CN214318030U - Measuring device and measuring system - Google Patents

Abstract

The utility model belongs to the technical field of medical instrument, concretely relates to measuring device and measurement system. The utility model provides a measuring device includes the sheath pipe and marks a survey subassembly, and the sheath pipe is hollow siphonozooid, marks a survey subassembly including mark a survey spare and at least one long and thin connecting piece that links to each other with mark a survey spare, marks a survey spare and has elasticity, and can partly compress at least and accept in the sheath intraductal so that carry, is positive spheroid form or is close positive spheroid form after releasing outside from the sheath intraductal when mark a survey spare, and has the developing nature under operating condition at least. The utility model discloses a measuring device is under operating condition, because the mapping piece of positive spheroid structure is the circular of constant size under arbitrary angle projection to this is the measuring basis, can guarantee the measuring accuracy under equipment such as DSA, and the treatment instrument of the suitable size correspondence specification of accurate selection improves the operation success rate. In addition, the boundary of the mapping piece of the regular sphere structure is clearer, and quick capture and accurate measurement are facilitated.

Description

Measuring device and measuring system

Technical Field

The utility model belongs to the technical field of medical instrument, concretely relates to measuring device and measurement system.

Background

During interventional procedures, a delivery channel is established via a sheath and an associated implant device is delivered to a target site, typically under Digital Subtraction Angiography (DSA) visualization. During the operation, under the X-ray fluoroscopy, the developing ring on the sheath tube is conveyed to the vicinity of the target position for positioning in vivo. Under a visual window of the planar projection of the digital subtraction angiography, the size of the treatment target position of the patient is measured and calculated by a digital imaging mode according to the self size of the developing ring or the distance between the two developing rings as a measurement reference. And selecting an instrument with a proper size and a corresponding specification according to the measured size, and further treating the target lesion part.

The developing ring is of a thin circular ring structure, and is limited by the size selection of the sheath, so that the size of the developing ring is limited, and the developing ring sometimes cannot clearly capture the boundary of the developing ring in a digital imaging test method, thereby affecting the accuracy of the test. In addition, sometimes, after the two imaging rings are placed in the body, the placed plane is not parallel to the projection plane of the digital subtraction angiography, so that the measurement distance between the two corresponding imaging rings has a large deviation, and the measurement of the target part is inaccurate.

SUMMERY OF THE UTILITY MODEL

The utility model aims at solving the problem of inaccurate measuring result when the development ring on the sheath tube is adopted to carry out digital subtraction angiography measurement. This object is achieved by:

a first aspect of the present invention provides a measurement device, the measurement device includes:

a sheath tube which is a hollow tubular body;

a mapping member that is resilient and at least partially compressively received within the sheath for delivery, assumes a regular or near-regular spherical configuration upon release from within the sheath to the exterior, and is contrast-competent at least in an operational state.

According to the utility model discloses a measuring device adopts and to have elasticity, and can compress the mapping piece of accomodating in the sheath at least partially and carry out internal measurement, and the mapping piece that is in operating condition is just spheroid form or is close just spheroid form and has the developing nature. Because the mapping component of the regular sphere structure is a circle with constant size under any angle projection, the measuring accuracy of DSA equipment and other equipment can be ensured by taking the circle as a measuring reference, the therapeutic equipment with proper size and corresponding specification can be accurately selected, and the success rate of the operation is improved. In addition, the size of the developer ring is limited by the size of the sheath, which can only be a very thin tubular structure, and it is not easy to capture the exact boundaries under DSA projection. And the utility model discloses well mark measuring piece of positive spheroid structure is more clear at the border under DSA isoprojection, and the projection size under arbitrary angle is invariable, is convenient for catch fast and accurate measurement, has reduced the operation time, has improved the fail safe nature of operation.

In addition, according to the utility model discloses a measuring device still can have following additional technical characterstic:

in some embodiments of the present invention, the measuring device further includes at least one elongated connector connected to the mapping member, a receiving hole extending along an axial direction of the sheath tube is formed in a wall of the sheath tube, and the connector is at least partially disposed in the receiving hole.

In some embodiments of the present invention, the sheath tube has a uniform wall thickness, and the diameter of the receiving hole is smaller than the thickness of the wall of the sheath tube; alternatively, a portion of the sheath tube that encloses the accommodation hole may protrude inward or outward with respect to other portions of the sheath tube.

In some embodiments of the present invention, in the compressed state, the mapping element is at least partially compressively received within the receiving hole.

