WO2019019937A1

WO2019019937A1 - Adjustable curved sheath and medical instrument

Info

Publication number: WO2019019937A1
Application number: PCT/CN2018/095962
Authority: WO
Inventors: 王刚; 江巍; 刘奎; 张德元; 马仁梅; 李安宁
Original assignee: 先健科技(深圳)有限公司
Priority date: 2017-07-27
Filing date: 2018-07-17
Publication date: 2019-01-31
Also published as: CN109689147B; CN109689147A

Abstract

Disclosed is an adjustable curved sheath (100), comprising a tube part (110), the tube part (110) comprising an outer tube (112) and a traction wire (117), wherein the outer tube (112) comprises a connecting tube (1121) and a tube body communicating with the connecting tube (1121), the tube body comprises a first tubular section (1123) and a second tubular section (1125), the first tubular section (1123) is fixedly connected to the connecting tube (1121), the second tubular section (1125) is fixedly connected to an end of the first tubular section (1123) away from the connecting tube (1121), at least one of the second tubular section (1125) and the first tubular section (1123) has flexibility, and when one of the second tubular section (1125) and the first tubular section (1123) has flexibility, the other is rigid and curved; and a free end of the traction wire (117) extends from one end of the connecting tube (1121) away from the tube body, and the traction wire (117) is slidable relative to the tube body and capable of driving the part of the tube body with flexibility to bend.

Description

Adjustable curved sheath and medical device

Technical field

The present invention relates to the field of medical devices, and more particularly to an adjustable curved sheath tube and a medical device.

Background technique

Adjustable curved sheath has been widely used in minimally invasive interventional diagnostic and therapeutic procedures to establish channels, deliver or retrieve instruments, import drugs or export body fluids. Compared with the ordinary sheath tube, the sheath has an adjustable bending function, and the freely adjusted bending at the distal end can quickly and reliably reach the target lesion position, thereby reducing the operation time.

At present, the adjustable elbow sheath on the market is only one end of the head end can be adjusted, but the outer tube below the head end of the adjustable curved sheath tube is in a non-bent state; or the distal end of the sheath tube has two different bending directions Fixed bend.

For the multi-segmented vascular access, only the curved end of the adjustable sheath can not fully meet the clinical requirements, and it is difficult to apply to all patients.

Summary of the invention

Based on this, it is necessary to provide a flexible curved sheath tube with high applicability.

In addition, a medical device is also provided.

An adjustable curved sheath tube comprising a tubular body portion, the tubular body portion comprising:

The outer tube includes a connecting tube and a tube body communicating with the connecting tube, the tube body including a first tubular section and a second tubular section, the first tubular section being fixed to the connecting tube, the second The tubular section is fixed to an end of the first tubular section away from the connecting tube, at least one of the second tubular section and the first tubular section has flexibility, and the second tubular section and the first One of the tubular segments is flexible and the other is rigid and curved;

Traction wire fixed to the tube body, the traction wire extends along the outer tube, and the free end of the traction wire extends out of the end of the connecting tube away from the tube body, the traction wire is opposite The tubular body is slidable and can drive the flexible portion of the tubular body to bend.

A medical device comprising the above-mentioned adjustable curved sheath tube.

Details of one or more embodiments of the invention are set forth in the accompanying drawings and description below. Other features, objects, and advantages of the invention will be apparent from the description and appended claims.

DRAWINGS

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the embodiments or the description of the prior art will be briefly described below. Obviously, the drawings in the following description are only It is a certain embodiment of the present invention, and those skilled in the art can obtain drawings of other embodiments according to the drawings without any creative work.

1 is a schematic structural view of an adjustable curved sheath tube according to an embodiment;

Figure 2 is a partial structural schematic view of the tubular body portion of the adjustable curved sheath tube shown in Figure 1;

Figure 3 is a partial cross-sectional view of the tubular body portion of the adjustable curved sheath tube of Figure 1;

Figure 4 is a partial enlarged view of Figure 3;

Figure 5 is a partial structural schematic view of the tubular body portion of the adjustable curved sheath tube shown in Figure 1;

Figure 6 is a structural schematic view of the developing member and the pulling wire of the tubular body portion of the adjustable curved sheath tube shown in Figure 1;

Figure 7 is a schematic view showing the tubular body portion of the adjustable curved sheath tube shown in Figure 1 in a bent state;

8 is a schematic structural view of a developing member and a pulling wire of a tubular body portion of an adjustable curved sheath tube according to another embodiment;

9 is a schematic structural view of an adjustable curved sheath tube according to another embodiment;

Figure 10 is a partial structural schematic view of the tubular body portion of the adjustable curved sheath tube shown in Figure 9;

Figure 11 is a schematic view showing the tubular body portion of the adjustable curved sheath tube shown in Figure 9 in a bent state;

Figure 12 is a schematic view showing the tubular body portion of the adjustable curved sheath tube shown in Figure 9 in another curved state;

Figure 13 is a schematic view showing the tubular body portion of the adjustable curved sheath tube shown in Figure 9 in a further curved state;

Figure 14 is a partial structural view of a tubular body portion of an adjustable curved sheath tube according to another embodiment;

Figure 15 is a partial structural view of a tubular body portion of an adjustable curved sheath tube of another embodiment;

16 is a schematic structural view of a medical device according to an embodiment;

Figure 17 is a schematic view showing the structure of the expansion and puncture device of the medical device shown in Figure 16;

Figure 18 is a schematic view showing the structure of the expansion and puncture device shown in Figure 17 in another state;

Figure 19 is a partial enlarged view of a portion II of Figure 17;

Figure 20 is a partial structural schematic view of the puncture assembly of the expansion puncture device shown in Figure 17;

Figure 21 is a cross-sectional view taken along line III-III of Figure 20;

Figure 22 is a schematic view showing the position of the distal end of the medical device shown in Figure 16 entering the right atrium;

Figure 23 is a schematic view showing the position of the tip end of the puncture needle of the medical instrument shown in Figure 16 passing through the interatrial septum into the left atrium;

Figure 24 is a schematic view showing the position of the adjustable curved sheath of the medical device shown in Figure 16 in the left atrium;

Figure 25 is a schematic view showing the structure of an expansion assembly of another embodiment.

