WO2021120917A1 - 输送鞘管和医疗器械 - Google Patents
输送鞘管和医疗器械 Download PDFInfo
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- WO2021120917A1 WO2021120917A1 PCT/CN2020/126982 CN2020126982W WO2021120917A1 WO 2021120917 A1 WO2021120917 A1 WO 2021120917A1 CN 2020126982 W CN2020126982 W CN 2020126982W WO 2021120917 A1 WO2021120917 A1 WO 2021120917A1
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- WIPO (PCT)
- Prior art keywords
- tube
- distal
- delivery sheath
- flexible tube
- hardness
- Prior art date
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Images
Classifications
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- 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
- A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
- A61M25/0133—Tip steering devices
- A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
- A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
-
- 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
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/005—Catheters; Hollow probes characterised by structural features with embedded materials for reinforcement, e.g. wires, coils, braids
- A61M25/0052—Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
-
- 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
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0662—Guide tubes
Definitions
- the present invention relates to the field of medical equipment, in particular to a delivery sheath and medical equipment.
- the delivery sheath is used to establish a delivery channel from outside the body to the body (mainly the diseased part), and the implanted device can be transported to the diseased part or recovered by the delivery channel.
- the delivery channel can also be used to inject drugs into the patient's body or to drain the body fluid in the patient's body.
- the existing delivery sheath for delivering the left atrial appendage occluder includes a preformed delivery sheath.
- the pre-shaped delivery sheath includes a single-bend pre-shaped delivery sheath 10.
- the single-curved pre-plasticized delivery sheath 10 includes a proximal section 11, a distal section 13 and a plastic-curved section 15.
- the proximal section 11 and the distal section 13 are both straight tubes in a natural state, and the proximal section 11 is located at the proximal side of the single-curved preformed delivery sheath 10, and the distal section 13 is located at the distal side of the single-curved preformed delivery sheath 10.
- the plastic bending section 15 is a curved tube structure in the natural state, and the number is one section.
- the plastic bending section 15 is located between the proximal section 11 and the distal section 13, and the proximal section 11 and the distal section 13 pass through the plastic bending. Segment 15 is connected.
- the extending direction of the proximal section 11 and the extending direction of the distal section 13 form an angle of 45°.
- the human body includes a heart 21 and an inferior vena cava 31, and the heart 21 includes a right atrium 23, a left atrium 25, atrial septum 27 and a left atrial appendage 29.
- the right atrium 23 communicates with the inferior vena cava 31.
- the interatrial septum 27 is located between the right atrium 23 and the left atrium 29.
- the interatrial septum 27 separates the right atrium 23 from the left atrium 29.
- the interatrial septum 27 has a first end 271 and a second end 272.
- the first end 271 is close to The apex of the heart, the second end 272 is arranged opposite to the first end and away from the apex, and the atrial septum has an extension direction extending from the second end 272 to the first end 271.
- the left atrial appendage 29 is roughly in a barrel-shaped structure, which has an open end and a closed end.
- the open end is an open structure.
- the open end allows the left atrial appendage 29 to communicate with the left atrium 25, and the closed end seals the left atrial appendage 29.
- the acute angle formed by the central axis 291 and the extending direction of the inferior vena cava is approximately 45°.
- the single-curved pre-plasticized delivery sheath 10 When the single-curved pre-plasticized delivery sheath 10 is used, it usually enters the right atrium 23 through the inferior vena cava 31, and then the atrial septum 27 is punctured so that the distal section 13 of the single-curved pre-plasticized delivery sheath 10 enters the left atrium. 25, and the proximal section 11 remains in the inferior vena cava 31.
- the proximal section 11 held in the inferior vena cava 31 can be regarded as coaxial with the inferior vena cava 31.
- the acute angle formed by the central axis 291 of the left atrial appendage 29 and the extending direction of the inferior vena cava 31 is approximately 45°, it is equivalent to the acute angle formed by the central axis 291 of the left atrial appendage 29 and the proximal section 11 of 45°.
- the atrial septum 27 will not change the angle between the proximal section 11 and the distal section 13, that is, the proximal section 11 and the distal section 13 after puncture
- the included angle of is 45°, which is equivalent to the acute angle formed by the extension direction of the inferior vena cava 31 and the distal section 13 after the puncture is 45°. Therefore, the distal end section 13 of the single-curved preformed sheath tube 10 can extend into the left atrial appendage 29, and the distal end section 13 coincides with the central axis 291 of the left atrial appendage 29.
- the angle between the central axis 291 of the left atrial appendage 29 and the extension direction of the inferior vena cava 31 is less than 45°, which is equivalent to the left
- the atrial appendage 29 takes the closed end as the axis, and the opening of the left atrial appendage 29 is deflected to the side of the first end 271 of the atrial septum 29 by a certain angle.
- the actual puncture point is higher than the ideal puncture point, that is, in the length direction of the atrial septum 29, the actual puncture point is facing away from the apex of the heart.
- the end section 13 cannot extend into the left atrial appendage, and the distal end section 13 of the single-curved preformed delivery sheath 10 cannot be coaxial with the central axis 291 of the left atrial appendage 29.
- the fixing disk of the left atrial appendage occluder is difficult to fix on the inner wall of the left atrial appendage 29, and the left atrial appendage occluder is easy to fall off and cause device embolism.
- the operator may move or rotate the proximal end of the single-curved pre-shaped delivery sheath 10 to change the position of the distal section 13.
- the distal section 13 is coaxial with the center axis 29 of the left atrial appendage 29.
- a delivery sheath tube includes a tube body part including an outer layer tube and a traction structure.
- the outer layer tube includes a connecting tube, a tube body and a distal tube.
- the tube body is located between the connecting tube and the distal tube. It includes a first flexible tube, a spacer tube and a second flexible tube.
- the spacer tube is arranged between the distal end of the first flexible tube and the proximal end of the second flexible tube.
- the hardness of the connecting tube is greater than that of the first and second flexible tubes.
- the traction structure includes a first traction wire and a second traction wire, the first traction wire is connected to the first flexible tube, and the second traction wire is connected to the second flexible tube ,
- the first traction wire and the second traction wire both extend in the outer tube, and the free end of the first traction wire and the free end of the second traction wire both extend out of the proximal end of the connecting tube, and the first traction wire can slide relative to the tube body , And can drive the first flexible tube to bend in the first plane, the second traction wire can slide relative to the tube body, can drive the second flexible tube to bend in the second plane, the first plane and the second plane are intersected and parallel Or coplanar.
- a medical device is further provided, and the medical device includes the above-mentioned delivery sheath.
- the delivery sheath When the above delivery sheath is used, the delivery sheath enters the right atrium from the inferior vena cava, and then the atrial septum is punctured. After the puncture, the distal tube and part of the tube body of the delivery sheath enter the left atrium, and then pass through the first traction The wire exerts a traction force on the distal end of the first flexible tube.
- the first flexible tube bends and deforms in the first plane and drives the distal end tube to move.
- the second traction wire exerts a traction force on the distal end of the second flexible tube.
- the tube bends and deforms in the second plane and drives the distal tube to move.
- the position of the distal tube can be adjusted in two dimensions through the first traction wire and the second traction wire, so that The distal tube is coaxial with the left atrial appendage, and the hardness of the connecting tube is greater than that of the first flexible tube and the second flexible tube, which can provide sufficient axial support for the delivery sheath, so that during the operation, the first flexible tube and The second flexible tube is adjusted on a stable structure, so that the first flexible tube and the second flexible tube can be controlled and the bending shape can be predicted, so that the delivery tube sheath can quickly complete the coaxiality with the left atrial appendage
- the hardness of the spacer tube is greater than the hardness of the first flexible tube and the second flexible tube, which can prevent the fulcrum of the second flexible tube from moving to the first flexible tube, thereby avoiding the second flexible tube bending
- the effect of influencing the shape of the first flexible tube enables the delivery tube sheath to quickly complete the coaxial operation with the left atrial appendage
- Fig. 1 is a schematic diagram of the structure of a single-bent preformed sheath in the prior art.
- Fig. 2 is a state diagram of the single-bend preformed sheath tube in use in the prior art.
- Fig. 3 is a schematic cross-sectional structure diagram of a delivery sheath according to an embodiment.
- Fig. 4 is a partial cross-sectional view of a delivery sheath according to an embodiment.
- Fig. 5 is a partial cross-sectional view of a delivery sheath according to an embodiment.
- Fig. 6 is a perspective view of a first fixing structure according to an embodiment.
- Fig. 7 is a schematic structural diagram of a first traction wire in cooperation with a first fixing structure according to an embodiment.
- Fig. 8 is a schematic structural diagram of a connecting pipe according to an embodiment.
- Fig. 9 is a state diagram of the delivery sheath of an embodiment when in use.
- Fig. 10 is a cross-sectional view of A-A in Fig. 9.
- Fig. 11 is a schematic structural diagram of a delivery sheath according to an embodiment.
- Fig. 12 is a schematic diagram of the structure of a delivery sheath according to an embodiment.
- Fig. 13 is a schematic cross-sectional view of a delivery sheath according to an embodiment.
- Fig. 14 is a schematic cross-sectional view of a delivery sheath according to an embodiment.
- Fig. 15 is a schematic diagram of the structure of a support according to an embodiment.
- Fig. 16 is a schematic diagram of the structure of a support according to an embodiment.
- Fig. 17 is a schematic diagram of the structure of a support according to an embodiment.
- Fig. 18 is a schematic diagram of the structure of a support according to an embodiment.
- Fig. 19 is a schematic view of the structure of a support according to an embodiment.
- distal and proximal are used as orientation words, where “distal” refers to the end far away from the operator during the operation, and “proximal” refers to the end close to the operator during the operation One end.
- the delivery sheath 60 provided in this embodiment is an adjustable bendable sheath, and the delivery sheath 60 includes a tube body portion 600, which is in a straight shape in a natural state.
- the tube portion 600 includes an inner layer tube 610, an intermediate layer 620, an outer layer tube 630, and a traction structure 640 stacked from the inside to the outside.
- the inner tube 610 is made of polymer material, which has high lubricity and low friction. Its inner surface is smooth, which can ensure that the implanted device (such as the left atrial appendage occluder, not shown) can pass through the inner surface smoothly.
- the material can be a polymer material such as PTFE (polytetrafluoroethylene).
- the middle layer 620 is a metal layer and is attached to the outer surface of the inner tube 610.
- the middle layer 620 may be a braided tube braided by metal wires.
- the middle layer 620 may also be a metal spring tube.
- the braided tube is braided by a braiding machine using metal wires.
- the metal spring tube is made by the spring machine that winds the spring.
- the outer tube 630 is made of polymer materials with different hardness (or different elasticity), and the material can be a polymer material such as Pebax (nylon elastomer).
- the middle layer 620 is tightly tied and attached to the outer surface of the inner layer tube 610, and then the outer layer tube 630 is sheathed, and then heat-melted to form the inner layer tube.
- the outer surface of the 610 is joined with the inner surface of the outer tube 630, so that the inner tube 610, the middle layer 620, and the outer tube 630 form an integrated structure.
- the outer tube 630 includes a connecting tube 631, a tube body 632 and a distal tube 633.
