Steam gun and steam ablation system
By designing a steam gun with movable outer sheath tube and steam needle, the problem of the inability to adjust the ablation range of steam needles is solved, and precise ablation of hyperplasia tissues of different depths and sizes is achieved, improving the treatment adaptability and ease of operation.
Patent Information
- Application Number
- CN202510732217.X
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-06-03
- Publication Date
- 2025-08-15
AI Technical Summary
In the prior art, the ablation range of steam needles cannot be flexibly adjusted, making it difficult to adapt to prostate hyperplasia tissues of different depths and sizes, resulting in poor ablation effect.
A steam gun is designed, including a movable outer sheath tube and a steam needle, which adjusts the ablation range by adjusting the number of output holes covered by the outer sheath tube, and controls the expansion and contraction of the steam needle with the ejection module and buttons to achieve adaptive ablation of tissues of different depths and sizes.
Accurate ablation of hyperplasia tissues of different depths and sizes is achieved, improving treatment adaptability and simplicity of operation without the need to add complex structures.
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Figure CN120477923A_ABST
Abstract
Description
Technical Field
[0001] The present application relates to the technical field of medical devices, and in particular to a steam gun and a steam ablation system. Background Art
[0002] Benign prostatic hyperplasia (BPH) is a common disease among middle-aged and elderly men, most commonly occurring in those over 50 years old. Its incidence shows a significant positive correlation with age. Symptoms can be alleviated with medication in early stages, but in later stages, surgery or minimally invasive ablation devices are required. Among the many surgical options, transurethral prostate steam ablation (TUPA) is an internationally advanced treatment technique. This technique precisely injects sterile water vapor into the hyperplastic prostate tissue via a guide needle, inducing tissue inactivation, apoptosis, and progressive necrosis in the target area. One to three months after surgery, the necrotic tissue atrophies or sloughs off and is excreted in the urine, creating a clear prostatic urethra and relieving urinary tract obstruction.
[0003] However, in existing transurethral thermal steam ablation protocols, the steam ablation needle is inserted obliquely through the urethra into the prostate tissue at a fixed depth each time. A set amount of steam is then delivered at this depth to ablate the hyperplastic tissue. Existing protocols generally use equal insertion depths and steam delivery energy to ensure a similar ablation range for each needle. However, anatomical studies have shown that the volume of prostate hyperplasia in the human body is not symmetrical. This ablation method suffers from insufficient ablation coverage on the side with the larger hyperplasia.
[0004] While the insertion depth of the steam ablation needle is adjustable, it is difficult to adjust the ablation range at the needle tip. Adjusting the ablation range at the needle tip by increasing or decreasing the steam pressure directly affects the ablation effect on the hyperplastic tissue. Current solutions cannot effectively ablate hyperplastic tissue of varying depths and sizes. Summary of the Invention
[0005] The present application provides a steam gun to solve the problem in the prior art that the ablation range of the steam needle cannot be flexibly adjusted, so that the steam needle can adaptively ablate hyperplastic tissues of different depths and sizes.
[0006] The present application also proposes a steam ablation system.
[0007] According to an embodiment of the first aspect of the present application, a steam gun comprises: a steam gun body and a steam needle assembly, wherein a fixed end of the steam needle assembly is connected to the steam gun body, and the steam needle assembly is movable relative to the steam gun body so as to extend or retract the steam needle assembly from the steam gun body; The steam needle assembly includes an outer sheath tube and a steam needle. The free end of the steam needle is provided with multiple output holes. The outer sheath tube is sleeved on the outside of the steam needle and can move relative to the steam needle to adjust the number of the output holes covered by the outer sheath tube.
[0008] According to one embodiment of the present application, the steam gun body includes an ejection module, an ejection button, and a retraction button, and the fixed end of the steam needle assembly is connected to the ejection module; The eject button and the retraction button are respectively connected to the ejection module, and the ejection module controls the steam needle assembly to extend or retract based on the action of the eject button or the retraction button.
[0009] According to one embodiment of the present application, the ejection module includes a sliding main seat and a guide push mechanism, and the eject button and the retraction button are respectively connected to the sliding main seat; The sliding main seat is connected to the guide pushing mechanism, and the fixed end of the steam needle assembly is fixed on the guide pushing mechanism; The sliding main seat and the guide push mechanism transmit the actions of the eject button and the retract button to the steam needle assembly.
