CN104117128A - Balloon catheter for mild hypothermia therapy - Google Patents

Balloon catheter for mild hypothermia therapy Download PDF

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Publication number
CN104117128A
CN104117128A CN201410345362.4A CN201410345362A CN104117128A CN 104117128 A CN104117128 A CN 104117128A CN 201410345362 A CN201410345362 A CN 201410345362A CN 104117128 A CN104117128 A CN 104117128A
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CN
China
Prior art keywords
heat exchange
foley
sacculus
mild hypothermia
balloon body
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Pending
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CN201410345362.4A
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Chinese (zh)
Inventor
刘冰
王涛
卢军
杨建华
李华莹
曾森
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BEIJING PUYI TECHNOLOGY Co Ltd
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BEIJING PUYI TECHNOLOGY Co Ltd
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Priority to CN201410345362.4A priority Critical patent/CN104117128A/en
Publication of CN104117128A publication Critical patent/CN104117128A/en
Pending legal-status Critical Current

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Abstract

The invention provides a balloon catheter for mild hypothermia therapy. The balloon catheter for mild hypothermia therapy comprises a multi-cavity catheter body and at least one heat exchange balloon arranged on the outer surface of the near end of the multi-cavity catheter body in a sealed and sleeved mode, each heat exchange balloon comprises a cylindrical balloon body with the two end openings, grooves protruding towards the radial outer side of each balloon body and axially extending along the corresponding balloon body are formed in the corresponding balloon body, and a non-planar structure is formed by the grooves. The heat exchange area of a heat exchange medium circulating on the inner side of the balloon catheter bodies and the patient blood flowing on the outer side of the balloon catheter body can be enlarged through the non-planar structure, heat exchange can be better conducted between the heat exchange medium in the heat exchange balloons and the patient blood, the heat exchange efficiency can be easily improved, and thus the cooling effect on the patient blood is improved.

