration physiological moniyoting sensor and ablation Element, without damaging device when applying treatment energy or enabling a device to convert between contraction state and expansion state Function.

Furthermore, it is necessary to which a kind of cryoablation foley's tube for treating auricular fibrillation He other arrhythmia cordis, can disappear Organizational parameter is sensed before and after, during melting in real time.Currently, " mapping " function of cryoablation conduit is usually by individually auxiliary Device is helped to handle.Conventional sensors are added to the undesirable volume that will increase sacculus in sacculus, this will need bigger pass Sheath is sent to introduce patient's body and withdraw from patient's body.

Have and repeatedly attempted sensor or mapping electrode being attached to sacculus, all there is limited success.Early stage solves Some disadvantages of scheme include increased volume or balloon profile, the becoming of removing from sacculus of electrode during expansion and contraction Gesture and be difficult to by conducting wire be routed to be connected to electrode etc..

Summary of the invention

The present invention relates to a kind of for treating the catheter in blood vessel system of internal illness.In one embodiment, intravascular Conduit system includes catheter shaft, the first inflatable (inflatable) sacculus and multiple electrodes.Catheter shaft has axis distal end, and axis is remote End is selectively positioned in vivo.First balloon-expandable is positioned in the proximate distal ends of catheter shaft.First balloon-expandable quilt It is configured to move between swelling state and basic contraction state.In the expanded state, the first balloon-expandable has greatest circle Week.Multiple electrodes are attached to the first balloon-expandable.Multiple electrodes can sense the intracorporal physiological parameter of body.In addition, multiple Electrode can be positioned remote from the largest circumference of the first balloon-expandable, so that being positioned in the first inflatable ball without electrode In the largest circumference of capsule.

In certain embodiments, the first balloon-expandable has inner surface and opposite outer surface.In some such realities It applies in example, electrode is positioned on the inner surface of the first balloon-expandable.

In another embodiment, the first balloon-expandable has inner surface and opposite outer surface.In this embodiment, Electrode is positioned on the outer surface of the first balloon-expandable.

In various embodiments, catheter in blood vessel system may also include the one or more fixed to the first balloon-expandable Flexible circuit.In some such embodiments, electrode is coupled to the first inflatable ball via one or more flexible circuits Capsule.In various embodiments, one or more flexible circuits can be positioned remote from the largest circumference of the first balloon-expandable. In some embodiments, each flexible circuit can be fixed to the first balloon-expandable towards the distal end of largest circumference.

In certain embodiments, at least two electrodes are positioned on each of one or more flexible circuits.In In some such embodiments, two electrodes on each flexible circuit form thermocouple.

In various embodiments, at least eight flexible circuits are positioned on the first balloon-expandable.Alternatively, at least 12 flexible circuits are positioned on the first balloon-expandable.

In some embodiments, when the first balloon-expandable is in basic contraction state, balloon-expandable includes multiple Ridge (spine).In certain embodiments, two flexible circuits are positioned between two adjacent ridges.In some embodiments, When the first balloon-expandable is in basic contraction state, two adjacent two flexible circuits are substantially facing with each other.

In another embodiment, catheter in blood vessel system may also include the second balloon-expandable, be positioned in first Inflatable ball is intracapsular.In some such embodiments, the second balloon-expandable has outer surface and opposite inner surface, and Multiple electrodes are positioned on the outer surface of the second balloon-expandable.

In various embodiments, catheter in blood vessel system further includes guidewire lumen and seal wire, and seal wire is by least partly fixed Position is in guidewire lumen.First balloon-expandable can be attached to guidewire lumen.Catheter in blood vessel system may also include control Device and multiple conductors.In certain embodiments, each conductor transmits electric signal between at least one electrode and controller.Telecommunications Number it can be based on physiological parameter.

In some embodiments, guidewire lumen has lumen distal, and each conductor is remote via the lumen of guidewire lumen End is routed to controller from least one electrode.

In certain embodiments, catheter in blood vessel system may also include reference electrode pair, and being positioned remote from first can Dilatation balloon.In these embodiments, for reference electrode to that can form thermocouple, which senses the temperature of a part of body Degree.Reference electrode can produce reference sensor output.In various embodiments, two generation sensors in multiple electrodes are defeated Out, sensor output is compared the temperature to determine a part of body with reference sensor output.

In another embodiment, catheter in blood vessel system may include catheter shaft, the first balloon-expandable, flexible circuit and Electrode pair.Catheter shaft can have axis distal end, be selectively positioned in vivo.First balloon-expandable can be positioned in and lead The proximate distal ends of pipe axis.First balloon-expandable can be configured as and move between swelling state and basic contraction state.It is soft Property circuit can be attached to the first balloon-expandable.Electrode is to can be fixed to flexible circuit.Electrode is internal to that can sense Physiological parameter.

