WO2018121356A1 - Measuring wire - Google Patents

Abstract

A measuring wire (10, 10a), comprising: a main part (12, 12a), and a guiding part (11, 11a) connected to the distal end of the main part (12, 12a). The main part (12, 12a) is provided with a development marker (13, 13a). The guiding part (11, 11a) comprises an elastic portion (111, 111a), and a flexible portion (110, 110a) connected to the distal end of the elastic portion (111, 111a). The flexible portion (110, 110a) is made of a macromolecular material and is softer than the distal end of the elastic portion (111, 111a). When the measuring wire (10, 10a) hits a wall, the flexible portion (110, 110a) bends and then the elastic portion (111, 111a) deforms. The degree of deformation of the elastic portion (111, 111a) from the proximal end to the distal end thereof increases. The flexible portion (110, 110a) and the elastic portion (111, 111a) are in an overall arc shape after being bent, avoiding forming a sharp angle that can injure human tissues such as a bronchial tube and the like.

Description

Measuring guide wire Technical field

The invention belongs to the technical field of interventional therapy, and relates to an interventional treatment device, in particular to a measurement guide wire.

Background technique

Interventional therapy is guided by medical imaging equipment, using a guide wire to establish a transport path, through the catheter to the instrument or diagnostic instrument into the human body for diagnosis and local treatment of the lesion.

When the delivery path is established using the guidewire, the measurement guidewire can be used for guidance, and once the tip of the measurement guidewire is determined to be in the desired position, the catheter can be delivered along the measurement guidewire until the distal end of the catheter reaches the desired position. If the diameter of the measuring guide wire differs greatly from the diameter of the catheter, the distal end of the catheter will easily damage the diseased tissue after reaching the desired position. Therefore, when transporting a device of a larger size, it is necessary to establish a path using a thicker measuring guide wire. The thicker measuring guide wire has a higher distal end hardness. When it is guided into the human body for guidance, especially when it is inserted into a weak tissue such as the lungs and bronchus, the tip of the wire tends to dampen the inner wall of the bronchi and cause it to be caused. Injury, leading to adverse events such as pneumothorax.

Summary of the invention

The present invention provides a distally flexible measuring guide wire that avoids damage to the tissue at its ends when it is guided into the body.

One technical solution adopted by the present invention to solve its technical problems is:

The utility model comprises a main body segment, a guiding segment connected to the main body segment and a developing mark disposed on the main body segment, the guiding segment comprising an elastic segment connected to the distal end of the main body segment, the elastic segment being from the proximal end The softening section is further softened to the distal end, and the guiding section further includes a flexible section connected to the distal end of the elastic section, the flexible section being made of a polymer material and softer than the distal end of the elastic section.

In an embodiment of the present technical solution, the measuring guide wire further includes a developing strip, and the developing strip is coaxial Located in the flexible section.

In an embodiment of the present invention, the flexible segment includes a connecting segment and a exposed segment, the connecting segment is connected to the elastic segment, and the developing strip is coaxially disposed in the exposed segment.

In an embodiment of the present technical solution, the connecting segment is inserted into the elastic segment, and the exposed segment constitutes a distal end portion of the measuring guide wire.

In an embodiment of the present technical solution, a part of the developing strip is also coaxially disposed in the connecting section.

In an embodiment of the present invention, the measuring guide wire further includes a developing member coaxially disposed in the flexible segment and closer to a distal end of the flexible segment than the developing strip.

In an embodiment of the present technical solution, the elastic segment includes an elastic tubular body having a continuous spiral slit, and from the distal end to the proximal end of the elastic segment, adjacent two slits of the elastic segment The axial spacing of the elastic segments gradually increases.

In an embodiment of the present invention, the elastic segment slit is filled with a polymer filler, and the polymer filler is fused with the connecting portion of the flexible segment, and the outer surface of the elastic segment is smooth.

In an embodiment of the present invention, the measuring guide wire further includes a connecting member connecting the main body segment and the elastic segment, and the proximal end of the connecting member is inserted into a lumen of the main body segment, the connection The distal end of the piece is inserted into the lumen of the elastic section.

In an embodiment of the present invention, the body segment includes a base body and a polymer film coated on the outside of the base body.

In an embodiment of the present invention, the main body segment includes a metal pipe base and a polymer coating, the development mark is disposed on an outer surface of the metal pipe, and the polymer is coated on an outer surface of the metal pipe base. .

In an embodiment of the present invention, the main body segment comprises a solid polymer column, a metal inner core is coaxially disposed in the main body segment, and the developing mark is disposed in the main body segment and is opposite to the metal The inner core is connected.

In an embodiment of the present technical solution, the metal pipe base has a pipe wall thickness of 0.01 to 1 mm.