Detailed ways

In order to facilitate the understanding of the present invention, the present invention will be described more fully hereinafter with reference to the accompanying drawings.

Referring to FIG. 1, an adjustable curved sheath tube 100 of an embodiment includes a tubular body portion 110 and an operating mechanism 150 for operating the tubular body portion 110.

2, FIG. 3 and FIG. 4, the tubular body portion 110 includes an outer tube 112, an inner tube 113, a developing member 115, a sliding tube 116, and a pulling wire 117.

The outer tube 112 includes a connecting tube 1121 and a tube body (not labeled) communicating with the connecting tube 1121. The connection tube 1121 has a higher hardness than the tube body. In the illustrated embodiment, the connecting tube 1121 is coaxial with the tubular body.

The tubular body includes a first tubular section 1123 and a second tubular section 1125. One end of the first tubular section 1123 is fixed to one end of the connecting tube 1121. One end of the second tubular section 1125 is fixed to an end of the first tubular section 1123 away from the connecting tube 1121, and the first tubular section 1123 and the second tubular section 1125 are both flexible. That is, the first tubular section 1123 and the second tubular section 1125 are portions in which the tubular body has flexibility. In the illustrated embodiment, the three sections of the second tubular section 1125, the first tubular section 1123, and the connecting tube 1121 are sequentially increased in hardness. In one embodiment, the second tubular section 1125, the first tubular section 1123, and the connecting tube 1121 are nylon elastomer (PEBAX) tubes of different hardnesses. Further, the hardness of the second tubular section is 30D to 40D. Further, the material of the second tubular section 1125 is 35D PEBAX, the material of the first tubular section 1123 is 55D PEBAX, and the material of the connecting tube 1121 is 72D PEBAX.

The first tubular section 1123 and the second tubular section 1125 are flexible such that bending can occur when the first tubular section 1123 and the second tubular section 1125 are subjected to a force. The first tubular section 1123 and the second tubular section 1125 have a bending angle of 0° to 180°, preferably 90°, so that the first tubular section 1123 can be controlled according to the lengths of the first tubular section 1123 and the second tubular section 1125. The radius of curvature of the second tubular section 1125, of course, when the adjustable curved sheath 100 is applied to a blood vessel or a heart, the desired bending angle can be designed according to the actual vascular or cardiac anatomy to determine the first tubular section 1123 and The length of the second tubular section 1125. In one embodiment, the first tubular section 1123 has a length of 30 mm to 70 mm and the second tubular section 1125 has a length of 20 mm to 40 mm.

The inner tube 113 is housed in the outer tube 112 and adheres to the inner wall of the outer tube 112. The inner tube 113 is coaxial with the outer tube 112. The inner wall of the inner tube 113 is a smooth surface to ensure smooth transportation of other instruments. In the illustrated embodiment, the material of the inner tube 113 is polytetrafluoroethylene (PTFE). In other embodiments, the material of the inner tube 113 may also be polyethylene terephthalate (PET), of course. The material of the inner tube 113 is not limited to PTFE or PET, and other materials which can ensure the inner wall of the inner tube 113 are smooth. It should be noted that the inner tube 113 can be omitted, as long as the inner wall of the outer tube 112 is smooth to ensure smooth transportation of other instruments. In other embodiments, an inner membrane can be formed on the inner surface of the outer tube 112. The material is selected from at least one of PTFE and PET. The inner film can be prepared by coating or the like as long as the inner wall of the outer tube 112 is made smooth.

The developing member 115 is located at one end of the second tubular section 1125 away from the first tubular section 1123. In the illustrated embodiment, the developing member 115 is a developing ring, and the developing member 115 is sleeved and fixed to the outer wall of the inner tube 113, and is fixed to the outer tube 112 by heat fusion. Further, the developing member 115 is coaxial with the outer tube 112.

It is to be noted that the developing member 115 is not limited to being a developing ring, and a developing coating layer may be formed on the inner wall of the outer tube 112 or the outer wall of the inner tube 113 by coating or the like as long as it can function as an X-ray developing. In one of the embodiments, the material of the developing member 115 is selected from at least one of ruthenium and platinum.

The sliding tube 116 is located between the inner tube 113 and the outer tube 112. The sliding tube 116 extends from an end of the second tubular section 1125 away from the first tubular section 1123 to an end of the connecting tube 1121 away from the first tubular section 1123. In the illustrated embodiment, the outer tube 112 is formed with a receiving passage (not shown), and the sliding tube 116 is received in the receiving passage. In one embodiment, in preparation, the sliding tube 116 wearing the supporting wire is fixed to the outer wall of the inner tube 113 by medical glue, and the outer tube 112 is sheathed, and all materials are thermally fused together by heating, due to The sliding tube 116 is internally provided with a supporting wire so that the sliding tube 116 is embedded in the outer tube 112 during heat fusion, thereby forming a receiving passage in the outer tube 112. Of course, in other embodiments, the tubular portion 110 further includes a reinforcing tube (not shown) that is embedded in the outer tube 112, and the reinforcing tube is sleeved on the surfaces of the inner tube 113 and the sliding tube 116. The reinforcing tube is a stainless steel braided mesh tube or a stainless steel spring tube. After the sliding tube 116 wearing the supporting wire is fixed to the outer wall of the inner tube 113 by the medical glue, the reinforcing tube is sleeved on the surface of the inner tube 113 and the sliding tube 116, and the outer tube 112 is placed and then heated by heating. The materials are hot melted together.