In another embodiment, catheter in blood vessel system may include catheter shaft, the first balloon-expandable and multiple electrodes.It leads Pipe axis can have axis distal end, be selectively positioned in vivo.First balloon-expandable can be positioned in the remote of catheter shaft Near end.First balloon-expandable can be configured as and move between swelling state and basic contraction state.First is inflatable Sacculus has inner surface and opposite outer surface.Each of multiple electrodes sense intracorporal physiological parameter.In certain embodiments, Multiple electrodes are attached to the inner surface of the first balloon-expandable.

In another embodiment, catheter in blood vessel system include catheter shaft, the first balloon-expandable, multiple electrodes and Two flexible circuits.Catheter shaft can have axis distal end, be selectively positioned in vivo.First balloon-expandable can be determined Proximate distal ends of the position in catheter shaft.First balloon-expandable can be configured as and move between swelling state and basic contraction state It is dynamic.The intracorporal one or more physiological parameters of multiple electrodes sensing.Two flexible circuits couple the electrodes to the first inflatable ball Capsule.In some embodiments, two flexible circuits can each of be attached to the first balloon-expandable.In various embodiments, When the first balloon-expandable is in basic contraction state, two flexible circuits are substantially facing with each other.

Detailed description of the invention

Combine appended specification novel feature of the invention will to be best understood and about knot of the invention from attached drawing The present invention of structure and its operation the two itself, similar reference symbol indicates similar part in the accompanying drawings, and in the accompanying drawings:

Fig. 1 is the schematic side elevational of one embodiment of patient and the freezing balloon catheter system with feature of present invention Figure；

Fig. 2A is one of one embodiment of a part of patient and the freezing balloon catheter system including foley's tube The simplified side view divided；

Fig. 2 B is the cross-sectional view of the foley's tube of the line 2B-2B interception in Fig. 2A；

Fig. 2 C is the simplification side view of a part of a part of patient and another embodiment of freezing balloon catheter system Figure；

Fig. 3 A is the cross-sectional view for freezing one embodiment of a part of balloon catheter system；

Fig. 3 B is the cross-sectional view for freezing another embodiment of a part of balloon catheter system；

Fig. 4 is the cross-sectional view of a part of the freezing balloon catheter system of the line 4-4 interception in Fig. 3 A；

Fig. 5 A is to include with another embodiment of the freezing balloon catheter system of the balloon-expandable shown in swelling state A part and sensor module a part perspective view；

Fig. 5 B is the end-view that a part of balloon catheter system is freezed shown in Fig. 5 A, and wherein balloon-expandable is with swollen Swollen state is shown；And

Fig. 5 C is the perspective view that a part of balloon catheter system is freezed shown in Fig. 5 A, and wherein balloon-expandable is with base This contraction state is shown.

Specific embodiment

It is retouched in the context of freezing balloon catheter system (being also referred to as " catheter in blood vessel system " sometimes below) herein The embodiment of the present invention is stated.It will be appreciated by those of ordinary skill in the art that it is of the invention it is described in detail below be only illustrative , it is no intended to it is limited in any way.The other embodiment of the present invention will be easy to be suggested to benefiting from this public affairs Open this technical staff of content.Now with detailed reference to embodiments of the present invention as shown in the drawings.

For the sake of clarity, it is not shown and describes all general characteristics of embodiment described herein.It will be appreciated, of course, that , many decisions specific to embodiment must be made, when developing any this actual implementation mode to realize out The specific objective (such as defer to and using relevant and relevant with business constraint) and these specific objectives of hair personnel by because Embodiment and developer and it is different.Moreover it will be understood that this development amount may be complicated and time-consuming, still It is still the normal work to do of engineering for the those of ordinary skill in the art for benefiting from present disclosure.

Although disclosure provided herein focuses primarily upon freezing, it will be appreciated that, the energy of various other forms It can be used for melting the heart tissue of illness.These may include radio frequency (RF), ultrasound and laser energy, using as nonexcludability Example.The present invention is directed to any or all of energy to these and other forms effectively.

Fig. 1 is the schematic side elevation of the one embodiment for the medical device 10 being used together with patient 12, and patient 12 can To be human or animal.Although the specific medical device 10 being illustrated and described herein belongs to and refers to freezing balloon catheter system 10, it should be understood that and it is appreciated that other kinds of medical device 10 can be benefited by the way that introduction provided herein is same. The design of freezing balloon catheter system 10 can change.In certain embodiments, embodiment such as shown in FIG. 1 freezes sacculus Conduit system 10 may include control system 14, fluid source 16, foley's tube 18, Handleset 20, console 22 and graphical display One or more of device 24.It should be understood that although fig 1 illustrate that being in the freezing ball of specific position, sequence and/or sequence The structure of balloon catheter 10, but these structures can be located at any position different from shown in Fig. 1 appropriate, sequence and/ Or sequence.

