WO2021143681A1 - 冷冻消融导管 - Google Patents

冷冻消融导管 Download PDF

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Publication number
WO2021143681A1
WO2021143681A1 PCT/CN2021/071300 CN2021071300W WO2021143681A1 WO 2021143681 A1 WO2021143681 A1 WO 2021143681A1 CN 2021071300 W CN2021071300 W CN 2021071300W WO 2021143681 A1 WO2021143681 A1 WO 2021143681A1
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WO
WIPO (PCT)
Prior art keywords
balloon
cavity
fluid
fluid inflow
hole
Prior art date
Application number
PCT/CN2021/071300
Other languages
English (en)
French (fr)
Inventor
刘玥
肖家华
Original Assignee
珠海大横琴科技发展有限公司
山前（珠海）医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 珠海大横琴科技发展有限公司, 山前（珠海）医疗科技有限公司 filed Critical 珠海大横琴科技发展有限公司
Priority to JP2022543167A priority Critical patent/JP2023511301A/ja
Priority to US17/758,787 priority patent/US20230044913A1/en
Priority to EP21740814.5A priority patent/EP4091562A4/en
Publication of WO2021143681A1 publication Critical patent/WO2021143681A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00172—Connectors and adapters therefor
    • A61B2018/00178—Electrical connectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • A61B2018/0025—Multiple balloons
    • A61B2018/00255—Multiple balloons arranged one inside another
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00434—Neural system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505—Urinary tract
    • A61B2018/00511—Kidney
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577—Ablation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0212—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques using an instrument inserted into a body lumen, e.g. catheter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/02—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by cooling, e.g. cryogenic techniques
    • A61B2018/0231—Characteristics of handpieces or probes
    • A61B2018/0262—Characteristics of handpieces or probes using a circulating cryogenic fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1061—Balloon catheters with special features or adapted for special applications having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1075—Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding

Definitions

  • the present application relates to the technical field of cryoablation medical devices, in particular to a cryoablation catheter.
  • Hypertension is a major risk factor for stroke, coronary heart disease, heart failure, vascular disease and chronic renal failure.
  • a number of clinical studies have shown that refractory hypertension accounts for 20% to 30% of the total number of hypertension.
  • Refractory hypertension refers to the inability to reach the target blood pressure value during the treatment of the highest tolerated dose of drugs (including the combination of three antihypertensive drugs including diuretics). These patients are high-risk groups of major cardiovascular events.
  • transcatheter radiofrequency ablation Renal Sympathetic Denervation, RDN
  • RDN transcatheter radiofrequency ablation
  • the kidney plays a key role in the regulation of blood pressure through the reabsorption of sodium and water, the regulation of renin release, and the interaction of sympathetic nerves.
  • the basic principle of RDN in the treatment of hypertension is: the local release of energy through the radiofrequency catheter or other devices inserted into the renal artery, through the inner and media of the renal artery, selectively destroy the renal sympathetic nerve fibers in the outer membrane, thereby reducing renal sympathy Nerve activity, blocking the role of sympathetic nerve overexcitation in maintaining high blood pressure, especially refractory hypertension.
  • the Chinese patent application with the publication number CN208625843U discloses a cryoablation catheter brought back into the liquid cavity.
  • the cryoablation catheter includes a handle unit, a delivery unit and a freezing unit connected in sequence, and the freezing unit includes a balloon and The cold source release structure arranged in the balloon, the delivery unit includes a sheath tube and a liquid injection cavity and a liquid return cavity arranged in the sheath tube, the proximal end of the sheath tube and the handle unit
  • the distal end of the sheath is in hermetically sealed connection with the proximal part of the balloon, the proximal end of the liquid injection cavity is in fluid communication with the liquid injection joint provided on the handle unit, and the injection
  • the distal end of the liquid cavity is arranged at the proximal end of the balloon and is in fluid communication with the balloon, and the liquid return port of the liquid return cavity is arranged in the distal part of the balloon;
  • the gas in the balloon improves the freezing performance of the cryoabl
  • the liquid return is performed through the circulating liquid return cavity, and the liquid in the balloon diffuses outward with the cooling source release structure as the center, and the freezing effect is poor.
  • the purpose of this application is to provide a cryoablation catheter to solve the technical problem of poor freezing effect of the cryoablation catheter in the prior art.
  • a cryoablation catheter which includes a balloon and a delivery catheter passing through the balloon.
  • the end closer to the balloon is closer to the balloon than the balloon.
  • the end is far away from the balloon.
  • the delivery catheter is provided with a fluid inflow cavity and a fluid outflow cavity.
  • the fluid inflow cavity extends into the balloon, and the fluid inflow cavity is provided outside
  • There is a spray head for injecting liquid into the balloon the spray head has a plurality of spray holes arranged around the outside of the fluid inflow cavity; the end of the fluid outflow cavity has a cross-section that closes the fluid outflow cavity, the The side wall of the fluid outflow cavity is provided with a backflow hole communicating with the balloon.
  • the delivery catheter further includes a guide wire lumen, and the guide wire lumen passes through the balloon.
  • the fluid inflow cavity and the guide wire cavity are both provided inside the fluid outflow cavity; after the cross section, the guide wire cavity is provided in the fluid inflow cavity internal.
  • the fluid inflow cavity and the guide wire cavity are arranged side by side inside the fluid outflow cavity.
  • the spray head includes a tube body covering the outside of the fluid inflow cavity, the nozzle holes are evenly arranged on the tube body, and the tube body is in communication with the fluid inflow cavity.
  • the fluid inflow cavity is located inside the fluid outflow cavity
  • the guide wire cavity is located inside the fluid inflow cavity
  • the fluid outflow cavity, the fluid inflow cavity and the guide wire cavity are concentric circular tubes.
  • the spray head is integrated with the fluid inflow cavity, and the spray hole is ringed on the side wall of the fluid inflow cavity.
  • the balloon adopts a single-layer balloon, both ends of the balloon are directly fixed on the delivery catheter, the nozzle is injected into the balloon, and the return hole is located in the balloon.
  • the inner side of the proximal side wall is located in the balloon.
  • the balloon adopts a double-layer balloon, and the nozzle holes are divided into a first nozzle hole for injecting liquid toward the gap between the double-layer balloon and a second nozzle hole for injecting liquid toward the inside of the double-layer balloon. Two nozzle holes.
  • the backflow hole is located in the gap between the double-layer balloons, and the first nozzle hole is located at the distal end of the double-layer balloon, and the backflow hole is located at the end of the double-layer balloon. Near end.
  • the input unit includes: an inlet end of the guidewire cavity connected to the guidewire cavity; The fluid inflow end communicated with the inflow cavity; the fluid outflow end communicated with the fluid outflow cavity; and a conduit electronic component adapter for communicating with external instruments.