The material of the sliding tube 116 is polytetrafluoroethylene (PTFE). Of course, the material of the inner tube 113 is not limited to PTFE, as long as the inner wall of the sliding tube 116 can be made smooth. It can be understood that the sliding tube 116 can be omitted when the outer tube 112 forms a smooth receiving passage.

Referring to FIG. 2 to FIG. 7 , one end of the pulling wire 117 is disposed on the sliding tube 116 and is fixed to the developing member 115 . In the illustrated embodiment, the pulling wire 117 is a wire, and preferably the material of the pulling wire 117 is a nickel titanium alloy. Of course, it should be noted that the material of the pulling wire 117 is not limited to a nickel-titanium alloy, and as long as the tensile strength is high, the pulling function can be achieved. One end of the pulling wire 117 is fixed to the developing member 115 by welding. Of course, when the developing member 115 is a developing coating, an anchoring ring fixed to the outer tube 112 may be disposed in the outer tube 112 to fix one end of the pulling wire 117, or one end of the pulling wire 117 may be bonded or the like. Directly fixed to the outer tube 112.

The pulling wire 117 extends from the end of the second tubular section 1125 away from the first tubular section 1123 along the sliding tube 116, and the free end of the pulling wire 117 extends out of the sliding tube 116 to connect the operating mechanism 150.

In the illustrated embodiment, the pulling wire 117 extends from the end of the second tubular section 1125 away from the first tubular section 1123 toward the end of the first tubular section 1123 away from the second tubular section 1125 along the cylindrical surface of the inner tube 113. . Of course, it should be noted that the extension curve of the pulling wire 117 is a smooth curve to facilitate the pulling force on the pulling wire 117 to slide the pulling wire 117 relative to the sliding tube 116. The pulling wire 117 extends straight from one end of the connecting pipe 1121 near the first tubular section 1123 toward an end away from the first tubular section 1123.

In one of the embodiments, when the outer tube 112 is in a naturally extended state, that is, when the outer tube 112 is a straight tube, the portion of the pulling wire 117 extending in the first tubular section 1123 is orthographically projected in a plane perpendicular to the axis of the first tubular section 1123. It is an arc with a circumferential angle of α. Preferably, α is from 0° to 180°, further 0°.

In one of the embodiments, the pulling wire 117 extends linearly in the first tubular section 1123.

Further, when the outer tube 112 is in a natural extension state, that is, when the outer tube 112 is a straight tube, the orthographic projection of the portion of the pulling wire 117 extending in the second tubular portion 1125 in a plane perpendicular to the axis of the second tubular portion 1125 is a circumferential angle. The arc of β. β is 0° to 180°, and more preferably 90°.

Referring again to FIG. 1 , the operating mechanism 150 includes a connector 151 , an operating handle 153 , and an operating member 155 . The connecting member 151 is fixed to the end of the connecting tube 1121 of the outer tube 112 away from the tubular body. In the illustrated embodiment, the connecting member 151 is substantially tubular, and is sleeved on the connecting tube 121 and fixed to the connecting tube 121. One end of the operating handle 153 is connected to the connecting member 151, and is disposed obliquely with respect to the connecting member 151 to facilitate gripping. The operating member 155 is provided on the joystick 153 and slidable relative to the operating handle 153 in a direction away from or near the connecting member 151.

The free end of the pulling wire 117 is fixed to the operating member 155 of the operating mechanism 150, so that sliding the operating member 155 away from the connecting member 151 can transmit the traction force to the pulling wire 117.

Of course, it should be noted that the pulling of the pulling wire 117 by the sliding of the operating member 155 of the operating mechanism 150 is only one of the modes, and the pulling wire 117 can also be controlled by other operating mechanisms, such as by rotating. The pulling wire 117 is tightened in such a manner that the pulling wire 117 can be slid relative to the outer tube 112 as long as a pulling force can be applied to the pulling wire 117.

When the adjustable bending sheath tube 100 is used, a pulling force is applied to the pulling wire 117 through the operating member 155 of the operating mechanism 150. After the pulling wire 117 is subjected to the pulling force, the force is transmitted to the developing member 115, and the developing member 115 is located in the second tubular portion. 1125 is away from one end of the first tubular section 1123, so that the traction force is applied to the end of the second tubular section 1225. The second tubular section 1225 is unilaterally biased away from the end of the first tubular section 1123, and the bending is biased toward the direction of the force. At the same time, the hardness of the first tubular section 1123 is greater than that of the second tubular section 1125, so that when the force transmitted by the pulling wire 117 is within a certain range, the first tubular section 1223 does not deform, and the force transmitted by the pulling wire 117 is greater than At a certain value, the first tubular section 1223 also bends as the traction wire 117 follows the end of the second tubular section 1123 away from the first tubular section 1123 toward the first tubular section 1123 away from the second tubular section 1125 along the inner tube. The cylindrical surface of 113 extends in a spiral curve such that the first tubular section 1123 is adjacent to the end of the second tubular section 1125 and the second tubular section 1125 is remote from the section of the first tubular section 1123. Different from, the first tubular section 1223 and the second tubular section 1125 can generate a multistage counter-bending effect, because of the greater hardness of the connection tube 1121 is within a certain range of tensile force, the connection tube 1121 is not deformed to maintain a straight shape.

The tubular body portion 110 of the adjustable curved sheath tube 100 is configured to have a flexible first tubular section 1223 and a second tubular section 1225. In use, a pulling force is applied to the pulling wire 117 through the free end of the pulling wire 117. The other end of the wire 117 is fixed to the tube body, and the pulling wire 117 is slidable relative to the first tubular section 1223 and the second tubular section 1225 to apply a pulling force to the tubular body. Since the first tubular section 1223 and the second tubular section 1225 are flexible, It will bend in the direction of the force, thus achieving multi-segment bending, which can better meet the clinical use requirements and has strong applicability.

It can be understood that the pipe body is not limited to a two-stage structure, and may also be a three-stage or three-stage structure. As long as the control pipe body is increased in hardness from the connecting pipe 1121 to the connecting pipe 1121, the hardness of each pipe body increases sequentially. Just fine.

