WO2015078114A1 - 一种分级扩张的经皮气管切开器 - Google Patents

一种分级扩张的经皮气管切开器 Download PDF

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Publication number
WO2015078114A1
WO2015078114A1 PCT/CN2014/072715 CN2014072715W WO2015078114A1 WO 2015078114 A1 WO2015078114 A1 WO 2015078114A1 CN 2014072715 W CN2014072715 W CN 2014072715W WO 2015078114 A1 WO2015078114 A1 WO 2015078114A1
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Prior art keywords
expansion
puncture needle
tube
inner core
stage
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PCT/CN2014/072715
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English (en)
French (fr)
Inventor
冯清亮
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冯清亮
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Publication of WO2015078114A1 publication Critical patent/WO2015078114A1/zh

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Classifications

    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • A61M16/0472—Devices for performing a tracheostomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/04—Tracheal tubes
    • A61M16/0465—Tracheostomy tubes; Devices for performing a tracheostomy; Accessories therefor, e.g. masks, filters
    • 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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies

Definitions

  • the present invention relates to the field of medical device technology, and in particular to a graded expanded percutaneous tracheostomy device. Background technique
  • tracheotomy The purpose of tracheotomy is to (1) relieve the obstruction of lower respiratory secretions caused by various causes. (2) Relieve laryngeal obstruction caused by various causes and improve breathing. (3) All kinds of causes cause respiratory weakness or respiratory arrest, and artificial mechanical breathing is required. In some head and neck surgeries, tracheotomy is required because the oral cannula affects the surgical procedure. Clinically, tracheotomy often requires emergency treatment. Patients who require tracheotomy or endotracheal intubation are not treated in time, directly leading to death. There are two kinds of tracheotomy: direct surgical incision and percutaneous tracheotomy. Various reports at home and abroad have the advantages of minimally invasive percutaneous tracheotomy, small complications, simple operation, etc. Currently, a variety of percutaneous tracheotomy techniques are available. It has been widely used in clinical practice.
  • This type of dilator has many advantages over the original dilator, including: A more flexible hydrophilic material is applied to the surface of the single-step dilator, and a single-step expansion can be performed. 1. 2 Gr iggas percutaneous expansion tracheotomy
  • Gr iggs described a percutaneous tracheal expansion technique with dilatation forceps expansion.
  • Gr iggs percutaneous dilatation tracheotomy using a modified Howard Kel ly bending forceps, after the guide wire is passed through the small hole at the top of the bending pliers by Howard Kel ly, the expansion pliers advances until they enter the trachea, both hands will The expansion forceps are opened and closed for expansion, in a single step or two steps, first to expand the soft tissue, then to expand the trachea, or two steps to complete.
  • Fantoni described a translaryngeal tracheotomy. This is a new percutaneous tracheotomy technique in which the tracheotomy catheter is pulled out of the trachea into the trachea and retrogradely dilated and placed into the tracheotomy catheter. Because of its outward stoma, the tracheal ring is easy to separate, resulting in less trauma and fewer complications, solving many of the problems that affect traditional tracheotomy and other percutaneous tracheostomy procedures.
  • the Ma l l inckrodt TLT kit and the hard shield bronchoscope guide are currently used.
  • the modified Fantoni technique was to change the rigid bronchoscope to a fiber-optic bronchoscope, insert a J-shaped guide wire, place the small airway tube in the original airway, and ventilate the patient during insertion of the tracheotomy catheter. This technique is beneficial for patients with severe hypoxemia and for patients who are prone to difficult intubation or have neck thrust injuries.
  • a new improved PercuTwi ts percutaneous tracheotomy device was designed by ⁇ ⁇ sch.
  • the designed percutaneous rotary dilator similar to an automatic puncture screw, has a hydrophilic coating on the dilator puncture line, which does not require the use of a tracheal wall expansion device to enter the trachea, allowing for a good expansion of the trachea.
  • the PercuTwi s t® dilator extends along the incision at any time while the endoscope is under direct vision and simultaneously expands the tracheal tube.
  • the Rusch PercuTwi s t® kit is currently used on the market. At present, this technology has been introduced into China and used as a safe, effective, simple and rapid tracheotomy technique for minimally invasive tracheotomy of critically ill patients.
  • the above percutaneous tracheotomy methods and materials are all foreign patents, each of which has its advantages, and is suitable for patients who have undergone tracheal intubation, and has the advantages of minimally invasive and less complications compared with conventional tracheotomy.
  • the shortcomings are as follows: (1) The operation is relatively complicated, the patient is not operated with tracheotomy, and the tracheal intubation is unsuccessful. It may cause suffocation, and it is not suitable for patients who have not undergone tracheal intubation and need emergency tracheotomy. . (2) It is not possible to cut the trachea quickly. (3) The above-described percutaneous incision method is performed with the aid of an air mirror. (4) When the tracheal tube is inserted, there is no protective effect of the catheter sheath, which may cause damage to the trachea, resulting in aspiration.
  • Ciproliferative tracheostomy devices after years of clinical research.
  • Chinese patent document CN101953701B discloses a percutaneous tracheotomy comprising: a tearable catheter sheath, a puncture needle and a tracheal tube; the puncture needle pierces the trachea and guides the tearable catheter sheath into the trachea, Pulling the puncture needle from the tearable catheter sheath; inserting the endotracheal tube into the tearable catheter sheath and guiding it into the trachea, and then tearing the tearable catheter sheath, The tracheal tube is left in the trachea.
  • the needle head is thickened from front to back to facilitate expansion of the opening in the tracheal wall.
  • the applicant has found that after the puncture needle cuts the tracheal wall, it is necessary to use a puncture needle to expand the opening on the trachea to an appropriate size, which is advantageous for placing the tracheal tube. For this reason, it is necessary that a relatively long portion of the needle head enters the trachea, thereby causing damage to the tracheal wall or the broncho bifurcation.
  • the present invention provides a graded expanded percutaneous tracheostomy device that solves the technical problem that the dilatation portion of the tracheal dilator is too long to damage the bronchial bifurcation or tracheal wall during the puncture.
  • the present invention also provides a ventilator interface on the tracheostomy device, thereby avoiding the technical problem of being unable to ventilate into the trachea during the puncture.
  • a graded expanded percutaneous tracheostomy device comprising a tearable catheter sheath, a tracheal tube, a puncture needle, a guide wire and a dilator;
  • the dilator is composed of a plurality of socketed expansion tubes; each of the dilation tubes has a cylindrical body portion, and the front end of the body portion is tapered to form a truncated cone-shaped expansion portion, and the rear end of the body portion is fixed a cylindrical sleeve portion, the outer wall of the front end of the socket portion is provided with an internal thread, and the rear end wall is provided with an external thread; among the two adjacent stages of the expansion tube, the sleeve portion of the rear stage expansion tube and the previous stage
  • the sockets of the dilation tube are connected by internal and external threads to form a body of the dilator; the body of the posterior dilation tube passes through the socket and body of the dilator of the previous stage And the flared portion of the expanded tube of the first stage extends at least partially beyond the expanded portion of the expander of the previous stage to form an expanded portion of the expander.
  • the tearable catheter sheath is sleeved on the outer wall of the socket of the first stage of the expansion tube.
  • the inner cavity of the puncture needle is hollow, and after the puncture needle pierces the airway wall, the guide wire is guided into the trachea through the inner cavity of the puncture needle; the puncture needle is pulled out, and then the guide wire guides the dilator to the trachea