Description

Mild hypothermia therapy foley's tube
Technical field
The present invention relates to a kind of mild hypothermia therapy foley's tube.
Background technology
In recent years, mild hypothermia therapy more and more concerns that are subject to domestic and international medical circle of role in hospital clinical treatment.Mild hypothermia therapy refers to by controlled reduction patient core temperature and carrys out the method that armour is avoided damage influence.At present, be generally applied in each clinical speciality field, section as inside and outside in nerve, Intensive Care Therapy, emergency department, Department of B urn, Anesthesia Department, division of cardiology, organ transplantation etc. at US and European area low temperature therapy.
Wherein, the main interior heat exchange cooling of the blood vessel art that adopts realizes mild hypothermia therapy, in this blood vessel, heat exchange cooling art is conventionally by catheter in blood vessel system, external brine circulation system and heat exchange controller three part compositions, wherein, catheter in blood vessel system is connected with external brine circulation system, form the closed cycle of a Sterile Saline, and change the mesohalobic temperature of external brine circulation system by heat exchange controller, thereby the saline of temperature control is input in catheter in blood vessel system, make it to carry out heat exchange by balloon surface and the blood samples of patients of catheter in blood vessel system, thereby be reached for the object that cental system high-risk patient or hypothermia patient carry out core temperature adjusting.
Application number is that CN201220730086.X discloses heat exchange foley's tube in a kind of mild hypothermia therapy blood vessel, as shown in Figure 1, comprises a multi-cavity catheter 4, heat exchange sacculus 5, multi-cavity Connection Block 3, extension pipe 2 and female Luer 1.Multi-cavity catheter 4 is the conduit of four cavity configurations, is connected with multi-cavity Connection Block 3 at the far-end of this multi-cavity catheter 4, and this multi-cavity Connection Block 3 connects multiple female Luer 1 by extension pipe 2; On the near-end of multi-cavity catheter 4, be provided with two heat exchange sacculus 5 with certain intervals, this heat exchange sacculus 5 is tightly connected with multi-cavity catheter 4, has soft 6 in the end welding that is provided with heat exchange sacculus 5 of multi-cavity catheter.Corresponding with each heat exchange sacculus 5, on the corresponding tube wall of multi-cavity catheter 4, also offer the near-end delivery outlet 42 that flows into the far-end input hole 41 in heat exchange sacculus 5 and flow out for the saline after heat exchange for the saline that carries out in advance heat exchange.Wherein, the low bullet deformation heat exchange sacculus that heat exchange sacculus 5 is made for plastic material, this heat exchange sacculus 5 has extraordinary mechanical strength, by physiological cycle saline, patient's body temperature is control effectively.
Summary of the invention
In view of this, main purpose of the present invention is, provides a kind of heat exchange area that can increase to improve the mild hypothermia therapy foley's tube of cooling-down effect.
For achieving the above object, the present invention proposes a kind of mild hypothermia therapy foley's tube, comprise that a multi-cavity catheter, sealing shroud are located at least one the heat exchange sacculus on the near-end outer surface of described multi-cavity catheter, described heat exchange sacculus comprises both ends open tubular balloon body, forms and can increase at the heat exchange medium of described foley's tube inner side circulation and the concavo-convex nonplanar structure of the heat exchange area of the blood samples of patients in described foley's tube flows outside in described balloon body.
Adopt said structure, owing to forming concavo-convex nonplanar structure in described balloon body, in the time that foley's tube is placed in patient vessel, at the heat exchange medium of described foley's tube inner side circulation (for example can increase by this nonplanar structure, saline) with heat exchange area in the blood samples of patients of described foley's tube flows outside, make the heat exchange medium in described heat exchange sacculus carry out heat exchange with patient's blood better, be conducive to improve heat exchanger effectiveness, thereby improve the cooling-down effect to blood samples of patients.
Preferably, on the internal face of described balloon body, form outstandingly towards the radial outside of described balloon body and along the axially extended groove of described balloon body, form described nonplanar structure by this groove.
Adopt said structure, form by described groove multiple passages that heat supply exchange media flows, can be to heat exchange medium mobile the playing the guiding role in heat exchange sacculus, thereby accelerate the flow velocity of heat exchange medium in heat exchange sacculus, heat exchange medium in heat exchange sacculus is upgraded in time, contribute to improve cooling-down effect.
Preferably, described groove comprises multiple, and these multiple grooves are parallel to the axial setting of described balloon body.
Adopt said structure, form by described groove multiple passages that heat supply exchange media flows, can be to heat exchange medium mobile the playing the guiding role in heat exchange sacculus, thereby accelerate the flow velocity of heat exchange medium in heat exchange sacculus, heat exchange medium in heat exchange sacculus is upgraded in time, contribute to improve cooling-down effect.
Preferably, described groove axially distributing in the shape of a spiral around described balloon body.
Adopt said structure, because described groove distributes in the shape of a spiral, can increase at the heat exchange medium of described foley's tube inner side circulation and the heat exchange area of the blood samples of patients in described foley's tube flows outside, make the heat exchange medium in described heat exchange sacculus carry out heat exchange with patient's blood better, be conducive to improve heat exchanger effectiveness, thereby improve the cooling-down effect to blood samples of patients.