Referring to FIG. 8 , the structure of the adjustable curved sheath tube of the other embodiment is substantially the same as that of the adjustable curved sheath tube 100 . The difference is that the structure of the tubular body portion is slightly different from the tubular body portion 110. In this embodiment, The pulling wire 217 of the tubular portion is folded around the developing member 215 to form a bent portion 2172, and the edge of one end of the developing member 215 abuts against the bent portion 2172. In use, both ends of the pulling wire 217 are free ends, and both ends of the pulling wire 217 are simultaneously connected to the operating mechanism.

In the illustrated embodiment, the pulling wire 217 is folded in half to form the bent portion 2172. Of course, in other embodiments, the pulling wire 217 may be wound around the developing member 215 at least once to form the bent portion 2172.

It can be understood that, in other embodiments, when the developing member is a developing coating, the pulling wire is fixed by the anchoring ring, and the pulling wire 217 is folded to form a bent portion 2172, and an edge of one end of the anchoring ring abuts the bent portion 2172 Just fine.

The adjustable curved sheath tube having the above structure does not need to be welded to fix the pulling wire 217 to the developing member 215, so that the material of the pulling wire 217 is more widely selected, and the material of the anchoring ring is fixed when the pulling wire is fixed by the anchoring ring. Choose more. The traction wire is fixed in the above manner, and the connection manner of the traction wire is similar to the flexible connection, and the connection strength and connection stability with the developing member 215 or the anchor ring are higher; it is easier to prepare without welding.

Referring to FIG. 9 and FIG. 10 simultaneously, the adjustable curved sheath tube 300 of another embodiment has substantially the same structure as the adjustable curved sheath tube 100, and the difference is that the traction wire of the tubular body portion 310 of the adjustable curved sheath tube 300 is The first traction wire 3171 and the second traction wire 3173 are included. Correspondingly, two developing members are respectively a first developing member 314 and a second developing member 315. The operating mechanism 350 includes a first operating member 3551 and a second operating member. 3553.

The first developing member 314 is located at one end of the first tubular section 3123 adjacent to the second tubular section 3125, and the second developing member 315 is located at an end of the second tubular section 3125 away from the first tubular section 3123.

One end of the first pulling wire 3171 is fixed to the first developing member 314, and the other end is connected to the first operating member 3551. The first traction wire 3171 extends linearly in a direction parallel to the axis of the first tubular section 3123. Of course, in other embodiments, the first traction wire 3171 extends in a spiral curve about the axis of the first tubular section 3123 to an end of the first tubular section 3123 adjacent the connecting tube 3121.

One end of the second pulling wire 3175 is fixed to the second developing member 315, and the other end is connected to the second operating member 3553. The second pulling wire 3175 extends straight in a direction parallel to the axis of the first tubular section 3123. Of course, in other embodiments, the first traction wire 3171 extends in a spiral curve about the axis of the first tubular section 3123 and the second tubular section 3125 to an end of the first tubular section 3123 adjacent to the connecting tube 3121.

In the illustrated embodiment, the plane of the first traction wire 3171 and the axis of the first tubular section 3123 and the plane of the second traction wire 3173 and the axis of the first tubular section 3123 form an angle θ. Preferably, θ is from 0° to 180°, and further preferably from 90°.

Referring to FIG. 11 to FIG. 13 together, when the adjustable bending sheath tube 300 is in use, a pulling force is applied to the second pulling wire 3173 by the operating mechanism 350, and after the second pulling wire 3173 is subjected to the pulling force, the force is transmitted to the first The second developing member 315 is located at one end of the second tubular section 3125 away from the first tubular section 3123, thereby applying a traction force to the end of the second tubular section 3125, and the second tubular section 3125 is away from the first tubular section 3123. When the one end is stressed by one side, the bending is biased toward the direction of the force; the pulling force is applied to the first pulling wire 3171 by the operating mechanism 350, and the first pulling wire 3171 is subjected to the pulling force, and then the force is transmitted to the first developing member 314. A developing member 314 is located at one end of the first tubular section 3123 near the second tubular section 3125, thereby applying a traction force to the end of the first tubular section 3123, and the end of the first tubular section 3125 is unilaterally biased to be biased toward the direction of the force. , the effect of multi-section anisotropic bending. By controlling the angle θ, the direction of the anisotropic bending can be controlled.

It should be noted that since the first tubular section 3171 and the second tubular section 3125 are controlled to be bent by the first pulling wire 3171 and the second pulling wire 3173, the hardness of the first tubular section 3123 and the second tubular section 3125 is not particularly required. . Of course, preferably, the three sections of the second tubular section 3125, the first tubular section 3123, and the connecting tube 3121 are sequentially increased in hardness to facilitate handling.

The adjustable curved sheath tube of another embodiment is substantially identical in construction to the adjustable curved sheath tube 100, with the following differences:

Referring to Figure 14, the second tubular section 4125 of the tubular body portion 410 has flexibility. The first tubular section 4123 has a rigid and curved shape, and the pulling wire 417 can drive the second tubular section 4125 to bend. That is, the second tubular section 4125 is a portion in which the tubular body has flexibility. In the natural state, the first tubular section 4123 is in a bent state. At this time, in order to facilitate the bending of the second tubular section 4125 by the pulling wire 417, the connection point of the pulling wire 417 and the developing member 415 is located on one side of the bending direction of the second tubular section 4125.

In one of the embodiments, the first tubular section 4123 is curved by a shaping process to provide a fixed angle. The hardness of the second tubular section 4125 is smaller than the hardness of the first tubular section 4123 and the connecting tube 4121. The second tubular section 4125 is made of a polymer material pipe having a small coefficient of friction, excellent folding resistance and excellent twist control, such as a nylon elastomer (PEBAX) tube. In one embodiment, the second tubular section 4125 has a hardness of 30D to 40D; the first tubular section 4123 has a hardness of 65D to 75D; and the connecting tube 4121 has a hardness of 65D to 75D. In the illustrated embodiment, the second tubular section 4125, the first tubular section 4123 and the connecting tube 4121 are joined together by hot melt.

