Balloons and medical systems

Abstract

A balloon is disclosed, comprising: a first balloon; a second balloon arranged around the first balloon; and a balloon layer discontinuously arranged on the second balloon or outside the first balloon.

Description

[0001] field

[0002] The present disclosure relates generally to the medical field. More specifically, the present disclosure relates to the medical field related to cardiac arrhythmias. background

[0003] The heart is divided into the left and right atria and the left and right ventricles. The sinoatrial node located in the upper part of the right atrium regularly issues pulse instructions. After a short delay in the atrioventricular node, the electrical signal reaches the entire heart through the conduction system, causing the heart to contract synchronously and coordinately. Every time the sinoatrial node generates an impulse, the heart beats once, which is medically called "sinus rhythm". It is the normal heart rhythm of the human body, with a frequency of 60-100 beats per minute.

[0004] However, the normal electrical conduction system in the heart may be disturbed by irregular electrical signals from outside the sinoatrial node, causing the heart to beat too fast and irregularly, and then develop into arrhythmia. The most common type of arrhythmia is atrial fibrillation. When it occurs, the patient's atrium will vibrate rapidly and irregularly. Atrial fibrillation increases the risk of stroke by 5 times, the mortality rate by 2 times, and the risk of heart failure by 3 times, greatly affecting the patient's health.

[0005] Overview

[0006] In one aspect, the present disclosure relates to a balloon comprising a first balloon; a second balloon disposed around the first balloon; and a balloon layer disposed discontinuously on the second balloon or outside the first balloon.

[0007] In certain embodiments, the balloon layer comprises a liquid with good thermal conductivity or a solid fluid with equivalent fluidity and thermal conductivity to the liquid.

[0008] In certain embodiments, the liquid with good thermal conductivity is selected from amalgam or gallium alloy.

[0009] In certain embodiments, the solid having good flow properties has a freezing point of about -20°C or less.

[0010] In certain embodiments, the solid having good flow properties has a freezing point of about -60°C or less.

[0011] In certain embodiments, there is a vacuum layer between the first balloon and the second balloon.

[0012] In certain embodiments, the compliance of the balloon layer is greater than the compliance of the first balloon and the second balloon.

[0013] In certain embodiments, the composition of the balloon layer contains thermoplastic elastomer (TPE), thermoplastic polyurethane elastomer (TPU), polyurethane (PU), or a mixture thereof.

[0014] In certain embodiments, the balloon further includes: a body; and a shaft disposed in the body and extending distally from the body.

[0015] In certain embodiments, the discontinuous balloon layer is located outside the second balloon.

[0016] In certain embodiments, the discontinuous balloon layer is located inside the second balloon.

[0017] In certain embodiments, the discontinuous balloon layer is located outside the first balloon.

[0018] In certain embodiments, a rotation mechanism is disposed on the shaft.

[0019] In certain embodiments, the other end of the rotating mechanism disposed on the shaft is close to the inner surface of the first balloon.

[0020] On the other hand, the present disclosure relates to a medical system, comprising: a cryoablation device; and a control unit connected to the cryoablation device, wherein the cryoablation device includes a balloon, the balloon including a first balloon; a second balloon arranged around the first balloon; and a balloon layer discontinuously arranged on the second balloon or outside the first balloon.

[0021] On the other hand, the present disclosure relates to a method for implementing pulmonary vein isolation (PVI), which includes: positioning a cryoablation device so that it contacts the pulmonary vein ostium (PVO) or pulmonary vein antrum (PVA) tissue of the heart of an individual in need of the method, and injecting a coolant into the cryoablation device, wherein the cryoablation device includes a balloon, the balloon including a first balloon; a second balloon arranged around the first balloon; and a balloon layer discontinuously arranged on the second balloon or outside the first balloon. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 A schematic diagram of a medical system including a cryoablation device according to certain embodiments of the present disclosure is shown.

[0023] Figure 2 A schematic diagram of a medical system including a cryoablation device according to certain embodiments of the present disclosure is shown.

