WO2019072047A1 - 弯曲囊导管牵开装置及其牵开方法 - Google Patents

弯曲囊导管牵开装置及其牵开方法 Download PDF

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Publication number
WO2019072047A1
WO2019072047A1 PCT/CN2018/103280 CN2018103280W WO2019072047A1 WO 2019072047 A1 WO2019072047 A1 WO 2019072047A1 CN 2018103280 W CN2018103280 W CN 2018103280W WO 2019072047 A1 WO2019072047 A1 WO 2019072047A1
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Prior art keywords
balloon
catheter
curved
pulling
esophagus
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PCT/CN2018/103280
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English (en)
French (fr)
Inventor
张传海
S尚卡
李凡奇
Original Assignee
上海科库医疗技术有限公司
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Application filed by 上海科库医疗技术有限公司 filed Critical 上海科库医疗技术有限公司
Priority to US16/757,262 priority Critical patent/US20210186621A1/en
Priority to EP18865903.1A priority patent/EP3695791A4/en
Priority to JP2020549849A priority patent/JP7280456B2/ja
Publication of WO2019072047A1 publication Critical patent/WO2019072047A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
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    • A61B90/04—Protection of tissue around surgical sites against effects of non-mechanical surgery, e.g. laser surgery
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    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
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    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
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    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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    • A61B2090/0807—Indication means
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    • A61M2210/00—Anatomical parts of the body
    • A61M2210/10—Trunk
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    • A61M2210/105—Oesophagus

Definitions

  • the present invention relates to a catheter retractor, and more particularly to a curved balloon catheter retracting device and a method of retracting the same.
  • Retractors also known as pull hooks, are used to retract tissue, reveal the scope of surgery, and facilitate exploration and operation. They can be divided into two types: hand-held hooks and automatic hooks. Available in a variety of shapes and sizes, you can choose the right hook for your surgery.
  • Tissue retractors are used in endoscopic and open surgery, including retractable endoscopy, laparoscopy, and general surgery. To accommodate the specific requirements of the surgical procedure, the length and diameter of such a tissue retractor can be fixed or can be varied.
  • a retractable endoscope tissue retractor can be used to hold the organ tissue to retract and manipulate it in some way.
  • a catheter retractor is used for tissue retraction during surgery, which completes the retraction operation through natural lumen intervention or open surgical intervention.
  • Surgery includes, but is not limited to, various types of laparoscopic surgery, cardiovascular surgery, brain surgery, digestive tract surgery, urological surgery, etc., including but not limited to the gastrointestinal tract, esophagus, airway, urethra, vagina , bladder, etc.
  • the purpose of retraction includes, but is not limited to, protecting a particular tissue, removing a particular tissue to facilitate surgical procedures.
  • FIG. 200580028684.5 provides a tissue removal/separation device.
  • the device includes a bladder that is expandable between a first tissue and a second tissue of the body.
  • the bladder has an expanded shape that is selected to be capable of removing or separating the first tissue from the second tissue in a manner suitable to protect the first tissue from the treatment applied to the second tissue.
  • this invention merely reveals the possibility of using capsule expansion to isolate human tissue.
  • An original inflatable balloon is not suitable for use in expanded isolation in any body tissue. Even the use of such a balloon to inflate a person's body to a certain extent poses a huge potential risk.
  • the balloon will adhere to human tissue at a certain pressure, although it can isolate different tissues but at the same time tightly fill the limited space between the two, making surgery more difficult if the ball is passed through sharp surgical devices and burning surgical means.
  • the object of the present invention is to provide a curved balloon catheter retracting device for natural lumen intervention or open surgical intervention to complete the retracting operation based on the above problems, and to solve the current precision and reliability of the catheter retractor and the balloon isolation device. It is unable to adapt to the problems of human surgery, thus achieving a simple and reliable catheter retraction.
  • the present invention provides a curved balloon catheter retracting device comprising: a catheter having a handle at one end, a positioner and a pulling capsule disposed outside the catheter, and one or more cavities in the catheter, the catheter portion At least one hole is provided through which at least one cavity fluidly charges the pulling bag, and the pulling bag is bent to one side when filled with fluid, and the handle can drive the catheter and the pulling bag to rotate.
  • the positioner may be a device containing a developer, and its position in the body can be observed by X-ray.
  • the positioner is one or more positioning balloons located in a fixed position of the catheter, and the positioning balloon is filled with fluid to catch the internal lumen of the human body.
  • the handle includes a portion that is held stationary and a portion that can be angled.
  • the handle has a scale indicating the angle, which is used to mark the relative azimuth angle of the pull bag when the handle is rotated.
  • the catheter adopts a material that is not easily twisted by itself; when the catheter is left to rotate outside the body cavity, the pulling capsule rotates at a certain angle.
  • the catheter has a length scale that marks the depth of catheter insertion.
  • One or more of the cavities are used to inflate the positioning balloon. At least one of the cavities is used to drain the fluid.
  • the cavity for draining the effusion, the opening position on the catheter is located at the upper end of the traction sac; if the balloon is positioned, the upper end of the balloon is positioned.
  • At least one of the cavities is for spraying the developer; the orifice for spraying the developer is located at the upper end of the pulling bladder; and if the balloon is positioned, the bladder is positioned between the pulling bladder and the upper end.