Since the second tubular section 4125 is flexible, bending can occur when the second tubular section 4125 is subjected to a force. In the illustrated embodiment, the second tubular section 4125 has a bend angle of 0 to 180° and the first tubular section has a bend angle of 25° to 65°. It can be understood that the radius of curvature of the first tubular section 4123 and the second tubular section 4125 can be controlled according to the lengths of the first tubular section 4123 and the second tubular section 4125 to accommodate different blood vessels and anatomical structures of the heart, or the tubular body When the 410 is applied to a blood vessel or a heart, the required bending angle can be designed according to the actual blood vessel or the anatomy of the heart to determine the lengths of the first tubular section 4123 and the second tubular section 4125. After the second tubular section 4125 is bent, the plane of the second tubular section 4125 is between 0° and 360°, and further 70° to 110°, with the plane of the first tubular section 4123. The angle formed by the plane of the second tubular section 4125 and the plane of the first tubular section 4123 can also be adjusted according to the actual vascular or cardiac anatomy.

When the adjustable curved sheath tube is in use, a pulling force is applied to the pulling wire 417 by the operating mechanism, and after the pulling wire 417 is subjected to the pulling force, the force is transmitted to the developing member 415, and the developing member 415 is located at the second tubular portion 4125 away from the first tubular shape. One end of the segment 4123, thereby applying a traction force to the end of the second tubular section 4125, and the second tubular section 4125 is unilaterally biased away from the end of the first tubular section 4123, and is deflected in a biased direction.

The first tubular section 4123 of the tubular body portion 410 of the adjustable curved sheath of the present embodiment has a rigid and curved shape, and the second tubular section 4125 is flexible and capable of being bent by force, and for a vascular passage having a small structural difference, For example, in the left atrium and the right atrium, most of the structures and angles formed are relatively uniform. The structure of the tube 410 of the adjustable curved sheath tube of the present embodiment not only satisfies the clinical use, but also has more convenient operation and simpler production and preparation.

Referring to Figure 15, the second tubular section 5125 of the tubular body portion 510 is rigid and curved, the first tubular section 5123 is flexible, and the pulling wire 517 can drive the first tubular section 5123 to bend. That is, the first tubular section 5123 is a portion in which the tubular body has flexibility. In the natural state, the second tubular section 5125 is in a bent state. In one of the embodiments, the second tubular section 5125 is curved by a shaping process to provide a fixed angle. At this time, the developing member 515 is located at one end of the first tubular section 5123 near the second tubular section 5125. In order to facilitate the pulling of the first tubular section 5123 by the pulling wire 517, the connection point of the pulling wire 517 and the developing member 515 is located on one side of the bending direction of the first tubular section 5123.

The hardness of the first tubular section 5123 is smaller than that of the second tubular section 5125 and the connecting tube 5121. The first tubular section 5123, the second tubular section 5125 and the connecting tube 5121 are joined together by hot melt. The first tubular section 5123 is made of a polymer material tube having a small coefficient of friction, excellent folding resistance and excellent twist control, such as a nylon elastomer (PEBAX) tube. In one embodiment, the first tubular section 5123 has a hardness of 30D to 40D; the second tubular section 5125 has a hardness of 65D to 75D; and the connecting tube has a hardness of 65D to 75D.

Since the first tubular section 5123 is flexible, bending can occur when the first tubular section 5123 is subjected to a force. In the illustrated embodiment, the first tubular section 5123 has a bend angle of 0-180° and the second tubular section 5125 has a bend angle of 70°-110°. It can be understood that the radius of curvature of the first tubular section 5123 and the second tubular section 5125 can be controlled according to the lengths of the first tubular section 5123 and the second tubular section 5125 to accommodate different blood vessels and anatomical structures of the heart, or the tubular body When applied to a blood vessel or a heart, the required bending angle can be designed according to the actual vascular or cardiac anatomy to determine the length of the first tubular section 5123 and the second tubular section 5125. After the first tubular section 5123 is bent, the plane in which the first tubular section 5123 is located is between 0° and 360°, and further 70° to 110°, in the plane in which the second tubular section 5125 is located. The angle formed by the plane of the first tubular section 5123 and the plane of the second tubular section 5125 can also be adjusted according to the actual vascular or cardiac anatomy.

When the adjustable curved sheath tube is in use, a pulling force is applied to the pulling wire 517 by the operating mechanism, and after the pulling wire 517 is subjected to the pulling force, the force is transmitted to the developing member 515, and the developing member 515 is located at the first tubular section 5123 near the second tubular shape. One end of the segment 5125, so that the traction force is applied to one end of the first tubular segment 5123 near the second tubular segment 5125, and the first tubular segment 5123 is unilaterally biased near the end of the second tubular segment 5125, and the bending is biased toward the direction of the force. .

The first tubular section 5123 of the tubular portion 510 of the adjustable curved sheath of the present embodiment has flexibility to be flexibly bent, and the second tubular section 5125 has a rigid and curved shape, and for a vascular passage having a small structural difference, The structure of the tubular body portion 510 of the adjustable curved sheath tube of the present embodiment not only satisfies the clinical use, but also has more convenient operation and simpler production and preparation.

Of course, the tube body is not limited to a two-stage structure, and may also be a three-stage and three-stage structure, that is, the number of the first tubular section 5123 and the second tubular section 5125 is not limited to each one, and the first tubular section 5123 The number of the second tubular segments 5125 can be adjusted as needed. In this case, the number of the pulling wires 517 can also be correspondingly increased according to the number of segments in which the tubular body has flexibility.

Referring to Figure 16, a medical device 20 of an embodiment includes the above-described adjustable curved sheath tube 100 and an expansion puncturing device. The structure of the adjustable bending sheath 100 is as shown in FIGS. 1 to 7 .