[0010] According to one embodiment of the present application, the guide pushing mechanism includes a connected clamping assembly and a pushing block, and the fixed end of the outer sheath is clamped and fixed on the clamping assembly; The sliding main seat is provided with a sliding groove, and the pushing block is slidably installed in the sliding groove.
[0011] According to one embodiment of the present application, the clamping assembly includes a first clamping block, the fixed end of the outer sheath is clamped and fixed on the first clamping block, and the first clamping block is connected to the pushing block; The first clamping block is provided with a first push column, and the first push column is connected to the pushing block.
[0012] According to one embodiment of the present application, the clamping assembly includes a first clamping member and a second clamping member, the fixed end of the outer sheath tube is clamped and fixed on the first clamping member, and one end of the steam needle is clamped and fixed on the second clamping member; The second clamping member can push the first clamping member to move, and the second clamping member is connected to the pushing block.
[0013] According to one embodiment of the present application, the second clamping member includes a guide plate, a connecting plate, a clamping plate, and a second push pin, the guide plate and the clamping plate are respectively arranged at both ends of the connecting plate to form a U-shaped structure, and the first clamping member is located in the opening of the U-shaped structure; One end of the second push column is connected to the connecting plate, and the other end is connected to the pushing block.
[0014] According to one embodiment of the present application, the ejection module further includes a blocking component; Along the extension direction of the steam needle assembly, the blocking assembly is arranged in front of the guide pushing mechanism to limit the maximum extension length of the steam needle assembly.
[0015] According to one embodiment of the present application, the blocking assembly includes an adjusting knob and a blocking member, wherein the adjusting knob is sleeved on the outside of the steam needle assembly, and the adjusting knob and the blocking member cooperate to transmit; The adjusting knob rotates along the circumference of the steam needle assembly to adjust the position of the blocking member in the axial direction of the steam needle assembly.
[0016] According to one embodiment of the present application, the blocking member includes a first blocking ring, which is sleeved on the outside of the steam needle assembly, and the adjusting knob is rotated to adjust the axial position of the first blocking ring to limit the maximum extension length of the steam needle assembly; or, the blocking member includes a first blocking column and a second blocking column, and the adjusting knob includes an outer sheath adjustment knob and a steam needle adjustment knob; the outer sheath adjustment knob is rotated to adjust the axial position of the first blocking column to limit the maximum extension length of the outer sheath; the steam needle adjustment knob is rotated to adjust the axial position of the second blocking column to limit the maximum extension length of the steam needle.
[0017] According to one embodiment of the present application, the ejection module further includes a housing, a first elastic member and a second elastic member; One end of the first elastic member is connected to the housing, and the other end is connected to the sliding main seat; the first elastic member provides power for the steam needle assembly to retract; One end of the second elastic member is connected to the housing or the linkage assembly, and the other end is connected to the sliding main seat; the second elastic member provides power for the steam needle assembly to extend.
[0018] According to one embodiment of the present application, the ejection module further includes a first limiting member, a first limiting portion is provided on the sliding main seat, and the first limiting member cooperates with the first limiting portion to provide limiting after the steam needle assembly extends to a preset position.
[0019] According to one embodiment of the present application, the first limiting member can move in a direction perpendicular to the extension direction of the steam needle assembly; the ejection module further includes a first trigger member; The first limiting member is provided with a first matching portion corresponding to the first triggering member. The first triggering member presses the first matching portion to move the first limiting member, thereby releasing the limiting effect of the first limiting member.
[0020] According to one embodiment of the present application, one end of the second elastic member is connected to the linkage assembly; the ejection module further includes a linkage assembly, the linkage assembly includes a support block and a linkage plate, and the support block is slidably mounted on the linkage plate; The linkage plate is fixedly connected to the sliding main seat, and the eject button pushes the linkage plate and the sliding main seat to move; One end of the second elastic member is connected to the support block, and the other end is connected to the sliding main seat; the support block is configured to push the pushing block to slide in the sliding groove under the action of the second elastic member.
[0021] According to one embodiment of the present application, the ejection module further includes a second limiting member, a second limiting portion is provided on the support block, and the second limiting member cooperates with the second limiting portion to provide limiting after the steam needle assembly retracts to a preset position.
[0022] According to one embodiment of the present application, the second limiting member is movable in a direction perpendicular to the extension direction of the steam needle assembly, and the ejection module further includes a second trigger member; The second position-limiting member is provided with a second matching portion corresponding to the second triggering member. The second triggering member presses the second matching portion to move the second position-limiting member, thereby releasing the limiting function of the second position-limiting member.