[0024] Figure 3A schematic diagram of a medical system including a cryoablation device according to certain embodiments of the present disclosure is shown.

[0025] Figure 4 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0026] Figure 5 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0027] Figure 6 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0028] Figure 7 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0029] Figure 8 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0030] Fig. 9 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0031] Fig.10 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0032] Fig.11 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0033] Fig.12 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0034] Fig.13 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0035] Fig.14 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0036] Fig.15 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0037] Fig.16 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0038] Fig.17 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0039] Fig.18 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0040] Fig.19 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0041] Fig. 20 A cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present disclosure is shown.

[0042] Fig.21 A partial enlarged view of a balloon layer disposed outside the first balloon in certain embodiments of the present disclosure is shown.

[0043] Fig. 22 A partial enlarged view of a balloon layer disposed inside the second balloon in certain embodiments of the present disclosure is shown.

[0044] Fig.23 A schematic diagram of a cryoablation device in an uninflated state located in the left atrium is shown according to certain embodiments of the present disclosure.

[0045] Fig.24 A schematic diagram of a cryoablation device in an uninflated state located in the left atrium is shown according to certain embodiments of the present disclosure.

[0046] Fig.25 A schematic diagram of a cryoablation device in an expanded state located in the left atrium according to certain embodiments of the present disclosure is shown.

[0047] Fig.26 A schematic diagram of a cryoablation device in an expanded state located in the left atrium according to certain embodiments of the present disclosure is shown.

[0048] Fig. 27 A schematic diagram of a cryoablation device in contact with a pulmonary vein ostium and inflated and loaded in the left atrium according to certain embodiments of the present disclosure is shown.

[0049] Fig.28 A schematic diagram of a cryoablation device in contact with a pulmonary vein ostium and inflated and loaded in the left atrium according to certain embodiments of the present disclosure is shown.

[0050] Fig.29 A schematic diagram of the distal end of a cryoablation device in an expanded state with a rotating mechanism installed according to certain embodiments of the present disclosure is shown.

[0051] Fig.30A schematic diagram of a rotation mechanism of certain embodiments of the present disclosure is shown.

[0052] Details

[0053] In the following description, certain specific details are included to provide a comprehensive understanding of each disclosed embodiment. However, those skilled in the relevant art will recognize that the embodiments can still be implemented without using one or more of these specific details and using other methods, components, materials, etc.

[0054] Unless otherwise required by the present disclosure, throughout the specification and the appended claims, the words "including," "comprising," "containing," and "having" should be interpreted in an open, inclusive sense, ie, "including but not limited to."

[0055] References throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" mean that at least one embodiment includes the specific referenced elements, structures, or features described in connection with that embodiment. Thus, the phrases "in one embodiment," "in an embodiment," "in another embodiment," or "in certain embodiments" appearing in different places throughout the specification do not necessarily all refer to the same embodiment. Furthermore, the specific elements, structures, or features may be combined in any appropriate manner in one or more embodiments.

[0056] definition

[0057] In the present disclosure, the term "compliance" refers to the ease with which an elastic body deforms under the action of an external force. A high compliance of an elastic body means that it has a strong deformation ability, that is, it can cause a large deformation under a small external force.

[0058] In the present disclosure, the term "thermoplastic elastomer (TPE)" refers to a type of elastomer that has the elasticity of rubber at room temperature and can be plasticized and molded at high temperature.

[0059] In the present disclosure, the term "thermoplastic polyurethanes (TPU)" refers to (AB) n A type block linear polymer, A is a polyester or polyether with a high molecular weight (1000 to 6000), B is a diol containing 2 to 12 straight-chain carbon atoms, and the chemical structure between the AB segments is diisocyanate.

[0060] In the present disclosure, the term "polyurethane (PU)" refers to a polymer containing urethane groups in the main chain of the macromolecule.

[0061] In the present disclosure, the term “having good thermal conductivity” means a thermal conductivity greater than 7 W / (m·K).