  • At least one of the cavities is for sucking the negative pressure, and the opening position is located at the two ends to position the middle of the balloon, and the hole for sucking the negative pressure may have one or more.
  • the pulling capsule can be made of a raw material mixed with a developer to have a function of fully developing under X-rays.
  • the pulling capsule is used for esophageal traction, and the pulling capsule is located between the second stenosis and the third stenosis of the esophagus. After filling the fluid, the diameter of the positioning balloon is larger than the diameter of the esophagus at the stenosis.
  • the present invention provides a curved balloon catheter retracting device comprising a handle and a plurality of a lumen catheter, two positioning balloons, and a pulling balloon; wherein three cavities of the multi-lumen catheter are respectively opened at positions where the three balloons are located, respectively, for respectively filling three balloons with fluid;
  • the balloon is located at both ends of the pulling capsule, and is filled with the esophagus for fixation when the fluid is filled; when the pulling capsule is filled with fluid, the bending causes the esophagus to bend and pull it away from the original position.
  • the four cavities are respectively located in the middle of the large cavity, and a plurality of small cavities in the periphery; each of the small cavities is respectively opened at a position where each of the capsules is located for inflating the capsules respectively;
  • a large cavity is positioned at the upper end of the balloon to allow drainage of saliva.
  • the other cavity communicates with the opening between the positioning balloon and the pulling balloon for evacuating the esophageal drawing site.
  • a further cavity can be used to eject the developer to the inner wall of the esophagus for displaying the esophageal bending condition.
  • the present invention provides a method of retracting a curved balloon catheter, comprising the steps of: inserting an unfilled curved balloon catheter into a lumen of a human body to be retracted; monitoring whether the positioning balloon reaches The predetermined position; the positioning balloon is filled with the fluid to be caught in the lumen of the human body; the fluid is filled into the pulling capsule to bend it to bend and retract the lumen of the human body.
  • a step of pumping the fluid by suctioning the negative pressure is further included, and then the pulling capsule is opened to achieve the purpose of bending the lumen.
  • the rotation of the catheter and the capsule is rotated by rotating the handle to drive the esophagus to rotate, thereby always avoiding the tissue or position that needs to be avoided during the operation.
  • the balloon is used for esophageal traction, the balloon is positioned between the second stenosis and the third stenosis of the esophagus, and the diameter of the positioning balloon after filling the fluid is greater than the diameter of the esophagus at the stenosis.
  • the positioning balloon is first filled into the fluid, and then the cavity is sucked by suctioning the negative pressure, and finally the pulling capsule is opened to achieve the purpose of bending the esophagus.
  • the invention has the beneficial effects that the invention provides a better device for tissue pulling, which has better controllability, safer use and more comfortable patient than the existing tissue pulling mode; specific, such as For the traction of the esophagus, the existing oral placement of the instrument can be changed to the nasal placement, and the operability is better; the use of the positioning balloon and the rotary scale enables the pulling operation (action site and pulling orientation) More precise; increased cavities and openings for more practical operations such as saliva drainage, spray developer, negative pressure and more.
  • Figure 1 is a schematic view of the structure of the present invention.
  • Figure 2 is a cross-sectional view of a catheter portion of the present invention.
  • Figure 3 is a schematic illustration of the handle portion of the present invention.
  • Figure 4 is a schematic illustration of one embodiment of the invention.
  • Figure 5 is a schematic illustration of another embodiment of the invention.
  • Figure 6 is a cross-sectional view of the catheter portion of the embodiment of Figure 5.
  • Figure 7 is a schematic illustration of yet another embodiment of the present invention.
  • Figure 8 is a cross-sectional view of the catheter portion of the embodiment of Figure 7.
  • Figure 9 is a schematic illustration of a curved balloon catheter retraction device for retracting the esophagus.
  • FIG. 1 is a schematic structural view of the present invention.
  • a curved balloon catheter retractor of the present invention is composed of a handle 2 having a draft tube and a valve 1 at one end, a positioner 3 and a pulling bag 4 disposed outside the catheter 5.
  • One or more cavities are provided in the duct 5, and at least one hole is provided in the duct 5 portion of the positioner 3, and at least one cavity is introduced into the fluid cavity controlled by the draft tube and the valve 1 through the hole
  • the positioner 3 and the pulling bladder 4 are filled and discharged, where the fluid is usually a liquid and a gas, and the pulling bladder 4 is bent to one side when filled with a fluid.
  • the gas is injected into the gas inlet by a syringe. Closing the draft tube and valve 1 after injecting gas allows the pulling bladder 4 to maintain gas pressure.
  • the pulling capsule 4 is located near the middle or the end of the catheter 5, and the upper and lower ends of the pulling capsule 4 are closed on the catheter 5 by laser welding or bonding.
  • the advantage of using laser welding is that retraction requires a large pressure inside the bladder to produce sufficient rigidity, sometimes up to 10 atmospheres, and only laser welding can ensure a reliable seal.
  • the material of the pulling capsule 4 of the present invention is semi-compliant or non-compliant, that is to say, in a large pressure range, the volume and shape of the pulling capsule 4 are small after expansion, thereby protecting the organ from being affected.
  • the positioner 3 can be two compliant positioning balloons 3 that are respectively fixed to the catheter 5 at both ends of the pulling capsule 4.