  • the wall is expanded step by step; the tracheal wall is expanded to a predetermined size port, the dilator is pulled out, and the tearable catheter sheath portion is left in the trachea; the tracheal tube is guided through the tearable sheath to the trachea, and the tear can be torn. Split the sheath and complete the puncture.
  • the puncture needle is provided with a puncture protector, and the puncture protector comprises:
  • the inner core has an inner core head and an inner core tail portion, and the inner core tail portion is provided with a card point, and the inner core inner cavity is hollow and matched with the outer diameter of the guide wire;
  • a fixing ring the fixing ring is fixed to the middle cavity of the puncture needle;
  • a spring the spring surrounds the inner core, and one end thereof is connected to the fixing ring!, and the other end abuts the pin point of the inner core tail portion;
  • the inner core tail passes through the fixing ring and is received in the inner cavity of the puncture needle; the outer diameter of the inner core head matches the inner diameter of the puncture needle head, and the inner core head passes through the inner core head Puncture the needle cavity and exposing it to the outside of the puncture needle head; the inner core head is compressed by the external resistance to retract the inner cavity of the puncture needle, and the resistance disappears and then protrudes outside the puncture needle head ;
  • the puncture needle is provided with a transparent window at the tail of the inner core.
  • the dilation tube is of the order of 2-7.
  • At least a portion of the outer wall of the expanded portion of the posterior expansion tube conforms to the opening of the flare of the dilator of the previous stage.
  • the rear end periphery of the body of the expansion tube is outwardly expanded to form a sheet connecting the socket.
  • the tearable catheter sheath has a sheath tube, one end of the sheath tube is fixed to the sheath tube joint, and the tube wall at the end of the sheath tube is also fixed to the joint portion extending along the tube wall of the sheath tube and the plate extending outward from the joint portion a moving portion, wherein the joint portion is fused on the tube wall, the sheath tube inner cavity is hollow and communicates with the sheath tube inner cavity; the socket portion.
  • the puncture needle, the tearable sheath tube, the dilation tube is curved in an equal arc, and the bending melon is close to a physiological curvature of 15 degrees.
  • the expansion tube is named as a first-stage expansion tube in the order of the socket, and a second-stage expansion tube in the second-stage expansion tube, wherein the first-stage expansion tube is the last-stage expansion tube, the N-th stage The expansion tube is the first stage expansion tube.
  • the use procedure of the dilator is as follows: 1) After the puncture needle is pulled out from the trachea, the dilatation portion of the first-stage dilation tube is expanded by the guide wire to expand the tracheal wall and enter the trachea; 2) when the dilation tube of the second stage is expanded After entering the trachea, the first stage expansion tube is rotated, the socket of the first stage expansion tube is separated from the socket of the second stage expansion tube, and the first stage expansion tube is pulled out; 3) the second stage is reused The expansion of the dilation tube continues to expand the tracheal wall and enter the trachea; 4) After the expansion of the third expansion tube enters the trachea, rotate the second expansion tube to make the socket of the first expansion tube and the third stage The socket of the dilation tube is separated, and the first-stage dilation tube is pulled out; 5) the expansion of the tracheal wall and the extraction process of the dilation tube are repeated until the first-stage expansion tube, that is, the N-th dilation tube is
  • the beneficial effects of the present invention are as follows:
  • the graded and expanded percutaneous tracheotomy device of the present invention solves the technical problem that the tracheotomy expander is too long and damages the bronchial bifurcation or the tracheal wall during the puncture, and can be quickly
  • the trachea is cut open and expanded to an appropriate size for tube placement.
  • Figure la is a schematic view showing the structure of a puncture needle of a graded expanded percutaneous tracheostomy device according to the present invention.
  • Figure 1b is a schematic view showing the structure of another embodiment of the puncture needle of the graded expanded percutaneous tracheotomy device of the present invention.
  • Figure lc is a schematic structural view of still another embodiment of the puncture needle of the graded expanded percutaneous tracheotomy according to the present invention.
  • FIG. 2 is a schematic view showing the structure of a guide wire of a graded expanded percutaneous tracheotomy device according to the present invention.
  • Figure 3a is a schematic view showing the structure of a tearable sheath of a graded expanded percutaneous tracheotomy according to the present invention.
  • Figure 3b is a schematic view showing the structure of another embodiment of the rupturable sheath of the graded expanded percutaneous tracheostomy device of the present invention.
  • 4 is a schematic view showing the structure of an endotracheal tube of a graded expanded percutaneous tracheostomy device according to the present invention.
  • Fig. 5a is a schematic view showing the overall structure of a dilator of a graded expanded percutaneous tracheostomy device according to the present invention.
  • Figure 5b is a schematic cross-sectional view of the graded expanded percutaneous tracheostomy dilator shown in Figure 5a.
  • Figure 5c is a schematic exploded view of the graded expanded percutaneous tracheostomy dilator shown in Figure 5a.
  • Fig. 5d is a schematic view showing the entire structure of another embodiment of the expander of the graded expanded percutaneous tracheostomy device of the present invention.
  • Figure 6a is a schematic view showing the structure of the tearable sheath tube in cooperation with the dilator.
  • Figure 6b is another schematic view of the tearable sheath of the present invention mated with the dilator.
  • Fig. 7a is a state diagram when the puncture needle 300 is used to puncture the outer wall of the trachea.
  • Fig. 7b is a view showing a state in which the puncture needle 300 enters the trachea.
  • Figure 7c is a view of the position of the puncture needle 300 within the trachea using a syringe.
  • Figure 7d shows the guidewire 500 being guided through the puncture needle 300 into the trachea.
  • Figure 7 e is the removal of the puncture needle 300, leaving the guide wire 500 in the trachea.
  • Figure 7f shows the dilator 100 guiding the expanded tracheal wall through the guidewire 500.
  • Fig. 7g shows a state in which the first stage expansion tube 10 of the dilator 100 expands the tracheal wall to a predetermined size.
  • Fig. 7h is a state in which the first stage expansion tube 10 of the dilator 100 is withdrawn.
  • Fig. 7i shows a state in which the air tube wall is expanded by the second stage expansion tube 10 to a predetermined size.
  • Fig. 7j shows the state of the dilator 100 after the second stage expansion tube 10 is removed.
  • Fig. 7k shows a state in which the tracheal wall is expanded by the third-stage dilation tube 10 and enters the trachea.
  • Figure 71 shows the removal of the third stage dilator tube 10, which is partially retained in the trachea and partially exposed outside the trachea.
  • Figure 7m shows the state in which the tracheal tube is guided through the rupturable sheath into the trachea.
  • Figure 7n shows the state of tearing through the rupturable sheath and retaining the endotracheal tube into the trachea.
  • Figure 7o shows the state in which the tracheal plug is withdrawn from the endotracheal tube.
  • the graded expanded tracheostomy device of the present invention includes a dilator 100, a tearable catheter sheath 200, a puncture needle 300, an endotracheal tube 400, and a guidewire 500.
  • the puncture needle 300 has a lumen hollow 310 and a tapered puncture needle head 320.
  • a structural view of another puncture needle 300 according to the present invention has a puncture protector 600 in the inner cavity of the puncture needle 300.
  • the puncture protector 600 includes an inner core 610, a retaining ring 620, and a spring 630.
  • the inner core has an inner core head 611 and an inner core tail portion 612.
  • the inner core is provided with a snap point 613, and the inner core inner cavity 614 is hollow and matched with the outer diameter of the guide wire 500.
  • the retaining ring 620 is secured to the lumen 310 in the middle of the puncture needle 300.
  • the spring 630 surrounds the inner core 610, and one end thereof is connected to the fixing ring 62 (H is connected, and the other end is connected to the card point 613 4 of the inner core 612. When the spring 630 is compressed or restored The inner core 610 is displaced.