In some embodiments of the present invention, the connecting member includes a first connecting member and a second connecting member, the first connecting member is at least partially disposed in the receiving hole, the second connecting member is at least partially disposed in the lumen of the sheath, and the first connecting member and the second connecting member are respectively connected to the mapping member.

In some embodiments of the invention, the connection member is a hollow-inside connection rod, the connection rod is at least partially disposed within the receiving hole or within the sheath, the hollow inside of the mapping member is in communication with the inside of the connection rod.

In some embodiments of the invention, the distal end of the connecting rod is in a pre-bent state in a natural state.

In some embodiments of the present invention, the mapping component and the connecting component constitute a mapping component, the mapping component further includes a conical sheath core head, the inside of the sheath core head is provided with a through hole running through the proximal end face and the distal end face thereof, the distal end of the connecting rod runs through behind the mapping component with the sheath core head is connected, just the through hole is communicated with the inside of the connecting rod.

The utility model discloses an on the other hand has still provided a measurement system, measurement system includes the aforesaid arbitrary measuring device, measurement system still includes:

a sheath core having a lumen and disposed at least partially within the sheath;

a guidewire disposed through the lumen of the sheath core.

The utility model discloses an on the other hand has still provided another kind of measurement system, measurement system includes the aforesaid arbitrary measuring device and seal wire, the seal wire is worn to locate the connecting rod with in the cavity of sheath core head.

Any of the above-mentioned measuring systems has the beneficial effects of any of the above-mentioned measuring devices, and is not described herein again.

Drawings

Various other advantages and benefits will become apparent to those of ordinary skill in the art upon reading the following detailed description of the preferred embodiments. The drawings are only for purposes of illustrating the preferred embodiments and are not to be construed as limiting the invention. Also, like parts are designated by like reference numerals throughout the drawings. Wherein:

fig. 1 is a partial structural schematic view of a measuring device when a mapping member is in an operating state according to an embodiment of the present invention;

fig. 2 is a partial structural view of the measurement device of fig. 1 with the mapping member in a compressed state;

FIG. 3 is an enlarged cross-sectional view of part A of FIG. 2;

fig. 4 is a schematic view of the structure of fig. 1 with the mapping element expanded into a regular spherical shape;

FIG. 5 is a schematic cross-sectional view of the sheath of FIG. 1;

FIG. 6 is a schematic cross-sectional view of another embodiment of the sheath of FIG. 1;

FIG. 7 is a schematic cross-sectional view of another embodiment of the sheath of FIG. 1;

FIG. 8 is a schematic view of a portion of a measurement system having the measurement device of FIG. 1;

FIG. 9 is a schematic view of a part of the structure of the measuring apparatus of FIG. 1 for ejecting a contrast medium toward an object to be measured;

FIG. 10 is a schematic partial projection view of the measuring apparatus and the object to be measured of FIG. 9;

fig. 11 is a partial structural schematic view of a measuring device according to a second embodiment of the present invention, when the mapping member is in an operating state;

fig. 12 is a partial structural view of the measurement device of fig. 11 with the mapping member in a compressed state;

FIG. 13 is a cross-sectional view of the sheath of FIG. 11;

FIG. 14 is a schematic view of a portion of the measurement system having the measurement device of FIG. 11;

fig. 15 is a partial structural schematic view of a measuring device according to a third embodiment of the present invention, when the mapping member is in an operating state;

fig. 16 is a partial structural view of the measurement device of fig. 15 with the map in a compressed state;

fig. 17 is a partial schematic structural view of a measuring device according to an embodiment of the present invention when the mapping member is in an operating state;

fig. 18 is a partial structural view of the measurement device of fig. 17 with the map in a compressed state.

The reference numerals in the drawings denote the following:

100: a measuring device;

10: sheath, 11: tube wall, 12: lumen, 13: an accommodation hole;

20: mapping assembly, 21: mapping, 21': map projection, 22: connecting rod, 23: first connecting member, 24: a second connecting member;

30: a conical head;

40: a sheath core print;

200: a sheath core;

300: a guide wire;

400: object to be measured, 400': projecting an object to be measured;

500: a contrast agent;

600: an X-ray receiving plane;

700: an X-ray emission plane;

800: x-rays.

Detailed Description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless specifically identified as an order of performance. It should also be understood that additional or alternative steps may be used.

Although the terms first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as "first," "second," and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the example embodiments.