- the connecting tube 631 is located at the proximal end of the tube body 632
- the distal tube 633 is located at the distal end of the tube body 632
- the tube body 632 is located between the connecting tube 631 and the distal tube 633.
- One end of the tube body 632 is connected to the connecting tube 631.
- the other end of the body 632 is connected to the distal tube 633.
- the tube body 632 includes a first flexible tube 6321, a spacer tube 6322, and a second flexible tube 6323.
- the proximal end of the first flexible tube 6321 is connected to the connecting tube 631.
- the spacer tube 6322 is a straight tube in its natural state, and the spacer tube 6322 is provided between the distal end of the first flexible tube 6321 and the proximal end of the second flexible tube 6323.
- the distal end of the second flexible tube 6323 is connected to the proximal end of the distal tube 633.
- the first flexible tube 6321 and the second flexible tube 6323 are adjustable bendable tubular structures, that is, the first flexible tube 6321 and the second flexible tube 6323 are The traction force can cause bending deformation.
- the hardness of the connecting pipe 631 is greater than that of the first flexible pipe 6321 and the second flexible pipe 6323.
- the hardness of the spacer pipe 6322 is greater than that of the first flexible pipe 6321 and the second flexible pipe 6323.
- the hardness of 633 is greater than the hardness of the first flexible tube 6321 and the second flexible tube 6323.
- the traction structure 640 includes a first traction wire 641a, a second traction wire 642a, a first fixing structure, and a 641b second fixing structure 642b.
- the first traction wire 641a is connected to the distal end of the first flexible tube 6321
- the second traction wire 642a is connected to the distal end of the second flexible tube 6323
- the first traction wire 641a and the second traction wire 642a are both straight in the outer tube 630
- the free end of the first traction wire 641a and the free end of the second traction wire 642a both extend out of the proximal end of the connecting tube 631.
- the first traction wire 641a is slidable relative to the tube body 632, and can drive the first flexible tube 6321 to bend to the side of the force in the first plane P (shown in FIG. 10).
- the second traction wire 642a is slidable relative to the tube body 632, and can drive the second flexible tube 6323 to bend to the side of the force in the second plane Q (shown in FIG. 10).
- the first plane P and the second plane Q intersect.
- the first fixing structure 641b and the second fixing structure 642b are both fixed in the tube body 632, and the first fixing structure 641b and the second fixing structure 642b are both annular bodies. Specifically, the first fixing structure 641b is provided at the distal end of the first flexible tube 6321, the distal end of the first fixing structure 641b is flush with the distal end of the first flexible tube 6321, and the first fixing structure 641b is embedded in the first flexible tube 6321. In 6321.
- the second fixing structure 642 b is provided at the distal end of the second flexible tube 6323, the distal end of the second fixing structure 642 b is flush with the distal end of the second flexible tube 6323, and the second fixing structure 642 b is embedded in the second flexible tube 6323.
- the side walls of the first fixing structure 641b and the second fixing structure 642b have three connecting holes. Since the distribution of the connecting holes on the first fixing structure 641b and the second fixing structure 642b is the same, only the connecting holes on the first fixing structure 641b are described here. Please refer to FIG. 6, the sidewall of the first fixing structure 641b is opened There are a first connecting hole 6411a, a second connecting hole 6411b, and a third connecting hole 6411c. Along the circumferential direction of the first fixing structure 641b, the second connecting hole 6411b is located between the first connecting hole 6411a and the third connecting hole 6411c.
- the hole centers of the first connecting hole 6411a, the second connecting hole 6411b, and the third connecting hole 6411c The line of can form a triangle 6412.
- the inner angle A formed by the triangle 6412 at the center of the second connecting hole 6411b is an obtuse angle.
- the first traction wire 641a sequentially passes through the first connecting hole 6411a, the second connecting hole 6411b, and the third connecting hole 6411c to be connected to the first fixing structure 641b.
- the second traction wire 642a sequentially passes through the three connecting holes 6411 of the second fixing structure 642b to be connected to the second fixing structure 642b.
- the hole centers of the first connecting hole 6411a and the third connecting hole 6411c are located on the same circumferential line of the first fixing structure 641b, and the first pulling wire 641a passes through the first connecting hole 6411a and the second connecting hole 6411b in sequence And the third connecting hole 6411c are connected to the first fixing structure 641b, so that the first traction wire 641a is formed at the first connecting hole 6411a, the second connecting hole 6411b, and the third connecting hole 6411c of the first fixing structure 641b.
- the angles are all obtuse angles, which can avoid stress concentration of the first traction wire 641a during use, and increase the service life.
- the structure of the second fixing structure 642b is the same as the structure of the first fixing structure 641b, and the connection between the second traction wire 642a and the second fixing structure 642b is the same as that of the first traction wire 641a and the first fixing structure 641b.
- the connection method is the same, and the stress concentration of the second traction wire 642a during use can also be avoided.
- the traction structure 640 only includes the above-mentioned first fixing structure 641b and the first traction wire 641a connected thereto, or the traction structure 640 only includes the above-mentioned second fixing structure 642b and the second traction wire 641a connected thereto. Traction wire 642a.
- the hardness of the first flexible tube 6321 ranges from 10D to 40D, which can ensure that the first flexible tube 6321 is adjustable in the first plane P.
- the hardness of the second flexible tube 6323 ranges from 10D to 40D, which can ensure that the second flexible tube 6323 is adjustable in the second plane Q.
- the hardness of the connecting tube 631 ranges from 55D to 72D, that is, the hardness of the connecting tube 631 is greater than the hardness of the first flexible tube 6321 and the second flexible tube 6323. Therefore, when the delivery sheath 60 meets the requirements of adapting to the vascular shape, the connecting tube 631 Provide sufficient axial support for the delivery sheath 60, so that during the operation, the first flexible tube 6321 and the second flexible tube 6323 are adjusted on a stable structure, so that the first flexible tube 6321 and the second flexible tube 6323 The controllable and predictable bending adjustment of the tube enables the delivery tube sheath 60 to quickly complete the coaxial operation with the left atrial appendage.
- the hardness of the spacer tube 6322 ranges from 55D to 72D, that is, the hardness of the spacer tube 6322 is greater than the hardness of the first flexible tube 6321 and the second flexible tube 6323, which can prevent the fulcrum of the second flexible tube 6323 from moving to the first flexible tube during bending.
- the effect of avoiding the influence of the shape of the first flexible tube 6321 when the second flexible tube 6323 is bent is achieved, so that the delivery tube sheath 60 can quickly complete the coaxial operation with the left atrial appendage.
- the hardness of the distal tube 633 ranges from 55D to 72D, which can ensure the axial strength of the distal tube 633, so that the distal tube 633 always maintains a straight shape when releasing or retrieving the implanted device, ensuring that the implanted device can be released smoothly And recycling.
- the connecting tube 631, the spacer tube 6322 and the distal tube 633 have the same hardness, and the hardness is all 72D, which can provide sufficient axial supporting force when the delivery sheath 60 meets the requirements of adapting to the shape of the blood vessel.
- the hardness of the first flexible tube 6321 is greater than or equal to the hardness of the second flexible tube 6323, which can also prevent the second flexible tube 6323 from affecting the shape of the first flexible tube 6321 when the second flexible tube 6323 is adjusted.
- the distal tube 633 cannot be coaxial with the left atrial appendage due to the influence of the shape of the first flexible tube 6321.
- the first traction wire 641a is made of a high-strength material, such as carbon fiber wire or nickel titanium wire.
- the first traction wire 641a is a multi-strand wire. Compared with a single wire, the fatigue stress of the multi-strand wire is smaller. When connected with the first fixed structure 641b, fatigue stress concentration fracture is not easy to occur, even if the first traction wire 641a is If one of the wires is broken, other wires can also adjust the angle of the sheath.
- the service life of the first traction wire 641a can be prolonged, and when a wire of the first traction wire 641a is broken, an abnormal noise (such as a "bang" sound) will be emitted, which can remind the operator, first One of the traction wires 641a has been damaged and should be used with care, and the operation process should be ended as soon as possible.
- an abnormal noise such as a "bang" sound
- the structure of the second traction wire 642a is the same as the structure and material of the first traction wire 641a, and both are multi-strand wires.
- the connecting tube 631 includes a proximal portion 6311 and a distal portion 6312, and the distal portion 6312 is connected to the first flexible tube 6321 of the tube body 632.
- the delivery sheath 60 has a first wall thickness in the length of the proximal portion 6311, and the delivery sheath 60 has a second wall thickness in the length of the distal portion 6312, and the first wall thickness is greater than the second wall thickness. Furthermore, the strength of the delivery sheath 60 in the length range of the proximal portion 6311 is enhanced.
- the traction structure 640 can be prevented from driving the tube body in the length range of the proximal portion 6311 of the delivery sheath 60. Bending deformation occurs (that is, to avoid “hunchback” deformation of the corresponding delivery sheath 60 within the length interval of the proximal portion 6311). In turn, compression of blood vessels and internal organs caused by the "hunchback" of the delivery sheath 60 can be avoided.
- the delivery sheath 60 is provided with a layer of high-hardness polymer material outside the outer tube 630, the hardness of the high-hardness polymer material ranges from 63D to 72D, and the high-hardness polymer material is designed
- the wall thickness and strength of the delivery sheath 60 in the length interval of the proximal portion 6311 can be enhanced.
- the thickness of the intermediate layer 620 within the length of the proximal portion 6311 is thickened to enhance the wall thickness and strength of the delivery sheath 60 within the length of the proximal portion 6311.
- the inner diameter of the delivery sheath 60 in each section is the same.
- the delivery sheath 60 has a first outer diameter at the first wall thickness portion, and the delivery sheath 60 has a second outer diameter at the second wall thickness portion.
- the outer diameter is greater than the second outer diameter.
- the first outer diameter of the delivery sheath 60 smoothly transitions to the second outer diameter, which can reduce the damage of the delivery sheath 60 to the patient's blood vessels and internal organs.
- the inner diameter and outer diameter of the delivery sheath 60 in each section are the same, and the wall thickness of the delivery sheath 60 in each section is the same.
- the delivery sheath 60 When the delivery sheath 60 is used, the delivery sheath 60 enters the right atrium 23 from the inferior vena cava 31, and then the atrial septum 27 is punctured. After the puncture, the distal end of the delivery sheath 60 633 and a part of the tube body 632 enter the left atrium 25, and then apply a traction force to the distal end of the first flexible tube 6321 through the first traction wire 641a.
- the first flexible tube 6321 bends and deforms in the first plane P, and the distal tube 633 can be The X position moves to the Y position, and then a traction force is applied to the distal end of the second flexible tube 6323 through the second traction wire 642a.
- the second flexible tube 6323 bends and deforms in the second plane Q, and the distal tube 633 can move from the Y position to Z position. So far, the distal tube 633 is coaxial with the left atrial appendage 29. Since the first plane P and the second plane Q intersect, the position of the distal tube 633 can be adjusted in two dimensions through the first traction wire 641a and the second traction wire 642a.