[0062] In the present disclosure, the term "inner side" refers to the side close to the inner lumen of the balloon.

[0063] In the present disclosure, the term "outside" refers to the side distal to the inner lumen of the balloon.

[0064] In this disclosure, the term "pulmonary vein isolation (PVI)" refers to the electrical conduction block between the pulmonary veins and the atria. DETAILED DESCRIPTION

[0065] In one aspect, the present disclosure relates to a balloon comprising a first balloon; a second balloon disposed around the first balloon; and a balloon layer disposed discontinuously on the second balloon or outside the first balloon.

[0066] refer to Figure 1 , a balloon 100 includes a first balloon 101 (inner balloon), a second balloon 102 (outer balloon) arranged around the first balloon 101 , and a balloon layer 103 discontinuously arranged on the outside of the second balloon 102 .

[0067] refer to Figure 2 , a balloon 200 includes a first balloon 201 (inner balloon), a second balloon 202 (outer balloon) arranged around the first balloon 201 , and a balloon layer 203 discontinuously arranged on the outside of the first balloon 201 .

[0068] The arrangement of other components in balloon 200 is similar or the same as that of balloon 100 .

[0069] refer to Figure 3 , a balloon 300 includes a first balloon 301 (inner balloon), a second balloon 302 (outer balloon) arranged around the first balloon 301 , and a balloon layer 303 discontinuously arranged on the inner side of the second balloon 302 .

[0070] The arrangement of other components in balloon 300 is similar to or the same as that of balloon 100 .

[0071] Continue to refer Figure 1 A vacuum layer 104 is provided between the first balloon 101 and the second balloon 102. In some embodiments, the vacuum layer 104 is provided mainly to detect whether the refrigerant inside the first balloon 101 leaks.

[0072] In some embodiments, a liquid with good thermal conductivity is included in the balloon layer 103. In some embodiments, exemplary examples of liquids that can be used in the present disclosure include, but are not limited to, amalgam and gallium alloys. In some embodiments, the freezing point of the liquid that can be used in the present disclosure is less than or equal to about -20°C. In some embodiments, the freezing point of the liquid that can be used in the present disclosure is less than or equal to about -60°C.

[0073] In certain embodiments, the balloon layer 103 contains a solid fluid having the same fluidity and thermal conductivity as the aforementioned liquid.

[0074] The compliance of balloon layer 103 is better than that of first balloon 101 and second balloon 102. In certain embodiments, exemplary examples of materials that can be used as components of balloon layer 103 include, but are not limited to, thermoplastic elastomers (TPE), thermoplastic polyurethane elastomers (TPU), and polyurethanes (PU).

[0075] In certain embodiments, exemplary examples of thermoplastic elastomers (TPE) that can be used in the present disclosure include, but are not limited to, styrenics (SBS, SIS, SEBS, SEPS), olefins (TPO, TPV), dienes (TPB, TPI), vinyl chlorides (TPVC, TCPE), urethanes (TPU), esters (TPEE), amides (TPAE), organic fluorines (TPF), silicones, and vinyls.

[0076] In certain embodiments, illustrative examples of thermoplastic polyurethane elastomers (TPU) that can be used in the present disclosure include, but are not limited to, polyester type, polyether type, and butadiene type.

[0077] Continue to refer Figure 1 The balloon 100 further includes a body 105 , and a shaft 106 disposed in the body 105 and extending distally from the body 105 .

[0078] The shaft 106 may include a guidewire lumen 107 , an injection tube 108 , a temperature sensor 109 , a pull wire 110 , and a tip 111 .

[0079] In certain embodiments, the guidewire lumen 107 can facilitate the injection of contrast agent to confirm that the vein is well occluded.

[0080] In certain embodiments, illustrative examples of contrast agents that can be used in the present disclosure include, but are not limited to, iodine and barium sulfate.

[0081] In certain embodiments, a guidewire placed through guidewire lumen 107 can help guide the catheter to the target vein.

[0082] In certain embodiments, the coolant is dispersed toward the inner surface of the first balloon 101 through the injection tube 108 .

