CN212037721U - Balloon and medical system - Google Patents

Balloon and medical system Download PDF

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Publication number
CN212037721U
CN212037721U CN201921277526.9U CN201921277526U CN212037721U CN 212037721 U CN212037721 U CN 212037721U CN 201921277526 U CN201921277526 U CN 201921277526U CN 212037721 U CN212037721 U CN 212037721U
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balloon
certain embodiments
layer
present
cryoablation device
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CN201921277526.9U
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李连波
郑欲晓
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Insight Lifetech Co Ltd
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Insight Lifetech Co Ltd
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Abstract

The utility model relates to a sacculus and medical system. The balloon includes: a first balloon; a second balloon disposed about the first balloon; and a balloon layer discontinuously disposed on the second balloon or outside the first balloon. Use the utility model discloses a sacculus, when laminating pulmonary vein, the better part of shutoff can be extruded to the relatively poor part of shutoff from the better part of shutoff to the reinforcing second sacculus improves the operation success rate to the whole shutoff effect of pulmonary vein mouth.

Description

Balloon and medical system
Technical Field
The present invention generally relates to the medical field. More specifically, the present invention relates to the medical field related to arrhythmia.
Background
The heart is divided into left and right atria and left and right ventricles. The sinoatrial node located in the upper portion of the right atrium issues pulse commands regularly. After a short delay at the atrioventricular node, the electrical signal reaches the whole heart through the conduction system, causing the heart to contract in a synchronized and coordinated manner. The heart beats once per impulse in the sinoatrial node, medically known as a "sinus rhythm". It is the normal heart rhythm of human body, and its frequency is 60-100 times per minute.
However, the normal electrical conduction system in the heart may be disturbed by irregular electrical signals from outside the sinoatrial node, resulting in tachycardia, irregular beating and further development of arrhythmia. One of the most common cardiac arrhythmias is atrial fibrillation. In onset, the atria of a patient experience rapid and irregular fibrillation. The risk of stroke caused by atrial fibrillation is increased by 5 times, the death rate is increased by 2 times, the risk of heart failure is also increased by 3 times, and the health of a patient is greatly influenced.
The contents of the utility model
In one aspect, the present disclosure is directed to a balloon comprising a first balloon; a second balloon disposed about the first balloon; and a balloon layer discontinuously disposed on the second balloon or outside the first balloon.
In certain embodiments, the balloon layer comprises a liquid having good thermal conductivity or a solid fluid having equivalent fluidity and thermal conductivity to the liquid.
In certain embodiments, the liquid having good thermal conductivity is selected from an amalgam or gallium alloy.
In certain embodiments, the freezing point of the solid with good fluidity is about-20 ℃ or less.
In certain embodiments, the freezing point of the solid with good fluidity is equal to or less than about-60 ℃.
In some embodiments, a vacuum layer is between the first balloon and the second balloon.
In certain embodiments, the compliance of the balloon layer is superior to the compliance of the first and second balloons.
In certain embodiments, the composition of the balloon layer comprises a thermoplastic elastomer (TPE), a thermoplastic polyurethane elastomer (TPU), a Polyurethane (PU), or mixtures thereof.
In some embodiments, the balloon further comprises: a body; and a shaft disposed in the body and extending distally from the body.
In some embodiments, the discontinuous balloon layer is located outside the second balloon.
In some embodiments, the discontinuous balloon layer is located inside the second balloon.
In some embodiments, the discontinuous balloon layer is located outside the first balloon.
In certain embodiments, a rotation mechanism is disposed on the shaft.
In some embodiments, the other end of the rotation mechanism disposed on the shaft is proximate to the inner surface of the first balloon.
In another aspect, the present invention relates to a medical system, comprising: a cryoablation device; and a control unit in communication with the cryoablation device, wherein the cryoablation device comprises a balloon comprising a first balloon; a second balloon disposed about the first balloon; and a balloon layer discontinuously disposed on the second balloon or outside the first balloon.
In yet another aspect, the present invention relates to a method of performing Pulmonary Vein Isolation (PVI), comprising: positioning a cryoablation device in contact with Pulmonary Vein Ostial (PVO) or anterior Pulmonary Vein Antrum (PVA) tissue of a heart of an individual in need of the method, wherein the cryoablation device comprises a balloon comprising a first balloon; a second balloon disposed about the first balloon; and a balloon layer discontinuously disposed on the second balloon or outside the first balloon.