  • the beneficial effect of the cryoablation catheter provided by the present application is that compared with the prior art, in the cryoablation catheter of the present application, fluid flows from the fluid inflow cavity into the balloon through the nozzle holes on the nozzle, and the nozzle holes are evenly distributed in the fluid inflow.
  • the outside of the cavity makes the inside of the balloon uniformly filled with frozen fluid, which can ensure the uniformity of heat exchange at various parts of the balloon axis, and then the fluid flows out from the return hole.
  • the structural design of the application can effectively improve the heat exchange efficiency of the fluid, and the production and processing technology is relatively simple.
  • Fig. 1 is a schematic structural diagram of a cryoablation catheter provided in Example 1 of the application;
  • Example 2 is a schematic diagram of the structure of the balloon of the cryoablation catheter provided in Example 1 of the application;
  • Figure 3 is a sectional structural view taken along line A-A in Figure 2;
  • Figure 4 is a sectional structural view taken along line B-B in Figure 2;
  • Figure 5 is a sectional structural view taken along line C-C in Figure 2;
  • FIG. 6 is a schematic diagram of the fluid flow direction of the cryoablation catheter provided in Example 1 of the application;
  • FIG. 7 is a schematic structural diagram of a cryoablation catheter provided in Embodiment 2 of the application.
  • Example 8 is a schematic diagram of the structure of the balloon of the cryoablation catheter provided in Example 2 of the application;
  • Figure 9 is a sectional view of the structure taken along the line D-D in Figure 8.
  • FIG. 10 is a schematic diagram of the fluid flow direction of the cryoablation catheter provided in Example 2 of this application;
  • Figure 11 is a sectional structural view taken along line E-E in Figure 10;
  • Figure 12 is a sectional structural view taken along line F-F in Figure 10;
  • FIG. 13 is a schematic diagram of the structure of the balloon of the cryoablation catheter provided in Example 3 of the application;
  • FIG. 14 is a schematic diagram of the fluid flow direction of the cryoablation catheter provided in Example 3 of this application;
  • Figure 15 is a cross-sectional structural view taken along line G-G in Figure 14;
  • Figure 16 is a sectional structural view taken along line H-H in Figure 14;
  • FIG. 17 is a schematic diagram of the structure of the balloon of the cryoablation catheter provided in Example 4 of the application.
  • connection should be understood in a broad sense, unless otherwise clearly specified and limited.
  • it can be a fixed connection or a detachable connection.
  • Connected or integrally connected it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
  • connection should be understood in a broad sense, unless otherwise clearly specified and limited.
  • it can be a fixed connection or a detachable connection.
  • Connected or integrally connected it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication between two components.
  • the specific meanings of the above terms in this application can be understood under specific circumstances.
  • the cryoablation catheter includes a balloon 1, a delivery catheter passing through the balloon 1, an input unit 4 provided at an end of the delivery catheter 2 away from the balloon 1, relative to the balloon 1.
  • the end close to the balloon 1 is the proximal end, and the end far away from the balloon 1 is the distal end.
  • the delivery catheter 2 is provided with a fluid inflow cavity 21, a fluid outflow cavity 22, and a guide wire cavity 23.
  • the fluid inflow lumen 21 and the guide wire lumen 23 can extend into the balloon 1, and a spray head 211 is sleeved on the outside of the delivery catheter 2 in the balloon 1.
  • the spray head 211 has a number of nozzles that can face the balloon 1. Internal injection holes (not separately identified, namely the first injection hole 2111 and the second injection hole 2112).
  • the end of the fluid outflow cavity 22 has a cross section 24 that closes the fluid outflow cavity 22, and the fluid outflow cavity 22 ends at this cross section 24.
  • the fluid outflow cavity 22 is provided with a backflow hole 221 on the side wall that communicates with the outer balloon 12.
  • the cryoablation catheter provided by the present application flows from the fluid inflow cavity 21 into the balloon 1 through the nozzle hole provided on the nozzle 211, and the nozzle hole on the nozzle 211 is arranged on the outside of the fluid inflow cavity 21.
  • the inside of the balloon 1 is evenly filled with frozen fluid, which can ensure the uniformity of heat exchange at various parts of the balloon 1 in the axial direction, and then flows out from the return hole 221.
  • the fluid inflow cavity 21 and the fluid outflow cavity 22 are both arranged in the delivery catheter 2.
  • the inner part of the tube is connected to form a return flow, which can effectively improve the heat exchange efficiency of the fluid, and the overall structure is simple, and the production and processing technology is simple.
  • the input unit 4 includes a fluid inflow end 42 connected to the fluid inflow cavity 21, a fluid outflow end 43 connected to the fluid outflow cavity 22, and a guide wire cavity inlet connected to the guide wire cavity 23 End 41, and a conduit electronic component adapter 44 for communicating with external instruments.
  • the cryoablation catheter also includes a handle 3 arranged at one end of the delivery catheter 2 away from the balloon 1. The handle 3 is sleeved on the outside of the delivery catheter 2 and can be conveniently held.
  • the delivery catheter 2 is a collection of tubes of the entire delivery pipeline, and the input unit 4 is arranged at an end of the delivery catheter 2 away from the balloon 1, and fluid flows in from the fluid inflow end 42.
  • the spray head 211 is sleeved on the outside of the fluid inflow cavity 21, and the spray hole of the spray head 211 is connected around the fluid inflow cavity 21, and the backflow hole 221 is placed on the fluid outflow cavity 22.
  • the fluid inflow cavity 21 is used to deliver the fluid into the balloon 1, and the spray hole and the return hole 221 of the spray head 211 are used to uniformly make the fluid flow into the balloon 1.
  • the fluid outflow cavity 22 is used to output the fluid in the balloon 1 so that the fluid can form a circulation.
  • the distal end of the fluid inflow end 42 is connected to the fluid inflow cavity 21, and the proximal end is connected to a Luer connector, which can be connected to external instruments through the Luer connector. Connection.
  • the distal end of the fluid outflow end 43 is connected to the fluid outflow cavity 22, and the proximal end is connected to a Luer connector, which can be connected to an external instrument through the Luer connector.
  • the catheter electronics adapter 44 can be connected to an external control device, so that information such as the control of the entire cryoablation catheter can be transmitted to the control device together, so as to realize the connection with the external control device.
  • the delivery catheter 2 further includes a guide wire cavity 23 through which the guide wire cavity 23 passes.
  • Balloon 1 the guide wire and other auxiliary related equipment can be inserted into the delivery catheter 2 through the guide wire lumen inlet end 41.
  • the guide wire lumen 23 penetrates the entire delivery catheter 2, and its proximal end is connected to the guide wire lumen inlet end 41. Direct or indirect contact with the human body through the guide wire lumen 23.
  • a separate guide wire cavity 23 may not be provided, which is not uniquely limited here.