In various embodiments, control system 14, which can control, discharges to foley's tube 18 and/or takes from foley's tube 18 Return frozen liquid 26.In various embodiments, control system 14 can control other one or more processes of foley's tube 18 Activation and/or deactivation.Additionally or in the alternative, control system 14 can be from the various knots in freezing balloon catheter system 10 Structure receives electric signal, including data and/or other information (hereinafter sometimes called " sensor output ").In some embodiments In, control system 14 can be absorbed and/or integrate sensor output, and/or from freezing balloon catheter system 10 in any knot Any other data or information that structure receives.Additionally or in the alternative, control system 14 can control the portion of foley's tube 18 Divide in the intracorporal positioning of patient 12, and/or can control any other suitable function of foley's tube 18.

Fluid source 16 includes frozen liquid 26, is being with or without during cryoablation operation from control system 14 Foley's tube 18 is delivered in the case where input.The type of the frozen liquid 26 used during cryoablation operation can become Change.In a nonexcludability embodiment, frozen liquid 26 may include liquid oxidatively Asia nitrogen.However, it is possible to use any other Suitable frozen liquid 26.

Foley's tube 18 is inserted into the internal of patient 12.In one embodiment, control system 14 can be used by ball Ductus bursae 18 is located in the internal of patient 12.Alternatively, foley's tube 18 can be by health care professionals (herein Otherwise referred to as " operator ") it is manually positioned at the internal of patient 12.In certain embodiments, using from foley's tube 18 Sensor export foley's tube 18 be located in the internal of patient 12.In various embodiments, sensor output is by control system System 14 receives, and then control system 14 can provide the information of the positioning about foley's tube 18 to operator.At least partly ground In the sensor output feedback received by control system 14, the adjustable foley's tube 18 of operator is intracorporal fixed in patient 12 Position.Although specifically referring to foley's tube 18 herein, it will be appreciated that can be used any suitable type medical device and/ Or conduit.

Handleset 20 is handled by operator and using to operate, position and control foley's tube 18.Handleset 20 Design and specific features can change to adapt to the design requirement of freezing balloon catheter system 10.In the embodiment shown in fig. 1, Handleset 20 is separated with control system 14, fluid source 16 and/or graphic alphanumeric display 24, but is electrically communicated and/or is flowed with it Body connection.In some embodiments, Handleset 20 can be integrated by least part of control system 14 and/or including in hand The inside of handle component 20.It should be understood that Handleset 20 may include than those of be specifically illustrated and described herein it is less or Additional component.

In the embodiment shown in fig. 1, console 22 includes control system 14, fluid source 16 and graphic alphanumeric display 24.So And in alternative embodiments, console 22 may include the additional structure for being not shown or describing herein.Again alternatively, control Platform 22 can not include the various structures shown in console 22 in Fig. 1.For example, in one embodiment, console 22 It does not include graphic alphanumeric display 24.

Graphic alphanumeric display 24 is provided to the operator of freezing balloon catheter system 10 can be before cryoablation operation, period The information used later.The details of graphic alphanumeric display 24 can depend on design requirement or the behaviour of freezing balloon catheter system 10 Specific needs, specification and/or the expectation of author and change.

In one embodiment, graphic alphanumeric display 24 can provide static vision data and/or information to operator.In addition Or alternatively, graphic alphanumeric display 24 can provide dynamic vision data and/or information to operator, such as video data or with Any other data of time change.In addition, in various embodiments, graphic alphanumeric display 24 may include one or more colors, Different sizes, brightness of variation etc., may be used as the alarm to operator.Additionally or in the alternative, graphic alphanumeric display can be with Audio data or information are provided to operator.

Fig. 2A is the simplification of a part of a part of patient 212 and one embodiment of freezing balloon catheter system 210A Side view.In this embodiment, freezing balloon catheter system 210A includes foley's tube 218A.The embodiment shown in Fig. 2A In, foley's tube 218A includes seal wire 226A, guidewire lumen 227A, catheter shaft 228A, internal balloon-expandable 230A (herein In sometimes referred to as " the first balloon-expandable " or " the first sacculus "), external inflatable sacculus 232A (herein sometimes referred to as " the second balloon-expandable " or " the second sacculus ") and sensor module 234A.As it is used herein, it is recognized that sacculus 230A or 232A can be described as the first sacculus or the second sacculus.It will also be appreciated that in some embodiments, it is as described herein Foley's tube can only have a balloon-expandable.In the embodiment shown in Fig. 2A, freezing balloon catheter system 210A's A part is positioned in the circulatory system 235A (herein otherwise referred to as " body ") of patient 212.It seal wire 226A and leads Fiber tube chamber 227A is inserted into the pulmonary vein 236A of patient, and catheter shaft 228A and sacculus 230A, 232A are along seal wire 226A and/or guidewire lumen 227A are moved near the mouth 238A of pulmonary vein 236A.