  • the inner core tail 612 passes through the fixing ring 620 and is received in the inner cavity 310 of the puncture needle 300; the outer diameter of the inner core head 611 and the puncture
  • the inner diameter of the head 320 of the needle 300 is matched, the inner core head 611 passes through the inner cavity 310 of the puncture needle 300 and is exposed outside the puncture needle head 320; the inner core head 320 is displaced by external resistance Thereby, the spring 600 is compressed, and the puncture needle lumen 310 is retracted, and the resistance disappears and then protrudes out of the puncture needle head 320.
  • the puncture needle 300 is directly opposite.
  • a transparent window 330 is disposed at the inner core tail portion 612.
  • both the puncture needle 300 and the protector 600 are bent at an angle close to the physiological curvature of the human trachea, which is 15 degrees.
  • the guide wire 500 is a J-shaped soft guide wire whose outer diameter matches the inner cavity of the puncture needle.
  • the puncture needle 300 pierces the airway wall, and the guide wire 500 enters the inner cavity of the puncture needle 300, and is guided through the lumen into the tracheal lumen, and the puncture needle is pulled out from the rear end of the guide wire 500.
  • the rupturable sheath 200 has a sheath 202 that is hollow within the lumen 201. Further having a sheath joint 203 fixed to one end of the sheath tube, the tube wall of the end of the sheath tube is further fixed to a joint portion 204 extending along the tube wall thereof and a pulling portion 205 extending outward from the joint portion, wherein The portion 204 is fused to the wall of the tube, and the inner lumen 206 of the sheath joint 203 is hollow and in communication with the sheath lumen 201.
  • the tearable sheath 200 is bent at an angle close to the physiological curvature of the human trachea.
  • the endotracheal tube 400 includes an endotracheal tube 401, an air bag 402 attached to an outer wall of the tracheal cannula 401, and an inner plug 403 extending through the inner cavity of the endotracheal tube 401.
  • the endotracheal tube 400 has two pairs of air pockets 402 attached to both ends of the outer wall of the endotracheal tube 401.
  • the dilator 100 is comprised of a plurality of phase-expanded dilation tubes 10, which in turn are designated as a first-stage dilation tube in accordance with the order of the posterior and forward-phase phases. , the second stage expansion tube, the third stage expansion tube... the Nth stage expansion tube, wherein N is greater than or equal to 3.
  • the rupturable sheath 200 is sleeved on the outside of the Nth and expansion tubes.
  • the dilator 100 can also be composed of only two stages of dilation tubes 10.
  • the number of the expansion tubes 10 can be flexibly set as needed, and is preferably 2-7. However, for ease of description, the present invention is described with the use of a dilator 100 having a 3'
  • the expansion tube 10 has a fixed sleeve portion 11 and a cylindrical body portion 12.
  • the outer diameter of the body portion 12 is less than or equal to the socket portion 11, and the diameter of the front end portion of the body portion 12 is tapered to form a circle.
  • the table-shaped expansion portion 13 is.
  • the outer wall of the front end of the first stage expansion tube 10-1 is provided with an external thread 101.
  • the inner wall of the rear end of the socket of the first stage expansion tube 10-1 1 is provided with an inner thread 102, and the outer wall of the front end is provided with an external thread 103.
  • the third stage expansion tube 10- ⁇ ⁇ socket portion 11-111 has an inner thread 104 on the inner wall of the rear end.
  • the front end external thread 101 of the first stage expansion cooperates with the internal thread 102 of the second stage expansion tube 10.
  • the front end external thread 103 of the second stage expansion tube 10-turn cooperates with the internal thread 104 of the third stage expansion tube 10- ⁇ .
  • the socket portion 11 of each stage of the expansion tube 10 is detachably coupled to the body of the dilator 100 by means of internal and external threaded engagement. It will be apparent that the outer diameter of the socket portion 11 of each stage of the expansion tube is the same.
  • the cylindrical body 12-1 of the first stage expansion tube passes through the socket portion 11- ⁇ and the body portion 12-11 of the second-stage expansion tube 10', and the first stage is expanded.
  • the expanded portion 13-1 of the tube extends beyond the expanded portion 13-11 of the second-stage expanded tube 10'.
  • the cylindrical body 12-11 of the second-stage dilation tube passes through the socket portion 11-III and the body portion 12- ⁇ of the third-stage expansion tube 10", and the expansion portion 13-11 of the second-stage expansion tube
  • the expansion portion 13-111 of the second-stage expansion tube 10' is extended.
  • the gap between the adjacent expansion portions 13 affects the expansion of the air tube wall, and the outer wall of the rear-stage expansion portion 13 is attached before The opening 14 of the flared portion 13 of the first stage of the dilator.
  • the dilation tube 10 of the stent 100 is bent at an angle close to the physiological level of the human trachea.
  • the tearable sheath 200 is sleeved outside the sleeve portion 11 of the Nth grade dilator tube 10.
  • the socket portion 11 of the Nth stage expansion tube 10 passes through the sheath tube.
  • the present invention takes the puncture needle 300 having the protector 600 shown in FIG. 1c as an example, and shows the use process of the graded expanded tracheotomy device as follows: Referring to FIG. 1c, the inner core head portion 611 of the puncture protector 600 of the puncture needle 300 is exposed outside the head portion 320 of the puncture needle 300 when not in use. Referring to FIG.
  • the inner core head 611 when the puncture needle 300 pierces the outer wall of the trachea, the inner core head 611 is subjected to a resistance opposite to the advancing direction, and a displacement opposite to the advancing direction occurs in the inner cavity 320 of the puncture needle 300.
  • the spring 630 is compressed to control the distance over which the inner core 610 is displaced. At this time, the operator can observe the displacement of the puncture needle tail 612 through the transparent window.
  • FIG. 7b after the puncture needle 300 enters the air pipe, the resistance received by the inner core head 611 disappears, and the spring 62 returns to the original length. At this time, the inner core head 611 extends again.
  • the syringe interface 340 of the puncture needle 300 is connected to the syringe 700 to detect whether the liquid in the syringe can enter the trachea without pressure. If not, adjust the position of the puncture needle 300, if it can enter, The position of the puncture needle 300 within the trachea is correct.
  • the guidewire 500 is passed through the inner core tail portion 612 of the puncture needle 300 into the inner core lumen and then advanced into the trachea. Referring to Fig.
  • the puncture needle 300 is pulled out along the tail of the guide wire 500, and the guide wire 500-end is placed in the trachea, and one end is extended outside the trachea; referring to Fig. 7f, the dilator is guided through the guide wire 500 into the trachea.
  • the tracheal wall is expanded by the first-stage dilation tube 10-1 and enters the trachea; referring to Fig.
  • the first-stage dilating tube 10-11 is rotated, so that The socket portion 12-1 of the first-stage expansion tube is separated from the socket portion 12-11 of the first-stage expansion tube 10- ⁇ , and the first-stage expansion tube is pulled out; referring to FIG. 7 i, the second-stage expansion is performed.
  • the dilating portion of the tube 10-11 continues to expand the tracheal wall and enter the trachea; referring to Fig.
  • the second-stage dilating tube 10-111 after the dilating portion of the third-stage dilating tube 10-111 enters the trachea, the second-stage dilating tube is rotated to make the second-stage dilating tube
  • the socket portion is separated from the socket portion of the third-stage expansion tube, and the second-stage expansion tube is pulled out; referring to FIG. 7k, the expansion portion of the third-stage expansion tube 10- ⁇ is used to continue to expand the air tube wall to the predetermined size.
  • the tearable sheath tube and the third-stage expansion tube 10-111 together enter the trachea; referring to Figure 71, pull out the third level expansion
  • the tube 10-11 1 the tearable catheter sheath 200 - partially retained in the trachea, a portion exposed outside the trachea; with reference to Figure 7m, the tracheal tube 400 is inserted into the tearable sheath 200; with reference to Figure 7n, the tear can be torn
  • the sheath tube 200 is split, and the tracheal tube 400 is partially placed in the trachea, and a part is outside the trachea, and the puncture tube is completed. Referring to FIG. 7o, the trachea plug in the tracheal tube 400 is pulled out to complete the tube.

