Kits designed for percutaneous nephrolithotomy surgery

Abstract

A kit designed for percutaneous nephrolithotomy surgery includes a puncture needle, a guidewire, a dilator, a balloon catheter, a sheath, and a drainage catheter. These components are placed in the same package, wherein the tip length of the dilator is substantially the same as the tip length of the balloon catheter. Alternatively, the kit includes a puncture needle, a guidewire, a plurality of dilators of different sizes, a sheath, and a drainage catheter. These components are placed in the same package, wherein the tip lengths of all dilators are substantially the same. This kit is convenient for physicians to use and helps reduce waste and lower costs. Furthermore, the use of this kit can greatly reduce the difficulty of the operation and increase the safety of the operation, thereby improving the reliability of the operation.

Description

Technical Field

[0001] The present disclosure relates to the field of percutaneous nephrolithotomy (PCNL) surgery, and more particularly to a kit designed for percutaneous nephrolithotomy surgery. Background Art

[0002] Percutaneous nephrolithotomy, commonly known as "hole-drilling stone removal," is a highly effective method for removing and crushing kidney stones. Almost all kidney stones can be removed using percutaneous nephrolithotomy. The success rate for renal pelvic stone removal is 96-98%, and for ureteral stone removal, it's 85%.

[0003] For percutaneous nephrolithotomy surgery, there are currently two methods for creating a nephrostomy channel (i.e., a stone removal path) for stone removal. One method uses a dilator to create the channel; the other method uses a balloon catheter to create the channel. Current products, especially balloon products, only include a portion of the required components. Physicians need to purchase several packages to obtain all the necessary components, which is very inconvenient for them. Moreover, this causes waste in two ways. First, the total cost of several individual packages is higher than the cost of a single package. Second, different packages may include the same components or additional (unnecessary) components. These components will not be used during surgery. It is also not allowed to sterilize these components for reuse. Physicians have to discard these components, which also causes waste.

[0004] For example, in the balloon dilation method, physicians must purchase currently available balloon dilation kits and fascia dilation kits in order to perform balloon dilation percutaneous nephrolithotomy surgery. The balloon dilation kit includes a balloon catheter, sheath, two-way valve, and inflation device. The fascia dilation kit includes a puncture needle, guidewire, dilators of different sizes, sheath, and drainage catheter. Only one sheath is required during the balloon dilation channel creation procedure, and under normal circumstances, only one dilator is required. The remaining unused new sheaths and several unused new dilators must be discarded after the procedure.

[0005] Another challenge with existing percutaneous nephrolithotomy is the difficulty physicians face in inserting the dilator / balloon catheter to the correct distance. To create a uniform channel without causing any undesirable damage to the patient, the components must be placed precisely within the tissue. However, ensuring consistent insertion depth is often difficult. Inserting too much can cause undesirable damage, while inserting too little can result in incomplete dilation. This increases the difficulty of the procedure, and even physicians skilled in this surgical procedure can cause additional damage to the patient due to improper technique. Summary of the Invention

[0006] Therefore, the purpose of the present disclosure is to provide a kit designed for percutaneous nephrolithotomy surgery, which includes all necessary components to facilitate physician use and is conducive to reducing waste and lowering costs.

[0007] Another purpose of the present disclosure is that, through this kit, the physician only needs to ensure that the first dilator is inserted into the correct position, and other dilators or balloon catheters can be inserted according to the same insertion depth as the first dilator, which will greatly reduce the difficulty of the operation and increase the safety of the operation, thereby improving the reliability of the operation.

[0008] The present disclosure provides two types of kits designed for percutaneous nephrolithotomy surgery, namely, a balloon catheter expansion method and a dilator expansion method. The kit for percutaneous nephrolithotomy surgery using the balloon catheter expansion method includes a puncture needle, a guidewire, a dilator, a balloon catheter, a sheath, and a drainage catheter, and can be referred to as a balloon catheter expansion kit. The kit for percutaneous nephrolithotomy surgery using the dilator expansion method includes a puncture needle, a guidewire, multiple dilators of different sizes, a sheath, and a drainage catheter, and can be referred to as a fascia expansion kit.