  • the delivery catheter 2 has an end connector 5 at the other end of the balloon 1.
  • the end connector 5 is used to fix the balloon 1.
  • the guidewire lumen 23 passes through the delivery catheter 2 and extends out of the balloon 1 and The end connecting piece 5 is connected, and the guide wire cavity 23 passes through the end connecting piece 5 to directly or indirectly contact the human body.
  • the middle part of the end connecting piece 5 is provided with an opening, and the guide wire cavity 23 can be the Opening, so as to directly or indirectly contact the external human body.
  • the fluid inflow cavity 21 and the guidewire cavity 23 are both provided in the cryoablation catheter.
  • the fluid flows out of the inside of the cavity 22; after the cross section 24, the guide wire cavity 23 is provided inside the fluid inflow cavity 21; specifically, the cross section 24 is used to block and block the fluid out of the cavity 22,
  • the backflow hole 221 is located at the proximal end of the cross section 24, and both the cross section 24 and the backflow hole 221 are provided inside the balloon 1.
  • the backflow hole 221 is provided inside the outer balloon 12 and can interact with the fluid in the outer balloon 12.
  • the communication ensures that the fluid in the balloon returns to the fluid outflow cavity 22 through the return hole 221.
  • the cross section 24 and the return hole 221 are arranged in sequence at the proximal end of the balloon 1 so that the liquid can flow out from the return hole 221 after being filled in the balloon 1 to prevent the liquid from flowing out of the return hole without filling the distal balloon 1 221 flows out, causing the problem of low fluid utilization.
  • the balloon 1 adopts a double-layer balloon 1
  • the spray head 211 includes a space between the double-layer balloons 1
  • the double-layer balloon 1 means that the balloon 1 has an inner layer 11 and an outer layer 12, the inner layer balloon 11 covers the inside of the outer layer balloon 12, and the inner layer balloon 11 and the outer layer There is a gap between the layer balloons 12 so that fluid can flow into between the inner layer balloon 11 and the outer layer balloon 12, and the proximal ends of the inner layer balloon 11 and the outer layer balloon 12 are directly fixed in the fluid outflow cavity 22
  • the outer edge and the distal end are fixed on the end connector 5.
  • the first spray hole 2111 is arranged inside the inner layer balloon 11 to inject liquid into the inner layer balloon 11, which may include a plurality of spray holes uniformly arranged in the inner layer balloon 11, and the spray holes may surround It is a ring-shaped and evenly spaced arrangement.
  • the second orifice 2112 is provided in the inner balloon 11, and the second orifice 2112 is also ring-shaped to inject liquid into the inner balloon 11.
  • the stability of the entire balloon 1 can be achieved by the double-layer balloon 1
  • the liquid between the inner balloon 11 and the outer balloon 12 can be cooled by the liquid of the inner balloon 11, and the liquid between the inner balloon 11 and the outer balloon 12 can be ensured through heat transfer.
  • the cooling degree is relatively high, and the cooling area is relatively uniform, which effectively avoids the problem of uneven cold and heat easily caused by a single-layer balloon.
  • the spray head 211 is placed in the balloon 1, the first spray holes 2111 are arranged in a single row at the distal end of the spray head 211, and the second spray holes 2112 are arranged in multiple rows at the spray head. The middle of 211.
  • the fluid outflow cavity 22 needs to be directly connected to the inside of the balloon 1 before the cross section 24, the fluid inflow cavity 21 and the guide wire cavity 23 are directly arranged inside the fluid outflow cavity 22 before the cross section 24, and the return hole 221 is directly It is arranged on the fluid outflow cavity 22, that is, on the outer side wall of the entire delivery conduit 2, so that the return effect is better and the structure and processing are simpler.
  • the fluid outflow cavity 22 has been blocked by the cross section 24, that is, there is no fluid outflow cavity 22.
  • the fluid inflow cavity 21 is sequentially connected with the spray head 211 and the end connector 5.
  • the nozzle 211 communicates with the inner balloon 11 and the outer balloon 12 and delivers fluid toward the inside.
  • the inner balloon 11 does not have a return hole 221.
  • the fluid flow rule when the inner balloon 11 is filled, the fluid It can flow in from the second nozzle hole 2112; when the inner balloon 11 is used, the fluid can flow out from the second nozzle hole 2112. This design effect is better and the structure and processing are simpler.
  • the fluid inflow cavity 21 and the guidewire cavity 23 are juxtaposed in the fluid outflow cavity 22's interior.
  • the outer side wall of the delivery catheter 2 is the outer side wall of the fluid outflow cavity 22, and two parallel fluid inlet pipelines 21 and the guide wire cavity 23 are arranged inside the delivery catheter 2.
  • a separate blocking component (not marked in the figure) is provided at the cross-section 24, the outer edge of the blocking component directly abuts the inner side wall of the delivery catheter 2, and the blocking component is provided with a fluid inflow cavity 21 and a guide wire cavity 23
  • the through hole through which the pipeline passes, and the through hole is in a sealed connection with the fluid inflow cavity 21 or the guide wire cavity 23, that is, the fluid outflow cavity 22 is blocked by the blocking member at this time, and the fluid inflow into the cavity 21 and the guide wire cavity 23 can still continue transportation.
  • the fluid inflow chamber 21 is no longer provided with a separate pipeline, that is, the fluid inflow chamber 21 is directly connected to the nozzle 211, and the guide wire chamber 23 is still provided with a separate pipeline.
  • separate pipelines are respectively arranged in front of the cross section 24, and adjusted after the cross section 24, which can be easily processed, has a relatively simple structure, and is convenient to process.
  • the fluid outflow cavity 22, the fluid inflow cavity 21, and the guide wire cavity 23 are all separate pipelines, and in the cross section A connecting duct is provided at 24, and the connecting duct is provided with a sealing surface at the cross section 24.
  • the pipeline of the fluid outflow cavity 22 can be directly fixed and sleeved on the connecting wire and communicated with the connecting wire and blocked by the blocking section 24, Both the fluid inflow cavity 21 and the guide wire cavity 23 can directly pass through the blocking surface. After the fluid inflow cavity 21 passes through the blocking surface, no separate pipeline is provided, so that the fluid directly flows into the inside of the connecting catheter.
  • the wire cavity 23 is still provided with a separate tube body to ensure the normal operation of the guide wire, which is not uniquely limited here.
  • the guide wire cavity 23 moves closer to the middle of the fluid inflow cavity 21 from the side wall of the fluid outflow cavity 22, so the fluid near the cross section 24 flows into the cavity 21.
  • the fluid flow rates on both sides are inconsistent, that is, the fluid flow rates on both sides of the guidewire cavity 23 are different in the bending area. Therefore, in order to ensure the uniformity of heat exchange inside the balloon 1, the first nozzle hole 2111 is set far away from the cross section 24. On the side.
