CN114145733B - Measuring device, measuring system and measuring method - Google Patents
Measuring device, measuring system and measuring method Download PDFInfo
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- CN114145733B CN114145733B CN202010929541.8A CN202010929541A CN114145733B CN 114145733 B CN114145733 B CN 114145733B CN 202010929541 A CN202010929541 A CN 202010929541A CN 114145733 B CN114145733 B CN 114145733B
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- 238000013507 mapping Methods 0.000 claims abstract description 130
- 238000005259 measurement Methods 0.000 claims abstract description 54
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- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
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- TZCXTZWJZNENPQ-UHFFFAOYSA-L barium sulfate Chemical compound [Ba+2].[O-]S([O-])(=O)=O TZCXTZWJZNENPQ-UHFFFAOYSA-L 0.000 description 2
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B5/1072—Measuring physical dimensions, e.g. size of the entire body or parts thereof measuring distances on the body, e.g. measuring length, height or thickness
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
- A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
- A61B5/1079—Measuring physical dimensions, e.g. size of the entire body or parts thereof using optical or photographic means
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
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- Pathology (AREA)
- Engineering & Computer Science (AREA)
- Dentistry (AREA)
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Abstract
The invention belongs to the technical field of medical instruments, and particularly relates to a measuring device, a measuring system and a measuring method. The measuring device comprises a sheath tube and a mapping assembly, wherein the sheath tube is a hollow tubular body, the mapping assembly comprises a mapping piece which is independent from the sheath tube, the mapping piece has elasticity and can be at least partially compressed and accommodated in the sheath tube for conveying, and the mapping piece is in a regular sphere shape or a shape similar to a regular sphere shape after being released from the interior of the sheath tube to the outside and has developability at least in a working state. In the invention, the mapping piece of the regular sphere structure is round with a constant size under any angle projection, and the mapping piece is taken as a measurement reference, so that the measurement accuracy under DSA equipment and other equipment can be ensured, the therapeutic equipment with a proper size and corresponding specification can be accurately selected, and the success rate of the operation can be improved. In addition, the boundary of the mapping piece of the regular sphere structure is clearer, the rapid capturing and accurate measurement are convenient, the operation time is shortened, and the safety and reliability of the operation are improved.
Description
Technical Field
The invention belongs to the technical field of medical instruments, and particularly relates to a measuring device, a measuring system and a measuring method.
Background
In interventional procedures, a delivery channel is established, typically under Digital Subtraction Angiography (DSA), by means of a sheath, and the associated implant device is delivered to the target site. In the surgical procedure, in vivo localization is performed under X-ray fluoroscopy by delivering a visualization ring on the sheath to the vicinity of the target site. Under the window of the planar projection of the digital subtraction angiography, the size of the treatment target position of the patient is calculated by taking the self size of the developing ring or the distance between the two developing rings as a measurement reference and adopting a digital imaging mode. And the instrument with the proper size corresponding to the specification is selected according to the measured size, so that the target lesion part is treated.
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 is difficult to clearly capture the boundary of the developing ring in a digital imaging test method sometimes, thereby affecting the accuracy of the test. In addition, sometimes, after the two developing rings are placed in the body, the placed plane is not parallel to the projection plane of the digital subtraction angiography, so that a larger deviation exists in the measurement distance between the two corresponding developing rings, and the measurement on the target part is inaccurate.
Disclosure of Invention
The invention aims to at least solve the problem that the measurement result is inaccurate when the imaging ring on the sheath tube is adopted for measurement under digital subtraction angiography. This object is achieved by:
a first aspect of the present invention proposes a measuring device comprising:
A sheath tube which is a hollow tubular body;
A mapping assembly comprising a mapping member that is relatively independent of the sheath, the mapping member being resilient and at least partially compressible for receipt within the sheath for delivery, the mapping member assuming a positive sphere or nearly positive sphere configuration upon release from within the sheath to the exterior and being developable at least in an operational state.