- the delivery sheath 60 of this embodiment can be applied to all anatomical forms of the heart, and the position of the distal tube 633 of the delivery sheath 60 can be adjusted from two dimensions to ensure that the distal tube 633 is coaxial with the left atrial appendage 29, thereby improving delivery
- the convenience of the operation of the sheath 60 can also save operation time and reduce the harm to the patient.
- a spacer tube 6322 is provided between the first flexible tube 6321 and the second flexible tube 6323, and the hardness of the spacer tube 6322 is greater than the hardness of the first flexible tube 6321 and the second flexible tube 6323.
- the fulcrum when the second flexible tube 6323 is bent can be locked at the end of the second flexible tube 6323 that abuts the spacer tube 6322 (that is, the proximal end of the second flexible tube 6323) to avoid
- the second flexible tube 6323 affects the shape of the first flexible tube 6321 when the second flexible tube 6323 is bent, thereby avoiding the inability of the distal tube 633 to be coaxial with the left atrial appendage due to the influence of the second flexible tube 6323 on the shape of the first flexible tube 6321 .
- the first plane P and the second plane Q are perpendicular to each other, the first flexible tube 6321 is adjusted in the first plane P, and the second flexible tube 6323 is adjusted in the second plane Q, which can further improve the delivery sheath 60
- the precision of bending adjustment reduces the operation time and improves the convenience of operation.
- the first plane P and the second plane Q are parallel and coplanar, or the first plane P and the second plane Q are parallel.
- the delivery sheath 60 cannot be coaxial with the left atrial appendage caused by the backward or forward puncture point.
- the backward puncture point means that In the plane where the interatrial septum is located, along the extending direction perpendicular to the interatrial septum, it is biased toward the back of the human body, and the forward direction of the puncture point is opposite to the backward direction of the puncture point.
- the delivery sheath 60 cannot be coaxial with the left atrial appendage caused by the forward or backward puncture point, and the high or low puncture point can also be avoided.
- the delivery sheath 60 cannot be coaxial with the left atrial appendage.
- the low puncture point refers to the direction of the apex along the extension direction of the atrial septum in the plane of the atrial septum, and the high puncture point and the puncture point The lower side is in the opposite direction.
- the difference between the second embodiment and the first embodiment is that the tube portion 600 is in a curved shape in a natural state.
- the first flexible tube 6321 is preformed into a curved tube structure in the first plane P, and the extension direction of the proximal end of the first flexible tube 6321 and the extension direction of the distal end of the first flexible tube 6321 form a clip.
- Angle B, the included angle B ranges from 45° to 90°.
- the second flexible tube 6323 When the second flexible tube 6323 is in the natural state, the second flexible tube 6323 is preformed into a curved tube structure in the second plane Q, and the proximal end of the second flexible tube 6323 extends in the same direction as the second flexible tube 6323
- the extending direction of the distal end forms an included angle C, and the included angle C ranges from 30° to 60°.
- the delivery sheath 60 is preformed on the basis of the first flexible tube 6321 and the second flexible tube 6323. Only the shape of the delivery sheath 60 needs to be fine-tuned to make the distal tube 633 of the delivery sheath 60 and the left atrial appendage Coaxial.
- one of the first flexible tube 6321 and the second flexible tube 6323 is bent in its natural state, that is, the extension direction of the proximal end of the first flexible tube 6321 is the same as that of the first flexible tube 6321.
- the extending direction of the distal end forms an included angle B, and the included angle B is 45° to 90°.
- the extending direction of the proximal end of the second flexible tube 6323 and the extending direction of the distal end of the second flexible tube 6323 form an included angle C, and the included angle C is 30° to 60°.
- the spacer tube 6322 is in a curved shape in the second plane Q when in its natural state.
- the spacer tube 6322 can be curved in the second plane Q by pre-molding.
- the bending direction of the spacer tube 6322 and the second flexible tube 6323 are opposite, so that the delivery sheath 60 has an "S" shape in its natural state.
- the extending direction of the proximal end of the spacer tube 6322 and the extending direction of the distal end of the spacer tube 6322 form an included angle D, and the included angle D ranges from 30° to 60°.
- the tube body 632 further includes a transition tube 6324, and the number of transition tubes 6324 may be one or more.
- the hardness of the transition tube 6324 is less than the hardness of the connecting tube 631, the spacer tube 6322 and the distal tube 633.
- the hardness of the transition pipe 6324 is greater than the hardness of the first flexible pipe 6321 and the second flexible pipe 6323.
- the hardness of the transition pipe 6324 ranges from 40D to 55D.
- the number of transition pipes 6324 is four. Specifically, a transition tube 6324 is provided between the distal end tube 633 and the second flexible tube 6323. When the implanted device is retrieved, it is possible to prevent the hardness difference between the second flexible tube 6323 and the distal end tube 633 from being too large. The delivery sheath 60 is bent at the junction of the second flexible tube 6323 and the distal tube 633. A transition tube 6324 is provided between the connecting tube 631 and the first flexible tube 6321. When the implanted device is recovered, it can be avoided that the hardness difference between the first flexible tube 6321 and the connecting tube 631 is too large. The junction of the first flexible tube 6321 and the connecting tube 631 is bent.
- a transition tube 6324 is provided between the spacer tube 6322 and the first flexible tube 6321.
- the first flexible tube 6321 and the spacer tube 6322 are bent at the junction.
- a transition tube 6324 is provided between the spacer tube 6322 and the second flexible tube 6323.
- the second flexible tube 6323 and the spacer tube 6322 are bent at the junction. This ensures that the delivery sheath 60 can safely retrieve the implanted device.
- the number and location of the transition pipes 6324 can also be selected according to actual requirements, for example, the number of transition pipes 6324 is one.
- the transition pipe 6324 may be provided between the spacer pipe 6322 and the second flexible pipe 6323. Alternatively, the transition pipe 6324 is provided between the spacer pipe 6322 and the first flexible pipe 6321. Alternatively, the transition pipe 6324 is provided between the connecting pipe 631 and the first flexible pipe 6321. Alternatively, the transition tube 6324 is provided between the distal tube 633 and the second flexible tube 6323.
- the delivery sheath 60 in this embodiment further includes a support 651, and the number of the support 651 is at least one.
- the support 651 is disposed on the outer surface of the intermediate layer 620, and the support 651 is located on the inner side of the outer surface of the outer tube 630.
- the number of support members 651 is multiple.
- the first flexible tube 6321 and the second flexible tube 6323 are both provided with a support 651 in the section where the first flexible tube 6321 and the second flexible tube 6323 are located.
- the distal end of the support 651 is fixedly connected to the first fixing structure 641b, so that the distal end of the support 651 and the first fixing structure 641b form an annular end surface, which can avoid the support The distal end of the 651 is too sharp.
- the distal end of the support 651 is fixedly connected to the second fixing structure 642b, so that the distal end of the support 651 and the first fixing structure 642b form an annular end surface, which can avoid the support The distal end of the 651 is too sharp.
- the supporting member 651 may be a wire material with super elasticity, and the wire diameter of the supporting member 651 is smaller than the wall thickness of the outer layer tube 630 so that the supporting member 651 can be arranged between the outer layer tube 630 and the middle layer 620.
- the support 651 can follow the first flexible tube 6321 to bend in the first plane P under the pulling action of the first traction wire 641a. Under the pulling action of the second traction wire 642a, the support 651 follows the second flexible tube 6323 to bend in the second plane Q.
- the supporting member 651 Since the supporting member 651 is super-elastic, the supporting member 651 will not hinder the bending deformation of the first flexible tube 6321 and the second flexible tube 6323, and the supporting member 651 can increase the axial direction of the first flexible tube 6321 and the second flexible tube 6323
- the supporting force in turn, can increase the axial supporting force of the delivery sheath 60 in the first flexible tube 6321 and the second flexible tube 6323, so that the delivery sheath 60 can increase its axial supporting force on the basis of its adjustable bending performance.
- the delivery sheath 60 has a stable shape, and the implanted device can be smoothly delivered and recovered.
- the first flexible tube 6321 is restored to its natural state under the superelastic action of the support 651, and the second flexible tube 6323 is supporting
- the super-elasticity of the support 651 compensates for the elastic hysteresis effect of the outer tube 630 during the morphological process in its natural state under the super-elastic action of the member 651.
- the number of support members 651 can also be 3, 4 or more, and the delivery sheath 60 is provided with a plurality of support members 651 along its circumference in the first flexible tube 6321, which can further improve the delivery sheath.
- the delivery sheath 60 is provided with a plurality of support members 651 along the circumference of the second flexible tube 6323, which can further improve the axial support force of the second flexible tube 6323.
- the number of the supporting member 651 may also be one, and the supporting member 651 may be provided in the section where one of the second flexible tube 6323 and the first flexible tube 6321 is located.
- the support 661 in other embodiments may also be a sheet material.
- the wall thickness of the support 661 is smaller than the wall thickness of the outer tube 630 so that the support 661 is more easily embedded in the outer tube 630.
- the supporting member 671 in this embodiment is a spiral body
- the supporting member 671 is sleeved on the outer surface of the intermediate layer 620
- the supporting member 671 is located On the inner side of the outer surface of the outer tube 630
- the support 671 is made of a super-elastic material.
- the support 671 includes a proximal section 6711, a spiral extension section 6712, and a distal section 6713.
- the spiral extension section 6712 is located at the proximal section 6711 Between and the distal section 6713.
- the proximal section 6711 of the support 671 is a closed ring-shaped body, and the distal end of the proximal section 6711 is connected with the spiral extension section 6712.
- the distal section 6713 of the support 671 is a closed ring.
- the first connecting hole 6411a, the second connecting hole 6411b, and the third connecting hole 6411c may not be provided on the fixing structure, but on the side wall of the distal section 6713 of the support 671, which can avoid the first traction wire 641a and the second traction
- the wire 642a exhibits stress concentration during use, which can also save a fixed structure material and reduce costs.
- the spiral extension 6712 has an extension 67121, which can be formed by cutting a pipe in the spiral extension 6712 by a laser, and the extension 6712 spirally extends in the spiral extension 6712.
- the extension body 67121 and the central axis 6714 of the support 671 form a clip
- the angle E ranges from 0° to 90°. It is possible to provide sufficient axial supporting force while ensuring that the support 671 can be bent in an adjustable manner.
- the included angle E formed by the extension 67121 and the central axis 6714 of the support 671 is in the range of 60° to 90°.
- the axial thickness L of the extension 67121 is 0.05mm-3.0mm.
- the axial thickness L of the extension 67121 is 0.1 mm-0.5 mm.
- the gap D between two adjacent extensions 67121 is 0.05mm-3.0mm.
- the gap D between two adjacent extensions 67121 is 0.1mm-0.5mm.
- the included angle E formed by the extension body 67121 and the central axis of the support 671 the smaller the included angle E, the larger the gap D between two adjacent extensions 67121, the better the adjustable bending performance of the support 671, the angle The larger the E, the smaller the gap D between the two adjacent extensions 67121, and the greater the axial supporting force of the support 671.
- the difference between the seventh embodiment and the eighth embodiment is that the support 681 in this embodiment is a keel structure.
- the sections where the first flexible pipe 6321 and the second flexible pipe 6323 are located are provided with a support 681.