  • the positioning balloon 3 is one or more, and when there is one, it can be placed at the proximal or distal end of the pulling balloon 4.
  • the positioning balloon 3 is a compliant balloon or a non-compliant balloon, and the long diameter is relatively small. In the case where the number of the positioning balloons 3 is plural, it may be fully filled with a fluid (gas or liquid) during use, or a part of the balloon may be filled with a fluid (gas or liquid).
  • the pulling capsule 4 is a non-compliant balloon, and the long diameter is relatively large.
  • the positioning balloon 3 and the pulling capsule 4 can be made of a material mixed with a developer to have a function of fully developing under X-rays.
  • Figure 2 is a cross-sectional view of the catheter portion of the present invention.
  • the catheter 5 has three cavities in cross section, two of which are for filling and deflation of the positioning balloon 3, and the other of which is for filling and releasing the sac.
  • FIG 3 is a schematic illustration of the handle portion of the present invention.
  • the handle 2 is used for operations such as inflation, injection, holding, and rotation.
  • the inflated and/or injected port 1 is determined according to a specific design and has one or more.
  • the handle 2 includes a portion that is held stationary and a portion that is rotatable.
  • the handle 2 has an angled scale 21 which, when rotated, is used to mark the relative angular orientation of the pulling bladder relative to the human organ or where the tissue needs to be pulled.
  • FIG. 4 is a schematic diagram of an embodiment of the present invention.
  • the positioner or positioning balloon 3 has a positioning mark 31 which may be a developing material such as barium sulfate contrast agent.
  • Other positioning devices such as infrared or radio frequency tags, can also be used to enable the physician to detect the location of the locator or positioning balloon 3 in the body outside of the patient.
  • the catheter 5 has a development line for use as an X-ray development.
  • FIG. 5 is a schematic diagram of another embodiment of the present invention.
  • Figure 6 is a cross-sectional view of the catheter portion of the embodiment of Figure 5.
  • the curved balloon catheter retraction device includes a handle 2, a four lumen catheter 5, two compliant positioning balloons 3, a semi-compliant or non-compliant traction balloon 4.
  • the four cavities are respectively located in the middle of the large cavity 53 and the surrounding three small cavities 51 and 52; the three small cavities are respectively opened at positions 511, 521, 522 where the three pockets are located, Inflate the three capsules separately.
  • a large, large cavity 53 in the middle positions the upper opening 531 of the balloon at the upper end for draining saliva.
  • the conduit 5 is a hollow conduit with one or more cavities inside. At least one cavity 51 in the cavity is specifically designed to fill the pulling bladder 4 with fluid. One or more of the cavities are used to inflate the positioning balloon 3. At least a cavity 53 in the cavity has a cavity for draining saliva; the cavity 53 for draining saliva is located at the upper end of the pull cup 4 at the opening 531 on the catheter 5; if the balloon 3 is positioned, At the upper end of the positioning balloon 3.
  • FIG. 7 is a schematic diagram of still another embodiment of the present invention.
  • Figure 8 is a cross-sectional view of the catheter portion of the embodiment of Figure 7. Unlike the previous embodiment, all of the cavities in this embodiment have no significant size.
  • the three cavities 51 and 52 of the four-lumen catheter 5 are respectively opened at the positions where the three balloons are located for inflating the three balloons.
  • Another cavity 54 is used to spray the developer (barium meal; barium sulfate); the hole 541 of the sprayed developer is located at the upper end of the pull cup 4; if the balloon 3 is positioned, the balloon 3 is positioned at the upper end of the pull bag 4 between.
  • the function of the spray developer is to enable the inner wall of the esophagus to be developed, clearly knowing the distance of retraction.
  • the cavity 54 is used to absorb negative pressure
  • the opening position is located between the two positioning balloons 3, and the holes for suctioning the negative pressure may have one or more.
  • the positioning balloon 3 is first inflated, and then the cavity 54 sucking the negative pressure is used for pumping, and finally the pulling bag 4 is opened to achieve the purpose of bending the esophagus.
  • the catheter uses a material that is not easily twisted; when the catheter is left to rotate outside the body lumen, the interior is simultaneously rotated by a certain proportion of angle. At the same time, the catheter has a length scale that marks the depth of catheter insertion.
  • the present invention also provides a retraction method by which a single-chamber/multi-lumen catheter tube that can be inserted into an animal can be inflated into an arc-shaped pulling capsule after injecting a fluid, the pulling capsule being linked to the catheter Externally, the catheter can be offset towards the protruding direction of the pull cup, and can be used in conjunction with an operating handle and other related accessories.
  • the product completes the retraction operation by natural lumen intervention or open surgical intervention.
  • Surgery includes, but is not limited to, various types of laparoscopic surgery, cardiovascular surgery, brain surgery, digestive tract surgery, and urological surgery.
  • the retracted tissue includes, but is not limited to, the gastrointestinal tract, the esophagus, the airway, the urethra, the vagina, the bladder, and the like.
  • the purpose of retraction includes, but is not limited to, protecting a particular tissue, removing a particular tissue to facilitate surgical procedures.
  • the curved balloon catheter of the retractor is inserted into the body by the handle of the human body through a natural cavity or a surgical procedure.