According to the measuring device, the elastic mapping piece which can be at least partially compressed and accommodated in the sheath tube is arranged, the mapping piece is in a regular sphere shape or is close to the regular sphere shape and has developability when in a working state, and the mapping piece of the regular sphere structure is in a circular shape with a constant size under any angle projection, so that the measuring device is used as a measuring standard, the measuring accuracy under DSA and other equipment can be ensured, the therapeutic equipment with a proper size and corresponding specification can be accurately selected, and the success rate of the operation is improved. Furthermore, the size of the developer ring is limited by the choice of sheath size, which can only be very thin tubular structures, and it is not easy to capture accurate boundaries under DSA projection. The boundary of the mapping piece with the regular sphere structure under the projection of DSA and the like is clearer, the projection size under any angle is constant, the rapid capturing and accurate measurement are convenient, the operation time is shortened, and the safety and reliability of the operation are improved.
In addition, the measuring device according to the invention may have the following additional technical features:
in some embodiments of the invention, the mapping assembly further comprises at least one elongated connector coupled to the mapping member, wherein the sheath has a receiving hole in a wall thereof extending in an axial direction of the sheath, and wherein the connector is at least partially disposed within the receiving hole.
In some embodiments of the invention, the wall thickness of the sheath is uniform, and the diameter of the receiving hole is smaller than the wall thickness of the sheath; or a portion of the sheath surrounding the receiving hole protrudes inward or outward relative to the other portion of the sheath.
In some embodiments of the invention, the mapping is at least partially compressed received within the receiving aperture in a compressed state.
In some embodiments of the invention, the connector comprises a first connector at least partially disposed within the receiving hole and a second connector at least partially disposed within the lumen of the sheath, the first connector and the second connector being respectively connected to the mapping.
In some embodiments of the invention, the connector is an internally hollow connector rod that is at least partially disposed within the sheath or within the receiving bore, the interior of the probe being hollow and communicating with the interior of the connector 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 invention, the mapping assembly further comprises a tapered sheath core, the interior of the sheath core is provided with a through hole penetrating through the proximal end face and the distal end face of the sheath core, the distal end of the connecting rod penetrates through the mapping piece and then is connected with the sheath core, and the through hole is communicated with the interior of the connecting rod.
Another aspect of the present invention also provides a measurement system, including any one of the measurement devices described above, the measurement system further including:
a sheath core having a cavity and at least partially disposed within the sheath;
the guide wire penetrates through the cavity of the sheath core.
Another aspect of the invention provides another measuring system comprising any one of the measuring devices described above and a guidewire threaded into the connecting rod and the lumen of the sheath-core head.
In another aspect, the present invention further provides a measurement method, according to any one of the above measurement systems, comprising the following steps:
Conveying the measuring device from outside the body to the position of a target to be measured in the body;
Deforming the mapping out of the tether of the sheath to assume a right sphere or nearly right sphere configuration;
Developing the mapping piece under digital angiography equipment, and measuring the measured size of the mapping piece after being projected under the digital angiography equipment and the measured size of the target to be measured after being projected under the digital angiography equipment;
According to the reference size of the mapping piece obtained by pre-measurement, calculating to obtain a size estimated value of the target to be measured, wherein the size estimated value is as follows: (reference dimension of the map/measured dimension of the map after projection) gamma, the measured dimension of the target to be measured after projection.
The measuring system and the measuring method of any one of the above have the beneficial effects of any one of the measuring devices described above, and are 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 reference numerals are used to designate like parts throughout the figures. Wherein:
FIG. 1 is a schematic view of a part of a measuring device according to an embodiment of the present invention when a test element is in an operating state;
FIG. 2 is a schematic view of a portion of the measuring device of FIG. 1 with the test element in a compressed state;
FIG. 3 is an enlarged cross-sectional view of the portion A of FIG. 2;
FIG. 4 is a schematic illustration of the structure of the test element of FIG. 1 inflated to a right sphere;
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 diagram of a portion of the structure of the measurement device of FIG. 1 for injecting contrast agent into a target to be measured;
FIG. 10 is a schematic view of a portion of the measurement device and object to be measured of FIG. 9;
FIG. 11 is a schematic diagram of a part of a measuring device in a working state of a testing element according to a second embodiment of the present invention;
FIG. 12 is a schematic view of a portion of the measuring device of FIG. 11 with the flag in a compressed state;
FIG. 13 is a schematic cross-sectional view of the sheath of FIG. 11;
FIG. 14 is a schematic view of a portion of a measurement system having the measurement device of FIG. 11;
FIG. 15 is a schematic view of a part of the structure of the measuring device when the testing element is in an operating state in the third embodiment of the present invention;
FIG. 16 is a schematic view of a portion of the measuring device of FIG. 15 with the flag in a compressed state;
FIG. 17 is a schematic view of a part of the structure of the measuring device when the testing element in the fourth embodiment of the present invention is in an operating state;
fig. 18 is a schematic view of a portion of the measuring device of fig. 17 with the flag in a compressed state.
