WO2012163083A1 - 一种心包穿刺针组件 - Google Patents

一种心包穿刺针组件 Download PDF

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Publication number
WO2012163083A1
WO2012163083A1 PCT/CN2012/000728 CN2012000728W WO2012163083A1 WO 2012163083 A1 WO2012163083 A1 WO 2012163083A1 CN 2012000728 W CN2012000728 W CN 2012000728W WO 2012163083 A1 WO2012163083 A1 WO 2012163083A1
Authority
WO
WIPO (PCT)
Prior art keywords
distal
guide wire
puncture needle
tip
pericardium
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CN2012/000728
Other languages
English (en)
French (fr)
Inventor
冯骥
龚杰
华新
汉森·索菲娅·王
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synaptic Medical Beijing Co Ltd
Original Assignee
Synaptic Medical Beijing Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Synaptic Medical Beijing Co Ltd filed Critical Synaptic Medical Beijing Co Ltd
Priority to US14/123,014 priority Critical patent/US9717523B2/en
Priority to EP12791952.0A priority patent/EP2716242B1/en
Priority to CN201280037018.8A priority patent/CN103764051B/zh
Publication of WO2012163083A1 publication Critical patent/WO2012163083A1/zh
Anticipated expiration legal-status Critical
Priority to US15/632,423 priority patent/US20170303959A1/en
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • 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
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/84—Drainage tubes; Aspiration tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3286—Needle tip design, e.g. for improved penetration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A61B2017/00318—Steering mechanisms
    • A61B2017/00331—Steering mechanisms with preformed bends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22038—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with a guide wire
    • A61B2017/22042—Details of the tip of the guide wire
    • A61B2017/22044—Details of the tip of the guide wire with a pointed tip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3403—Needle locating or guiding means
    • A61B2017/3405—Needle locating or guiding means using mechanical guide means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B2017/3454—Details of tips
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/09—Guide wires
    • A61M2025/09175—Guide wires having specific characteristics at the distal tip
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/122—Pericardium

Definitions

  • the present invention relates to a piercing needle assembly, and more particularly to a pericardium needle assembly.
  • a pericardium is a layer of connective tissue membrane that is tightly wrapped around the heart. During an extracardiac ablation procedure, the pericardium, which is placed against the outer wall of the heart, must be artificially routed to facilitate passage of the ablation device through the passage between the outer wall of the heart and the pericardium.
  • the existing pericardial puncture device has various shapes, such as the Chinese patent CN00257117.X discloses a non-invasive pericardium puncture needle, including an outer sleeve, a needle core and an end cap; the outer sleeve is an inner hollow sleeve outside the core The flexible sleeve has a solid needle that is secured to the end of the outer sleeve by an end cap. After the core is inserted into the pericardium, the core is withdrawn, and the outer cannula continues to be delivered into the pericardial cavity, and the pericardial effusion or drug is injected.
  • the existing puncture needles are mostly straight needle structures. In clinical operation, puncture failure is often caused by insufficient needle insertion, and sometimes the heart muscle is stabbed because the needle is too deep.
  • the invention provides a pericardial puncture needle assembly, comprising: a guide wire and a piercing needle, wherein the guide wire extends in the puncture needle; the guide wire comprises a distal curved section and a proximal straight section, The distal curved section is formed by bending of the guide wire, the end of which is a pointed structure; the guide wire is made of a highly elastic material, and the distal end of the guide wire is not more than 3 mm from the tip end. The tip is rotated through an angle of at least 90 degrees over the length.
  • the tip is rotated through an angle of at least 90 degrees from the tip within a length of 1 - 2 mm at the distal curved portion of the guidewire.
  • the pointed structure includes a curved section having a radius of curvature of not more than 2 mm in a length range of not more than 3 mm from the tip end.
  • the curved shape of the distal curved section from the proximal end of the pointed structure is involute or spiral or irregularly curved.
  • the curvature of the distal curved portion from the proximal end of the pointed structure is involute or spiral, and the radius of curvature thereof Gradually become larger or stepwise.
  • the curved portion of the distal curved section from the proximal end of the pointed structure is irregularly curved, including at least one bend, after the tip has been rotated through 90 degrees.
  • the curved shape of the distal curved section from the proximal end of the pointed structure comprises a first curved portion and a second curved portion.
  • the radius of curvature of the first curved portion is not more than 1.5 mm, and the radius of curvature of the second curved portion is not more than 2 mm.
  • the portion of the distal curved section that extends from the proximal end of the pointed structure toward the proximal end of the guidewire is a cylindrical structure having a diameter of 0.2-l mm.
  • the portion of the distal curved section that extends from the proximal end of the pointed structure toward the proximal end of the guidewire is a sheet-like structure having a width of preferably 0.2-lmm.
  • the piercing needle is composed of two sections of tubes, including a distal tube and a proximal tube, the distal tube having a length of 40-100 mm, and the proximal tube having a length of 60 -120mm
  • the distal end of the piercing needle has a diameter smaller than the diameter of its proximal end.
  • the inner diameter of the proximal end portion of the puncture needle is 0.5-2.5 mm, and the inner diameter of the distal end portion is 0.2-1.5 mm.
  • the outer portion of the puncture needle is sleeved with an outer sleeve, and the distal end of the outer sleeve has a spherical structure.
  • the pericardial puncture needle assembly does not cause damage to the heart when the pericardium is pierced.
  • FIG. 1 is a perspective structural view of a pericardium piercing needle assembly in accordance with an embodiment of the present invention
  • FIG. 2 is a plan view showing the structure of a pericardium piercing needle assembly in accordance with a preferred embodiment of the present invention
  • Figure 3 is a cross-sectional view taken along line B-B of Figure 2, showing the internal structure of a pericardium puncture needle assembly of a preferred embodiment of the present invention
  • Figure 4 is a cross-sectional view taken along line A-A of Figure 2, showing a cross-sectional structure of a pericardium puncture needle assembly of a preferred embodiment of the present invention
  • Figure 5 is an enlarged view of the portion C of Figure 1 showing the distal curved portion of the pericardial puncture needle assembly of the preferred embodiment of the present invention
  • Figure 6 is a view showing the structure of the distal end curved portion of the guide wire 13 of the pericardium-piercing assembly according to still another embodiment of the present invention
  • Figure 7 is a schematic view showing the structure of a pericardium puncture needle assembly 10 according to another embodiment of the present invention.
