CN113208709A

CN113208709A - Development enhanced puncture sheath tube and puncture assembly

Info

Publication number: CN113208709A
Application number: CN202110770103.6A
Authority: CN
Inventors: 汤亮; 李�瑞; 赵丹儒; 闫伟; 徐晓丽
Original assignee: Shanghai Pushi Medical Equipment Co ltd; Shanghai Interventional Medical Equipment Co ltd
Current assignee: Shanghai Pushi Medical Equipment Co ltd; Shanghai Interventional Medical Equipment Co ltd
Priority date: 2021-07-08
Filing date: 2021-07-08
Publication date: 2021-08-06
Anticipated expiration: 2041-07-08
Also published as: CN113208709B

Abstract

The invention discloses a development enhanced puncture sheath and a puncture assembly, wherein the development enhanced puncture sheath comprises: a sheath body having a proximal end and a distal end; the sheath body further has a sheath channel communicating the proximal end and the distal end; a developing cavity is arranged in the wall body of the far end of the sheath tube body. The far end of the development enhanced puncture sheath tube is provided with a development cavity, and the development cavity can weaken the reflection of the far end of the puncture sheath tube on sound waves, so that the obtained sound wave image has larger contrast, and the position of the far end of the puncture sheath tube can be determined by an operator.

Description

Development enhanced puncture sheath tube and puncture assembly

Technical Field

The invention relates to the field of puncture sheaths, in particular to a development enhanced puncture sheath and a puncture assembly.

Background

Percutaneous access catheters normally do not go anterograde directly to the left atrium, and although they may go retrograde through the two turns of the aortic and mitral valves into the left atrium, they are cumbersome to manipulate. Puncturing the interatrial septum may enable and simplify left heart system examination procedures from the right atrium to the left atrium of the catheter.

In recent 20 years, with the development of cardiovascular intervention, particularly percutaneous catheter intervention such as valve repair, atrial fibrillation ablation, left atrial appendage occlusion and other treatment methods, atrial septal puncture is increasingly emphasized, and the technology becomes one of the technologies that an electrophysiologist must master.

The interventional operation through the catheter needs to be carried out under the guidance of ultrasonic equipment and fluoroscopy equipment, and the position of the developing enhanced puncture sheath in the catheter is obtained through images of the external ultrasonic equipment and the fluoroscopy equipment. Therefore, it is important to accurately determine the position of the in vivo imaging enhanced puncture sheath, and a slight deviation may cause secondary damage to the patient.

At present, based on the prior art, the operator needs at least the support of the above two image auxiliary devices, and even under the above two auxiliary devices, the accurate position of the in vivo development enhanced puncture sheath may not be accurately determined, and the risk of mistaken puncture with a high probability exists.

In view of the foregoing, there is a need for improvements to existing puncture sheaths.

Disclosure of Invention

In view of the above technical problems, an object of the present invention is to provide a development enhanced puncture sheath and a puncture assembly, wherein a distal end of the development enhanced puncture sheath has a development cavity, and the development cavity can weaken reflection of a distal end of the puncture sheath on an acoustic wave, so that an obtained acoustic image has a large contrast, and an operator can determine a position of the distal end of the puncture sheath more easily.

In order to achieve the above object, an object of the present invention is to provide a development-enhanced puncture sheath, including:

a sheath body having a proximal end and a distal end;

the sheath body further has a sheath channel communicating the proximal end and the distal end;

a developing cavity is arranged in the wall body of the far end of the sheath tube body.

Preferably, the developing chamber is an arc-shaped chamber, a length extending direction of the arc-shaped developing chamber coincides with a circumferential extending direction of the distal end wall body, and an arc degree of the arc-shaped developing chamber coincides with an arc degree of the distal end wall body.

Preferably, the arc-shaped developing chamber has a large gap between the middle cavities and a small gap between the two sides cavities.

Preferably, a height of a cavity gap in the middle of the developing chamber is a first dimension, and a thickness of a wall of the distal end of the sheath body is a second dimension, the first dimension being between one-third and two-thirds of the second dimension.

