CN109689147B - Adjustable bent sheath tube and medical instrument - Google Patents
Adjustable bent sheath tube and medical instrument Download PDFInfo
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- CN109689147B CN109689147B CN201880001665.0A CN201880001665A CN109689147B CN 109689147 B CN109689147 B CN 109689147B CN 201880001665 A CN201880001665 A CN 201880001665A CN 109689147 B CN109689147 B CN 109689147B
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- tubular section
- tube
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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
Abstract
An adjustable bending sheath tube (100) comprises a tube body part (110), wherein the tube body part (110) comprises an outer tube (112) and a traction wire (117), the outer tube (112) comprises a connecting tube (1121) and a tube body communicated 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 with the connecting tube (1121), the second tubular section (1125) is fixedly connected with one end, far away from the connecting tube (1121), of the first tubular section (1123), at least one of the second tubular section (1125) and the first tubular section (1123) is flexible, and when one of the second tubular section (1125) and the first tubular section (1123) is flexible, the other one of the second tubular section (1125) and the first tubular section (1123) is rigid and is in a bending shape; the free end of the traction wire (117) extends out of one end of the connecting pipe (1121) far away from the pipe body, and the traction wire (117) can slide relative to the pipe body and can drive the flexible part of the pipe body to bend.
Description
Technical Field
The invention relates to the field of medical instruments, in particular to an adjustable bent sheath tube and a medical instrument.
Background
Adjustable curved sheaths have been widely used in minimally invasive interventional diagnostic and therapeutic procedures for creating channels, delivering or retrieving instruments, infusing drugs, or removing bodily fluids. Compare ordinary sheath pipe, the sheath pipe has the adjustable curved function, through the free accent of distal end curved, can reach target pathological change position fast, reliable to reduce operation time.
At present, the adjustable bending sheath tube in the market can be bent only by 1 section of the head end, but the outer tube below the head end of the adjustable bending sheath tube is in a non-bending state; or the distal end of the sheath has 2 fixed bends with different bending directions.
Aiming at a multi-section bent blood vessel access, the head end of the adjustable bent sheath tube is only bent, so that the clinical use requirement cannot be completely met, and the adjustable bent sheath tube is difficult to be suitable for all patients.
Disclosure of Invention
Therefore, a sheath tube with adjustable bending has to be provided.
In addition, a medical instrument is also provided.
An adjustable bend sheath comprising a body portion, the body portion comprising:
the outer tube comprises a connecting tube and a tube body communicated with the connecting tube, the tube body comprises a first tubular section and a second tubular section, the first tubular section is fixedly connected with the connecting tube, the second tubular section is fixedly connected with one end, far away from the connecting tube, of the first tubular section, at least one of the second tubular section and the first tubular section is flexible, and when one of the second tubular section and the first tubular section is flexible, the other one of the second tubular section and the first tubular section is rigid and bent; and
the traction wire is fixedly connected with the pipe body, the traction wire extends along the outer pipe, the free end of the traction wire extends out of one end, far away from the pipe body, of the connecting pipe, the traction wire is relative to the pipe body and can slide, and the flexible part of the pipe body can be driven to bend.
A medical appliance, which comprises the adjustable bent sheath tube.
The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the 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 description of the embodiments or the prior art will be briefly described below, it is obvious that the drawings in the following description are only some embodiments of the present invention, and for those skilled in the art, other drawings of the embodiments can be obtained according to the drawings without creative efforts.
FIG. 1 is a schematic structural view of an embodiment of an adjustable bending sheath;
fig. 2 is a partial structural view of a tube body portion of the adjustable bending sheath shown in fig. 1;
FIG. 3 is a partial cross-sectional view of the body portion of the adjustable bending sheath of FIG. 1;
FIG. 4 is an enlarged view of a portion of FIG. 3;
fig. 5 is a partial structural view of a tube body portion of the adjustable bending sheath shown in fig. 1;
FIG. 6 is a schematic view of the structure of the developing member and the drawing wire of the tube portion of the adjustable bending sheath shown in FIG. 1;
FIG. 7 is a schematic view of the flexible sheath shown in FIG. 1 with the tubular body in a curved state;
FIG. 8 is a schematic view of a developing member and a drawing wire of a tube portion of an adjustable bending sheath according to another embodiment;
FIG. 9 is a schematic structural view of another embodiment of an adjustable bending sheath;
fig. 10 is a partial structural view of a tube body portion of the adjustable bending sheath shown in fig. 9;
FIG. 11 is a schematic view of the body portion of the adjustable bending sheath of FIG. 9 in a bent state;
FIG. 12 is a schematic view of the body portion of the adjustable bending sheath of FIG. 9 in another bending state;
FIG. 13 is a schematic view of the body portion of the adjustable bending sheath of FIG. 9 in yet another state of bending;
fig. 14 is a partial structural view of a tube body portion of another embodiment of an adjustable bending sheath;
fig. 15 is a partial structural view of a tube body portion of another embodiment of an adjustable bending sheath;
FIG. 16 is a schematic structural view of an embodiment of a medical device;
FIG. 17 is a schematic view of the structure of the dilation puncturing device of the medical device shown in FIG. 16;
FIG. 18 is a schematic structural view of the dilation puncturing device of FIG. 17 in another state;
fig. 19 is a partial enlarged view of a portion II of fig. 17;
FIG. 20 is a schematic view of a portion of the spike assembly of the dilation puncturing device shown in FIG. 17;
FIG. 21 is a sectional view taken along line III-III of FIG. 20;
FIG. 22 is a schematic view of the medical device of FIG. 16 in a position in which the distal end of the medical device has been advanced into the right atrium;
FIG. 23 is a schematic view of the position of the tip of the needle of the medical device of FIG. 16 passing through the interatrial septum and into the left atrium;
FIG. 24 is a schematic view of the adjustable bend sheath of the medical device of FIG. 16 remaining in position in the left atrium;
FIG. 25 is a schematic view of another embodiment expansion assembly.