[0023] According to one embodiment of the present application, a push rod is provided on the eject button, and when the eject button abuts against the linkage plate and continues to push the sliding main seat to move a first distance, the push rod contacts the second trigger member; Under the deformation action of the second elastic member, the support block moves at least a first distance and hits the push block to provide power to extend the steam needle assembly.
[0024] According to one embodiment of the present application, the steam gun further comprises a guide sheath, wherein a fixed end of the guide sheath is connected to the steam gun body, and a free end of the guide sheath is provided with a sidewall opening; A mirror sheath and the steam needle assembly are arranged in the guide sheath, and the free end of the steam needle assembly extends from the side wall opening; the mirror sheath is used to provide a channel for the flushing liquid.
[0025] According to one embodiment of the present application, the clamping assembly is provided with a through hole, and the mirror sheath passes through the through hole, so that the clamping assembly is sleeved on the outside of the mirror sheath.
[0026] According to one embodiment of the present application, the output holes are arranged in 2 to 6 rows along the circumferential direction of the steam needle; and in 4 to 8 rows along the axial direction of the steam needle.
[0027] According to a second aspect of the present application, a steam ablation system includes a steam source, an irrigation liquid source, and the aforementioned steam gun, wherein the steam source and the irrigation liquid source are respectively connected to the steam gun; The steam gun also includes an electronic controller configured to control the generation of steam from the steam source and its delivery to the steam needle assembly, as well as to control the delivery of a flushing liquid.
[0028] According to a steam ablation system of an embodiment of the third aspect of the present application, the steam ablation system includes an imaging device and the aforementioned steam gun, and the imaging device is communicatively connected to the steam gun.
[0029] According to one embodiment of the present application, the imaging device is a magnetic resonance imaging device, a computer tomography scanner or a color ultrasound diagnostic device.
[0030] The above one or more technical solutions in the embodiments of the present application have at least one of the following technical effects: The outer sheath is placed on the outside of the steam needle. By moving the outer sheath relative to the steam needle and adjusting the number of steam needle output holes covered by the outer sheath, the ablation range of the steam needle can be adjusted, effectively addressing hyperplastic tissue of different depths and sizes. By controlling the relative distance between the steam needle and the outer sheath, the number of steam delivery holes exposed after puncturing the tissue can be controlled. The ablation range can be adjusted according to the patient's degree of prostate hyperplasia, improving the adaptability and accuracy of the treatment. This application can adjust the ablation range without adding other complex structures, and the operation is simple and the applicability is strong.
[0031] Additional aspects and advantages of the present application will be given in part in the description below, and in part will become obvious from the description below, or will be learned through practice of the present application. BRIEF DESCRIPTION OF THE DRAWINGS
[0032] In order to more clearly illustrate the technical solutions in the embodiments of the present application or related technologies, the following briefly introduces the drawings required for use in the embodiments or related technical descriptions. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.
[0033] Figure 1 This is a schematic diagram of the structure of the steam gun provided by this application Figure 1 .
[0034] Figure 2 This is a schematic diagram of the structure of the steam gun provided by this application Figure 2 (Shell is hidden).
[0035] Figure 3 This is a schematic diagram of the structure of the ejection module provided by this application Figure 1 .
[0036] Figure 4 This is a schematic diagram of the structure of the ejection module provided by this application Figure 2 (The installation sleeve is omitted).
[0037] Figure 5 This is a schematic diagram of the structure of the sliding main seat and linkage assembly provided by this application Figure 1 .
[0038] Figure 6 This is a structural diagram of the first limiting member provided in this application.
[0039] Figure 7 It is a structural schematic diagram of the front end of the steam needle assembly provided in this application.
[0040] Figure 8 It is a structural schematic diagram of the clamping assembly and the blocking assembly provided in this application.
[0041] Figure 9 This is a schematic diagram of the structure of the ejection module provided by this application Figure 3 .
[0042] Figure 10 This is a schematic diagram of the structure of the sliding main seat and linkage assembly provided by this application Figure 2 .
[0043] Figure 11 This is another structural diagram of the clamping assembly and adjustment knob provided in this application Figure 1 (The adjusting knob includes a steam needle adjusting knob and an outer sheath adjusting knob; the clamping assembly includes a first clamping piece and a second clamping piece).