In one embodiment, internal balloon-expandable 230A can be by relatively non-compliant (non-compliant) or half The material for complying with (semi-compliant) is made.Some representative materials suitable for the application include PET (poly- terephthaldehyde Sour glycol ester), nylon, polyurethane and these materials copolymer, such as polyether block amide (PEBA), trade name(supplier Arkema), using as nonexcludability example.In another embodiment, it is referred to as in the industry(DuPont^TM) polyester block copolymer be also suitable material for internal balloon-expandable 230A.With outside Balloon-expandable 232A is compared, and internal balloon-expandable 230A can be relatively nonelastic.

In certain embodiments, external inflatable sacculus 232A can be made of material that complying with relatively.These materials exist It is known in this technology.One nonexcludability example is aliphatic polyether polyurethane, and wherein carbon atom links in open chain, packet Include alkane, alkene and acetylene.Another available example follows trade name(Lubrizol).From with different Other usable polymers of the polyurethane-type thermoplastic polymer of normal elongation characteristics are also suitable for external inflatable sacculus 232A.In one embodiment, by being doped with the material of conductive metal or the manufacture of other conductive materials, sacculus can be made Any of 230A, 232A are conductive.These conductive sacculus are particularly suitable for external inflatable sacculus 232A as described herein.

During use, internal balloon-expandable 230A can partially or completely be expanded, so that internal balloon-expandable At least part of the outer surface 240A of 230A be expanded against external balloon-expandable 232A inner surface 242A (although in order to Understand and it can be readily appreciated that shows the sky between internal balloon-expandable 230A and external inflatable sacculus 232A in fig. 2 Between).In addition, at certain positions between internal balloon-expandable 230A and external inflatable sacculus 232A, it can be swollen in inside There may be the open spaces between balloon interstices 244A, such as sacculus 230A, 232A after swollen sacculus 230A expansion.As herein Provided, once inside balloon-expandable 230A sufficiently expands, the outer surface 245A of external inflatable sacculus 232A is then It can be positioned in the circulatory system 235A of patient 212, with the mouth 238A with pulmonary vein 236A to be treated is adjacent and/or base Sealing is formed in sheet.

In the embodiment shown in Fig. 2A, sensor module 234A is at the lumen distal 246A of guidewire lumen 227A or attached Closely is positioned and/or be embedded in guidewire lumen 227A.As it is used herein, lumen distal 246A is to be firstly inserted into patient The part of guidewire lumen 227A in 212 circulatory system 235A.In the embodiment shown in Fig. 2A, the edge sensor module 234A Guidewire lumen 227A be positioned between lumen distal 246A and external inflatable sacculus 232A.Using this design, once The mouth 238A of external inflatable sacculus 232A and pulmonary vein 236A to be treated is adjacent and/or forms sealing, sensor module 234A is just positioned in pulmonary vein 236A to be treated.Thus, due to more stable in closed pulmonary vein 236A and/or by The environment of control, sensor module 234A can more accurately sense the various physiological parameters in pulmonary vein 236A.

Sensor module 234A is configured as one or more physiological parameters in sensing pulmonary vein 236A.In addition, sensing Sensor about physiological parameter can be exported and be supplied to control system 14 (showing in Fig. 1) for storage by device assembly 234A And/or processing.In a nonexcludability embodiment, sensor module 234A may include multiple and different sensor, including the One sensor 252AF, second sensor 252AS and 3rd sensor 252AT.However, it should be understood that sensor module 234A In can alternatively include any appropriate number of sensor (being more than or less than three).In addition, in one embodiment, passing Sensor 252AF, 252AS, 252AT may include one or more thermocouples.

In one embodiment, first sensor 252AF, second sensor 252AS and 3rd sensor 252AT can not It include pressure sensor, temperature sensor and electrode by particular order, or any combination thereof.Alternatively, first sensor 252AF, second sensor 252AS and 3rd sensor 252AT may include the sensor of multiple same types, and can arrange Except the sensor of one or more types.In one embodiment, pressure sensor (such as MEMS or " MEMS " sensing Device) pressure in the blood of pulmonary vein 236A can be sensed.Temperature sensor can sense the blood temperature in pulmonary vein 236A. Electrode can sense the current potential in the blood of pulmonary vein 236A.The sensor of these types is in the perioperative purposes of cryoablation It is it is known that and understanding with benefit.