Detailed Description
To facilitate an understanding of the invention, the invention will now be described more fully with reference to the accompanying drawings.
Referring to fig. 1, an embodiment of the adjustable bending sheath 100 includes a tube portion 110 and an operating mechanism 150 for operating the tube portion 110.
Referring to fig. 2, 3 and 4, the tube body 110 includes an outer tube 112, an inner tube 113, a developing member 115, a sliding tube 116 and a drawing wire 117.
The outer tube 112 includes a connecting tube 1121 and a tube body (not shown) communicating with the connecting tube 1121. The connection tube 1121 has a higher hardness than the tube body. In the illustrated embodiment, the connection tube 1121 is coaxial with the shaft.
The body includes a first tubular section 1123 and a second tubular section 1125. One end of the first tubular section 1123 is fixedly connected to one end of the connection tube 1121. One end of the second tubular section 1125 is fixedly connected to one end of the first tubular section 1123 away from the connecting tube 1121, and both the first tubular section 1123 and the second tubular section 1125 are flexible. That is, the first tubular section 1123 and the second tubular section 1125 are portions of the tube body having flexibility. In the illustrated embodiment, the hardness of the second tubular segment 1125, the first tubular segment 1123, and the connecting tube 1121 increase in three segments in order. In one embodiment, the second tubular section 1125, the first tubular section 1123, and the connection tube 1121 are nylon elastomer (PEBAX) tubes of different durometer. Further, the hardness of the second tubular section is 30D-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 connection tube 1121 is 72D PEBAX.
The first and second tubular sections 1123, 1125 are flexible so that they bend when the first and second tubular sections 1123, 1125 are subjected to a force. The bending angles of the first tubular section 1123 and the second tubular section 1125 are both 0-180 °, preferably 90 °, so that the curvature radii of the first tubular section 1123 and the second tubular section 1125 can be controlled according to the lengths of the first tubular section 1123 and the second tubular section 1125, of course, when the adjustable bending sheath 100 is applied to a blood vessel or a heart, the required bending angles can be designed according to the actual anatomical structure of the blood vessel or the heart, and further the lengths of the first tubular section 1123 and the second tubular section 1125 can be determined. 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 inside the outer tube 112, and is bonded 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 smooth to ensure smooth transportation of other instruments. In the illustrated embodiment, the material of the inner tube 113 is Polytetrafluoroethylene (PTFE), and in other embodiments, the material of the inner tube 113 may also be polyethylene terephthalate (PET), but the material of the inner tube 113 is not limited to PTFE or PET, and any other material may be used to ensure the inner wall of the inner tube 113 is smooth. In other embodiments, an inner film may be formed on the inner surface of the outer tube 112, and the material of the inner film may be at least one selected from PTFE and PET. The inner membrane may be prepared by coating or the like as long as the inner wall of the outer tube 112 is smooth.
The display 115 is located at an end of the second tubular section 1125 remote from the first tubular section 1123. In the illustrated embodiment, the developing member 115 is a developing ring, and the developing member 115 is fixed to the outer wall of the inner tube 113 by being fitted around the outer wall and is fixed to the outer tube 112 by heat fusion. Further, the developing member 115 is coaxial with the outer tube 112.
The developing member 115 is not limited to a developing ring, and a developing coating 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 perform the developing function under X-ray. In one embodiment, the material of the developing member 115 is at least one selected from tantalum 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 remote from the first tubular section 1123 to an end of the connecting tube 1121 remote from the first tubular section 1123. In the illustrated embodiment, the outer tube 112 is formed with a receiving channel (not shown) in which the sliding tube 116 is received. In one embodiment, the sliding tube 116 threaded with the supporting wires is fixed on the outer wall of the inner tube 113 by medical glue, the outer tube 112 is sleeved on the sliding tube, all materials are melted together by heating, and the supporting wires are threaded in the sliding tube 116, so that the sliding tube 116 is embedded into the outer tube 112 during melting, and a receiving channel is formed in the outer tube 112. Of course, in other embodiments, the tube body 110 further includes a reinforcing tube (not shown) 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 reinforced pipe is a stainless steel woven mesh pipe or a stainless steel spring pipe. After the sliding tube 116 with the supporting wires is fixed on the outer wall of the inner tube 113 by medical glue, the reinforcing tube is sleeved on the surfaces of the inner tube 113 and the sliding tube 116, and all materials are hot-melted together by heating after the outer tube 112 is sleeved.
The material of the sliding tube 116 is Polytetrafluoroethylene (PTFE), but the material of the inner tube 113 is not limited to PTFE, as long as the inner wall of the sliding tube 116 is smooth. It will be appreciated that the sliding tube 116 may be omitted when the outer tube 112 forms a smooth receiving channel.
Referring to fig. 2 to 7, one end of the pulling wire 117 is inserted through the sliding tube 116 and fixed to the developing device 115. In the illustrated embodiment, the pull wire 117 is a metal wire, and preferably, the material of the pull wire 117 is nitinol. Of course, the material of the traction wire 117 is not limited to nitinol, as long as the tensile strength is high to achieve the traction function. One end of the drawing 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 fixedly connected to the outer tube 112 may be disposed in the outer tube 112 to fix one end of the pull wire 117, or one end of the pull wire 117 may be directly fixed to the outer tube 112 by adhesion or the like.
The pull wire 117 extends from the end of the second tubular section 1125 distal to the first tubular section 1123 along the slide tube 116, and a free end of the pull wire 117 extends out of the slide tube 116 to connect to the actuator 150.