  • Figure 8 is an enlarged view of D in Figure 7;
  • FIG. 9 is a schematic structural view of a distal curved section 32 according to still another embodiment of the present invention.
  • FIG. 10 is a schematic structural view of a distal curved section 32 according to still another embodiment of the present invention;
  • Figure 12 is a cross-sectional view taken along line E-E of Figure 11 .
  • FIG. 1 is a schematic perspective view of a preferred pericardium puncture needle assembly 10 of the present invention, including a puncture needle 12 within which a guide wire 1.3 extends.
  • the guidewire is an elongated, bendable flexible structure that includes a distal curved section and a proximal straight section.
  • the distal end curved section of the guide wire 13 is formed by bending the guide wire, and the end thereof has a pointed structure; the guide wire 13 is made of a highly elastic material, and the distal curved section is adapted to recover from the straightened state.
  • the tip is rotated at an angle of at least 90 degrees over a length of no more than 3 mm from the tip at the distal curved section of the guidewire.
  • the pointed structure of the present invention means that the tip end of the guide wire is rotated through 90 degrees and within a length not exceeding 3 mm.
  • a part of the guide wire has a tip surface having a minimum radius of curvature of not more than 0.1 mm.
  • the pointed structure includes a distal end and a proximal end.
  • the tip of the present invention refers to the distal end of the pointed structure, which is very sharp and may be a microscopic spherical structure.
  • a joint 11 is also fixed to the proximal end of the puncture needle 12.
  • FIG. 2 is a plan view showing the planar structure of a pericardium puncture needle assembly 10 in accordance with a preferred embodiment of the present invention
  • Figure 3 is a cross-sectional view of a pericardium penetrating needle 10 in accordance with a preferred embodiment of the present invention, showing the joint 11, The connection relationship between the puncture needle 12 and the guide wire 13
  • Fig. 4 is a cross-sectional view taken along line BB shown in Fig. 2.
  • the puncture needle 12 is a tubular structure comprising a distal end and a proximal end, and may be made of any suitable biocompatible material, such as a stainless steel material or a nickel titanium alloy material.
  • the distal end of the piercing needle 12 may be a needleless structure, and the distal end of the puncture needle 12 may also be a structure with a needle tip.
  • the puncture needle 12 may be integrally formed from a length of a tube or may be a two-piece tube connection.
  • the puncture needle 12 may include a distal tube 21 and a proximal tube 22, as shown in FIG.
  • One method of connecting the distal tube 21 and the proximal tube 22 is to insert the distal end of the distal tube 21 into the proximal tube 22 and secure it by bonding or welding.
  • the distal tube 21 and the proximal tube 22 may be made of the same material or may be made of different materials.
  • the distal tube 21 is made of a Nitinol material
  • the proximal tube 22 is made of a stainless steel material, which ensures a certain degree of curvature of the puncture needle 12 in the body.
  • the diameter of the piercing needle 12 can be set by a person skilled in the art according to actual needs.
  • the puncture needle 12 may be a tubular structure of uniform diameter or may have different diameters at the distal end and the proximal end.
  • its diameter is 0.5-1.0 mm.
  • the diameter of the distal end of the puncture needle 12 is smaller than the diameter of the proximal end thereof, because the proximal end of the puncture needle 12 needs to provide a certain Supporting force, and the distal end of the puncture needle 12 needs to have a certain degree of softness for achieving bending.
  • the proximal end portion of the puncture needle 12 has an inner diameter of 0.5-2.5 mm and the distal end portion has an inner diameter of 0.2-1.5 mm.
  • the length of the puncture needle 12 can be set by a person skilled in the art according to actual needs.
  • the puncture needle 12 when the puncture needle 12 is composed of a distal tube 21 and a proximal tube 22, the distal tube 21 may have a length of 40-100 mm, and the length of the proximal tube 22 may be 60-120 mm; the length of the connecting portion between the distal tube 21 and the proximal tube 22 can be set by a person skilled in the art according to actual needs.
  • Figure 5 is an enlarged view of a portion C of Figure 1 showing the structure of the distal end curved portion of the guide wire 13 of the pericardium puncture needle assembly of one embodiment of the present invention
  • Figure 6 is a further embodiment of the present invention.
  • the guide wire 13 is an elongate, flexible, flexible structure that can be made of any suitable highly elastic material, such as a nickel titanium alloy material.
  • the guide wire 13 includes a distal curved section 32 and a proximal straight section, and the distal curved section 32 is formed by bending of the guide wire.
  • the structure of the distal curved section 32 is a structure adapted to return from a straightened state to a predetermined curved shape, since the guidewire is made of a highly elastic material such that the distal curved section 32 is at the puncture needle 12 The inner state is in a straight state, and when it is passed out from the puncture needle 12, it can be restored to a predetermined shape.
  • the distal curved section 32 may be formed integrally with the guide wire 13 or may be formed separately.
  • the guide wire 13 may be a solid structure having no cavity inside, or may be other suitable structures.
  • the distal end of the distal curved section 32 is a pointed structure that can be used to pierce the pericardium without causing damage.
  • the tip is rotated at an angle of at least 90 degrees over a length of no more than 3 mm from the tip at the distal curved section of the guidewire.
  • the tip is rotated through an angle of at least 90 degrees from a tip end at a distal curved portion of the guidewire.
  • the pointed structure includes a curved section 323 having a radius of curvature of no more than 2 mm, ranging from a tip end to a length of no more than 3 mm.
  • the curved shape of the distal curved section 32 from the proximal end of the pointed structure may be a spiral, involute It can also be other suitable irregular bends, such as arc and line combination, involute and line combination or other suitable shape.
  • the radius of curvature may be gradually larger or stepwise; the distal end is curved.
  • the curved portion of the segment 32 from the proximal end of the pointed structure is an irregular curved shape, such as when the arc is combined with a straight line, the involute is combined with a straight line, or other suitable curved shape, the change in the radius of curvature may also be Regular, if it may be gradually enlarged or stepwise, but as the guide wire is further bent, its radius of curvature begins to become smaller, and then gradually becomes larger or stepwise becomes larger.