[0009] In any of the above two kits, all the components included therein can be placed in the same package. The package is formed with a plurality of compartments, such as grooves, which can be used to securely place the components to prevent them from colliding with each other and being damaged during transportation.

[0010] For balloon catheter dilation kits, the dilator tip length is substantially the same as the balloon catheter tip length; for fascia dilation kits, all dilators have substantially the same tip length. Here, the dilator tip length refers to the length of the distal cone portion of the dilator, while the balloon catheter tip length refers to the length from the distal tip of the balloon catheter to the shoulder of the distal cone of the balloon catheter.

[0011] By setting the tip lengths to be substantially the same, the aforementioned other problem can be solved, achieving the aforementioned other objective of the present disclosure. The applicant believes that the aforementioned other problem arises because, in existing products, the tips of the dilator and balloon catheter have different lengths, and this tip portion is ineffective in dilating the channel (this portion may be referred to as the ineffective portion). During use, the presence of this tip often leads to inconsistent insertion of the various components.

[0012] Preferably, the tip length may be 0.8 cm to 3 cm, for example, 1.2 cm or 2 cm.

[0013] In either of the above two kits, one or more of the introducer needle, dilator, balloon catheter, sheath, and drainage catheter may be provided with graduated markings.

[0014] In the above-mentioned balloon catheter dilation kit, the size of the sheath tube matches the size of the balloon catheter; the size of the drainage catheter is 2 Fr less than that of the balloon catheter.

[0015] The balloon catheter dilatation kit may further include a drainage bag, a filling device, a stopcock, and / or a fixing device. Preferably, the drainage bag may have a capacity of 500 ml to 3000 ml.

[0016] The size of the balloon catheter dilation kit can be set to 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr, or 32Fr.

[0017] In the above fascia dilation kit, the size of the sheath matches the size of the dilator with the largest size; the size of the drainage catheter is 2 Fr less than the size of the dilator with the largest size.

[0018] The fascia expansion kit may also include a drainage bag and / or a fixing device. The capacity of the drainage bag may be 500ml to 3000ml.

[0019] The size of the fascia expansion kit can be set to 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr, or 32Fr.

[0020] In any of the above two kits, the sheath can be a normal sheath or a tearable sheath.

[0021] Other objects, features and details of the present disclosure will become more fully apparent with reference to the following detailed description of exemplary embodiments taken in conjunction with the accompanying drawings and from the appended claims.

[0022] The advantages of the respective embodiments and various additional embodiments will become apparent to those skilled in the art upon reading the following detailed description of the respective embodiments with reference to the accompanying drawings listed below. Furthermore, the various features of the drawings discussed below are not necessarily drawn to scale. The dimensions of the various features and elements in the drawings may be expanded or reduced to more clearly illustrate the embodiments of the present disclosure. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] The present disclosure is further described below with reference to the accompanying drawings and embodiments, wherein the same reference numerals designate similar or identical elements throughout the drawings and the description thereof.

[0024] Figure 1 1 is an overall schematic diagram of a balloon catheter dilation kit designed for percutaneous nephrolithotomy surgery according to a first embodiment of the present disclosure.

[0025] Figure 2 According to the first embodiment of the present disclosure Figure 1 Schematic diagram of the tip of the balloon catheter and dilator.

[0026] Figure 3 1 is an overall schematic diagram of a fascia expansion kit designed for percutaneous nephrolithotomy surgery according to a second embodiment of the present disclosure.

[0027] Figure 4 According to the second embodiment of the present disclosure Figure 3 Schematic diagram of the tip of the dilator. DETAILED DESCRIPTION

[0028] The various illustrative embodiments of the present disclosure are described below. In this specification, for the sake of explanation only, various systems, structures and devices are schematically depicted in the accompanying drawings, but not all features of the actual systems, structures and devices are described, such as well-known functions or structures are not described in detail to avoid unnecessary details that make the present disclosure unclear. It should be understood that in any actual application, many specific implementation decisions need to be made to achieve the specific goals of the developer or user, and system-related and industry-related restrictions need to be followed, and these specific goals may vary from one actual application to another. In addition, it should be understood that such specific implementation decisions, although complex and time-consuming, are routine tasks for those of ordinary skill in the art who benefit from this application.