In the illustrated embodiment, the pull wire 117 extends curvilinearly along the cylindrical surface of the inner tube 113 from the end of the second tubular section 1125 distal to the first tubular section 1123 to the end of the first tubular section 1123 distal to the second tubular section 1125. Of course, it should be noted that the extension curve of the pull wire 117 is a smooth curve to facilitate applying a pulling force to the pull wire 117 to slide the pull wire 117 relative to the slide tube 116. The pull wire 117 extends linearly from the end of the connection tube 1121 that is proximal to the first tubular section 1123 to the end distal to the first tubular section 1123.
In one embodiment, when the outer tube 112 is in a naturally extended state, i.e., the outer tube 112 is a straight tube, the orthogonal projection of the portion of the pull wire 117 extending in the first tubular section 1123 onto a plane perpendicular to the axis of the first tubular section 1123 is an arc with a circumferential angle α. Preferably, α is 0 ° to 180 °, and further 0 °.
In one embodiment, the pull wire 117 extends linearly within the first tubular section 1123.
Further, when the outer tube 112 is in a natural extension state, i.e. the outer tube 112 is a straight tube, the orthogonal projection of the portion of the traction wire 117 extending in the second tubular section 1125 on a plane perpendicular to the axis of the second tubular section 1125 is an arc with a circumferential angle β. β is 0 ° to 180 °, and more preferably 90 °.
Referring to fig. 1 again, the operating mechanism 150 includes a connecting member 151, an operating handle 153 and an operating member 155. The connecting member 151 is fixedly connected to an end of the connecting tube 1121 of the outer tube 112 away from the tube body. In the illustrated embodiment, the connection member 151 is substantially tubular, and is sleeved on the connection tube 121 and fixed to the connection tube 121. The operating handle 153 is connected to the connecting member 151 at one end thereof, and is disposed to be inclined with respect to the connecting member 151 for easy gripping. The operating member 155 is provided on the operating handle 153 and is slidable relative to the operating handle 153 in a direction away from or toward the connecting member 151.
The free end of the pull wire 117 is fixedly connected to the operating member 155 of the operating mechanism 150 such that sliding the operating member 155 in a direction away from the attachment member 151 transfers the pulling force to the pull wire 117.
Of course, it should be noted that the operation of the pulling wire 117 by sliding the operation member 155 of the operation mechanism 150 is only one way, and the pulling wire 117 may be controlled by an operation mechanism with other structure, for example, the pulling wire 117 may be tightened by rotating and winding, as long as the pulling force is applied to the pulling wire 117 to slide the pulling wire 117 relative to the outer tube 112.
When the sheath tube 100 is used, a pulling force is applied to the pulling wire 117 through the operation member 155 of the operation mechanism 150, the pulling wire 117 is under the pulling force and transmits the acting force to the developing member 115, the developing member 115 is located at one end of the second tubular section 1125 far away from the first tubular section 1123, so as to apply a pulling force to the end of the second tubular section 1225, one end of the second tubular section 1225 far away from the first tubular section 1123 is unilaterally stressed and is biased to be bent in the stress direction, meanwhile, the first tubular section 1123 has a hardness greater than that of the second tubular section 1125, so that when the acting force transmitted by the pulling wire 117 is within a certain range, the first tubular section 1223 is not deformed, when the acting force transmitted by the pulling wire 117 is greater than a certain value, the first tubular section 1223 is also bent, because the pulling wire 117 extends along the spiral curve of the inner cylindrical tube 113 from one end of the second tubular section 1125 far away from the first tubular section 1123 to one end of the first tubular section 1125, therefore, the direction of the pulling force applied to the end of the first tubular section 1123 close to the second tubular section 1125 is different from the direction of the pulling force applied to the end of the second tubular section 1125 far away from the first tubular section 1123, so that the first tubular section 1223 and the second tubular section 1125 can generate multi-section anisotropic bending effect, and the connection tube 1121 is not deformed and kept straight within a certain pulling force range because the connection tube 1121 has higher hardness.
Above-mentioned body part 110 of adjustable curved sheath pipe 100 sets up the shaft into first tubulose section 1223 and second tubulose section 1225 that have flexibility, during the use, the free end through pull wire 117 exerts pulling force to pull wire 117, the other end and the shaft rigid coupling of pull wire 117, thereby pull wire 117 slides first tubulose section 1223 and second tubulose section 1225 relatively and exerts pulling force to the shaft, because first tubulose section 1223 and second tubulose section 1225 have flexibility, can be partial to the direction of force production and bend, thereby realize the multistage bending, can satisfy clinical operation requirement better, the suitability is stronger.
It should be understood that the tube body is not limited to the two-segment structure, and may be a three-segment structure or a structure with more than three segments, as long as the stiffness of each segment of the tube body increases in the direction from the distance from the connection tube 1121 to the approach of the connection tube 1121.
Referring to fig. 8, another embodiment of the bendable sheath is substantially the same as the bendable sheath 100, and the difference is: the structure of the tube portion is slightly different from that of the tube portion 110, and in this embodiment, the drawing wire 217 of the tube portion is folded in half around the developing member 215 to form a bending portion 2172, and an edge of one end of the developing member 215 abuts against the bending portion 2172. When in use, both ends of the traction wire 217 are free ends, and both ends of the traction wire 217 are connected with the operating mechanism at the same time.
In the illustrated embodiment, the pull wire 217 is folded in half to form the fold 2172, although in other embodiments, the pull wire 217 may be wrapped at least once around the developer 215 to form the fold 2172.
It is understood that in other embodiments, when the developing member is a developing coating, the pulling wire is fixed by the anchoring ring, the pulling wire 217 is folded in half to form the bending portion 2172, and the edge of one end of the anchoring ring abuts against the bending portion 2172.
The adjustable bending sheath tube with the structure does not need to adopt a welding mode to fix the traction wire 217 to the developing part 215, so that the traction wire 217 is more widely selected, and when the traction wire is fixed by using the anchoring ring, the anchoring ring is more selected. The traction wire is fixed by adopting the mode, the connection mode of the traction wire is similar to flexible connection, and the connection strength and the connection stability with the developing piece 215 or the anchoring ring are higher; the preparation process is easy without welding.