Preferably, described groove comprises multiple, and these multiple grooves are many spiral distribution.
Adopt said structure, because multiple grooves are many spiral distribution, can increase at the heat exchange medium of described foley's tube inner side circulation and the heat exchange area of the blood samples of patients in described foley's tube flows outside, make the heat exchange medium in described heat exchange sacculus carry out heat exchange with patient's blood better, be conducive to improve heat exchanger effectiveness, thereby improve the cooling-down effect to blood samples of patients.
Preferably, the cross sectional shape of described groove be triangle, rectangle, zigzag, at least one in trapezoidal.
Preferably, be formed with at the both ends open place of described balloon body the seal nipple being closely socketed on described multi-cavity catheter outer surface.
Adopt said structure, because foley's tube is tightly connected by the seal nipple and the multi-cavity catheter formation that are formed on its both ends open place, be conducive to the sealing that ensures that both connect.
Preferably, described balloon body is made up of medical macromolecular materials.
Preferably, the far-end near described heat exchange sacculus on the tube wall of described multi-cavity catheter offers far-end input hole, offers near-end delivery outlet near the near-end of described heat exchange sacculus.
Brief description of the drawings
Fig. 1 is the overall schematic of mild hypothermia therapy foley's tube in prior art;
Fig. 2 is the overall schematic of mild hypothermia therapy foley's tube in the present invention;
Fig. 3 is the overall schematic of mild hypothermia therapy heat exchange sacculus in the present invention;
Fig. 4 is the oblique view of the heat exchange of mild hypothermia therapy shown in Fig. 3 sacculus;
Fig. 5 is the sectional view of the heat exchange of mild hypothermia therapy shown in Fig. 3 sacculus.
Detailed description of the invention
Below with reference to Fig. 2~Fig. 5, mild hypothermia therapy of the present invention is described in detail by the detailed description of the invention of foley's tube.
Mild hypothermia therapy foley's tube in the present embodiment is the aseptic disposable use flexible conduit that gets involved design for femoral vein, jugular vein or subclavian vein, as shown in Figure 2, foley's tube comprises a multi-cavity catheter 4, heat exchange sacculus 5, multi-cavity Connection Block 3, extension pipe 2 and female Luer 1.The conduit that multi-cavity catheter 4 is three-cavity structure, be connected with a multi-cavity Connection Block 3 at the far-end of this multi-cavity catheter 4, this multi-cavity Connection Block 3 connects three female Luer 1 by three extension pipes 2, wherein, the extension pipe 2 that is positioned at left side is communicated with the input cavity of multi-cavity catheter 4 by multi-cavity Connection Block 3, in order to the saline that does not carry out heat exchange in external brine circulation system is delivered in multi-cavity catheter 4; The extension pipe 2 that is positioned at right side is communicated with the output cavity of multi-cavity catheter 4 by multi-cavity Connection Block 3, in order to the saline after heat exchange is drained into external brine circulation system again; Extension pipe 2 in the middle of being positioned at is connected with other chambeies of multi-cavity catheter 4, for guiding standard guide wire or infusion chamber.Heat exchange sacculus 5 is two, and these two heat exchange sacculus 5 are configured in the near-end of multi-cavity catheter 4 and both have certain intervals, conventionally fills saline solution serve as the medium of heat exchange at heat exchange sacculus 5 and multi-cavity catheter 4 in the cavity surrounding.The end welding that is provided with heat exchange sacculus 5 at multi-cavity catheter 4 has soft 6, and these soft the 6 use slightly polyurethane agent of soft pliable song are made, and it is easy at patient vessel's tract interpolation pipe.
The maximum difference of the present invention and prior art is, the concrete structure existence difference of heat exchange sacculus 5.As shown in Figure 2 to 4, in the present embodiment, heat exchange sacculus 5 comprises a both ends open tubular balloon body 51, the two ends end sections of this balloon body 51 is closing in shape, form respectively the seal nipple 53 being connected with aforementioned closing in shape part one in the end, two ends of balloon body 51, sealing joint 53 is the sleeve of a circle.Balloon body 51 and seal nipple 53 are made by medical macromolecular materials, and wherein, heat exchange sacculus 5 is low bullet deformation heat exchange sacculus of being made by plastic material, and this heat exchange sacculus 5 has extraordinary mechanical strength.
On the internal face of balloon body 51, form five grooves 52 (as shown in Figure 4) outstanding towards the radial outside of this balloon body 51, the cross section of each groove 52 is similar to and is trapezoidal.Form the multiple protruding 52a shown in Fig. 2 and Fig. 3 by the sidewall that forms these five grooves 52.As shown in Figures 2 and 3, five grooves 52 are set parallel to each other, and these five grooves 52 axially distribute in the shape of a spiral around balloon body 51, and or rather, aforementioned five grooves 52 are around parallel torsion shape of being axially of balloon body 51.The moulding process of heat exchange sacculus be roughly plastics → fusion plastification → extrude in pipe → cooling pipe → sacculus mould, heat pipe → gas injection stretching inflation → goods cooling → demoulding → post processing → goods.In addition, to the comparatively complicated heat exchange sacculus of shape, in production process, the selecting of technological parameter such as stretching inflation temperature, draw ratio, rate of extension, inflation air pressure, inflation time, inflation speed, cooldown rate are different from ordinary construction sacculus, need carrying out test and improvement repeatedly.
On the common outer surface that is closely socketed in multi-cavity catheter 4 shown in Fig. 2 of the sacculus of heat exchange shown in Fig. 3~Fig. 55, support the use, form and be tightly connected with multi-cavity catheter 4 by the seal nipple 53 at heat exchange sacculus 5 two ends.Corresponding with each heat exchange sacculus 5, on the corresponding tube wall of multi-cavity catheter 4, also offer far-end input hole 41 and near-end delivery outlet 42, wherein, this far-end input hole 41 flows in heat exchange sacculus 5 for the saline that carries out in advance heat exchange, and near-end delivery outlet 42 is discharged from heat exchange sacculus 5 for the saline after heat exchange.