The measuring guidewire of the present invention comprises a body segment, an elastic segment connected to the distal end of the body segment, and a development mark on the outer surface of the body segment, the elastic segment is softer from the proximal end to the distal end, and the flexible segment is made of a polymer material and is softer than the distal end of the elastic segment, compared to the prior art When the invention extends into the bronchial tissue or the like in the human body, when the flexible segment touches the inner wall of the human body tissue such as the bronchial wall, the softer head end thereof is first bent, and the proximal end bending degree is less changed, and the operator according to X The ray can more intuitively observe the degree of bending of the distal end, thereby judging whether the measuring guide wire reaches the predetermined position, the deformation range of the proximal end to the distal end of the elastic section is larger and larger, and the overall shape after the bending is curved, thereby It can avoid sharp edges and corners during bending and cause damage to human tissues such as bronchus.

DRAWINGS

The present invention will be further described below in conjunction with the accompanying drawings and embodiments, in which:

1 is a schematic structural view of a measuring guide wire according to an embodiment of the present invention;

Figure 2 is a partial cross-sectional view of the flexible section of the measuring guide wire of Figure 1;

Figure 3 is a schematic view showing the structure of the elastic section of the measuring guide wire shown in Figure 1;

Figure 4 is a schematic view of the elastic section of Figure 3 taken along its length and expanded;

Figure 5 is a partial cross-sectional view of the guiding section of the measuring guide wire of Figure 1;

Figure 6 is a partial structural view of the main body section of the measuring guide wire shown in Figure 1;

Figure 7 is a schematic view showing the structure of the developing mark of the measuring guide wire shown in Figure 1;

Figure 8 is a schematic structural view of the connecting member of the measuring guide wire shown in Figure 1;

9 is a schematic structural view of a measuring guide wire according to another embodiment of the present invention;

10 is a schematic structural view of a main body segment of a measuring guide wire according to an embodiment of the present invention;

11 is a schematic structural view of another main body section of a measuring guide wire according to an embodiment of the present invention;

12 is a schematic structural view of another main body segment of a measuring guide wire according to an embodiment of the present invention;

FIG. 13 is a schematic structural view of another main body segment of a measuring guide wire according to an embodiment of the present invention; FIG.

14 is a schematic structural view of still another main body section of a measuring guide wire according to an embodiment of the present invention;

15 is a schematic structural view of an elastic section of a measuring guide wire according to another embodiment of the present invention;

Figure 16 is a schematic view of the elastic section of Figure 15 taken along its length and expanded.

LIST OF REFERENCE NUMERALS: measuring guide wire-10, guiding section -11, body section -12, developing mark-13, elastic section - 111, flexible section - 110, handle -16, metal base - 120, connecting section - 1102, revealing section 1101, connecting piece - 14.

detailed description

The above described objects, features and advantages of the present invention will become more apparent from the aspects of the appended claims. Numerous specific details are set forth in the description below in order to provide a thorough understanding of the invention. However, the present invention can be implemented in many other ways than those described herein, and those skilled in the art can make similar modifications without departing from the spirit of the invention, and thus the invention is not limited by the specific embodiments disclosed below.

In the field of intervention, the end near the operator is usually referred to as the proximal end, and the end far from the operator is referred to as the distal end.

Unless otherwise defined, all technical and scientific terms used herein have the same meaning meaning meaning The terminology used in the description of the present invention is for the purpose of describing particular embodiments and is not intended to limit the invention. The term "and/or" used herein includes any and all combinations of one or more of the associated listed items.

Referring to FIG. 1 , FIG. 6 and FIG. 7 , the measuring guide wire 10 according to an embodiment of the invention includes a guiding section 11 at the distal end and a main body section 12 connected to the proximal end of the guiding section 11 . A plurality of sets of development marks 13 are disposed at intervals of the segment 12. The guiding section 11 comprises an elastic section 111 connected to the distal end of the body section 12 and a flexible section 110 constituting the distal end of the measuring guide wire 10. A handle 16 for facilitating pushing and holding is also provided at the proximal end of the measuring guide wire.

The main body segment 12 includes a tubular metal substrate 120, a biocompatible polymer film (not shown) coated on the outer surface of the metal substrate 120, and a plurality of sets of development marks spaced apart on the outer surface of the metal substrate 120. 13. The starting end of the polymeric film is located at the junction of the body section 12 and the elastic section 111, which covers all of the development marks 13 on the body section 12. The polymer film can make the outer surface of the main body segment 12 smooth, and can prevent the main body segment 12 from damaging tissues such as bronchus in the human body. The polymer film can be made of a polymer solution having excellent chemical stability, water resistance, weathering resistance, good low compressibility, good biocompatibility, high mechanical strength, non-toxicity, and odorless properties, such as silicone rubber. Or polyurethane solution.