  • a nozzle 211 with a tube body sheathed outside the fluid inflow chamber 21, the nozzle 211 of the tube body is connected to the fluid inflow chamber 21, and the first nozzle hole 2111 and the second nozzle hole 2112 are both opened in the tube On the nozzle 211 of the body, through the transfer of the nozzle 211 of the tube body, the first nozzle hole 2111 and the second nozzle hole 2112 can evenly spray fluid, thereby ensuring the uniformity of heat exchange inside the balloon 1.
  • the return hole 221 is located in the gap between the double-layer balloon 1, and the first spray hole 2111 Located at the distal end of the double-layer balloon 1, the return hole 221 is located at the proximal end of the double-layer balloon 1.
  • the liquid sprayed through the second spray hole 2112 needs to flow back to the inside of the spray head 211 through the second spray hole 2112, and then The first orifice 2111 is sprayed into the space between the inner balloon 11 and the outer balloon 12, so that the liquid can be recycled, and the liquid flowing into the inner balloon 11 can also be repeatedly applied to the inner balloon 11
  • the liquid between the outer balloon 12 and the outer balloon 12 is cooled, thereby ensuring the uniformity of cooling in the entire balloon 1.
  • the return hole 221 is arranged at the proximal end of the flow channel between the inner layer balloon 11 and the outer layer balloon 12, which can ensure that the liquid can achieve complete circulation in the double-layer balloon 1 and prevent the liquid from directly flowing from the return hole 221 without circulation. Outflow.
  • the inner side of the inner balloon 11 near the proximal end may also be provided with a reflux hole 221, which is not uniquely limited here.
  • the return hole 221 is arranged in the outer balloon 12, and at this time, it can be ensured that the fluid passes through the inner balloon 11, and then flows into the outer balloon 12 to flow out. So that the fluid in the balloon 1 can flow sufficiently.
  • the difference between this embodiment and the embodiment 1 is that the balloon 1 adopts a single-layer balloon, and the balloon The proximal end of 1 is directly fixed on the outer edge of the fluid outflow cavity 22, and the distal end is fixed on the end connector 5.
  • the spray head 211 injects liquid into the balloon 1, and the return hole 221 is located on the inner side of the proximal side wall of the balloon 1.
  • the spray head 211 may only include the second spray hole 2112 that directly sprays liquid into the balloon 1.
  • second spray holes 2112 are directly and evenly spaced around the outer side of the spray head 211, and the second spray holes 2112 may also extend along the transmission direction of the conveying pipe 2.
  • the backflow hole 221 is provided at the proximal end of the balloon 1, and the backflow hole 221 is provided inside the balloon 1, which can ensure that the liquid can achieve complete circulation in the balloon 1 and prevent the liquid from directly flowing out of the backflow hole 221 without circulation.
  • the delivery catheter 2 adopts a multi-lumen tube, and in front of the cross section 24, The fluid inflow cavity 21 and the guide wire cavity 23 are both arranged inside the fluid outflow cavity 22; after the cross section 24, the guide wire cavity 23 is arranged inside the fluid inflow cavity 21, Before the cross section 24, the fluid inflow cavity 21 is located inside the fluid outflow cavity 22, and the guide wire cavity 23 is located inside the fluid inflow cavity 21.
  • the delivery catheter 2 adopts a way of nesting multiple pipes layer by layer.
  • the fluid outflow cavity 22 Since the fluid outflow cavity 22 needs to be directly connected to the inside of the balloon 1 before the cross section 24, the fluid outflow cavity 22 is located at the outermost position before the cross section 24. Layer, the tube body of the fluid inflow cavity 21 is directly arranged inside the fluid outflow cavity 22, and the outside of the pipe of the fluid inflow cavity 21 is the fluid outflow cavity 22; then the tube body of the guidewire cavity 23 is directly arranged in the fluid outflow cavity 22 Inside, the outside of the conduit of the guidewire cavity 23 is the fluid inflow cavity 21; at this time, the return hole 221 can be directly arranged on the outer side wall of the entire delivery catheter 2, so that the return effect is better and the structure and processing are simpler.
  • the gap between the outer edge of the fluid inflow cavity 21 and the delivery conduit 2 is blocked by the cross section 24, that is, there is no fluid outflow cavity 22.
  • the blocking method for the cross section 24 at this time can be to drain the fluid out of the cavity.
  • the inner side wall of 22 is glued to the outer side wall of the delivery catheter 2, or a sealing member is provided to seal the end of the fluid outflow cavity 22. At this time, the sealing effect of the cross section 24 can be achieved.
  • the nozzle 211 of the fluid inflow cavity 21 needs to communicate with the inside of the balloon 1 and deliver fluid toward the inside of the balloon 1. Therefore, the fluid inflow cavity 21 is directly arranged at the outermost part of the delivery catheter 2, and the fluid can be directly injected into the cavity 21.
  • the outer wall of and the outer wall of the delivery catheter 2 are attached and fixed.
  • the spray head 211 is directly sleeved on the outside of the fluid inflow cavity 21, so that the liquid flows into the balloon 1 through the spray head 211; or, the spray head 211 is directly integrated with the fluid inflow cavity 21 as a component, and the spray hole is directly opened in the fluid inflow cavity 21
  • the spraying effect of the spray hole is better and the structure and processing are simpler.
  • the guidewire lumen 23 is always located in the middle area of the entire delivery catheter 2, the flow rate and flow rate of the fluid on both sides of the guidewire lumen 23 are the same, so the nozzle 211 can be directly opened in The fluid flows into the through holes on the side wall of the cavity 21, which can achieve the effect of uniform heat exchange.
  • the fluid outflow cavity 22, the fluid inflow cavity 21, and the guide wire cavity 23 are Concentric circular tubes.
  • the nesting method of the fluid outflow cavity 22, the fluid inflow cavity 21, and the guide wire cavity 23 is layered nesting, and the concentric circular tube is adopted, that is, the three cavities are concentric, which can be more convenient at this time Production and processing, and can ensure that the flow of the liquid on both sides is consistent, avoiding the problem of excessive flow on one side.
  • the difference between this embodiment and Example 1 is that the balloon 1 still uses a double-layer balloon 1, but the delivery catheter 2 uses For a multi-lumen tube, the structure and layout of the double-layer balloon 1 are the same as those in Example 1, and the structure of the delivery catheter 2 is the same as that of the delivery catheter 2 in Example 3.