The reference numerals in the drawings are as follows:
100: a measuring device;
10: sheath, 11: pipe wall, 12: lumen, 13: a receiving hole;
20: mapping component, 21: mapping, 21': map projection, 22: connecting rod, 23: first connector, 24: a second connector;
30: a conical head;
40: a sheath core head;
200: a sheath core;
300: a guide wire;
400: target to be measured, 400': projecting a target 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" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "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 an order of performance is explicitly stated. It should also be appreciated 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 ease 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. Accordingly, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.
In the field of interventional medical devices, it is common to use a "distal end" to refer to the end of the device that is distal from the operator during a surgical procedure, a "proximal end" to refer to the end of the device that is proximal to the operator during a surgical procedure, an "axial" to refer to the length direction along the device, and a "radial" to refer to the direction perpendicular to the "axial". And defines the "proximal", "distal", "axial" and "radial" of any component of the instrument in accordance with this principle.
Embodiment one
As shown in fig. 1 and 2, the measuring device 100 in the present 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 21 and the sheath 10 are two relatively independent components, i.e., the mapping 21 is not attached to the sheath 10. The mapping 21 is resilient and may be at least partially compressively received within the sheath 10 for delivery. The mapping member 21 assumes a positive sphere or nearly positive sphere form after being released from the inside of the sheath 10 to the outside, and has developability at least in an operating state. In other embodiments, the connector 22 is not necessarily fixedly connected to the mapping member 21, and the mapping member 21 may be accommodated in the sheath 10 for delivery by other auxiliary components, and may be detached from the sheath 10 when needed.
According to the measuring device 100 of the present invention, the elastic and at least partially compressible mapping member 21 accommodated in the sheath tube 10 is provided, 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 index gauge 21 is compressed by an external force, and is accommodated in the sheath 10, for example. The operating state is a state in which the index 21 expands to a regular sphere or a nearly regular sphere. The mapping 21 in the working state is in a regular sphere form or a nearly regular sphere form and has developability. Because the mapping piece 21 of the regular sphere structure is round with a constant size under any angle projection, the mapping piece is taken as a measurement reference, the measurement accuracy under DSA equipment and other equipment can be ensured, the therapeutic equipment with a proper size and corresponding specification can be accurately selected, and the success rate of the operation is improved. In addition, the size of the developing ring can only be a very thin tubular structure due to the limitations of sheath size selection, and it is not easy to capture an accurate boundary under DSA projection. In this embodiment, the boundary of the mapping piece 21 with the regular sphere structure under the projection of DSA is clearer, and the projection size under any angle is constant, so that the rapid capturing 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 in a darker color after projection. The more powerful an object is in blocking X-rays, the darker the color. It is understood that two objects of the same material are darker the greater the volume. The image displayed by the DSA is mainly a projection image formed after the equipment receives the X-rays passing through the human body, so that the plane of the projection image is perpendicular to the irradiation direction of the X-rays. The actual size of the tested object can be obtained through conversion through the proportional relation between the reference object with known actual size and the size of the projected image. The specific calculation method comprises the following steps: reference object measurement pixel/reference object actual size value=target object measurement pixel/target object actual size estimation. Theoretically, under the same DSA equipment, the larger the reference object, namely the more pixel points are occupied in the projection image, the more pixel point base numbers are used for facilitating the equal ratio conversion in the equal ratio conversion, and meanwhile, the clearer the boundary of the reference object is, the more test points are facilitated to be selected, and the accuracy of test results is further facilitated.