  • the angle between the orientation of the tip and the direction of advancement of the guidewire is greater than 90 degrees, so that the heart is not broken; even with the distance The end curved section 32 gradually enters the pericardium, and the angle between the orientation of the tip and the direction of advancement of the guide wire is less than 90 degrees.
  • the guide wire since the guide wire is long and soft, the force on the guide wire cannot be transmitted to the tip end, and therefore, it is not easy to The heart causes damage.
  • the tip may be within a curved, three-dimensional enclosure of the distal curved section, which is less susceptible to damage to the pericardium during puncture; even if the tip is in a curved, three-dimensional enclosure of the distal curved section.
  • the guide wire since the guide wire is long and soft, the force on the guide wire cannot be transmitted to the tip end, and therefore, it is not easy to cause damage to the heart.
  • the curved shape of the distal curved section 32 from the proximal end of the pointed structure is an involute and a straight line;
  • the distal curved section 32 includes at least one bend, which may be one bend, two bends, three bends, or more bends.
  • the curved shape of the distal curved section 32 from the proximal end of the pointed structure includes a first curved portion 321 and a second curved portion 322.
  • the radius of curvature of the first curved portion 321 and the second curved portion 322 may be between the first curved portion 321 and the second curved portion 322 or between the second curved portion 322 and the curved portion 323 of the pointed structure.
  • a person skilled in the art can perform setting according to actual needs.
  • the first curved portion 321 has a radius of curvature of not more than 1.5 mm
  • the second curved portion 322 has a radius of curvature not greater than 2mm.
  • the portion of the distal curved section 32 that extends from the proximal end of the pointed structure toward the proximal end of the guidewire may be a cylindrical structure, the diameter of which may be set by a person skilled in the art according to actual needs, in a preferred embodiment of the invention. , its diameter is 0.2-lmm.
  • the portion of the distal curved section 32 that extends from the proximal end of the pointed structure toward the proximal end of the guidewire may also be a sheet-like structure, as shown in Fig. 5, having a width of 0.2-lmm.
  • the width of the sheet structure refers to the width indicated by 324 shown in FIG.
  • a cannula (not shown) may be disposed in the piercing needle as shown in FIG. 1, FIG. 2 or FIG. 3, and the sleeve extends in the piercing needle 12, and the proximal end thereof Fixed to the joint 11, the distal end of the sleeve may be a free end or may be fixed at the distal end of the puncture needle 12.
  • the distal end of the guide wire 13 enters the puncture needle 12 through the cannula, the internal axis of the puncture needle 12
  • the proximal end of the guide wire 13 may be fixed to the joint 11 or may be a free end as needed, and is not fixed.
  • the puncture needle 12 may also have no sleeve therein. When the piercing needle is used, the guide wire 13 is pushed into the puncture needle 12 by a guide wire pusher, and the pusher also functions as a sleeve. The role.
  • the joint 11 is fixed to the proximal end of the piercing needle 12, which may be a Luer connector.
  • the guide wire 13 can be used to input medicine or other liquid into the body, and can also be used for The fluid is taken from the body.
  • the distal curved section 32 when the pericardial puncture needle assembly is in use, when the distal curved section 32 is all located within the puncture needle 12, the distal curved section 32 is in a straightened state.
  • the guide wire 13 When the guide wire 13 is pushed forward, the tip end of the distal curved section 32 pierces the pericardium, the guide wire 13 gradually enters the inside of the pericardium, and the distal curved section 32 begins to slowly bend until it is restored.
  • the puncture needle 12 enters the inside of the pericardium, and the puncture is completed.
  • the guide wire 13 is withdrawn from the body, and during the extraction process, the guide wire 13 returns from the bent state to the straightened state, and is returned to the puncture needle 12.
  • the guide wire 11 can be passed through the joint 11 Injecting drugs, contrast agents, or extracting fluid from the body.
  • Fig. 7 is a schematic view showing the structure of a pericardium puncture needle assembly 10 according to another embodiment of the present invention.
  • Figure 8 is an enlarged view of the portion D in Figure 7.
  • the puncture needle assembly 10 includes a puncture needle 12 within which the guide wire 13 extends.
  • the guidewire 13 is an elongated, bendable flexible structure that includes a distal end and a proximal end.
  • the guide wire 13 includes a distal curved section 32 and a proximal straight section, the distal end of the distal curved section being a pointed structure.
  • a vacuum device is further fixed at the proximal end of the puncture needle 12, and the distal end of the puncture needle has a certain lateral abutment area, so that a certain adsorption area is formed between the distal end of the piercing needle and the tissue, thereby generating a negative Pressure.
  • the guide wire 13 is made of a highly elastic material, and the distal curved section 32 is formed by bending the guide wire 13, and its structure is a structure suitable for returning from a straightened state to a predetermined curved shape.
  • the tip is rotated through an angle of at least 90 degrees at a distal end of the guidewire that does not exceed 3 mm from the tip.
  • the distal curved section 32 can also be other suitable curved shapes.
  • the pointed structure includes a curved section having a radius of curvature of no more than 2 mm.
  • the distal curved section 32 may be involute from the proximal end of the pointed structure, such as a square involute, a triangular involute or the like, and a radius of curvature thereof. Continuously large or stepwise, as shown in Figures 7 and 8.
  • the negative pressure device includes a connecting valve 14 and a negative pressure tee 15, and the connecting valve 14 and the negative pressure tee 15 are connected by a negative pressure connecting pipe 16.
  • the connecting valve 14 may be of integral construction or may be constructed separately.
  • the connecting flange 14 includes a valve body 141 having a distal end, a proximal end and a central chamber.
  • the distal end of the valve body 141 is provided with a lower end cover 142, and the proximal end of the valve body 141 is provided with an upper end cover 143.
  • the proximal end of the puncture needle 12 is fixed in the lower end cap 142, and the end portion thereof may also be covered with a protective tube.
  • a sealing piece 144 is further disposed in the upper end cover 143 to function as a seal.
  • One end of the negative pressure connecting pipe 16 is fixed to the connecting valve 14, and the other end is fixed to the negative pressure tee 15.
  • the puncture needle 12 is provided with a sleeve 17, and the sleeve 17 extends inside the puncture needle 12, and the proximal end thereof extends outside the connection valve 14.
  • the guide wire 13 enters the puncture needle 12 through the cannula 17 and extends within the piercing needle 12.