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Abstract

一种冷冻消融导管，包括球囊（1）和穿过球囊（1）的输送导管（2），输送导管（2）内设有：流体流入腔（21）和流体流出腔（22），流体流入腔（21）延伸至球囊（1）内，流体流入腔（21）的侧壁开设有朝向球囊（1）内注液的喷头（211），喷头（211）具有若干环设于流体流入腔（21）的外部的喷孔（2111、2112）；流体流出腔（22）的末端具有封闭流体流出腔（22）的截面（24），流体流出腔（22）在侧壁上开设有与球囊（1）连通的回流孔（221）。流体从流体流入腔（21）经过喷孔（2111、2112）流入球囊（1），喷孔（2111、2112）均匀分布于流体流入腔（21）外侧，使得球囊（1）内部均匀地充盈冷冻流体，能够保证球囊（1）轴向各部位换热的均匀性，而后流体由回流孔（221）流出。该结构设计可有效提高流体的换热效率，且生产加工工艺较为简单。

Description

冷冻消融导管 技术领域
本申请涉及冷冻消融医疗器械的技术领域，具体涉及一种冷冻消融导管。
背景技术
高血压是脑卒中、冠心病、心力衰竭、血管疾病和慢性肾衰竭的主要危险因素。多项临床研究显示顽固性高血压占高血压总数的20％至30％。顽固性高血压是指在最高耐受剂量的药物治疗(包括利尿剂的三种降压药联合治疗)的过程中，仍无法达到目标血压值。这些病人是主要心血管事件的高风险人群。近年来，国外已有前瞻性队列研究和随机对照研究表明，经导管射频消融去肾交感神经术(Renal Sympathetic Denervation，RDN)对于部分顽固性高血压患者具有显著且持久的降压作用，具有广阔的临床应用前景。
肾脏通过钠水重吸收、肾素释放的调节以及交感神经的相互作用对血压调控起关键作用。RDN治疗高血压的基本原理是：通过置入肾动脉的射频导管或其他器械局部释放能量，透过肾动脉的内、中膜，选择性破坏外膜的肾交感神经纤维，从而达到降低肾交感神经活性，阻断交感神经过度兴奋在维持高血压尤其是顽固性高血压中的作用。
公开号为CN208625843U的中国专利申请，其公开了一种带回液腔的冷冻消融导管，所述冷冻消融导管包括顺次连接的手柄单元、输送单元和冷冻单元，所述冷冻单元包括球囊和被设置在所述球囊内的冷源释放结构，所述输送单元包括鞘管和被设置在所述鞘管内的注液腔和回液腔，所述鞘管的近端与所述手柄单元的远端密封连接，所述鞘管的远端与所述球囊的近端部分密封连接，所述注液腔的近端与所述手柄单元上设置的注液接头流体连通，所述注液腔的远端被设置在所述球囊的近端并与所述球囊流体连通，所述回液腔的回液口被设置在所述球囊的远端部分内；有效地排除了球囊内气体，提高了冷冻消融导管的冷冻性能，提高了冷冻效率。
但是上述专利申请中，其通过循环的回液腔进行回液，球囊内的液体以冷源释放结构为中心向外扩散，其冷冻效果较差。
发明内容
本申请的目的在于提供一种冷冻消融导管，以解决现有技术中的冷冻消融导管的冷冻效果较差的技术问题。
为实现上述目的，本申请采用的技术方案是：提供一种冷冻消融导管，包括球囊和穿过所述球囊的输送导管，相对于所述球囊，靠近所述球囊的一端为近端，远离所述球囊一端为远端，且所述输送导管内设有：流体流入腔和流体流出腔，所述流体流入腔延伸至所述球囊内，所述流体流入腔的外侧设有朝向所述球囊内注液的喷头，所述喷头具有若干环设于所述流体流入腔的外部的喷孔；所述流体流出腔的末端具有封闭所述流体流出腔的截面，所述流体流出腔在侧壁上开设有与所述球囊连通的回流孔。
进一步的，所述输送导管还包括导丝腔，所述导丝腔穿过所述球囊。
进一步的，在所述截面前，所述流体流入腔和所述导丝腔均设于所述流体流出腔的内部；在所述截面后，所述导丝腔设于所述流体流入腔的内部。
进一步的，在所述截面前，所述流体流入腔和所述导丝腔并列设于所述流体流出腔的内部。
进一步的，所述喷头包括包覆于所述流体流入腔外侧的管体，所述喷孔均匀环设于所述管体上，且所述管体与所述流体流入腔相连通。
进一步的，在所述截面前，所述流体流入腔位于所述流体流出腔的内部，且所述导丝腔位于所述流体流入腔的内部。
进一步的，在所述截面前，所述流体流出腔、所述流体流入腔和所述导丝腔为同心圆管。
进一步的，所述喷头与所述流体流入腔为一体，且所述喷孔环设于所述流体流入腔的侧壁上。
进一步的，所述球囊采用单层球囊，所述球囊的两端直接固定于所述输送导管上，所述喷头朝所述球囊内注液，所述回流孔位于所述球囊的近端侧壁的内侧。
进一步的，所述球囊采用双层球囊，所述喷孔分为朝向所述双层球囊之间的间隙注液的第一喷孔以及朝向所述双层球囊内部注液的第二喷孔。
进一步的，所述回流孔位于所述双层球囊之间的间隙内，且所述第一喷孔位于所述双层球囊的远端，所述回流孔位于所述双层球囊的近端。
进一步的，其还包括设于所述输送导管远离所述球囊的一端的手柄和输入单元，所 述输入单元包括：与所述导丝腔相连通的导丝腔入口端；与所述流体流入腔相连通的流体流入端；与所述流体流出腔相连通的流体流出端；以及用于与外部仪器连通的导管电子元件转接头。
本申请提供的冷冻消融导管的有益效果在于：与现有技术相比，本申请的冷冻消融导管，流体从流体流入腔经过喷头上的喷孔流入至球囊内，喷孔均匀分布于流体流入腔外侧，使得球囊内部均匀地充盈冷冻流体，能够保证球囊轴向各部位换热的均匀性，而后流体由回流孔流出。本申请结构设计可有效提高流体的换热效率，且生产加工工艺较为简单。
附图说明
为了更清楚地说明本申请具体实施方式或现有技术中的技术方案，下面将对具体实施方式或现有技术描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图是本申请的一些实施方式，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本申请实施例1提供的冷冻消融导管的结构示意图；
图2为本申请实施例1提供的冷冻消融导管的球囊处的结构示意图；
图3为沿图2中A-A线的剖视结构图；
图4为沿图2中B-B线的剖视结构图；
图5为沿图2中C-C线的剖视结构图；
图6为本申请实施例1提供的冷冻消融导管的流体流向的示意图；
图7为本申请实施例2提供的冷冻消融导管的结构示意图；
图8为本申请实施例2提供的冷冻消融导管的球囊处的结构示意图；
图9为沿图8中D-D线的剖视结构图；