Mild hypothermia therapy shown in Fig. 2 need and start external member with heat exchange controller while implementing in blood vessel heat exchange cooling art with foley's tube and be used in conjunction with, wherein, heat exchange controller is one to comprise the integrated machine electrical heating/refrigerator of temperature monitoring, temperature control equipment, heat-exchange device and peristaltic pump, and the temperature that system is adjusted heating/cooling bath automatically realizes the default patient's target temperature of the doctor in charge; Starting external member is encapsulated in PETG tray box and Tyvek paper lid.With starting external member, heat exchange controller and mild hypothermia therapy shown in the present foley's tube are coupled together, the input cavity of foley's tube 4 is connected to the input female Luer that starts external member, the output cavity of foley's tube 4 is connected to the loop female Luer that starts external member, for the temperature control saline solution of circulation provides a loop.While implementing the interior cooling of body, saline is pumped into the heat-exchange tube intracavity that heat exchange sacculus 5 and multi-cavity catheter 4 outer surfaces form, the saline injecting is expanded heat exchange sacculus 5 and contacts to implement heat exchange with patient's blood circulation, by physiological cycle saline, patient's body temperature is control effectively.
Below according to action principle with set forth the technique effect of the heat exchange of mild hypothermia therapy in the present invention sacculus in conjunction with concrete experimental data.
According to " the steady heat conduction of monolayer planomural " computing formula q=λ * A* △ t/b, q is thermal conduction rate, λ is material heat conductivity, A is heat exchange area, △ t is temperature difference, b is material thickness, known q is relevant to λ, A, △ t and b, and material heat conductivity λ belongs to the intrinsic physical attribute of material, belong to constant, temperature difference △ t is determined by normal saline temperature gap in human body temperature and sacculus, material wall thickness b is for meeting the required pressure minima of sacculus, therefore,, as long as improve sacculus contact area, can increase heat exchanger effectiveness.
With concrete data, the technique effect that heat exchange sacculus is realized is described below.According to object heat energy formula Q=C × m × △ T, Q reaches preset temperature institute calorific requirement for human body; C is human body specific heat capacity, and at this, to regard specific heat of water as be C=4200J/ (kg* DEG C) by approximate human body specific heat; M is body mass, supposes that it is m=70kg that body weight is 70 kilograms; △ T is body temperature lowering temperature, at this, △ T is made as to 1 DEG C, i.e. 1 DEG C of body temperature lowering.According to the steady heat propagation formula q=λ * A* △ t/b of monolayer planomural, q is exchange rate; λ is sacculus material polyurethane heat conduction coefficient 0.025w/ (m* DEG C); A1 is three common sacculus gross areas of cryogenic catheter system, A1=0.0043m 2; A2 is cryogenic catheter system sacculus (1 common sacculus+2 spiral sacculus), gross area A2=0.0054m 2; △ t is 40 DEG C of hypothesis human body temperature, 0.5 DEG C of temperature in foley's tube, △ t=39.5 DEG C; B is sacculus wall thickness b=0.00005m.1 DEG C of required time t=Q/q=of body temperature lowering (C × m × △ T) ÷ (λ * A* △ t/b), 1 DEG C of required time t=3466S of body temperature lowering in the time using ordinary construction sacculus as calculated, 1 DEG C of required time t=2757S of body temperature lowering in the time using helical structure sacculus, adopts spiral balloon structure can make body temperature lowering speed promote 20%.Visible, by form multiple grooves 52 that parallel torsion shape is arranged that are on the surface of heat exchange sacculus 5, can increase the contact area of heat exchange sacculus 5 and blood samples of patients, make the saline in heat exchange sacculus 5 carry out heat exchange with patient's blood better, be conducive to improve heat exchanger effectiveness, thereby improve the cooling-down effect to blood samples of patients.
In addition, in the present embodiment, owing to forming the nonplanar structure in the present invention by multiple grooves 52, these multiple groove 52 entirety are parallel torsion shape arranges, and multiple passages that multiple grooves 52 form for saline flow, adopt this structure, can be to saline mobile the playing the guiding role in heat exchange sacculus 5, thereby accelerate the flow velocity of saline in heat exchange sacculus, the saline in heat exchange sacculus is upgraded in time, contribute to improve cooling-down effect.
The foregoing is only preferred embodiment of the present invention, in order to limit the present invention, within the spirit and principles in the present invention not all, any amendment of doing, be equal to replacement, improvement etc., within all should being included in protection scope of the present invention.
For example, in the above-described embodiments, on the internal face of heat exchange sacculus 5, form the approximate surface area that is trapezoidal groove 52 and increases heat exchange sacculus 5 of multiple cross sections, thereby increase the heat exchange area of saline and blood, but not limited thereto, core of the present invention is to form concavo-convex nonplanar structure in balloon body, this concavo-convex nonplanar structure also can be equally distributed circular protrusions, be the groove of single-wire helix shape or bifilar helix shape or multi-thread spiral distribution, be parallel to heat exchange balloon shaft to the multiple grooves that arrange, and reach and increase the structure of surface area etc. by other shapes.The cross section of nonplanar structure also can be at least one in triangle, rectangle, zigzag, trapezoidal and other special shapes.