The material of the metal substrate 120 may be stainless steel, nickel-titanium alloy or cobalt-chromium alloy, and the wall thickness of the metal substrate 120 is 0.01 to 1 mm to prevent the development mark 13 from being distinguished from the metal substrate 120 under X-rays after the body segment 12 is inserted into the body. If the tube wall of the metal base 120 is too thick, the development contrast of the developing mark 13 and the metal base 120 may be lowered, resulting in difficulty in distinguishing between the two under the same X-ray. The metal base 120 can be wound from a plurality of metal wires, has good elasticity and flexibility, and has good pushability. The pushability here means that the main body segment 12 has a certain rigidity, and the guide wire is measured. 10 When pushing through the push pipe, the measuring guide wire 10 can be pushed along the channel without excessive bending of the main body segment 12 due to excessive bending of the main body segment 12, resulting in bending in the tube or human tissue, and the pushing cannot be continued. The plurality of wires constituting the main body segment 12 in the embodiment are spring wires having a certain elasticity, and the metal base body 120 which is wound has a certain elasticity, and can ensure elasticity in the main body segment 12, thereby ensuring that the main body segment 12 is not easily bent. Fold out sharp edges and corners and increase their service life. In other embodiments, the metal substrate 120 can be a metal tube having a smooth surface, such as a nickel-titanium tube. The plurality of sets of development marks 13 each have a specific feature. In the present embodiment, the plurality of sets of development marks 13 are distinguished by the number of the developing members 130 included, and the first group of development marks 13 includes one developing member 130, and the second group of developing marks 13 includes two developing members 130, the third group of developing marks 13 includes three developing members 130, and so on, each group of developing marks is spaced apart from each other by 20 mm, and the first group of developing marks 13 are spaced from the leading end of the measuring guide wire 10. For the 70 mm, the purpose of this particular feature is to allow the operator to measure the X-ray according to the nearest exposure from the guide of the guidewire when measuring one end of the guidewire 10 into the body tissue for measurement. The set of development marks 13 of the diseased tissue directly determines the distance measured by the measurement guidewire 10, thereby facilitating subsequent selection of a medical device of a suitable specification. By this design, the operator does not need to check the number of development marks 13 in the target area, and the extension length of the measurement guide wire 10 can be directly determined according to the specific feature of the development mark exposed outside the push device, which can reduce the measurement for the measurement. Time to improve accuracy.

The developing member 130 may be annular and sleeved outside the main body metal base 120. The developing member 130 adopts a material with better visibility under X-rays, such as gold, platinum, tungsten, tantalum and the like. The material has good developability, and under the same environment, the development effect under X-ray is clear, and the developing part The thickness of the 130 is not excessively large. If the thickness of the developing member 130 is too large, when it is sleeved outside the metal substrate 120, a relatively prominent protrusion is formed on the surface of the main body portion 12, which increases the risk of damaging the human body. The thickness of the developing member is 0.01-0.5 mm, and the connection between the developing member 130 and the metal base 120 of the main body portion 12 may be: welding, bonding, splicing, etc., and is not specifically limited herein. In other embodiments, the developing member 130 may have other shapes or configurations that function to identify the measuring guide wire 10 as long as it can be identified under X-rays.

Referring to Figure 1, the elastic section 111 is becoming softer from the proximal end to the distal end. The guiding section 11 serves as a direct contact of the distal end of the measuring guide wire 10 with the inner wall of the human tissue. The flexible section 110 is made of a biocompatible polymeric material that is softer and more susceptible to deformation than the elastic section 111. The flexible section 110 can also be softer from the proximal end to the distal end, i.e., the guide section 11 becomes softer from the proximal end to the distal end. The flexible section 110 can also have the same softness from the distal end to the proximal end. It can be understood that the portion of the guiding section 11 connected to the main body section 12 has strong bending resistance, and is close to the bending resistance of the main body section 12 which is wound by a plurality of wires, and the bending resistance. It refers to the minimum force required to cause bending deformation. The greater the force required, the stronger the bending resistance is, and the less likely it is to deform. The smaller the force required, the easier it is to deform and the bending resistance. The weaker. Since the elastic segment 111 is softer from the proximal end to the distal end, and the flexible segment 110 is made of a polymer material and has better flexibility, when the guiding segment 11 extends into a tissue such as a bronchus in the human body, When the flexible segment 110 touches the inner wall of the human tissue such as the bronchial wall, the softer head end is first bent, and the proximal end is less curved, and the operator can more intuitively observe the bending degree of the distal end according to the X-ray. And determining whether the measuring guide wire 10 reaches the predetermined position, and the gradual bending resistance of the guiding portion 11 can ensure that when the distal end of the guiding segment 11 hits the wall, the bending of the entire guiding segment 11 is a gradual process, that is, from The deformation from the proximal end to the distal end is larger and larger, and the overall shape after the bending is curved, so it can be understood that any part of the guiding section 11 does not have a sharp bend in the body, thereby avoiding the cause. The guiding section 11 produces sharp edges and corners when bent, and causes damage to human tissues such as bronchus.