[0083] In certain embodiments, illustrative examples of coolants that can be used in the present disclosure include, but are not limited to, liquid nitrogen and nitrous oxide.

[0084] In certain embodiments, temperature sensor 109 is used to monitor the temperature of the evaporated coolant.

[0085] In certain embodiments, illustrative examples of temperature sensors that can be used in the present disclosure include, but are not limited to, thermocouples and thermal resistors.

[0086] The body 105 defines a proximal portion 120 and a distal portion 130 .

[0087] The proximal end 112 and the distal end 113 of the first balloon 101 and the proximal end 114 and the distal end 115 of the second balloon 102 may be coupled to the shaft 106 or the body 105 .

[0088] In certain embodiments, illustrative examples of materials that can be used to bond the proximal and distal ends 112, 113 of the first balloon 101 and the proximal and distal ends 114, 115 of the second balloon 102 to the shaft 106 or body 105 include, but are not limited to, biocompatible adhesives.

[0089] In certain embodiments, illustrative examples of biocompatible adhesives that can be used in the present disclosure include, but are not limited to, medical grade instant adhesives.

[0090] In certain embodiments, illustrative examples of medical grade instant adhesives that can be used in the present disclosure include, but are not limited to, instant adhesives containing epoxy resins as ingredients.

[0091] In certain embodiments, such as Figure 1 and Figure 6 As shown, the proximal end 112 of the first balloon 101 is coupled to the distal portion 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the tip 111 .

[0092] exist Figure 1 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0093] exist Figure 6 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0094] In certain embodiments, such as Figure 4 and Figure 7As shown, the proximal end 112 of the first balloon 101 is coupled to the proximal end portion 116 of the shaft 106 near the distal end portion 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the tip 111 .

[0095] exist Figure 4 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0096] exist Figure 7 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0097] In certain embodiments, such as Figure 5 and 8 As shown, the proximal end 112 of the first balloon 101 is coupled to the proximal end portion 116 of the shaft 106 at a distance from the distal end portion 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the tip 111 .

[0098] exist Figure 5 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0099] exist Figure 8 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0100] In certain embodiments, such as Fig. 9 and Fig.12 As shown, the proximal end 112 of the first balloon 101 is coupled to the distal portion 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the distal portion 117 of the shaft 106 near the tip 111 .

[0101] exist Fig. 9 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0102] exist Fig.12 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0103] In certain embodiments, such as Fig.10 and Fig.13 As shown, the proximal end 112 of the first balloon 101 is coupled to the proximal end portion 116 of the shaft 106 near the distal end portion 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the distal end portion 117 of the shaft 106 near the tip 111 .

[0104] exist Fig.10In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0105] exist Fig.13 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0106] In certain embodiments, such as Fig.11 and 14 As shown, the proximal end 112 of the first balloon 101 is coupled to the proximal end 116 of the shaft 106 at a distance from the distal end 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the distal end 117 of the shaft 106 near the tip 111 .

[0107] exist Fig.11 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0108] exist Fig.14 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0109] In certain embodiments, such as Fig.15 and 18 As shown, the proximal end 112 of the first balloon 101 is coupled to the distal portion 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the distal portion 117 of the shaft 106 at a distance from the tip 111 .

[0110] exist Fig.15 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0111] exist Fig.18 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0112] In certain embodiments, such as Fig.16 and 19 As shown, the proximal end 112 of the first balloon 101 is coupled to the proximal end 116 of the shaft 106 near the distal end 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the distal end 117 of the shaft 106 at a certain distance from the tip 111 .

[0113] exist Fig.16 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0114] exist Fig.19 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0115] In certain embodiments, such as Fig.17 and 20 As shown, the proximal end 112 of the first balloon 101 is coupled to the proximal end 116 of the shaft 106 at a distance from the distal end 130 of the body 105 , and the distal end 113 of the first balloon 101 is coupled to the distal end 117 of the shaft 106 at a distance from the tip 111 .

[0116] exist Fig.17 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the second balloon 102 .