Referring to fig. 9 and 10, another embodiment of the adjustable bending sheath 300 has substantially the same structure as the adjustable bending sheath 100, except that: the drawing wires of the body portion 310 of the adjustable bending sheath 300 include a first drawing wire 3171 and a second drawing wire 3173, and correspondingly, there are two developing members, which are a first developing member 314 and a second developing member 315, respectively, and the operating mechanism 350 includes a first operating member 3551 and a second operating member 3553.
The first display member 314 is located at an end of the first tubular segment 3123 proximate to the second tubular segment 3125 and the second display member 315 is located at an end of the second tubular segment 3125 distal from the first tubular segment 3123.
One end of the first traction wire 3171 is fixedly connected to the first developing element 314, and the other end is connected to the first operating element 3551. The first pull wire 3171 extends linearly in a direction parallel to the axis of the first tubular segment 3123. Of course, in other embodiments, the first pull wire 3171 extends in a helical curve about the axis of the first tubular segment 3123 to an end of the first tubular segment 3123 proximate the connecting tube 3121.
One end of the second traction wire 3175 is fixedly connected to the second display member 315, and the other end is connected to the second operating member 3553. The second pull wire 3175 extends linearly in a direction parallel to the axis of the first tubular segment 3123. Of course, in other embodiments, the first pull wire 3171 extends in a helical curve about the axis of the first tubular segment 3123 and the second tubular segment 3125 to an end of the first tubular segment 3123 proximate the connecting tube 3121.
In the illustrated embodiment, the plane in which the first pull wire 3171 lies along the axis of the first tubular segment 3123 forms an angle θ with the plane in which the second pull wire 3173 lies along the axis of the first tubular segment 3123. Preferably, θ is 0 ° to 180 °, and more preferably 90 °.
Referring to fig. 11 to 13, when the adjustable curved sheath 300 is in use, the operating mechanism 350 applies a pulling force to the second pulling wire 3173, the second pulling wire 3173 is pulled to transmit the acting force to the second developing element 315, the second developing element 315 is located at an end of the second tubular segment 3125 far from the first tubular segment 3123, so as to apply the pulling force to the end of the second tubular segment 3125, and a single side of the end of the second tubular segment 3125 far from the first tubular segment 3123 is stressed, and is deflected toward the direction of the stress; the first traction wire 3171 is pulled by the operating mechanism 350, the first traction wire 3171 is pulled and transmits the force to the first developing member 314, the first developing member 314 is located at one end of the first tubular segment 3123 close to the second tubular segment 3125, so that the traction force is applied to the end of the first tubular segment 3123, the end of the first tubular segment 3125 is stressed on one side and is deflected to the stress direction, and the multi-segment anisotropic bending effect is generated. By controlling the angle θ, the direction of the anisotropic bend can be controlled.
It should be noted that, since the first and second tubular sections 3123 and 3125 are controlled to bend by the first and second pulling wires 3171 and 3173, the stiffness of the first and second tubular sections 3123 and 3125 has no special requirement. Of course, it is preferable that the hardness of the second tubular section 3125, the first tubular section 3123, and the connection pipe 3121 is sequentially increased for easy manipulation.
Another embodiment of the adjustable bending sheath is substantially the same as the adjustable bending sheath 100, except that:
referring to fig. 14, the second tubular segment 4125 of the tubular body portion 410 is flexible, the first tubular segment 4123 is rigid and curved, and the pull wire 417 is capable of inducing the second tubular segment 4125 to bend. I.e., second tubular segment 4125 is a portion of the tube body that is flexible. And in a natural state, the first tubular segment 4123 is in a bent state. At this time, in order to facilitate the traction wire 417 to bend the second tubular section 4125, the connection point of the traction wire 417 and the developing member 415 is located at one side of the bending direction of the second tubular section 4125.
In one embodiment, the first tubular segment 4123 is formed into a curved shape by a shaping process to assume a fixed angle. The second tubular section 4125 has a lower durometer than the first tubular section 4123 and the connecting tube 4121. The second tubular section 4125 is made of a polymeric material tube having a low coefficient of friction and excellent fracture resistance and torsional control, such as a nylon elastomer (PEBAX) tube. In one embodiment, the second tubular segment 4125 has a durometer of 30D to 40D; the first tubular segment 4123 has a hardness of 65D to 75D; the hardness of the connection tube 4121 is 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 heat staking.
Because of the flexibility of second tubular segment 4125, it may flex when second tubular segment 4125 is subjected to a force. In the illustrated embodiment, the second tubular section 4125 has a bend angle of 0-180 ° and the first tubular section has a bend angle of 25-65 °. It is understood that the radii of curvature of the first and second tubular segments 4123, 4125 can be controlled according to the length of the first and second tubular segments 4123, 4125 to accommodate different anatomical structures of the blood vessel and heart, or the tube 410 can be applied to the blood vessel or heart by designing the required bending angle according to the actual anatomical structure of the blood vessel or heart to determine the length of the first and second tubular segments 4123, 4125. After the second tubular section 4125 is bent, the plane of the second tubular section 4125 is 0 to 360 degrees, and further 70 to 110 degrees, to the plane of the first tubular section 4123. The angle between the plane of the second tubular segment 4125 and the plane of the first tubular segment 4123 may also be adjusted based on the actual anatomy of the vessel or heart.
When the adjustable bent sheath tube is used, the pulling force is applied to the pulling wire 417 through the operating mechanism, the pulling force is transmitted to the developing part 415 after the pulling force is applied to the pulling wire 417, the developing part 415 is positioned at one end of the second tubular section 4125 far away from the first tubular section 4123, so that the pulling force is applied to the tail end of the second tubular section 4125, and one end of the second tubular section 4125 far away from the first tubular section 4123 is subjected to unilateral stress, and then the adjustable bent sheath tube is deflected to the stress direction to be bent.