The material of the flexible section 110 is a polymer elastic material, such as silica gel, polytetrafluoroethylene, PEBA material or other polymer materials. Since the polymer elastic material has softer characteristics than the metal material, when it directly contacts the human body such as the bronchus When the inner wall of the tissue is not soft due to its own soft characteristics The human body tissue such as the inner wall of the bronchus causes damage, and the elastic resistance of the polymer elastic material is lower. During the measurement of the guide wire implantation, the distal end of the flexible segment 110 serves as the distal end of the measurement guide wire, due to the measurement of the guide wire implant. In the process of entering, the distal end of the flexible segment 110 is an end that is in direct contact with the tissue in the human body, and the distal end surface of the flexible segment 110 is preferably designed as a circular arc surface to prevent it from damaging the tissue in the human body, and the measuring guide wire is implanted. During the process, when it touches a tissue such as a bronchi or a lung in a human body, the flexible segment 110 has a softer property and a lower bending resistance, and is more easily bent so as not to cause a contusion to the tissue in the human body.

Referring to FIG. 2 , an elastic measuring guide wire according to an embodiment of the present invention has a flexible section 110 including a connecting section 1102 and a revealing section 1101 , wherein the connecting section 1102 and the exposed section 1101 can be integrally formed, directly fabricated by a mold or cut by a die. The connecting section 1102 and the exposing section 1101 can be separately manufactured, and then they are fastened by glue bonding or other means, and are not specifically limited herein. The radial dimension of the connecting section 1102 of the flexible section 110 is smaller than the radial dimension of the exposed section 1101, and the connecting section 1102 and the exposed section 1101 are stepped. In this embodiment, the main body of the connecting section 1102 and the exposed section 1101 of the flexible section 110 are preferably cylindrical, and the connecting section 1102 is on the same horizontal line as the axis of the exposed section 1101. Further, referring to FIG. 1 , FIG. 2 and FIG. 5 , the elastic segment 111 is tubular, and at least the distal end is open, that is, the elastic segment 111 can be a hollow tubular shape, and the distal end of the elastic segment 111 can be inserted into the connecting segment 1102 of the flexible segment 110 . The radial dimension of the connecting section 1102 is the same as the inner diameter of the lumen of the elastic section 111. When the flexible section 110 is connected with the elastic section 111, the connecting section 1102 can be inserted into the lumen of the elastic section 111, because the polymer material has a certain elasticity. When the connecting section 1102 is inserted into the lumen of the elastic section 111, the connecting section 1102 can be properly compressed, and the elasticity of the material can ensure that it is tightly fastened by the lumen of the elastic section 111 and is filled in the elastic section 111. The lumen, thus effectively avoiding the problem of poor connection reliability caused by other connection methods. Preferably, the exposed section 1101 of the flexible section 110 has the same radial dimension as the outer section of the elastic section 111. When the connecting section 1102 of the flexible section 110 is inserted into the lumen of the elastic section 111, the connecting section 1102 and the exposed section 1101 The step width of the joint can be the same as the thickness of the wall of the elastic section 111, so that the outer surface of the joint of the flexible section 110 and the elastic section 111 can be ensured to be smooth, thereby ensuring smoothness of the outer surface of the measuring guide wire and avoiding the cause. The surface has protrusions that cause damage to tissues and organs in the human body, and can also reduce the difficulty of subsequent processing.

Please refer to FIG. 3 and FIG. 4 together. In this embodiment, the elastic segment 111 is laser cut by a nickel-titanium tube. The tubular body has a grooved shape, and its bending resistance from the distal end to the proximal end is gradually enhanced under the same external force (that is, the deformation ability from the distal end to the proximal end is gradually weakened under the same external force, That is, it is harder and harder from the distal end to the proximal end, so as to be able to guide the measuring guide wire better. It can be understood that, since the elastic segment 111 is a tubular body having a plurality of slots, the bending resistance of the elastic segment 111 can be changed as the spacing of the adjacent slots changes, and those skilled in the art can set according to actual needs. Adjacent grooving spacing is used to achieve the gradual change of the bending resistance of the elastic section 111. It can also be understood that in other embodiments, the elastic segment 111 can also be a tubular body with a gradually increasing diameter from the distal end to the proximal end, or other forms of tubular body, as long as it can ensure that it is far from the same external force. The end-to-end resistance to bending is gradually enhanced.