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Abstract

一种分级扩张的经皮气管切开器，包括可撕裂导管鞘（200）、气管导管（400）、穿刺针（300）、导丝（500）和扩张器（100）；所述扩张器（100）由数级套接的扩张管（10）组成；相邻的两级所述扩张管（10）中，后一级扩张管的套接部（11）与前一级的扩张管的套接部之间通过内、外螺纹连接，从而形成所述扩张器的体部（12）；后一级扩张管的体部穿过前一级的所述扩张管的套接部和体部，且后一级扩张管的扩张部至少部分伸出前一级的所述扩张管（10）的扩张部外，从而形成所述扩张管（10）的扩张部。该分级扩张的经皮气管切开器，解决了气管扩张器扩张部分太长，在穿刺过程中损伤支气管分叉部或气管壁的技术问题。

Description

一种分级扩张的经皮气管切开器 技术领域
本发明涉及医疗器械技术领域， 具体地， 涉及一种分级扩张的经皮气管切开器。 背景技术
气管切开目的是（ 1 )解除各种原因引起的下呼吸道分泌物阻塞。 （ 2 )解除各种原因引起 的喉梗阻， 改善呼吸。 （ 3 )各种原因引起呼吸衰弱或呼吸停止， 需行人工机械呼吸。 某些头 颈部手术， 因口腔插管影响手术操作， 需行气管切开。 临床上气管切开常常需急诊处理， 需 行气管切开或气管插管患者而未及时处理， 直接导致患者死亡。 气管切开有直接手术切开和 经皮气管切开两种， 国内外各种报道经皮气管切开具有微创、 并发症小、 操作简单等优点， 目前， 多种经皮气管切开技术在临床得到了广泛应用。
目前临床应用的几种主要经皮气管切开技术比较
从 1985年开始，有诸多研究报告公开讨论了有关经皮气管切开的方法， 由于在文献中这 些技术均具有共同的特征， 即都使用了进入气管内的穿刺针和导引管， 所有气管切开技术都 被冠于 "经皮" 气管切开术。 经皮气管切开技术最常使用的是 Gr iggs GWDF和 Ciag l ia PDT 技术， 以及新近推出的经喉气管切开术和螺旋扩张器扩张技术。 它们在器械设计思路， 技术 创新和思维模式等方面存在着不同的差异。
1. 1 Ciag l ia经皮扩张气管切开技术
1985年， 美国纽约伊丽莎白医院的一位胸外科医生 Pasqua le C iag l ia , 受 Brant igan和 Grow进行环甲膜切开技术以及经皮肾穿刺术器械的启示，研制了 7个多级扩张器，应用 Cook 公司提供的成套器械，在 26例病人成功实施了 Ciagl ia经皮扩张气管切开术。 1999年 C iag l ia 对他的原创序列扩张器械又作了进一步的改进， 使它变为单步 Blue Rhino扩张器械， 扩张器 被改成像蓝色犀牛角一样的一个弯曲呈锥形亲水的扩张器。 这种扩张器较原来的扩张器有诸 多优点， 包括： 在单步扩张器表面涂有更具弹性的亲水性的材料， 可以实施单步扩张等。 1. 2 Gr iggas经皮扩张气管切开技术
1990年， Gr iggs描述了一种扩张钳扩张的经皮气管扩张技术。 Gr iggs经皮扩张气管切 开术， 使用一把改良的 Howard Kel ly弯钳， 导丝经由 Howard Kel ly扩张弯钳顶端的小孔穿 过后， 扩张钳向前推进， 直到进入气管内， 两手将扩张钳打开合上进行扩张， 分单步或两步 操作， 首先扩张软组织， 然后扩张气管， 或两步操作一次完成。
1. 3 Fantoni经喉气管切开技术
1997年， Fantoni描述了经喉气管切开术。 这是一种新的经皮气管切开技术， 气管切开 导管是由气管内向气管外牵出， 并进行倒退扩张和置入气管切开导管。 由于其外向造口， 气 管环易于分离， 所以创伤更小， 并发症更少， 解决了影响传统气管切开技术和其它经皮气管 切开术使用过程中的许多问题。目前使用的是 Ma l l inckrodt TLT成套工具和硬盾气管镜导引。 改良 Fantoni技术， 是将硬质气管镜改为应用纤维气管镜， 插入 J形导丝， 使用小号气管导 管置于原气道， 在插入气管切开导管期间予病人通气。 该技术对严重低氧血症病人及预见难 插管困难或有颈推损伤的病人是有益的。
1. 4 单步旋转扩张气管切开技术
2002年， 由 Ι ϋ sch公司设计了一种 PercuTwi s t最新改进的经皮气管切开扩张器械。 设 计的经皮旋转扩张器， 类似于一个自动穿刺螺钉， 在扩张器穿刺线上有一亲水性包被， 不需 借助气管壁扩张装置进入气管， 能够好的对气管进行扩张。 与扩张钳扩张气管不同， PercuTwi s t®扩张器沿切口， 可在任何时候在内窥镜直视下， 同时对上抬的气管进行扩张。 目前市场上常用的是 Rusch PercuTwi s t®成套工具。 目前， 此技术已引进我国， 并把它作为 一种安全、 有效、 简单和快速的气管切开技术， 用于危重病人的微创气管切开术。
1. 5球囊式经皮扩张气管切开术 2003年， Zgoda和 Berger >¾告了一种新的经皮扩张气管切开术： 球嚢式经皮扩张气管 切开术。 并相继进行了动物实验和临床验证； 2007年通过了 FDA认证， 由 Cook (Cook Inc. , Bloomington, IN, USA)公司推出了商品用 Ciagl ia Blue Do lphin球嚢式经皮扩张气管切开 器械包（包括一个头部带有球囊的导管插管和扩张器装置， Cook充盈装置、 导丝、 导入针、 TFE 鞘套管针、 针插、 14Fr.扩张器）。 设计了一种可用于扩张的球囊， 实施单步式扩张。 扩 张时必须使用压力表监测充盈压力。