As shown in fig. 3 and 4, the sheath tube 10 in this 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 10 surrounding the receiving hole 13 protrudes outward relative to the other portion of the sheath 10, as shown in the cross-sectional view of the sheath 10 in fig. 5. The connector 22 is at least partially disposed within the receiving hole 13, and the probe 21 is at least partially disposed within the receiving hole 13 when in a compressed state. Specifically, the connecting member 22 in the present embodiment is a connecting rod 22 having a hollow interior, and thus the connecting rod 22 has a cavity extending along its length. The mapping 21 is a hollow, balloon-like structure that may be wholly or partially received within the receiving bore 13 after being compressed for delivery from outside the body to a target location within the body with the sheath 10. The connecting rod 22 has a certain flexibility and is thus able to bend as the sheath 10 conforms to the vessel in the body. The distal end of the connecting rod 22 is fixedly connected with the mapping member 21, and the cavity of the connecting rod 22 is communicated with the inside of the mapping member 21, so that substances such as gas or liquid and the like can be conveyed to the inside of the mapping member 21 through the inner cavity of the connecting rod 22 by the proximal end of the connecting rod 22 to fill the mapping member 21, so that the mapping member 21 gradually expands and is separated from the accommodating hole 13, and finally, the working state with the positive sphere structure shown in fig. 4 is presented. In addition, negative pressure can be pumped to the inside of the mapping member 21 through the internal cavity of the connecting rod 22, so that the mapping member 21 is gradually compressed, and is at least partially accommodated into the accommodating hole 13 after the connecting rod 22 is retracted proximally.
The distal end of the connecting rod 22 may protrude from the distal end of the receiving bore 13 after pushing the connecting rod 22 distally. The proximal end of the connecting rod 22 protrudes from the proximal end of the receiving hole 13 and connects filling and negative pressure pumping devices to fill or pump negative pressure to the mapping 21. The receiving hole 13 has a diameter much smaller than that of the lumen 12 and may be provided at any position in the circumferential direction of the tube wall 11. In other embodiments, as shown in fig. 6, the wall thickness of the sheath 10 is uniform, and the diameter of the accommodating hole 13 is smaller than the thickness of the wall 11 of the sheath 10, and the accommodating hole 13 is disposed at a middle position of the wall 11 along the radial direction, so that only the axial hole of the sheath 10 is required to be directly formed in the wall 11 based on the existing structure of the sheath 11. In other embodiments, as shown in fig. 7, a portion of the sheath 10 surrounding the receiving hole 13 may be provided to protrude inward with respect to other portions of the sheath 10.
The proximal end face of the accommodating hole 13 is flush with the proximal end face of the sheath tube 10, and 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, i.e., the axial length of the accommodating hole 13 is smaller than that of the sheath tube 10, and the distal end face of the accommodating hole 13 and the distal end face of the sheath tube 10 are spaced apart from each other by a certain distance along the axial direction of the sheath tube 10, so that the distal opening of the sheath tube 10 is not blocked after the mapping piece 21 is in a working state, thereby ensuring smooth measurement process.
The connecting rod 22 in this embodiment is made of a material having a certain supporting property, such as polyethylene, nylon, pebax (polyethylene glycol), etc. The proximal end of the connecting rod 22 extends a distance beyond the proximal end face of the sheath 10 to facilitate its axial movement within the receiving bore 13 of the sheath 10 to release the mapping 21 at the distal end of the sheath 10. The mapping member 21 in the working state is in a regular sphere shape or a shape close to a regular sphere shape, and is in a circular shape with a constant size under the projection of any angle, and can be used for various anatomical structures of human bodies.