The elastic section 111 includes a continuous spiral groove 2502. In the unfolding plane of the elastic section 111 along its axial direction, the distance between the adjacent two slits 2502 is gradually increased from the distal end to the proximal end of the elastic section 111 to reach the elastic section 111 from the distal end to the near end. The end bending resistance is gradually enhanced.

It can be understood that the elastic section 111 is extended along the axial direction of the elastic section 111 from the distal end to the proximal end of the elastic section 111, and the extending direction 2505 of the slit 2502 of the elastic section 111 and the elastic section 111 The angle G between the axial directions 2504 is constant, the slit of the elastic section 111 is gradually smaller along the width of the axial direction 2504 of the elastic section 111, and the spacing between the adjacent two slits 2502 is gradually increased. It is also possible to achieve the purpose of gradually increasing the bending resistance of the elastic section 111 from the distal end to the proximal end.

It can be understood that, in the unfolding plane of the elastic section 111 along its axial direction, from the distal end to the proximal end of the elastic section 111, the slit of the elastic section 111 is constant along the width of the axial direction 2504 of the elastic section 111, and the elasticity When the acute angle between the extending direction 2505 of the slit 111 and the axial direction 2504 of the elastic segment 111 is gradually increased, the interval between the adjacent two slits 2502 is gradually increased, and the elastic segment 111 can also be obtained. The end-to-end resistance to bending is gradually enhanced

Referring to FIG. 5 , the elastic segment 111 is further filled with a polymer filler (not shown) having the same material as the flexible segment 110 , and the polymer filler and the flexible segment 110 are The connecting segments are fused and the outer surface of the elastic segment 111 is smoothed. Since the elastic section 111 is an elastic tubular body having a continuous spiral groove cut by a nickel-titanium tube, a continuous grooving is formed on the surface thereof, and the surface thereof has a rib, and protrudes into a tissue such as a human bronchus. When it is easy to build on human tissues such as bronchus In the present embodiment, the sipe is filled with the same polymer filler as the flexible segment 110, and the connecting segments of the polymer filler flexible segment 110 are fused, and the elastic segments 111 are continuously grooved. Full, so that the outer surface of the elastic segment 111 is smooth. On the one hand, the friction between the elastic segment 111 and the conveying device can be reduced, so that the pushing is smoother, and on the other hand, the surface of the elastic segment 111 can be ensured to be smooth without ribs, and when the elastic segment 111 is bent by force, the human bronchus can be ensured. Such tissue causes damage.

Referring to FIG. 2 and FIG. 5 together, the flexible body 110 is provided with a developing body 15 into which the proximal end of the developing body 15 is inserted into the lumen of the elastic section 111 with the connecting section 1102 of the flexible section 110. The developing body 15 is disposed in the flexible section 110. Since the flexible section 110 is made of a polymer material, the developing body 15 can be embedded in the flexible section 110, and the developing body 15 can be disposed in the flexible section 110 by other methods. Specifically limited. When the connecting section 1102 of the flexible section 110 is inserted into the lumen of the elastic section 111, the proximal end of the developing body 15 projects into the lumen of the elastic section 111. Here, the flexible section 110 is made of a polymer material. Since the apparatus needs to be operated under the aid of X-rays, and the polymer material itself has poor developability, in the present embodiment, the developing body 15 is disposed in the flexible section 110. During the implantation process, the filament can be developed by the developing body 15 in the flexible section 110, and at the same time, since the proximal end of the developing body 15 protrudes into the lumen of the elastic section 111, when the measuring guide wire is in the process of implantation, development The body 15 not only can show the bending change of the flexible segment 110, but also can develop the bending change of the elastic segment 111, thereby ensuring the accuracy and safety of the operation. Further, since the flexible segment 110 and the elastic segment 111 are different in material, The bending resistance of the flexible section 110 is smaller than the bending resistance of the elastic section 111. When the measuring guide wire twists the organ or the tissue, the sharp deformation difference between the flexible section 110 and the elastic section 111 is highly likely to occur, resulting in a large difference in deformation. The region of the present invention generates a large stress concentration, which in turn causes a break between the flexible segment 110 and the elastic segment 111. Thus, in the embodiment, the developing body 15 includes the developing strip 151 and the developing ring 152, wherein The developing strip 151 includes a mandrel and a developing material wound thereon. The developing material is preferably a heavy metal such as gold, platinum or tungsten which has a better developing effect under X-rays, and the mandrel may preferably be a nickel-titanium alloy having better elasticity. Cobalt-chromium alloy or the like, this design can ensure that the developing body 15 has good elasticity, and when it is disposed inside the flexible section 110, its proximal end is inserted into the elastic section 111 with the connecting section 1102 of the flexible section 110, due to itself It has certain elasticity and can provide certain stress support to the flexible section 110 and the elastic section 111, which is equivalent to reducing the bending resistance between the flexible section 110 and the elastic section 111. The gap of the force, so that the guiding section has a gradual bending resistance from the distal end to the proximal end, that is, the bending resistance gradually becomes stronger from the distal end to the proximal end, thereby being able to avoid the violent between the flexible section 110 and the elastic section 111. The difference in deformation, in turn, can avoid breakage between the flexible section 110 and the elastic section 111.