以上经皮气管切开方法及材料均为国外专利， 各有其优点， 适用于已行气管插管患者， 相对传统气管切开术而言， 具有微创、 并发症少的优点。 其不足之处有： （1 )操作相对复杂， 在未行气管切开， 且气管插管不成功患者操作， 有造成窒息可能， 不宜用于未行气管插管而 需行紧急气管切开患者。 （2 ) 不能做到快速切开气管。 （3 )上述有的经皮切开方法需气气镜 辅助下进行。 （4 )在插入气管导管时， 因没有导管鞘的保护作用， 有导致气管破损可能， 从 而造成误吸。
为此， 本申请人经过多年临床研究， 开发了多种经皮气管切开器。 如中国专利文献 CN101953701B公开了一种经皮气管切开器， 包括： 可撕裂导管鞘， 穿刺针和气管导管； 所述 穿刺针刺破气管并引导所述可撕裂导管鞘进入气管后，从所述可撕裂导管鞘拔出所述穿刺针； 将所述气管导管插入所述可撕裂导管鞘内， 并经其引导进入气管， 而后， 撕裂所述可撕裂导 管鞘， 将气管导管留置于气管中。 该穿刺针头部从前到后由细变粗以利于对气管壁上的开口 进行扩张。
然而， 本申请人在临床应用中发现， 穿刺针切开气管壁后， 需要用穿刺针将气管上的开 口扩张至适当大小， 才有利于放置气管导管。 为此， 就需要穿刺针头部相当长的一部分都进 入气管， 由此， 会造成损伤气管壁或支气管分叉部。
因此， 亟待开发新的经皮气管切开器， 其适用于各类需行气管切患者， 具有快速、微创、 安全、 成功率高、 操作筒单、 并发症少的优点， 价格便宜， 适用于各级医院。 发明内容
为了克服现有技术的不足， 本发明提供了一种分级扩张的经皮气管切开器， 解决了气管 扩张器扩张部分太长， 在穿刺过程中损伤支气管分叉部或气管壁的技术问题。 同时本发明也 在气管切开器上设置了呼吸机接口， 从而也避免了穿刺过程中， 不能向气管中通气的技术问 题。
本发明的技术方案如下： 一种分级扩张的经皮气管切开器， 包括可撕裂导管鞘、 气管导 管、 穿刺针、 导丝和扩张器；
所述扩张器由数级套接的扩张管组成； 每一级所述扩张管具有圆柱形的体部， 该体部的 前端渐缩形成圓台形的扩张部， 该体部的后端固接一圆柱形的套接部， 套接部前端外壁设有 内螺紋， 后端壁设有外螺纹； 相邻的两级所述扩张管中， 后一级扩张管的套接部与前一级的 扩张管的套接部之间通过内、 外螺纹连接， 从而形成所述扩张器的体部； 后一级扩张管的体 部穿过前一级的所述扩张器的套接部和体部， 且后一级扩张管的扩张部至少部分伸出前一级 的所述扩张器的扩张部外， 从而形成所述扩张器的扩张部。
所述可撕裂导管鞘套接于最前一级所述扩张管的套接部的外壁上。
所述穿刺针内腔中空， 所述穿刺针刺破气管壁后， 所述导丝经所述穿刺针内腔引导进入 气管； 拔出穿刺针， 而后所述导丝引导所述扩张器对气管壁进行逐级扩张； 气管壁扩张至预 定大小口， 拔出扩张器， 将可撕裂导管鞘部分留置在气管中； 将气管导管经可撕裂鞘管引导 部分至于气管中， 撕裂可撕裂鞘管， 完成穿刺。
较佳地， 所述穿刺针内设有穿刺保护器， 所述穿刺保护器包括：
内芯， 所述内芯具有内芯头部和内芯尾部， 内芯尾部上设有卡点， 内芯内腔中空并与所 述导丝外径相匹配；
固定环， 所述固定环固接于所述穿刺针中部内腔； 弹簧， 所述弹簧环绕所述内芯， 且其一端与所述固定环!氐接， 另一端与所述内芯尾部的 卡点抵接；
所述内芯尾部穿过所述固定环并容置于所述穿刺针内腔； 所述内芯头部外径与所述穿刺 针头部内径相匹配， 所述内芯头部穿过所述穿刺针内腔并棵露于所述穿刺针头部外； 所述内 芯头部受外界阻力压缩所述弹簧， 缩回所述穿刺针内腔， 阻力消失后又伸出所述穿刺针头部 外；
所述穿刺针正对所述内芯尾部处设有透明窗。
较佳地， 所述扩张管为 2-7级。
后一级扩张管的扩张部的外壁至少有一部分贴合前一级的所述扩张器的扩 部的开口。 所述扩张管的体部的后端周边向外扩张形成连接所述套接部的薄片。
所述可撕裂导管鞘具有鞘管， 鞘管一端固接鞘管接头， 鞘管该端的管壁上还固接沿着鞘 管的管壁延伸的结合部以及从结合部向外延伸的扳动部， 其中， 结合部熔结在管壁上， 所述 鞘管接头内腔中空并与所述鞘管内腔连通； 所述套接部。
较佳地， 所述穿刺针， 所述可撕裂鞘管， 所述扩张管以相等的弧度弯曲， 弯曲瓜度接近 生理弧度 15度。
为了便于描述,将所述扩张管按套接的顺序依次命名为第 1级扩张管，第 2级扩张管 第 N级扩张管， 其中第 1级扩张管为最后一级扩张管， 第 N级扩张管为最前一级扩张管。 所 述扩张器的使用过程如下： 1 )穿刺针从气管拔出后， 经导丝引导用第 1级扩张管的扩张部扩 张气管壁并进入气管内； 2 ) 当第 2级扩张管的扩张部进入气管后， 旋转第 1级扩张管， 使第 1级扩张管的套接部与第 2级扩张管的套接部分离， 并拔出第 1级扩张管； 3 )再用第 2级扩 张管的扩张部继续扩张气管壁并进入气管内； 4 ) 当第 3级扩张管的扩 部进入气管后， 旋转 第 2级扩张管， 使第 1级扩张管的套接部与第 3级扩张管的套接部分离， 拔出第 1级扩张管； 5 )重复气管壁的扩张和扩张管的拔出过程， 至到剩下最前一级扩张管， 即第 N级扩张管； 6 ) 用第 N级扩张管的扩张部继续扩张气管壁至开口到预定大小； 7 )拔出第 N级扩张管， 可撕裂 导管鞘一部分留置在气管中，一部分露出在气管外； 8 )将气管导管插入可撕裂鞘管中， 撕裂 可撕裂鞘管， 使气管导管一部分留置在气管中， 一部分在气管外， 完成穿刺置管。