Drawings
Fig. 1 illustrates a schematic view of a medical system including a cryoablation device according to certain embodiments of the present invention.
Fig. 2 illustrates a schematic view of a medical system including a cryoablation device according to certain embodiments of the present invention.
Fig. 3 illustrates a schematic view of a medical system including a cryoablation device according to certain embodiments of the present invention.
Fig. 4 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 5 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 6 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 7 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 8 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 9 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 10 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 11 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 12 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 13 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 14 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 15 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 16 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 17 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 18 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 19 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 20 illustrates a cross-sectional view of the distal end of a cryoablation device in an expanded state according to certain embodiments of the present invention.
Fig. 21 illustrates a close-up view of a balloon layer disposed outside of a first balloon in certain embodiments of the invention.
Fig. 22 shows a close-up view of a balloon layer disposed inside a second balloon in certain embodiments of the invention.
Fig. 23 illustrates a schematic view of a cryoablation device in an unexpanded state in the left atrium according to certain embodiments of the present invention.
Fig. 24 illustrates a schematic view of a cryoablation device in an unexpanded state in the left atrium according to certain embodiments of the present invention.
Fig. 25 illustrates a schematic view of a cryoablation device in an expanded state in the left atrium according to certain embodiments of the present invention.
Fig. 26 illustrates a schematic view of a cryoablation device in an expanded state in the left atrium according to certain embodiments of the present invention.
Fig. 27 illustrates a schematic view of a cryoablation device positioned in the left atrium in contact with the ostium of a pulmonary vein and inflated under loading, in accordance with certain embodiments of the present invention.
Fig. 28 shows a schematic view of a cryoablation device positioned in the left atrium in contact with the ostium of a pulmonary vein and inflated with a filling material, in accordance with certain embodiments of the present invention.
Fig. 29 illustrates a distal end view of a cryoablation device in an expanded state with a rotation mechanism installed, in accordance with certain embodiments of the present invention.
Figure 30 shows a schematic view of a rotary mechanism according to certain embodiments of the present invention.
Detailed Description
In the following description, certain specific details are included to provide a thorough understanding of various embodiments of the invention. One skilled in the relevant art will recognize, however, that the embodiments can be practiced without one or more of the specific details, or with other methods, components, materials, and so forth.
Unless otherwise required by the specification, the terms "comprising," "including," and "having" are to be construed in an open, inclusive sense, i.e., "including but not limited to," throughout the specification and appended claims.
Reference throughout the specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" means that a particular reference element, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases "in one embodiment" or "in an embodiment" or "in another embodiment" or "in certain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular elements, structures, or characteristics may be combined in any suitable manner in one or more embodiments.
Definition of
In the present invention, the term "compliance" refers to the degree of difficulty of the elastomer deforming under the action of an external force. The high compliance of the elastomer means that the elastomer has strong deformability, i.e. can cause large deformation under the action of small external force.
In the present invention, the term "thermoplastic elastomer (TPE)" refers to a kind of elastomer having rubber elasticity at normal temperature and plastic molding at high temperature.
In the present invention, the term "Thermoplastic Polyurethanes (TPU)" means (AB)nA is high molecular weight (1000-6000) polyester or polyether, B is diol containing 2-12 straight chain carbon atoms, and the chemical structure between AB chain segments is diisocyanate.
In the present invention, the term "Polyurethane (PU)" is a polymer containing urethane groups in the main chain of a macromolecule.
In the present invention, the term "having good thermal conductivity" means that the thermal conductivity is more than 7W/(m.K).
In the present invention, the term "inboard" refers to a side of the balloon proximal to the inner lumen.
In the present invention, the term "outside" refers to a side of the distal balloon lumen.
In the present invention, the term "Pulmonary Vein Isolation (PVI)" refers to an electrical conduction block between the pulmonary vein and the atrium.
Detailed description of the preferred embodiments
In one aspect, the present disclosure is directed to a balloon comprising a first balloon; a second balloon disposed about the first balloon; and a balloon layer discontinuously disposed on the second balloon or outside the first balloon.
Referring to fig. 1, a balloon 100 includes a first balloon 101 (inner balloon), a second balloon 102 (outer balloon) disposed around the first balloon 101, and a balloon layer 103 discontinuously disposed outside the second balloon 102.
