A percutaneous nephrolithotomy dilation guidewire and its application method

Abstract

This invention discloses a percutaneous nephrolithotomy (PCNL) dilation guidewire and its usage method. The PCNL dilation guidewire comprises a rigid tube, a semi-rigid pre-bent section, and a soft section connected in sequence. The rigid tube is a hollow tube. The end of the soft section not connected to the semi-rigid pre-bent section enters from the end of the rigid tube connected to the semi-rigid pre-bent section and exits from the other end of the rigid tube. The semi-rigid pre-bent section is connected to the sidewall of the rigid tube and extends along the axial direction of the rigid tube. The semi-rigid pre-bent section bends towards the soft section in its natural state. Under the traction of the free end of the soft section, the semi-rigid pre-bent section can bend to form a resistance ring, making its projected length in the radial direction of the rigid tube greater than a set value. The dilation guidewire of this invention has a closed-loop structure at its tip, which can prevent the dilation sheath from dilating too deeply, thereby avoiding damage to the contralateral renal calyx mucosa and renal tissue.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a percutaneous nephrolithotomy dilation guidewire and its method of use. Background Technology

[0002] The information disclosed in the background section of this invention is intended only to enhance the understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] During percutaneous nephrolithotomy, the target renal calyx is punctured with a trocar under ultrasound or X-ray guidance. The puncture needle core is removed, and a dilator guidewire is placed through the trocar. The trocar is then removed, and dilators of different diameters are used to dilate along the guidewire to establish a satisfactory operating channel.

[0004] Commonly used percutaneous nephrolithotomy (PCNL) dilation guidewires include zebra guidewires and "J"-shaped guidewires. Zebra guidewires are thin at the tip and gradually thicken towards the posterior end. During the procedure, the zebra guidewire is inserted into the target renal calyx along the puncture cannula. To prevent dislodgement, it is generally coiled within the calyx for 10-15 cm. This curvature helps prevent damage to the contralateral renal calyx mucosa and renal tissue from the dilation sheath. The "J"-shaped guidewire is a soft, curved guidewire at the tip and rigid in the remainder. During the procedure, the curved tip is first straightened and inserted into the calyx through the puncture cannula. To prevent dislodgement, the curved tip is generally placed entirely within the target calyx. Zebra and "J"-shaped guidewires share three common characteristics: ① The tip is soft, avoiding damage to the contralateral renal calyx mucosa and renal tissue; ② The guidewire length is greater than the puncture needle length, preventing dislodgement; ③ The guidewire is coiled within the calyx, forming a curve to prevent damage to the contralateral renal calyx mucosa and renal tissue from the dilation sheath during dilation.

[0005] In clinical use, zebra guidewires and "J"-shaped guidewires have the following drawbacks: ① Edema of the renal calyx mucosa, rough handling, and excessive guidewire placement within the renal calyx can directly damage the renal calyx mucosa and renal tissue, leading to bleeding and urinary extravasation. In severe cases, the dilating sheath may penetrate the contralateral renal tissue during dilation along the guidewire. ② The use of dilating sheaths of different diameters along the guidewire can easily cause guidewire displacement or even loss of the puncture channel. ③ Even when the guidewire is coiled within the renal calyx, slight deviations in the dilation direction accompanied by excessive dilation depth during dilation with the dilating sheath may result in excessive bending of the guidewire, causing damage to the contralateral renal calyx mucosa and renal tissue along with the dilating sheath. Currently, there is no dilating guidewire in the technology that can solve these problems. Summary of the Invention

[0006] In view of this, the present invention provides a percutaneous nephrolithotomy dilator guidewire and its method of use, which solves the problems of easy loss of puncture channel and damage to contralateral renal calyx mucosa and renal tissue by the dilator sheath along with the dilator guidewire during operation.

[0007] In a first aspect, the present invention provides a percutaneous nephrolithotomy dilation guidewire, comprising a rigid tube, a semi-rigid pre-bent section, and a soft section connected in sequence.

[0008] The rigid tube is a hollow tube body; the diameter of the soft section is smaller than the inner diameter of the rigid tube; the end of the soft section that is not connected to the semi-rigid pre-bent section enters from the end of the rigid tube that is connected to the semi-rigid pre-bent section and exits from the other end of the rigid tube.

[0009] The semi-rigid pre-bent section is connected to the side wall of the hardened tube and extends along the axial direction of the hardened tube. The semi-rigid pre-bent section bends toward the soft section in its natural state. Under the traction of the free end of the soft section, the semi-rigid pre-bent section can bend to form a resistance ring, so that its projected length in the radial direction of the hardened tube is greater than a set value.