[0117] exist Fig. 20 In the illustrated embodiment, the balloon layer 103 is discontinuously disposed on the outside of the first balloon 101 .

[0118] In certain embodiments, the proximal and distal ends of the second balloon are configured similarly to the proximal and distal ends of the first balloon.

[0119] In certain embodiments, such as Figure 1 and Figure 6 As shown, the proximal end 114 of the second balloon 102 is coupled to the distal portion 130 of the body 105 , and the distal end 115 of the second balloon 102 is coupled to the tip 111 .

[0120] In certain embodiments, the proximal end 114 of the second balloon 102 is coupled to the proximal end portion 116 of the shaft 106 proximate the distal end portion 130 of the body 105 , and the distal end 115 of the second balloon 102 is coupled to the tip 111 .

[0121] In certain embodiments, the proximal end 114 of the second balloon 102 is coupled to the proximal portion 116 of the shaft 106 at a distance proximal to the distal portion 130 of the body 105 , and the distal end 115 of the second balloon 102 is coupled to the tip 111 .

[0122] In certain embodiments, the proximal end 114 of the second balloon 102 is coupled to the distal portion 130 of the body 105 , and the distal end 115 of the second balloon 102 is coupled to the distal portion 117 of the shaft 106 proximate the tip 111 .

[0123] In certain embodiments, the proximal end 114 of the second balloon 102 is coupled to the proximal end portion 116 of the shaft 106 near the distal end portion 130 of the body 105 , and the distal end 115 of the second balloon 102 is coupled to the distal end portion 117 of the shaft 106 near the tip 111 .

[0124] In some embodiments, the proximal end 114 of the second balloon 102 is coupled to the proximal portion 116 of the shaft 106 at a distance from the distal portion 130 proximal to the body 105 , and the distal end 115 of the second balloon 102 is coupled to the distal portion 117 of the shaft 106 proximal to the tip 111 .

[0125] In certain embodiments, the proximal end 114 of the second balloon 102 is coupled to the distal portion 130 of the body 105 , and the distal end 115 of the second balloon 102 is coupled to the distal portion 117 of the shaft 106 at a distance from the tip 111 .

[0126] In some embodiments, the proximal end 114 of the second balloon 102 is coupled to the proximal portion 116 of the shaft 106 near the distal portion 130 of the body 105 , and the distal end 115 of the second balloon 102 is coupled to the distal portion 117 of the shaft 106 at a certain distance from the end 111 .

[0127] In some embodiments, the proximal end 114 of the second balloon 102 is coupled to the proximal portion 116 of the shaft 106 at a distance from the distal portion 130 close to the body 105, and the distal end 115 of the second balloon 102 is coupled to the distal portion 117 of the shaft 106 at a distance from the end 111.

[0128] In certain embodiments, a rotation mechanism 500 is disposed on the shaft 106 .

[0129] In certain embodiments, the other end of the rotating mechanism 500 of the present disclosure is close to the inner surface of the first balloon 101 .

[0130] In certain embodiments, a rotation mechanism 500 that can be used in the present disclosure includes a universal joint 501, an extension rod 502, and an end effector 503, wherein the extension rod is connected to the universal joint, and the end effector is installed at one end of the extension rod.

[0131] In certain embodiments, a universal joint 501 that can be used in the present disclosure includes a base 504 , a cross shaft 505 , and a yoke 506 , wherein the cross shaft 505 is mounted on the base 504 , and the yoke 506 is mounted on the cross shaft 505 .

[0132] In certain embodiments, illustrative examples of end effectors that can be used with the present disclosure include, but are not limited to, brushes.

[0133] In certain embodiments, when the balloon of the present disclosure is attached to the pulmonary vein, the liquid or solid in the balloon layer can be squeezed from the better-sealed portion to the worse-sealed portion, thereby enhancing the overall sealing effect of the second balloon (outer balloon) on the pulmonary vein orifice and improving the success rate of the operation.