The first tubular section 4123 of the body part 410 of the adjustable-bending sheath tube of the embodiment has rigidity and is in a bending shape, the second tubular section 4125 has flexibility and can be stressed to bend, and most of structures and formed angles are consistent for blood vessels with smaller structural differences, such as a left room and a right room.
Another embodiment of the adjustable bending sheath is substantially the same as the adjustable bending sheath 100, except that:
referring to fig. 15, the second tubular segment 5125 of the tubular body portion 510 is rigid and curved, and the first tubular segment 5123 is flexible, such that the pull wire 517 can drive the first tubular segment 5123 to bend. That is, the first tubular segment 5123 is a portion of the tubular body having flexibility. While in the natural state, the second tubular section 5125 is in a bent state. In one embodiment, the second tubular segment 5125 is formed into a curved shape by a shaping process to assume a fixed angle. At this time, the developing member 515 is located at an end of the first tubular section 5123 adjacent to the second tubular section 5125. In order to facilitate the traction wire 517 to bend the first tubular segment 5123, the connection point of the traction wire 517 and the developing member 515 is located on one side of the bending direction of the first tubular segment 5123.
The first tubular section 5123 has a hardness less 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 connection tube 5121 are connected together by heat fusion. The first tubular section 5123 is made of a polymeric material tube with a low friction coefficient and excellent fracture resistance and torsion control, such as a nylon elastomer (PEBAX) tube. In one embodiment, the first tubular segment 5123 has a durometer of 30D to 40D; the hardness of the second tubular section 5125 is 65D-75D; the hardness of the connecting pipe is 65D-75D.
Because the first tubular segment 5123 is flexible, it can flex when the first tubular segment 5123 is subjected to a force. In the illustrated embodiment, the first tubular section 5123 has a bend angle of 0 to 180 ° and the second tubular section 5125 has a bend angle of 70 to 110 °. It can be understood that the radius of curvature of the first tubular segment 5123 and the second tubular segment 5125 can be controlled according to the length of the first tubular segment 5123 and the second tubular segment 5125 to adapt to different anatomical structures of the blood vessel and the heart, or when the tube is applied to the blood vessel or the heart, the required bending angle can be designed according to the actual anatomical structure of the blood vessel or the heart to further determine the length of the first tubular segment 5123 and the second tubular segment 5125. After the first tubular section 5123 is bent, the plane of the first tubular section 5123 and the plane of the second tubular section 5125 form an angle of 0 to 360 degrees, and further form an angle of 70 to 110 degrees. The angle between the plane of the first tubular segment 5123 and the plane of the second tubular segment 5125 can also be adjusted according to the actual anatomy of the blood vessel or heart.
When the adjustable bent sheath tube is used, the pulling force is applied to the pulling wire 517 through the operating mechanism, the pulling force is transmitted to the developing part 515 after the pulling force acts on the pulling wire 517, the developing part 515 is located at one end, close to the second tubular section 5125, of the first tubular section 5123, so that the pulling force is applied to one end, close to the second tubular section 5125, of the first tubular section 5123, the unilateral force is applied to one end, close to the second tubular section 5125, of the first tubular section 5123, and the bending can be generated in the direction of the applied force.
The first tubular section 5123 of the body part 510 of the adjustable bending sheath tube of the embodiment has flexibility, can be stressed to bend, and the second tubular section 5125 has rigidity and is in a bending shape, so that the structure of the body part 510 of the adjustable bending sheath tube of the embodiment can meet the requirement of clinical use, the operation is more convenient and more convenient, and the production and the preparation are simpler.
Of course, the tube body is not limited to a two-segment structure, but may also be a structure with three or more segments, that is, the number of the first tubular segment 5123 and the second tubular segment 5125 is not limited to one segment, the number of the first tubular segment 5123 and the second tubular segment 5125 may be adjusted as required, and at this time, the number of the pull wires 517 may also be correspondingly increased according to the number of the segments of the tube body having flexibility.
Referring to fig. 16, one embodiment of a medical device 20 includes the adjustable curved sheath 100 and an expandable puncturing device as described above. The structure of the adjustable bending sheath 100 is shown in fig. 1 to 7.
Referring to fig. 17 and 18 together, the dilation penetration assembly includes a dilation assembly 800 and a penetration assembly 900.
Referring also to fig. 19, the expansion assembly 800 includes an expansion tube 810 and a locking element 830. In the illustrated embodiment, one end of the dilation tube 810 is provided with a nipple 815. The joint 815 includes an operating portion 8151, a locking portion 8153, and an assembling portion 8155. The operating portion 8151 is cylindrical and has a larger diameter than the operating portion 8151 and the fitting portion 8155 to facilitate the holding operation. The locking portion 8153 is connected to one end of the operating portion 8151 and to the expanding tube 810. The fitting portion 8155 is connected to the other end of the operation portion 8151. In the illustrated embodiment, the operating portion 8151, the locking portion 8153, the fitting portion 8155, and the expanding tube 810 are integrally formed. The operation portion 8151, the locking portion 8153 and the assembling portion 8155 are provided with through holes communicated with the expanding tube 810 for inserting the puncture needle 930 of the puncture assembly 900.
The locking element 830 is sleeved on the locking portion 8153 and is fixedly connected with the locking portion 8153. The locking element 830 can be fixedly connected to the actuating element 150. Specifically, the locking element 830 is a locking cap with internal threads, and the end of the connecting element 151 of the actuator 150 remote from the body portion 110 is formed with an engaging portion 1512 (shown in fig. 1). In the illustrated embodiment, the joint 1512 is a male screw formed on the surface of the coupler 151 and can be attached to the locking element 830, but in another embodiment, a male screw may be provided on the surface of the locking element 830 and a female screw may be provided on the coupler 151 to match the male screw, and the locking element 830 and the coupler 151 may be connected by another method such as engagement.
