JPH09164U - Medical device inserted into tubular organ - Google Patents

Abstract

(57) Abstract: [PROBLEMS] To provide a medical guide wire in which strength and flexibility at the distal end portion are both satisfied. SOLUTION: The whole is composed of a metal or resin tube 12, a slit 14 or a hole is formed at the tip of the tube 12 to give flexibility, and a curved head 13 is formed at the tip. Then, the medical guide wire 11 is obtained.

Description

[Detailed description of the invention]

[0001]

[Technical field to which the invention belongs]

 The present invention relates to a medical guide wire suitable for a guide wire for a catheter used when inserting a catheter into a blood vessel, a ureter, a bile duct, a trachea or the like.

[0002]

[Prior art]

 2. Description of the Related Art In recent years, medical guidewires have been used as inspection and treatment instruments for human tubular organs such as blood vessels, ureters, bile ducts, and tracheas. For example, in cardiac catheterization, a guide wire is inserted prior to percutaneous insertion of a catheter to administer a drug such as a contrast agent into a blood vessel.

As the medical guide wire, for example, a wire made of a metal such as stainless steel or a shape memory alloy and having a tapered tip, or a coil in which a thin wire is closely wound around the tip of the wire Various types have been proposed, such as a type with a coil attached and a core wire inserted inside the coil.

In these guide wires, the proximal end has a certain degree of rigidity so that the operation at hand extends to the distal end, and the distal end is formed sufficiently flexible so as not to damage the tissue at the time of insertion. That is especially required. For this reason, as described above, the tip of the wire is tapered, the coil is attached to the tip of the wire, or the core wire is inserted into the coil to improve rigidity and tip end on the base side. It is designed to have both flexibility and flexibility.

As one of such guide wires, a guide wire as shown in FIG. 4 has already been proposed. In the figure, reference numeral 41 is a wire body, and a tip portion 41a is formed in a tapered shape. Reference numeral 42 denotes a coil closely wound, the base end portion of which is welded to the tip end portion 41a of the wire body 41, and the tip end portion is melted to form a curved head portion 43. The distal end portion 41a of the wire body 41 is welded to the head portion 43 at its tip end, and has a structure in which a coil 42 is integrally attached to the wire body 41.

FIG. 5 shows another conventional example in which a coil is attached to the tip of a metal wire. In the figure, reference numeral 51 is a metal wire body, and a tip portion 51a is formed in a taper shape. The proximal end of the coil 52 tightly wound and the safety wire 54 disposed inside the coil 52 are welded to the distal end 51a. The tip of the coil 52 is melted to form a curved head 53, and the tip of the safety wire 54 is welded to the head 53.

[0007]

[Problems to be solved by the device]

 In the guide wire shown in FIG. 4, a coil 42 is welded to the tip portion 41a of the wire body 41 to give flexibility to the tip portion, and the tip end of the tip portion 41a of the wire body 41 is attached to the coil 42. It is welded to the head portion 43 of the to regulate the expansion of the coil 42.

However, in the above structure, although the coil 42 has the loop at the base end thereof welded to the peripheral surface of the distal end portion 41a of the wire body 41, the portion 42a where the coil 42 separates from the wire body 41 is It is a single wire. That is, the load applied to the coil 42 is concentrated on one wire of the portion 42 a where the coil 42 is separated from the wire body 41. Further, the tip end portion 41a of the wire main body 41 which is welded to the head portion 43 through the center of the coil 42 is actually very thin, and sufficient strength cannot be obtained against the load applied to the coil 42. Often. Therefore, with this guide wire, there is a risk that the coil 42 may be broken at the portion 42a that separates from the wire body 41 during use.

Further, in the guide wire shown in FIG. 5, the tip end portion 51 a of the wire body 51 is not connected to the head portion 53 of the coil 52, and instead the safety wire 54 is connected to the wire body 51. The extension of the coil 52 is regulated by connecting the tip portion 51a and the head portion 53 of the coil 52.

However, also in this guide wire, the portion 52a where the coil 52 is separated from the wire body 51 is a single wire, and the load applied to the coil 52 is concentrated in this portion. Further, while the safety wire 54 is generally made of a flat wire, the tip portion 51a of the wire body 51 is tapered, so that the contact area at the welded portion cannot be wide and a sufficient fixing force can be obtained. I can't. Therefore, even in this guide wire, there is a risk that the connecting portion between the wire body 51 and the coil 52 may be broken during use.