Preferably, an angle between a connecting line between the farthest ends of the two sides of the developing chamber and the central axis of the sheath channel ranges from 45 ° to 120 °.

Preferably, the developing chamber is an annular cavity circumferentially provided around a wall of the distal end of the sheath body.

Preferably, the number of the developing chambers is plural, and the plural developing chambers are arranged at intervals around the sheath channel.

Preferably, the inner wall of the developing chamber has a plurality of regularly or irregularly arranged reflecting protrusions for reflecting and refracting the sound wave multiple times when the sound wave enters or leaves the developing chamber to reduce the intensity of the sound wave.

Preferably, the visualization enhanced penetration sheath further comprises a visualization enhancing member installed in the visualization cavity.

Preferably, the sheath body further includes an injection channel extending from the proximal end to the distal end, and the injection channel communicates with the developing chamber;

the visualization enhancing member is a contrast agent that is injectable into the visualization cavity through the injection channel.

Preferably, the visualization-enhanced puncture sheath further includes an injection joint that is mounted to the proximal end of the sheath body and that communicates with the injection channel, through which a contrast agent can be injected into the injection channel, and through which opening and closing of the injection channel can be controlled.

Preferably, the sheath body further includes an outflow channel, and the injection channel and the outflow channel are respectively communicated with the developing chamber;

or, the developing cavity comprises a first developing cavity and a second developing cavity, and the developing cavity further comprises a communication channel for communicating the first developing cavity with the second developing cavity; the injection channel is communicated with the first developing cavity, and the outflow channel is communicated with the second developing cavity;

the development enhanced puncture sheath tube further comprises a discharge joint, and the discharge joint is communicated with the outflow channel.

Preferably, the sheath body further comprises an intermediate section between the proximal end and the distal end, wherein the intermediate section is fabricated from a flexible material.

Preferably, the intermediate section comprises an inner layer, an outer layer and a reinforcing layer located between the inner layer and the outer layer.

Preferably, the junction of the distal end and the intermediate section forms a step structure in the sheath channel to restrain the puncture needle.

Preferably, the joint comprises a joint main body and a valve, wherein the liquid inlet of the joint main body is communicated with the injection channel, the valve is installed on the joint main body and used for controlling the connection and disconnection between the liquid inlet and the injection channel, and the liquid inlet of the joint main body is suitable for being communicated with a suction device.

Preferably, the intermediate section has a first extending projection and the distal end has a second extending projection, the first and second extending projections being connected to each other in a stacked relationship.

Preferably, the sheath body further comprises a heat-shrinkable tube, and the heat-shrinkable tube is sleeved at the joint of the distal end and the middle section.

According to another aspect of the present invention, there is further provided a development-enhanced lancing assembly comprising:

the development-enhanced puncture sheath of any one of the above;

the puncture needle, the pjncture needle be suitable for install in the sheath pipe passageway of development enhancement formula puncture sheath pipe, the head end of pjncture needle has spacing portion, spacing portion be suitable for with the step structure cooperation of development enhancement formula puncture sheath pipe, in order to right the pjncture needle install in the degree of depth in the sheath pipe passageway carries on spacingly.

Compared with the prior art, the development enhanced puncture sheath provided by the invention has at least one of the following beneficial effects:

1. according to the development enhanced puncture sheath and the puncture assembly provided by the invention, the distal end of the development enhanced puncture sheath is provided with the development cavity, and the reflection of the distal end of the puncture sheath on sound waves can be weakened by the development cavity, so that the obtained sound wave image has larger contrast, and an operator can determine the position of the distal end of the puncture sheath more conveniently;

2. according to the development enhanced puncture sheath and the puncture assembly provided by the invention, the inner wall of the development cavity of the development enhanced puncture sheath is provided with a plurality of regularly or irregularly arranged reflection protrusions, and the reflection protrusions are used for reflecting and refracting sound waves for multiple times when the sound waves enter or leave the development cavity so as to reduce the intensity of the sound waves;