The mapping member 21 in this embodiment is an elastomer, and may be made of a material such as silica gel, polyurethane, or polyolefin, and a liquid with developing property, such as iodinated alcohol, is injected into the mapping member 21 through the connecting rod 22, so that the mapping member 21 has a certain developing property, and can be better identified under DSA projection. In another embodiment, X-ray developable materials such as BaSO4, (BIO) 2CO3, etc. may be added uniformly to these materials to enhance the developability of the mapping 21. In this embodiment, the developing material-added silicone material is used to form the hollow bladder-shaped mapping member 21. The sphere diameter of the filled mapping 21 has a value in the range of 4-20mm, preferably 6-12mm, which has the effect of ensuring that the mapping 21 is of sufficient size to ensure accuracy of measurement while avoiding excessive space occupation and operational impact. The hollow capsule structure of the probe 21 in this embodiment has no compliance, and the probe 21 located outside the sheath 10 can be inflated to a standard regular sphere shape or a nearly regular sphere shape with a constant size after a certain pressure is applied to the inside of the probe 21 by the connection rod 22, and in a specific embodiment, a liquid with developing property, such as iodinated alcohol, is injected into the probe 21 by the connection rod 22, so that the developing property of the probe 21 is further enhanced. In other embodiments, if the mapping 21 itself has sufficient developability, a liquid or gas that does not have developability may be injected into the mapping 21 to fully expand the mapping 21.
As shown in fig. 1 and 2, the distal end of the sheath 10 in this embodiment may be provided with a taper head 30 for preventing tissue from being damaged, the taper head 30 is a generally hollow annular body, and the outer diameter of the taper head 30 gradually decreases from the proximal end to the distal end. The tapered head 30 is fixedly attached, e.g., welded or bonded, to the distal end of the sheath 10, with the junction transitioning smoothly to reduce scratching of blood vessels and other tissue. The axial length of the conical head 30 is 1-6mm, preferably 2-4mm, and the too short length can lead to larger conical surface transition of the conical head 30 and is easy to scratch blood vessels and other tissues; too long a length will result in a correspondingly longer section of thinner wall thickness at the distal end portion of the bit 30, which will tend to collapse the distal end of the bit 30 during use. In this embodiment, the tip 30 may be regarded as a part of the structure of the sheath 10, and the axial length of the sheath 10 is relatively extended, so that the distance between the distal end surface of the accommodating hole 13 and the distal end surface of the sheath 10 is actually greater than or equal to the axial length of the tip 30, and the distance between the distal end surface of the accommodating hole 13 and the distal end surface of the tip 30 is preferably 2-15mm, so that the filled mapping member 21 is prevented from blocking the distal opening of the sheath 10.
Fig. 8 is a schematic view of a part of a measuring system including the measuring device 100 in fig. 1. As shown in fig. 8, the measurement system in the present 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 hollow, and the distal end is tapered to smoothly enter the body with the sheath 10 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 invention also provides a measuring method, and as shown in fig. 8 and 9, the measuring system according to the embodiment at least comprises the following steps:
Delivering the measuring device 100 in any of the above embodiments from outside the body to the inside the body at the position where the target 400 to be measured is located; deforming the mapping 21 from the compressed state to a regular sphere or nearly regular sphere shape, out of the restraint of the sheath 10; developing the mapping 21 under a digital angiographic apparatus (such as a Digital Subtraction Angiographic (DSA) apparatus, particularly not limited thereto), and measuring a measured dimension of the mapping 21 after DSA projection, a measured dimension of the object 400 to be measured after projection; based on the reference size (i.e., actual size) of the target 21 previously measured outside the body, the size estimation value of the target 400 to be measured is calculated as: (reference dimension of the map 21/measured dimension of the map 21 after projection) —measured dimension of the target 400 to be measured after projection. Wherein the mapping 21 itself is developable or the mapping 21 is developable after being injected with a liquid having developability.