[0029] The terms and phrases used herein should be understood and interpreted as having a meaning consistent with the understanding of those terms and phrases by those skilled in the relevant art. No special definition of a term or phrase, i.e., a definition that is different from the ordinary and customary meaning as understood by those skilled in the art, is intended to be implied by consistent usage of a term or phrase herein. For terms or phrases that are intended to have a special meaning, i.e., a meaning that is different from that understood by those skilled in the art, such special definition will be explicitly set forth in the specification as a definition, directly and unambiguously giving the special definition of the term or phrase.

[0030] Throughout the following description and claims, unless the content requires otherwise, the word "include" and variations such as "comprises" are to be interpreted in an open, inclusive sense, that is, as in "including but not limited to."

[0031] In this disclosure, the terms "first," "second," etc., are used for descriptive purposes only and should not be understood to indicate or imply relative importance or implicitly specify the number of the technical features indicated. Thus, a feature defined as "first," "second," etc. may explicitly or implicitly include one or more of the features. In the description of this disclosure, "plurality" means two or more, unless otherwise specifically defined.

[0032] In this disclosure, unless otherwise expressly specified or limited, terms such as "mounted," "connected," "coupled," "connected," and "fixed" should be understood broadly. For example, they may refer to fixed, detachable, or integral connections; mechanical or electrical connections; direct or indirect connections through an intermediary; and internal communication between two components. Those skilled in the art will understand the specific meanings of these terms in this disclosure based on specific circumstances.

[0033] In the present disclosure, for the convenience of description, an operator (eg, a physician) is used as a reference object, and the side close to the operator is referred to as the “proximal side” and the side away from the operator is referred to as the “distal side”.

[0034] First embodiment

[0035] The balloon catheter dilation kit 1 provided for percutaneous nephrolithotomy surgery according to the first embodiment of the present disclosure is shown in FIG. Figure 1 shown.

[0036] The balloon catheter dilation kit 1 is composed of the following components:

[0037] a) an 18G puncture needle 11;

[0038] b) a 0.035″ or 0.038″ guide wire 12;

[0039] c) an 8Fr dilator or a 10Fr dilator (only the 8Fr dilator 13 is shown in the figure);

[0040] d) a balloon catheter 14 of the same size as the set of the kit;

[0041] e) a sheath 15 that can match the size of the balloon catheter 14;

[0042] f) a drainage catheter 16 , which is 2 Fr smaller than the size of the balloon catheter 14 ;

[0043] g) a drainage bag 17, the capacity of which may be 500ml to 3000ml;

[0044] h) a filling device 18;

[0045] i) a stopcock 19; and

[0046] j) A fixing device 10.

[0047] The set size of the balloon catheter dilation kit 1 can include 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr, or 32Fr. The set size is the inner diameter size of the desired final nephrostomy channel (i.e., stone removal path). The specifications or nominal sizes of the balloon catheter 14 are the same. For example, Figure 1 As shown, the set size of the balloon catheter dilation kit 1 can be 24Fr, which can be called a 24Fr balloon catheter dilation kit. In the 24Fr balloon catheter dilation kit, the specification or nominal size of the balloon catheter 14 is 24Fr, the size of the sheath 15 is 24Fr, and the size of the drainage catheter 16 is 22Fr; and the dilator can be selected to be 8Fr (such as Figure 1 Physicians can choose to use balloon catheter dilation kits of various sizes based on patient needs, symptoms, and other conditions.

[0048] The kit may include all or some of the above components.

[0049] The components included in the kit can be placed in a package having a plurality of compartments, such as grooves, formed therein for securely placing the components to prevent them from colliding with each other and being damaged during handling.