For convenience of description, spatially relative terms, such as "inner", "outer", "lower", "below", "upper", "above", and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. Such spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the example term "below … …" can include both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

In the field of interventional medical device technology, it is common to use "distal" to refer to the end of the device that is distal from the operator during a surgical procedure, "proximal" to refer to the end of the device that is proximal to the operator during a surgical procedure, "axial" to refer to the direction along the length of the device, and "radial" to refer to the direction perpendicular to the "axial" direction. And defines "proximal", "distal", "axial" and "radial" for any component of the instrument in accordance with this principle.

Implementation mode one

As shown in fig. 1 and 2, the measurement device 100 in this embodiment includes a sheath 10 and a mapping assembly 20. The sheath 10 is a hollow tubular body. The mapping assembly 20 includes a mapping member 21 and at least one elongate connector 22 coupled to the mapping member 21. The mapping element 21 and the sheath 10 are two relatively independent components, i.e., the mapping element 21 is not disposed in conjunction with the sheath 10. The mapping member 21 is resilient and may be at least partially compressively received within the sheath 10 for delivery. The mapping member 21 is in a regular spherical shape or a nearly regular spherical shape when released from the inside of the sheath 10 to the outside, and has visualization properties at least in a working state. In other embodiments, the connector 22 does not have to be fixedly connected to the mapping element 21, and the mapping element 21 may be received in the sheath 10 for delivery by other auxiliary components and may be detached from the sheath 10 when necessary.

According to the measuring device 100 of the present invention, the elastic property is provided, and the mapping member 21 accommodated in the sheath tube 10 can be at least partially compressed, and the mapping member 21 in the compressed state is switched to the working state by the connecting member 22. The compressed state is a state in which the mapping member 21 is compressed by an external force, for example, accommodated in the sheath 10. The operational state is a state in which the mapping member 21 is expanded to a regular spherical shape or a nearly regular spherical shape. The mapping member 21 in the working state is in or near a regular spherical shape and is visualized. Because the mapping part 21 of the regular sphere structure is a circle with a constant size under any angle projection, the accuracy of measurement under DSA equipment and other equipment can be ensured by taking the circle as a measurement reference, therapeutic instruments with proper sizes and corresponding specifications can be accurately selected, and the success rate of the operation is improved. In addition, the size of the developer ring is limited by the size selection of the sheath, and the developer ring can only be a very thin tubular structure, and the accurate boundary cannot be easily captured under the DSA projection. In the embodiment, the boundary of the mapping part 21 of the regular sphere structure under the DSA and other projections is clearer, the projection size under any angle is constant, rapid capture and accurate measurement are facilitated, the operation time is shortened, and the safety and reliability of the operation are improved.

In DSA perspective, the object is displayed as a darker color after projection. The stronger the object's ability to block X-rays, the darker the color. It is understood that two objects of the same material are used, the greater the volume the darker the color. The DSA displays an image mainly as a projection image formed by the device receiving the X-ray transmitted through the human body, so that the plane of the projection image is perpendicular to the irradiation direction of the X-ray. Therefore, the actual size of the tested target can be obtained through conversion according to the proportional relation between the standard object with the known actual size measured on the projected image and the size on the projected image. The specific calculation method comprises the following steps: and (3) determining the reference object measurement pixel point/the reference object actual size value as the target object measurement pixel point/target object actual size estimated value. Theoretically, under the same DSA equipment, the larger the reference object is, namely, the more pixel points are occupied in a projected image, the more the pixel point base number is, the more the geometric scaling is facilitated, and meanwhile, the clearer the boundary of the reference object is, the more the test point is facilitated to be selected, and the more the accuracy of a test result is facilitated.