Further, as described above, since the safety wire 54 is generally made of a flat wire, the rigidity of the tip end portion tends to be directional, and the effect of making the tip end flexible by the coil 52 may be impaired. , Which was a cause of poor operability.

Therefore, an object of the present invention is to provide a medical guide wire in which the strength and flexibility of the distal end portion are both satisfactory.

[0013]

[Means for Solving the Problems]

 In order to achieve the above-mentioned object, the medical guide wire of the present invention is entirely made of a metal or resin tube, and a slit or hole is formed at the tip of this tube to give flexibility, and the tip is provided. It is characterized in that a curved head is formed.

In the medical guide wire of the present invention, since the entire guide wire is made of a tube and a hole or slit is formed at the distal end of the tube to give flexibility, the flexibility of the distal end is directional. It never happens. Moreover, since the entire guide wire is made of an integrated tube, the tip portion does not break. Further, since it is made of an integrated tube, the slidability in the tubular organ is improved. Furthermore, since the tube has a hollow inside and the slit or hole is provided at the tip as described above, it is possible to directly inject a drug such as a contrast agent without using a catheter. .

[0015]

[Embodiment of the invention]

 1, 2 and 3 show one embodiment of the medical guide wire according to the present invention. For convenience, only the tip of the guide wire is shown enlarged.

These guide wires 11, 21, 31 are entirely made of a metal or resin tube 12, and slits 14, 24 or holes 34 are formed at the tip of this tube to give flexibility, Moreover, the tip is melted to form the curved head 13. The material of the metal or resin tube 12 may be any as long as it does not corrode in the body and has a rigidity that allows insertion into a blood vessel or the like, but stainless is preferable as the metal, and the resin is, for example, a fluororesin. Etc. are preferably used.

As a method for forming the slits 14, 24 or the holes 34 at the tip of the tube 12, for example, a method by etching, a method by machining or the like is preferably adopted. The method by etching is, for example, a method in which the resist resin is applied to the entire surface of at least the tip portion of the tube 12 and the resist resin in the portion where the slits or holes are provided is peeled off, and then the tip portion is immersed in an etching solution for corrosion. It is preferably adopted. However, the resist resin may be pattern-printed on the tip of the tube 12 from the beginning, or the resist resin may be applied and then patterned by photoetching. The etching of the tip portion of the tube 12 may be electrolytic etching or the like. Further, as a method of machining, a method of cutting a desired slit or hole or providing it with a laser or the like is adopted.

In the guide wire 11 of FIG. 1, slits 14 extending in a direction perpendicular to the axial center of the tube 12 are formed at the distal end of the tube 12 at predetermined intervals in the axial direction of the tube 12. The slits 14 may be formed at regular intervals along the axial direction of the tube 12, or may be formed so that the intervals become narrower toward the tip end. Desired flexibility can be imparted by adjusting the length and interval of the slits 14.

The guide wire 21 shown in FIG. 2 has a slit 24 formed in a spiral shape at the tip of the tube 12. In this case, desired flexibility can be obtained by changing the pitch of the spiral of the slit 24. In this embodiment, the pitch is narrowed as it approaches the tip, so that the tip becomes more flexible.

The guide wire 31 shown in FIG. 3 is formed by randomly forming holes 34 at the tip of the tube 12. Desired flexibility can be imparted by adjusting the size and arrangement density of the holes 34. In this embodiment, the closer to the tip, the higher the arrangement density of the holes 34, so that the tip becomes more flexible.

The guide wires 11, 21, 31 have a hollow inside the tube 12 and have slits 14, 24, and holes 34 formed at the distal ends thereof. Alternatively, a drug such as a contrast agent can be administered through the inside of these guide wires 11, 21, 31.

[0022]

[Effect of the invention]

 As described above, according to the medical guide wire of the present invention, it is possible to increase the strength at the tip end portion of the wire to prevent breakage and the like, and to give the tip end portion non-directional flexibility. The operability can be improved.

[Submission date] October 21, 1996

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Full text

[Correction method] Change

[Correction contents] [Detailed description of the invention]

[0001]

[Technical field to which the invention belongs]

This invention is, for example a blood vessel, ureter, bile duct, a medical instrument to be inserted into a tubular organ such as the trachea.

[0002]

[Prior art]

 2. Description of the Related Art In recent years, medical guidewires have been used as inspection and treatment instruments for human tubular organs such as blood vessels, ureters, bile ducts, and tracheas. For example, in cardiac catheterization, a guide wire is inserted prior to percutaneous insertion of a catheter to administer a drug such as a contrast agent into a blood vessel.

