Prostate balloon and forming mold thereof

Abstract

The invention relates to the technical field of medical instruments, and particularly discloses a prostate balloon and a forming mold thereof. Through the calabash-shaped double-expansion-section structure, effective expansion of hyperplasia parts is achieved on the prostate balloon, expansion force distribution better conforms to anatomical pathology, and the prostate balloon is particularly suitable for mainstream bilateral lobe hyperplasia types. Due to the introduction of the axial contraction section, a'low-pressure area 'or a'pressure buffer zone' is created structurally, damage to the urethral ridge is actively avoided, the treatment safety is greatly improved, and the clinical pain point which cannot be avoided by a traditional balloon is solved. The problems of size fluctuation and uneven wall thickness in the forming process of the gourd-shaped balloon are effectively solved through the positioning and heat insulation design of the special mold. By adopting the structural combination of the high-thermal-conductivity metal die head and the low-thermal-conductivity PEEK die head sleeve, the thermal field distribution in the forming process is stabilized.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a prostate balloon and its molding die. Background Technology

[0002] Benign prostatic hyperplasia (BPH) often presents as symmetrical or asymmetrical enlargement of the left and right lobes, causing the urethra to be compressed into a "dumbbell" shape in this area. In the middle of the urethra, there is an important anatomical landmark and sensitive area—the verumontanum (urethral crest). Using a cylindrical or unilaterally enlarged balloon for dilation results in a uniform, ring-shaped pressure distribution, which has significant drawbacks: firstly, for patients with asymmetrical enlargement, the uniform pressure distribution may lead to uneven dilation; secondly, it applies the same ring-shaped pressure to the urethral crest region as to the lateral lobes, potentially causing unnecessary compression, irritation, or even damage.

[0003] The current technology lacks a balloon specifically designed for the anatomical characteristics of bilateral prostatic hyperplasia, as well as a mold capable of stably shaping such a balloon. This limits the improvement of the safety and efficiency of minimally invasive prostate treatment. An ideal device should be able to apply independent, balanced, and controllable expansion forces to both lobes, while avoiding or reducing pressure on the mid-urethral ridge. This is a function that a single-lumen, uniformly expanding balloon cannot achieve. Summary of the Invention

[0004] Therefore, the purpose of this invention is to provide a prostate balloon and its molding mold to overcome the shortcomings of existing prostate dilation balloons, which, although capable of independently and evenly dilating the hyperplastic area, cannot effectively protect the urethral crest region.

[0005] To achieve the above objectives, the present invention provides the following technical solution: In a first aspect, the present invention provides a prostate balloon, which is a single-cavity structure integrally blow-molded. When inflated, it is a gourd-shaped balloon, which is composed of a distal enlarged segment and a proximal enlarged segment connected by a narrowing segment.

[0006] The distal and proximal enlarged segments are configured to align with and expand the prostatic urethral hyperplasia area, respectively; the narrowing segment is adapted to the urethral crest area, and its diameter is significantly smaller than that of the distal and proximal enlarged segments.

[0007] The gourd-shaped double dilatation segments precisely correspond to the left and right lobe regions of the prostatic urethra, respectively. Upon filling, these two dilatation segments simultaneously and evenly apply radial expansion forces to the bilateral hyperplastic tissues. The position and size of the axial contraction segment are precisely designed to fit the urethral crest (colon) region in the middle of the urethra. This segment has a significantly smaller diameter than the dilatation segments; its function is not expansion, but rather "bridging" and "pressure buffering." Physically, it connects the two dilatation segments; functionally, it prevents the expansion pressures acting on the two segments from superimposing in this region, thus significantly reducing or even avoiding excessive compression and damage to the sensitive urethral crest, achieving active protection of key anatomical structures.

[0008] Based on the above technical solution, further, the distal enlarged segment and the proximal enlarged segment have the same diameter, ranging from 15mm to 35mm; the diameter of the reduced-diameter segment is 30% to 60% smaller than the diameter of the distal enlarged segment.

[0009] For diameters of the same type, a tolerance of ±10% is allowed.

[0010] The minimum diameter of the constricted segment is 30% to 60% smaller than the diameter of the distal enlarged segment to accommodate anatomical differences among patients.

[0011] Based on the above technical solution, the axial length of the reduced diameter section is further 5mm to 15mm.

[0012] The diameter of the narrowed section is 30% to 60% smaller than that of the distal expanded section, and the axial length of the narrowed section is 5 mm to 15 mm, in order to form a clear "pressure isolation zone".

[0013] Based on the above technical solution, the gourd-shaped balloon is further made of one or a mixture of two of TPU, PU, ​​and PA.