[0044] Figure 12 This is another structural diagram of the clamping assembly and adjustment knob provided in this application Figure 2 (The adjusting knob includes a steam needle adjusting knob and an outer sheath adjusting knob; the clamping assembly includes a first clamping member and a second clamping member; and there is a linkage between the steam needle adjusting knob and the outer sheath adjusting knob).
[0045] Reference numerals: 1. Ejection module; 11. Sliding main seat; 111. First limiting portion; 113. Sliding groove; 12. Guide pushing mechanism; 13. Blocking assembly; 131. Adjusting knob; 132. Steam needle adjusting knob; 133. Outer sheath adjusting knob; 134. Blocking member; 135. First blocking ring; 136. First blocking column; 137. Second blocking column; 14. Housing; 15. Linkage assembly; 151. Support block; 1511. Second limiting portion; 1512. Cylindrical protrusion; 152. Linkage plate; 161. First elastic member; 162. Second elastic member; 163. First limiting member; 164. First matching portion; 165. Second limiting member; 166. Second matching portion; 167. First triggering member; 168. Second triggering member; 2. Steam needle assembly; 21. Steam needle; 211. Output hole; 22. Outer sheath; 3. Guide sheath; 31. Sidewall opening; 32. Mirror sheath; 33. Guide fillet head; 34. Guide tube; 4. Clamping assembly; 41. First clamping block; 42. First push pin; 43. First clamping member; 44. Second clamping member; 441. Guide plate; 442. Connecting plate; 443. Clamping plate; 444. Second push pin; 5. Push block; 6. Steam gun body; 61. Pop-up button; 611. Push rod; 612. Abutment surface; 62. Retract button; 63. Flush button; 64. Ablation button; 65. Hot steam module; 66. Mounting sleeve. DETAILED DESCRIPTION
[0046] The following embodiments of the present invention are described in further detail with reference to the accompanying drawings and examples. The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.
[0047] In the description of the embodiments of the present application, it should be noted that the terms "center", "longitudinal", "lateral", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", etc., indicating the orientation or positional relationship, are based on the orientation or positional relationship shown in the accompanying drawings, and are only for the convenience of describing the embodiments of the present application and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the embodiments of the present application. In addition, the terms "first", "second", and "third" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.
[0048] In the description of the embodiments of this application, it should be noted that, unless otherwise specified or limited, the terms "connected" and "connection" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections; they can refer to direct connections or indirect connections through an intermediate medium. Those skilled in the art will understand the specific meanings of the above terms in the embodiments of this application based on the specific circumstances.
[0049] In the embodiments of the present application, unless otherwise expressly specified or limited, a first feature being "above" or "below" a second feature may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Furthermore, a first feature being "above," "above," and "above" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. A first feature being "below," "below," and "below" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.
[0050] In the description of this specification, the description with reference to the terms "one embodiment", "some embodiments", "example", "specific example", or "some examples" means that the specific features, structures, materials or characteristics described in conjunction with the embodiment or example are included in at least one embodiment or example of the embodiments of the present application. In this specification, the schematic representations of the above terms do not necessarily refer to the same embodiment or example. Moreover, the specific features, structures, materials or characteristics described can be combined in any one or more embodiments or examples in a suitable manner. In addition, those skilled in the art can combine and combine different embodiments or examples described in this specification and the features of different embodiments or examples, unless they are contradictory.
[0051] A steam gun according to the first embodiment of the present application, such as Figures 1 to 12 As shown, the steam gun includes: a steam gun body 6 and a steam needle assembly 2, the fixed end of the steam needle assembly 2 is connected to the steam gun body 6, and the steam needle assembly 2 can be moved relative to the steam gun body 6 so that the steam needle assembly 2 is extended from or retracted from the steam gun body 6; the steam needle assembly 2 includes an outer sheath tube 22 and a steam needle 21, and the free end of the steam needle 21 is provided with a plurality of output holes 211, the outer sheath tube 22 is sleeved on the outside of the steam needle 21, and the outer sheath tube 22 can be moved relative to the steam needle 21 to adjust the number of output holes 211 covered by the outer sheath tube 22.
[0052] The steam needle assembly 2 is mounted on the steam gun body 6 and can be operated by a button to puncture and retract. The steam needle assembly 2 includes an outer sheath 22 and a steam needle 21. The outer sheath 22 and steam needle 21 advance or retract together to achieve puncture and retraction of the steam needle assembly 2.