As the medical guide wire, for example, a wire made of a metal such as stainless steel or a shape memory alloy and having a tapered distal end, or a coil in which a thin wire is closely wound around the distal end of the wire is used. Various types have been proposed, such as a type with a coil attached and a core wire inserted inside the coil.

In these guide wires, the proximal end has a certain degree of rigidity so that the operation at hand extends to the distal end, and the distal end is formed sufficiently flexible so as not to damage the tissue at the time of insertion. That is especially required. For this reason, as described above, the tip of the wire is tapered, the coil is attached to the tip of the wire, or the core wire is inserted into the coil to improve rigidity and tip end on the base side. It is designed to have both flexibility and flexibility.

As one of such guide wires, a guide wire as shown in FIG. 3 has already been proposed. In the figure, reference numeral 41 is a wire body, and a tip portion 41a is formed in a tapered shape. Reference numeral 42 denotes a coil closely wound, the base end portion of which is welded to the tip end portion 41a of the wire body 41, and the tip end portion is melted to form a curved head portion 43. The distal end portion 41a of the wire body 41 is welded to the head portion 43 at its tip end, and has a structure in which a coil 42 is integrally attached to the wire body 41.

FIG. 4 shows another conventional example in which a coil is attached to the tip of a metal wire. In the figure, reference numeral 51 is a metal wire body, and a tip portion 51a is formed in a taper shape. The proximal end of the coil 52 tightly wound and the safety wire 54 disposed inside the coil 52 are welded to the distal end 51a. The tip of the coil 52 is melted to form a curved head 53, and the tip of the safety wire 54 is welded to the head 53.

Further, in US Pat. No. 3,841,308, an end of a coil that is in close contact is formed into an open coil, and the outer periphery of the coil is covered with a thin and flexible synthetic resin tube. the holes provided in the front end of the coil to secure the closure, the distal end of the guidewire inserted into the inner portion of the coil catheter comprising secured to the closure body shown opened. In this catheter, when the occluding body is pulled by the guide wire , the tube is compressed and the hole can be closed.

[0008]

[Problems to be solved by the device]

In the guide wire shown in FIG. 3 , the tip end 41a of the wire body 41 is welded to the coil 42 so that the tip end portion has flexibility, and the tip of the tip end portion 41a of the wire body 41 is attached to the coil 42. It is welded to the head portion 43 of the to regulate the expansion of the coil 42.

However, in the above structure, although the coil 42 has the loop at the base end thereof welded to the peripheral surface of the distal end portion 41a of the wire body 41, the portion 42a where the coil 42 separates from the wire body 41 is It is a single wire. That is, the load applied to the coil 42 is concentrated on one wire of the portion 42 a where the coil 42 is separated from the wire body 41. Further, the tip end portion 41a of the wire main body 41 which is welded to the head portion 43 through the center of the coil 42 is actually very thin, and sufficient strength cannot be obtained against the load applied to the coil 42. Often. Therefore, with this guide wire, there is a risk that the coil 42 may be broken at the portion 42a that separates from the wire body 41 during use.

Further, in the guide wire shown in FIG. 4 , the tip end 51 a of the wire body 51 is not connected to the head 53 of the coil 52, and instead the safety wire 54 is connected to the wire body 51. The extension of the coil 52 is regulated by connecting the tip portion 51a and the head portion 53 of the coil 52.

However, also in this guide wire, the portion 52a where the coil 52 is separated from the wire main body 51 is a single wire, and the load applied to the coil 52 is concentrated in this portion. Further, while the safety wire 54 is generally made of a flat wire, the tip portion 51a of the wire body 51 is tapered, so that the contact area at the welded portion cannot be wide and a sufficient fixing force can be obtained. I can't. Therefore, even in this guide wire, there is a risk that the connecting portion between the wire body 51 and the coil 52 may be broken during use.

Further, catheter shown in U.S. Patent No. 3,841,308, since such that the catheter and guidewire assembly integrally, when you are use in the chemical injection as a catheter, integrally interpolated guide There want occurs a large flow resistance by the wire, may not be injected a sufficient amount of the chemical short time, or a resin tube of the catheter is inflated large supply pressure is added, the tubular organ inner wall intends want are squeezed There was fear.