图10为本申请实施例2提供的冷冻消融导管的流体流向的示意图；
图11为沿图10中E-E线的剖视结构图；
图12为沿图10中F-F线的剖视结构图；
图13为本申请实施例3提供的冷冻消融导管的球囊处的结构示意图；
图14为本申请实施例3提供的冷冻消融导管的流体流向的示意图；
图15为沿图14中G-G线的剖视结构图；
图16为沿图14中H-H线的剖视结构图；
图17为本申请实施例4提供的冷冻消融导管的球囊处的结构示意图。
附图标记说明：
1、球囊；2、输送导管；3、手柄；4、输入单元；5、端部连接件；11、内层球囊；12、外层球囊；21、流体流入腔；211、喷头；2111、第一喷孔；2112、第二喷孔；22、流体流出腔；221、回流孔；23、导丝腔；24、截面；41、导丝腔入口端；42、流体流入端；43、流体流出端；44、导管电子元件转接头。
具体实施方式
下面将结合附图对本申请的技术方案进行清楚、完整地描述，显然，所描述的实施例是本申请一部分实施例，而不是全部的实施例。基于本申请中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本申请保护的范围。
在本申请的描述中，需要说明的是，术语“中心”、“上”、“下”、“左”、“右”、“竖直”、“水平”、“内”、“外”等指示的方位或位置关系为基于附图所示的方位或位置关系，仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作，因此不能理解为对本申请的限制。此外，术语“第一”、“第二”、“第三”仅用于描述目的，而不能理解为指示或暗示相对重要性。
在本申请的描述中，需要说明的是，除非另有明确的规定和限定，术语“安装”、“相连”、“连接”应做广义理解，例如，可以是固定连接，也可以是可拆卸连接，或一体地连接；可以是机械连接，也可以是电连接；可以是直接相连，也可以通过中间媒介间接相连，可以是两个元件内部的连通。对于本领域的普通技术人员而言，可以具体情况理解上述术语在本申请中的具体含义。
此外，下面所描述的本申请不同实施方式中所涉及的技术特征只要彼此之间未构成冲突就可以相互结合。
实施例1
请一并参阅图1至图6，现对本申请提供的冷冻消融导管进行说明。所述冷冻消融导管，包括球囊1、穿过所述球囊1的输送导管2、设于所述输送导管2远离所述球囊1的一端的输入单元4，相对于所述球囊1，靠近所述球囊1的一端为近端，远离所述球囊1一端为远端，所述输送导管2内设有流体流入腔21、流体流出腔22和导丝腔23。流体流入腔21和导丝腔23可以延伸至所述球囊1内，并且位于所述球囊1内的输送导 管2的外侧套设有喷头211，喷头211上具有若干可以朝向球囊1的内部注液的喷孔(未单独标识，即为第一喷孔2111和第二喷孔2112)。所述流体流出腔22的末端具有封闭所述流体流出腔22的截面24，所述流体流出腔22止于此截面24。所述流体流出腔22在侧壁上开设有与所述外层球囊12连通的回流孔221。
本申请提供的冷冻消融导管，与现有技术相比，流体从流体流入腔21经过喷头211上设置的喷孔流入球囊1，喷头211上的喷孔环设于流体流入腔21的外侧，使得球囊1的内部均匀的充盈冷冻流体，能够保证球囊1轴向各部位换热的均匀性，然后再由回流孔221流出，流体流入腔21和流体流出腔22均设置在输送导管2的内部并连通形成回流，可有效提高流体的换热效率，且整体的结构简单，生产加工工艺简单。
所述输入单元4包括与所述流体流入腔21相连通的流体流入端42、与所述流体流出腔22相连通的流体流出端43，与所述导丝腔23相连通的导丝腔入口端41，以及用于与外部仪器连通的导管电子元件转接头44。冷冻消融导管还包括设于所述输送导管2远离所述球囊1的一端的手柄3，该手柄3套设于输送导管2的外部，可以方便拿持。
具体的，输送导管2即为整个输送管道的管体集合，输入单元4设置在输送导管2远离球囊1的一端，流体从流体流入端42流入。与喷头211套设在设置在流体流入腔21的外侧，且喷头211的喷孔环绕流体流入腔21设置相连，回流孔221置于流体流出腔22上。流体流入腔21用于将流体输送至球囊1内，喷头211的喷孔和回流孔221用于均匀的使得流体流入球囊1。流体流出腔22用于输出球囊1内的流体，使得流体可以形成循环，流体流入端42的远端与流体流入腔21相连，近端连接鲁尔接头，通过鲁尔接头可以实现与外部仪器的连接。流体流出端43的远端与流体流出腔22相连，近端连接鲁尔接头，通过鲁尔接头可以实现与外部仪器的连接。导管电子元件转接头44可以和外部的控制仪器相连接，从而将整个冷冻消融导管的控制等信息一并传递给控制仪器，从而实现与外部控制设备的连接。
进一步地，请一并参阅图1至图6，作为本申请提供的冷冻消融导管的一种具体实施方式，所述输送导管2还包括导丝腔23，所述导丝腔23穿过所述球囊1。具体的，导丝及其他辅助相关的器材可以经过导丝腔入口端41插入至输送导管2内，导丝腔23贯穿整根输送导管2，其近端与导丝腔入口端41相连，可通过导丝腔23与人体直接或间接的接触。当然，根据实际情况和具体需求，在本申请的其他实施例中，还可以不设置单独的导丝腔23，此处不作唯一限定。
输送导管2在球囊1的另一端具有端部连接件5，端部连接件5用于对球囊1进行 固定的，所述导丝腔23穿过输送导管2并延伸出球囊1与端部连接件5相连通，且导丝腔23穿过该端部连接件5直接与人体直接或间接的接触，端部连接件5的中间部位开设有开口，导丝腔23既可以为该开口，从而与外部人体直接或间接的接触。
进一步地，请参阅图4至图6，作为本申请提供的冷冻消融导管的一种具体实施方式，在所述截面24前，所述流体流入腔21和所述导丝腔23均设于所述流体流出腔22的内部；在所述截面24后，所述导丝腔23设于所述流体流入腔21的内部；具体的，截面24用于将流体流出腔22进行隔断和封堵，回流孔221位于截面24的近端，并且截面24和回流孔221均设置在球囊1的内部，回流孔221设于外层球囊12的内部，且可以和外层球囊12内的流体相连通，保证球囊内的流体经回流孔221回流至流体流出腔22。截面24和回流孔221均依次设置在球囊1的近端，使得液体可以在球囊1内充盈后再从回流孔221流出，避免液体未将远端的球囊1充盈即已经从回流孔221流出，导致流体的利用率不高的问题。