[0134] In certain embodiments, the balloons of the present disclosure can be suitable for patients with irregular pulmonary vein ostia.

[0135] In certain embodiments, the vacuum layer in the balloon of the present disclosure can be used to detect whether the refrigerant inside the first balloon (inner balloon) has leaked.

[0136] In certain embodiments, the use of the rotating mechanism of the present disclosure can provide additional force, thereby further enhancing the overall occlusion effect of the second balloon (outer balloon) on the pulmonary vein ostium.

[0137] On the other hand, the present disclosure relates to a medical system, comprising: a cryoablation device; and a control unit connected to the cryoablation device, wherein the cryoablation device includes a balloon, the balloon including a first balloon; a second balloon arranged around the first balloon; and a balloon layer discontinuously arranged on the second balloon or outside the first balloon.

[0138] refer to Figure 1 The medical system 500 may include a cryoablation device 300 and a control unit 400 connected to the cryoablation device 300, wherein the cryoablation device 300 includes a balloon 100, and the balloon 100 includes a first balloon 101 (inner balloon), a second balloon 102 (outer balloon) arranged around the first balloon 101, and a balloon layer 103 discontinuously arranged on the outside of the second balloon 102.

[0139] The cryoablation device 300 may include a body 105 and one or more balloons 100 or 200 .

[0140] The body 105 defines a proximal portion 120 and a distal portion 130 .

[0141] The proximal portion 120 of the body 105 can include a handle 140. In certain embodiments, the handle 140 includes one or more knobs, levers, connectors, cables, or other components for guiding, operating, and controlling the cryoablation device 300.

[0142] In certain embodiments, handle 140 may connect cryoablation device 300 to control unit 400 .

[0143] In certain embodiments, the control unit 400 may include a first fluid supply device 401 .

[0144] In certain embodiments, the first fluid supply 401 may include one or more containers for holding a coolant.

[0145] In certain embodiments, the control unit 400 may include a second fluid supply 402 .

[0146] In some embodiments, the second fluid supply 402 may include one or more containers for containing a non-cooled fluid used to inflate the first balloon.

[0147] In certain embodiments, the control unit 400 may include a control device 403 .

[0148] In certain embodiments, illustrative examples of control devices that can be used with the present disclosure include, but are not limited to, pumps.

[0149] In certain embodiments, the control unit 400 may include one or more valves 404 .

[0150] In certain embodiments, illustrative examples of valves that can be used in the present disclosure include, but are not limited to, solenoid valves and electric valves.

[0151] In certain embodiments, exemplary examples of solenoid valves that can be used in the present disclosure include, but are not limited to, straight-through solenoid valves and proportional solenoid valves.

[0152] In certain embodiments, the balloon that can be used in the cryoablation device 300 of the medical system 500 of the present disclosure may also be the balloon 200 or 300 of the present disclosure.

[0153] On the other hand, the present disclosure relates to a method for implementing pulmonary vein isolation (PVI), which includes: positioning a cryoablation device so that it contacts the pulmonary vein ostium (PVO) or pulmonary vein antrum (PVA) tissue of the heart of an individual in need of the method, and injecting a coolant into the cryoablation device, wherein the cryoablation device includes a balloon, the balloon including a first balloon; a second balloon arranged around the first balloon; and a balloon layer discontinuously arranged on the second balloon or outside the first balloon.

[0154] In certain embodiments, the subject is a mammal.

[0155] In certain embodiments, the subject is a human.

[0156] In certain embodiments, a cryoablation device is delivered to the left atrium (LA) of a subject.

[0157] In certain embodiments, a sheath (not shown) is threaded through the vasculature of a subject into the right atrium (RA) of the heart.

[0158] In certain embodiments, illustrative examples of vasculature that can be used in the present disclosure include, but are not limited to, the femoral artery, the brachial artery, and the radial artery.

[0159] In some embodiments, once the sheath is within the right atrium, a separate device (not shown) can be passed through the sheath and used to puncture the septum between the right atrium and the left atrium. The puncturing device can be removed from the sheath and the individual's body.