Specifically, in the conventional interventional procedure, after the vascular puncture 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 location of the target 400 to be measured. The sheath core 200 is sleeved in the sheath tube 10, the distal end of the sheath core 200 extends out of the distal end of the sheath tube 10, then the proximal end of the guide wire 300 is penetrated into the distal cavity of the sheath core 200, and the distal end of the sheath tube 10 and the distal end of the sheath core 200 are guided by the guide wire 300 to move to the position of the target 400 to be measured; wherein the mapping assembly 20 has been assembled into 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 proximal end of the connecting rod 22 is used for injecting a liquid with developing property, which generates a certain pressure on the mapping piece 21, into the mapping piece 21, and the mapping piece 21 is filled, so that the mapping piece 21 fills to a specific size and is separated from the sheath 10, and at the moment, the mapping piece 21 is switched from a compressed state to an operating state. The contrast agent 500 is injected through the lumen 12 of the sheath 10 toward the object 400 to be measured, so that the object 400 to be measured exhibits a shape profile under DSA. The measurement size is obtained by calibrating the size of the projected target 21 in the display image of the DSA, and the measurement size is obtained by calibrating the size of the projected target 400 to be measured. According to the principle of digital imaging, the actual size estimation value of the target 400 to be measured is calculated according to the scaling of the above-mentioned equal ratio.
Wherein the mapping 21 may be placed at any angle. As shown in fig. 10, the map 21 produces a map projection 21' in the X-ray receiving plane 600 under the irradiation of X-rays 800 emitted by the X-ray emitting plane 700. Since the mapping member 21 in the working state is in a regular sphere shape or a shape similar to a regular sphere, it is in a circular shape with a constant size under any angle projection, and thus, the error of the base size after projection is not caused by the placement position of the mapping member 21. Meanwhile, the target 400 to be measured generates the target projection 400' to be measured under the irradiation of the X-ray 800, so that the actual size estimation value of the target 400 to be measured can be calculated according to the actual diameter of the standard 21, the reference size of the standard projection 21', and the measured size of the target projection 400 '. The object 400 to be measured in the present embodiment is a tissue simulation 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 in the human or animal body.
The mapping 21 may optionally be depressurized after the measurement is completed and inflated when it is used again. For example, the liquid in the mapping member 21 can be completely pumped out of the body by the negative pressure pumping device and the connecting rod 22, so as to complete the pressure release of the mapping member 21. After the measurement is completed, other related operations are performed according to the operation requirement, such as selecting a plugging device with proper size and corresponding specification for implantation, and the like. After the operation is completed, the decompressed mapping members 21 are received in the distal ends of the receiving holes 13 by pulling the retracting connecting rod 22 proximally, and are withdrawn outside the body together with the sheath 10.
Second embodiment
The same parts as those of the first embodiment are not described in detail herein, and only the different parts will be described below with reference to the accompanying drawings. As shown in fig. 11, 12 and 13, the connector in this embodiment includes a first connector 23 and a second connector 24, where the first connector 23 is at least partially disposed in the accommodating hole 13, and 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 connected to two ends of the mapping member 21, respectively.
When the mapping 21 is placed within the sheath 10 for delivery, as shown in fig. 12, the mapping 21 is located within the distal lumen of the sheath 20. By pulling the second connector 24 proximally, the control probe 21 is received within the distal lumen of the sheath 10.
When the probe 21 is disengaged from the sheath 10 for measurement, as shown in fig. 11, the probe 21 is located between the distal end face of the receiving hole 13 and the distal end face of the bit 30. In other embodiments, the operative mapping 21 is located between the distal end face of the receiving bore 13 and the distal end face of the sheath 10 when the bit 30 is not provided. The deployment of the mapping 21 from the distal end of the sheath 10 can be controlled by pulling the first connector 23 proximally.
The first connecting piece 23 and the second connecting piece 24 are respectively arranged in the accommodating hole 13 and the lumen 12 which are independent of each other, so that the tightness in the lumen 12 is ensured, and the risk of operation caused by leakage into the accommodating hole 13 when the lumen 12 is exhausted or contrast medium is injected is prevented. And (5) pulling.
The mapping member 21 in this embodiment is a foamed elastomer, and has a sponge-like structure, and the material may be silica gel, polyurethane, polyolefin, etc., which has relatively good elasticity and good compressibility after foaming. The foamed elastomer is more beneficial than the hollow saccular structure to ensure the regular sphere structure of the mapping piece 21 and increase the accuracy of measurement. The material capable of developing under X-rays, such as BaSO 4、(BIO)2CO3, can be further added uniformly to the material for manufacturing the mapping member 21, so that the developability of the foamed elastomer is enhanced, and the developability of the mapping member 21 is enhanced. Pulling the first connector 23 and the second connector 24 in this embodiment may be a pulling rope, a wire having a certain flexibility, a pulling rod, or the like.