- the support 681 includes a keel 6811 and a plurality of skeletons 6812, and the plurality of skeletons 6812 are along the axial direction of the keel 6811.
- the two ends of the plurality of skeletons 6812 are respectively connected to the two sides of the keel 6811, the keel 6811 and the plurality of skeletons 6812 together form an annular storage space 6813, the middle layer 620 (that is, the tube of the delivery sheath 60 The wall) is accommodated in the receiving space 6813 so that the support 681 is sleeved outside the middle layer 620 (that is, the support 681 is provided in the delivery sheath 60).
- the frameworks 6812 are arranged at intervals, so that there is a space for deformation between the frameworks 6812, and the bending resistance of the support 681 can be reduced to ensure that the support 681 does not hinder the first flexible tube 6321 and 6321.
- the frameworks 6812 are spaced apart from each other, which can also allow the polymer material of the outer tube 630 to be embedded, which can prevent the support 681 from sliding along the outer tube 630 axially, thereby avoiding the support
- the proximal end of 681 pierces the polymer material of the outer tube 630.
- the supporting member 681 can increase the axial supporting force of the first flexible tube 6321 and the second flexible tube 6323, and avoid bending of the delivery sheath 60.
- the interval section where the support 681 is located can also be selected according to actual requirements.
- the support member 681 is only provided in the interval section where the first flexible tube 6321 is located.
- the support 681 is provided only in the section where the second flexible tube 6323 is located.
- the most distal skeleton 6812 of the plurality of skeletons 6812 has a distal end surface 68121, and the distal end of the keel 6811 is flush with the distal end surface 68121, or the distal end of the keel 6811 is located on the proximal side of the distal end surface 68121 . It can be avoided that the distal end of the keel 6811 pierces the outer tube 630 when the delivery sheath 60 is adjusted.
- the most proximal skeleton 6812 of the plurality of skeletons 6812 has a proximal end surface 68122, and the proximal end of the keel 6811 is flush with the proximal end surface 68122, or the proximal end of the keel 6811 is located on the distal side of the proximal end surface 68122. It can be avoided that the distal end of the keel 6811 pierces the outer tube 630 when the delivery sheath 60 is adjusted.
- the distal end of the support 681 is provided with the above-mentioned first connecting hole 6411a, second connecting hole 6411b and third connecting hole 6411c, which can avoid stress concentration of the first traction wire 641a and the second traction wire 642a during use, and Can save a fixed structure of material and reduce costs.
- the first connecting hole 6411a, the second connecting hole 6411b, and the third connecting hole 6411c may be provided at the distal end of the keel 6811.
- the first connecting hole 6411a, the second connecting hole 6411b, and the third connecting hole 6411c may be provided on the skeleton 6812 at the distal end of the support 681.
- the length L2 of the support 681 is equal to the length of the first flexible pipe 6321.
- the length L2 of the support 681 is equal to the length L2 of the first flexible pipe 6321.
- the lengths of the two flexible pipes 6323 are equal.
- the width L1 of the keel 6811 is less than half of the circumference L3 of any frame 6812, that is, L1 ⁇ L3/2.
- the support member 681 can have The super-elastic Nitinol tube is made by laser cutting.
- the difference between the eighth embodiment and the seventh embodiment is that the keel 691 is also provided with a hollow structure 6913, and the elastic nylon of the outer tube 630 can enter the hollow structure 6913 to enlarge the keel 691 and the outer
- the contact area of the layer tube 630 can increase the bonding strength of the elastic nylon of the support member 691 and the outer layer tube 630, increase the fatigue life of the support member 691, and prolong the service life.
- the shape of the hollow structure 6913 may be rectangle, circle, oval, square, triangle, rhombus, etc.
- the shape of the hollow structure 6913 is a rhombus.
- the shape of the hollow structure 6913 is a rhombus, which improves the bendable deformation ability of the support 691, thereby reducing the hindering effect of the support 691 on the bending deformation of the first flexible tube 6321 and the second flexible tube 6323.
- the joint portion of the keel 6911 and the skeleton 6912 is provided with a groove 6914, so that the material of the keel 6911 has a deformation space when the keel 6911 is bent and deformed, and the compliance of the support member 691 when it is bent is increased.
- the frame 6912 includes a first connection portion 69121 and a second connection portion 69123 disposed on both sides of the keel 6911, the first connection portion 69121 and the second connection portion 69123 are symmetrical about the axis of the keel 6911.
- the free end of the first connecting portion 69121 is provided with a buckle 69122.
- the buckle 69122 is T-shaped.
- the free end of the second connecting portion 69123 is provided with a slot 69124, and the slot 69124 has elasticity.
- the slot width of the slot 69124 can be enlarged within a certain range under the action of external force.
- the size of the slot 69124 along the axis of the keel 6912 can be enlarged to a certain extent.
- the shape of the groove 69124 matches with the buckle 69122, so that the groove 69124 can accommodate the buckle 69122, and the buckling cooperation between the groove 69124 and the buckle 69122 is realized to form a receiving space 6813.
- the buckle 69122 is inserted into the groove 69124 so that the first connecting portion 69121 is engaged with the second connecting portion 69123. Due to the elasticity of the groove 69124, the groove width of the groove 69124 can be enlarged within a certain range under the action of external force.
- the buckle 69122 can slide along the length of the groove 69124 in the groove 69124, that is, the circumference of the frame 6912 is in a certain range.
- the range is variable, so that the support 691 can be applied to the delivery sheath 60 of various tube diameters.
- the support 711 of this embodiment further includes a plurality of proximal reinforcement ribs 7115, distal reinforcement ribs 7116, and intermediate reinforcement ribs 7117.
- the reinforcing ribs 7115, the distal reinforcing ribs 7116, and the middle reinforcing ribs 7117 are all arranged along the length direction of the keel 7111, and the proximal reinforcing ribs 7115, the distal reinforcing ribs 7116 and the middle reinforcing ribs 7117 are all arranged in pairs.
- a pair of proximal stiffeners 7115 are provided between the proximal end of the support 711 adjacent to the two skeletons 7112, and the pair of proximal stiffeners 7115 are symmetrical with respect to the longitudinal center axis 7118 of the support 711.
- a pair of distal reinforcement ribs 7116 is provided between the two adjacent frameworks 7112 at the distal end of the support 711, and the pair of distal reinforcement ribs 7116 are symmetrical with respect to the longitudinal center axis 7118 of the support 711.
- a middle reinforcing rib 7117 is provided between the adjacent two skeletons 7112 between the proximal reinforcing rib 7115 and the distal proximal reinforcing rib 7116, and the middle reinforcing ribs 7117 are distributed in pairs in the longitudinal center.
- the middle stiffeners 7117 arranged in pairs are symmetrical about the longitudinal center axis 7118.
- the proximal stiffeners 7115, the distal stiffeners 7116 and the middle stiffeners 7117 can increase the axial supporting force of the support, thereby increasing the conveying The axial support force of the sheath 60.
- the support 711 is symmetrical about its transverse central axis 7119.
- the proximal reinforcement ribs 7115, the distal reinforcement ribs 7116, and the intermediate reinforcement ribs 7117 are all arranged at a distance from the keel 7111. Specifically, the distance from the proximal stiffener 7115 to the longitudinal central axis 7118 is equal to the distance from the distal stiffener 7116 to the longitudinal central axis 7118, both of which are D1. The distance between the middle rib 7117 and the longitudinal center axis 7118 is D2, and D1 is greater than or equal to D2.
- the proximal stiffener 7115, the distal stiffener 7116, and the intermediate stiffener 7117 are all arranged at a distance from the keel 7111, and D1 is greater than or equal to D2, which increases the axial support force of the support 711 while increasing The compliance of the support 711 when it is bent, thereby reducing the traction required when the support 711 is adjusted.
- the proximal stiffeners 7115, the distal stiffeners 7116, and the intermediate stiffeners 7117 arranged in pairs are all symmetrical about the longitudinal center axis 7118, and the support member 711 is symmetrical about the transverse center axis 7119, which can also increase the axial direction of the support member 711.
- the compliance of the supporting member 711 when bending is increased, thereby reducing the traction force required for the supporting member 711 to adjust the bending.
- the distance between the proximal stiffener 7115 and the longitudinal central axis 7118 is not equal to the distance between the distal stiffener 7116 and the longitudinal central axis 7118, and the distance between the proximal stiffener 7115 and the longitudinal central axis 7118 is not equal to the distance between the proximal stiffener 7115 and the longitudinal central axis 7118.
- the distance between the end stiffener 7116 and the longitudinal center axis 7118 is greater than the distance between the middle stiffener 7117 and the longitudinal center axis 7118. It can also increase the axial support force of the support 711 and increase the compliance of the support 711 when it is bent. Therefore, the traction force required by the support 711 to adjust the bending is reduced.
- This embodiment provides a medical device, including the delivery sheath in the foregoing embodiment.