[0010] Preferably, the soft section is provided with a scale to indirectly determine the bending condition of the semi-rigid pre-bending section.

[0011] Preferably, it also includes a fixing clip, which is disposed at the end of the hardened tube away from the semi-hardened pre-bent section, to prevent relative movement between the hardened tube and the soft section.

[0012] Preferably, the length of the soft section is at least 5 cm longer than the sum of the lengths of the hard tube and the semi-hard pre-bent section.

[0013] Furthermore, the length of the rigid tube is 50-70cm, the length of the semi-rigid pre-bent section is 1-2cm, and the length of the soft section is 80-100cm.

[0014] Furthermore, the semi-rigid pre-bending section includes an arc-shaped section and a bent section, the bent section being connected to the soft section, and the length of the bent section being 2-4 mm.

[0015] Preferably, the projected length of the resistance ring of the semi-rigid pre-bent section in the radial direction of the rigid tube is greater than 3 mm, and more preferably 4-6 mm.

[0016] Preferably, the outer diameter of the rigid tube is 0.5-1 mm and the inner diameter is 0.3-0.6 mm; the diameter of the soft section is 0.1-0.3 mm.

[0017] Preferably, the diameter of the semi-rigid pre-bent section gradually tapers in the direction from the hard tube to the soft tube; the minimum diameter of the semi-rigid pre-bent section is the same as the diameter of the soft tube.

[0018] Secondly, the present invention provides a method for using the above-mentioned percutaneous nephrolithotomy dilation guidewire, comprising the following steps:

[0019] The semi-rigid pre-bent section of the dilating guidewire is straightened by external force, placed along the puncture cannula, the rigid tube is fixed, and the puncture cannula is removed.

[0020] Insert the fascia expander or balloon expander along the skin incision into the expansion guidewire to the connection between the rigid tube and the semi-rigid pre-bent segment. Pull the soft segment until the semi-rigid pre-bent segment forms the corresponding mark of the resistance ring, and fix the soft segment.

[0021] Apply a fascia dilator or balloon dilator along the dilation guidewire to form an expansion channel. When the fascia dilator or balloon dilator touches the resistance ring formed by the semi-rigid pre-bent section and is blocked, remove the fascia dilator or balloon dilator.

[0022] After the expansion channel is completed, the soft section is released from fixation, thereby releasing the resistance ring formed by the semi-rigid pre-bent section, and then the expansion guidewire is withdrawn.

[0023] As can be seen from the above technical solution, the present invention has achieved the following beneficial effects:

[0024] (1) The front end of the dilation guidewire of the present invention has a closed-loop structure, which will not damage the contralateral renal calyx mucosa and renal tissue even if the operation is rough or the insertion is too deep. At the same time, it can effectively prevent the guidewire from falling out and avoid losing the puncture channel.

[0025] (2) When using a fascia dilator or balloon dilator for dilation, the dilator will encounter resistance that is difficult to overcome when it encounters the resistance ring at the front end of the dilation guidewire, thus avoiding excessive dilation of the dilation sheath and thus avoiding damage to the contralateral renal calyx mucosa and renal tissue. Attached Figure Description

[0026] The accompanying drawings, which form part of this specification, are used to provide a further understanding of the invention. The illustrative embodiments and descriptions of the invention are used to explain the invention and do not constitute an undue limitation thereof. Obviously, those skilled in the art can obtain other drawings based on these drawings without any inventive effort.

[0027] Figure 1 This is a schematic diagram of the percutaneous nephrolithotomy dilation guidewire of the present invention in its free state;

[0028] Figure 2 This is a schematic diagram of the percutaneous nephrolithotomy dilation guidewire under external force straightening according to the present invention;

[0029] Figure 3 This is a schematic diagram of another embodiment of the percutaneous nephrolithotomy dilation guidewire of the present invention in its free state;

[0030] Figure 4 This is a schematic diagram of the formation of a resistance loop using a percutaneous nephrolithotomy guidewire according to the present invention;

[0031] In the diagram, 1 is the rigid tube; 2 is the semi-rigid pre-bent section; 3 is the soft section; 4 is the fixing clamp; 5 is the resistance ring; 6 is the arc section; and 7 is the bent section. Detailed Implementation

[0032] It should be noted that the following detailed descriptions are exemplary and intended to provide further illustration of the invention. Unless otherwise specified, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains.