3. according to the development enhanced puncture sheath and the puncture assembly provided by the invention, the development enhancing part is arranged in the development cavity of the development enhanced puncture sheath, and the development effect of the far end of the puncture sheath can be further improved through the development enhancing part;

4. the development enhanced puncture sheath tube and the puncture assembly provided by the invention are better suitable for development scenes adopting ultrasonic development alone, or fluoroscopy development alone, or a development scene with both the ultrasonic development and the fluoroscopy development, and compared with the prior art, the development enhanced puncture sheath tube and the puncture assembly can reduce the requirement of an operation on auxiliary equipment, simplify the operation process and reduce the operation risk.

Drawings

FIG. 1 is a perspective view of a visualization enhanced puncture sheath of a preferred embodiment of the present invention;

FIG. 2 is a schematic cross-sectional view of a visualization enhanced penetration sheath according to a preferred embodiment of the present invention;

FIG. 3 is a schematic vertical sectional view of a visualization enhanced penetration sheath according to a preferred embodiment of the present invention;

fig. 4 is a cross-sectional view of a first modified embodiment of the development-enhancing puncture sheath according to the preferred embodiment of the present invention;

fig. 5 is a sectional view of a second modified embodiment of the development-enhancing puncture sheath according to the preferred embodiment of the present invention;

fig. 6 is a sectional view of a third modified embodiment of the development-enhancing puncture sheath according to the preferred embodiment of the present invention;

fig. 7 is a sectional view of a fourth modified embodiment of the development-enhancing puncture sheath according to the preferred embodiment of the present invention;

FIG. 8 is a perspective view of a fifth preferred embodiment of a visualization enhanced penetration sheath of the preferred embodiment of the present invention;

fig. 9 is a cross-sectional view of a fifth preferred embodiment of the development-enhancing piercing sheath of the preferred embodiment of the present invention;

fig. 10 and 11 are sectional views of a sixth preferred embodiment of the development-enhancing puncture sheath according to the preferred embodiment of the present invention;

fig. 12 is a perspective view of a sixth preferred embodiment of a visualization enhanced penetration sheath of the preferred embodiment of the present invention;

fig. 13 is a cross-sectional view of a seventh preferred embodiment of the development-enhancing puncture sheath according to the preferred embodiment of the present invention;

fig. 14 is a cross-sectional view of a development-enhancing lancing assembly according to a preferred embodiment of the present invention.

The reference numbers illustrate:

the sheath body 1, the proximal end 11, the distal end 12, the development cavity 120, the first development cavity 1201, the second development cavity 1202, the communication passage 1203, the outflow passage 16, the reflection protrusion 121, the development section 122, the development section inner layer 1221, the development section reinforcing layer 1222, the development section outer layer 1223, the sheath passage 10, the injection passage 13, the intermediate section 14, the inner layer 141, the outer layer 142, the reinforcing layer 143, the first extension protrusion 144, the second extension protrusion 145, the step structure 15, the joint 2, the joint main body 21, the valve 22, the injection joint 31, the discharge joint 32, the injection pipe 311, the injection valve 312, the injection port 313, the discharge pipe 321, the discharge valve 322, the discharge port 323, and the puncture needle 100.

Detailed Description

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following description will be made with reference to the accompanying drawings. It is obvious that the drawings in the following description are only some examples of the invention, and that for a person skilled in the art, other drawings and embodiments can be derived from them without inventive effort.

For the sake of simplicity, only the parts relevant to the invention are schematically shown in the drawings, and they do not represent the actual structure as a product. In addition, in order to make the drawings concise and understandable, components having the same structure or function in some of the drawings are only schematically illustrated or only labeled. In this document, "one" means not only "only one" but also a case of "more than one".

It should be further understood that the term "and/or" as used in this specification and the appended claims refers to and includes any and all possible combinations of one or more of the associated listed items.

In this context, it is to be understood that, unless otherwise explicitly stated or limited, the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either a fixed connection, a removable connection, or an integral connection; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

In addition, in the description of the present application, the terms "first", "second", and the like are used only for distinguishing the description, and are not intended to indicate or imply relative importance.