The spike assembly 900 includes a handle 910, a spike 930, a connector 950, and an adjustment member 970.
Referring also to fig. 20, the handle 910 is generally cylindrical. The handle 910 has a sliding groove 912 and a positioning groove 914. The sliding groove 912 is recessed inward from an outer surface of the handle 910 and extends along a length of the handle 910. The positioning groove 914 communicates with the sliding groove 912 and extends in the axial direction of the handle 910. In the illustrated embodiment, the positioning groove 914 is provided in plural, and the plural positioning grooves 914 are arranged along the axial direction of the handle 910. Of course, axial alignment along the handle 910 refers to a general direction, and in some embodiments, all of the detents 914 are located on one side of the sliding slot 912, and in other embodiments, some of the detents 914 are located on one side of the sliding slot 912 and some of the detents 914 are located on the other side of the sliding slot 912, which can be understood to be axial alignment.
Referring to fig. 21, the adjusting member 970 has a substantially cylindrical shape. The adjusting member 970 is sleeved on the handle 910, and a protrusion 972 capable of cooperating with the sliding groove 912 and the positioning groove 914 is disposed on an inner wall of the adjusting member 970. 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 groove 912, the adjusting member 970 is rotated to the position of one of the positioning grooves 914, and the protrusion 972 can slide to the positioning groove 914 to be positioned. In other embodiments, the handle 910 may be provided with an external thread on the surface thereof, and the adjusting member 970 may be provided with an internal thread, so that the adjusting member 970 and the handle 910 can be adjusted and positioned by rotation.
It should be noted that there may be two sliding grooves 912 and two protrusions 972, so as to ensure smooth sliding of the adjusting member 970.
A stop 916 is formed at one end of the handle 910. In the illustrated embodiment, the stopper 916 is a boss formed on the handle 910 and is partially received in the sliding groove 912. Further, the limiting portions 916 are wedge-shaped bosses, two in number, and are symmetrically arranged along the circumferential direction of the handle 910. Of course, in other embodiments, the position-limiting portion 916 may also be a protruding ring, and in some embodiments, the position-limiting portion 916 may also be a nut that is screwed to one end of the handle 910, so as to facilitate the assembly of the connection member 950, in short, it is only necessary to prevent the connection member 950 from falling off the handle 910.
An external thread 918 is formed on the end of the handle 910 remote from the stop 916 to facilitate interfacing with other components.
One end of the puncture needle 930 is inserted into the end of the handle 910 having the stopper 916. The puncture needle 930 can be accommodated in the expansion tube 810.
Referring to fig. 19, the connecting member 950 includes a supporting portion 952 and a connecting portion 954. The connecting portion 954 is substantially cylindrical and can be fitted to the handle 910. The abutting portion 952 is a convex ring protruding from the inner wall of the connecting portion 954. In the illustrated embodiment, the abutting portion 952 protrudes from one end of the connecting portion 954, and 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 stopper portion 916, so that the connecting member 950 can slide on the handle 910 relatively and cannot be separated from the end of the handle 910 where the abutting portion 952 is disposed.
The fitting portion 8155 is formed with an external thread, and the connecting portion 954 is fittable to the fitting portion 8155 and provided with an internal thread to be fitted with the external thread of the fitting portion 8155, so that the connecting member 950 and the joint 815 are fitted together by screwing the connecting portion 954 to the fitting portion 8155. Of course, in other embodiments, a female screw may be formed in the mounting portion 8155 and a corresponding male screw may be formed in the connecting portion 954 to be engaged therewith, or both may be fixed by other means such as engagement.
Referring to fig. 16, in use, the adjusting element 970 is slid along the handle 910 toward the positioning groove 914 near the position-limiting portion 916 and positioned such that the adjusting element 970 abuts against the connecting element 950, the puncture needle 930 is inserted into the dilation tube 810, the connecting portion 954 of the connecting element 950 is sleeved on the assembling portion 8155 and screwed with the assembling portion 8155, and the puncture needle 930 is accommodated in the dilation tube 810, thereby assembling the dilation puncture device. The expansion tube 810 is inserted into the body portion 110 from the connector 151, and the locking elements 830 are threaded into the engagement portions 1512 to assemble the expansion assembly 800 to the body portion 110.
The use of the medical device 20 will be described in detail below with reference to the drawings for performing left atrial appendage occlusion surgery.
When the left auricle plugging operation is performed, the short puncture blood vessel guide wire enters the body through femoral vein puncture, and then the puncture blood vessel sheath tube slowly enters the blood vessel along the short puncture blood vessel guide wire. After the puncture blood vessel sheath enters, the short puncture blood vessel guide wire is withdrawn, and the puncture blood vessel sheath is reserved to obtain and maintain the access of instrument exchange and hemostasis. Then enters the blood vessel guide wire 30 with the J-shaped tip along the puncture blood vessel sheath, and when the blood vessel guide wire reaches the right atrium through the femoral vein and the inferior vena cava, the blood vessel guide wire is kept in the body and is withdrawn from the puncture blood vessel sheath. The adjustable curved sheath 100 assembled with the dilation puncture device is then inserted proximally of the vascular guidewire and advanced until the distal tip of the body portion 110 is in the right atrium (as shown in fig. 22), and the vascular guidewire is withdrawn.
The body portion 110 is slowly pushed and the dilation and puncture device is maintained in a fixed position relative to the body portion 110, preventing relative movement of the components until the distal end of the body portion 110 reaches the appropriate puncture fossa ovalis. The adjustment member 970 is positioned such that the adjustment member 970 slides proximally and is positioned, and the handle 910 is gently pushed to push the puncture needle 930 out of the distal end of the dilation tube 810 and out to the right atrial fossa ovalis.