As shown in fig. 3 and 4, the sheath tube 10 of the present embodiment includes a tube wall 11 and a lumen 12 surrounded by the tube wall 11, and the tube wall 11 is provided with a receiving hole 13 extending in the axial direction of the sheath tube 10. The portion of the sheath tube 10 that encloses the receiving hole 13 projects outward relative to the other portion of the sheath tube 10, as shown in the cross-sectional view of the sheath tube 10 in fig. 5. The connectors 22 are at least partially disposed within the receiving holes 13, and the mapping member 21 is at least partially disposed within the receiving holes 13 in a compressed state. Specifically, the connecting member 22 in this embodiment is a connecting rod 22 having a hollow interior, and thus the connecting rod 22 has a cavity therein extending along the length thereof. The mapping member 21 is a hollow balloon-like structure that can be wholly or partially received within the receiving hole 13 after being compressed so as to be delivered from outside the body to a target location inside the body, carried by the sheath 10. The connecting rod 22 has a certain flexibility and thus is able to bend as the sheath 10 conforms to the blood vessel in vivo. The distal end of the connecting rod 22 is fixedly connected with the mapping part 21, and the cavity of the connecting rod 22 is communicated with the inside of the mapping part 21, so that substances such as gas or liquid can be delivered to the inside of the mapping part 21 through the inner cavity of the connecting rod 22 through the proximal end of the connecting rod 22, so as to fill the mapping part 21, gradually expand the mapping part 21 and separate from the accommodating hole 13, and finally, the working state with the regular sphere structure shown in fig. 4 is presented. Further, a negative pressure may be drawn through the interior cavity of the connecting rod 22 into the interior of the mapping member 21, causing the mapping member 21 to be gradually compressed and at least partially received into the receiving bore 13 after the connecting rod 22 is proximally withdrawn.

The distal end of the connecting rod 22 may protrude from the distal end of the receiving hole 13 after pushing the connecting rod 22 toward the distal end. The proximal end of the connector rod 22 extends from the proximal end of the receiving bore 13 and is connected to an inflation and aspiration device to inflate or aspirate the mapping member 21. The receiving hole 13 has a diameter much smaller than that of the lumen 12 and can be provided at any position in the circumferential direction of the tube wall 11. In another embodiment, as shown in fig. 6, the wall thickness of the sheath tube 10 is uniform, the diameter of the accommodating hole 13 is smaller than the thickness of the tube wall 11 of the sheath tube 10, and the accommodating hole 13 is provided at the middle position of the tube wall 11 in the radial direction, so that the tube wall 11 is directly provided with the hole in the axial direction of the sheath tube 10 on the basis of the structure of the conventional sheath tube 11. In another embodiment, as shown in fig. 7, the portion of the sheath tube 10 surrounding the receiving hole 13 may be provided to protrude inward relative to the other portion of the sheath tube 10.

The proximal end face of the accommodating hole 13 is flush with the proximal end face of the sheath tube 10, the distal end face of the accommodating hole 13 is closer to the proximal end than the distal end face of the sheath tube 10, that is, the axial length of the accommodating hole 13 is smaller than the axial length of the sheath tube 10, and a certain distance is formed between the distal end face of the accommodating hole 13 and the distal end face of the sheath tube 10 along the axial interval of the sheath tube 10, so that the mapping part 21 does not block the distal opening of the sheath tube 10 after being in a working state, and smooth measurement process is ensured.

The connecting rod 22 in this embodiment is made of a material having a certain supporting property, such as polyethylene, nylon, pebax (polyethylene glycol), and the like. The proximal end of the connecting rod 22 protrudes a distance beyond the proximal end face of the sheath 10 to facilitate manipulation of its axial movement within the receiving hole 13 of the sheath 10 to release the mapping member 21 at the distal end of the sheath 10. The mapping member 21 in the working state of the orthosphere shape or the shape close to the orthosphere shape is a circle with a constant size in projection at any angle, and can be used for various anatomical structures of human bodies.

The mapping member 21 in this embodiment is an elastic body, and may be made of materials such as silicone, polyurethane, and polyolefin, and a liquid with developability, such as iodized alcohol, is injected into the mapping member 21 through the connecting rod 22, so that the mapping member 21 has a certain developability, and can be better identified under DSA projection. In another embodiment, materials developable by X-rays, such as BaSO4, (BIO), can be uniformly added to these materials₂CO₃Etc. to enhance visualization of the map 21. In the present embodiment, the mapping member 21 having a hollow capsule-like structure is made of a silicone material to which a developing material is added. The sphere diameter of the inflated mapping member 21 ranges from 4mm to 20mm, preferably from 6mm to 12mm, and the preferred diameter has the effect of ensuring that the mapping member 21 has a sufficient size, ensuring the accuracy of measurement, and avoiding the phenomenon of occupying too large space and affecting the operation. The hollow saccular structure of the mapping member 21 in this embodiment has no compliance, and the mapping member 21 located outside the sheath 10 can be expanded to a standard spherical shape or a shape close to a standard spherical shape with a constant size only after a certain pressure is applied to the inside of the mapping member 21 through the connecting rod 22, specifically, a liquid with visualization property, such as iodized alcohol, is injected into the mapping member 21 through the connecting rod 22, so as to further enhance the visualization property of the mapping member 21. In other embodiments, if the map 21 itself has sufficient visualization, a non-visualization liquid or gas may be injected into the map 21 to inflate the map 21.