Referring to fig. 2, a balloon 200 includes a first balloon 201 (inner balloon), a second balloon 202 (outer balloon) disposed around the first balloon 201, and a balloon layer 203 discontinuously disposed outside the first balloon 201.
The other components of balloon 200 are arranged in a manner similar or identical to balloon 100.
Referring to fig. 3, a balloon 300 includes a first balloon 301 (inner balloon), a second balloon 302 (outer balloon) disposed about the first balloon 301, and a balloon layer 303 discontinuously disposed inside the second balloon 302.
The other components of balloon 300 are arranged in a manner similar or identical to balloon 100.
With continued reference to fig. 1, a vacuum layer 104 is disposed between the first balloon 101 and the second balloon 102. In some embodiments, vacuum layer 104 is provided primarily to detect the presence of a leak of cryogen inside first balloon 101.
In certain embodiments, a liquid with good thermal conductivity is included in balloon layer 103. In certain embodiments, illustrative examples of liquids that can be used in the present invention include, but are not limited to, amalgams and gallium alloys. In certain embodiments, the freezing point of the liquids that can be used in the present invention is about-20 ℃ or less. In certain embodiments, the freezing point of the liquids that can be used in the present invention is about-60 ℃ or less.
In certain embodiments, a solid fluid having equivalent fluidity and thermal conductivity to the aforementioned liquids is included in balloon layer 103.
The compliance of balloon layer 103 is superior to the compliance of first balloon 101 and second balloon 102. In certain embodiments, illustrative examples of materials that can be a component of balloon layer 103 include, but are not limited to, thermoplastic elastomers (TPEs), thermoplastic polyurethane elastomers (TPUs), and Polyurethanes (PUs).
In certain embodiments, illustrative examples of thermoplastic elastomers (TPEs) that can be used in the present invention include, but are not limited to, styrenes (SBS, SIS, SEBS, SEPS), olefins (TPO, TPV), dienes (TPB, TPI), vinyl chlorides (TPVC, TCPE), urethanes (TPU), esters (TPEE), amides (TPEE), organofluorine (TPF), silicones, and ethylenes.
In certain embodiments, illustrative examples of thermoplastic polyurethane elastomers (TPU) that can be used in the present invention include, but are not limited to, polyester type, polyether type, and butadiene type.
With continued reference to fig. 1, balloon 100 further includes a body 105, and a shaft 106 disposed in body 105 and extending distally from body 105.
The shaft 106 may include a guidewire lumen 107, an infusion tube 108, a temperature sensor 109, a pull wire 110, and a tip 111.
In certain embodiments, the guidewire lumen 107 may facilitate the injection of contrast media to confirm good vein occlusion.
In certain embodiments, illustrative examples of contrast agents that can be used in the present invention include, but are not limited to, iodine and barium sulfate.
In certain embodiments, a guidewire placed through the guidewire lumen 107 may help guide the catheter to the target vein.
In certain embodiments, the coolant is dispersed through the injection tube 108 toward the inner surface of the first balloon 101.
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.
In certain embodiments, a temperature sensor 109 is used to monitor the temperature of the vaporized coolant.
In certain embodiments, illustrative examples of temperature sensors that can be used with the present invention include, but are not limited to, thermocouples and thermal resistors.
Body 105 defines a proximal portion 120 and a distal portion 130.
Proximal end 112 and distal end 113 of first balloon 101 and proximal end 114 and distal end 115 of second balloon 102 may be joined to shaft 106 or body 105.
In some embodiments, illustrative examples of materials that can be used to bond proximal end 112 and distal end 113 of first balloon 101 and proximal end 114 and distal end 115 of second balloon 102 to shaft 106 or body 105 include, but are not limited to, biocompatible adhesives.
In certain embodiments, illustrative examples of biocompatible adhesives that can be used in the present invention include, but are not limited to, medical grade instant adhesives.
In certain embodiments, illustrative examples of medical grade flash glues that can be used with the present invention include, but are not limited to, flash glues with an epoxy resin in the composition.
In some embodiments, as shown in fig. 1 and 6, proximal end 112 of first balloon 101 is coupled to distal portion 130 of body 105 and distal end 113 of first balloon 101 is coupled to tip 111.