Additionally or in the alternative, sensor 252AF, 252AS, 252AT (or additional sensing in sensor module 234A Device) in one may include Vltrasonic device/sensor, seal wire 226A, guidewire lumen 227A and/or biography can be assisted in Position of the sensor component 234A in the circulatory system of patient 212.More specifically, Vltrasonic device/sensor can provide sensing Device output, when freezing balloon catheter system 210A when in use, which exports the use to freezing balloon catheter system 210A Family accurately shows position of the sensor module 234A in pulmonary vein 236A.

In certain embodiments, control system 14 (showing in Fig. 1) is configured as processing and integrated sensor output with true Surely the normal operation of balloon catheter system 210A is freezed.It is exported based on sensor, control system 14 can determine needs to freezing The operation of balloon catheter system 210A carries out certain modifications.

Control system 14 can stop the delivering (showing in Fig. 1) of frozen liquid 26, can increase fluid flow rate to obtain It is more cooling, reduce fluid flow rate, and/or can have initial flow rate with by temperature be reduced to set point then change flow velocity with Keep set temperature.In certain embodiments, control system 14 can also change circulation time and/or fluid delivery amount.

Fig. 2 B is the cross-sectional view of the foley's tube 218A of the line 2B-2B interception in Fig. 2A.In this embodiment, sacculus is led Pipe 218A includes seal wire 226A, guidewire lumen 227A and sensor module 234A.In this embodiment, guidewire lumen 227A has 248A and outer perimeter 250A inside lumen.Seal wire 226A is positioned in inside the lumen of guidewire lumen 227A in 248A.In the reality It applies in example, sensor module 234A is positioned in inside the lumen of guidewire lumen 227A between 248A and outer perimeter 250A.

As shown in Figure 2 B, sensor module 234A includes first sensor 252AF.Sensor 252AS, 252AT are not scheming It is shown in 2B.However, sensor module 234A includes sensor conductor 254AS, 254AT, by sensor 252AS, 252AT The sensor output of (showing in Fig. 2A) is transmitted to control system 14 (showing in Fig. 1).Sensor module 234A further includes being used for First sensor 252AF (does not show so as to the sensor conductor that the output of the sensor of sensor 252AF is transmitted to control system 14 Out).Alternatively, sensor 252AF, 252AS, 252AT can be wirelessly communicated with control system 14.

In one embodiment, sensor module 234A can be at least partly (if not completely) by sensor Outer cover 255A covering.Sensor outer cover 255A may include elastic material, by one in sensor 252AF, 252AS, 252AT Or multiple blood with the circulatory system of patient 212 are isolated, and can be inserted into patient 212 and removed from patient 212 Period inhibits the damage to one or more of sensor 252AF, 252AS, 252AT.In one embodiment, outside sensor Lid 255A can be a part of guidewire lumen 227A.Sensor module 234A can also be contained in sensor housing 256A, Sensor housing 256A can form a part of guidewire lumen 227A.

Fig. 2 C is the simplification of a part of a part of patient 212 and another embodiment of freezing balloon catheter system 210C Side view.In this embodiment, freezing balloon catheter system 210C includes foley's tube 218C.The embodiment shown in Fig. 2A In, foley's tube 218C includes that seal wire 226C, guidewire lumen 227C, catheter shaft 228C, internal balloon-expandable 230C, outside can Dilatation balloon 232C and sensor module 234C.In this embodiment, balloon catheter system 210C is freezed shown in Fig. 2 C Part be positioned in the circulatory system of patient 212.The lung that seal wire 226C and guidewire lumen 227C is inserted into patient 212 is quiet In arteries and veins 236C, and along seal wire 226C and/or guidewire lumen 227C to be moved to lung quiet by catheter shaft 228C and sacculus 230C, 232C Near the mouth 238C of arteries and veins 236C.

Internal balloon-expandable 230C and external inflatable sacculus 232C can by a manner of being described with previous text slightly The material of micro- similar mode is constituted.In addition, inside balloon-expandable 230C and external inflatable sacculus 232C can with elder generation The slightly similar mode of preceding manner described herein is operated.However, in embodiment shown in fig. 2 C, sensor module 234C is positioned between internal balloon-expandable 230C and external inflatable sacculus 232C.In one embodiment, sensor Component 234C can adhere to or be otherwise fixedly secured to the outer surface 240C of internal balloon-expandable 230C.In some embodiments In, sensor module 234C can adhere to or be otherwise fixedly secured to internal balloon-expandable in balloon interstices 244C 230C。

Alternatively, sensor module 234C can be positioned in internal balloon-expandable 230C and external inflatable sacculus Another location between 232C.Thus, sensor module 234C can be sensed to be sent out at or near the mouth 238C of pulmonary vein 236C Raw various physiological parameters.It includes mentioning that sensor module 234C, which is placed on an advantage between two sacculus 230C, 232C, For the firm connection with the outer surface 240C as the inside balloon-expandable 230C not complied with relatively, to provide for combining The more preferable surface of the structure of all sensor module 234C as described herein.It can on the contrary, structure to be integrated to the outside better conformed to Dilatation balloon 232C can lead to conducting wire and/or sensor fluffs, this can lead to twines with slim and frahile cardiac structure (valve etc.) Knot.By being integrated to the outer surface 240C of internal balloon-expandable 230C, to realize safety benefits.