Referring to Figures 17 and 18 together, the expansion piercing device includes an expansion assembly 800 and a piercing assembly 900.

Referring also to FIG. 19, the expansion assembly 800 includes a dilation tube 810 and a closure member 830. In the illustrated embodiment, one end of the dilation tube 810 is provided with a joint 815. The joint 815 includes an operation portion 8151, a lock portion 8153, and a fitting portion 8155. The operation portion 8151 has a cylindrical shape and has a diameter larger than that of the operation portion 8151 and the fitting portion 8155 to facilitate the gripping operation. The lock portion 8153 is connected to one end of the operation portion 8151 and is connected to the expansion tube 810. The mounting portion 8155 is connected to the other end of the operating portion 8151. In the illustrated embodiment, the operating portion 8151, the locking portion 8153, the mounting portion 8155, and the expansion tube 810 are integrally formed. The operation portion 8151, the lock portion 8153, and the fitting portion 8155 are provided with through holes communicating with the expansion tube 810 for insertion of the puncture needle 930 of the puncture assembly 900.

The locking member 830 is sleeved on the locking portion 8153 and fixedly connected to the locking portion 8153. The latch 830 can be fixedly coupled to the operating mechanism 150. Specifically, the locking member 830 is a locking cap formed with an internal thread, and an end of the connecting member 151 of the operating mechanism 150 away from the tubular portion 110 is formed with an engaging portion 1512 (shown in FIG. 1). In the illustrated embodiment, the engaging portion 1512 is an external thread formed on the surface of the connecting member 151 so as to be assembled with the locking member 830. Of course, in other embodiments, the engaging member 830 may be disposed outside the surface of the locking member 830. The threading member is provided with a matching internal thread on the connecting member 151. Of course, the locking member 830 and the connecting member 151 can also be connected by other means such as snapping.

The piercing assembly 900 includes a handle 910, a puncture needle 930, a connector 950, and an adjustment member 970.

Referring also to Figure 20, the handle 910 is generally cylindrical. The handle 910 is provided with a sliding slot 912 and a positioning slot 914. The chute 912 is recessed inwardly from the outer surface of the handle 910 and extends along the length of the handle 910. The positioning groove 914 is in communication with the chute 912 and extends in the axial direction of the handle 910. In the illustrated embodiment, the positioning slots 914 are plural, and the plurality of positioning slots 914 are arranged along the axial direction of the handle 910. Of course, the axial arrangement along the handle 910 refers to a general direction. In some embodiments, all of the positioning slots 914 are located on one side of the sliding slot 912. In other embodiments, the partial positioning slot 914 is located in the sliding slot. On one side of the 912, a portion of the positioning groove 914 is located on the other side of the chute 912, and is understood to be arranged in the axial direction.

Referring also to Figure 21, the adjustment member 970 is generally cylindrical. The adjusting member 970 is sleeved on the handle 910, and the inner wall of the adjusting member 970 is provided with a protrusion 972 that can cooperate with the sliding slot 912 and the positioning groove 914. When the adjusting member 970 is pushed axially along the handle 910, the protrusion 972 of the adjusting member 970 can slide along the sliding slot 912, and the position of one of the positioning slots 914 rotates the adjusting member 970, and the protrusion 972 can slide to the positioning groove 914 for positioning. . Of course, in other embodiments, an external thread may be disposed on the surface of the handle 910, and an internal thread is disposed on the adjusting member 970 to adjust and position the adjusting member 970 and the handle 910 by rotating.

It should be noted that there may be two chutes 912 and two protrusions 972, thereby ensuring smooth sliding of the adjusting member 970.

One end of the handle 910 forms a limit portion 916. In the illustrated embodiment, the limiting portion 916 is a boss formed on the handle 910 and partially received in the sliding slot 912. Further, the limiting portion 916 is a wedge-shaped boss and the number is two, and is symmetrically disposed along the circumference of the handle 910. In other embodiments, the limiting portion 916 can also be a structure such as a convex ring. In some embodiments, the limiting portion 916 can also be a nut screwed to one end of the handle 910 to facilitate assembly of the connecting member 950. In short, as long as the connector 950 can be prevented from falling off the handle 910.

The end of the handle 910 away from the limiting portion 916 is formed with an external thread 918 to facilitate docking with other components.

One end of the puncture needle 930 is inserted into one end of the handle 910 where the limiting portion 916 is disposed. The puncture needle 930 can be housed in the dilation tube 810.

Referring to FIG. 19 , the connector 950 includes a resisting portion 952 and a connecting portion 954 . The connecting portion 954 is substantially cylindrical and can be sleeved on the handle 910. The abutting portion 952 is a convex ring that is convexly provided on the inner wall of the connecting portion 954. In the illustrated embodiment, the abutting portion 952 protrudes inwardly from one end of the connecting portion 954. The inner diameter of the abutting portion 952 is slightly larger than the outer diameter of the handle 910 and can be blocked by the limiting portion 916, thereby making the connection The piece 950 can slide relative to the handle 910 and cannot be disengaged from the end of the handle 910 where the abutment portion 952 is disposed.

The fitting portion 8155 is formed with an external thread, and the connecting portion 954 can be sleeved on the fitting portion 8155 and provided with an internal thread that cooperates with the external thread of the fitting portion 8155, thereby connecting the connecting member 950 by screwing the connecting portion 954 with the fitting portion 8155. It is assembled with the joint 815. Of course, in other embodiments, the internal thread may be formed on the mounting portion 8155, and the external thread corresponding to the connecting portion 954 may be formed correspondingly, and the two may be fixed by other means such as engagement.