[0050] Preferably, except for the stopcock and the fixing device, all other components can be provided with scale marks to facilitate the physician to keep track of the usage of the components at any time during use, such as insertion depth, filled volume, filling pressure, etc.

[0051] The sheath can be a common sheath or a tearable sheath.

[0052] In particular, in the balloon catheter dilation kit 1, the tip length L of the dilator 13 is substantially the same as the tip length L' of the distal end of the balloon catheter 14. Figure 2 As shown, the tip length of the dilator refers to the length of the distal tapered portion of the dilator, and the tip length of the balloon catheter refers to the length from the distal tip of the balloon catheter to the shoulder of the distal tapered portion of the balloon catheter. The tip lengths L and L' can range from 0.8 cm to 3 cm, for example, 1.2 cm. The difference between the tip length L of the dilator and the tip length L' of the balloon catheter is less than 4 mm, and they can be considered to be substantially the same length.

[0053] During surgery, the physician can use X-ray and / or ultrasound fluoroscopy to guide the insertion of the puncture needle 11. After the puncture needle is in place, the physician can record its insertion depth. Then, with the guidance of the guide wire 12 and the assistance of graduated markings, an 8Fr dilator 13 or a 10Fr dilator, for example, is inserted to a depth equal to the puncture needle insertion depth plus the tip length (for example, the tip length is 1.2 cm). The insertion depth of the balloon catheter 14 subsequently inserted is the same as the insertion depth of the dilator 13.

[0054] This kit solves the aforementioned technical problems existing in the prior art. Specifically, physicians no longer need to purchase multiple packages to obtain all necessary components. Instead, they only need to purchase one kit to ensure they have all the necessary components, which is very convenient for physicians. Furthermore, all components in the kit are required during surgery, eliminating waste.

[0055] Furthermore, the tips of the dilator and balloon catheter in the kit of the present disclosure are designed to be substantially the same length, making it easy for the physician to insert the balloon catheter to the correct distance during use. This significantly reduces surgical difficulty, avoids unwanted damage to the patient, and ensures the reliability and safety of the procedure.

[0056] Second embodiment

[0057] According to the second embodiment of the present disclosure, a fascia expansion kit 2 designed for percutaneous nephrolithotomy surgery is provided. Figure 3 shown.

[0058] The fascia expansion kit 2 is composed of the following components:

[0059] a) an 18G puncture needle 21;

[0060] b) a 0.035″ or 0.038″ guide wire 22;

[0061] c) a plurality of dilators 23a to 23f of different sizes, the number and size of the dilators depending on the set size of the kit;

[0062] d) a tearable sheath 25 sized to match the largest dilator 23 f;

[0063] e) a drainage catheter 26, the size of which is 2Fr less than the largest size of the dilator 23f;

[0064] f) a drainage bag 27, which may have a capacity of 500ml to 3000ml; and

[0065] g) A fixing device 20.

[0066] The set size of the fascia expansion kit 2 can include 8Fr, 10Fr, 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr, or 32Fr. The set size is the inner diameter of the desired final nephrostomy passage (i.e., stone removal path). The size of the largest dilator 13f is the same as the set size. For example, Figure 3 As shown, the set size of the fascia expansion kit 2 can be 18Fr, which can be called an 18Fr fascia expansion kit. In this case, the size of the largest dilator 13f is 18Fr, the size of the sheath 25 is 18Fr, and the size of the drainage catheter 26 is 16Fr; the sizes of the other dilators 23a to 23e are 8Fr, 10Fr, 12Fr, 14Fr, and 16Fr (in Figure 3 In the illustrated embodiment, there are six dilators, of which the largest dilator 23f is sheathed together with the sheath 25. A physician may choose to use fascia dilator kits of various sizes depending on the patient, condition, and other circumstances.

[0067] A kit may include all or some of the above components.

[0068] As with the first embodiment, the components of the kit according to the second embodiment can be placed in a package having a plurality of compartments, such as grooves, formed therein for stably placing the components to prevent them from colliding with each other and being damaged during transportation.