In the embodiment shown in fig. 1, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 6, the balloon layer 103 is discontinuously disposed outside the first balloon 101.
In some embodiments, as shown in fig. 4 and 7, proximal end 112 of first balloon 101 is joined to proximal end portion 116 of shaft 106 proximate distal end portion 130 of body 105, and distal end 113 of first balloon 101 is joined to tip 111.
In the embodiment shown in fig. 4, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 7, balloon layer 103 is discontinuously disposed outside of first balloon 101.
In some embodiments, as shown in fig. 5 and 8, proximal end 112 of first balloon 101 is joined to proximal portion 116 of shaft 106 at a distance from distal portion 130 of body 105, and distal end 113 of first balloon 101 is joined to tip 111.
In the embodiment shown in fig. 5, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 8, the balloon layer 103 is discontinuously disposed outside the first balloon 101.
In some embodiments, as shown in fig. 9 and 12, proximal end 112 of first balloon 101 is joined to distal portion 130 of body 105, and distal end 113 of first balloon 101 is joined to distal portion 117 of shaft 106 proximate end 111.
In the embodiment shown in fig. 9, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 12, the balloon layer 103 is discontinuously disposed outside the first balloon 101.
In some embodiments, as shown in fig. 10 and 13, proximal end 112 of first balloon 101 is joined to proximal portion 116 of shaft 106 proximate distal portion 130 of body 105, and distal end 113 of first balloon 101 is joined to distal portion 117 of shaft 106 proximate tip 111.
In the embodiment shown in fig. 10, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 13, balloon layer 103 is discontinuously disposed outside of first balloon 101.
In some embodiments, as shown in fig. 11 and 14, proximal end 112 of first balloon 101 is joined to proximal portion 116 of shaft 106 at a distance from distal portion 130 of body 105, and distal end 113 of first balloon 101 is joined to distal portion 117 of shaft 106 proximate tip 111.
In the embodiment shown in fig. 11, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 14, balloon layer 103 is discontinuously disposed outside of first balloon 101.
In some embodiments, as shown in fig. 15 and 18, proximal end 112 of first balloon 101 is joined to distal portion 130 of body 105, and distal end 113 of first balloon 101 is joined to distal portion 117 of shaft 106 at a distance from tip 111.
In the embodiment shown in fig. 15, balloon layer 103 is discontinuously disposed outside of second balloon 102.
In the embodiment shown in fig. 18, the balloon layer 103 is discontinuously disposed outside the first balloon 101.
In some embodiments, as shown in fig. 16 and 19, proximal end 112 of first balloon 101 is joined to proximal portion 116 of shaft 106 proximate distal portion 130 of body 105, and distal end 113 of first balloon 101 is joined to distal portion 117 of shaft 106 at a distance from tip 111.
In the embodiment shown in fig. 16, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 19, balloon layer 103 is discontinuously disposed outside of first balloon 101.
In some embodiments, as shown in fig. 17 and 20, proximal end 112 of first balloon 101 is joined to proximal portion 116 of shaft 106 at a distance from distal portion 130 of body 105, and distal end 113 of first balloon 101 is joined to distal portion 117 of shaft 106 at a distance from tip 111.
In the embodiment shown in fig. 17, the balloon layer 103 is discontinuously disposed outside the second balloon 102.
In the embodiment shown in fig. 20, the balloon layer 103 is discontinuously disposed outside the first balloon 101.
In some embodiments, the proximal and distal ends of the second balloon are arranged in a manner similar to the proximal and distal ends of the first balloon.
In some embodiments, as shown in fig. 1 and 6, the proximal end 114 of the second balloon 102 is joined to the distal portion 130 of the body 105 and the distal end 115 of the second balloon 102 is joined to the tip 111.
In some embodiments, the proximal end 114 of the second balloon 102 is joined 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 joined to the tip 111.
In some embodiments, the proximal end 114 of the second balloon 102 is joined to the proximal end portion 116 of the shaft 106 at a distance from the distal end portion 130 proximal to the body 105, and the distal end 115 of the second balloon 102 is joined to the tip 111.
In some 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.
In some embodiments, the proximal end 114 of the second balloon 102 is joined 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 joined to the distal end portion 117 of the shaft 106 proximate the tip 111.
In some embodiments, the proximal end 114 of the second balloon 102 is joined 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 joined to the distal portion 117 of the shaft 106 proximal to the tip 111.