[0160] In certain embodiments, a cryoablation device 300 of the present disclosure may be passed through the sheath and into the left atrium.

[0161] In certain embodiments, such as Fig.23 or Fig.24 As shown, the cryoablation device 300 of the present disclosure may be passed through the vasculature of an individual and into the left atrium with the balloon 100 or 200 or 300 in an uninflated state.

[0162] like Fig.25 or Fig.26 As shown, once the cryoablation device 300 is located in the left atrium, the first balloon 101 or 201 or 301 of the cryoablation device 300 may begin to expand.

[0163] In certain embodiments, releasing a non-cooling fluid into the lumen of the first balloon 101 or 201 or 301 may expand the first balloon 101 or 201 or 301 , thereby causing the second balloon 102 or 202 or 302 to expand.

[0164] In certain embodiments, the first fluid supply 401 or the second fluid supply 402 of the control unit 401 may be activated to release the coolant or the non-cooling fluid.

[0165] In certain embodiments, the present disclosure relates to a method for performing pulmonary vein isolation (PVI) comprising introducing a guidewire into a target vein, inflating and positioning a balloon in a cryoablation device, occluding the pulmonary vein ostium, and injecting a coolant into the cryoablation device, thereby completing pulmonary vein isolation.

[0166] In certain embodiments, the occlusion of the pulmonary vein ostium is determined by injecting contrast agent.

[0167] In certain embodiments, when the pulmonary vein ostium is well occluded, a coolant is injected into the cryoablation device.

[0168] In certain embodiments, after pulmonary vein isolation is complete, the balloon is deflated and withdrawn into the sheath.

[0169] In the present disclosure, relational terms such as first and second, etc. are used merely to distinguish one entity or operation from another entity or operation, but do not necessarily require or imply any such actual relationship or order between these entities or operations.

[0170] It can be understood from the foregoing that although the specific embodiments of the present disclosure are described for the purpose of illustrative illustration, various modifications or improvements may be made by those skilled in the art without departing from the spirit and scope of the present disclosure. These modifications or improvements should all fall within the scope of the claims appended to the present disclosure.

Claims

1. A balloon comprising: First balloon; a second balloon disposed around the first balloon; as well as a balloon layer disposed discontinuously on the second balloon or outside the first balloon; The balloon layer is used to enhance the overall blocking effect of the second balloon on the pulmonary vein orifice.

2. The balloon as claimed in claim 1, wherein the balloon layer comprises a liquid with good thermal conductivity or a solid fluid having equivalent fluidity and thermal conductivity to the liquid.

3. The balloon of claim 2, wherein the liquid is selected from a mercury alloy or a gallium alloy. The balloon as claimed in claim 2 , wherein the freezing point of the liquid is less than or equal to −20° C. .

5. The balloon as described in claim 1, wherein a vacuum layer is provided between the first balloon and the second balloon.

6. The balloon of claim 1, wherein the compliance of the balloon layer is better than the compliance of the first balloon and the second balloon.

7. The balloon of claim 6, wherein the composition of the balloon layer contains a thermoplastic elastomer (TPE).

8. The balloon of claim 6, wherein the composition of the balloon layer contains a thermoplastic polyurethane elastomer.

9. The balloon of claim 6, wherein the composition of the balloon layer contains polyurethane (PU).

10. The balloon of claim 1, further comprising: The entity; and A shaft is disposed in the body and extends distally from the body.

11. The balloon of any one of claims 1 to 10, wherein the discontinuous balloon layer is located outside the second balloon.

12. The balloon of any one of claims 1 to 10, wherein the discontinuous balloon layer is located inside the second balloon.

13. The balloon of claim 10, wherein a rotation mechanism is disposed on the shaft.

14. The balloon of claim 13, wherein the other end of the rotating mechanism is close to the inner surface of the first balloon.

15. Medical system, including: Cryoablation devices; as well as a control unit in communication with the cryoablation device, The cryoablation device comprises the balloon according to any one of claims 1 to 14.

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