[0069] Preferably, except for the guide wire and the fixing device, all other components can be provided with scale marks to facilitate the physician to grasp the usage status of the components at any time during use, such as insertion depth, filled volume, filling pressure, etc.

[0070] In this embodiment, the sheath is shown as a tearable sheath. Of course, a common sheath that cannot be torn can also be used.

[0071] In particular, in the fascia dilation kit, the tip lengths L of all dilators 23a to 23f are substantially the same, such as Figure 4 As shown in FIG. Here, the tip length L of the dilator refers to the length of the distal cone portion of the dilator. The tip length L can be 0.8 cm to 3 cm, for example, 2 cm. The difference in tip length between different dilators is less than 4 mm and can be considered to be substantially the same tip length.

[0072] During the procedure, the physician can use X-ray and / or ultrasound fluoroscopy to guide the insertion of puncture needle 21. After puncture needle 23 is positioned, the physician can record its insertion depth. Using guidewire 22 and graduated markings as a guide, dilators 23a through 23f are inserted sequentially, from small to large, to a depth equal to the insertion depth of puncture needle 23 plus the tip length (e.g., a tip length of 2 cm).

[0073] Like the first embodiment, the kit according to the second embodiment solves the aforementioned technical problems existing in the prior art and achieves beneficial technical effects, which will not be described in detail here.

[0074] The present disclosure may include any feature or feature combination or generalization disclosed herein, whether implicit or explicit, and is not limited to the scope of any limitation listed above. Any elements, features and / or structural arrangements described herein may be combined in any suitable manner.

[0075] The particular embodiments disclosed above are exemplary only, and it will be apparent to those skilled in the art having the benefit of the teachings herein that the present disclosure may be modified and practiced in different but equivalent manners. For example, the method steps described above may be performed in a different order. Furthermore, no limitations are intended to the details of construction or design shown herein except as described in the claims below. It is therefore apparent that changes and modifications may be made to the specific embodiments disclosed above, and all such variations are considered to fall within the scope and spirit of the present disclosure. The protection sought herein is therefore set forth in the claims appended hereto.

Claims

1. A kit designed for percutaneous nephrolithotomy surgery, comprising a puncture needle, a guide wire, a dilator, a balloon catheter, a sheath, and a drainage catheter, wherein these components are placed in the same package, The dilator has a distal cone portion located at the distal end of the dilator, and the balloon catheter has a distal tip and a distal cone located at the distal end of the balloon catheter, wherein the tip length of the dilator is the same as the tip length of the balloon catheter, wherein the "tip length of the dilator" refers to the length of the distal cone portion of the dilator, and the "tip length of the balloon catheter" refers to the length of the portion from the distal tip of the balloon catheter to the shoulder of the distal cone of the balloon catheter.

2. The kit according to claim 1, wherein The tip length is 0.8 cm to 3 cm.

3. The kit according to claim 2, wherein: The tip length is 1.2 cm.

4. The kit according to claim 1, wherein: A plurality of compartments are formed in the package.

5. The kit according to claim 1, wherein: One or more of the puncture needle, guide wire, dilator, balloon catheter, sheath and drainage catheter are provided with scale marks.

6. The kit according to claim 1, wherein: The size of the sheath matches the size of the balloon catheter.

7. The kit according to claim 1, wherein: The sheath tube of the kit is a tearable sheath tube.

8. The kit according to claim 1, wherein: The size of the drainage catheter is 2 Fr smaller than that of the balloon catheter.

9. The kit according to claim 1, wherein: The kit may further include one or more of the following components: a drainage bag, an inflation device, a stopcock, and a fixation device.

10. The kit of claim 1, wherein: The kit further comprises a drainage bag, and the capacity of the drainage bag is 500 ml to 3000 ml.

11. The kit of claim 1, wherein: The size of the kit is set to 12Fr, 14Fr, 16Fr, 18Fr, 20Fr, 22Fr, 24Fr, 26Fr, 28Fr, 30Fr, or 32Fr.

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