  • a joint 11 is also connected at the proximal end of the connecting valve 14, which may be a Luer connector.
  • the guide wire 13 can be used for inputting drugs or other liquids into the body, and can also be used for the body. Extract the fluid.
  • the remaining structures of the guide wire 13 and the piercing needle 12 are the same as those of the embodiment shown in Figures 1 to 5.
  • Figure 9 is a schematic block diagram of a distal curved section 32 in accordance with yet another embodiment of the present invention.
  • the guide wire 13 is an elongated, flexible flexible structure comprising a distal curved section 32 and a proximal straight section, the guidewire being made of a highly elastic material.
  • the distal curved section 32 is formed by bending the guide wire 13 and has a pointed structure at its end.
  • the structure of the distal curved section 32 is a structure suitable for returning from a straightened state to a predetermined curved shape.
  • the tip is rotated through an angle of at least 90 degrees over a length of no more than 3 mm from the tip.
  • the pointed structure includes a curved section having a radius of curvature of not more than 2 mm in a range of not more than 3 mm from the tip end.
  • the distal curved section 32 may be helical from the proximal end of the pointed structure, as shown in Fig. 9, the radius of curvature continuously increases.
  • the distal curved section 32 can also be other suitable curved shapes.
  • Figure 10 is a block diagram showing the distal curved section 32 in accordance with yet another embodiment of the present invention.
  • the guide wire 13 is an elongated, flexible flexible structure comprising a distal curved section 32 and a proximal straight section, the guidewire being made of a highly elastic material.
  • the distal curved section 32 is formed by bending the guide wire 13 and has a pointed structure at its distal end.
  • the structure of the distal curved section 32 is a structure suitable for returning from a straightened state to a predetermined curved shape.
  • the pointed structure includes a curved section having a radius of curvature of no more than 2 mm.
  • the distal curved section 32 may be irregularly curved from the proximal end of the pointed structure. As shown in FIG. 10, the radius of curvature change is irregular, such as may be Gradually larger or stepwise, but As the guide wire is further bent, its radius of curvature begins to become smaller, and then gradually becomes larger or stepwise becomes larger or so repeated.
  • the distal curved section 32 can also be other suitable curved shapes.
  • FIG 11 is a schematic view showing the structure of a pericardium puncture needle assembly 10 according to still another preferred embodiment of the present invention
  • Figure 12 is a cross-sectional view taken along line E-E of Figure 11 .
  • the pericardium puncture needle 10 includes a puncture needle 12 within which the guide wire 13 extends.
  • the guidewire is an elongated, bendable flexible structure that includes a distal curved section 32 and a proximal straight section.
  • the guide wire is made of a highly elastic material.
  • the distal curved section 32 is formed by bending of the guide wire and has a pointed structure at its distal end; the distal curved section 32 is adapted to return from a straightened state to a predetermined curved shape.
  • the tip is rotated through an angle of at least 90 degrees from the tip end at a distance of no more than 3 mm from the tip end of the guide wire.
  • the pointed structure includes a curved section having a radius of curvature of not more than 2 mm in a range of not more than 3 mm from the tip end.
  • a joint 11 is also fixed to the proximal end of the puncture needle 12.
  • the distal curved section 32 may be spiral from the proximal end of the pointed structure, and as shown in Figs. 11 and 12, the radius of curvature continuously increases.
  • the distal curved section 32 can also be other suitable curved shapes.
  • the outer portion of the puncture needle 12 is sheathed with an outer sleeve 18 that includes a distal end and a proximal end.
  • the distal end of the outer sleeve 18 is a spherical structure 81 and may be other suitable shapes.
  • the spherical structure 81 and the outer sleeve 18 may be formed separately or integrally.
  • the outer sleeve 18 can be made of any suitable biocompatible material, such as a stainless steel material. When the spherical structure 81 is formed separately from the outer sleeve 18, the same material may be used, or a different material may be used.
  • the proximal end of the outer sleeve 18 is secured to the joint 19, for example, by gluing or other suitable means.
  • the joint 19 can be of any suitable construction, such as a luer fitting.
  • the joint 11 can slide freely at the proximal end of the joint 19 or can be fixed by self-locking.
  • the pericardium When the pericardial puncture is performed, the pericardium can be abutted against the distal end of the puncture needle 12, or the perforating needle 12 can be withdrawn from the outside of the body, and the spherical structure of the distal end of the outer cannula 18 can be directly used. The pericardium is placed in close contact to complete the puncture.