[0053] The front end of the steam needle 21 is provided with multiple output holes 211. When the steam needle assembly 2 penetrates into human tissue, the steam needle assembly 2 penetrates to a set depth and reaches a preset position. High-temperature steam of 103°C is discharged through the output hole 211 to ablate the diseased hyperplastic tissue at the preset position to achieve a therapeutic effect.
[0054] The relative position between the outer sheath 22 and the steam needle 21 can be adjusted to change the number of output holes 211 covered by the outer sheath 22. When the number of output holes 211 covered by the outer sheath 22 is small, the output holes 211 at the front end of the steam needle 21 that are more unobstructed can output more steam, thereby achieving a larger ablation range; when the number of output holes 211 covered by the outer sheath 22 is large, the output holes 211 at the front end of the steam needle 21 that are less unobstructed can output less steam, thereby achieving a smaller ablation range. When the output holes 211 of the steam needle 21 are completely exposed to the outer sheath 22, all the delivery holes can spray steam outward, and at this time the ablation range is the largest; when the steam needle 21 is retracted a certain distance relative to the outer sheath 22, part of the output holes 211 are blocked by the outer sheath 22, and at this time the ablation range is reduced.
[0055] The outer sheath 22 is sleeved on the outside of the steam needle 21. By moving the outer sheath 22 relative to the steam needle 21 and adjusting the number of steam needle 21 output holes 211 covered by the outer sheath 22, the ablation range of the steam needle 21 can be adjusted, effectively addressing hyperplastic tissues of different depths and sizes. By controlling the relative distance between the steam needle 21 and the outer sheath 22, the number of steam delivery holes exposed after piercing the tissue can be controlled. The ablation range can be adjusted according to the degree of prostate hyperplasia in the patient, thereby improving the adaptability and accuracy of the treatment. This application does not require changing the steam pressure or other related structures, is simple to operate, and has strong applicability.
[0056] According to one embodiment of the present application, Figures 1 to 3 As shown, the steam gun body 6 includes an ejection module 1, an ejection button 61 and a retraction button 62, and the fixed end of the steam needle assembly 2 is connected to the ejection module 1; the ejection button 61 and the retraction button 62 are respectively connected to the ejection module 1, and the ejection module 1 controls the extension or retraction of the steam needle assembly 2 based on the action of the ejection button 61 or the retraction button 62.
[0057] The ejection module 1 features an ejection button 61 and a retraction button 62, allowing for precise control of the steam needle assembly 2's extension and retraction. Pressing the ejection button 61 activates the ejection module 1 and extends the steam needle assembly 2 to a preset depth, allowing the steam needle assembly 2 to penetrate the skin. Upon completion of treatment or in other situations, pressing the retraction button 62 retracts the steam needle assembly 2.
[0058] The ejection module 1 with electric or mechanical transmission is used to realize the transmission control of extending and retracting the steam needle 21, and cooperates with "the outer sheath 22 to move relative to the steam needle 21 to adjust the number of output holes 211 covered by the outer sheath 22", so as to accurately match the ablation range requirements of different hyperplastic tissues.
[0059] According to one embodiment of the present application, Figure 3 、 Figure 4 、 Figure 5 、 Figure 9 and Figure 10 As shown, the ejection module 1 includes a sliding main seat 11 and a guide pushing mechanism 12, and the ejection button 61 and the retraction button 62 are respectively connected to the sliding main seat 11; the sliding main seat 11 is connected to the guide pushing mechanism 12, and the fixed end of the steam needle assembly 2 is fixed on the guide pushing mechanism 12; the sliding main seat 11 and the guide pushing mechanism 12 transmit the actions of the ejection button 61 and the retraction button 62 to the steam needle assembly 2.
[0060] The mechanical linkage between the main sliding seat 11 and the guide push mechanism 12 ensures stable movement and precise positioning of the steam needle assembly 2. The eject button 61 and retract button 62 drive the linear motion of the main sliding seat 11, transmitting the operating force to the steam needle assembly 2 via the guide push mechanism 12, ensuring accurate puncture and preventing deviation or jitter caused by manual puncture.
[0061] According to one embodiment of the present application, Figure 9 As shown, the guide pushing mechanism 12 includes a connected clamping assembly 4 and a pushing block 5, and the fixed end of the outer sheath 22 is clamped and fixed on the clamping assembly 4; a sliding groove 113 is provided on the sliding main seat 11, and the pushing block 5 can be slidably installed in the sliding groove 113.