  • the position and rotation angle of the catheter can be adjusted with the handle with the aid of the imaging device indication, and the positioning and angle can be locked with the handle.
  • the bladder can be inflated through the gas injection port provided with the handle or any other gas injection path. After the balloon is inflated and inflated and curved, the catheter tube will also bend at least for a certain degree, and the curved portion of the balloon catheter can complete the retraction or displacement effect of the tissue.
  • Atrial fibrillation is the most common arrhythmia, and atrial fibrillation radiofrequency ablation has been recognized in recent years as a better solution than drug therapy and conventional surgery.
  • Complications of atrial esophageal fistula occur from the spatial relationship between the left atrium and the esophagus. Because the esophagus is located in the posterior mediastinum, it is separated from the posterior wall of the left atrium by the pericardial sinus, while the posterior wall of the left atrium and the anterior wall of the esophagus are thin. The high temperature and high energy in the ablation procedure may cause excessive damage to the esophagus.
  • FIG. 9 is a schematic diagram of the curved capsule catheter retractor pulling the esophagus.
  • a catheter having a balloon externally is inserted into the patient's natural or surgically formed lumen, the balloon portion is inserted into the lumen position to be retracted, the balloon is inflated to expand the balloon, and the balloon is inflated and then bent to one side to pull the catheter to bend. And the patient's lumen is bent to achieve the retraction displacement.
  • the catheter 5 is inserted into the esophagus from the nasal cavity.
  • the balloon 3 When the distal end positioning balloon 3 enters between the second narrow and third narrow stenosis, the balloon 3 is positioned to extend and pushes to the third stenosis; The balloon 3 is positioned such that it is caught under the second stenosis; then the intermediate pulling sac 4 is stretched to bend it to cause the esophagus to bend.
  • the catheter 5 and the balloons 3, 4 are rotated by rotating the handle 2, so that the direction of deviation of the esophagus in the body changes, thereby always avoiding the ablation point of cardiac ablation.