Continued pushing on the handle 910 causes the tip of the needle 930 to pass through the interatrial septum and into the Left Atrium (LA) (see fig. 23). After maintaining the puncture needle 930 in place in the left atrium, the expansion assembly 800 and the body portion 110 are advanced along the puncture needle 930 into the left atrium. After the distal end of the body portion 110 has been fully advanced, the position of the adjustment member 970 is adjusted so that the adjustment member 970 slides and positions toward the coupling member 950 so that the puncture needle 930 is retracted inside the dilation tube 810, and the dilation puncture device is withdrawn, leaving the body portion 110 in the left atrium (see FIG. 24) and establishing an extracorporeal passageway to the body.
The actuator 150 (see fig. 1-7) is manipulated to align the distal end of the body portion 110 with the entrance site 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, the pulling wire 117 is subjected to the pulling force and transmits the pulling force to the developing member 115, the developing member 115 is located at an end of the second tubular section 1125 away from the first tubular section 1123, so that the pulling force is applied to an end of the second elastic section 1225, a single-sided force applied to an end of the second elastic section 1225 away from the first tubular section 1123 deflects toward the force applying direction and bends, at the same time, the first tubular section 1123 has a greater hardness than the second tubular section 1125, so that the first tubular section 1223 is not deformed when the pulling force transmitted by the pulling wire 117 is within a certain range, and when the force transmitted by the pulling wire 117 is greater than a certain value, the first tubular section 1223 also bends, because the pulling wire 117 extends spirally along the cylindrical surface of the inner tube 113 from an end of the second tubular section 1125 away from the end of the first tubular section 1125 toward an end of the first tubular section 1123, therefore, the direction of the pulling force applied to the end of the first tubular section 1123 close to the second tubular section 1125 is different from the direction of the pulling force applied to the section of the second tubular section 1125 far from the first tubular section 1123, so that the first tubular section 1223 and the second tubular section 1125 can generate a multi-section anisotropic bending effect, and the connection tube 1121 is harder, so that the connection tube 1121 is not deformed and remains straight in a certain pulling force range.
In the above embodiments, the proximal end and the distal end are defined by positions at the time of use, and the position close to the operator is the proximal end and the position far from the operator is the distal end.
When the medical device 20 is used, the puncture needle 930 simultaneously performs the functions of puncturing and establishing a track without replacing the tube body 110 in the middle; the distance between the adjusting part 970 and the limiting part 916 is controlled by adjusting the position of the adjusting part 970 on the handle 910, so that the relative movement stroke of the handle 910 and the expansion assembly 800 can be accurately controlled, the length of the puncture needle 930 extending out of the expansion tube 810 can be controlled, and the puncture depth can be accurately controlled.
It should be noted that in the above embodiments, the expansion tubes 810 are all straight tubes, and in other embodiments, as in the embodiment shown in fig. 25, the expansion tube 810' of the expansion assembly 800' is a bent tube, and the end of the expansion tube 810' is bent and extended obliquely. Since the puncture needle has elasticity, it can be bent along with the extension tube 810 when being inserted into the extension tube 810.
It is to be understood that the structure of the adjustable bending sheath 100 of the medical device 20 is not limited to the above structure, and in other embodiments, the adjustable bending sheath of the medical device may be an adjustable bending sheath corresponding to the structure shown in fig. 8 to 13, an adjustable bending sheath 300, an adjustable bending sheath having the tube portion 410, or an adjustable bending sheath having the tube portion 510.
The medical instrument is only one application mode of the adjustable bending sheath, and the adjustable bending sheath can be applied to medical instruments needing multi-section anisotropic bending.
The technical features of the embodiments described above may be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the embodiments described above are not described, but should be considered as being within the scope of the present specification as long as there is no contradiction between the combinations of the technical features.
The above-mentioned embodiments only express several embodiments of the present invention, and the description thereof is specific and detailed, but not to be understood as limiting the scope of the invention. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the inventive concept, which falls within the scope of the present invention. Therefore, the protection scope of the present patent shall be subject to the appended claims.
Claims (19)
1. An adjustable bend sheath comprising a body portion, the body portion comprising:
the outer tube comprises a connecting tube and a tube body communicated with the connecting tube, the tube body comprises a first tubular section and a second tubular section, the first tubular section is fixedly connected with the connecting tube, the second tubular section is fixedly connected with one end, far away from the connecting tube, of the first tubular section, and at least one of the second tubular section and the first tubular section has flexibility; and
the traction wire is fixedly connected with the tube body, extends along the outer tube, and has a free end extending out of one end of the connecting tube far away from the tube body, and can slide relative to the tube body and drive the flexible part of the tube body to bend;
the traction wires comprise a first traction wire and a second traction wire, the second traction wire is fixedly connected with one end, far away from the first tubular section, of the second tubular section, and the first traction wire is fixedly connected with one end, close to the second tubular section, of the first tubular section;
the tube body portion further includes an inner tube received within the outer tube, the pull wire being positioned between the outer tube and the inner tube.
2. The adjustable bend sheath of claim 1, wherein the first and second tubular segments are each flexible, the first tubular segment having a stiffness greater than a stiffness of the second tubular segment.
3. The adjustable bend sheath of claim 2, wherein said pull wire extends linearly over said first tubular section; or
The traction wire extends from one end, close to the second tubular section, of the first tubular section to one end, far away from the second tubular section, of the first tubular section in a spiral curve mode around the axis of the pipe body, and the orthographic projection of the extension part of the traction wire on the first tubular section on a plane perpendicular to the axis of the first tubular section is in an arc shape with a circumferential angle alpha.
4. The adjustable bending sheath of claim 2, wherein the pull wire extends from an end of the second tubular section far from the first tubular section to an end of the second tubular section near the first tubular section in a spiral curve around the axis of the tube body, and an orthographic projection of a part of the pull wire extending in the second tubular section on a plane perpendicular to the axis of the second tubular section is an arc with a circumferential angle β.