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Abstract

一种心包穿刺针组件（10），包括导丝（13）和穿刺针（12），所述导丝（13）在所述的穿刺针（12）内延伸；所述导丝（13）包括远端弯曲段（32）和近端直段，所述远端弯曲段（32）由所述导丝（13）弯曲构成，其末端为尖形结构；所述导丝（13）由高弹性材料制成，在所述导丝的远端弯曲段（32）处从尖端开始不超过3mm的长度范围内，所述尖端转过的角度为至少90度。所述心包穿刺针组件（10），在对心包进行穿刺时，不会对心脏造成损害。

Description

种心包穿刺针组件
相关申请的交叉援引 本申请要求 2011年 5月 27日提交的中国专利申请 201110139534.9的 说
优先权， 在此通过援引将其全部内容并入本文。 书
技术领域 本发明涉及一种穿剌针组件， 具体的讲涉及一种心包穿刺针组件。
背景技术 心包是心脏外围紧紧包裹着的一层结缔组织膜结构。 在进行心外消融 手术的时候， 必须人为的把紧贴于心脏外壁的心包打一个通路， 以便于消 融设备通过该通路进入心脏外壁和心包之间进行消融。 目前现有的心包穿刺设备形状多样，如中国专利 CN00257117.X公开一 种无创心包穿刺针， 包括外套管、 针芯和端封帽； 所述的外套管为内空的 套在针芯外面的有柔性的套管， 针芯为实心的穿剌针， 通过端封帽固定于 外套管的末端。 在针芯剌入心包后， 将针芯退出， 外套管继续送入心包腔， 抽取心包积液或注入药物。 但是， 现有的穿刺针多为直针结构， 在临床操作时， 常因进针不到位 而导致穿刺失败， 有时也因进针过深而刺伤心肌。
发明内容 本发明提供一种心包穿刺针组件， 其特征在于： 包括导丝和穿剌针， 所 述导丝在所述的穿刺针内延伸； 所述导丝包括远端弯曲段和近端直段， 所 述远端弯曲段由所述导丝弯曲构成， 其末端为尖形结构； 所述导丝由高弹 性材料制成， 在所述导丝的远端弯曲段处从尖端开始不超过 3mm的长度范 围内， 所述尖端转过的角度至少为 90度。
优选的， 在所述导丝的远端弯曲段处从尖端开始 l-2mm的长度范围内， 所述尖端转过的角度至少为 90度。
优选的， 从尖端开始不超过 3mm的长度范围内， 所述尖形结构包括一 曲率半径不大于 2mm的弯曲段。
当所述尖端转过 90度后， 所述远端弯曲段从尖形结构近端开始的弯形 是渐开线状或螺旋线状或不规则弯形。
在本发明的一个具体实施方案中， 当所述尖端转过 90度后， 所述远端 弯曲段从尖形结构近端开始的弯形为渐开线状或螺旋线状时， 其曲率半径 呈逐渐变大或阶梯性变大。
在本发明的一个具体实施方案中， 当所述尖端转过 90度后， 所述远端 弯曲段从尖形结构近端开始的弯形是不规则弯形， 包括至少一个弯曲部。
优选的， 所述远端弯曲段从尖形结构近端开始的弯形包括第一弯曲部 和第二弯曲部。
所述第一弯曲部的曲率半径为不大于 1.5mm， 所述第二弯曲部的曲率半 径为不大于 2mm。
在一个优选的实施方案中， 所述远端弯曲段从尖形结构近端开始向导丝 近端延伸的部分是圆柱形结构， 其直径为 0.2- lmm。 在另一个优选的实施方案中， 所述远端弯曲段从尖形结构近端开始向导 丝近端延伸的部分是片状结构， 其宽度优选为 0.2-lmm。
在一个优选的实施方案中， 所述穿剌针由两段管连接构成， 包括远端管 和近端管， 所述远端管的长度为 40-100mm， 所述近端管的长度为 60-120mm
所述穿剌针远端的直径小于其近端的直径。
所述穿刺针近端部分的内径为 0.5-2.5mm， 远端部分的内径为 0.2-1.5mm。
优选的，所述穿刺针的外部套有外套管，所述外套管的远端为球形结构。 在本发明的优选实施方式中， 所述的心包穿刺针组件在对心包进行穿剌 时， 不会对心脏造成损害。
附图说明
图 1 是根据本发明一种具体实施方式的心包穿剌针组件的立体结构示 意图；
图 2所示的是根据本发明优选实施例的心包穿剌针组件的平面结构示 意图；
图 3所示的是沿图 2所示的 B-B线的剖视图， 示出了本发明优选实施 例的心包穿刺针组件的内部结构；
图 4所示的是沿图 2所示的 A-A线的剖视图， 示出了本发明优选实施 例的心包穿刺针组件的横截面结构；
图 5所示的是图 1中 C处的放大图， 示出了本发明优选实施例的心包 穿刺针组件的远端弯曲段结构； 图 6所示的是本发明又一种实施方式的心包穿剌组件的导丝 13远端弯 曲段的结构；
图 7所示的是本发明的另一个实施方式的心包穿刺针组件 10的结构示 意图；
图 8所示的是图 7中 D处的放大图；
图 9是根据本发明的又一实施方式的远端弯曲段 32的结构示意图； 图 10是根据本发明的又一实施方式的远端弯曲段 32的结构示意图； 图 11是根据本发明的又一优选实施方式的心包穿刺针组件 10的结构 示意图；
图 12是根据图 11中 E-E线的剖视图。
具体实施方式
下面通过实施例， 并结合附图， 对本发明的技术方案作进一步详细的 说明， 但本发明不仅仅限于下面的实施例。
图 1所示的是本发明的一种优选的心包穿刺针组件 10的立体结构示意 图， 包括穿刺针 12， 导丝 1.3在所述的穿刺针 12内延伸。所述导丝为细长、 可弯曲的柔性结构， 其包括远端弯曲段和近端直段。 所述导丝 13的远端弯 曲段由所述导丝弯曲构成， 其末端为尖形结构； 所述导丝 13由高弹性材料 制成， 所述远端弯曲段适合于从伸直状态恢复成预定弯形。 在所述导丝的 远端弯曲段处从尖端开始不超过 3mm的长度范围内， 所述尖端转过的角度 至少为 90度。 当所述导丝的尖端穿过心包后， 所述尖端的朝向与所述导丝 的推进方向之间的角度大于 90度， 因此不易对心包造成损伤。 本发明所述 的尖形结构是指所述导丝的尖端转过 90度且在不超过 3mm的长度范围内 的一部分导丝， 其尖端表面的最小曲率半径不大于 0.1mm。 所述尖形结构 包括远端和近端。 本发明所述尖端是指所述尖形结构的远端末端， 其非常 锋利， 可以为微观球面结构。 在穿刺针 12的近端还固定有接头 11。