  • the esophagus is evacuated by using the opening hole, and after reaching a certain negative pressure range, the pulling capsule 4 is further opened to achieve the purpose of bending the esophagus.
  • the opening can also be used to spray the developer so that the curved portion of the esophagus can be developed under X-rays.
  • the catheter when used for esophageal traction, the catheter is inserted into the esophagus through the nasal cavity or the oral cavity in a state where the traction balloon and the positioning balloon are not inflated. After reaching the position, the direction of the bending is determined by the marking on the catheter and the handle.
  • the upper knob device rotates the entire catheter, causing the traction balloon to rotate, thereby retracting the esophagus in a new direction away from the new ablation point.
  • the traction capsule is used between the second stenosis and the third stenosis of the esophagus when the esophagus is pulled.
  • the diameter of the positioning balloon is larger than the diameter of the esophagus in the stenosis.
  • the length of the traction sac is 10-15 cm, and the working pressure is 2-8 atm.
  • the opening distance is 2-4 cm.

Abstract

一种弯曲囊导管牵开装置，其特征在于包括：一端具有手柄（2）的导管（5），设于导管（5）外部的定位器（3）和牵拉囊（4），导管（5）内设有一个或多个空腔，导管部分设有至少一个孔，至少一个空腔通过该孔对牵拉囊（4）进行流体充放，牵拉囊（4）充有流体时会向一侧弯曲，手柄（2）可带动导管（5）和牵拉囊（4）旋转，从而实现一种简单可靠的牵开。

Description

弯曲囊导管牵开装置及其牵开方法 技术领域
本发明涉及一种导管牵开器，尤其是一种弯曲囊导管牵开装置及其牵开方法。
背景技术
牵开器(retractors)又称拉钩，用以牵开组织，显露需手术范围，便于探查和操作，可分为手持拉钩和自动拉钩两类。有各种不同形状和大小的规格，可根据手术需要选择合适的拉钩。
传统的牵开器需要较大的操作空间，这就需要造成较大的手术创口。同时传统的牵开器多用金属制造，同时有尖锐端，容易造成病人的二次创伤，损伤重要器官组织。
目前可伸缩组织牵开器逐渐得到广泛应用，它可以穿过可伸缩内窥镜的工作腔。组织牵开器应用于内窥镜和开腔手术中，包括可伸缩的内窥镜检查、腹腔镜检查和普通外科手术。为了适应外科手术中的具体要求，这种组织牵开器的长度和直径可以是固定不变的或可以改变的。可伸缩内窥镜组织牵开器可用来固定住器官组织，从而以某种方式将其牵开和进行操作。
导管牵开器用于手术中的组织牵开用，所述产品通过自然腔道介入或 者开放式手术介入完成牵开操作。手术包括但不仅限于各类腹腔镜手术、心血管大类手术、脑部手术、消化道手术、泌尿疾病手术等，所牵开组织包括但不仅限于胃肠道、食道、气道、尿道、阴道、膀胱等。牵开目的包括但不仅限于保护特定组织、移开特定组织以方便手术操作。
利用囊膨胀变形使得组织之间产生间隙是一种较金属牵拉器更优的做法，它体积小，可以在不过度伤害人体组织的前提下放入需要隔离的人体组织部分。同时膨胀后的囊表面光滑柔软，不易对人体组织造成损伤。例如中国专利200580028684.5就提供一种组织移除/分离设备。该设备包括可以在身体的第一组织和第二组织之间膨胀的囊。该囊具有膨胀形状，其被选择为能够以一种适于保护第一组织不受对第二组织应用治疗的影响的方式来将第一组织从第二组织移除或分离。
但是这一发明仅仅是揭示了利用囊膨胀隔离人体组织的可能性，一个原始的充气球囊并不适合在任何人体组织中用于膨胀隔离。甚至在一定程度上使用这种球囊往人体内充气会造成巨大的潜在风险。而且该球囊在一定气压下会紧贴人体组织，虽然可以隔离不同组织但同时也紧密填塞了两者之间的有限空间使得手术更加困难，如果通过锋利手术器件和灼烧的手术手段时球囊还存在着爆裂的风险。因此该球囊膨胀装置相较于机械牵开器，不能有效实现大位移的牵开并且不占用手术空间，它只能起到隔离人体组织的作用。此外从体外来判断球囊具体所处位置也比较困难，而一般来说此类手术通常相当精密。同时体内积液也较难排除，导致新增风险。
因此，需要一种更加完善并且适合人体手术实际情况的利用球囊作为牵开器的手术装置，以结合球囊膨胀和机械牵开两者的优点。
发明内容