Please refer to FIG. 16 at the same time. In use, the adjusting member 970 is slid along the handle 910 toward the positioning groove 914 of the limiting portion 916 and positioned to abut the connecting member 950, and the puncture needle 930 is inserted into the expansion tube 810 to be connected. The connecting portion 954 of the member 950 is sleeved on the mounting portion 8155 and screwed into the mounting portion 8155. At this time, the puncture needle 930 is housed in the dilating tube 810, and the dilating and puncture device is assembled. The expansion tube 810 is inserted into the tubular body portion 110 from the connector 151, and the closure member 830 is screwed with the engagement portion 1512 to assemble the expansion assembly 800 to the tubular body portion 110.

The use of the medical device 20 described above will be described in detail below by taking the left atrial appendage surgery as an example with reference to the accompanying drawings.

For the left atrial appendage occlusion surgery, a short puncture vascular guide wire is inserted into the body through the femoral vein, and then the vascular sheath is inserted into the blood vessel along the short puncture vascular guide wire. After the puncture of the vascular sheath, the short puncture of the vascular guidewire is withdrawn, and the puncture of the vascular sheath is retained to maintain and maintain the instrument exchange and hemostasis. Then, along the puncture vessel sheath, the vascular guide wire 30 of the "J"-shaped tip enters the right atrium through the femoral vein and the inferior vena cava, and the vascular guide wire remains in the body, and the puncture vessel sheath is withdrawn. Then, at the proximal end of the vascular guidewire, the adjustable curved sheath tube 100 assembled with the expansion puncturing device is inserted and pushed until the distal end of the tubular body portion 110 is in the right atrium (as shown in Fig. 22). Out of the blood vessel guide wire.

The tubular body portion 110 is slowly urged and maintains the expansion puncture device in a relatively fixed position relative to the tubular body portion 110 to prevent relative changes in position of the components until the distal end of the tubular body portion 110 reaches the appropriate punctured fossa ovalis. The position of the adjustment member 970 is adjusted such that the adjustment member 970 is slid and positioned proximally, and the handle 910 is gently pushed to push the puncture needle 930 from the distal end of the dilation tube 810 to extend to the right atrium fossa.

Pushing the handle 910 continues to allow the tip of the puncture needle 930 to pass through the interatrial septum into the left atrium (LA) (Fig. 23). While maintaining the position of the puncture needle 930 in the left atrium, the expansion assembly 800 and the body portion 110 are introduced into the left atrium along the puncture needle 930. After the distal end of the tubular body portion 110 is integrally accessed, the position of the adjusting member 970 is adjusted, and the adjusting member 970 is slid and positioned to the connecting member 950, so that the puncture needle 930 is retracted into the inside of the dilating tube 810, and then the dilating and puncture device is withdrawn, and the tube body is retained. Part 110 is in the left atrium (Fig. 24), establishing a passage from the body to the body.

The operating mechanism 150 (as in Figures 1-7) is manipulated such that the distal end of the tubular portion 110 is aligned with the entrance position of the left atrial appendage. That is, a pulling force is applied to the pulling wire 117 by the operating member 155 of the operating mechanism 150. After the pulling wire 117 is subjected to the pulling force, the force is transmitted to the developing member 115, and the developing member 115 is located at the end of the second tubular portion 1125 away from the first tubular portion 1123. Therefore, the traction force is applied to the end of the second elastic segment 1225, and the second elastic segment 1225 is unilaterally biased away from the end of the first tubular segment 1123, and the bending is biased toward the direction of the force, and at the same time, the hardness of the first tubular segment 1123 The second tubular section 1125 is larger than the second tubular section 1125, so that when the force transmitted by the pulling wire 117 is within a certain range, the first tubular section 1223 is not deformed, and when the force transmitted by the pulling wire 117 is greater than a certain value, the first tubular section 1223 Bending also occurs as the traction wire 117 extends along the cylindrical surface of the inner tube 113 along one end of the second tubular section 1125 away from the first tubular section 1123 toward the first tubular section 1123 away from the second tubular section 1125. Thus, the first tubular section 1123 is adjacent to the end of the second tubular section 1125 and the second tubular section 1125 is different from the direction of the tensile force experienced by the section of the first tubular section 1123, thus the first tubular section 12 23 and the second tubular section 1125 can produce a multi-section anisotropic bending effect. Because the hardness of the connecting tube 1121 is larger, the connecting tube 1121 does not deform and maintain a straight shape within a certain tensile force range.

It should be noted that the proximal end and the distal end mentioned in the above embodiments are determined by the position at the time of use, the position close to the operator is the proximal end, and the distance from the operator is the distal end.

When the medical device 20 is used, the puncture needle 930 can simultaneously perform the function of puncturing and establishing the track, and the tube body portion 110 need not be replaced in the middle; and the adjusting member 970 and the limiting portion 916 are controlled by adjusting the position of the adjusting member 970 at the position of the handle 910. The distance between the handle 910 and the expansion assembly 800 can be precisely controlled, and the length of the puncture needle 930 from the dilation tube 810 can be controlled to precisely control the penetration depth.

It should be noted that, in the above embodiment, the expansion tube 810 is a straight tube. In other embodiments, as in the embodiment shown in FIG. 25, the expansion tube 810' of the expansion assembly 800' is an elbow, a dilation tube. The end of the 810' is bent and extended. Since the puncture needle has elasticity, when the dilation tube 810 is inserted, the dilation tube 810 can be bent.

It can be understood that the structure of the adjustable curved sheath tube 100 of the medical device 20 is not limited to the above structure. In other embodiments, the adjustable curved sheath tube of the medical device may also have the corresponding structure shown in FIGS. 8-13. An adjustable curved sheath tube, an adjustable curved sheath tube 300, an adjustable curved sheath tube having a tubular body portion 410, or an adjustable curved sheath tube having a tubular body portion 510.

The above-mentioned medical device is only one of the application methods of the adjustable curved sheath tube, and the above-mentioned adjustable curved sheath tube can be applied as long as the medical instrument requiring multiple segments of the opposite bending is required.