[0062] The clamping assembly 4 is used to securely hold the steam needle assembly 2. It can hold the steam needle 21 and the outer sheath 22. "The outer sheath 22 can move relative to the steam needle 21" means that after the outer sheath 22 and steam needle 21 have adjusted their relative positions and moved, the clamping assembly 4 simultaneously clamps the steam needle 21 and the outer sheath 22, allowing them to advance together for puncture.
[0063] The pusher block 5 is slidably mounted within the sliding groove 113 of the main sliding seat 11. The pusher block 5 is connected to the clamping assembly 4. When the pusher block 5 is pushed, it drives the clamping assembly 4 forward (or backward), thereby advancing (or retracting) the steam needle assembly 2. The sliding groove 113 of the main sliding seat 11 not only limits and guides the pusher block 5, but also propels it through the front and rear walls. Specifically, after sliding a certain distance within the sliding groove 113, the pusher block 5 reaches the end of the groove 113, where it is then driven by the main sliding seat 11. In other words, when the retraction button 62 is actuated, the main sliding seat 11 responds and slides. After a short distance, the main sliding seat 11 drives the pusher block 5 along with it, which in turn drives the clamping assembly 4 along with it, retracting the steam needle assembly 2. Similarly, when the eject button 61 is actuated, the aforementioned process can be followed (or alternatively, it can be activated via the subsequent linkage assembly 15).
[0064] According to one embodiment of the present application, Figures 4 to 10 As shown, the clamping assembly 4 includes a first clamping block 41, the fixed end of the outer sheath 22 is clamped and fixed on the first clamping block 41, and the first clamping block 41 is connected to the pushing block 5; a first push column 42 is provided on the first clamping block 41, and the first push column 42 is connected to the pushing block 5.
[0065] The clamping assembly 4 realizes the stable fixation and precise displacement control of the outer sheath 22 through the mechanical linkage design of the first clamping block 41 and the pushing block 5. The first clamping block 41 forms a rigid clamp on the fixed end of the outer sheath 22 to prevent the shaking of the instrument during the operation from affecting the operation accuracy. In actual application, the first clamping block 41 can be a hollow cylindrical structure. The first clamping block 41 is sleeved on the outside of the mirror sheath 32, and the first clamping block 41 has a through clamping groove axially opened on the outer peripheral surface, and the fixed end of the outer sheath tube 22 is clamped and fixed in the clamping groove.
[0066] The first clamping block 41 is connected to the pushing block 5 via a first pushing post 42 .
[0067] According to one embodiment of the present application, Figure 4 and Figure 8 As shown, the ejection module 1 further includes a blocking assembly 13 ; located in front of the guide mechanism 12 along the extension direction of the steam needle assembly 2 , the blocking assembly 13 limits the maximum extension length of the steam needle assembly 2 . The blocking assembly 13 precisely limits the maximum extension length of the steam needle assembly 2 through a mechanical limiter. Of course, in some cases, an inductive feedback device or other structure may also be used to limit the maximum extension length of the steam needle assembly 2 .
[0068] Positioning the blocking assembly 13 at the maximum travel of the clamping assembly 4 limits the maximum extension length of the steam needle assembly 2, which is also the required insertion depth of the steam needle assembly 2 during surgery. By adjusting the position of the blocking assembly 13, the maximum extension length of the steam needle assembly 2 can be adjusted.
[0069] According to one embodiment of the present application, Figure 4 and Figure 8 As shown, the blocking assembly 13 includes an adjusting knob 131 and a blocking member 134. The adjusting knob 131 is sleeved on the outside of the steam needle assembly 2, and the adjusting knob 131 and the blocking member 134 cooperate in transmission; the adjusting knob 131 rotates circumferentially along the steam needle assembly 2 to adjust the axial position of the blocking member 134 in the steam needle assembly 2.
[0070] The operator can directly turn the adjustment knob 131 to change the position of the blocking member 134, thereby controlling the maximum extension length of the steam needle assembly 2 (ie, the insertion depth of the steam needle assembly 2 in this operation).
[0071] The adjusting knob 131 and the blocking member 134 may be threadedly connected, that is, the inner surface of the adjusting knob 131 and the outer surface of the blocking member 134 are provided with matching threads, and the threaded matching converts the rotation of the adjusting knob 131 into axial movement of the blocking member 134.