本发明的目的在于基于上述问题而为自然腔道介入或者开放式手术介入完成牵开操作提供一种弯曲囊导管牵开装置，解决当前导管牵开器和球囊隔离装置精度和可靠性不高，无法适应人体手术的问题，从而实现一种简单可靠的导管牵开。
为了达到上述目的，本发明提供一种弯曲囊导管牵开装置，包括：一端具有手柄的导管，设于导管外部的定位器和牵拉囊，导管内设有一个或多个空腔，导管部分设有至少一个孔，至少一个空腔通过该孔对牵拉囊进行流体充放，该牵拉囊充有流体时会向一侧弯曲，所述手柄可带动导管和牵拉囊旋转。
其中，定位器可以是一个采用含有显影剂的装置，可以通过X光观察其在体内的位置。定位器是一个或多个位于导管固定位置的定位球囊，该定位球囊充有流体后能卡住人体内部腔管。手柄包括握持不动的部分，以及可旋调角度的部分。手柄上有标明角度的刻度，当旋转手柄时，用来标记牵拉囊相对方位角度。导管采用不易自体扭转的材质；当导管留在人体腔道外面部分旋转时，牵拉囊同时旋转一定比例的角度。导管上有长度的刻度，用来标记导管插入的深度。空腔中有一个或多个用来给定位球囊充气。空腔中至少 有一个用来引流积液。引流积液的空腔，其在导管上的开口位置位于牵拉囊的上端；如有定位球囊，则在定位球囊上端。空腔中至少有一个用来喷显影剂；喷显影剂的孔位于牵拉囊的上端；如有定位球囊，则在牵拉囊和上端定位球囊之间。空腔中至少有一个用来吸负压，其开孔位置位于两端定位球囊中间，用来吸负压的孔可以有一个或多个。牵拉囊，可以采用混有显影剂的原料制作，使其具有在X射线下完全显影的功能。所述的牵拉囊用于食管牵拉，牵拉囊位于食管的第二狭窄和第三狭窄之间，充入流体后定位球囊的直径大于狭窄处食管直径。
本发明的另一目的在于提供一种弯曲囊导管牵开装置，用于心脏消融手术的食道牵开，为了实现这一发明目的，本发明提供了一种弯曲囊导管牵开装置包括手柄、多腔导管、两个定位球囊、一个牵拉囊；其中多腔导管中三个空腔分别在三个球囊所处的位置开孔，用来给三个球囊分别充流体；两个定位球囊位于牵拉囊两端，充有流体时分别卡住食管用于固定；牵拉囊充有流体时弯曲带动食道弯曲，使之牵离原有位置。
其中所述的四个空腔的位置分别为中间的大空腔，以及周围的多个小空腔；各个小空腔分别在各个囊所处的位置开孔，用来给囊分别充气；中间较大的空腔在上端定位球囊的上面开孔，用来引流唾液。另一个空腔连通定位球囊和牵拉囊之间开孔，用来对食管牵拉部位抽气。再一个空腔可以用来向食道内壁喷射显影剂，用于显示食道弯曲状况。
本发明的又一目的是提供一种安全有效的弯曲囊导管牵开方法。为了实 现这一发明目的，本发明提供了一种弯曲囊导管牵开方法，其特征在于包括以下步骤：将未充流体弯曲囊导管插入需牵开的人体管腔内；监控定位球囊是否到达预定位置；将定位球囊充入流体使其卡在人体管腔内；向牵拉囊充入流体使其弯曲达到弯曲牵开人体管腔的目的。
其中将定位球囊充流体之后，还包括一个利用吸负压的空腔抽流体的步骤，然后再撑开牵拉囊，达到弯曲管腔的目的。
本发明的再一目的是提供一种弯曲囊导管牵开方法，用于食管牵开，其特征在于包括以下步骤：将囊导管从口腔或鼻腔插入食道，当末端定位球囊进入食道第二狭窄和第三狭窄之间时，撑开末端定位球囊，并继续推送至第三狭窄上面；撑开上端定位球囊，使其卡在第二狭窄下面；然后通过导管和手柄上的标记，确定弯曲的方向与心脏的相对位置，撑开中间的牵拉囊，使其弯曲，带动食道弯曲，远离心脏或心脏手术位置。
其中在使用过程中当需要移动牵拉囊的位置时，通过旋转手柄带动导管和囊旋转，带动食管旋转，从而始终避开手术中需要避开的组织或位置。当囊用于食管牵拉时，囊位于食管的第二狭窄和第三狭窄之间，充入流体后的定位球囊的直径大于狭窄处食管直径。使用时先将定位球囊充入流体，再利用吸负压的空腔抽气，最后撑开牵拉囊，达到弯曲食管的目的。
本发明的有益效果是：本发明为组织牵拉提供了一种更好的器械，相对于现有组织牵拉方式，其可控性更好，使用更安全，患者更加舒适；特定的，如用于食道牵拉，可将现有经口放置器械的方式改为经鼻放置，操作性更好； 定位球囊和旋转刻度的使用，使得牵拉的操作(作用位点和牵拉方位)更加精确；增加的空腔和开孔，实现了唾液引流、喷显影剂、抽负压等更多实用性的操作。
附图说明
图1是本发明的结构示意图。
图2是本发明导管部分的截面图。
图3是本发明手柄部分的示意图。
图4是本发明一个实施例的示意图。
图5是本发明另一个实施例的示意图。
图6是图5实施例的导管部分的截面图。
图7是本发明又一个实施例的示意图。
图8是图7实施例的导管部分的截面图。
图9是弯曲囊导管牵开装置牵开食管示意图。
具体实施方式
下面将结合附图和实施例对本发明做进一步的详述：
首先请参阅图1，图1是本发明的结构示意图。如图1所示，本发明的一种弯曲囊导管牵开器，由以下几部分组成：一端具有导流管及阀1的手柄2，设于导管5外部的定位器3和牵拉囊4，导管5内设有一个或多个空腔，在定位器3内的导管5部分设有至少一个孔，至少一个空腔由导流管和阀1控制的进放流体空腔，通过该孔对定位器3和牵拉囊4进行充放流体，这里的流体通常是液体和气体，该牵拉囊4充有流体时会向一侧弯曲。在一个实施例中，由注射器向进气口注入气体。注入气体后关闭导流管和阀1可使得 牵拉囊4保持气体压力。一般来说牵拉囊4位于导管5靠近中或末端外部，采用激光焊接或粘接将牵拉囊4上下两端封闭在导管5上。采用激光焊接的好处是，牵开需要囊内部具有较大的压力以产生足够的刚性，有时会达到10个大气压，只有激光焊接才能保证密封可靠。本发明的牵拉囊4材料是半顺应性或非顺应性的，也就是说在较大的压力范围内，该牵拉囊4膨胀后体积和外形的变化都很小，从而保护器官不受过度挤压。定位器3可以是两个顺应性的定位球囊3，分别固定设于牵拉囊4两端的导管5上。在一些实施例中所述定位球囊3为一个或多个，当有一个时，可放置在牵拉囊4的近端或远端。定位球囊3为顺应性球囊或非顺应性球囊，长径比较小。定位球囊3的数量为多个的情况下，在使用过程中可以全部充流体(气体或液体)，也可以选择部分球囊充流体(气体或液体)。而所述牵拉囊4为非顺应性球囊，长径比较大。定位球囊3和牵拉囊4可以采用混有显影剂的原料制作，使其具有在X射线下完全显影的功能。