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Abstract
一种输送鞘管（60）和医疗器械，输送鞘管（60）包括外层管（630）和牵引结构（640），外层管（630）包括连接管（631）、管身（632）及远端管（633），管身（632）位于连接管（631）与远端管（633）之间，管身（632）包括第一柔性管（6321）、间隔管（6322）以及第二柔性管（6323），间隔管（6322）设于第一柔性管（6321）的远端与第二柔性管（6323）的近端之间，连接管（631）的硬度大于第一、第二柔性管（6321、6323）的硬度，间隔管（6322）的硬度大于第一、第二柔性管（6321、6323）的硬度，牵引结构（640）包括第一牵引丝（641a）和第二牵引丝（642a），第一牵引丝（641a）与第一柔性管（6321）的远端相连，第二牵引丝（642a）与第二柔性管（6323）的远端相连，第一牵引丝（641a）能够带动第一柔性管（6321）在第一平面（P）内产生弯曲，第二牵引丝（642a）带动第二柔性管（6323）在第二平面（Q）内产生弯曲，第一平面（P）与第二平面（Q）相交。该输送鞘管（60）可确保输送鞘管（60）与左心耳（29）同轴。
Description
本发明涉及医疗器械领域，特别是涉及一种输送鞘管和医疗器械。
微创介入手术由于其创伤较小，越来越受到医生和患者的青睐。在微创手术中，输送鞘管用于建立体外至体内(主要是病变部位)的输送通道，植入器械可由该输送通道输送至病变部位或回收。通过该输送通道还可以向患者体内输入药物或将患者体内的体液导出。
现有的用于输送左心耳封堵器的输送鞘管包括经预塑型的输送鞘管。
如图1所示，预塑型的输送鞘管包括单弯预塑型输送鞘管10。具体地，单弯预塑型输送鞘管10包括近端段11、远端段13和塑弯段15，近端段11和远端段13在自然状态下均为直型管，近端段11位于单弯预塑型输送鞘管10的近端一侧，远端段13位于单弯预塑型输送鞘管10的远端一侧。塑弯段15在自然状态下为一段弯曲形态的管结构，其数量为一段，塑弯段15位于近端段11和远端段13之间，近端段11和远端段13通过塑弯段15相连。近端段11的延伸方向与远端段13的延伸方向呈45°夹角。
如图2所示，人体包括心脏21和下腔静脉31，心脏21包括右心房23、左心房25、房间隔27和左心耳29。右心房23与下腔静脉31相连通。房间隔27位于右心房23与左心房29之间，房间隔27将右心房23与左心房29隔开，房间隔27具有第一端部271和第二端部272，第一端部271靠近心尖，第二端部272与第一端部相对设置并远离心尖，房间隔具有由第二端部272向第一端部271延伸的延伸方向。左心耳29大致呈桶状结构，其具有开放端和封闭端，开放端为开口结构，该开放端可使得左心耳29与左心房25相连通，封闭端对左心耳29进行封闭，左心耳29的中心轴线291与下腔静脉的延伸方向所形成的锐角大致为45°。
单弯预塑型输送鞘管10在使用时，一般是经下腔静脉31进入右心房23，再对房间隔27进行穿刺使得单弯预塑型输送鞘管10的远端段13进入左心房25内，并且近端段11保持在下腔静脉31内。保持在下腔静脉31内的近端段11可视为与下腔静脉31同轴。由于左心耳29的中心轴线291与下腔静脉31的延伸方向形成的锐角大致为45°，也就相当于左心耳29的中心轴线291与近端段11形成的锐角为45°。在房间隔27的穿刺点选择正确的情况下，房间隔27不会改变近端段11与远端段13之间的夹角，也就是说，近端段11与穿刺后的远端段13的夹角为45°，相当于下腔静脉31的延伸方向与穿刺后的远端段13形成的锐角为45°。因此，单弯预塑型鞘管10的远端段13可伸入左心耳29内，且远端段13与左心耳29的中心轴线291重合。
但是在实际操作中，实际的穿刺点与理想的穿刺点经常会出现偏差，并且有部分患者的左心耳29的中心轴线291与下腔静脉31的延伸方向的夹角小于45°，相当于左心耳29以封闭端为轴，左心耳29的开口向房间隔29的第一端部271一侧偏转一定角度。在对房间隔29进行穿刺时，当房间隔穿刺的位置不合适的时候，例如实际穿刺点相较于理想穿刺点偏高，即在房间隔29的长度方向，实际的穿刺点朝远离心尖的方向偏离理想的穿刺点，单弯预塑型输送鞘管10的远端段13可能在左心耳29的开口处与左心耳29的侧壁相抵，造成单弯预塑型输送鞘管10的远端段13无法伸入左心耳内，并且单弯预塑型输送鞘管10的远端段13无法与左心耳29的中心轴线291同轴。在此情况下，输送或者释放左心耳封堵器，左心耳封堵器的固定盘难以固定于左心耳29的内壁，左心耳封堵器易脱落造成器械栓塞。
在手术过程中，操作者可能会通过移动或者转动单弯预塑型输送鞘管10的近端以改变远端段13的位置，但是由于穿刺点偏高，不论如何移动或推拉，也无法使得远端段13与左心耳29的中心轴线29同轴。
发明内容
基于此，有必要提供一种输送鞘管，以解决现有技术中输送鞘管无法与左心耳同轴的问题。
一种输送鞘管，包括管体部分，管体部分包括外层管和牵引结构，外层管包括连接管、管身及远端管，管身位于连接管与远端管之间，管身包括第一柔性管、间隔管以及第二柔性管，间隔管设于第一柔性管的远端与第二柔性管的近端之间，连接管的硬度大于第一、第二柔性管的硬度，间隔管的硬度大于第一、第二柔性管的硬度，牵引结构包括第一牵引丝和第二牵引丝，第一牵引丝与第一柔性管相连，第二牵引丝与第二柔性管相连，第一牵引丝和第二牵引丝均在外层管内延伸，且第一牵引丝的自由端和第二牵引丝的自由端均延伸出连接管的近端，第一牵引丝相对管身可滑动，并能够带动第一柔性管在第一平面内产生弯曲，第二牵引丝相对管身可滑动，能够带动第二柔性管在第二平面内产生弯曲，第一平面与第二平面相交、平行或共面。
在其中一个实施例中还提供一种医疗器械，医疗器械包括上述的输送鞘管。
上述输送鞘管使用时，输送鞘管由下腔静脉进入右心房，然后再对房间隔进行穿刺，在穿刺后输送鞘管的远端管和管身的一部分进入左心房，然后通过第一牵引丝对第一柔性管的远端施加牵引力，第一柔性管在第一平面内弯曲变形并带动远端管运动，然后通过第二牵引丝对第二柔性管的远端施加牵引力，第二柔性管在第二平面内弯曲变形并带动远端管运动，由于第一平面和第二平面相交，因此通过第一牵引丝和第二牵引丝可在两个维度上调整远端管的位置，使得远端管与左心耳实现同轴，连接管的硬度大于第一柔性管和第二柔性管的硬度，可为输送鞘管提供足够轴向支撑力，使得在手术过程中，第一柔性管和第二柔性管在稳定的结构上进行调弯，进而使得第一柔性管和第二柔性管的调弯可控以及弯曲形态可预测，进而使得输送管鞘管能够快速完成与左心耳的同轴的操作，间隔管的硬度大于第一柔性管和第二柔性管的硬度，可以避免对第二柔性管调弯时的支点移动至第一柔性管上，进而达到避免第二柔性管调弯时影响第一柔性管的形态的效果，使得输送管鞘管能够快速完成与左心耳的同轴的操作。
图1为现有技术中单弯预塑型鞘管的结构示意图。
图2为现有技术中单弯预塑型鞘管使用时的一状态图。
图3为一实施例的输送鞘管的剖视结构示意图。
图4为一实施例的输送鞘管的局部剖视图。
图5为一实施例的输送鞘管的局部剖视图。
图6为一实施例的第一固定结构的立体图。
图7为一实施例的第一牵引丝与第一固定结构配合的结构示意图。
图8为一实施例的连接管的结构示意图。
图9为一实施例的输送鞘管使用时的状态图。
图10为图9中的A-A的剖视图。
图11为一实施例的输送鞘管的结构示意图。
图12为一实施例的输送鞘管的结构示意图。
图13为一实施例的输送鞘管的剖视结构示意图。
图14为一实施例的输送鞘管的剖视结构示意图。
图15为一实施例的支撑件的结构示意图。
图16为一实施例的支撑件的结构示意图。
图17为一实施例的支撑件的结构示意图。
图18为一实施例的支撑件的结构示意图。
图19为一实施例的支撑件的结构示意图。
为使本发明的上述目的、特征和优点能够更加明显易懂，下面结合附图对本发明的具体实施方式做详细的说明。在下面的描述中阐述了很多具体细节以便于充分理解本发明。但是本发明能够以很多不同于在此描述的其它方式来实施，本领域技术人员可以在不违背本发明内涵的情况下做类似改进，因此本发明不受下面公开的具体实施的限制。
需要说明的是，当元件被称为“固定于”或“设置于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。本文所 使用的术语“垂直的”、“水平的”、“左”、“右”以及类似的表述只是为了说明的目的，并不表示是唯一的实施方式。
除非另有定义，本文所使用的所有的技术和科学术语与属于本发明的技术领域的技术人员通常理解的含义相同。本文中在本发明的说明书中所使用的术语只是为了描述具体的实施方式的目的，不是旨在于限制本发明。本文所使用的术语“及/或”包括一个或多个相关的所列项目的任意的和所有的组合。
为了更加清楚地描述本申请的结构，采用“远端”、“近端”作为方位词，其中“远端”表示手术过程中远离操作者的一端，“近端”表示手术过程中靠近操作者的一端。
第一实施例
请参阅图3，本实施例提供的输送鞘管60为可调弯的鞘管，输送鞘管60包括管体部分600，管体部分600在自然状态下呈直线形态。
管体部分600包括由内至外层叠的内层管610、中间层620、外层管630和牵引结构640。
内层管610由高分子材料制成，具有高润滑性、低摩擦性，其内表面光滑，可保证植入器械(例如左心耳封堵器，图未示)顺畅地从内表面通过，其材料可以为PTFE(聚四氟乙烯)等高分子材料。
中间层620为金属层，贴设于内层管610的外表面上。请参阅图4，中间层620可以是由金属丝编织的编织管。请参阅图5，中间层620也可以是金属弹簧管。编织管是由编织机利用金属丝编织而成。金属弹簧管是由绕制弹簧的弹簧机绕制而成。
外层管630由硬度不同(或者说是弹性不同)的高分子材料制成，其材料可以为Pebax(尼龙弹性体)等高分子材料。
在制作输送鞘管60的过程中，将中间层620束紧并贴设于内层管610的外表面上，然后套上外层管630，再进行热熔成型，热熔后的内层管610的外表面与外层管630的内表面相接合，进而使得内层管610、中间层620和外层管630形成一体的结构。
请再次参阅图3，外层管630包括连接管631、管身632及远端管633。连 接管631位于管身632的近端，远端管633位于管身632的远端，管身632位于连接管631与远端管633之间，管身632的一端与连接管631相连，管身632的另一端与远端管633相连。
管身632包括第一柔性管6321、间隔管6322以及第二柔性管6323。第一柔性管6321的近端与连接管631相连。间隔管6322在其自然状态下为直形管，间隔管6322设于第一柔性管6321的远端与第二柔性管6323的近端之间。第二柔性管6323的远端与远端管633的近端相连，第一柔性管6321和第二柔性管6323为可调弯的管状结构，即第一柔性管6321和第二柔性管6323受牵引力作用可发生弯曲变形，连接管631的硬度大于第一柔性管6321和第二柔性管6323的硬度，间隔管6322的硬度大于第一柔性管6321和第二柔性管6323的硬度，远端管633的硬度大于第一柔性管6321和第二柔性管6323的硬度，第一柔性管6321和第二柔性管6323受牵引力作用弯曲变形时，连接管631、间隔管6322和远端管633均不发生弯曲变形。