Further, in the catheter shown in the above-mentioned US Pat. No. 3,841,308, the coil pitch at the tip of the coil covered with the synthetic resin tube is opened to give flexibility, but the coil is closely attached. Since the rigidity suddenly changes at the transition from the wound portion to the loosely wound portion, it is difficult to bend the portion in such a manner that it bends or is unnaturally deformed to be bent into a smooth shape. As a result, by inserting in profundity bear internal tubular organs in the body, passed through a like irregularity or branch points of bending and the inner wall of the tubular organ, it is difficult to guide the affected area to tip without attaching scratch the inner wall It was

Therefore, an object of the present invention is to provide a medical device to be inserted into a tubular organ in which the strength and flexibility of the distal end portion are both satisfied.

[0015]

[Means for Solving the Problems]

To achieve the above object, a first aspect of the present invention, the internal is from the cavity of a metal or resin tubing, slit extending the distal end of the tube in the circumferential direction, is Konzuke Kuhodo the interval to the tip changing the distribution as close formed, thereby it is provided a medical device as the tip-sided among the above end high flexibility is inserted into the tubular organ, wherein the granted is there.

[0016] The second of the present invention, the internal consists cavity of the metal tube, the slits extending in the distal end portion of the tube in the circumferential direction, changes the I Uni distribution proximate its distance closer to the tip it is formed by, thereby a shall provide a medical device high not flexible enough tip-sided among the tip is inserted into the tubular organ, wherein the granted.

Furthermore, a third aspect of the present invention, the internal consists cavity of the metal tube, the distal end portion outer peripheral a helical slit of the tube is formed by narrowing the pitch of the helix closer to the tip, the the width of the helical metal strip formed between the slits so as nearly as narrower closer to the tip, the tubular organ which is characterized that you higher flexibility as from the end among the tip has been applied A medical device to be inserted is provided.

According to a first aspect of the present invention, whole - since the conjugated tubing, rather greens may be formed like folding definitive the tip, the sliding property even better in the tubular organ. Further, the tube is a hollow inside thereof, Runode been said earlier end provided slit bets, the flow path resistance at the time of injection when using the liquid injection applications such as contrast medium small, chemical Can be completed in a short time to reduce the burden on the patient.

Further, the distal end portion of the tube, a slit extending in the circumferential direction is formed by changing the distribution to close the spacing Hodoso approaching the tip, thereby higher tip-sided Among the tip Since flexibility is imparted, it is possible to obtain a change in flexibility such that the flexibility is closer to the distal end and closer to the rigidity of the tube main body as it is further away from the distal end .

[0020] Therefore, to insert deep into the inner tubular organ in the body, passed through a like irregularity or branch points of bending and the inner wall of the tubular organ to tip when guiding to the affected area, pushed by gradually cutting-edge ( the tip portion of the tip) is very flexible, for example guide property to advance along the inner wall while exploring the inner wall as the insect head antennae protruding forward tip is very good good.

[0021] Then, the distal end portion of the immediately following the cutting edge, while supporting flexible state-of-the-art, and later to Hikitsuzuka the following tip that, to confirm the course just a little bit further and then to continue Ku tip towards the front part of the slightly co Upon further reliably supported tip while increasing rigidity, further confirm the path by Hikitsuzuka the tip followed further, that such action is generated continuously in the axial direction Accordingly, to the base portion near the cutting edge among the tip, gradually establish the path while increasing gradually the stiffness can and this lead to the rigidity of the tube body. Conversely, while increasing gradually the flexibility from the base toward even up to the most advanced in the distal portion, cutting-edge can go supple support as the tip of the antennae.

As a result of the above-mentioned action, when the distal end is guided to the affected part by inserting it deeply into the tubular organ in the body and passing through the bending of the tubular organ and the irregularities and branch points of the inner wall, etc. proceed along the inner wall of the tubular organ working as antennae, cutting-edge never wear scratch the inner wall of the tubular organ.

Further, by providing the slits extending in the circumferential direction, it is possible to provide sufficient flexibility with a smaller opening area as compared with the case where the slits are provided in parallel with the longitudinal direction of the tube , and for the same reason. As compared with the case where round holes or square holes are provided , sufficient flexibility can be obtained with a small number of slits.

[0024] According to a second aspect of the present invention, the material of the tube by the limited metal, without tube also an elongated tube in phantom is inflated, as a result, the application of the medicine injection because it can maintain injection pressure to a high pressure during use, to reduce the time required for injection can reduce the burden of patient.

Further, according to the third aspect of the present invention, since the spiral slit can be continuously processed, it is easier to process than a circular hole or a divided slit, and an extremely fine metal tube which is generally difficult to process. It can be easily applied to the case of processing. Even if the slit width is constant, the spiral pitch of the slit is changed to change the width of the metal strip formed between the slits to change the flexibility . Processing becomes even easier.