As shown in fig. 1 and 2, the distal end of the sheath tube 10 in the present embodiment may be provided with a conical head 30 for preventing tissue damage, and the conical head 30 is a substantially hollow annular body, and the outer diameter of the conical head 30 gradually decreases from the proximal end to the distal end. The conical head 30 is fixedly connected to the distal end of the sheath 10, such as by welding or bonding, and the junction is smoothly transitioned to reduce scratching of blood vessels and other tissues. The axial length of the conical head 30 ranges from 1 mm to 6mm, preferably from 2mm to 4mm, and the too short length can cause the conical surface of the conical head 30 to have large transition and easily scratch blood vessels and other tissues; an excessive length results in a correspondingly longer section with a thinner wall thickness at the distal portion of bit 30, which tends to cause the distal end of bit 30 to collapse during use. In this embodiment, the conical head 30 may be regarded as a part of the structure of the sheath tube 10, and the axial length of the sheath tube 10 is relatively extended, so that the distance from the distal end surface of the receiving hole 13 to the distal end surface of the sheath tube 10, actually the distance from the distal end surface of the receiving hole 13 to the distal end surface of the conical head 30, is greater than or equal to the axial length of the conical head 30, so as to prevent the filled mapping part 21 from blocking the distal opening of the sheath tube 10, and the distance is preferably 2-15 mm.

Fig. 8 is a schematic partial structure diagram of a measurement system including the measurement apparatus 100 in fig. 1. As shown in fig. 8, the measurement system in this embodiment includes the measurement device 100 in any of the above embodiments, and further includes a sheath core 200 and a guide wire 300. The sheath core 200 is at least partially disposed within the sheath 10, and the guidewire 300 is at least partially disposed through the lumen of the sheath core 200 for guiding movement of the measurement device 100. Wherein, the sheath core 200 is a hollow structure, and the distal end is tapered, so as to smoothly carry the sheath tube 10 into the body at the puncture. The majority of the sheath core 200 is housed within the lumen of the sheath 10 with the distal end extending beyond the distal end of the sheath 10. The majority of the guidewire 300 is housed within the lumen of the sheath-core 200 with the distal end extending beyond the distal end of the sheath-core 200.

The utility model also provides a measuring method, it is shown with fig. 8 and fig. 9 to combine, includes following step at least when measuring according to the measurement system among this embodiment:

transporting the measuring apparatus 100 in any of the above embodiments from outside the body to the position of the object 400 to be measured inside the body; deforming the mapping member 21 from the compressed state to a regular spherical shape or a nearly regular spherical shape out of the constraint of the sheath 10; visualizing the map 21 under a digital angiography device (such as, but not limited to, a Digital Subtraction Angiography (DSA) device), and measuring a measured size of the map 21 after DSA projection, a measured size of the object to be measured 400 after projection; based on the reference dimension (i.e., actual dimension) of the mapping element 21 measured in advance in vitro, the estimated dimension of the object 400 to be measured is calculated as: (reference dimension of map 21/measured dimension of map 21 after projection) x measured dimension of object to be measured 400 after projection. Wherein the mapping member 21 itself is visualized or the mapping member 21 is visualized after being injected with a liquid having visualization.

Specifically, in a conventional interventional procedure, after a puncture of a blood vessel is successful, the distal end of the guide wire 300 is delivered into the body along the blood vessel at the puncture, and finally reaches the position of the object 400 to be measured. Sheathing the sheath core 200 in the sheath tube 10, wherein the distal end of the sheath core 200 extends out of the distal end of the sheath tube 10, then penetrating the proximal end of the guide wire 300 into the distal cavity of the sheath core 200, and guiding the distal ends of the sheath tube 10 and the sheath core 200 to move to the position of the target 400 to be measured through the guide wire 300; wherein the mapping assembly 20 has been assembled within the sheath 10 prior to delivery of the sheath 10 into the body. The guidewire 300 and sheath core 200 are withdrawn from the body. The mapping member 21 is inflated by injecting a developing liquid into the mapping member 21 through the proximal end of the connecting rod 22, so that the mapping member 21 is inflated to a specific size and separated from the sheath 10, and at this time, the mapping member 21 is switched from the compressed state to the working state. The contrast agent 500 is ejected through the lumen 12 of the sheath 10 toward the object 400 to be measured, so that the object 400 to be measured shows a shape profile under DSA. And calibrating the projected size of the mapping part 21 in the DSA display image to obtain a measured size, and calibrating the projected size of the target 400 to be measured to obtain the measured size. And calculating to obtain the actual size estimation value of the object 400 to be measured according to the digital imaging principle and the geometric conversion.