In this embodiment, the proximal end face of the receiving hole 13 is flush with the proximal end face of the sheath 10, and the distance between the distal end face of the receiving hole 13 and the distal end face (or the taper head 30) of the sheath 10 is greater than or equal to the diameter of the probe 21, preferably 6-25mm, so as to ensure that a proper distance is maintained between the probe 21 and the distal opening of the sheath 10, preventing the test or treatment target from deviating from the DSA window, and at the same time preventing the probe 21 from blocking the distal opening of the sheath 10, preventing operation.
As shown in fig. 14, the measurement system including the measurement device in the present embodiment is different from that in the first embodiment in that: the mapping member 21 in the first embodiment is accommodated in the accommodating hole 13 in the compressed state, and the initial position of the mapping member 21 in the present embodiment is set outside the body, that is, after the sheath tube 10 reaches the target position to be measured under the guiding action of the guide wire 300, the mapping member 21 is conveyed to the target position inside the body by the lumen 12 of the sheath tube 10, so as to perform measurement; and when the mapping 21 is switched from the delivery state to the working state, the first connector 23 is pulled proximally so that the mapping 21 protrudes from the distal lumen of the sheath 10 and moves into position.
The method of measuring by the measuring system according to the present embodiment is substantially the same as that of the first embodiment, and the main points are that:
The mapping 21 is always located outside the proximal end of the sheath 10 when the sheath 10 is delivered from outside the body to inside the body. After the guidewire 300 and sheath core 200 are withdrawn from the body, the first connector 23 is pulled proximally at the proximal end of the sheath 10 to pull the mapping member 21 and the second connector 24 from the body along the lumen 12 of the sheath 10 to near the distal open position of the sheath 10. The drawing of the mapping 21 out of the distal end of the sheath 10 then continues, as the mapping 21 naturally expands to assume or approximate a right sphere configuration. The first connector 23 or the second connector 24 is then pulled proximally as required by the projection position to adjust the position of the mapping 21 outside the sheath 10. After the measurement is completed, the second connector 24 is pulled proximally to draw the mapping 21 from outside the sheath 10 into the distal opening of the sheath 10 until fully received within the lumen 12 distal of the sheath 10, and the mapping 21 is withdrawn from the body along with the sheath 10.
Embodiment III
The same parts as those of the first embodiment are not described in detail, and only the different parts will be described in conjunction with the drawings. As shown in fig. 15 and 16, the connecting member in this embodiment is a connecting rod 22 with a hollow interior, the connecting rod 22 is at least partially disposed in the lumen 12 of the sheath 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 similar to a regular sphere after self-expansion, and the center of the sphere is provided with 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 21 and the connecting rod 22 may be of unitary construction. The material of the connecting rod 22 may be a non-metallic material with certain thermoplasticity such as polyurethane, polyolefin, pebax, etc., or a metallic material with certain setting capability such as stainless steel, nickel titanium, etc. In this embodiment, the connecting rod 22 is preferably a hollow nickel-titanium rod, and the distal end thereof is bent in a natural state after heat setting, so that the mapping member 21 is bent and pressed close to the outer wall of the distal end of the sheath 10 under the action of automatic bending of the distal end of the connecting rod 22 after being unfolded outside the sheath 10, thereby avoiding blocking the operation of the distal end of the sheath 10.
Since the connecting rod 22 in the present embodiment is disposed in the lumen 12 and the inside of the connecting rod 22 is hollow, the guide wire 300 can be inserted therein, and thus can function as a sheath core. In this embodiment, the measuring device and the measuring system thereof may not include the sheath core 200 as in the first embodiment.
The measurement system according to the present embodiment performs measurement in substantially the same manner as in the first embodiment, except that:
When the sheath 10 is delivered from outside the body to inside the body, it is not delivered with the sheath core 200, but is delivered along the guidewire 300 to a target site inside the body together with the mapping member 21 and the connecting rod 22 housed in the lumen 12 of the sheath 10. Thereafter, only the guidewire is 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 is automatically bent toward one side after extending out of the distal end of the sheath tube 10, so that the mapping member 21 which is self-expanded into or near to the regular sphere shape is moved to the outer wall position around the distal end opening of the sheath tube 10, and then the related imaging and measurement operations 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 from the body together with the sheath 10.