Referring to fig. 1 to 7, the visualization enhancement type puncture sheath provided by the present invention is illustrated, which is capable of facilitating an operator to determine a specific position of a tip end of the puncture sheath in a patient, and reducing a risk of a wrong puncture.

Referring to fig. 1 and 2, specifically, the visualization enhancement type puncture sheath includes a sheath body 1, the sheath body 1 has a proximal end 11 and a distal end 12, and the sheath body 1 further has a sheath channel 10 communicating the proximal end 11 and the distal end 12. A developing chamber 120 is provided in the wall body of the distal end 12 of the sheath body 1.

In the use process of the development enhanced puncture sheath provided by the invention, the distal end 12 of the sheath body 1 is inserted into a human body, ultrasonic waves are transmitted to the distal end 12 of the sheath body 1 through ultrasonic equipment, and the position of the distal end 12 of the sheath body 1 in the human body can be determined by receiving the reflected ultrasonic waves.

In this preferred embodiment, the distal end 12 of the sheath body 1 is provided with the developing cavity 120, the ability of the developing cavity 120 to reflect ultrasonic waves and the ability of the wall body to reflect ultrasonic waves have obvious differences, and the position of the distal end 12 of the sheath body 1 can be accurately obtained by obtaining the obtained ultrasonic image, so that an operator can observe the real-time advancing position of the puncture sheath in a human body channel, and the risk of mistaken puncture is reduced.

Referring to fig. 3, further, in the preferred embodiment, the developing chamber 120 is an arc-shaped chamber, the length extension direction of the arc-shaped developing chamber 120 is consistent with the circumferential extension direction of the wall of the distal end 12, and the radian of the arc-shaped developing chamber 120 is consistent with the radian of the wall of the distal end 12.

It should be noted that, in the preferred embodiment, the arc-shaped developing chamber 120 can increase the length of the developing chamber 120 extending in the wall of the distal end 12, increase the size of the developing chamber 120, and further improve the developing effect. On the other hand, the arc-shaped inner wall of the developing chamber 120 is arc-shaped, and the direction of sound reflection can be changed, so that the intensity of reflected sound waves can be further reduced, and the developing enhancement effect can be further improved.

Further, the gap between the middle cavities of the arc-shaped developing chambers 120 is large, and the gaps between the two cavities are small. In other words, the present invention provides the developing chamber 120 with a non-uniform gap, a larger gap in the middle and a smaller gap on both sides. When the ultrasonic wave is reflected, the reflection efficiency is low at the position close to the middle of the developing cavity 120, and the image is darker; the reflection efficiency is slightly higher near the ends of the developing chamber 120 and the image is brighter. That is, according to the present invention, the developing chamber 120 is designed to have a structure form in which the gap between the middle cavities is large and the gaps between the two cavities are small, so that the imaging effect of dark middle and bright two sides can be presented in the ultrasonic image corresponding to the developing chamber 120, and the recognition degree can be further improved.

Further preferably, the height of the cavity gap in the middle of the developing chamber 120 is a first dimension T, and the thickness of the wall of the distal end 12 of the sheath body 1 is a second dimension T, the first dimension being between one-third and two-thirds of the second dimension.

Designing the first size to be one-third to two-thirds of the second size enables to maintain the structural strength of the distal end 12 of the sheath body 1 while maintaining the development enhancement effect.

Preferably, the first size is one-half of the second size.

Preferably, the first dimension is in the range of 0.7-1.4mm and the second dimension is in the range of 1-2 mm.

Referring to fig. 3, an angle a between a line connecting a farthest end of both sides of the developing chamber 120 and the central axis of the sheath channel 10 ranges from 45 ° to 120 °. Preferably, an angle between a line connecting a farthest end of both sides of the developing chamber 120 and the central axis of the sheath channel 10 is 90 °. Referring to fig. 4, it is further preferable that the number of the developing chambers 120 in the wall of the distal end 12 of the sheath body 1 is plural, such as two, three or more, and the plural developing chambers 120 surround the sheath passage 10, being arranged in the wall of the distal end 12 of the sheath body 1 at intervals.