5. The adjustable bend sheath of claim 1, wherein the tube portion further comprises a first developing member at an end of the first tubular section proximal to the second tubular section and a second developing member at an end of the second tubular section distal from the first tubular section.
6. The adjustable sheath of claim 5, wherein the first and second developing members are developing rings, the first developing member is fixedly connected to the first tubular section, and the second developing member is fixedly connected to the second tubular section; the first traction wire is fixedly connected with the first developing part, and the second traction wire is fixedly connected with the second developing part.
7. The bendable sheath according to claim 1, wherein the second tubular section is flexible, the first tubular section is rigid and is bent, the second pulling wire is fixedly connected to an end of the second tubular section away from the first tubular section, the second pulling wire can drive the second tubular section to bend, and a bending angle of the first tubular section is 25 ° to 65 °.
8. The adjustable bend sheath of claim 7, wherein the second tubular segment has a durometer of 30D-40D.
9. The adjustable sheath of claim 6, wherein one end of the pull wire is welded to the developer; or
The traction wire forms a bending part, and the edge of the developing piece far away from the first tubular section abuts against the bending part.
10. The bendable sheath according to claim 1, wherein the first tubular section is flexible, the second tubular section is rigid and curved, the first pulling wire is fixedly connected to an end of the first tubular section close to the second tubular section, the first pulling wire can drive the first tubular section to bend, and a bending angle of the second tubular section is 70 ° to 110 °.
11. The adjustable bend sheath of claim 10, wherein the first tubular segment has a durometer of 30D-40D.
12. The adjustable-bending sheath according to any one of claims 1 to 11, wherein the first tubular segment has a length of 30 mm to 70 mm, and the second tubular segment has a length of 20 mm to 40 mm.
13. The adjustable-bending sheath tube according to any one of claims 1 to 11, wherein an inner membrane is formed on the inner wall of the outer tube, and the surface of the inner membrane is smooth.
14. The adjustable bending sheath pipe according to any one of claims 1 to 11, wherein the pipe body portion further comprises an inner pipe bonded to an inner wall of the outer pipe, and an inner surface of the inner pipe is smooth.
15. The adjustable bending sheath of claim 14, wherein the body portion further comprises a sliding tube between the inner tube and the outer tube, the pull wire being disposed through the sliding tube.
16. The adjustable bending sheath of claim 15, wherein the outer tube is formed with a receiving channel, and the sliding tube is received in the receiving channel.
17. The adjustable bending sheath pipe according to any one of claims 1 to 11, wherein the pipe body portion further comprises a reinforcing pipe embedded in the outer pipe.
18. The adjustable bending sheath of any one of claims 1 to 11, further comprising an operating mechanism for operating the body portion, wherein a free end of the pull wire is connected to the operating mechanism.
19. A medical device comprising the adjustable bend sheath of any one of claims 1-18.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2017106245311 | 2017-07-27 | ||
| CN201710624531 | 2017-07-27 | ||
| CN2017114649162 | 2017-12-28 | ||
| CN201711464916.2A CN109965946B (en) | 2017-12-28 | 2017-12-28 | Dilatation puncture device, assembly and medical instrument |
| PCT/CN2018/095962 WO2019019937A1 (en) | 2017-07-27 | 2018-07-17 | Adjustable curved sheath and medical instrument |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN109689147A CN109689147A (en) | 2019-04-26 |
| CN109689147B true CN109689147B (en) | 2022-05-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201880001665.0A Active CN109689147B (en) | 2017-07-27 | 2018-07-17 | Adjustable bent sheath tube and medical instrument |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN109689147B (en) |
| WO (1) | WO2019019937A1 (en) |
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| CA3162237A1 (en) * | 2019-12-17 | 2021-06-24 | Anning Li | Delivery sheath and medical device |
| CN111166994A (en) * | 2020-02-05 | 2020-05-19 | 上海汇禾医疗科技有限公司 | Sleeve assembly and instrument transportation system comprising same |
| CN114642820A (en) * | 2020-12-18 | 2022-06-21 | 先健科技(深圳)有限公司 | Medical delivery catheter |
| CN112774001A (en) * | 2021-01-27 | 2021-05-11 | 康迪泰科(北京)医疗科技有限公司 | Medical catheter and method of using medical catheter |
| CN114177477B (en) * | 2021-11-26 | 2024-02-13 | 上海以心医疗器械有限公司 | Bending adjusting device, bending adjusting sheath tube and medical system |
| CN114469226A (en) * | 2021-12-23 | 2022-05-13 | 杭州唯强医疗科技有限公司 | Sheath pipe adjustable bending device and intracavity crack plugging system |
| CN114424972B (en) * | 2021-12-31 | 2023-12-08 | 杭州德柯医疗科技有限公司 | Self-adaptive guiding device and transcatheter treatment system |
| CN115025365A (en) * | 2022-06-13 | 2022-09-09 | 上海普实医疗器械股份有限公司 | Adjustable bent catheter |
| CN115400322B (en) * | 2022-08-11 | 2023-11-07 | 宁波琳盛高分子材料有限公司 | Reinforced composite sheath tube |
| CN115474888B (en) * | 2022-08-11 | 2023-04-18 | 中国人民解放军陆军军医大学第二附属医院 | Blood vessel intracavity operation catheter with visual function |
| WO2024041285A1 (en) * | 2022-08-26 | 2024-02-29 | 融和医疗科技(浙江)有限公司 | Object ablation system, control method and apparatus, medium, and electronic device |
| CN116650805A (en) * | 2023-04-24 | 2023-08-29 | 昌明生物科技（苏州）有限公司 | Bending-adjusting catheter sheath device and bending-adjusting method thereof |
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Also Published As
| Publication number | Publication date |
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| WO2019019937A1 (en) | 2019-01-31 |
| CN109689147A (en) | 2019-04-26 |
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