图 2所示的是根据本发明的优选实施例的心包穿刺针组件 10的平面结 构示意图； 图 3所示的是根据本发明的优选实施例的心包穿剌针 10的剖视 图， 表示接头 11、 穿刺针 12以及导丝 13之间的连接关系； 图 4所示的是 沿图 2所示的 B-B线的剖视图。所述穿刺针 12为管状结构， 其包括远端和 近端， 可由任何合适的生物相容性的材料制成， 如不锈钢材料或镍钛合金 材料。 所述穿剌针 12的远端可以是无针尖结构， 所述穿刺针 12的远端也 可以是带有针尖的结构。
所述穿刺针 12可由一段管一体成型， 也可以是两段管连接构成。 所述 穿刺针 12由两段管连接构成时， 可以是包括远端管 21和近端管 22， 如图 3所示。 所述远端管 21和近端管 22的一种连接方法为， 将所述远端管 21 的末端插入所述近端管 22 内， 通过粘结或焊接进行固定。 所述远端管 21 和近端管 22可由相同的材料制成， 也可由不同的材料制成。 例如， 所述远 端管 21 由镍钛合金材料制成， 所述近端管 22由不锈钢材料制成， 这样可 以保证所述穿刺针 12在体内的一定的弯曲度。
所述穿剌针 12的直径， 本领域技术人员可以根据实际需要进行设定。 所述穿刺针 12可以是直径均一的管状结构， 也可以是远端和近端具有不同 的直径。 当所述穿刺针 12为直径均一的管状结构时， 其直径为 0.5-1.0mm。 当所述穿刺针 12的远端和近端具有不同的直径时， 优选的， 所述穿刺针 12 远端的直径小于其近端的直径， 因为所述穿刺针 12的近端需要提供一定的 支撑力， 而所述穿刺针 12的远端需要有一定的柔软度， 用来实现弯曲。 在 一个具体实施方案中， 所述穿刺针 12近端部分的内径为 0.5-2.5mm， 远端 部分的内径为 0.2-1.5mm。
所述穿刺针 12的长度， 本领域技术人员可以根据实际需要进行设定。 在一个具体实施方案中， 当所述穿刺针 12由远端管 21和近端管 22连接构 成时， 所述远端管 21的长度可以为 40-100mm， 所述近端管 22的长度可以 60-120mm; 所述远端管 21和所述近端管 22之间的连接部分的长度， 本领 域技术人员可以根据实际需要进行设定。
图 5所示的是图 1中 C处的放大图， 表示本发明一种实施方式的心包 穿刺针组件的导丝 13远端弯曲段的结构； 图 6所示的是本发明又一种实施 方式的心包穿刺针组件的导丝 13远端弯曲段的结构。 如图 3、 图 5和图 6 所示， 所述导丝 13为细长、 可弯曲的柔性结构， 其可由任何合适的高弹性 材料制成， 例如镍钛合金材料。 所述导丝 13包括远端弯曲段 32和近端直 段， 所述远端弯曲段 32由所述导丝弯曲构成。 所述远端弯曲段 32的结构 是适合于从伸直状态恢复成预定弯形的结构， 由于所述导丝采用高弹性材 料制成， 使得所述远端弯曲段 32在所述穿刺针 12内时为伸直状态， 当从 所述穿刺针 12内穿出时， 可以恢复到预定弯形。 所述远端弯曲段 32可以 与所述导丝 13—体构成， 也可以分体构成。 所述导丝 13可以是实心结构， 其内部没有空腔， 也可以是其它合适的结构。
如图 3、 图 5和图 6所示， 所述远端弯曲段 32的末端是尖形结构， 可 用于对心包进行穿剌， 而不易造成损伤。 在所述导丝的远端弯曲段处从尖 端开始不超过 3mm的长度范围内， 所述尖端转过的角度至少为 90度。 优 选的， 在所述导丝的远端弯曲段处从尖端开始 l-2mm的长度范围内， 所述 尖端转过的角度至少为 90度。 从尖端开始不超过 3mm的长度范围内， 所 述尖形结构包括一弯曲段 323， 其曲率半径不大于 2mm。
如图 3、 图 5和图 6所示， 当所述尖端转过 90度后， 所述远端弯曲段 32从尖形结构的近端处开始的弯形可以是螺旋线状、 渐开线状， 也可以是 其他适合的不规则弯形， 如圆弧与直线结合、 渐开线与直线结合或其他合 适的弯形。所述远端弯曲段 32从尖形结构的近端处开始的弯形为螺旋线状、 渐开线状时， 其曲率半径可以是呈逐渐变大或阶梯性变大； 所述远端弯曲 段 32从尖形结构的近端处开始的弯形为不规则弯形， 如圆弧与直线结合、 渐开线与直线结合或其他合适的弯形时， 其曲率半径的变化也可以是不规 律的， 如可以是呈逐渐变大或阶梯性变大， 但是随着导丝的进一步弯曲， 其曲率半径开始变小， 随后再逐渐变大或阶梯性变大。 所述的远端弯曲段 32的远端刺破心包后， 所述尖端的朝向与所述导丝的推进方向之间的角度 大于 90度， 因此不会剌破心脏； 即使随着所述远端弯曲段 32逐渐进入心 包， 尖端的朝向与导丝的推进方向之间的角度小于 90度， 此时由于导丝很 长且柔软， 导丝上的力无法传递到尖端， 因此， 也不易对心脏造成损伤。 所述尖端可以是处于所述远端弯曲段的弯形的立体包围之内， 在进行穿刺 的时候， 不易对心包造成损伤； 即使所述尖端处于所述远端弯曲段的弯形 的立体包围之外， 由于导丝很长且柔软， 导丝上的力无法传递到尖端， 因 此， 也不易对心脏造成损伤。
如图 5所示， 在该实施例中， 当所述尖端转过 90度后， 所述远端弯曲 段 32从尖形结构的近端处开始的弯形是渐开线与直线结合； 如图 6所示， 在该实施例中， 当所述尖端转过 90度后， 所述远端弯曲段 32从尖形结构 的近端处开始的弯形是螺旋线与直线结合。 所述远端弯曲段 32包括至少一 个弯曲部， 可以是一个弯曲部、 两个弯曲部、 三个弯曲部或更多弯曲部。 如图 5和图 6所示， 所述远端弯曲段 32从尖形结构的近端处开始的弯形包 括第一弯曲部 321和第二弯曲部 322。 所述第一弯曲部 321与第二弯曲部 322之间， 以及第二弯曲部 322与尖形结构的弯曲部 323之间的导丝， 优选 为在与所述穿刺针 12平行的方向上延伸。所述第一弯曲部 321与第二弯曲 部 322之间或第二弯曲部 322与尖形结构的弯曲部 323之间可以为一段直 所述第一弯曲部 321和第二弯曲部 322的曲率半径， 本领域技术人员 可以根据实际需要进行设定， 例如， 在本发明一个实施方式中， 所述第一 弯曲部 321的曲率半径不大于 1.5mm， 所述第二弯曲部 322的曲率半径不 大于 2mm。