[0014] Secondly, the present invention provides a molding die for a prostate balloon, comprising a distal mold head sleeve, a mold cavity, a proximal mold head, and a proximal mold head sleeve connected in sequence, wherein a tubular channel connects the distal mold head sleeve, the mold cavity, the proximal mold head, and the proximal mold head sleeve.

[0015] Based on the above technical solution, the mold cavity is further formed by the mating of two gourd-shaped half-molds with their inner surfaces. The proximal end of the mold cavity can be inserted into the proximal mold head, so that the two half-molds fit together precisely without producing obvious gaps, thus avoiding deformation and performance degradation of the formed balloon.

[0016] Based on the above technical solution, the outer wall of the far end of the mold cavity is further provided with an annular positioning and fixing step that cooperates with the external heating device.

[0017] The external heating device is a heating water jacket. The annular positioning and fixing step precisely engages with the corresponding structure of the heating water jacket. Through this structure, the mold is mechanically locked axially after installation, fundamentally preventing any displacement of the mold cavity during operation and ensuring the absolute stability and repeatability of the molding position.

[0018] Based on the above technical solution, the distal mold head sleeve and the proximal mold head sleeve are made of high-temperature resistant and heat-insulating polyetheretherketone; the mold cavity and the proximal mold head are made of beryllium copper, a metal with high thermal conductivity.

[0019] Based on the above technical solution, the height of the fixed step is further 0.05mm to 1.0mm.

[0020] The proximal mold head and the distal mold head are respectively installed at both ends of the mold cavity in the axial direction to seal the cavity port and provide an air inflation channel.

[0021] The die head is fitted onto the outside of the proximal and distal die heads. Another key structural feature of this invention lies in the differentiated combination of materials: the die head is made of polyetheretherketone (PEEK), a polymer material with low thermal conductivity; while the proximal and distal die heads are made of metallic materials (such as beryllium copper or aluminum alloys) with significantly higher thermal conductivity than PEEK.

[0022] The high thermal conductivity metal die head ensures that heat is quickly and evenly transferred to the junction between the die head and the die cavity; while the low thermal conductivity PEEK die head sleeve acts as a highly efficient heat insulation device, encasing the outside of the die head and greatly preventing heat loss from the die head area to the outside. The thermal conductivity of PEEK is approximately between 0.25 and 0.35 W / m·K, far lower than that of metal materials such as aluminum or copper. This structure more effectively confines heat to the forming cavity area, resulting in a more uniform temperature distribution along the axial direction throughout the entire gourd forming cavity.

[0023] The height of the annular positioning step is between 0.05 mm and 1.0 mm. This height range provides reliable positioning strength without affecting the ease of assembly and disassembly of the mold. The die head near the mold cavity is made of beryllium copper, such as C17200 beryllium copper alloy, which combines excellent thermal conductivity, wear resistance, and sufficient strength. This ensures the structural strength and surface machining accuracy of the mold, and guarantees that the mold cavity and die head have similar coefficients of thermal expansion during thermal cycling, maintaining dimensional stability over long-term use.

[0024] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention utilizes a gourd-shaped double-expansion segment structure to achieve effective expansion of the hyperplastic area on a prostate balloon. The distribution of expansion force is more consistent with anatomical pathology, making it particularly suitable for the mainstream bilateral lobe hyperplasia type. The introduction of the axial contraction segment structurally creates a "low-pressure zone" or "pressure buffer zone," actively avoiding damage to the urethral ridge, significantly improving treatment safety, and solving a clinical pain point that traditional balloons cannot avoid.

[0025] 2. The assembly, positioning, and heat insulation design of the special mold in this invention effectively solves the problems of dimensional fluctuations and uneven wall thickness in the molding of gourd-shaped balloons. By using a combination of a high thermal conductivity metal mold head and a low thermal conductivity PEEK mold head sleeve, the thermal field distribution during the molding process is stabilized. This effectively reduces heat loss in the cavity port area, making the heating and stretching of the balloon tube more uniform across the gourd-shaped curved surface, thus solving the core problem of uneven wall thickness in complex-shaped balloons and significantly improving the mechanical properties and safety reliability of the product. The structural improvements of this invention are clear, and without changing the basic blow molding process, it is easy to modify and implement on existing equipment, possessing excellent practicality and promotional value. Attached Figure Description

[0026] To more clearly illustrate the embodiments of the present invention, the accompanying drawings involved in the embodiments will be briefly described below.