[0072] In addition to the simple threaded connection between the adjusting knob 131 and the blocking member 134, an improvement can be made: a threaded slideway is provided on the inner surface of the adjusting knob 131, and a protrusion that cooperates with the slideway is provided on the outer surface of the blocking member 134. The protrusion slides in the slideway, so that the rotation of the adjusting knob 131 is converted into the axial movement of the blocking member 134. Figure 11 and Figure 12 As shown by the dotted lines within the two adjustment knobs.
[0073] The ablation depth is mainly controlled by the insertion depth and the number of exposed steam holes (i.e., output holes 211), so the adjustment knob 131 is designed with fixed gears (not stepless control), and each gear increase or decrease corresponds to an increase or decrease in the number of exposed steam holes. In specific use, the adjustment knob 131 can form an automated solution through a mechanism such as a photoelectric tube or a knob encoder, so that the host can obtain the corresponding insertion information and output steam that matches the exposed steam holes. Since the steam temperature is designed to be 103°C, the pressure of the output steam is mainly used to control the energy required for ablation. The ablation energy at different depths can be measured in the form of an in vitro experiment, and will be automatically matched by the system host during the execution process, without the need for calculation or temporary adjustment during the operation.
[0074] According to one embodiment of the present application, Figure 8As shown, the blocking member 134 includes a first blocking ring 135 , which is sleeved on the outside of the steam needle assembly 2 . The adjusting knob 131 is rotated to adjust the axial position of the first blocking ring 135 to limit the maximum extension length of the steam needle assembly 2 .
[0075] The blocking member 134 can be an annular structure. The axial position of the first blocking ring 135 can be adjusted by adjusting the knob 131, creating a quantifiable mechanical limit mechanism. Turning the adjusting knob 131 causes the first blocking ring 135 to move axially along the steam needle assembly 2. Preset scale lines can be set on the adjusting knob 131, and the locking mechanism can be used to precisely define the maximum extension length of the steam needle 21.
[0076] According to one embodiment of the present application, the ejection module 1 also includes a shell 14, a first elastic member 161 and a second elastic member 162; one end of the first elastic member 161 is connected to the shell 14, and the other end is connected to the sliding main seat 11; the first elastic member 161 provides power when the steam needle assembly 2 retracts; one end of the second elastic member 162 is connected to the shell 14 or the linkage assembly 15, and the other end is connected to the sliding main seat 11; the second elastic member 162 provides power when the steam needle assembly 2 extends.
[0077] The aforementioned sliding main seat 11 , the guide pushing mechanism 12 , and the clamping assembly 4 can all be disposed in the housing 14 .
[0078] By means of a double elastic member linkage design, an automatic telescopic power system of the steam needle assembly 2 is constructed, which does not require other electric or hydraulic power sources, simplifies the structure of the steam gun, and improves the reliability of the steam gun.
[0079] The first elastic member 161 and the second elastic member 162 may be springs, and in some cases, they may be replaced by magnetic members.
[0080] According to one embodiment of the present application, Figure 3 、 Figure 4 and Figure 6 As shown, the ejection module 1 further includes a first limiting member 163 , and a first limiting portion 111 is provided on the sliding main seat 11 . The first limiting member 163 cooperates with the first limiting portion 111 to provide limiting after the steam needle assembly 2 extends to a preset position.
[0081] The first stopper 163 cooperates with the first stopper 111 on the main sliding seat 11 to limit the position of the steam needle assembly 2 after puncture, ensuring that the steam needle assembly 2 maintains a stable penetration depth without retreating or shaking. The first stopper 163 and the first stopper 111 on the main sliding seat 11 are mechanically restrained and rigidly contacted, producing a specific vibration or sound to alert the operator that the steam needle assembly 2 has reached the preset position.
[0082] According to one embodiment of the present application, Figure 3 、 Figure 4 and Figure 6 As shown, the first limiting member 163 can move in a direction perpendicular to the extension direction of the steam needle assembly 2; the ejection module 1 also includes a first trigger member 167; a first matching portion 164 corresponding to the first trigger member 167 is provided on the first limiting member 163, and the first trigger member 167 squeezes the first matching portion 164 to move the first limiting member 163 to release the limiting effect of the first limiting member 163.
[0083] The steam needle assembly 2 extends forward to puncture, or retracts backward. The first limiting member 163 can move up and down to limit or release the limit. When the first limiting member 163 is located in a relatively upper position and contacts the first limiting portion 111 of the sliding main seat 11, the first limiting member 163 limits the sliding main seat 11, thereby restricting the retraction of the steam needle assembly 2. When the first limiting member 163 moves downward and disengages from the first limiting portion 111 of the sliding main seat 11, the limiting effect of the first limiting member 163 is released, and the sliding main seat 11 moves backward under the action of the first elastic member 161, driving the push block 5, the clamping assembly 4 and the steam needle assembly 2 to move backward.