Further, referring to FIG. 5, the preferred distance between the proximal end of the developing body 15 and the proximal end of the flexible section 110 is 0.5 mm to 20 mm. A person skilled in the relevant art can select the depth at which the developing body is inserted into the elastic segment 111 according to the difference in bending resistance between the flexible segment 110 and the elastic segment 111 to ensure that the flexible segment 110 and the elastic segment 111 are connected. No breakage occurs when the external force is bent.

Referring to FIG. 5, the developing body 15 includes a developing strip 151 disposed in the axial direction of the flexible section 110. The developing strip 151 has a certain length, and the developing strip 151 has a better developing effect when the flexible strip 110 and the elastic section 111 are bent, and the bending change of the developing strip 151 itself can show the outer flexible section 110 and the elastic section 111. The bending variation, preferably, the developing strip 151 is disposed in the axial direction of the flexible segment 110 to maximize the length of the developing strip 151, ensuring that it remains in the flexible section 110, thereby enabling better development. At the same time, it can provide better elasticity, thereby providing greater stress support and preventing breakage between the flexible section 110 and the elastic section 111. At the same time, since the apparatus needs to be operated with X-ray assistance, the developing strip 151 is disposed in the flexible section 110, and the proximal end projects into the elastic section 111, which ensures that the flexible section is developed during the measurement of the guidewire implantation process. The degree of bending of the 110 and the elastic section 111, when the flexible section 110 is displayed to be bent to a certain extent, the operator can judge whether or not the end of the measuring guide wire has reached the predetermined position based on the development result, thereby being able to measure the safety of the use of the guide wire. Further, the developing body 15 further includes a developing member 152 which is adjacent to the distal end of the flexible section 110, preferably disposed at the distal end of the flexible section 110, and is disposed at the end of the flexible section 110 since the developing strip 151 is thinner. The developing member 152 can better develop the position information of the distal end of the measuring guide wire when the measuring guide wire is implanted, which is more advantageous for the operator to judge the position of the distal end portion of the measuring guide wire, thereby improving the safety of the operation and the operation. accuracy. In this embodiment, the developing member has an annular shape. It can be understood that in other embodiments, the developing member may have other shapes such as a block shape or a triangular shape, as long as the position information of the distal end of the measuring guide wire can be developed. can.

Referring to FIG. 1 and FIG. 8 together, the measuring guide wire 10 is further provided with a connecting member 14 for connecting the main body segment 12 and the guiding portion 11. In the embodiment, the connecting member 14 is a cylindrical short tube, and the connecting member 14 near The end is inserted into the lumen of the body segment 12, the distal end of the connector 14 is inserted into the lumen of the elastic segment 111, and the distal end surface of the body segment 12 is fitted to the proximal end surface of the elastic segment 111, through the connector 14 The main body segment 12 is connected to the elastic segment 111, and the outer wall of the proximal end of the connecting member 14 is welded to the inner wall of the lumen of the main body segment 12. On the other hand, the outer wall of the distal end of the connecting member 14 is welded to the inner wall of the lumen of the elastic segment 111. The main body segment 12 is directly connected to the end surface of the elastic segment 111. In this embodiment, the welding point is added, so that the connection between the main body segment and the elastic segment is more firm. Further, the elastic segment 111 is connected through the cylindrical short tube. The main body segment 12 can improve the bending resistance of the joint. When the distal end of the guiding segment 11 hits the wall, the elastic segment 111 will be correspondingly bent. At this time, the straightening state of the main body segment 12 should be ensured to ensure measurement. Accuracy, since the main body segment 12 itself has a certain elasticity, when the elastic segment 111 connected thereto is bent, the main body segment 12 is caused to bend, in this embodiment, between the elastic segment 111 and the main body segment 12 Join connector 1 4, can bear the bending force to a large extent, because of its own strong rigidity, it can ensure that the joint does not produce excessive deformation, to ensure that the body segment 12 welded to its proximal end will not bend, further guarantee The accuracy of the measurement.