Fourth embodiment
The same parts as those of the third embodiment are not described in detail herein, and only the different parts will be described below with reference to the drawings. As shown in fig. 17 and 18, the measuring device in this embodiment further includes a sheath core 40, and a through hole penetrating the proximal end face and the distal end face of the sheath core 40 is provided at the inner center thereof. The distal ends of the connecting rods 22 are sequentially and respectively penetrated in the through holes of the mapping piece 21 and the sheath core head 40 from near to far, and the proximal ends of the sheath core head 40 are fixedly connected with the distal ends of the mapping piece 21. In other embodiments, the distal end of the connecting rod 22 is not threaded within the through-hole of the sheath-core head 40, e.g., the distal end of the connecting rod 22 is connected to the sheath-core head 40 after penetrating the probe 21, the proximal end of the sheath-core head 40 is connected to the distal end of the probe 21, and the through-hole of the sheath-core head 40 is in communication with the internal cavity of the connecting rod 22. The structure of this embodiment is substantially identical to that of the third embodiment, except that the distal end of the mapping assembly in this embodiment is provided with a tapered sheath core 40, and the sheath core 40 has a gradually decreasing outer diameter from its proximal end to its distal end, thereby reducing damage to tissue.
The measurement system according to the present embodiment basically corresponds to the third embodiment in the steps, and the main points are that: when the sheath 10 is delivered from outside the body to inside the body, it is delivered along the guidewire 300 to a target site inside the body together with the connecting rod 22, the mapping member 21 and the sheath core 40 housed in the lumen 12 of the sheath 10.
The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention are intended to be included in the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.
Claims (8)
1. A measurement device, comprising:
A sheath tube which is a hollow tubular body;
A mapping assembly, the mapping assembly comprises a mapping piece which is independent relative to the sheath pipe, the mapping piece has elasticity and can be at least partially compressed and accommodated in the sheath pipe for conveying, the mapping piece takes a positive sphere shape or a nearly positive sphere shape after being released from the sheath pipe to the outside and has developability at least in an operating state, the mapping assembly also comprises at least one slender connecting piece connected with the mapping piece, a containing hole extending along the axial direction of the sheath pipe is arranged on the pipe wall of the sheath pipe, the slender connecting piece is at least partially arranged in the containing hole, and the mapping piece is at least partially compressed and accommodated in the containing hole; wherein the elongated connector is a hollow interior connecting rod.
2. The measurement device according to claim 1, wherein a wall thickness of the sheath is uniform, and a diameter of the accommodation hole is smaller than the wall thickness of the sheath; or a portion of the sheath surrounding the receiving hole protrudes inward or outward relative to the other portion of the sheath.
3. The measurement device of claim 1, wherein the elongate connector comprises a first connector at least partially disposed within the receiving aperture and a second connector at least partially disposed within the lumen of the sheath, the first connector and the second connector being respectively connected to the mapping.
4. The measurement device of claim 1, wherein the connecting rod is at least partially disposed within the sheath or within the receiving bore, the interior of the probe being hollow and in communication with the interior of the connecting rod.
5. The measurement device of claim 4, wherein the distal end of the connecting rod is pre-bent in a natural state.
6. The measurement device of claim 4, wherein the mapping assembly further comprises a tapered sheath-core, wherein the interior of the sheath-core is provided with a through-hole extending through the proximal and distal end faces thereof, wherein the distal end of the connecting rod extends through the mapping member and is connected to the sheath-core, and wherein the through-hole is in communication with the interior of the connecting rod.
7. A measurement system comprising the measurement device of any one of claims 1 to 5, the measurement system further comprising:
a sheath core having a cavity and at least partially disposed within the sheath;
the guide wire penetrates through the cavity of the sheath core.
8. A measuring system comprising the measuring device of claim 6 and a guidewire threaded into the connecting rod and the lumen of the sheath-core.
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