Referring to fig. 5, a second modified embodiment of the developing sheath provided by the present invention is illustrated, in which the inner wall of the developing chamber 120 has a plurality of regularly or irregularly arranged reflecting protrusions 121, and the plurality of reflecting protrusions 121 are used for reflecting and refracting the sound wave multiple times when the sound wave enters or leaves the developing chamber 120, so as to reduce the intensity of the sound wave.

In the second modified embodiment, by providing a plurality of the reflection protrusions 121 on the inner wall of the developing chamber 120, the plurality of the reflection protrusions 121 can reflect and refract the acoustic wave a plurality of times, the intensity of the acoustic wave can be further reduced, and the propagation direction of the acoustic wave can be changed.

Referring to fig. 6, a third modified embodiment of the developing sheath provided by the present invention is explained, in which the developing chamber 120 is an annular cavity circumferentially provided along the wall body of the distal end 12 of the sheath body 1. By designing the developing chamber 120 to be annular, in the use, no matter which angle the sheath body 1 is at, the developing chamber 120 can play a developing enhancing effect.

Referring to fig. 7, a fourth modified embodiment of the developing sheath provided by the present invention is explained, in which the developing-enhanced piercing sheath further includes a developing-enhancing member installed in the developing chamber 120.

Preferably, the visualization enhancing member is a contrast agent, the sheath body 1 further includes an injection channel 13, the injection channel 13 extends from the proximal end 11 to the distal end 12, and the injection channel 13 communicates with the visualization cavity 120. The contrast agent can be injected into the developing chamber 120 through the injection passage 13.

The development-enhanced puncture sheath further includes a joint 2, the joint 2 is attached to the proximal end 11 of the sheath body 1, and the joint 2 is in communication with the injection channel 13, the contrast medium can be injected into the injection channel 13 through the joint 2, and the opening and closing of the injection channel 13 can be controlled through the joint 2.

When the number of the developing chambers 120 of the sheath body 1 is plural, a communicating passage is further provided in the wall body of the distal end 1, the communicating passage communicates the plural developing chambers 120, and the contrast medium can be injected into the plural developing chambers 120 through one injection passage 13. Alternatively, the sheath body 1 has a plurality of the injection channels 13, and each of the imaging chambers 120 has at least one of the injection channels 13, respectively, to inject the contrast agent into the different imaging chambers 120, respectively.

Alternatively, in some variations of the invention, the development enhancer is a metal filament, such as but not limited to a developable metal filament of tungsten-gold, palladium-iridium alloy, etc., with a diameter of 0.7mm to 1.4 mm. In the manufacturing process of the sheath tube body 1, the metal wire is embedded in the wall body of the distal end 12. Alternatively, the development enhancer in the form of a metal filament can fill a portion of the development chamber 120 or fill the entire development chamber 120, either from or integral with the wall material of the distal end 12. It is understood that the developing enhancer in the metal wire shape can not only improve the developing effect of the developing enhancer but also improve the structural strength of the distal end 12 of the sheath body 1.

Preferably, the contrast agent is an ultrasound contrast agent suitable for ultrasound. Optionally, the contrast agent can also be a contrast agent suitable for fluoroscopy or CT scanning. Examples of the type of the contrast agent include, but are not limited to, iohexol, iopromide, ioversol, iobitridol, iodixanol, fluorocarbon gas-encapsulated microbubble contrast agents, liquid fluorocarbon nanoemulsions, and the like.

Referring to fig. 8 and 9, a fifth modified embodiment of the visualization sheath provided by the present invention is explained, the sheath body 1 further includes an intermediate section 14 between the proximal end 11 and the distal end 12, wherein the intermediate section 14 is made of a flexible material.

It is noted that the intermediate section 14 is made of a flexible material, and that the intermediate section 14 is bendable, capable of changing its shape during use depending on the application environment, but is incompressible along its length.