Wherein the mapping member 21 can be placed at any angle. As shown in fig. 10, the map 21 is under the illumination of X-rays 800 emitted by the X-ray emission plane 700, which produces map projections 21' within the X-ray reception plane 600. Because the mapping member 21 in the working state is in a regular sphere shape or a shape close to the regular sphere shape, and is a circle with a constant size in any angle projection, the error of the projected basic size caused by the placing position of the mapping member 21 can be avoided. Meanwhile, the object 400 to be measured generates an object projection 400 ' to be measured under the irradiation of the X-ray 800, so that an estimated value of the actual size of the object 400 to be measured can be calculated according to the actual diameter of the mapping element 21, the measured size of the mapping element projection 21 ' and the measured size of the object projection 400 ' to be measured. The object 400 to be measured in this embodiment is a tissue-mimicking structure of the left atrial appendage in a human or animal body. It will be appreciated that the object to be measured may also be other tissue structures within the human or animal body.

Optionally, the mapping member 21 is deflated after the measurement is completed, and then inflated for further use. For example, the liquid in the mapping member 21 may be completely pumped out of the body by the negative pressure pumping device and the connection rod 22, i.e., the pressure relief of the mapping member 21 is completed. And after the measurement and calculation are finished, other related operations are carried out according to the surgical requirements, such as selecting an occluder with a proper size and a corresponding specification for implantation and the like. After the operation is completed, the decompressed mapping member 21 is retracted into the distal end of the receiving hole 13 by pulling the retracting connecting rod 22 proximally, and is withdrawn out of the body together with the sheath tube 10.

Second embodiment

The parts of the second embodiment that are the same as the parts of the first embodiment will not be described again, and only the parts that are different from the parts of the first embodiment will be described below with reference to the drawings. Referring to fig. 11, 12 and 13, the connectors of the present embodiment include a first connector 23 and a second connector 24, the first connector 23 is at least partially disposed in the receiving hole 13, the second connector 24 is at least partially disposed in the lumen 12 of the sheath 10, and the first connector 23 and the second connector 24 are respectively connected to two ends of the mapping member 21.

When the mapping member 21 is placed within the sheath 10 for delivery, as shown in fig. 12, the mapping member 21 is located within the distal lumen of the sheath 20. By pulling the second connector 24 proximally, the mapping member 21 may be controlled to be received within the distal lumen of the sheath 10.

When the mapping member 21 is detached from the sheath 10 for measurement, as shown in fig. 11, the mapping member 21 is located between the distal end surface of the receiving hole 13 and the distal end surface of the bit 30. In other embodiments, when the awl point 30 is not provided, the mapping member 21 in the working state is located between the distal end surface of the receiving hole 13 and the distal end surface of the sheath 10. The mapping member 21 may be controlled to protrude from the distal end of the sheath 10 by pulling the first connector 23 proximally.

The first connector 23 and the second connector 24 are respectively arranged in the accommodating hole 13 and the lumen 12 which are independent from each other, so that the sealing performance in the lumen 12 is ensured, and the leakage into the accommodating hole 13 and the operation risk caused when the gas is exhausted from the lumen 12 or the contrast medium is injected are prevented.

The mapping member 21 in this embodiment is a foamed elastomer, has a spongy structure, is made of silica gel, polyurethane, polyolefin, and the like, has relatively good elasticity, and has good compressibility after being foamed. Compared with a hollow saccular structure, the foamed elastomer is more favorable for ensuring the regular spherical structure of the mapping part 21 and increasing the accuracy of measurement. The mapping member 21 may be made of a material that is further uniformly doped with a material capable of being visualized under X-rays, such as BaSO₄、(BIO)₂CO₃And the like, to enhance the developability of the foamed elastomer, making the developability of the map 21 stronger. The first connecting member 23 and the second connecting member 24 in the drawing and pulling embodiment may be a pulling rope, a wire having certain flexibility, a pulling rod, or the like.