牵引结构640包括第一牵引丝641a、第二牵引丝642a、第一固定结构和641b第二固定结构642b。
第一牵引丝641a与第一柔性管6321的远端相连，第二牵引丝642a与第二柔性管6323的远端相连，第一牵引丝641a和第二牵引丝642a均在外层管630内直线延伸，且第一牵引丝641a的自由端和第二牵引丝642a的自由端均延伸出连接管631的近端。第一牵引丝641a相对管身632可滑动，并能够带动第一柔性管6321在第一平面P(在图10中示出)内向受力一侧产生弯曲。第二牵引丝642a相对管身632可滑动，能够带动第二柔性管6323在第二平面Q(在图10中示出)内向受力一侧产生弯曲。第一平面P与第二平面Q相交。
第一固定结构641b和第二固定结构642b均固定于管身632中，第一固定结构641b和第二固定结构642b均为环状体。具体地，第一固定结构641b设于第一柔性管6321的远端，第一固定结构641b的远端与第一柔性管6321的远端平齐，且第一固定结构641b嵌入第一柔性管6321中。第二固定结构642b设于第二柔性管6323的远端，第二固定结构642b的远端与第二柔性管6323的远端平齐，且第二固定结构642b嵌入第二柔性管6323中。
第一固定结构641b和第二固定结构642b的侧壁开设三个连接孔。由于第一固定结构641b和第二固定结构642b上的连接孔的分布相同，在此仅以第一固定结构641b上的连接孔进行说明，请参阅图6，第一固定结构641b的侧壁开设有第一连接孔6411a、第二连接孔6411b和第三连接孔6411c。沿第一固定结构641b的圆周方向，第二连接孔6411b位于第一连接孔6411a与第三连接孔6411c之间，第一连接孔6411a、第二连接孔6411b和第三连接孔6411c的孔心的连线可形成一个三角形6412。三角形6412在第二连接孔6411b的孔心所形成的内角A为钝角。第一牵引丝641a依次穿过第一连接孔6411a、第二连接孔6411b和第三连接孔6411c以与第一固定结构641b相连。第二牵引丝642a依次穿过第二固定结构642b的三个连接孔6411以与第二固定结构642b相连。
请参阅图7，第一连接孔6411a和第三连接孔6411c的孔心位于第一固定结构641b的同一圆周线上，第一牵引丝641a依次穿过第一连接孔6411a、第二连接孔6411b和第三连接孔6411c以与第一固定结构641b相连，使得第一牵引丝641a在第一固定结构641b的第一连接孔6411a、第二连接孔6411b和第三连接孔6411c三处形成的夹角均为钝角，进而可以避免第一牵引丝641a在使用过程中出现应力集中，提高使用寿命。
可以理解地，第二固定结构642b的结构与第一固定结构641b的结构相同，第二牵引丝642a与第二固定结构642b之间的连接方式与第一牵引丝641a与第一固定结构641b的连接方式相同，也可以避免第二牵引丝642a在使用过程中出现应力集中。
在其他实施例中，牵引结构640只包括上述的第一固定结构641b以及与之相连的第一牵引丝641a，或者，牵引结构640只包括上述的第二固定结构642b以及与之相连的第二牵引丝642a。
第一柔性管6321的硬度范围为10D至40D，可以保证第一柔性管6321在第一平面P内可调弯。第二柔性管6323的硬度范围为10D至40D，可以保证第二柔性管6323在第二平面Q内可调弯。
连接管631的硬度范围为55D至72D，即连接管631的硬度大于第一柔性管6321和第二柔性管6323的硬度，如此，在输送鞘管60满足适应血管形态的 要求下，连接管631为输送鞘管60提供足够轴向支撑力，使得在手术过程中，第一柔性管6321和第二柔性管6323在稳定的结构上进行调弯，使得第一柔性管6321和第二柔性管6323的调弯可控以及弯曲可预测，使得输送管鞘管60能够快速完成与左心耳的同轴的操作。间隔管6322的硬度范围为55D至72D，即间隔管6322的硬度大于第一柔性管6321和第二柔性管6323的硬度，可以避免第二柔性管6323调弯时的支点移动至第一柔性管6321上，进而达到避免第二柔性管6323调弯时影响第一柔性管6321的形态的效果，使得输送管鞘管60能够快速完成与左心耳的同轴的操作。远端管633的硬度范围为55D至72D，可以保证远端管633的轴向强度，使远端管633在释放或回收植入器械时，始终保持直线形态，保证植入器械能够顺畅的释放和回收。优选地，连接管631、间隔管6322和远端管633硬度相同，硬度均为72D，可以在输送鞘管60满足适应血管形态的要求下，提供足够的轴向支撑力。
第一柔性管6321的硬度大于或等于第二柔性管6323的硬度，也可以避免第二柔性管6323在调弯时，影响第一柔性管6321的形态，进而可以避免由于第二柔性管6323对第一柔性管6321的形态影响所造成的远端管633无法与左心耳同轴。
第一牵引丝641a采用高强度材料，例如碳纤维丝或者镍钛丝。第一牵引丝641a均为多股丝，与单根丝相比，多股丝的疲劳应力更小，与第一固定结构641b连接时，不易发生疲劳应力集中断裂，即使第一牵引丝641a中的某根丝断裂，其他丝也可调节鞘管的角度。可以延长第一牵引丝641a的使用寿命，并且，当第一牵引丝641a的某根丝发生断裂，则会发出的异响声(例如“嘭”的声响)，可以提醒操着者，第一牵引丝641a中的某根丝已损坏，应小心使用，尽快结束操作过程。
第二牵引丝642a的结构与第一牵引丝641a的结构和材料均相同，均为多股丝。
请参图8，连接管631包括近端部分6311和远端部分6312，远端部分6312与管身632的第一柔性管6321相连。输送鞘管60在近端部分6311的长度区间内具有第一壁厚，输送鞘管60在远端部分6312的长度区间内具有第二壁厚， 第一壁厚大于第二壁厚。进而增强输送鞘管60在近端部分6311的长度区间内的强度，在对输送鞘管60调弯时，可避免牵引结构640带动输送鞘管60的近端部分6311的长度区间内的管体发生弯曲变形(即可避免近端部分6311的长度区间内对应的输送鞘管60发生“驼背”变形)。进而可避免输送鞘管60“驼背”所导致压迫血管和内脏器官。
具体地，输送鞘管60在其外层管630之外设有一层硬度高的高分子材料，该硬度较高的高分子材料的硬度范围为63D至72D，该硬度较高的高分子材料设于近端部分6311对应的长度区间内，可增强输送鞘管60在近端部分6311的长度区间内的壁厚和强度。或者，加厚近端部分6311的长度区间内的中间层620的厚度，以增强输送鞘管60在近端部分6311的长度区间内的壁厚和强度。
输送鞘管60在各区间段内的内径均相同，输送鞘管60在第一壁厚的部分具有第一外径，输送鞘管60在第二壁厚的部分具有第二外径，第一外径大于第二外径。输送鞘管60的第一外径平滑过渡至第二外径，可减小输送鞘管60对病人血管及内脏器官的伤害。
当然，在其他实施例中，输送鞘管60在各区间段内的内径、外径均相同，输送鞘管60在各区间段内的壁厚均相同。
请一并参阅图9和图10，输送鞘管60使用时，输送鞘管60由下腔静脉31进入右心房23，然后再对房间隔27进行穿刺，穿刺后输送鞘管60的远端管633和管身632的一部分进入左心房25，然后通过第一牵引丝641a对第一柔性管6321的远端施加牵引力，第一柔性管6321在第一平面P内弯曲变形，远端管633可由X位置运动至Y位置，然后通过第二牵引丝642a对第二柔性管6323的远端施加牵引力，第二柔性管6323在第二平面Q内弯曲变形，远端管633可由Y位置运动至Z位置。至此，远端管633与左心耳29实现同轴。由于第一平面P和第二平面Q相交，因此通过第一牵引丝641a和第二牵引丝642a可在两个维度上调整远端管633的位置。本实施例的输送鞘管60可以适用于所有解剖形态的心脏，可从两个维度调整输送鞘管60的远端管633的位置，保证远端管633与左心耳29同轴，进而提高输送鞘管60操作的便利性，同时还可以节约手术时间，可降低对患者的伤害。
在第一柔性管6321与第二柔性管6323之间设有间隔管6322，且该间隔管6322的硬度大于第一柔性管6321和第二柔性管6323的硬度，在操作第二牵引丝642a对第二柔性管6323调弯时，可将第二柔性管6323弯曲时的支点锁定在第二柔性管6323中与间隔管6322相抵的端部(即第二柔性管6323的近端)，从而避免第二柔性管6323在调弯时，影响第一柔性管6321的形态，进而可以避免由于第二柔性管6323对第一柔性管6321的形态影响所造成的远端管633无法与左心耳同轴。
优选地，第一平面P与第二平面Q相互垂直，第一柔性管6321在第一平面P你调弯，第二柔性管6323在第二平面Q内调弯，可进一步提高输送鞘管60的调弯精度降低手术时间，提高操作的便利性。
在其他实施例中，第一平面P与第二平面Q平行共面，或者，第一平面P与第二平面Q平行。当第一平面P与第二平面Q平行共面时，可以避免穿刺点偏后或者偏前所导致的输送鞘管60无法与左心耳同轴，需要理解地，刺点偏后是指，在房间隔所在的平面内，沿垂直于房间隔的延伸方向，偏向人体的后背，穿刺点偏前的方向与穿刺点偏后的方向相反。当第一平面P与第二平面Q平行时，既可以避免穿刺点偏前或者偏后所导致的输送鞘管60无法与左心耳同轴，还可以避免穿刺点偏高或者偏低所导致的输送鞘管60无法与左心耳同轴，需要理解地，刺点偏低是指，在房间隔所在的平面内，沿房间隔的延伸方向偏向心尖的方向，刺点偏高的方向与刺点偏低的方向相反。
第二实施例
请参阅图11，第二实施例与第一实施例的不同之处在于，管体部分600在自然状态时为弯曲形态。具体地，第一柔性管6321在第一平面P内预塑型成弯曲的管结构，第一柔性管6321近端端部的延伸方向与第一柔性管6321远端端部的延伸方向形成夹角B，该夹角B的范围为45°至90°。
第二柔性管6323在自然状态时，第二柔性管6323在第二平面Q内预塑型成弯曲的管结构，第二柔性管6323在近端端部的延伸方向与第二柔性管6323在远端端部的延伸方向形成夹角C，该夹角C的范围为30°至60°。
输送鞘管60在第一柔性管6321和第二柔性管6323预塑型的基础上，只需要对输送鞘管60的形态进行微调，即可使得输送鞘管60的远端管633与左心耳同轴。
在其他实施例中，第一柔性管6321和第二柔性管6323两者之一，在其自然状态下为弯曲形，即第一柔性管6321近端端部的延伸方向与第一柔性管6321远端端部的延伸方向形成夹角B，该夹角B为45°至90°。或者，第二柔性管6323近端端部的延伸方向与第二柔性管6323远端端部的延伸方向形成夹角C，该夹角C为30°至60°。
第三实施例
请参阅图12，本实施例与第二实施例的不同之处在于，间隔管6322在其自然状态时，在第二平面Q内呈弯曲形态。具体地，可通过预塑型的方式，使得间隔管6322在第二平面Q内呈弯曲形态。间隔管6322与第二柔性管6323的弯曲方向相反，使输送鞘管60在其自然状态下呈“S”型。间隔管6322近端端部的延伸方向与间隔管6322远端端部的延伸方向形成夹角D，夹角D的范围为30°至60°。