[0027] Figure 1 This is a schematic diagram of the balloon of the present invention in its inflated state; Figure 2 This is a schematic diagram of the balloon mold cavity described in this invention; Figure 3 This is a schematic diagram showing the disassembled structure of the balloon molding mold described in this invention; Figure 4 This is a schematic diagram of the assembly of the balloon mold described in this invention; Figure 5 This is a schematic diagram of the assembly of the balloon mold cavity and the heating water jacket according to the present invention; In the diagram: 1. Gourd-shaped balloon; 11. Distal expansion section; 12. Reduction section; 13. Proximal expansion section; 2. Mold cavity; 21. Semi-cylindrical mold cavity; 22. Semi-cylindrical mold cavity; 23. Gourd-shaped cavity; 24. Fixed step; 3. Proximal mold head; 4. Proximal mold head sleeve; 5. Distal mold head sleeve; 6. Pipe channel; 7. Heating water jacket. Detailed Implementation

[0028] The present invention will be described in detail below with reference to the embodiments. However, the implementation of the present invention is not limited thereto. Obviously, the embodiments described below are only some embodiments of the present invention. For those skilled in the art, other similar embodiments can be obtained without creative effort and all fall within the protection scope of the present invention. Example

[0029] like Figure 1 As shown, the prostate balloon is a single-cavity, blow-molded structure with a unique "gourd-shaped" overall external profile when inflated. This gourd shape consists of two distally enlarged segments 11 and 13 with approximately the same or similar diameters, and a narrowed segment 12 connecting the two enlarged segments. The narrowed segment 12 is the axially contracting segment.

[0030] Specifically, the two enlarged segments 11 and 13 are designed as the working segments for treatment. Their dimensions are precisely configured to align with and effectively expand the prostatic hyperplasia area, thereby achieving precise and effective dilation. The narrowed segment 12 connecting the two segments is adapted to the specific anatomical structure of the patient's urethra, especially the urethral crest region. The diameter of the narrowed segment 12 is significantly smaller than that of the enlarged segments 11 and 13. Its function is to locate and isolate the balloon, ensuring that during treatment, the enlarged segments of the balloon can accurately target the area while avoiding unnecessary over-dilation and damage to sensitive or normal structures such as the urethral crest.

[0031] like Figure 2 and Figure 3 As shown, the molding die used to manufacture the aforementioned balloon is crucial for achieving the gourd-shaped balloon. The die mainly includes a mold cavity 2, a proximal mold head 3, a proximal mold head sleeve 4, and a distal mold head sleeve 5.

[0032] The mold cavity 2 is the core forming component of the entire mold, and the shape of its internal cavity directly determines the final shape of the balloon. This mold cavity is formed by the mating of two symmetrical semi-cylindrical mold bodies (i.e., semi-cylindrical mold cavity 21 and semi-cylindrical mold cavity 22). The inner surfaces of these two half-molds are precision-machined to form curved surfaces that perfectly match the outer contour of the target "gourd-shaped" balloon. When the two half-molds are mated and locked by the proximal mold head, their inner surfaces together form a sealed, complete gourd-shaped cavity 23. Furthermore, a raised annular positioning step 24 is provided on the outer wall of the mold cavity 2. The main function of this step is to precisely position and engage with the external heating device.

[0033] The distal die head sleeve 4 and the proximal die head 3 are respectively disposed at both ends of the mold cavity 2 along its axial direction. Together with the mold cavity, they form a complete balloon forming channel. To optimize the molding process, especially the heating efficiency of the raw material tube during blow molding, the proximal die head 3 and the main body of the mold cavity 2 are made of a metal material with a significantly higher thermal conductivity than polyetheretherketone (PEEK), such as beryllium copper. Furthermore, a tube channel 6 for the raw material tube to pass through is provided at its center.

[0034] The center of the die head sleeve (4, 5) is provided with a channel for the balloon material tubing to pass through. The die head sleeve is preferably made of polyetheretherketone (PEEK), which has excellent high temperature resistance and good dimensional stability, and can withstand the high temperature and high pressure environment during blow molding. At the same time, the difference in thermal expansion between it and the metal die head is controllable, which helps to achieve precise fit and smooth mold opening and closing.

[0035] During operation, pre-extruded tubular balloon material (e.g., TPU tubing) is inserted into the channel of the die head sleeve and placed in the closed mold cavity. After mold closing, an external heating device heats the entire mold while simultaneously introducing high-pressure gas into the tubular material. The softened material expands under gas pressure until it completely adheres to the inner wall of the gourd-shaped cavity 23 of the mold. After cooling and solidification, the desired gourd-shaped balloon 1 is formed. When opening the mold, the die heads 3 and 4 are first separated from the mold cavity 2, and then the two semi-cylindrical mold cavities 21 and 22 are separated to remove the formed balloon. Example

[0036] Based on the structure described in Example 1, this example further defines the key dimensional parameters.