所述远端弯曲段 32从尖形结构近端处开始向导丝近端延伸的部分可以 是圆柱形结构， 其直径可由本领域技术人员根据实际需要进行设定， 在本 发明的优选实施方案中， 其直径为 0.2-lmm。 所述远端弯曲段 32从尖形结 构近端处开始向导丝近端延伸的部分也可以是片状结构， 如图 5所示， 其 宽度为 0.2-lmm。所述片状结构的宽度是指图 5中所示的 324所指出的宽度。
如图 1、图 2或图 3所示的所述穿剌针内还可以设有套管（图中未示出）， 所述套管在所述的穿剌针 12内延伸， 其近端固定于所述接头 11上， 所述 套管的远端可以为自由端， 也可以固定在所述穿刺针 12的远端。 所述导丝 13的远端通过所述套管进入所述穿刺针 12内， 在所述穿刺针 12的内部轴 向上延伸； 所述导丝 13的近端， 根据需要， 可以固定于所述接头 11上， 也可以是自由端， 不进行固定。 所述穿刺针 12内也可以没有套管， 当使用 所述穿剌针时， 用导丝推送器将所述导丝 13推送至所述穿刺针 12内， 所 述推送器也起到套管的作用。
所述接头 11 固定于所述穿剌针 12的近端， 其可以是鲁尔接头， 在穿 刺完成后， 将导丝 13抽出后， 可用于向体内输入药物或其他液体， 也可以 用于从体内抽取积液。
根据本发明一优选的实施例， 所述的心包穿刺针组件在使用时， 当所 述远端弯曲段 32全部位于所述穿刺针 12内时， 所述远端弯曲段 32为伸直 状态。 当向前推送所述导丝 13的时候， 所述远端弯曲段 32的尖端刺破心 包， 所述导丝 13逐渐进入心包内部， 所述远端弯曲段 32开始慢慢弯曲， 至其恢复为预定形状， 穿刺针 12进入心包内部， 穿刺完成。将所述导丝 13 抽出体外， 抽出过程中， 导丝 13从弯曲状态恢复为伸直状态， 退回至所述 穿刺针 12中， 所述导丝 13退出体外后， 可通过所述接头 11向体内注射药 物、 造影剂或抽取体内积液。
图 7所示的是本发明的另一个实施方式的心包穿刺针组件 10的结构示 意图。 图 8所示的是图 7中 D处的放大图。 如图 7和图 8所示， 所述穿刺 针组件 10包括穿刺针 12， 导丝 13在所述的穿刺针 12内延伸。 所述导丝 13为细长、可弯曲的柔性结构， 其包括远端和近端。所述导丝 13包括远端 弯曲段 32和近端直段， 所述远端弯曲段的末端是尖形结构。 在穿刺针 12 的近端还固定有负压装置， 所述穿刺针的远端具有一定的侧向贴靠面积， 以便穿剌针的远端与组织之间具有一定的吸附面积， 从而产生负压。 所述导丝 13采用高弹性材料制成， 所述远端弯曲段 32由所述导丝 13 弯曲构成， 其结构是适合于从伸直状态恢复成预定弯形的结构。 在所述导 丝的远端处从尖端幵始不超过 3mm的长度范围内， 所述尖端转过的角度至 少为 90度。 所述远端弯曲段 32也可以是其他合适的弯形。 从尖端开始不 超过 3mm的长度范围内， 所述尖形结构包括一弯曲段， 其曲率半径不大于 2mm。 当所述尖端转过 90度后， 所述远端弯曲段 32从尖形结构近端处开 始可以是渐开线状， 如正方形渐开线状、 三角形渐开线状或其它， 其曲率 半径连续变大或阶梯性变大， 如图 7和图 8所述。
所述负压装置包括连接阀 14和负压三通 15， 所述连接阀 14和负压三 通 15之间通过负压连接管 16连接。 所述连接阀 14可以是整体构成， 也可 以分体构成， 如图 7所示， 所述连接阔 14包括阀体 141， 其具有远端、 近 端和中心腔室。， 所述阀体 141的远端设有下端盖 142， 所述阀体 141的近 端设有上端盖 143。 所述穿刺针 12的近端固定于所述下端盖 142内， 其端 部还可以套有一段保护管。所述上端盖 143内还设有一密封片 144， 起到密 封的作用。 所述负压连接管 16的一端固定在所述连接阀 14上， 另一端固 定在所述负压三通 15上。
优选的， 所述穿刺针 12内设有套管 17， 所述套管 17在所述穿刺针 12 内延伸， 其近端延伸出所述连接阀 14的外部。 导丝 13通过套管 17进入所 述的穿刺针 12内， 并在所述穿剌针 12内延伸。
在所述连接阀 14的近端还连接有接头 11， 其可以是鲁尔接头， 在穿刺 完成后， 将导丝 13抽出后， 可用于向体内输入药物或其他液体， 也可以用 于从体内抽取积液。 图 7和图 8所示的实施方式中， 所述导丝 13和穿剌针 12的其余结构 同图 1至图 5所示的实施方式。
图 9是根据本发明的又一实施方式的远端弯曲段 32的结构示意图。 如 图 9所示， 所述导丝 13为细长、 可弯曲的柔性结构， 其包括远端弯曲段 32 和近端直段， 所述导丝采用高弹性材料制成。 所述远端弯曲段 32， 由所述 导丝 13弯曲构成， 其末端是尖形结构。 所述远端弯曲段 32的结构是适合 于从伸直状态恢复成预定弯形的结构。
在所述导丝的远端处从尖端幵始不超过 3mm的长度范围内， 所述尖端 转过的角度至少为 90度。 从尖端开始不超过 3mm的长度范围内， 所述尖 形结构包括一弯曲段， 其曲率半径不大于 2mm。 当所述尖端转过 90度后， 所述远端弯曲段 32从尖形结构近端处幵始可以是螺旋线状， 如图 9所示， 其曲率半径连续变大。 所述远端弯曲段 32也可以是其他合适的弯形。
图 10是根据本发明的又一实施方式的远端弯曲段 32的结构示意图。 如图 10所示， 所述导丝 13为细长、 可弯曲的柔性结构， 其包括远端弯曲 段 32和近端直段， 所述导丝采用高弹性材料制成。所述远端弯曲段 32， 由 所述导丝 13弯曲构成， 其末端是尖形结构。 所述远端弯曲段 32的结构是 适合于从伸直状态恢复成预定弯形的结构 。