In this embodiment, sensor module 234C be configured as sensing pulmonary vein 236C nearby or one in it or more A physiological parameter.In addition, sensor module 234C can be to 14 (Fig. 1 of control system for storing and/or handling physiological parameter In show) provide sensor output.In a nonexcludability embodiment, sensor module 234C may include multiple and different biography Sensor, including first sensor 252CF, second sensor 252CS and 3rd sensor 252CT.However, it should be understood that passing May include any appropriate number of sensor in sensor component 234C, can than three sensors it is less or more.One In a embodiment, sensor module 234C may include flexible circuit, which can be incorporated into internal balloon-expandable The outer surface 240C of 230C.Alternatively, sensor module 234C may include the communication means of any other suitable type Or the wiring between sensor 252CF, 252CS, 252CT and control system 14.Additionally, or alternatively, sensor 252CF, 252CS, 252CT can be wirelessly communicated with control system 14.

Sensor 252CF, 252CS, 252CT can be slightly similar in a manner of being described with previous text mode grasped Make.In certain embodiments, control system 14 is configured as processing and integrated sensor output and freezes foley's tube system to determine The normal function of system 210C.It is exported based on sensor, control system 14 can determine needs to freezing balloon catheter system 210C Function carry out certain modifications.

Although various sensors have shown and described in previous embodiment, it is positioned in (1) lumen distal 246A and outside Between balloon-expandable 232A, or between (2) internal balloon-expandable 230C and external inflatable sacculus 232C, but recognize , alternate embodiment may include the one or more being positioned between lumen distal 246A and external inflatable sacculus 232A Sensor and the one or more sensings being positioned between internal balloon-expandable 230C and external inflatable sacculus 232C Device.In other words, in this alternative embodiment, sensor can be positioned at two positions, without departing from freezing as described herein The spirit of balloon catheter system 10.In addition, one or more sensors can be positioned on seal wire 226A.No matter the position of sensor Set how, from sensor collection to all data may be sent to control system 14 for user (health care doctor Or other users) or by control system 14 use itself.

Fig. 3 A is the cross-sectional view for freezing one embodiment of a part of balloon catheter system 310A.In this embodiment, Freezing balloon catheter system 310A includes guidewire lumen 327A, catheter shaft 328A, internal balloon-expandable 330A, external inflatable Sacculus 332A, sensor module 334A and fluid injection conduit line (line) 358A.In the embodiment as shown in fig. 3 a, sensor Component 334A is positioned and/or is embedded at or near the axis distal end 346A of catheter shaft 328A can in outside in catheter shaft 328A The outside of dilatation balloon 332A, as described earlier in this article.In addition, in this embodiment, fluid injection conduit line 358A is extended through External inflatable sacculus 332A and internal balloon-expandable 330A, and enter 362A inside internal balloon-expandable.Fluid injection Pipeline 358A can be configured and/or be positioned in any suitable manner.Although fluid injection conduit line 358A is shown as in figure 3 a Straight tube, but fluid injection conduit line 358A can be coiled, or can have any other suitable geometry or construction.Control System 14 (showing in Fig. 1) processed can guide frozen liquid 324 to be assigned to inside internal balloon-expandable in 362A, to melt Internal balloon-expandable 330A is suitably filled with during operation.

Fig. 3 B is the cross-sectional view for freezing another embodiment of a part of balloon catheter system 310B.In this embodiment, Freezing balloon catheter system 310B includes guidewire lumen 327B, catheter shaft 328B, internal balloon-expandable 330B, external inflatable Sacculus 332B, sensor module 334B and fluid injection conduit line 358B.In the embodiment shown in figure 3b, sensor module 334B It is positioned between internal balloon-expandable 330B and external inflatable sacculus 332B, as described earlier in this article.In addition, in the reality It applies in example, fluid injection conduit line 358B extends through external inflatable sacculus 332B and internal balloon-expandable 330B, and enters 362B inside internal balloon-expandable.Fluid injection conduit line 358B can be configured and/or be positioned in any suitable manner.Although Fluid injection conduit line 358B is shown as straight tube in figure 3b, but fluid injection conduit line 358B can be coiled, or can have Any other suitable geometry or construction.It is interior that control system 14 (showing in Fig. 1) can guide frozen liquid 324 to be assigned to Inside portion's balloon-expandable in 362B, to be suitably filled with internal balloon-expandable 330B during ablation procedures.