第四实施例
请参阅图13，本实施例与第一实施例的不同之处在于，管身632还包括过渡管6324，过渡管6324的数量可以是一个，也可以是多个。过渡管6324的硬度小于连接管631、间隔管6322和远端管633的硬度。过渡管6324的硬度大于第一柔性管6321、第二柔性管6323的硬度。过渡管6324的硬度范围为40D至55D。
本实施例中过渡管6324的数量为四个。具体地，远端管633与第二柔性管6323之间设有一过渡管6324，在回收植入器械时，可以避免由于第二柔性管6323与远端管633的硬度相差过大，所导致的输送鞘管60在第二柔性管6323与远端管633相接合处弯折。连接管631与第一柔性管6321之间设有一过渡管6324，在回收植入器械时，可以避免由于第一柔性管6321与连接管631的硬度相差过 大，所导致的输送鞘管60在第一柔性管6321与连接管631相接合处弯折。间隔管6322与第一柔性管6321之间设有一过渡管6324，在回收植入器械时，可以避免由于第一柔性管6321与间隔管6322的硬度相差过大，所导致的输送鞘管60在第一柔性管6321与间隔管6322相接合处弯折。间隔管6322与第二柔性管6323之间设有一过渡管6324，在回收植入器械时，可以避免由于第二柔性管6323与间隔管6322的硬度相差过大，所导致的输送鞘管60在第二柔性管6323与间隔管6322相结合处弯折。从而确保输送鞘管60能够安全地回收植入器械。
当然，在其他实施例中，也可以根据实际需求选择过渡管6324的数量和设置位置，例如过渡管6324的数量为一个。过渡管6324可以设于间隔管6322与第二柔性管6323之间。或者，过渡管6324设于间隔管6322与第一柔性管6321之间。或者，过渡管6324设于连接管631与第一柔性管6321之间。或者，过渡管6324设于远端管633与第二柔性管6323之间。
第五实施例
请参阅图14，第五实施例与第四实施例的不同之处在于，本实施例中的输送鞘管60还包括支撑件651，支撑件651的数量至少为一个。支撑件651设于中间层620外表面的外侧，且支撑件651位于外层管630的外表面的内侧。
本实施例中，支撑件651的数量为多个。第一柔性管6321和第二柔性管6323所在的区间段内均设有支撑件651。在第一柔性管6321所在的区间段内，支撑件651的远端与第一固定结构641b固定连接，使得支撑件651的远端与第一固定结构641b共同形成环形的端面，可以避免支撑件651的远端过于尖锐，在第一柔性管6321由弯曲形态恢复至其自然状态时的形态过程中，即使支撑件651在外层管630内相对滑动也不会刺穿外层管630，进而避免器官组织被刺伤。在第二柔性管6323所在的区间段内，支撑件651的远端与第二固定结构642b固定连接，使得支撑件651的远端与第一固定结构642b共同形成环形的端面，可以避免支撑件651的远端过于尖锐，在第二柔性管6323由弯曲形态恢复至其自然状态时的形态过程中，即使支撑件651在外层管630内相对滑动也不会刺穿外层管630，进而避免器官组织被刺伤。
支撑件651可以为具有超弹性的丝材，支撑件651的丝径小于外层管630的壁厚，以便于将支撑件651设于外层管630和中间层620之间。
支撑件651在第一牵引丝641a的牵拉作用下，可跟随第一柔性管6321在第一平面P内弯曲。支撑件651在第二牵引丝642a的牵拉作用下，跟随第二柔性管6323在第二平面Q内弯曲。由于支撑件651具有超弹性，因此，支撑件651不会阻碍第一柔性管6321和第二柔性管6323的弯曲变形，支撑件651能够增加第一柔性管6321和第二柔性管6323的轴向支撑力，进而可提高输送鞘管60在第一柔性管6321和第二柔性管6323内的轴向支撑力，使得输送鞘管60在具有可调弯性能的基础上，增强其轴向支撑力。使输送鞘管60具有稳定的形态，能够顺利地输送、回收植入器械。
第一牵引丝641a和第二牵引丝642a的牵拉力撤消后，第一柔性管6321在支撑件651的超弹性作用下恢复至其自然状态时的形态过程中，第二柔性管6323在支撑件651的超弹性作用下其自然状态时的形态过程中，支撑件651的超弹性性能弥补了外层管630的弹性迟滞效应。
在其他实施例中，支撑件651的数量还可以为3个、4个或更多个，输送鞘管60在第一柔性管6321内沿其周向设有多个支撑件651，可进一步提高输送鞘管60弯曲部分的轴向支撑力。输送鞘管60在第二柔性管6323内沿其周向设有多个支撑件651，可进一步提高第二柔性管6323的轴向支撑力。
在其他实施例中，支撑件651的数量也可以是一个，支撑件651可以设于第二柔性管6323和第一柔性管6321其中之一所在的区间段内。
其他实施例中的支撑件661也可以是片材。支撑件661的壁厚小于外层管630的壁厚以使得支撑件661更易嵌入外层管630内。
第六实施例
请参阅图15，第六实施例与第五实施例的不同之处在于，本实施例中的支撑件671为螺旋体，支撑件671套设于中间层620外表面的外侧，且支撑件671位于外层管630的外表面的内侧，支撑件671由具有超弹性的材料制成，支撑件671包括近端段6711、螺旋延伸段6712和远端段6713，螺旋延伸段6712位 于近端段6711与远端段6713之间。
支撑件671的近端段6711为一封闭的环状体，近端段6711的远端与螺旋延伸段6712相连。
支撑件671的远端段6713为一封闭的环状体。第一连接孔6411a、第二连接孔6411b、第三连接孔6411c可不设于固定结构上，而设于支撑件671的远端段6713侧壁上，可以避免第一牵引丝641a和第二牵引丝642a在使用过程中出现应力集中，还可以节约一个固定结构的材料，降低成本。
螺旋延伸段6712具有延伸体67121，延伸体67121可由激光在螺旋延伸段6712内的管材上切割所形成，延伸体67121在螺旋延伸段内6712螺旋延伸。
沿平行于支撑件671的中心轴线6714方向切割支撑件671的一侧壁，且沿支撑件671的径向展开切割后的支撑件671，延伸体67121与支撑件671的中心轴线6714形成的夹角E的范围为0°至90°。可以在保证支撑件671可调弯的情况下，提供足够的轴向支撑力。优选地，延伸体67121与支撑件671的中心轴线6714形成的夹角E的范围为60°至90°，在输送鞘管调弯过程中，提高输送鞘管60的抗折性能，同时提高输送鞘管60的轴向支撑力。延伸体67121的轴向厚度L为0.05mm-3.0mm，在输送鞘管调弯过程中，提高输送鞘管的抗折性能，同时提高输送鞘管的轴向支撑力。优先地，延伸体67121的轴向厚度L为0.1mm-0.5mm。相邻两延伸体67121的间隙D为0.05mm-3.0mm。优先地，相邻两延伸体67121的间隙D为0.1mm-0.5mm，在输送鞘管调弯过程中，提高输送鞘管的抗折性能，同时提高输送鞘管的轴向支撑力。可以理解地，延伸体67121与支撑件671的中心轴线形成的夹角E，夹角E越小，相邻两延伸体67121的间隙D越大，支撑件671可调弯性能越好，夹角E越大，相邻两延伸体67121的间隙D越小，支撑件671的轴向支撑力更大。
第七实施例
请参阅图16和图17，第七实施例与第八实施例的不同之处在于，本实施例中的支撑件681为龙骨结构。
本实施例中，第一柔性管6321和第二柔性管6323所在的区间段均设有支 撑件681，支撑件681包括一龙骨6811和多个骨架6812，多个骨架6812沿龙骨6811的轴向(长度方向)间隔排列，多个骨架6812的两端分别与龙骨6811的两侧相连，龙骨6811与多个骨架6812共同形成一环形的收容空间6813，中间层620(即输送鞘管60的管壁)收容于收容空间6813内以使得支撑件681套设于中间层620外(即支撑件681设于输送鞘管60中)。支撑件681的远端受牵引力作用时，各骨架6812彼此间隔排列，使得各骨架6812之间具有变形的空间，可降低支撑件681弯曲阻力，以保证支撑件681不阻碍第一柔性管6321和第二柔性管6323的调弯，同时，各骨架6812彼此间隔排列，还可供外层管630的高分子材料嵌入，可避免支撑件681沿外层管630轴向滑动，进而可避免支撑件681的近端刺穿外层管630的高分子材料。并且，由于龙骨6811可提供轴向支撑力，因此，支撑件681可以提高第一柔性管6321和第二柔性管6323的轴向支撑力，避免输送鞘管60折弯。
当然，在其他实施例中，也可根据实际需求选择支撑件681所在的区间段，例如，仅在第一柔性管6321所在的区间段内设置支撑件681。或者，仅在第二柔性管6323所在的区间段内设置支撑件681。
多个骨架6812中最远端的骨架6812具有远端端面68121，龙骨6811的远端端部与远端端面68121平齐，或者，龙骨6811的远端端部位于远端端面68121的近端侧。可以避免在输送鞘管60调弯时，龙骨6811的远端刺穿外层管630。
多个骨架6812中最近端的骨架6812具有近端端面68122，龙骨6811的近端端部与近端端面68122平齐，或者，龙骨6811的近端端部位于近端端面68122的远端侧。可以避免在输送鞘管60调弯时，龙骨6811的远端刺穿外层管630。
支撑件681的远端设有上述的第一连接孔6411a、第二连接孔6411b和第三连接孔6411c，可以避免第一牵引丝641a和第二牵引丝642a在使用过程中出现应力集中，还可以节约一个固定结构的材料，降低成本。具体地，第一连接孔6411a、第二连接孔6411b和第三连接孔6411c可设于龙骨6811的远端。或者，第一连接孔6411a、第二连接孔6411b和第三连接孔6411c可设于支撑件681远端的骨架6812上。
支撑件681安装于第一柔性管6321内时，支撑件681的长度L2与第一柔 性管6321的长度相等，支撑件681安装于第二柔性管6323内时，支撑件681的长度L2与第二柔性管6323的长度相等。龙骨6811的宽度L1小于任一骨架6812周长L3的一半，即L1＜L3/2。如此，使龙骨6811的硬度适中，在提高输送鞘管60轴向支撑力的同时，保证输送鞘管60可以在第一牵引丝641a、第二牵引丝642a带动下弯曲变形，支撑件681可由具有超弹性的镍钛合金管材经过激光切割而成。
第八实施例
请参阅图18，第八实施例与第七实施例的不同之处在于，龙骨691上还设有镂空结构6913，外层管630的弹性尼龙可进入镂空结构6913内，增大龙骨691与外层管630的接触面积，可以提高支撑件691与外层管630的弹性尼龙的结合强度，以及提高支撑件691疲劳寿命，延长使用周期。镂空结构6913的形状可以为矩形、圆形、椭圆形、方形、三角形、菱形等。优选地，镂空结构6913的形状为菱形。镂空结构6913的形状为菱形，提高支撑件691的可弯曲变形能力，进而降低支撑件691对第一柔性管6321和第二柔性管6323弯曲变形的阻碍作用。龙骨6911与骨架6912相接合的部位设有凹槽6914，使得龙骨6911在弯曲变形时其材料具有变形空间，增大支撑件691弯曲时的顺应性。