[0033] This invention addresses the risks associated with commonly used zebra guidewires and "J"-shaped guidewires in percutaneous nephrolithotomy, such as damage to the renal calyx mucosa and renal tissue, and loss of puncture channels during the procedure. It provides a percutaneous nephrolithotomy dilation guidewire. Please refer to [reference needed]. Figures 1 to 4 It should be noted that the present invention Figures 1-4 For illustrative purposes only.

[0034] In one specific embodiment, the present invention provides a percutaneous nephrolithotomy dilation guidewire, comprising a rigid tube 1, a semi-rigid pre-bent section 2, and a soft section 3 connected in sequence.

[0035] The rigid tube 1 is a hollow tube; the diameter of the soft section 3 is smaller than the inner diameter of the rigid tube 1; the end of the soft section 3 that is not connected to the semi-rigid pre-bent section 2 enters from the end of the rigid tube 1 that is connected to the semi-rigid pre-bent section 2 and exits from the other end of the rigid tube 1.

[0036] The semi-rigid pre-bent section 2 is connected to the sidewall of the rigid tube 1 and extends along the axial direction of the rigid tube 1. In its natural state, the semi-rigid pre-bent section 2 bends towards the soft section 3, as shown below. Figure 1 As shown; under the traction of the free end of the soft section 3, the semi-rigid pre-bent section 2 can bend to form a resistance ring 5, making its projected length in the radial direction of the hardened tube 1 greater than a set value, such as... Figure 4 As shown.

[0037] The semi-rigid pre-bent section 2 of this invention can straighten under external force to ensure that the dilating guidewire can be smoothly inserted into the puncture cannula, such as... Figure 2 As shown.

[0038] The present invention has a scale on the soft segment 3 to indirectly determine the bending condition of the semi-hard pre-bending segment 2. When the semi-hard pre-bending segment 2 bends to form the resistance ring 5, there are specific marks on the scale to facilitate the fixing of the soft segment 3.

[0039] The present invention also includes a fixing clip 4, which is disposed at the end of the rigid tube 1 away from the semi-rigid pre-bent section 2 to prevent relative movement between the rigid tube 1 and the soft section 3. The present invention does not impose any special limitations on the structure of the fixing clip 4; a commonly used fixing clip structure in the art can be adopted. The fixing clip 4 can be detachable or fixed to the rigid tube 1, as long as it can effectively prevent relative movement between the rigid tube 1 and the soft section 3. When the fixing clip 4 is fixed to the rigid tube 1, its projection in the radial direction of the rigid tube 1 must be smaller than the inner diameter of the tip of the fascia dilator or balloon dilator, so that the fascia dilator or balloon dilator can smoothly insert the dilation guidewire to the connection point between the rigid tube 1 and the semi-rigid pre-bent section 2.

[0040] The length of the soft segment 3 in this invention is at least 5 cm longer than the sum of the lengths of the rigid tube 1 and the semi-rigid pre-bent segment 2. This is to ensure that the soft segment 3 can smoothly pass through the rigid tube 1. The length of the rigid tube 1 of the dilating guidewire in this invention is 50-70 cm, the length of the semi-rigid pre-bent segment 2 is 1-2 cm, and the length of the soft segment 3 is 80-100 cm.

[0041] In another specific embodiment of the present invention, the semi-rigid pre-bent section 2 includes an arc-shaped section 6 and a bent section 7, wherein the bent section 7 is connected to the soft section 3, and the length of the bent section 7 is 2-4 mm. Figure 3 As shown. The bent section 7 bends toward the soft section 3, and the angle between it and the arc-shaped section 6 is 60° to 120°. The existence of the bent section 7 is to provide the torque when the semi-rigid pre-bent section 2 is pulled to form the resistance ring 5, thereby making it easier to form the resistance ring 5.

[0042] In this invention, the projected length of the resistance ring 5 in the semi-rigid pre-bent section 2 in the radial direction of the rigid tube 1 is greater than 3 mm, preferably 4-6 mm. This is to ensure that the projected length of the resistance ring 5 in the radial direction of the rigid tube 1 is greater than the inner diameter of the tip of the fascia dilator or balloon dilator, so that the dilator encounters a strong resistance when it meets the resistance ring 5 at the tip of the dilating guidewire, avoiding excessive dilation of the dilating sheath and thus preventing damage to the contralateral renal calyx mucosa and renal tissue. In addition, the resistance ring 5 formed by the semi-rigid pre-bent section 2 is a closed loop, so even if the operation is rough or the insertion is too deep, it will not damage the contralateral renal calyx mucosa and renal tissue. Since the traction end is at the free end of the soft section 3, guidewire dislodgement can be effectively avoided, thereby preventing loss of the puncture channel.