接着请参阅图2，图2是本发明导管部分的截面图。在图2中，导管5的横截面有三个空腔，其中两个空腔52是用于向定位球囊3充放气，另一个空腔51是用于向牵拉囊4充放气。
图3是本发明手柄部分的示意图。所述手柄2用于充气、注射、握持和旋转等操作。所述充气和(或)注射的口1，根据具体设计确定，有一个或多个。所述手柄2包括握持不动的部分，以及可旋转角度的部分。所述手柄2上有标明角度的刻度21，当旋转手柄2时，用来标记牵拉囊相对人体器官或需要牵拉组织所处的相对角度方位。
接下来请参阅图4，图4是本发明一个实施例的示意图。在图4中，定位器或定位球囊3上有一个定位标志31，它可以是显影材料，例如硫酸钡造影剂。也可以是其他定位装置例如红外或者射频标签等，能够使得医生在病人体外测到定位器或定位球囊3在体内的具体位置。在一些实施例中导管5上有显影线，作为X射线下显影使用。
请参阅图5和图6，图5是本发明另一个实施例的示意图。图6是图5实施例的导管部分的截面图。所述弯曲囊导管牵开装置包括手柄2、四腔导管5、两个顺应性定位球囊3、一个半顺应性或非顺应性牵拉囊4。四个空腔的位置分别为中间的大空腔53，以及周围的三个小空腔51和52；三个小空腔分别在三个囊所处的位置开孔511、521、522，用来给三个囊分别充气。中间较大的大空腔53在上端定位球囊的上面开孔531，用来引流唾液。
所述导管5是中空导管，导管5内部有一个或多个空腔。所述空腔中有至少一个空腔51专门用来给牵拉囊4充入流体。所述空腔中有一个或多个用来给定位球囊3充气。所述空腔中至少空腔53有一个用来引流唾液；所述引流唾液的空腔53，其在导管5上的开口531位置位于牵拉囊4的上端；如有定位球囊3，则在定位球囊3上端。
请参阅图7和图8，图7是本发明又一个实施例的示意图。图8是图7实施例的导管部分的截面图。与上一实施例不同，在本实施例中所有空腔没有明显的大小之分。四腔导管5的三个空腔51和52分别在三个球囊所处的位置开孔，用来给3个球囊分别充气。另一个空腔54用来喷显影剂(钡餐； 硫酸钡)；喷显影剂的孔541位于牵拉囊4的上端；如有定位球囊3，则在牵拉囊4和上端定位球囊3之间。喷显影剂的作用在于使食管内壁能够显影出来，明确知道牵开的距离。
在另一些实施例中所述空腔54用来吸负压，其开孔位置位于两个定位球囊3中间，用来吸负压的孔可以有一个或多个。具体的，使用时先将定位球囊3充气，再利用吸负压的空腔54抽气，最后撑开牵拉囊4，达到弯曲食管的目的。
所述导管使用不易扭转的材质；当导管留在人体腔道外面部分旋转时，内部同时旋转一定比例的角度。同时，导管上有长度的刻度，用来标记导管插入的深度。
本发明还提供了一种牵开方法，通过可介入动物体内的单腔/多腔导管管路，注入流体后能膨胀成弧形的牵拉囊，所述牵拉囊链接于所述导管的外部，所述导管可以朝所述牵拉囊的凸出方向偏移，可配有操作手柄及其他相关配件联合使用。用于手术中的组织牵开用，所述产品通过自然腔道介入或者开放式手术介入完成牵开操作。手术包括但不仅限于各类腹腔镜手术、心血管大类手术、脑部手术、消化道手术、泌尿疾病手术等。所牵开组织包括但不仅限于胃肠道、食道、气道、尿道、阴道、膀胱等。牵开目的包括但不仅限于保护特定组织、移开特定组织以方便手术操作。
经人体自然腔道或者手术方式，用手柄调控将牵开器的弯曲囊导管介入体内。可以在影像设备指示帮助下，用手柄调节导管的位置和旋转角度， 可以用手柄锁定定位和角度。可通过手柄附带的注气口或者任何其他注气通路完成对囊的充气。囊充气后膨胀并呈现弯曲状，导管管路也会至少有一段发生不同程度的弯曲，最终囊导管的弯曲部分能完成组织的牵开或移位效果。
以房颤消融并发症为例介绍导管牵开器的作用。房颤动是最常见的心律失常，而房颤射频消融治疗近年来逐步被认知为比起药物治疗和常规外科手术更好的解决方案。心房食管瘘并发症的发生源于左心房和食管临近的空间关系。由于食管位于后纵隔，与左心房后壁仅以心包斜窦相隔，而左心房后壁和食管前壁均很薄，消融手术中的高温高能量很有可能对食管造成过度损伤。心房食管瘘并发症具有极高的死亡率，为了使手术安全必须牵开食道使其远离心脏，图9是弯曲囊导管牵开器牵开食管示意图。图9中将一段外部设有囊的导管插入病人自然或手术形成腔道内，将囊部分插入需要牵开的腔道位置，对导管充气使囊膨胀，囊充气膨胀后向一侧弯曲拉动导管弯曲并导致病人腔道弯曲，实现牵开位移。
使用时，将导管5从鼻腔插入食道，当末端定位球囊3进入食道第二狭窄和第三狭窄之间时，撑开末端定位球囊3，并继续推送至第三狭窄上面；撑开上端定位球囊3，使其卡在第二狭窄下面；然后撑开中间的牵拉囊4，使其弯曲，带动食道弯曲。在使用过程中，通过旋转手柄2带动导管5和球囊3、4旋转，使得食道在体内的偏移方向发生变化，从而始终避开心脏消融的消融点。在定位球囊3撑开后，使用开孔对食道进行抽气，达到一定负压范围后，再撑开牵拉囊4，达到弯曲食道的目的。开孔同时也可以用来喷显影剂，使得食道弯曲部分在X射线下能够显影。
具体的，用于食管牵拉时，先在牵拉囊和定位球囊未充气的状态下，将导管通过鼻腔或口腔插入食道，到达位置后，通过导管和手柄上的标记，确定弯曲的方向与心脏的相对位置，然后将牵拉囊充气撑开，用牵拉囊的刚性牵开食管；当需要在水平截面上旋转调整牵拉囊的定位时(心脏消融更换消融点时)，通过手柄上的旋钮装置旋转整个导管，带动牵拉囊旋转，从而在新的方向上牵开食管使其远离新的消融点。牵拉囊用于食管牵拉时位于食管的第二狭窄和第三狭窄之间，定位球囊的直径大于狭窄处食管直径，牵拉囊的长度为10-15cm，工作气压2-8atm，牵开距离2-4cm。