Claims (9)

1. a mild hypothermia therapy foley's tube, comprises that a multi-cavity catheter (4), sealing shroud are located at least one the heat exchange sacculus (5) on the near-end outer surface of described multi-cavity catheter (4), it is characterized in that,
Described heat exchange sacculus (5) comprises both ends open tubular balloon body (51), can increase at the heat exchange medium of described foley's tube inner side circulation and the concavo-convex nonplanar structure of the heat exchange area of the blood samples of patients in described foley's tube flows outside upper formation of described balloon body (51).
2. mild hypothermia therapy foley's tube according to claim 1, it is characterized in that, on the internal face of described balloon body (51), form outstandingly towards the radial outside of described balloon body (51) and along the axially extended groove (52) of described balloon body (51), form described nonplanar structure by this groove (52).
3. mild hypothermia therapy foley's tube according to claim 2, is characterized in that, described groove (52) comprises multiple, and these multiple grooves (52) are parallel to the axial setting of described balloon body (51).
4. mild hypothermia therapy foley's tube according to claim 2, is characterized in that, described groove (52) axially distributes in the shape of a spiral around described balloon body (51).
5. mild hypothermia therapy foley's tube according to claim 4, is characterized in that, described groove (52) comprises multiple, and these multiple grooves (52) are many spiral distribution.
6. mild hypothermia therapy foley's tube according to claim 2, is characterized in that, the cross sectional shape of described groove (52) is triangle, rectangle, zigzag, at least one in trapezoidal.
7. mild hypothermia therapy foley's tube according to claim 1, it is characterized in that, be formed with the seal nipple (53) being closely socketed on described multi-cavity catheter (4) outer surface at the both ends open place of described balloon body (51).
8. mild hypothermia therapy foley's tube according to claim 1, is characterized in that, described balloon body (51) is made up of medical macromolecular materials.
9. mild hypothermia therapy foley's tube according to claim 1, it is characterized in that, far-end near described heat exchange sacculus (5) on the tube wall of described multi-cavity catheter (4) offers far-end input hole (41), offers near-end delivery outlet (42) near the near-end of described heat exchange sacculus (5).
CN201410345362.4A 2014-07-18 2014-07-18 Balloon catheter for mild hypothermia therapy Pending CN104117128A (en)