In some embodiments, the proximal end 114 of the second balloon 102 is joined to the distal portion 130 of the body 105, and the distal end 115 of the second balloon 102 is joined to the distal portion 117 of the shaft 106 at a distance from the tip 111.
In some embodiments, the proximal end 114 of the second balloon 102 is joined 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 joined to the distal end portion 117 of the shaft 106 at a distance from the tip 111.
In some embodiments, the proximal end 114 of the second balloon 102 is joined 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 joined to the distal portion 117 of the shaft 106 at a distance from the tip 111.
In certain embodiments, a rotation mechanism 500 is disposed on the shaft 106.
In certain embodiments, the other end of rotation mechanism 500 of the present invention is proximate to the inner surface of first balloon 101.
In certain embodiments, a rotary mechanism 500 that can be used with the present invention includes a gimbal 501, an extension rod 502, and an end effector 503, wherein the extension rod is connected to the gimbal and the end effector is mounted at one end of the extension rod.
In certain embodiments, a universal joint 501 that can be used in the present invention comprises a base 504, a cross 505, and a yoke 506, wherein the cross 505 is mounted to the base 504 and the yoke 506 is mounted to the cross 505.
In certain embodiments, illustrative examples of end effectors that can be used with the present invention include, but are not limited to, brushes.
In some embodiments, use the utility model discloses a sacculus, when laminating pulmonary vein, the intraformational liquid of sacculus or solid can be extruded the relatively poor part of shutoff from the better part of shutoff to reinforcing second sacculus (outer sacculus) is to the whole shutoff effect of pulmonary vein mouth, improves the operation success rate.
In certain embodiments, the balloon of the present invention can be suitable for patients with irregular pulmonary vein ostia.
In certain embodiments, the vacuum layer in the balloons of the present invention can be used to detect whether the cryogen inside the first balloon (the inner balloon) leaks.
In certain embodiments, additional force can be provided using the rotation mechanism of the present invention to further enhance the overall occlusion effect of the second balloon (outer balloon) on the ostium of the pulmonary vein.
In another aspect, the present invention relates to a medical system, comprising: a cryoablation device; and a control unit in communication with the cryoablation device, wherein the cryoablation device comprises a balloon comprising a first balloon; a second balloon disposed about the first balloon; and a balloon layer discontinuously disposed on the second balloon or outside the first balloon.
Referring to fig. 1, a medical system 500 may include a cryoablation device 300 and a control unit 400 in communication with the cryoablation device 300, wherein the cryoablation device 300 includes a balloon 100, the balloon 100 including a first balloon 100 (inner balloon), a second balloon 102 (outer balloon) disposed around the first balloon 101, and a balloon layer 103 discontinuously disposed outside the second balloon 102.
The cryoablation device 300 may include a body 105 and one or more balloons 100 or 200.
Body 105 defines a proximal portion 120 and a distal portion 130.
The proximal portion 120 of the body 105 may include a handle 140. In certain embodiments, the handle 140 includes one or more knobs, levers, connectors, cables, or other components for guiding, manipulating, and controlling the cryoablation device 300.
In certain embodiments, the handle 140 may connect the cryoablation device 300 to the control unit 400.
In certain embodiments, the control unit 400 may include a first fluid supply 401.
In certain embodiments, the first fluid supply 401 may include one or more containers for holding coolant.
In certain embodiments, the control unit 400 may include a second fluid supply 402.
In certain embodiments, second fluid supply 402 may include one or more containers for holding the uncooled fluid used to inflate the first balloon.
In certain embodiments, the control unit 400 may comprise a control device 403.
In certain embodiments, illustrative examples of control devices that can be used with the present invention include, but are not limited to, pumps.
In certain embodiments, the control unit 400 may include one or more valves 404.
In certain embodiments, illustrative examples of valves that can be used with the present invention include, but are not limited to, solenoid valves and electrically operated valves.
In certain embodiments, illustrative examples of solenoid valves that can be used with the present invention include, but are not limited to, straight-through solenoid valves and proportional solenoid valves
In certain embodiments, the balloon that can be used in the cryoablation device 300 of the medical system 500 of the present invention may also be the balloon 200 or 300 of the present invention.