[0026]

[Embodiment of the invention]

1 and 2 show an embodiment in which the present invention is applied to a medical guide wire that also serves as a catheter . For the sake of convenience, only the tip of the guide wire is shown enlarged in the figure.

These guide wires 11, 21 are entirely made of a metal or resin tube 12, and slits 14, 24 are formed at the tip of this tube to give flexibility, and Is melted to form a curved head portion 13. The material of the metal or resin tube 12 may be any material as long as it does not corrode in the body and has a rigidity that allows insertion into a blood vessel or the like, but stainless steel is preferable as the metal and, for example, fluorine is used as the resin. Resin or the like is preferably used.

[0028] As a method for forming the slits 14, 2 4 to the distal end of the tube 12, for example, a method by etching, a method in accordance with machining is preferably employed. The method according to etching grayed is a resist resin was applied cloth on the entire surface of at least the tip portion of the tube 12, after removing the resist resin portion provided with a slit bets, a method of corrosion by immersing the tip etching grayed solution Etc. are preferably adopted. However, the resist resin may be pattern-printed on the tip of the tube 12 from the beginning, or the resist resin may be applied and then patterned by photoetching. The etching of the tip of the tube 12 may be electrolytic etching or the like. As a method by machining, cutting a desired slit bets, and a method of providing a laser or the like is employed.

The guide wire 11 1, the distal end of the tube 12, perpendicular to the axis of the tube 12, i.e., the slit 14 extending in the circumferential direction, and is formed in Jo Tokoro intervals. The slits 14 are formed along the axial direction of the tube 12 so that the distance between them becomes narrower toward the tip . As a result, the tip nearest Rihodo high flexibility Among the tip is applied.

The guide wire 21 shown in FIG. 2 is formed by forming a slit 24 in a spiral shape at the tip of the tube 12. In this case, by narrowing as rather Konzuke the pitch of the helix of the slit 24 in the tip, narrowing the width of the spiral metallic or synthetic resin strip 25 formed between and if the slit 24, Among tip Higher flexibility is provided toward the tip .

[0031] The guide wire 11, 2 1 is an internal cavity of the tube 12, or One, because the tip portion has a slit 14, 2 4 is formed, these guide wire Ya -11 It is also possible to administer a drug such as a contrast agent through the inside of 21.

[0032]

As has been described above devised], according to the medical device to be inserted into a tubular organ of the present invention, it is possible to prevent breakage or the like to increase the strength at the tip, and even among the tip above closer to the high end flexibility imparted, it is possible to improve the insertion operability during on guide wire or a catheter or the like within the tubular organ of the medical device.

[Brief description of the drawings]

FIG. 1 is a partial perspective view showing an embodiment of a medical guide wire according to the present invention.

FIG. 2 is a partial side view showing another embodiment of the medical guide wire according to the present invention.

FIG. 3 is a partial side view showing still another embodiment of the medical guide wire according to the present invention.

FIG. 4 is a partial cross-sectional view showing an example of a conventional medical guide wire.

FIG. 5 is a partial cross-sectional view showing another example of a conventional medical guide wire.

[Explanation of symbols]

 11, 21, 31 Guide wire 12 Tube 13 Head 14, 24 Slit 34 Hole

────────────────────────────────────────────────── ───

[Procedure amendment]

[Submission date] October 21, 1996

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Full text

[Correction method] Change

[Correction contents]

[Document Name] Statement

[Title of device] Medical device to be inserted into tubular organ

[Utility model registration claims]

[Brief description of the drawings]

FIG. 1 is a partial perspective view showing an embodiment in which the present invention is applied to a medical guide wire that also serves as a catheter.

FIG. 2 is a partial side view showing another embodiment in which the present invention is applied to a medical guide wire that also serves as a catheter.

FIG. 3 is a partial cross-sectional view showing an example of a conventional medical guidewire.

FIG. 4 is a partial cross-sectional view showing another example of a conventional medical guidewire.

[EXPLANATION OF SYMBOLS] 11,2 1 guidewire 12 tube 13 head 14, 24 slit 25 metal or synthetic resin strip

[Procedure amendment 2]

[Document name to be amended] Drawing

[Correction target item name] All figures

[Correction method] Change

[Correction contents]

FIG.

[Fig. 2]

[Figure 3]

FIG. 4

Claims (1)

[Utility model registration claims] 1. A tube made entirely of metal or resin, which is provided with a slit or hole at the tip thereof to impart flexibility, and a curved head portion is formed at the tip. A medical guide wire characterized in that