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Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017064134A1 (en) * 2015-10-12 2017-04-20 Acandis Gmbh & Co. Kg Balloon catheter for endovascular temperature control
CN108211095A (en) * 2018-01-12 2018-06-29 佛山博骏生物科技有限公司 A kind of conduit of intravascular mild hypothermia therapy
CN108939257A (en) * 2018-04-11 2018-12-07 上海长海医院 A kind of head end releasable Balloon microcatheters
CN109248371A (en) * 2018-09-20 2019-01-22 郑州嘉豫医疗器械有限公司 A kind of novel sacculus molding equipment
CN112402771A (en) * 2020-11-20 2021-02-26 东莞天天向上医疗科技有限公司 Convex-concave expansion balloon and production and use method thereof
CN112439122A (en) * 2019-09-05 2021-03-05 尤东侠 Balloon dilatation catheter
CN115137549A (en) * 2022-01-29 2022-10-04 瓴科医疗科技(杭州)有限公司 Double-layer heat exchange balloon for sub-hypothermia treatment

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US6719724B1 (en) * 1999-02-19 2004-04-13 Alsius Corporation Central venous line catheter having multiple heat exchange elements and multiple infusion lumens
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US7255709B2 (en) * 1998-04-21 2007-08-14 Alsius Corporation Intravascular heat exchange catheter with temperature sensor
CN204092804U (en) * 2014-07-18 2015-01-14 北京普益盛济科技有限公司 Mild hypothermia therapy foley's tube

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Publication number Priority date Publication date Assignee Title
US6589271B1 (en) * 1998-04-21 2003-07-08 Alsius Corporations Indwelling heat exchange catheter
US7255709B2 (en) * 1998-04-21 2007-08-14 Alsius Corporation Intravascular heat exchange catheter with temperature sensor
US6719724B1 (en) * 1999-02-19 2004-04-13 Alsius Corporation Central venous line catheter having multiple heat exchange elements and multiple infusion lumens
US20050038420A1 (en) * 2002-05-20 2005-02-17 M.A.J.M. Huybregts Cooling cannula system and method for use in cardiac surgery
CN204092804U (en) * 2014-07-18 2015-01-14 北京普益盛济科技有限公司 Mild hypothermia therapy foley's tube

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2017064134A1 (en) * 2015-10-12 2017-04-20 Acandis Gmbh & Co. Kg Balloon catheter for endovascular temperature control
CN108211095A (en) * 2018-01-12 2018-06-29 佛山博骏生物科技有限公司 A kind of conduit of intravascular mild hypothermia therapy
CN108211095B (en) * 2018-01-12 2023-10-27 佛山博骏生物科技有限公司 Catheter for intravascular sub-low temperature treatment
CN108939257A (en) * 2018-04-11 2018-12-07 上海长海医院 A kind of head end releasable Balloon microcatheters
CN109248371A (en) * 2018-09-20 2019-01-22 郑州嘉豫医疗器械有限公司 A kind of novel sacculus molding equipment
CN109248371B (en) * 2018-09-20 2023-10-20 郑州必特奥医疗科技有限公司 Novel sacculus former
CN112439122A (en) * 2019-09-05 2021-03-05 尤东侠 Balloon dilatation catheter
CN112402771A (en) * 2020-11-20 2021-02-26 东莞天天向上医疗科技有限公司 Convex-concave expansion balloon and production and use method thereof
CN112402771B (en) * 2020-11-20 2021-10-08 东莞天天向上医疗科技有限公司 Convex-concave expansion balloon and production and use method thereof
CN115137549A (en) * 2022-01-29 2022-10-04 瓴科医疗科技(杭州)有限公司 Double-layer heat exchange balloon for sub-hypothermia treatment

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