本发明的有益效果为： 本发明所述分级扩张的经皮气管切开器， 解决了气管切开器扩张 部分过长， 在穿刺过程中损伤支气管分叉部或气管壁的技术问题， 能够快速将气管切开并扩 张至适当大小， 利于置管。 附图说明：
图 la、 为本发明所述分级扩张的经皮气管切开器的穿刺针的结构示意图。
图 lb、 为本发明所述分级扩张的经皮气管切开器的穿刺针的另一实施例的结构示意图。
图 lc、 为本发明所述分级扩张的经皮气管切开器的穿刺针的再一实施例的结构示意图。
图 2、 为本发明所述分级扩张的经皮气管切开器的导丝的结构示意图。
图 3a、 为本发明所述分级扩张的经皮气管切开器的可撕裂鞘管的结构示意图。
图 3b、 为本发明所述分级扩张的经皮气管切开器的可撕裂鞘管的另一实施例的结构示意图。 图 4、 为本发明所述分级扩张的经皮气管切开器的气管导管的结构示意图。
图 5a、 为本发明所述分级扩张的经皮气管切开器的扩张器的整体结构示意图。
图 5b、 为图 5a所示分级扩张的经皮气管切开器扩张器的剖面结构示意图。
图 5c、 为图 5a所示分级扩张的经皮气管切开器扩张器的分解结构示意图。
图 5d、 为本发明所述分级扩张的经皮气管切开器的扩张器的另一实施例的整体结构示意图。 图 6a为本发明所述可撕裂鞘管与所述扩张器配合的结构示意图。
图 6b为本发明所述可撕裂鞘管与所述扩张器配合的另一结构示意图。
图 7a 为用所述穿刺针 300刺破气管外壁时状态图。
图 7b 为所述穿刺针 300进入气管后的状态图。 图 7c 为用注射器检测穿刺针 300在气管内的位置。
图 7 d为导丝 500经穿刺针 300引导进入气管。
图 7 e为拔出穿刺针 300, 将导丝 500留置于气管中。
图 7f 为所述扩张器 100经过导丝 500引导扩张气管壁。
图 7g为所述扩张器 100第 1级扩张管 10扩展气管壁至预定大小后的状态。
图 7h为拔出所述扩张器 100第 1级扩张管 10的状态。
图 7 i为用第 2级扩张管 10扩张气管壁至预定大小的状态。
图 7j为所述扩张器 100除掉第 2级扩张管 10后的状态。
图 7k为用第 3级扩张管 10扩张气管壁并进入气管后的状态。
图 71为拔出第 3级扩张管 10 , 可撕裂导管鞘 200—部分留置在气管中， 一部分露出在气管 外。
图 7m为气管导管经可撕裂鞘管引导进入气管的状态。
图 7n为撕裂经可撕裂鞘管， 保留气管导管进入气管的状态。
图 7o为从所述气管导管中拔出气管栓的状态。 具体实施方式
参照图 la-5d, 本发明所述分级扩张的气管切开器， 包括扩张器 100,可撕裂导管鞘 200、 穿刺针 300,气管导管 400、 导丝 500。
参照图 la、 图 lb和图 lc,所述穿刺针 300具有内腔中空 310和尖细的穿刺针头部 320。 参照图 lb为本发明另一穿刺针 300的结构示意图， 该穿刺针 300 内腔具有穿刺保护器 600。 该穿刺保护器 600包括： 内芯 610 , 固定环 620, 弹簧 630。 所述内芯具有内芯头部 611 和内芯尾部 612， 内芯上设有卡点 613， 内芯内腔 614中空并与所述导丝 500外径相匹配。 所 述固定环 620固接于所述穿刺针 300中部的内腔 310。 所述弹簧 630环绕所述内芯 610， 且其 一端与所述固定环 62(H氐接， 另一端与所述内芯 612的卡点 613 4氐接。 当所述弹簧 630压缩 或复原时， 带动所述内芯 610位移。 所述内芯尾部 612穿过所述固定环 620并容置于所述穿 刺针 300的内腔 310; 所述内芯头部 611的外径与所述穿刺针 300的头部 320内径相匹配， 所述内芯头部 611穿过所述穿刺针 300内腔 310并棵露于所述穿刺针头部 320外； 所述内芯 头部 320受外界阻力位移， 从而压缩所述弹簧 600， 缩回所述穿刺针内腔 310， 阻力消失后又 伸出所述穿刺针头部 320外。 为了便于观察所述内芯的位移情况， 所述穿刺针 300正对所述 内芯尾部 612处设有透明窗 330。
参照图 lc, 所述穿刺针 300和所述保护器 600均以接近人体气管生理弧度的角度弯曲， 该弯曲弧度为 15度。
参照图 2 , 所述导丝 500为 J型头软导丝， 其外径与所述穿刺针内腔相匹配。 使用时， 所述穿刺针 300刺破气管壁， 导丝 500进入所述穿刺针 300内腔， 并经其引导进入气管内腔， 从导丝 500后端拔出所述穿刺针。
参照图 3a和图 3b,所述可撕裂鞘管 200具有内腔 201 中空的鞘管 202。 还具有固接于该 鞘管一端的鞘管接头 203 , 鞘管该端的管壁上还固接沿其管壁延伸的结合部 204 以及从结合 部向外延伸的扳动部 205， 其中， 结合部 204熔结在管壁上， 所述鞘管接头 203 内腔 206 中 空并与所述鞘管内腔 201连通。
参照图 3b, 所述可撕裂鞘管 200以接近人体气管生理弧度的角度弯折。
参照图 4 , 所述气管导管 400包括气管插管 401 , 附着于所述气管插管 401外壁的气囊 402和穿设于所述气管插管 401 内腔中的内栓 403 , 该实施例中， 所述气管导管 400具有两副 气嚢 402， 分别附着于所述气管插管 401外壁的两端。