Further, the intermediate section 14 includes an inner layer 141, an outer layer 142, and a reinforcing layer 143 between the inner layer 141 and the outer layer 142. The reinforcing layer 143 may be formed of a woven wire mesh of stainless steel or the like for increasing the torsional rigidity of the intermediate section 14 and for simultaneously transmitting the torque applied to the intermediate section 14 to the distal end. The outer diameter of the sheath body may have a range, preferably not more than 8.5f (french).

The distal end 12 is a relatively short tubular structure, which may be similar to the structure of the intermediate section 14, or may be more flexible. In some embodiments, the distal end 12 is a single layer structure, preferably having an outer diameter of no more than 8.5F (French).

Preferably, the material used for the distal end 12 and the intermediate section 14 should have a heat deflection temperature such that it does not undergo a change in stiffness in the human body due to a change in temperature. Preferably, the material of the inner layer 141 is PEBAX, Pellethane, etc., with a hardness in the range of 25-65D, i.e., a low to middle Shore hardness polymeric material. Preferably, the material of the distal end 12 may be polyurethane or PEBAX.

Preferably, the injection channel 13 is located between the outer layer 142 and the reinforcing layer 143.

Optionally, in other preferred embodiments of the present invention, the development enhancing member is a wire, the wire is installed to the injection passage, and a length of the wire is greater than a length of the injection passage. The length of the metal wire is one or a combination of platinum, rhodium, palladium, molybdenum and tungsten. With the arrangement, the sheath tube can be used in a single ultrasonic environment, and can further enhance the developing effect in an environment needing light-sensitive fluoroscopy or CT scanning.

Referring to fig. 9, the junction of the distal end 12 and the intermediate section 14 forms a step structure 15 in the sheath channel 10 to limit the puncture needle. When the puncture sheath tube is matched with the puncture needle for use, the step structure 15 can be contacted with the step surface at the head end of the puncture needle, so that tactile feedback is provided for an operator, the operator can reach the position, the puncture needle is stopped to advance, and the operation safety is improved.

Further, the middle section 14 has a first extending protrusion 144, the distal end 12 has a second extending protrusion 145, and the first extending protrusion 144 and the second extending protrusion 145 are connected to each other in a stacked manner.

The sheath tube body 1 further comprises a heat-shrinkable tube, and the heat-shrinkable tube is sleeved at the joint of the distal end 12 and the middle section 14.

The distal end 12 is attached or bonded to the intermediate section 14 by heat staking. When the far end 12 is assembled in a hot melting mode, the first extending protrusion 144 and the second extending protrusion 145 are overlapped, the heat-shrinkable tube is arranged outside the overlapped part to form protection, the heat-shrinkable tube can be made of Fluorinated Ethylene Propylene (FEP) or polyethylene terephthalate (PET), the heat-shrinkable tube is heated through a hot melting gun or a heating furnace to shrink the heat-shrinkable tube, the part is further heated to melt the heat-shrinkable tube, the sheath tube is cooled, the heat-shrinkable tube is used as a process auxiliary object to protect a processing section, uniform transition between tubular structures is kept, and the heat-shrinkable tube can be removed after being cooled.

Referring to fig. 10 to 12, in a sixth modified embodiment of the developing sheath provided by the present invention, the developing chamber 120 includes a first developing chamber 1201 and a second developing chamber 1202, and the developing chamber 120 further includes a communication passage 1203 that communicates the first developing chamber 1201 and the second developing chamber 1202. The sheath body 1 further comprises an outflow channel 16. The injection passage 13 communicates with the first developing chamber 1201, and the outflow passage 16 communicates with the second developing chamber 1202.

During the injection of the developer, the developer can be injected from the injection passage 13 into the first developing chamber 1201, and the developer in the first developing chamber 1201 can enter the second developing chamber 1202 through the outflow passage 16 and can be discharged from the outflow passage 16. It is to be noted that, in the process of injecting the developer through the injection passage 13, the gas in the first developing chamber 1201, the second developing chamber 1202 and the communication passage 1203 can be discharged through the outflow passage 16, facilitating the injection of the developer from the injection passage 13.