The technical features of the above-described embodiments may be arbitrarily combined. For the sake of brevity of description, all possible combinations of the technical features in the above embodiments are not described. However, as long as there is no contradiction between the combinations of these technical features, All should be considered as the scope of this manual.

The above-described embodiments are merely illustrative of several embodiments of the present invention, and the description thereof is more specific and detailed, but is not to be construed as limiting the scope of the invention. It should be noted that a number of variations and modifications may be made by those skilled in the art without departing from the spirit and scope of the invention. Therefore, the scope of the invention should be determined by the appended claims.

Claims

An adjustable curved sheath tube comprising a tubular body portion, the tubular body portion comprising:

The outer tube includes a connecting tube and a tube body communicating with the connecting tube, the tube body including a first tubular section and a second tubular section, the first tubular section being fixed to the connecting tube, the second The tubular section is fixed to an end of the first tubular section away from the connecting tube, at least one of the second tubular section and the first tubular section has flexibility, and the second tubular section and the first One of the tubular segments is flexible and the other is rigid and curved;

Traction wire fixed to the tube body, the traction wire extends along the outer tube, and the free end of the traction wire extends out of the end of the connecting tube away from the tube body, the traction wire is opposite The tubular body is slidable and can drive the flexible portion of the tubular body to bend.
The adjustable curved sheath tube according to claim 1, wherein said first tubular section and said second tubular section each have flexibility, and said pulling wire is capable of driving said first tubular section and said second tubular shape a segment is bent, the traction wire being secured to an end of the second tubular section remote from the first tubular section, the traction wire being from the end of the second tubular section away from the first tubular section to the The second tubular section extends in a curve proximate to an end of the first tubular section, the first tubular section having a hardness greater than the hardness of the second tubular section.
The adjustable curved sheath tube according to claim 2, wherein said pulling wire extends linearly in said first tubular section; or

The traction wire extends from the end of the first tubular section adjacent to the second tubular section toward the end of the first tubular section away from the second tubular section in a spiral curve around the axis of the tubular body. The orthographic projection of the portion of the pulling wire that extends in the first tubular section in a plane perpendicular to the axis of the first tubular section is an arc having a circumferential angle a.
The adjustable curved sheath tube according to claim 2, wherein said pulling wire is adjacent said first tubular portion from said one end of said second tubular section away from said first tubular section toward said second tubular section One end of the segment extends in a spiral curve around the axis of the tubular body, and the orthographic projection of the portion of the pulling wire extending in the second tubular segment in a plane perpendicular to the axis of the second tubular segment is a circumferential angle The arc of β.
The adjustable curved sheath tube of claim 2, wherein the traction wire comprises a first traction wire and a second traction wire, the second traction wire and the second tubular segment being remote from the first One end of the tubular section is fixed, and the first pulling wire is fixed to an end of the first tubular section adjacent to the second tubular section.
The adjustable curved sheath tube according to claim 5, wherein said tubular body portion further comprises a first developing member and a second developing member, said first developing member being located in said first tubular portion adjacent to said An end of the second tubular section, the second developing member is located at an end of the second tubular section away from the first tubular section.
The adjustable curved sheath tube according to claim 6, wherein the first developing member and the second developing member are developing rings, and the first developing member is fixed to the first tubular portion The second developing member is fixed to the second tubular segment; the first pulling wire is fixed to the first developing member, and the second pulling wire is fixed to the second developing member.
The adjustable curved sheath tube according to claim 1, wherein said second tubular section has flexibility, said first tubular section has a rigid and curved shape, said pulling wire and said second tubular section Adjacent to one end of the first tubular section, the traction wire can drive the second tubular section to bend, and the first tubular section has a bending angle of 25° to 65°.
The adjustable curved sheath tube according to claim 2 or 8, wherein the second tubular section has a hardness of 30D to 40D.
The adjustable curved sheath tube according to claim 2 or 8, wherein the tubular body portion further comprises a developing member, the developing member being located at an end of the second tubular section away from the first tubular section.
The adjustable curved sheath tube according to claim 10, wherein the developing member is a developing ring and is fixed to the second tubular section, and one end of the pulling wire is welded and fixed to the developing member; or

The pulling wire forms a bent portion, and the developing member abuts the bent portion away from an edge of the first tubular section.
The adjustable curved sheath tube according to claim 1, wherein said first tubular section has flexibility, said second tubular section has a rigid and curved shape, said pulling wire and said first tubular section Adjacent to one end of the second tubular section, the pulling wire can drive the first tubular section to bend, and the second tubular section has a bending angle of 70° to 110°.
The adjustable curved sheath tube according to claim 12, wherein said first tubular section has a hardness of 30D to 40D.
The adjustable curved sheath tube according to any one of claims 1 to 13, wherein the first tubular section has a length of 30 mm to 70 mm, and the second tubular section has a length of 20 mm to 40 mm. Millimeter.
The adjustable curved sheath tube according to any one of claims 1 to 13, characterized in that the inner wall of the outer tube is formed with an inner membrane, and the inner membrane surface is smooth.
The adjustable curved sheath tube according to any one of claims 1 to 13, wherein the tubular body portion further comprises an inner tube bonded to an inner wall of the outer tube, the inner surface of the inner tube being Smooth surface.
The adjustable curved sheath tube according to claim 16, wherein the tubular body portion further comprises a sliding tube between the inner tube and the outer tube, the pulling wire being threaded through the sliding tube.
The adjustable curved sheath tube according to claim 17, wherein the outer tube is formed with a receiving passage, and the sliding tube is received in the receiving passage.
The adjustable curved sheath tube according to any one of claims 1 to 13, wherein the tubular body portion further comprises a reinforcing tube embedded in the outer tube.
The adjustable curved sheath tube according to any one of claims 1 to 13, further comprising an operating mechanism for operating the tubular body portion, the free end of the pulling wire being coupled to the operating mechanism.
A medical device comprising the adjustable curved sheath tube according to any one of claims 1 to 20.