In yet another aspect, the present invention relates to a method of performing Pulmonary Vein Isolation (PVI), comprising: positioning a cryoablation device in contact with Pulmonary Vein Ostial (PVO) or anterior Pulmonary Vein Antrum (PVA) tissue of a heart of an individual in need of the method, wherein the cryoablation device comprises a balloon comprising a first balloon; a second balloon disposed about the first balloon; and a balloon layer discontinuously disposed on the second balloon or outside the first balloon.
In certain embodiments, the subject is a mammal.
In certain embodiments, the subject is a human.
In certain embodiments, a cryoablation device is delivered to the Left Atrium (LA) of an individual.
In certain embodiments, a sheath (not shown) is passed through the vasculature of the individual into the Right Atrium (RA) of the heart.
In certain embodiments, illustrative examples of vasculature that can be used in the present invention include, but are not limited to, the femoral artery, the brachial artery, and the radial artery.
In some embodiments, when the sheath is within the right atrium, a separate device (not shown) may be passed through the sheath and used to pierce the septum between the right atrium and the left atrium. The pierced device may be removed from the sheath and the body of the individual.
In certain embodiments, the cryoablation device 300 of the present invention may be passed through a sheath and into the left atrium.
In certain embodiments, as shown in fig. 23 or 24, the cryoablation device 300 of the present invention may be passed through the vasculature of an individual and into the left atrium with the balloon 100 or 200 or 300 in an unexpanded condition.
As shown in fig. 25 or 26, once the cryoablation device 300 is positioned within the left atrium, the first balloon 101 or 201 or 301 of the cryoablation device 300 may begin to expand.
In some embodiments, releasing the non-cooling fluid into the lumen of the first balloon 101 or 201 or 301 may inflate the first balloon 101 or 201 or 301, thereby inflating the second balloon 102 or 202 or 302.
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 non-cooling fluid.
In certain embodiments, the present invention relates to a method of performing Pulmonary Vein Isolation (PVI) comprising introducing a guidewire into a target vein, inflating and positioning a balloon in a cryoablation device, sealing the ostium, and injecting a coolant into the cryoablation device to complete the pulmonary vein isolation.
In certain embodiments, the occlusion of the ostium of a pulmonary vein is judged by injecting a contrast agent.
In certain embodiments, a coolant is injected into the cryoablation device with the pulmonary vein ostia well-sealed.
In certain embodiments, after completion of pulmonary vein isolation, the balloon is deflated and withdrawn into the sheath.
In the present invention, relational terms such as first and second, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions.
From the foregoing it will be appreciated that, although specific embodiments of the invention have been described herein for purposes of illustration, various modifications or improvements may be made by those skilled in the art without departing from the spirit and scope of the invention. Such variations and modifications are intended to fall within the scope of the appended claims.

Claims (10)

1. A balloon, characterized in that the balloon comprises:
a first balloon;
a second balloon disposed about the first balloon; and
a balloon layer discontinuously disposed on the second balloon or outside the first balloon;
wherein the balloon layer is used for enhancing the overall occlusion effect of the second balloon on the pulmonary vein orifice.
2. The balloon of claim 1, wherein the balloon layer comprises a liquid with good thermal conductivity or a solid fluid with equivalent fluidity and thermal conductivity to the liquid.
3. The balloon of claim 1, wherein a vacuum layer is between the first balloon and the second balloon.
4. 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.
5. The balloon of claim 1, further comprising:
a body; and
a shaft disposed in the body and extending distally from the body.
6. The balloon of any one of claims 1-5, wherein the discontinuous balloon layer is located outside the second balloon.
7. The balloon of any one of claims 1-5, wherein the discontinuous balloon layer is located inside the second balloon.
8. The balloon of claim 5, wherein a rotation mechanism is disposed on the shaft.
9. The balloon of claim 8, wherein the rotation mechanism comprises a universal joint, an extension rod, and an end effector.
10. Medical system, characterized in that it comprises:
a cryoablation device; and
a control unit in communication with the cryoablation device,
wherein the cryoablation device comprises a balloon of any of claims 1-9.
CN201921277526.9U 2019-08-08 2019-08-08 Balloon and medical system Active CN212037721U (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110338902A (en) * 2019-08-08 2019-10-18 深圳北芯生命科技有限公司 Sacculus and medical system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110338902A (en) * 2019-08-08 2019-10-18 深圳北芯生命科技有限公司 Sacculus and medical system

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