参照图 5a-5d, 所述扩张器 100由数根相套接的扩张管 10组成， 依扩张管 10依照由后向 前的相套接的顺序， 扩张管依次被命名为第 1级扩张管， 第 2级扩张管， 第 3级扩张管 ...... 第 N级扩张管， 其中 N大于等于 3。 所述可撕裂鞘管 200套接于第 N跟扩张管外侧。 显然， 所述扩张器 100也可以仅有两级扩张管 10 组成。
需要说明的是， 所述扩张管 10的个数可根据需要灵活设置， 优选为 2-7个。 然而， 为了 便于描述， 本发明选取具有 3跟扩张管 10的扩张器 100进行说明。
参照图 5a-5d， 所述扩张管 10具有固接的套接部 11和圆柱形的体部 12， 体部 12的外径 小于或等于套接部 11 , 体部 12前端直径渐缩形成圓台形扩 部 1 3。 第 1级扩张管 10-1的套 接部 11-1前端外壁设有外螺纹 101。 第 1级扩张管 10-1 1的套接部 11- II后端内壁设有内螺 纹 102 , 前端外壁设有外螺紋 103。 第 3级扩张管 10-Ι Π的套接部 11-111后端内壁设有内螺 紋 104。 其中第 1级扩张的前端外螺纹 101与第 2级扩张管 10的内螺纹 102相配合。 而第 2 级扩张管 10-Π的前端外螺紋 103与第 3级扩张管 10-Ι Π的内螺紋 104相互配合。各级扩张 管 10的套接部 11依靠内外螺纹配合可拆卸连接并形成扩张器 100的体部。 显而易见的， 各 级扩张管的套接部 11的外径相同。
在参照图 5a-5c, 第 1级扩张管的圓柱形的体部 12-1穿过第 2级扩张管 10' 的套接部 11- Π和体部 12-11, 并将第 1级扩张管的扩张部 13-1伸出第 2级扩张管 10' 的扩张部 13-11。 第 2 级扩张管的圆柱形的体部 12-11穿过第 3级扩张管 10" 的套接部 11- III和体部 12-ΠΙ, 并将第 II级扩张管的扩张部 13-11伸出第 2级扩张管 10' 的扩张部 13-111。 为了避免在扩张气管时， 相邻扩张部 13之间的缝隙家着气管壁影响扩张， 后一级扩 部 13的外壁贴合前一级的所述 扩张器的扩张部 13的开口 14。
参照图 5d,所述 张器 100的扩张管 10以接近人体气管生理 度的角度弯折。
参照图 6a和图 6b， 所述可撕裂鞘管 200套接于第 N级扩张管 10的套接部 11外侧。 第 N 级扩张管 10的套接部 11穿过所述鞘管。 为了详细阐述本发明所述分级扩张的气管切开器的使用过程，本发明以图 l c所示具有保 护器 600的穿刺针 300为例， 展示所述分级扩张的气管切开器使用过程如下： 参照图 lc， 未 使用时， 所述穿刺针 300的穿刺保护器 600的所述内芯头部 611棵露在所述穿刺针 300头部 320外。 参照图 7a,当所述穿刺针 300刺破气管外壁时， 所述内芯头部 611受到与前进方向相 反的阻力而在所述穿刺针 300内腔 320内发生与前进方向相反的位移， 此时， 所述弹簧 630 压缩， 从而控制所述内芯 610位移的距离。 此时， 手术操作者可通过透明窗观察到穿刺针尾 部 612的位移。 参照图 7b,当所述穿刺针 300进入气管后， 所述内芯头部 611受到的阻力消 失， 所述弹簧 62恢复原来的长度， 此时， 所述内芯头部 611又伸出所述穿刺针头部 320 , 手 术操作者可通过透明窗 330观察到所述内芯尾部 612回复原位。 参照图 7c,通过所述穿刺针 300的注射器接口 340与注射器 700连接， 检测注射器内的液体能否在无压力下进入气管， 如不能， 调整所述穿刺针 300的位置， 如能够进入， 则所述穿刺针 300在气管内的位置正确。 参照图 7d,将导丝 500经穿刺针 300的内的内芯尾部 612进入内芯内腔， 而后前行进入气管。 参照图 7 e ,沿着导丝 500尾部拔出穿刺针 300， 将导丝 500—端留置与气管中， 一端伸出在 气管外； 参照图 7f,所述扩张器经过导丝 500引导进入气管， 参照图 7g用第 1级扩张管 10-1 扩张气管壁并进入气管内； 参照图 7g, 当第 1级扩张管 10-11的扩张部 13进入气管后， 旋 转第 1级扩张管，使第 1级扩张管的套接部 12-1与第 1级扩张管 10-Π的套接部 12-11分离， 并拔出第 1级扩张管； 参照图 7 i ,再用第 2级扩张管 10-11的扩张部继续扩张气管壁并进入 气管内； 参照图 7 j ,当第 3级扩张管 10-111的扩张部进入气管后， 旋转第 2级扩张管， 使第 2级扩张管的套接部与第 3级扩张管的套接部分离， 拔出第 2级扩张管； 参照图 7k,用第 3级 扩张管 10-Π Ι的扩张部继续扩张气管壁至开口到预定大小，使可撕裂鞘管和第 3级扩张管 10-111一起进入气管内； 参照图 71 ,拔出第 3级扩张管 10-11 1， 可撕裂导管鞘 200—部分留 置在气管中， 一部分露出在气管外； 参照图 7m,将气管导管 400插入可撕裂鞘管 200中； 参 照图 7n,撕裂可撕裂鞘管 200 , 使气管导管 400—部分留置在气管中， 一部分在气管外， 完成 穿刺置管， 参照图 7o,拔出气管导管 400中的气管栓， 完成置管。
以上内容是结合具体的优选实施方式对本发明所作的进一步详细说明， 不能认定本发明 的具体实施只局限于这些说明。 对于本发明所属技术领域的普通技术人员来说， 在不脱离本 发明构思的前提下， 其架构形式能够灵活多变， 可以派生系列产品。 只是做出若干简单推演 或替换， 都应当视为属于本发明由所提交的权利要求书确定的专利保护范围。