In this embodiment, the proximal end surface of the receiving hole 13 is flush with the proximal end surface of the sheath tube 10, and the distance between the distal end surface of the receiving hole 13 and the distal end surface (or the conical head 30) of the sheath tube 10 is greater than or equal to the diameter of the mapping part 21, which is preferably 6-25mm, in order to ensure that the mapping part 21 and the distal opening of the sheath tube 10 keep a proper distance, prevent the testing or treating target from deviating out of the DSA window, and simultaneously prevent the mapping part 21 from blocking the distal opening of the sheath tube 10 and interfering with the operation.

As shown in fig. 14, the measurement system including the measurement device according to the present embodiment is different from the measurement system according to the first embodiment in that: the mapping member 21 in the first embodiment is accommodated in the accommodating hole 13 in a compressed state, and the initial position of the mapping member 21 in the first embodiment is set outside the body, that is, the mapping member 21 is transported to the target position in the body from the lumen 12 of the sheath 10 after the sheath 10 reaches the target position to be measured under the guiding action of the guide wire 300, so as to perform measurement; and when switching the mapping member 21 from the delivery state to the active state, pulling the first connector 23 proximally to cause the mapping member 21 to protrude from the distal lumen of the sheath 10 and move into position.

The method for performing measurement by the measurement system in the present embodiment is substantially the same as the method in the first embodiment, and is different mainly in that:

the mapping member 21 remains outside the proximal end of the sheath 10 when the sheath 10 is delivered from outside the body to inside the body. After withdrawing the guidewire 300 and sheath core 200 out of the body, the first connector 23 is pulled proximally at the proximal end of the sheath 10 to pull the mapping 21 and second connector 24 from outside the body along the lumen 12 of the sheath 10 to near the distal opening location of the sheath 10. The mapping member 21 is then pulled further out of the distal end of the sheath 10, whereupon the mapping member 21 naturally expands to assume a regular spherical or nearly regular spherical configuration. The first connector 23 or the second connector 24 is then pulled proximally as needed for the projected location to adjust the position of the mapping member 21 outside the sheath 10. After the measurement is completed, the second connector 24 is pulled proximally to pull the mapping element 21 from the outside of the sheath 10 into the distal opening of the sheath 10 until the mapping element is completely contained in the lumen 12 at the distal end of the sheath 10, and the mapping element 21 is withdrawn out of the body together with the sheath 10.

Third embodiment

Parts in the third embodiment that are the same as those in the first embodiment will not be described again, and only different parts will be described below with reference to the drawings. As shown in fig. 15 and 16, the connecting member in the present embodiment is a hollow connecting rod 22, the connecting rod 22 is at least partially disposed in the lumen 12 of the sheath tube 10, and the distal end of the connecting rod 22 is in a pre-bent state in a natural state. The mapping member 21 in this embodiment is a solid elastomer, and is in a regular sphere shape or a shape close to a regular sphere after self-expansion, and the center of the sphere has a through hole, and the distal end of the connecting rod 22 is inserted into the through hole and fixedly connected with the mapping member 21. The mapping member 21 and the connecting rod 22 may be a unitary structure. The material of the connecting rod 22 may be non-metallic material with certain thermoplasticity, such as polyurethane, polyolefin, Pebax, etc., or metallic material with certain shaping ability, such as stainless steel, nickel titanium, etc. In the present embodiment, the connection rod 22 is preferably a hollow nickel-titanium rod, and the distal end of the connection rod is bent in a natural state after being heat-set, so that the mapping component 21 can be bent and attached to the outer wall of the distal end of the sheath 10 under the action of the automatic bending of the distal end of the connection rod 22 after being unfolded outside the sheath 10, thereby avoiding blocking the operation of the distal end of the sheath 10.

Since the connection rod 22 in the present embodiment is provided in the lumen 12 and the connection rod 22 is hollow inside, the guide wire 300 can be inserted therein, and thus can function as a sheath-core. In this embodiment, the measurement device and the measurement system thereof may not include the sheath core 200 as in the first embodiment.

When the measurement is performed by the measurement system according to the present embodiment, the procedure is basically the same as that of the first embodiment, and the difference is mainly that:

when the sheath 10 is delivered from the outside of the body to the inside of the body, it is no longer delivered together with the sheath core 200, but is delivered along the guidewire 300 to a target position inside the body together with the mapping member 21 and the connection rod 22 accommodated in the lumen 12 of the sheath 10. The guidewire is then simply withdrawn and the mapping member 21 is pushed out of the distal end of the sheath 10 by pushing the connecting rod 22 distally. The distal end of the connecting rod 22 extends out of the distal end of the sheath tube 10 and then automatically bends toward one side, so that the mapping component 21, which is self-expanded into a regular spherical shape or a shape close to the regular spherical shape, is moved to the outer wall position of the periphery of the distal opening of the sheath tube 10, and then the relevant operations such as imaging and measurement are performed. After the measurement is completed, the connecting rod 22 is pulled proximally, the mapping member 21 is retracted into the lumen 12 of the sheath 10, and the mapping member 21 is withdrawn out of the body together with the sheath 10.