Referring to FIG. 9, a measuring guide wire 10a according to another embodiment of the present invention includes a guiding portion 11a and a main body segment 12a connected to a proximal end of the guiding portion 11a. The main body segment 12a is provided with a plurality of sets of developing marks spaced apart. The lead segment 11a is more and more deformable from the proximal end to the distal end, and the distal end of the guiding segment 11 is provided with a flexible segment 110a.

The base of the main body segment 12a is a solid cylinder made of a polymer material, and the main body segment 12a may be made of polytetrafluoroethylene, Pebax, nylon, or silica gel. The connection of the developing mark 13a and the base of the main body segment 12a may be bonding, or as shown in FIG. 10, by utilizing the fact that the developing mark 13a itself has plastic deformation and the main body portion 12a of the polymer material has good elasticity, the inner diameter is The developing mark 13a slightly larger than the base of the main body segment 12a is sleeved on the outer surface of the base of the main body segment 12a, and then applies a radial force to the developing mark 13a to reduce the inner diameter to be smaller than the outer diameter of the main body segment 12a, thereby The development mark 13a is fixed on the base of the main body section 12a. The plurality of sets of development marks 13a are each provided with a specific feature. The number of the developing members 130 in 13a is distinguished. The first group of developing marks 13a includes one developing member 130a, the second group developing mark 13a includes two developing members 130a, and the third group of developing marks 13a includes three. Developing member 130a, And so on, each set of development marks is 20 mm apart, and the first set of development marks 13a is 70 mm from the head end of the measuring guide wire 10. The purpose of this particular feature is: when measuring the guide wire extending from the push duct in the human tissue When measuring internally, the operator can directly determine the distance measured by the measuring guide wire based on the most recent set of development marks exposed from the push device. In this design mode, the operator does not need to count the number of development marks in the target area, and directly determines the extension distance of the measurement guide wire, which can reduce the time taken for measurement and improve the accuracy.

Referring to FIG. 11, the specific features of the plurality of sets of development marks may also be set as follows. On the first development mark 130d closest to the guide section 11, a number 1 and a second development mark 130d may be cut on the surface thereof. The surface thereof is cut out by the number 2, the third development mark 130d, the number 3 is cut on the surface thereof, and so on, wherein each of the development marks is 20 mm apart, and the first development mark is spaced from the head end of the measurement guide wire 10. At 70 mm, the purpose of this particular feature is to allow the operator to directly determine the measurement guidewire based on the most recent set of development marks exposed from the pusher when the measurement guidewire extends beyond the push conduit for measurement in body tissue. The distance measured. In this design mode, the operator does not need to count the number of development marks in the target area, and directly determines the extension distance of the measurement guide wire, which can reduce the time taken for measurement and improve the accuracy. As shown in FIG. 12, the specific feature of the plurality of sets of development marks may also be that each of the development marks has a different shape, and by designing each of the development marks to have different shapes, when a certain development mark 130e on the measurement guide wire is exposed The operator can directly judge the measurement distance from the specific shape, which is convenient and quick. In addition, the specific features of each group of development marks can also be color, size, etc., which will not be repeated here.

Referring to FIG. 9 and FIG. 13 together, in the embodiment, since the main body segment 12a is a solid columnar body made of a polymer material, the bending resistance is poor, and it is easy to bend when subjected to an external force, and is pushed by using a pushing device. When the guide wire 10a is measured, the main body segment 12a is easily bent, so that it cannot be pushed. Therefore, a metal inner core 1201 is disposed in the main body segment 12a. The metal inner core 1201 is disposed on the axis of the main body segment 12a and penetrates the main body. In the segment 12a, the metal inner core 1201 has a better hardness than the polymer material. When the metal inner core 1201 is formed in the main body portion 12a, the main body portion 12a is improved in bending resistance, thereby having a good pushing force when used. When the pushing device pushes the measuring guide wire 10a, the main body segment 12a does not cause excessive bending and cannot be pushed. The metal inner core 1201 may be a nickel titanium alloy, not Metal such as stainless steel or cobalt chrome.

Correspondingly, referring to FIG. 14, in other embodiments, the development mark 130c may also be disposed inside the main body segment base 120c, and the metal inner core 1201c may be connected to the development mark 130c by welding, bonding, and splicing. Preferably, the development mark 130c and the metal inner core 1201c may be a whole made of the same piece of material which is machined or otherwise processed.

Referring to FIGS. 15 and 16, in the embodiment, the elastic segment 111a is a slotted tubular body formed by laser cutting of a nickel-titanium tube, and its bending resistance from the distal end to the proximal end under the same external force. Gradually enhanced to better guide the measurement guide wire. It can be understood that, since the elastic segment 111a is a tubular body having a plurality of slots, the bending resistance of the elastic segment 111a can be changed as the spacing of the adjacent slots changes, and those skilled in the art can set according to actual needs. Adjacent grooving spacing is used to achieve the purpose of gradual bending resistance of the elastic section 111a.