进一步地，请参阅图6，作为本申请提供的冷冻消融导管的一种具体实施方式，所述球囊1采用双层球囊1，所述喷头211包括朝向所述双层球囊1之间的间隙注液的第一喷孔2111以及朝向所述双层球囊内部注液的第二喷孔2112。具体的，双层球囊1是指该球囊1具有内层球囊11和外层球囊12，内层球囊11包覆于外层球囊12的内部，内层球囊11和外层球囊12之间具有间隙，使得流体可以流入至内层球囊11和外层球囊12之间，且内层球囊11和外层球囊12的近端直接固定在流体流出腔22的外缘，远端固定在端部连接件5上。第一喷孔2111设置在内层球囊11的内部可以对内层球囊11的内部进行注液，其可以包括多个均匀设置在内层球囊11内的喷孔，且喷孔可以环绕为环形且均匀且间隔的布置。第二喷孔2112设置在内层球囊11内，且第二喷孔2112也为环形朝向内层球囊11内注液，通过双层的球囊1既可以使得整个球囊1的稳定性增加，并且可以由内层球囊11的液体对内层球囊11和外层球囊12之间液体进行冷却，通过热传递保证内层球囊11和外层球囊12之间的液体的冷却程度较高，且冷却区域较为均匀，有效地避免了单层球囊容易导致的冷热不均的问题。
优选的，所述喷头211置于球囊1内，所述第一喷孔2111为单排环设于所述喷头211的远端，所述第二喷孔2112多排环设于所述喷头211的中部。
由于在截面24前流体流出腔22需要直接与球囊1的内部相连通，因此在截面24前将流体流入腔21和导丝腔23均直接设置在流体流出腔22的内部，回流孔221直接设置在流体流出腔22，即整个输送导管2的外侧壁上，使得回流的效果更好且结构和加 工较为简单。在截面24后，流体流出腔22已经由截面24封堵，即不存在流体流出腔22。流体流入腔21依次与喷头211和端部连接件5相连接。喷头211和内层球囊11、外层球囊12的内部相连通并朝向其内部输送流体，内层球囊11未设立回流孔221，根据流体流动规律，充盈内层球囊11时，流体可从第二喷孔2112流入；当内层球囊11时，流体可从第二喷孔2112流出，此种设计效果更好且结构和加工较为简单。
进一步地，参阅图5，作为本申请提供的冷冻消融导管的一种具体实施方式，在所述截面24前，所述流体流入腔21和所述导丝腔23并列设于所述流体流出腔22的内部。具体的，在截面24前，输送导管2的外侧壁即为流体流出腔22的外侧壁，且在输送导管2的内部设置两根相并列的流体流入腔21和导丝腔23的管线。在截面24处设置一单独的阻挡部件(图中未标识)，该阻挡部件的外缘直接和输送导管2的内侧壁相抵接，且阻挡部件上开设有供流体流入腔21和导丝腔23的管线穿过的通孔，且通孔处与流体流入腔21或导丝腔23密封连接，即此时流体流出腔22被该阻挡部件隔断，流体流入腔21和导丝腔23仍可以继续运输。在截面24后，流体流入腔21不再设置单独的管线，即流体流入腔21直接和喷头211相连，导丝腔23仍然设置单独的管线。采用此种方式制成的导管，在截面24前分别设置单独的管线，在截面24后再进行调整，即可以方便加工且结构较为简单，加工方便。
当然，根据实际情况和具体需求，在本申请的其他实施例中，还可以为：在截面24前，流体流出腔22、流体流入腔21和导丝腔23均为单独的管线，且在截面24处设置有一连接导管，该连接导管在截面24处设置有一封堵面，流体流出腔22的管线可以直接固定套设在连接导线上并和连接导线相连通并由封堵截面24封堵，流体流入腔21和导丝腔23均可以直接穿过该封堵面，流体流入腔21在穿过封堵面后不再设置单独的管线，使得流体直接汇入至该连接导管的内部，导丝腔23仍然设置的单独的管体，从而保证导丝的正常工作，此处不作唯一限定。
由于在本实施例中，导丝腔23在靠近截面24处时，导丝腔23由位于流体流出腔22的侧壁朝向流体流入腔21的中间靠拢，因此靠近截面24处的流体流入腔21两侧的流体流速不一致，即导丝腔23在发生弯折的区域两侧的流体的流速不同，因此为了保证球囊1内部的换热均匀性，将第一喷孔2111设在远离截面24的一侧。
其中，还可以采用在流体流入腔21的外侧套设有一管体的喷头211，管体的喷头211和流体流入腔21相连通，第一喷孔2111和第二喷孔2112均开设在该管体的喷头211上，通过该管体的喷头211的中转，使得第一喷孔2111和第二喷孔2112能够均匀 的喷出的流体，进而保证球囊1内部的换热均匀性。
进一步地，请参阅图6，作为本申请提供的冷冻消融导管的一种具体实施方式，所述回流孔221位于所述双层球囊1之间的间隙内，且所述第一喷孔2111位于所述双层球囊1的远端，所述回流孔221位于所述双层球囊1的近端。由于内层球囊11内的容量有限且内层球囊11内未设置回流孔221，因此经第二喷孔2112喷出的液体需经过第二喷孔2112回流至喷头211的内部，然后再由第一喷孔2111喷入至内层球囊11和外层球囊12之间，使得液体可以实现循环使用，且内层球囊11内部流入的液体还可以反复的对内层球囊11和外层球囊12之间的液体进行冷却，从而保证了整个球囊1内冷却的均匀性。回流孔221设置在内层球囊11和外层球囊12之间流道的近端，可以保证液体可以在双层球囊1内实现完整的循环，避免液体未经过循环直接从回流孔221流出。当然，根据实际情况和具体需求，在本申请的其他实施例中，内层球囊11的内部靠近近端的一侧也可以设置有回流孔221，此处不作唯一限定。
优选的，回流孔221设置在外层球囊12内，此时可以保证流体均经过内层球囊11的内部，然后流至外层球囊12内部流出。使得球囊1内的流体可以充分的流动。
实施例2
请参阅图7至图12，作为本申请提供的冷冻消融导管的另一种具体实施方式，本实施例与实施例1的区别在于：所述球囊1采用单层球囊，所述球囊1的近端直接固定在流体流出腔22的外缘，远端固定在端部连接件5上。所述喷头211朝所述球囊1内注液，所述回流孔221位于所述球囊1的近端侧壁的内侧。其中，喷头211可以仅包括直接朝向球囊1内喷液体的第二喷孔2112，
且若干个第二喷孔2112直接均匀间隔的环绕在喷头211的外侧，第二喷孔2112还可以沿着输送导管2的传动方向延伸布置。回流孔221设在球囊1的近端，且回流孔221设置在球囊1的内部，可以保证液体可以在球囊1内实现完整的循环，避免液体未经过循环直接从回流孔221流出。
实施例3