Fig. 4 is the cross-sectional view for freezing a part of balloon catheter system 310A comprising what the line 4-4 in Fig. 3 A was intercepted Foley's tube 318A.In the embodiment shown in fig. 4, catheter shaft 328A is around guidewire lumen 327A and fluid injection conduit line 358A.In addition, being sensor conductor 354AF, 354AS, 348A, seal wire 326A inside 354AT, lumen in guidewire lumen 327A With catheter body 364A.Catheter body 364A contains the various structures in catheter shaft 328A.

Alternate embodiment includes being placed on pressure sensor by the sealing of three conductors, sensor housing and closing wiring In the component of pipe composition.In this embodiment, which inwardly passes through conduit, is routed to handle from the axis distal end of catheter shaft Component and/or control system.

Fig. 5 A is the perspective view for freezing a part of another embodiment of balloon catheter system 510.In this embodiment, cold Freeze a part that balloon catheter system 510 includes catheter shaft 528, balloon-expandable 568 and sensor module 534.In Fig. 5 A Shown in embodiment, balloon-expandable 568 is shown at swelling state.In addition, in fig. 5, for clarity, omitting Seal wire 226A, 226C (being shown in Fig. 2A and 2C respectively).

In the embodiment shown in Fig. 5 A, catheter shaft 528 may include that one or more reference electrodes 569 (form thermocouple Two reference electrodes 569 show in fig. 5).Reference electrode 569 can be used for providing reference sensor output, with to operator Known temperature at or near its position is provided.As provided in further detail herein, the reference sensor of reference electrode 569 is exported It can export and be compared with the sensor of the other parts of sensor module 534, to assist in determining for balloon-expandable 568 Position (mapping), temperature, pressure etc., or it is used for any suitable purpose during ablation procedures.

In this embodiment, balloon-expandable 568 can represent internal balloon-expandable 230A (showing in Fig. 2A) or outside Balloon-expandable 232A (is shown) in Fig. 2A.Alternatively, balloon-expandable 568 can be single balloon-expandable, wherein not having There is sacculus to be positioned in its inner space.

Sensor module 534 may include multiple electrodes 572, be fixed to balloon-expandable 568 in internal inflatable ball It (is shown in Fig. 2A) on the outer surface 240A (being shown in Fig. 2A) of capsule 230A (being shown in Fig. 2A), in external balloon-expandable 232A Inner surface (being shown in Fig. 2A) on, and/or the outer surface 245A (being shown in Fig. 2A) of external inflatable sacculus 232A on.One In a embodiment, electrode 572 can adhere to balloon-expandable 568 with flexible adhesives.Alternatively, electrode 572 can lead to Any other suitable mode is crossed fixed to balloon-expandable 568.Any appropriate number of electrode 572 can be used.

In the embodiment shown in Fig. 5 A, electrode 572 can be electrode, and (a pair of electrodes 572 for forming thermocouple exists to 573 Identified in Fig. 5 A), wherein each electrode is positioned in and/or is embedded into flexible circuit 574 to 573.In this embodiment, often A electrode can provide sensor output, sensor output and reference electrode 569 or any other one or more electricity to 573 Sensor output extremely pair is compared, to determine any special electrodes to the temperature at or near 573.Shown in Fig. 5 A In embodiment, multiple flexible circuits 574 are positioned on balloon-expandable 568 and/or are fixed to balloon-expandable 568.

Fig. 5 B is a part that the freezing balloon catheter system 510 of swelling state is shown at shown in Fig. 5 A End-view.In figure 5B, for clarity, seal wire 226A, 226C (showing in Fig. 2A and 2C respectively) is omitted.In the implementation In example, flexible circuit 574 and/or electrode 572 can be with slightly radially or spoke-like mode is positioned in balloon-expandable 568 On surface.For example, in one embodiment, flexible circuit 574 and/or electrode 572 can be on balloon-expandables 568 with basic Upper evenly spaced radial mode extends.Alternatively, flexible circuit 574 and/or electrode 572 can be in balloon-expandables 568 It is upper that there is any other suitable configuration.In certain embodiments, in radial arrangement (and other configurations), electrode 572 can To provide mapping information to operator, operator is allowed to determine balloon-expandable 568 in patient 12 (for example, showing in Fig. 1 Intracorporal positioning out).