The elastic section 111a includes a plurality of sets of elongated slit groups 1601 to 1608. Each set of slots (e.g., 1601) is comprised of two or more parallel slots 1601a and 1601b, each having a width 1609. The axes of the extending directions of the groove groups 1601 to 1608 form a certain angle F. There is a gap 1610 between adjacent sets of two slots. The bending resistance of the elastic segment 111a can be adjusted by adjusting the number of slots and the width 1609 in each group of slits, the size of the angle F, and the size of the interval 1610. Preferably, the number of parallel slits 1601 may be 2 to 6, the distance 1609 may be 0.05 to 1 mm, the angle F is preferably 5 to 85 degrees, and the interval 1610 is preferably 0.1 to 1.0 mm. Combining parallel grooving sets (1601 ~ 1608) of different widths 1609 onto the same nickel-titanium tube can achieve the purpose of gradually increasing the bending resistance of the elastic section 111a from the distal end to the proximal end under the same external force.

In order to achieve the gradual resistance of the elastic section 111a against bending, a feasible way is that from the distal end to the proximal end, the angle F of the adjacent two slit sets is constant, and the width 1609 of the slit is gradually reduced; The feasible way is that from the distal end to the proximal end, the width 1609 of the slots in the adjacent two slot groups is constant, and the angle F is gradually increased. It can be understood that the effect of gradually increasing the bending resistance of the elastic segment 111a from the distal end to the proximal end can also be achieved by simultaneously changing the angle F of the adjacent two slit groups and the width 1609 of the slit.

It can be understood that in other embodiments of the present invention, the elastic segment 111 can be other structures as long as It can be softened from the far end to the near end.

The embodiments of the present invention have been described above with reference to the drawings, but the present invention is not limited to the specific embodiments described above, and the specific embodiments described above are merely illustrative and not restrictive, and those skilled in the art In the light of the present invention, many forms may be made without departing from the spirit and scope of the invention as claimed.

Claims (14)

A measuring guide wire comprising a body segment, a guiding segment connected to the body segment, and a developing mark disposed on the body segment, the guiding segment comprising an elastic segment connected to a distal end of the body segment, The elastic segment is softened from the proximal end to the distal end, and the guiding segment further comprises a flexible segment connected to the distal end of the elastic segment, the flexible segment being made of a polymer material and having a ratio The distal end of the elastic segment is soft. The measuring guidewire according to claim 1, wherein said measuring guide wire further comprises a developing strip, said developing strip being disposed in said flexible section. The measuring guide wire according to claim 2, wherein the flexible section comprises a connecting section and a exposed section, the connecting section is connected to the elastic section, and the developing strip is disposed on the exposed section Inside. The measuring guidewire according to claim 3, wherein the connecting section is inserted into the elastic section, and the exposed section constitutes a distal end portion of the measuring guide wire. The measuring guidewire according to claim 4, wherein a portion of the developing strip is further disposed in the connecting section. The measuring guidewire according to any of claims 2-5, wherein said measuring guide wire further comprises a developing member disposed in said flexible section and being closer to said flexibility than said developing strip The far end of the segment. The measuring guidewire according to claim 1, wherein said elastic section comprises an elastic tubular body having a continuous helical slit, from the distal end to the proximal end of said elastic section, adjacent to said elastic section The distance between the two slits in the axial direction of the elastic section gradually becomes larger. The measuring guide wire according to claim 7, wherein the slit of the elastic section is filled with a polymer filler, and the polymer filler is fused with the connecting section of the flexible section, and The outer surface of the elastic segment is smooth. The measuring guide wire according to claim 1, wherein said measuring guide wire further comprises a connecting member connecting said main body segment and said elastic segment, said connecting member being inserted at a proximal end into said main body segment In the lumen, the distal end of the connector is inserted into the lumen of the elastic segment. The measuring guide wire according to claim 1, wherein said body segment comprises a base body And a polymer film coated on the outside of the substrate. The measuring guide wire according to claim 9, wherein the main body segment comprises a metal pipe base and a polymer coating, and the development mark is disposed on an outer surface of the metal pipe, and the polymer is coated in the The outer surface of the metal pipe base. The measuring guide wire according to claim 1, wherein the main body segment comprises a polymer solid columnar body, the main body segment is provided with a metal inner core, and the developing mark is disposed in the main body segment, and Connected to the metal core. The measuring guide wire according to claim 11, wherein said body segment base body is formed by winding a plurality of wires. The measuring guide wire according to claim 11, wherein the metal pipe base has a wall thickness of 0.01 to 1 mm.

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