请参阅图13至图16，作为本申请提供的冷冻消融导管的另一种具体实施方式，本实施例与实施例1的区别在于：输送导管2采用多腔管道，在所述截面24前，所述流体流入腔21和所述导丝腔23均设于所述流体流出腔22的内部；在所述截面24后，所 述导丝腔23设于所述流体流入腔21的内部，在所述截面24前，所述流体流入腔21位于所述流体流出腔22的内部，且所述导丝腔23位于所述流体流入腔21的内部。具体的，输送导管2采用多个管道层层嵌套的方式，由于在截面24前流体流出腔22需要直接与球囊1的内部相连通，因此在截面24前将流体流出腔22位于最外层，流体流入腔21的管体直接设置在流体流出腔22的内部，流体流入腔21的管道外侧即为流体流出腔22；再将导丝腔23的管体直接设置在流体流出腔22的内部，导丝腔23的管道外侧即为流体流入腔21；此时回流孔221可以直接设置在整个输送导管2的外侧壁上，使得回流的效果更好且结构和加工较为简单。
在截面24后，流体流入腔21的外缘和输送导管2之间的间隙由截面24进行封堵，即不存在流体流出腔22，此时的截面24的封堵方法可以为将流体流出腔22的内侧壁粘合于输送导管2的外侧壁上，或者设置一封堵件将流体流出腔22的末端进行封堵，此时既可以达到截面24的封堵效果。流体流入腔21的喷头211需要和球囊1的内部相连通并朝向球囊1内部输送流体，因此直接将流体流入腔21设置在输送导管2的最外部，此时可以直接将流体流入腔21的外壁和输送导管2的外壁贴合固定。直接将喷头211套设于流体流入腔21的外侧，使得液体经过喷头211流入至球囊1的内部；或者，喷头211直接和流体流入腔21为一个部件，喷孔直接开设在流体流入腔21的侧壁上，使得喷孔的喷洒效果更好且结构和加工较为简单。
优选的，在本实施例中，由于导丝腔23始终位于整个输送导管2的中间区域，因此导丝腔23两侧的流体的流速和流量均是相同的，因此喷头211可以为直接开设在流体流入腔21的侧壁上的通孔，既可以实现均匀换热的效果。
进一步地，参阅图16，作为本申请提供的冷冻消融导管的一种具体实施方式，在所述截面24前，所述流体流出腔22、所述流体流入腔21和所述导丝腔23为同心圆管。具体的，流体流出腔22、流体流入腔21和导丝腔23的嵌套方式为层层嵌套，且采用同心圆管的方式即为三个腔体为同圆心的，此时可以更方便生产和加工，并且能够保证两侧的液体的流量一致，避免单侧流量过大的问题。
实施例4
请参阅图17，作为本申请提供的冷冻消融导管的另一种具体实施方式，本实施例与实施例1的区别在于：所述球囊1仍采用双层球囊1，但输送导管2采用多腔管道，所述双层球囊1的结构和布局与实施例1中一致，所述输送导管2和实施例3中的输送导 管2的结构一致。
显然，上述实施例仅是为清楚地说明所作的举例，而并非对实施方式的限定。对于所属领域的普通技术人员来说，在上述说明的基础上还可以做出其它不同形式的变化或变动。这里无需也无法对所有的实施方式予以穷举。而由此所引伸出的显而易见的变化或变动仍处于本申请创造的保护范围之中。

Claims (12)

  1. 冷冻消融导管，其特征在于，包括球囊(1)和穿过所述球囊(1)的输送导管(2)，相对于所述球囊(1)，靠近所述球囊(1)的一端为近端，远离所述球囊(1)一端为远端，且所述输送导管(2)内设有：
    流体流入腔(21)，所述流体流入腔(21)延伸至所述球囊(1)内，所述流体流入腔(21)的外侧设有朝向所述球囊(1)内注液的喷头(211)，所述喷头(211)具有若干环设于所述流体流入腔(21)的外部的喷孔；以及
    流体流出腔(22)，所述流体流出腔(22)的末端具有封闭所述流体流出腔(22)的截面(24)，所述流体流出腔(22)在侧壁上开设有与所述球囊(1)连通的回流孔(221)。
  2. 如权利要求1所述的冷冻消融导管，其特征在于：所述输送导管(2)还包括导丝腔(23)，所述导丝腔(23)穿过所述球囊(1)。
  3. 如权利要求2所述的冷冻消融导管，其特征在于：在所述截面(24)前，所述流体流入腔(21)和所述导丝腔(23)均设于所述流体流出腔(22)的内部；在所述截面(24)后，所述导丝腔(23)设于所述流体流入腔(21)的内部。
  4. 如权利要求3所述的冷冻消融导管，其特征在于：在所述截面(24)前，所述流体流入腔(21)和所述导丝腔(23)并列设于所述流体流出腔(22)的内部。
  5. 如权利要求4所述的冷冻消融导管，其特征在于：所述喷头(211)包括包覆于所述流体流入腔(21)外侧的管体，所述喷孔均匀环设于所述管体上，且所述管体与所述流体流入腔(21)相连通。
  6. 如权利要求3所述的冷冻消融导管，其特征在于：在所述截面(24)前，所述流体流入腔(21)位于所述流体流出腔(22)的内部，且所述导丝腔(23)位于所述流体流入腔(21)的内部。
  7. 如权利要求6所述的冷冻消融导管，其特征在于：在所述截面(24)前，所述流体流出腔(22)、所述流体流入腔(21)和所述导丝腔(23)为同心圆管。
  8. 如权利要求7所述的冷冻消融导管，其特征在于：所述喷头(211)与所述流体流入腔(21)一体，且所述喷孔环设于所述流体流入腔(21)的侧壁上。
  9. 如权利要求1至8任一项所述的冷冻消融导管，其特征在于：所述球囊(1)采用单层球囊(1)，所述球囊(1)的两端直接固定于所述输送导管(2)上，所述喷头(211)朝所述球囊(1)内注液，所述回流孔(221)位于所述球囊(1)的近端侧壁的内侧。
  10. 如权利要求1至8任一项所述的冷冻消融导管，其特征在于：所述球囊(1)采用双层球囊(1)，所述喷孔分为朝向所述双层球囊(1)之间的间隙注液的第一喷孔(2111)以及朝向所述双层球囊(1)内部注液的第二喷孔(2112)。
  11. 如权利要求10所述的冷冻消融导管，其特征在于：所述回流孔(221)位于所述双层球囊(1)之间的间隙内，且所述第一喷孔(2111)位于所述双层球囊(1)的远端，所述回流孔(221)位于所述双层球囊(1)的近端。
  12. 如权利要求2至8任一项所述的冷冻消融导管，其特征在于：其还包括设于所述输送导管(2)远离所述球囊(1)的一端的手柄(3)和输入单 元(4)，所述输入单元(4)包括：
    与所述导丝腔(23)相连通的导丝腔入口端(41)；
    与所述流体流入腔(21)相连通的流体流入端(42)；
    与所述流体流出腔(22)相连通的流体流出端(43)；以及
    用于与外部仪器连通的导管电子元件转接头(44)。
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