本领域内技术人员还可在本发明的创作精神内作其他变形，这些依据本发明的创作精神而衍生的各种变形仍应属本发明的保护范围之内。

Claims (24)

  1. 一种弯曲囊导管牵开装置，其特征在于包括：一端具有手柄的导管，设于导管外部的定位器和牵拉囊，导管内设有一个或多个空腔，导管部分设有至少一个孔，至少一个空腔通过该孔对牵拉囊进行流体充放，该牵拉囊充有流体时会向一侧弯曲，所述手柄可带动导管和牵拉囊旋转。
  2. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的定位器是一个采用含有显影剂的装置，可以通过X光观察其在体内的位置。
  3. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的定位器是一个或多个位于导管固定位置的定位球囊，该定位球囊充有流体后能卡住人体内部腔道。
  4. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的手柄包括握持不动的部分，以及可旋调角度的部分。
  5. 如权利要求4所述的弯曲囊导管牵开装置，其特征在于所述的手柄上有标明角度的刻度，当旋转手柄时，用来标记牵拉囊相对方位角度。
  6. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的导管采用不易自体扭转的材质；当导管留在人体腔道外面部分旋转时，牵拉囊同时旋转一定比例的角度。
  7. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的导管上有长度的刻度，用来标记导管插入的深度。
  8. 如权利要求3所述的弯曲囊导管牵开装置，其特征在于所述的空腔中 有一个或多个用来给定位球囊充流体。
  9. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的空腔中至少有一个用来引流积液。
  10. 如权利要求9所述的弯曲囊导管牵开装置，其特征在于所述的引流积液的空腔，其在导管上的开口位置位于牵拉囊的上端；如有定位球囊，则在定位球囊上端。
  11. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的空腔中至少有一个用来喷显影剂；喷显影剂的孔位于牵拉囊的上端；如有定位球囊，则在牵拉囊和上端定位球囊之间。
  12. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的空腔中至少有一个用来吸负压，其开孔位置位于两端定位球囊中间，用来吸负压的孔可以有一个或多个。
  13. 如权利要求1所述的弯曲囊导管牵开装置，其特征在于所述的牵拉囊，可以采用混有显影剂的原料制作，使其具有在X射线下完全显影的功能。
  14. 如权利要求3所述的弯曲囊导管牵开装置，其特征在于所述的牵拉囊用于食管牵拉，牵拉囊位于食管的第二狭窄和第三狭窄之间，充入流体后的定位球囊的直径大于狭窄处食管直径。
  15. 一种弯曲囊导管牵开装置，用于食道牵开，其特征在于包括：手柄、多腔导管、两个定位球囊、一个牵拉囊；其中多腔导管中三个空腔分别在三个囊所处的位置开孔，用来给三个囊分别充流体；两个定位球囊位于牵拉囊两端，充有流体时分别卡住食管用于固定；牵拉囊充有流体时弯曲带动食道弯曲，使之牵离原有位置。
  16. 如权利要求15所述的弯曲囊导管牵开装置，其特征在于所述的多腔空腔包括中间的大空腔，以及周围的小空腔；周围小空腔分别在各个囊所处的位置开孔，用来给囊分别充入流体；中间较大的空腔在上端定位球囊的上面开孔，用来引流积液。
  17. 如权利要求15所述的弯曲囊导管牵开装置，其特征在于所述的另一个空腔在两端定位球囊之间开孔，用来抽气使得食管的整个待牵拉段更好的贴附于囊导管外部，易于更有效的整体牵拉。
  18. 如权利要求15所述的弯曲囊导管牵开装置，其特征在于所述的再一个空腔可以用来向食道内壁喷射显影剂，用于显示食道弯曲状况。
  19. 一种弯曲囊导管牵开方法，其特征在于包括以下步骤：将未充入流体的弯曲囊导管插入需牵开的人体管腔内；监控定位球囊是否到达预定位置；将定位球囊充入流体使其卡在人体管腔内；向牵拉囊充入流体使其弯曲，达到弯曲牵开人体管腔的目的。
  20. 如权利要求19所述的弯曲囊导管牵开方法，其特征在于将定位球囊充入流体之后，还包括一个利用吸负压的空腔抽流体的步骤，然后再撑开牵拉囊，达到弯曲管腔的目的。
  21. 一种弯曲囊导管牵开方法，用于食管牵开，其特征在于包括以下步骤：将囊导管从口腔或鼻腔插入食道，当末端定位球囊进入食道第二狭窄和第三狭窄之间时，撑开末端定位球囊，并继续推送至第三狭窄上面；撑开上端定位球囊，使其卡在第二狭窄下面；然后通过导管和手柄上的标记，确定弯曲的方向与心脏的相对位置，撑开中间的牵拉囊，使其弯曲，带动食道弯曲。
  22. 如权利要求21所述的弯曲囊导管牵开方法，其特征在于在使用过程中当需要移动牵拉囊的位置时，通过旋转手柄带动导管和囊旋转，带动牵拉囊旋转，从而在新的方向上牵开食管使其远离需要避开的组织或位置。
  23. 如权利要求21所述的弯曲囊导管牵开方法，其特征在于当囊用于食管牵拉时，囊位于食管的第二狭窄和第三狭窄之间，充气后的定位球囊的直径大于狭窄处食管直径。
  24. 如权利要求21所述的弯曲囊导管牵开方法，其特征在于使用时先将定位球囊充气，再利用吸负压的空腔抽气，最后撑开牵拉囊，达到弯曲食管的目的。
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