In the embodiment shown in Fig. 5 B, there are 12 flexible circuits 574 to be positioned on balloon-expandable 568, each There are two electrodes 572 for flexible circuit tool.It is recognized, however, that the flexibility of any suitable quantity (being more than or less than 12) Circuit 574 and/or electrode 572 or combinations thereof can be used.In the embodiment shown in Fig. 5 A and 5B, electrode 572 and/or soft The distal end of property circuit 574 towards the largest circumference 575 of balloon-expandable 568 is positioned, and not along or about inflatable ball The largest circumference 575 of capsule 568 positions.As it is used herein, " largest circumference " is to be in swelling state in balloon-expandable 568 When balloon-expandable 568 largest circumference.When balloon-expandable 568 is in contraction state, by foley's tube 18 (in Fig. 1 Show) it is inserted into patient 12 and/or removes 18 period of foley's tube from patient 12, balloon-expandable 568 is less heavy And it is easier to be positioned and/or be retracted into the sheath (not shown) of balloon-expandable 568.In alternative embodiments, Electrode 572 and/or flexible circuit 574 are positioned in the proximal end of the largest circumference 575 of balloon-expandable 568, and not along or Largest circumference 575 around balloon-expandable 568 positions.

In one embodiment, flexible circuit 574 is via sensor conductor 254AS, 254AT, 354AF, 354AS, 354AT (showing in Fig. 2 B and/or 4) and control system 14 (show) telecommunication in Fig. 1, can be with base those of previously described herein This is similar and slightly similarly positions.Alternatively, sensor conductor can position in another appropriate manner.For example, In one embodiment, one or more sensors conductor can at the 346A of axis distal end (for example, being shown in Fig. 3 A) along can A part of dilatation balloon 568 extends, and (can show in Fig. 2 C into guidewire lumen 227A (showing in Fig. 2A), 227C Out), or along guidewire lumen 227A (being shown in Fig. 2A), 227C (being shown in Fig. 2 C) extend.

Fig. 5 C is the perspective view that a part of balloon catheter system 510 is freezed shown in Fig. 5 A, wherein balloon-expandable 568 are shown at basic contraction state.In this embodiment, balloon-expandable 568 can be internal balloon-expandable or outer Portion's balloon-expandable.Alternatively, balloon-expandable 568 can be single sacculus rather than two balls as previously described herein One in capsule.

In a contracted state, balloon-expandable 568 becomes slightly pleating to allow between one or more flexible circuits 574 Ridge 576, each flexible circuit 574 include electrode 572 at least one electrode to 573.By this design, work as inflatable ball When capsule 568 is in contraction state, flexible circuit 574 itself is not folded.However, the ridge 576 between flexible circuit 574 is in the systole phase Between and be in contraction state when inhibit undesirable removing of the flexible circuit 574 from balloon-expandable 568.In addition, shrinking Under state, balloon-expandable 568 is pleated, this is conducive to smaller, the more organized profile of balloon-expandable 568, so as to from The body of patient 12 (showing in Fig. 1) removes.

In one embodiment, in a contracted state, two flexible circuits 574 be positioned in two adjacent ridges 576 it Between.In one embodiment, two flexible circuits 574 being positioned between two adjacent ridges 576 are adjacent to each other.Alternatively Ground, two flexible circuits 574 being positioned between two adjacent ridges 576 do not need adjacent to each other.By this design, two A such adjacent flexible circuit 574 and/or two adjacent electrode pairs 573 when balloon-expandable 568 is shunk will substantially that This is faced.In other words, in one embodiment, balloon-expandable 568 is included within two such adjacent flexible circuits 574 And/or fold or folding line between two such adjacent electrode pairs 573, so that when balloon-expandable 568 is substantially and/or complete When full contraction, adjacent flexible circuit 574 as every two will be substantially facing with each other.

In this embodiment, when balloon-expandable 568 is substantially completely shunk, flexible circuit 574 will be alternately: in ridge It is substantially facing adjacent flexible circuit 574 on 576 side, and is substantially away from another phase on the opposite side of ridge 576 Adjacent flexible circuit 574.In such embodiments, two flexible circuits 574 be positioned in two of balloon-expandable 568 it is adjacent Between ridge 576.In other words, when balloon-expandable 568 is in contraction state, ridge 576 is more closely moved toward each other, Two flexible circuits 574 being positioned between two adjacent ridges 576 can rotate toward each other, so that 574 base of flexible circuit It is facing with each other in sheet.In addition, passing through this design, it is suppressed that the folding or crumple of flexible circuit 574.

Although should be understood that many different embodiments this article has illustrated and described freezing balloon catheter system 10, But the one or more features of any one embodiment can be with the one or more features of one or more of other embodiments Combination, so long as combination meet the intent of the present invention.

Although the multiple illustrative aspects and embodiment of freezing balloon catheter system 10, ability is discussed above Its certain modifications, displacement, addition and sub-portfolio will be recognized in field technique personnel.Therefore, it is intended that claims appended below and The claim being introduced below be interpreted as including all such modifications in its true spirit and range, displacement, addition and Sub-portfolio.