Alternatively, in some modified embodiments of the present invention, the number of the developing chambers 120 is one chamber, and the injection passage 13 and the outflow passage 16 are respectively communicated with the developing chambers 120.

In the process of forming the developing chamber 120, the injection channel 13, and the outflow channel 16, a polymer material tube is bonded to the developing section reinforcing layer 1222 or the reinforcing layer 143, the polymer material tube may be polyimide, a metal wire or a metal sheet with a corresponding size is embedded in the polymer material tube, after an outer sleeve is sleeved on the polymer material tube, a heat-shrinkable tube is arranged on the outer sleeve, the heat-shrinkable tube is heated by a heat melting gun or a heating furnace to shrink, after a sheath tube is subjected to heat melting and flow change, the sheath tube is cooled, the metal wire or the metal sheet is taken out after the cooling, the developing chamber 120, the injection channel 13, and the outflow channel 16 are formed, and the heat-shrinkable tube can be removed after the sheath tube is cooled.

The connector 2 comprises a connector main body 21 and a valve 22, wherein a liquid inlet of the connector main body 21 is communicated with the injection channel 13, the valve 22 is installed on the connector main body 21 and used for controlling the connection and disconnection between the liquid inlet and the injection channel 13, and the liquid inlet of the connector main body 21 is suitable for being communicated with a suction device.

Referring to fig. 12, the adapter 2 includes an injection adapter 31 and a discharge adapter 32, the injection adapter 31 communicating with the injection passage 13, and the discharge adapter 32 communicating with the discharge passage 16.

The injection connector 31 includes an injection pipe 311, an injection valve 312, and an injection port 313, and the injection pipe 311 is connected to the sheath body 1 and is communicated with the injection channel 13. The injection valve 312 is used for controlling the on-off between the main inlet 313 and the injection pipeline 311.

The discharge joint 32 includes a discharge pipe 321, a discharge valve 322, and a discharge port 323, and the discharge pipe 321 is connected to the sheath body 1 and communicates with the outflow channel 16. The discharge valve 322 is used for controlling the connection and disconnection between the discharge port 323 and the discharge pipe 321.

Referring to fig. 13, a seventh modified embodiment of the developing sheath provided by the present invention is explained, in which the distal end 12 of the sheath body 1 is also a multilayer laminated structure. In the present modified embodiment, the distal end 12 of the sheath body 1 includes a developing section 122. The developer stage 122 is a relatively short tubular structure, similar to the structure of the intermediate stage 14, including a developer stage inner layer 1221, a developer stage reinforcing layer 1222, and a developer stage outer layer 1223, and may have greater flexibility. In some embodiments, the development stage 122 may also be a single layer structure. The outer diameter of the development section 122 preferably does not exceed 8.5f (french).

Preferably, the materials used for the developer section 122 and the intermediate section 14 should have a heat deflection temperature such that they do not undergo a change in stiffness in the human body due to a temperature change. Preferably, the materials of the inner layer 141, the outer layer 142, the inner developing stage layer 1221 and the outer developing stage layer 1223 include PEBAX, Pellethane, etc., and have a hardness in the range of 25-65D, i.e., a low to middle shore hardness. The developing section 122 may be made of polyurethane.

The developing section 122 and the intermediate section 14 are connected or bonded by heat fusion.

Referring to fig. 14, according to another aspect of the present invention, the present invention further provides a development-enhanced lancing assembly, comprising:

the development enhanced puncture sheath and puncture needle 100 according to embodiment 1, wherein the puncture needle 100 is adapted to be installed in the sheath channel 10 of the development enhanced puncture sheath, the tip of the puncture needle 100 has a limiting portion, and the limiting portion is adapted to cooperate with the step structure 15 of the development enhanced puncture sheath to limit the depth of the puncture needle 100 installed in the sheath channel 10.