Claims

权 利 要 求
1、 一种分级扩张的气管切开器， 其特征在于， 包括可撕裂导管鞘、 气管导管、 穿刺针、 导丝和扩张器；
所述扩张器由数级套接的扩张管组成； 每一级所述扩张管具有圆柱形的体部， 该体部的 前端渐缩形成圓台形的扩张部， 该体部的后端固接一圆柱形的套接部， 套接部前端外壁设有 内螺紋， 后端壁设有外螺纹； 相邻的两级所述扩张管中， 后一级扩张管的套接部与前一级的 扩张管的套接部之间通过内、 外螺纹连接， 从而形成所述扩张器的体部； 后一级扩张管的体 部穿过前一级的所述扩张器的套接部和体部， 且后一级扩张管的扩张部至少部分伸出前一级 的所述扩张器的扩张部外， 从而形成所述扩张器的扩张部。
2、 如权利要求 1所述的分级扩张的气管切开器， 其特征在于， 所述可撕裂导管鞘套接于 最前一级所述扩张管的套接部的外壁上。
3、 如权利要求 1所述的分级扩张的气管切开器， 其特征在于， 所述穿刺针内腔中空， 所 述穿刺针刺破气管壁后， 所述导丝经所述穿刺针内腔引导进入气管； 拔出穿刺针， 而后所述 导丝引导所述扩张器对气管壁进行逐级扩张； 气管壁扩张至预定大小口， 拔出扩张器， 将可 撕裂导管鞘部分留置在气管中； 将气管导管经可撕裂鞘管引导部分至于气管中， 撕裂可撕裂 鞘管， 完成穿刺。
4、如权利要求 3所述的分级扩张的气管切开器， 其特征在于， 所述穿刺针内设有穿刺保 护器， 所述穿刺保护器包括：
内芯， 所述内芯具有内芯头部和内芯尾部， 内芯尾部上设有卡点， 内芯内腔中空并与所 述导丝外径相匹配；
固定环， 所述固定环固接于所述穿刺针中部内腔；
弹簧， 所述弹簧环绕所述内芯， 且其一端与所述固定环 4氐接， 另一端与所述内芯尾部的 卡点抵接；
所述内芯尾部穿过所述固定环并容置于所述穿刺针内腔； 所述内芯头部外径与所述穿刺 针头部内径相匹配，所述内芯头部穿过所述穿刺针内腔并棵露于所述穿刺针头部外； 所述内 芯头部受外界阻力压缩所述弹簧， 缩回所述穿刺针内腔， 阻力消失后又伸出所述穿刺针头部 外。
5、如权利要求 4所述的分级扩张的气管切开器， 其特征在于， 所述穿刺针正对所述内芯 尾部处设有透明窗。
6、 如权利要求 1所述的分级扩张的气管切开器， 其特征在于， 所述扩张管为 2-7级。
7、如权利要求 1所述的分级扩张的气管切开器， 其特征在于， 后一级扩张管的扩张部的 外壁至少有一部分贴合前一级的所述扩张器的扩？长部的开口。
8、 如权利要求 1所述的分级扩张的气管切开器， 其特征在于， 所述穿刺针、 所述可撕裂 鞘管和所述扩张管以相等的弧度弯曲， 弯曲弧度为 15度。
PCT/CN2014/072715 2013-11-29 2014-02-28 一种分级扩张的经皮气管切开器 WO2015078114A1 (zh)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102015122810A1 (de) * 2015-12-23 2017-06-29 Tracoe Medical Gmbh Einführhilfe

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108938051A (zh) * 2017-05-25 2018-12-07 广州市番禺区中心医院 一种直视下经皮肾穿刺造瘘扩张器

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2455204Y (zh) * 2000-12-26 2001-10-24 欧阳红先 脂肪切割器
CN101400311A (zh) * 2006-04-28 2009-04-01 金伯利-克拉克环球有限公司 透过皮肤的扩张装置
US7811303B2 (en) * 2003-08-26 2010-10-12 Medicine Lodge Inc Bodily tissue dilation systems and methods
CN102018549A (zh) * 2010-12-31 2011-04-20 冯清亮 一种经皮气管切开器
US20120017913A1 (en) * 2010-07-26 2012-01-26 Schumacher James F Tracheostomy Tube Loading Catheter
US8307824B2 (en) * 2008-06-27 2012-11-13 Kimberly-Clark Worldwide, Inc. Method of performing a tracheostomy
EP2550988A1 (en) * 2011-07-26 2013-01-30 Cook Medical Technologies LLC Loading dilator
CN203763175U (zh) * 2013-11-29 2014-08-13 冯清亮 一种分级扩张的经皮气管切开器

Family Cites Families (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4895564A (en) * 1988-06-08 1990-01-23 Farrell Edward M Percutaneous femoral bypass system
SE505615C2 (sv) * 1993-01-08 1997-09-22 Hans Elgerot Kateter med ett antal teleskopiskt utdragbara rör
US7402141B2 (en) * 2003-08-27 2008-07-22 Heuser Richard R Catheter guidewire system using concentric wires
US7625355B2 (en) * 2005-11-17 2009-12-01 Chun Ho Yu Easy drainage catheter assembly
CN101103932B (zh) * 2007-05-21 2011-11-30 刘鸿玉 一种多用经皮穿刺建道、造瘘引流装置
US8211136B2 (en) * 2007-08-31 2012-07-03 Kimberly-Clark Worldwide, Inc. Stoma dilator
WO2009052327A1 (en) * 2007-10-19 2009-04-23 C.R. Bard, Inc. Introducer including shaped distal region
JP5377944B2 (ja) * 2007-11-30 2013-12-25 住友ベークライト株式会社 胃瘻用シース、シース付きダイレータ、挿入補助具付き胃瘻用シース、胃瘻カテーテルキット
US20090163942A1 (en) * 2007-12-20 2009-06-25 Cuevas Brian J Tracheostomy punch dilator
CN201379888Y (zh) * 2009-02-16 2010-01-13 北京微创介入医疗装备有限公司 复合结构经皮肾扩张系统
CN101507853B (zh) * 2009-03-17 2011-05-11 青岛大学医学院附属医院 一种微创气管套管
CN201905970U (zh) * 2010-10-28 2011-07-27 冯清亮 一种经皮气管切开器
CN202052191U (zh) * 2011-03-18 2011-11-30 罗洪波 经皮肾通道扩张器套件
CN103007416A (zh) * 2011-09-20 2013-04-03 武汉金至园科技有限公司 一种前端形状可变的经皮肾穿刺扩张管
CN202637044U (zh) * 2012-03-23 2013-01-02 冯清亮 一种微创经皮气管切开器
CN202568401U (zh) * 2012-05-31 2012-12-05 汪涛 一种经皮胆囊穿刺造瘘套件
CN203123288U (zh) * 2013-02-28 2013-08-14 冯清亮 一种经皮气管扩张器

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN2455204Y (zh) * 2000-12-26 2001-10-24 欧阳红先 脂肪切割器
US7811303B2 (en) * 2003-08-26 2010-10-12 Medicine Lodge Inc Bodily tissue dilation systems and methods
CN101400311A (zh) * 2006-04-28 2009-04-01 金伯利-克拉克环球有限公司 透过皮肤的扩张装置
US8307824B2 (en) * 2008-06-27 2012-11-13 Kimberly-Clark Worldwide, Inc. Method of performing a tracheostomy
US20120017913A1 (en) * 2010-07-26 2012-01-26 Schumacher James F Tracheostomy Tube Loading Catheter
CN102018549A (zh) * 2010-12-31 2011-04-20 冯清亮 一种经皮气管切开器
EP2550988A1 (en) * 2011-07-26 2013-01-30 Cook Medical Technologies LLC Loading dilator
CN203763175U (zh) * 2013-11-29 2014-08-13 冯清亮 一种分级扩张的经皮气管切开器

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102015122810A1 (de) * 2015-12-23 2017-06-29 Tracoe Medical Gmbh Einführhilfe
US20180280647A1 (en) * 2015-12-23 2018-10-04 Tracoe Medical Gmbh Insertion Aid
US10869980B2 (en) 2015-12-23 2020-12-22 Tracoe Medical Gmbh Insertion aid

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