在所述导丝的远端处从尖端开始不超过 3mm的长度范围内， 所述尖端 转过的角度至少为 90度。 从尖端开始不超过 3mm的长度范围内， 所述尖 形结构包括一弯曲段， 其曲率半径不大于 2mm。 当所述尖端转过 90度后， 所述远端弯曲段 32从尖形结构近端处开始可以是不规则弯形， 如图 10所 示， 其曲率半径变化是不规律的， 如可以是呈逐渐变大或阶梯性变大， 但 是随着导丝的进一步弯曲， 其曲率半径开始变小， 随后再逐渐变大或阶梯 性变大或如此反复。 所述远端弯曲段 32也可以是其他合适的弯形。
图 11是根据本发明的又一优选实施方式的心包穿刺针组件 10的结构示 意图； 图 12是根据图 11中 E-E线的剖视图。 如图 11和图 12所示， 所述 心包穿刺针 10包括穿刺针 12， 导丝 13在所述的穿刺针 12内延伸。所述导 丝为细长、 可弯曲的柔性结构， 其包括远端弯曲段 32和近端直段。 所述导 丝由高弹性材料制成。 所述远端弯曲段 32， 由所述导丝弯曲构成， 其末端 为尖形结构； 远端弯曲段 32适合于从伸直状态恢复成预定弯形。 在所述导 丝的远端处从尖端开始不超过 3mm的长度范围内， 所述尖端转过的角度至 少为 90度。 从尖端开始不超过 3mm的长度范围内， 所述尖形结构包括一 弯曲段， 其曲率半径不大于 2mm。 在穿刺针 12的近端还固定有接头 11。
当所述尖端转过 90度后， 所述远端弯曲段 32从尖形结构近端处开始 可以是螺旋线状， 如图 11和图 12所示， 其曲率半径连续变大。 所述远端 弯曲段 32也可以是其他合适的弯形。
所述穿刺针 12的外部套有外套管 18，其包括远端和近端。所述外套管 18的远端为球形结构 81， 也可以是其它合适的形状。 所述球形结构 81与 所述外套管 18可以分体形成， 也可以一体形成。 所述外套管 18可以由任 何合适的生物相容性材料制成， 例如， 不锈钢材料。 当所述球形结构 81与 所述外套管 18分体形成时，可以采用相同的材料，也可以采用不同的材料。 所述外套管 18的近端固定到接头 19上， 例如， 可以通过粘接或其它合适 的方法固定。 所述接头 19可以为任何合适的结构， 例如鲁尔接头。 所述接 头 11可以在所述接头 19的近端自由滑动， 也可以通过自锁固定。 当所述 穿刺针 12进入胸腔后， 通过控制接头 11使得所述穿刺针 12的远端退至所 述外套管 18内， 此时当所述外套管 18向前推进的时候， 不容易伤害到组 织。在进行心包穿刺的时候，可以用所述穿刺针 12的远端对心包进行贴靠， 也可以将所述穿剌针 12退出体外， 直接采用所述外套管 18远端的球形结 构 8】对心包进行贴靠， 从而完成穿刺。
本发明的实施方式并不限于上述实施例所述， 在不偏离本发明的精神 和范围的情况下， 本领域普通技术人员可以在形式和细节上对本发明做出 各种改变和改进， 而这些均被认为落入了本发明的保护范围。

Claims

权 利 要 求 书
1. 一种心包穿剌针组件， 其特征在于包括导丝和穿刺针， 所述导丝在所述 穿刺针内延伸； 所述导丝包括远端弯曲段和近端直段， 所述远端弯曲段 由所述导丝弯曲构成，其末端为尖形结构；所述导丝由高弹性材料制成， 在所述导丝的远端弯曲段处从尖端开始不超过 3mm的长度范围内， 所 述尖端转过的角度至少为 90度。
2. 根据权利要求 1所述的心包穿剌针组件， 其特征在于在所述导丝的远端 弯曲段处从尖端幵始 l-2mm 的长度范围内， 所述尖端转过的角度至少 为 90度。
3. 根据权利要求 1或 2所述的心包穿剌针组件， 其特征在于从尖端开始不 超过 3mm的长度范围内，所述尖形结构包括一曲率半径不大于 2mm的
4. 根据权利要求 1或 2或 3所述的心包穿刺针组件， 其特征在于当所述尖 端转过 90度后，所述远端弯曲段从尖形结构近端处开始的弯形是渐开线状 或螺旋线状或不规则弯形。 '
5. 根据权利要求 4所述的心包穿刺针组件，其特征在于当所述尖端转过 90 度后， 所述远端弯曲段从尖形结构近端处开始的弯形是渐开线状或螺旋线 状， 其曲率半径呈逐渐变大或阶梯性变大。
6. 根据权利要求 4所述的心包穿剌针组件，其特征在于当所述尖端转过 90 度后， 所述远端弯曲段从尖形结构近端处开始的弯形是不规则弯形， 包括 至少一个弯曲部。
7.根据权利要求 6所述的心包穿刺针组件， 其特征在于所述远端弯曲段从 尖形结构近端处开始的弯形包括第一弯曲部和第二弯曲部； 优选的， 所述 第一弯曲部的曲率半径不大于 1.5mm， 所述第二弯曲部的曲率半径不大于 2mm。
8. 根据上述权利要求所述的心包穿刺针组件， 其特征在于所述远端弯曲段 从尖形结构近端处开始向导丝近端延伸的部分是圆柱形结构， 其直径为 0.2-lmm。
9. 根据上述权利要求所述的心包穿剌针组件， 其特征在于所述远端弯曲段 从尖形结构近端处开始向导丝近端延伸的部分是片状结构， 其宽度为 0.2-lmm。
10. 根据上述权利要求所述的心包穿刺针组件， 其特征在于所述穿刺针由 两段管连接构成， 包括远端管和近端管， 所述远端管的长度为 40-100mm， 所述近端管的长度为 60-120mm。
11. 根据权利要求 10所述的心包穿剌针组件， 其特征在于所述穿剌针远端 的直径小于其近端的直径， 优选的， 所述穿剌针近端部分的内径为
0.5-2.5mm, 远端部分的内径为 0.2-1.5mm。
12. 根据上述权利要求所述的心包穿刺针组件， 其特征在于所述穿剌针的 近端固定有负压装置。
13.根据上述权利要求所述的心包穿剌针组件， 其特征在于所述穿刺针的外 部套有外套管， 所述外套管的远端为球形结构。
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US20170303959A1 (en) 2017-10-26
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