骨架6912包括相对设置于龙骨6911两侧的第一连接部69121和第二连接部69123，第一连接部69121与第二连接部69123关于龙骨6911的轴线对称。第一连接部69121的自由端设有卡扣69122。优选地，卡扣69122为T形。第二连接部69123的自由端设有卡槽69124，卡槽69124具有弹性，卡槽69124受外力作用其槽宽可在一定范围内变大。也就是说，受外力作用，卡槽69124沿龙骨6912轴线的尺寸可一定程度的变大。卡槽69124的形状与卡扣69122相配合，以使得卡槽能69124够容纳卡扣69122，并且实现卡槽69124与卡扣69122的卡接配合形成收容空间6813。卡扣69122插入卡槽69124以使得第一连接部69121与第二连接部69123卡接。由于卡槽69124具有弹性，卡槽69124受外力作用其槽宽可再一定范围内变大，卡扣69122在卡槽69124内可沿卡槽69124的长度方向滑动，即骨架6912的周长在一定范围内可变，进而使得支撑件691可以 适用多种管径的输送鞘管60。
第九实施例
请参阅图19，第九实施例与第八实施例的不同之处在于，本实施例的支撑件711还包括多个近端加强筋7115、远端加强筋7116及中间加强筋7117，近端加强筋7115、远端加强筋7116及中间加强筋7117均沿龙骨7111的长度方向延伸延伸排布，近端加强筋7115、远端加强筋7116及中间加强筋7117均成对设置。在支撑件711的近端相邻两骨架7112之间设有一对近端加强筋7115，该对近端加强筋7115关于支撑件711的纵向中心轴7118对称。在支撑件711的远端相邻两骨架7112之间设有一对远端加强筋7116，该对远端加强筋7116关于支撑件711的纵向中心轴7118对称。沿支撑件711的长度方向，在近端加强筋7115与远端近端加强筋7116之间的相邻的两骨架7112之间设有中间加强筋7117，中间加强筋7117成对分布于纵向中心轴线7118的两侧，成对设置的中间加强筋7117关于纵向中心轴线7118对称，近端加强筋7115、远端加强筋7116及中间加强筋7117可增加支撑件的轴向支撑力，进而增加输送鞘管60的轴向支撑力。支撑件711关于其横向中心轴7119对称。
沿支撑件711的宽度方向，近端加强筋7115、远端加强筋7116及中间加强筋7117均与龙骨7111间距设置。具体地，近端加强筋7115到纵向中心轴7118的距离与远端加强筋7116到纵向中心轴7118的距离相等，均为D1。中间加强筋7117到纵向中心轴7118的距离为D2，D1大于或等于D2。
本实施例中，近端加强筋7115、远端加强筋7116及中间加强筋7117均与龙骨7111间距设置，D1大于或等于D2，在增大支撑件711的轴向支撑力的同时，增大支撑件711弯曲时的顺应性，进而减小支撑件711调弯时所需牵引力。成对设置的近端加强筋7115、远端加强筋7116及中间加强筋7117均关于纵向中心轴7118对称，以及支撑件711关于横向中心轴线7119对称，也可在增大支撑件711的轴向支撑力的同时，增大支撑件711弯曲时的顺应性，进而减小支撑件711调弯时所需牵引力。
当然，在其他实施例中，近端加强筋7115到纵向中心轴7118的距离与远 端加强筋7116到纵向中心轴7118的距离不相等，近端加强筋7115到纵向中心轴7118的距离与远端加强筋7116到纵向中心轴7118的距离均大于中间加强筋7117到纵向中心轴7118的距离，也可在增大支撑件711的轴向支撑力的同时，增大支撑件711弯曲时的顺应性，进而减小支撑件711调弯时所需牵引力。
第十实施例
本实施例提供一种医疗器械，包括上述实施例中的输送鞘管。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本发明的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对发明专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本发明构思的前提下，还可以做出若干变形和改进，这些都属于本发明的保护范围。因此，本发明专利的保护范围应以所附权利要求为准。
Claims (20)
- 一种输送鞘管，包括管体部分，其特征在于，所述管体部分包括：外层管，包括连接管、管身及远端管，所述管身位于所述连接管与所述远端管之间，所述管身包括第一柔性管、间隔管以及第二柔性管，所述间隔管设于所述第一柔性管的远端与所述第二柔性管的近端之间，所述连接管的硬度大于所述第一、第二柔性管的硬度，所述间隔管的硬度大于所述第一、第二柔性管的硬度，及牵引结构，所述牵引结构包括第一牵引丝和第二牵引丝，所述第一牵引丝与所述第一柔性管的相连，所述第二牵引丝与所述第二柔性管的相连，所述第一牵引丝和所述第二牵引丝均在所述外层管内延伸，且所述第一牵引丝的自由端和所述第二牵引丝的自由端均延伸出所述连接管的近端，所述第一牵引丝相对所述管身可滑动，并能够带动所述第一柔性管在第一平面内产生弯曲，所述第二牵引丝相对所述管身可滑动，能够带动所述第二柔性管在第二平面内产生弯曲，所述第一平面与所述第二平面相交、平行或共面。
- 如权利要求1所述的输送鞘管，其特征在于，所述第一柔性管的硬度大于或等于所述第二柔性管的硬度。
- 如权利要求1所述的输送鞘管，其特征在于，所述管身还包括过渡管，所述过渡管设于所述间隔管与所述第一柔性管之间，所述过渡管的硬度小于所述间隔管的硬度，所述过渡管的硬度大于所述第一柔性管的硬度，或，所述过渡管设于所述间隔管与所述第二柔性管之间，所述过渡管的硬度小于所述间隔管的硬度，所述过渡管的硬度大于所述第二柔性管的硬度，或，所述过渡管设于所述连接管与所述第一柔性管之间，所述过渡管的硬度小于所述连接管的硬度，所述过渡管的硬度大于所述第一柔性管的硬度，或，所述过渡管设于所述远端管与所述第二柔性管之间，所述过渡管的硬度小于所述远端管的硬度，所述过渡管的硬度大于所述第二柔性管的硬度。
- 如权利要求1所述的输送鞘管，其特征在于，所述第一平面与所述第二平面相互垂直。
- 如权利要求1所述的输送鞘管，其特征在于，所述牵引结构还包括固定 于所述管身中的第一固定结构和/或第二固定结构，所述第一固定结构设于所述第一柔性管的远端，所述第二固定结构设于所述第二柔性管的远端，所述第一固定结构和/或所述第二固定结构的侧壁开设有第一连接孔、第二连接孔及第三连接孔，沿所述第一固定结构和/或所述第二固定结构的圆周方向，所述第二连接孔位于所述第一连接孔和所述第三连接孔之间，所述第一连接孔、所述第二连接孔和所述第三连接孔的孔心的连线可形成三角形；所述三角形中在所述第二连接孔的孔心所形成的内角为钝角，所述第一牵引丝依次穿过所述第一固定结构的所述第一连接孔、所述第二连接孔、所述第三连接孔以与所述第一固定结构相连，和/或，所述第二牵引丝依次穿过所述第二固定结构的所述第一连接孔、所述第二连接孔、所述第三连接孔以与所述第二固定结构相连。
- 如权利要求1所述的输送鞘管，其特征在于，所述管身还包括设于所述管身中的至少一个支撑件，当所述支撑件的数量为一个时，所述支撑件设于所述第一柔性管或所述第二柔性管所在的区间段内，当所述支撑件的数量为多个时，所述第一柔性管和所述第二柔性管所在的区间段内均设有所述支撑件。
- 如权利要求6所述的输送鞘管，其特征在于，所述支撑件包括沿螺旋线延伸的延伸体，沿平行于所述支撑件的中心轴线方向切割所述支撑件的一侧壁后，再沿所述支撑件的径向展开切割后的所述支撑件，所述延伸体与所述支撑件的中心轴线形成的夹角E的范围为60°至90°。
- 如权利要求1所述的输送鞘管，其特征在于，所述第一柔性管在自然状态下为弯曲形态，所述第一柔性管近端端部的延伸方向与所述第一柔性管远端端部的延伸方向形成夹角B，所述夹角B的范围为45°至90°。
- 如权利要求1所述的输送鞘管，其特征在于，所述间隔管在其自然状态下为直线形态或弯曲形态，当所述间隔管在其自然状态下弯曲形态时，所述间隔管在所述第二平面内呈弯曲形态，所述间隔管的弯曲方向与所述第二柔性管的弯曲方向相反，当所述间隔管在其自然状态下为直线形态时，所述间隔管在所述第二平面内呈直线形态。
- 如权利要求6所述的输送鞘管，设于输送鞘管的管壁中，其特征在于，所述支撑件包括龙骨和多个骨架，所述多个骨架沿所述龙骨的轴向间隔排列， 所述多个骨架的两端分别与所述龙骨的两侧相连，所述龙骨与所述多个骨架共同形成收容空间，所述输送鞘管的管壁收容于所述收容空间内。
- 如权利要求10所述的输送鞘管，其特征在于，所述多个骨架中最远端的骨架具有远端端面，所述龙骨的远端端部与所述远端端面平齐，或者，所述龙骨的远端端部位于所述远端端面的近端侧。
- 如权利要求10所述的输送鞘管，其特征在于，所述多个骨架中最近端的骨架具有近端端面，所述龙骨的近端端部与所述近端端面平齐，或者，所述龙骨的近端端部位于所述近端端面的远端侧。
- 如权利要求10所述的输送鞘管，其特征在于，所述多个骨架均包括第一连接部和第二连接部，所述第一连接部和所述第二连接部相对设置于所述龙骨的两侧，所述第一连接部的自由端设有卡扣，所述第二连接部的自由端设有卡槽，所述卡扣与所述卡槽卡接配合。
- 如权利要求13所述的输送鞘管，其特征在于，所述卡槽具有弹性，所述卡槽受外力作用其槽宽可变大。
- 如权利要求10所述的输送鞘管，其特征在于，所述龙骨上还设有镂空结构。
- 如权利要求10所述的输送鞘管，其特征在于，所述支撑件还包括近端加强筋、远端加强筋及中间加强筋，所述近端加强筋、所述远端加强筋及所述中间加强筋均沿所述龙骨的长度方向延伸排布，所述远端加强筋设于所述支撑件的远端相邻两所述骨架之间，所述近端加强筋设于所述支撑件的近端相邻两所述骨架之间，所述中间加强筋设于所述近端加强筋与所述远端加强筋之间的相邻两所述骨架之间。
- 如权利要求16所述的输送鞘管，其特征在于，所述近端加强筋、所述远端加强筋及所述中间加强筋均与所述龙骨间距设置，所述近端加强筋到所述支撑件的纵向中心轴的距离大于所述中间加强筋到所述支撑件的纵向中心轴的距离，所述远端加强筋到所述支撑件的纵向中心轴的距离大于所述中间加强筋到所述支撑件的纵向中心轴的距离。
- 如权利要求6所述的输送鞘管，其特征在于，所述支撑件包括多个首尾 相拼接的中空子部件，每个所述中空子部件的近端均包括沿所述中空子部件的圆周方向分布的多个近端凸起，相邻两个近端凸起之间形成一个近端凹槽；每个所述中空子部件的远端均包括沿所述中空子部件的圆周方向分布的多个远端凸起，相邻两个远端凸起之间形成一个远端凹槽，所述中空子部件的近端凸起的数量等于同一所述中空子部件的远端凸起的数量，所述中空子部件上的一个所述远端凹槽与同一所述中空子部件上的一个所述近端凸起对齐，一个所述中空子部件上多个所述近端凸起与另一个所述中空子部件的多个所述远端凹槽啮合。
- 如权利要求18所述的输送鞘管，其特征在于，所述近端凸起的连接其近端和远端的斜边上设有近端凸部，和/或，所述远端凸起的连接其近端和远端的斜边上设有远端凹部。
- 一种医疗器械，其特征在于，所述医疗器械包括如权利要求1至19中任意一项所述的输送鞘管。
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