[0037] The diameter of each enlarged segment of the balloon 1 (i.e., the distal enlarged segment 11 and the proximal enlarged segment 13) is preferably between 15 mm and 35 mm. This size range can effectively match the size of the prostatic hyperplasia area in most patients.

[0038] The minimum diameter of the constricted section 12 of the balloon 1 is 30% to 60% smaller than the diameter of the inflated sections 11 and 13.

[0039] The axial length of the reduced-diameter section 12 of the balloon 1 is preferably 5 mm to 15 mm. This length range is sufficient to cover and accommodate the typical length of the urethral crest region.

[0040] The material of the balloon 1 is preferably one or a mixture of two of the following materials: TPU, PU, ​​and PA. Example

[0041] This embodiment further refines the structural parameters of the molding die.

[0042] The height of the annular positioning step 24 on the outer wall of the mold cavity 2 is preferably 0.05 mm to 1.0 mm, in order to achieve precise radial positioning and axial limiting with the heating device.

[0043] The material of the proximal die head 3 of the forming mold is preferably beryllium copper. Beryllium copper not only has excellent thermal conductivity, but also good machinability, wear resistance and a certain strength.

[0044] Furthermore, the mold cavity 2 of the molding die is preferably made of beryllium copper. Using the same beryllium copper material as the mold head to manufacture the mold cavity can achieve consistency in the coefficient of thermal expansion of the entire mold system, maintain precise cavity dimensions and mold closing clearance during repeated heating-cooling cycles, and ensure the stability and repeatability of the spherical balloon molding dimensions. Example

[0045] The difference between this embodiment and embodiment 2 is that: The distal enlarged section 2 and the proximal enlarged section 3 have a diameter of 35 mm; the diameter of the reduced diameter section 12 is 60% smaller than the diameter of the distal enlarged section 2; the axial length of the reduced diameter section 12 is 15 mm; and the height of the fixed step 24 is 1.0 mm. Example

[0046] The difference between this embodiment and embodiment 2 is that: The distal enlarged section 2 and the proximal enlarged section 3 have a diameter of 15 mm; the diameter of the reduced diameter section 12 is 30% smaller than the diameter of the distal enlarged section 2; the axial length of the reduced diameter section 12 is 5 mm; and the height of the fixed step 24 is 0.05 mm.

[0047] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely preferred examples and are not intended to limit the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the present invention as claimed. The scope of protection of the present invention is defined by the appended claims and their equivalents.

[0048] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A prostate balloon, characterized in that, It is a single-cavity structure formed by blow molding. When inflated, it is a gourd-shaped balloon (1). The gourd-shaped balloon (1) is composed of a distal expansion section (2) and a proximal expansion section (3) connected by a narrowing section (12).

2. The prostate balloon according to claim 1, characterized in that, The distal enlarged segment (2) and the proximal enlarged segment (3) have the same diameter, ranging from 15 mm to 35 mm; the diameter of the reduced-diameter segment (12) is 30% to 60% smaller than that of the distal enlarged segment (2).

3. A prostate balloon according to claim 1, characterized in that, The axial length of the reduced diameter section (12) is 5 mm to 15 mm.

4. A prostate balloon according to claim 1, characterized in that, The gourd-shaped balloon (1) is made of one or a mixture of two of TPU, PU, ​​and PA.

5. A molding die for a prostate balloon as described in any one of claims 1 to 4, characterized in that, It is composed of a distal mold head sleeve (5), a mold cavity (2), a proximal mold head (3) and a proximal mold head sleeve (4) connected in sequence, and a pipe channel (6) connects the distal mold head sleeve (6), the mold cavity (2), the proximal mold head (3) and the proximal mold head sleeve (4).

6. The molding die for a prostate balloon according to claim 5, characterized in that, The mold cavity (2) is formed by two gourd-shaped half molds fitting together. The proximal end of the mold cavity (2) can be inserted into the proximal mold head so that the two half molds fit together precisely without producing obvious gaps. The outer wall of the far end of the mold cavity (2) is provided with an annular positioning and fixing step (24) that fits with the external heating device (7).

7. The molding die for a prostate balloon according to claim 5, characterized in that, The distal mold head sleeve (5) and the proximal mold head sleeve (4) are made of high-temperature resistant and heat-insulating polyetheretherketone; the mold cavity (2) and the proximal mold head (3) are made of beryllium copper with high thermal conductivity.

8. The molding die for a prostate balloon according to claim 6, characterized in that, The height of the fixed step (24) is 0.05 mm to 1.0 mm.

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