Embodiment IV

The parts in the fourth embodiment that are the same as those in the third embodiment will not be described again, and only the parts that are different from each other will be described below with reference to the drawings. As shown in fig. 17 and 18, the measuring device of the present embodiment further includes a sheath-core head 40, and the inner center of the sheath-core head 40 is provided with a through hole penetrating through the proximal end surface and the distal end surface thereof. The distal end of the connecting rod 22 sequentially penetrates through the through holes of the mapping component 21 and the sheath core head 40 from near to far, and the proximal end of the sheath core head 40 is fixedly connected with the distal end of the mapping component 21. In other embodiments, the distal end of the connecting rod 22 is not inserted into the through hole of the sheath core 40, for example, the distal end of the connecting rod 22 is connected to the sheath core 40 after penetrating the mapping device 21, the proximal end of the sheath core 40 is connected to the distal end of the mapping device 21, and the through hole of the sheath core 40 is communicated with the inner cavity of the connecting rod 22. The structure of the present embodiment is substantially the same as that of the third embodiment, but the difference is that the distal end of the gauge assembly in the present embodiment is provided with a tapered sheath-core 40, and the outer diameter of the sheath-core 40 gradually decreases from the proximal end to the distal end, thereby reducing the damage to the tissue.

When measurement is performed by the measurement system according to the present embodiment, the procedure is basically the same as that of the third embodiment, and the differences are mainly that: when the sheath 10 is delivered from the outside to the inside of the body, the sheath is delivered to a target position inside the body along the guide wire 300 together with the connection rod 22, the mapping member 21, and the sheath core head 40 received in the lumen 12 of the sheath 10.

The above description is only for the preferred embodiment of the present invention, but the scope of the present invention is not limited thereto, and any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope of the present invention should be covered by the present invention. Therefore, the protection scope of the present invention shall be subject to the protection scope of the claims.

Claims (10)

1. A measuring device, comprising:

a sheath tube which is a hollow tubular body;

a mapping member that is resilient and at least partially compressively received within the sheath for delivery, assumes a regular or near-regular spherical configuration upon release from within the sheath to the exterior, and is contrast-competent at least in an operational state.

2. The measurement device of claim 1, further comprising at least one elongated connector connected to the mapping member, wherein a receiving hole is formed in a wall of the sheath tube and extends in an axial direction of the sheath tube, and wherein the connector is at least partially disposed in the receiving hole.

3. The measurement device according to claim 2, wherein the sheath tube has a uniform wall thickness, and the receiving hole has a diameter smaller than the thickness of the wall of the sheath tube; alternatively, a portion of the sheath tube that encloses the accommodation hole may protrude inward or outward with respect to other portions of the sheath tube.

4. The measurement device of claim 2, wherein in a compressed state, the map is at least partially compressively received within the receiving bore.

5. The measurement device of claim 2, wherein the connector comprises a first connector at least partially disposed within the receiving bore and a second connector at least partially disposed within the lumen of the sheath, the first and second connectors each being coupled to the mapping member.

6. The measurement device of claim 2, wherein the connector is a hollow-interior connector rod disposed at least partially within the receiving bore or the sheath, the mapping member being hollow and in communication with an interior of the connector rod.

7. A measuring device according to claim 6, wherein the distal end of the connecting rod is pre-bent in its natural state.

8. The measuring device of claim 6, wherein the mapping component and the connecting component form a mapping component, the mapping component further comprises a conical sheath-core head, a through hole is formed in the sheath-core head and penetrates through the proximal end face and the distal end face of the sheath-core head, the distal end of the connecting rod penetrates through the mapping component and then is connected with the sheath-core head, and the through hole is communicated with the inside of the connecting rod.

9. A measuring system, characterized in that it comprises a measuring device according to any one of claims 1 to 7, the measuring system further comprising:

a sheath core having a lumen and disposed at least partially within the sheath;

a guidewire disposed through the lumen of the sheath core.

10. A measurement system comprising the measurement device of claim 8 and a guidewire disposed through the lumen of the connecting rod and the sheath-core head.

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