[0043] The outer diameter of the rigid tube 1 of this invention is 0.5-1 mm, and the inner diameter is 0.3-0.6 mm; the diameter of the soft section 3 is 0.1-0.3 mm. When the soft section 3 is inserted into the rigid tube 1, the edge of the rigid tube 1 is set as an arc surface to reduce the friction between the soft section 3 and the rigid tube 1.

[0044] The diameter of the semi-rigid pre-bent section 2 of the present invention gradually tapers in the direction from the rigid tube 1 to the soft section 3; its minimum diameter is the same as that of the soft section 3, ensuring the reliable connection between the semi-rigid pre-bent section 2 and the soft section 31.

[0045] In another specific embodiment of the present invention, a method for using the above-mentioned percutaneous nephrolithotomy dilation guidewire is provided, comprising the following steps:

[0046] The semi-rigid pre-bent section 2 of the dilation guidewire is straightened by external force, placed along the puncture cannula, the rigid tube 1 is fixed, and the puncture cannula is removed.

[0047] Insert the fascia expander or balloon expander along the skin incision into the expansion guidewire to the connection between the rigid tube 1 and the semi-rigid pre-bent section 2, pull the soft section 3 until the semi-rigid pre-bent section 2 is at the corresponding scale of the resistance ring 5, and fix the soft section 3.

[0048] A fascia dilator or balloon dilator is used to form an expansion channel along the expansion guidewire. The fascia dilator or balloon dilator is blocked when it touches the resistance ring 5 formed by the semi-rigid pre-bent section 2. The fascia dilator or balloon dilator is then withdrawn.

[0049] After the expansion channel is completed, the soft section 3 is released from fixation, thereby releasing the resistance ring 5 formed by the semi-hard pre-bent section 2, and then the expansion guide wire is withdrawn.

[0050] The above description is merely a preferred embodiment of the present invention and is not intended to limit the invention. Various modifications and variations can be made to the present invention by those skilled in the art. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the scope of protection of the present invention.

Claims

1. A percutaneous nephrolithotomy dilation guidewire, characterized in that, It includes a rigid tube, a semi-rigid pre-bent section and a soft section connected in sequence; it also includes a fixing clamp, which is disposed at the end of the rigid tube away from the semi-rigid pre-bent section; The rigid tube is a hollow tube body; the diameter of the soft section is smaller than the inner diameter of the rigid tube; the end of the soft section that is not connected to the semi-rigid pre-bent section enters from the end of the rigid tube that is connected to the semi-rigid pre-bent section and exits from the other end of the rigid tube. The semi-rigid pre-bent section is connected to the side wall of the hardened tube and extends along the axial direction of the hardened tube. The semi-rigid pre-bent section bends toward the soft section in its natural state. Under the traction of the free end of the soft section, the semi-rigid pre-bent section can bend to form a resistance ring, so that its projected length in the radial direction of the hardened tube is greater than 3mm. The diameter of the semi-rigid pre-bent section gradually tapers from the hard tube toward the end where the soft tube connects to the semi-rigid pre-bent section; the minimum diameter of the semi-rigid pre-bent section is the same as the diameter of the soft tube.

2. The percutaneous nephrolithotomy dilation guidewire as described in claim 1, characterized in that, The soft segment is marked with graduations.

3. The percutaneous nephrolithotomy dilation guidewire as described in claim 1, characterized in that, The length of the soft section is at least 5 cm longer than the sum of the lengths of the hard tube and the semi-hard pre-bent section.

4. The percutaneous nephrolithotomy dilation guidewire as described in claim 3, characterized in that, The length of the rigid tube is 50-70cm, the length of the semi-rigid pre-bent section is 1-2cm, and the length of the soft section is 80-100cm.

5. The percutaneous nephrolithotomy dilation guidewire as described in claim 4, characterized in that, The semi-rigid pre-bending section includes an arc-shaped section and a bending section. The bending section is connected to the soft section, and the length of the bending section is 2-4 mm.

6. The percutaneous nephrolithotomy dilation guidewire as described in claim 1, characterized in that, The outer diameter of the hard tube is 0.5-1 mm, and the inner diameter is 0.3-0.6 mm; the diameter of the soft section is 0.1-0.3 mm.

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