It should be noted that the above embodiments can be freely combined as necessary. The foregoing is only a preferred embodiment of the present invention, and it should be noted that it is obvious to those skilled in the art that various modifications and improvements can be made without departing from the principle of the present invention, and these modifications and improvements should also be considered as the protection scope of the present invention.

Claims

1. Development enhancement mode puncture sheath pipe, its characterized in that includes:

a sheath body having a proximal end and a distal end;

2. The visualization enhanced penetration sheath of claim 1, wherein the visualization cavity is an arcuate cavity, a length extension of the arcuate visualization cavity coinciding with a circumferential extension of the distal wall, and an arc of the arcuate visualization cavity coinciding with an arc of the distal wall.

3. The development-enhancing puncture sheath according to claim 2, wherein the arc-shaped development chamber has a large cavity gap in the middle and a small cavity gap on both sides.

4. The visualization enhanced penetration sheath of claim 3, wherein a height of a cavity gap in a middle of the visualization cavity is a first dimension, a thickness of a wall of the distal end of the sheath body is a second dimension, and the first dimension is between one-third and two-thirds of the second dimension.

5. The visualization enhancing puncturing sheath of claim 3, wherein an angle between a line connecting a distal-most end of the two sides of the visualization cavity and a central axis of the sheath channel ranges from 45 ° to 120 °.

6. The visualization enhanced penetration sheath of claim 1, wherein said visualization cavity is an annular cavity circumferentially disposed around a wall of said distal end of said sheath body.

7. The visualization enhancing puncturing sheath of claim 1, wherein the number of the visualization lumens is plural, the plural visualization lumens being arranged at intervals around the sheath channel.

8. The visualization enhancing penetration sheath of any one of claims 1 to 7, wherein the inner wall of the visualization cavity has a plurality of regularly or irregularly arranged reflection protrusions for reflecting and refracting the sound wave a plurality of times when the sound wave enters or exits the visualization cavity to reduce the intensity of the sound wave.

9. The visualization enhanced puncturing sheath of claim 8, wherein the visualization enhanced puncturing sheath further comprises a visualization enhancing member mounted within the visualization cavity.

10. The visualization enhanced puncturing sheath of claim 9, wherein the sheath body further comprises an injection channel extending from the proximal end to the distal end, and wherein the injection channel is in communication with the visualization lumen;

11. The visualization enhanced puncture sheath according to claim 10, further comprising an injection joint that is mounted to the proximal end of the sheath body and that communicates with the injection channel, through which a contrast agent can be injected into the injection channel, and through which opening and closing of the injection channel can be controlled.

12. The visualization enhancing puncture sheath according to claim 11, wherein the sheath body further comprises an outflow channel, the injection channel and the outflow channel communicating with the visualization cavity, respectively;

13. The visualization enhanced piercing sheath of claim 8, wherein the sheath body further comprises an intermediate section between the proximal end and the distal end, wherein the intermediate section is fabricated from a flexible material.

14. The visualization enhanced piercing sheath of claim 13, wherein the intermediate section comprises an inner layer, an outer layer, and a reinforcing layer between the inner layer and the outer layer.

15. The visualization enhanced puncturing sheath of claim 13, wherein the connection of the distal end to the intermediate section forms a step structure in the sheath channel to constrain a puncturing needle.

16. The visualization enhanced puncturing sheath of claim 11, wherein the adaptor comprises an adaptor body and a valve, wherein the liquid inlet of the adaptor body is in communication with the injection channel, the valve is mounted to the adaptor body for controlling the connection and disconnection between the liquid inlet and the injection channel, and the liquid inlet of the adaptor body is adapted to communicate with a suction device.

17. The visualization enhancing piercing sheath of claim 13, wherein the intermediate section has a first extending protrusion and the distal end has a second extending protrusion, the first extending protrusion and the second extending protrusion being connected to each other in a stacked manner.

18. The visualization enhancing puncturing sheath of claim 17, wherein the sheath body further comprises a heat shrink tube sleeved at a junction of the distal end and the intermediate section.

19. Development enhancement formula puncture assembly, its characterized in that includes:

the visualization enhanced penetration sheath of any one of claims 1-18;