[0084] The first trigger member 167 and the retraction button 62 may be an integral component, such as Figure 3 、 Figure 4 and Figure 6 As shown, when the compression return button 62 is pressed, the first trigger member 167 is also moved, so that the first limiting member 163 is separated from the first limiting portion 111, thereby realizing the rebound of the steam needle assembly 2.
[0085] According to one embodiment of the present application, Figure 3 、 Figure 4 、 Figure 5 、 Figure 9 and Figure 10 As shown, one end of the second elastic member 162 is connected to the linkage assembly 15; the ejection module 1 also includes a linkage assembly 15, the linkage assembly 15 includes a support block 151 and a linkage plate 152, the support block 151 is slidably mounted on the linkage plate 152; the linkage plate 152 is fixedly connected to the sliding main seat 11, and the ejection button 61 pushes the linkage plate 152 and the sliding main seat 11 to move; one end of the second elastic member 162 is connected to the support block 151, and the other end is connected to the sliding main seat 11; the support block 151 is configured to push the pushing block 5 to slide in the sliding groove 113 under the action of the second elastic member 162.
[0086] The other end of the second elastic member 162 is connected to the sliding main seat 11, and it can be: a blind hole is provided on the sliding main seat 11, and most of the second elastic member 162 is located in the blind hole, so that when the steam needle assembly 2 is in the retracted state, the sliding main seat 11 and the support block 151 are in contact.
[0087] The eject button 61 drives the sliding main seat 11 to move by pressing against the linkage plate 152. Before the steam needle assembly 2 moves forward for puncture (that is, when the steam needle assembly 2 is in the retracted state), a distance is pulled between the sliding main seat 11 and the support block 151, so that the second elastic member 162 is deformed to a certain extent, thereby accumulating power for the steam needle assembly 2 to puncture.
[0088] According to one embodiment of the present application, Figures 3 to 5 As shown, the ejection module 1 further includes a second limiting member 165 , and a second limiting portion 1511 is provided on the support block 151 . The second limiting member 165 cooperates with the second limiting portion 1511 to provide limiting after the steam needle assembly 2 retracts to a preset position.
[0089] The first stopper 111 is provided on the main sliding seat 11, and the second stopper 1511 is provided on the support block 151. When the steam needle 21 is in the retracted state, the support block 151 is restrained by the second stopper 165. The support block 151 is connected to the main sliding seat 11 via the second elastic member 162, and the main sliding seat 11 is also restrained from moving.
[0090] According to one embodiment of the present application, Figures 3 to 5 As shown, the second limiting member 165 can move in a direction perpendicular to the extension direction of the steam needle assembly 2, and the ejection module 1 also includes a second trigger member 168; a second matching portion 166 corresponding to the second trigger member 168 is provided on the second limiting member 165, and the second trigger member 168 squeezes the second matching portion 166 to move the second limiting member 165 to release the limiting effect of the second limiting member 165.
[0091] The steam needle assembly 2 extends forward to puncture, or retracts backward. The second limiting member 165 can move up and down to limit or release the limit. When the second limiting member 165 is located in a relatively upper position and contacts the second limiting portion 1511 of the support block 151, the second limiting member 165 limits the support block 151, preventing the sliding main seat 11 from moving forward, thereby limiting the advancement of the steam needle assembly 2. When the second limiting member 165 moves downward and disengages from the second limiting portion 1511 of the support block 151, the limiting effect of the second limiting member 165 is released, and the support block 151 moves toward the sliding main seat 11 under the action of the second elastic member 162. The cylindrical protrusion 1512 on the support block 151 hits the push block 5 located in the sliding groove 113, thereby causing the push block 5, the clamping assembly 4 and the steam needle assembly 2 to move forward.
[0092] The second trigger member 168 and the eject button 61 can be split components, so that after a certain distance is pulled between the sliding main seat 11 and the support block 151, the support block 151 is released, and the second elastic member 162 with a certain deformation drives the support block 151 to move.
[0093] According to one embodiment of the present application, Figure 3 and Figure 5 As shown, a push rod 611 is provided on the eject button 61. When the eject button 61 abuts against the linkage plate 152 and continues to push the sliding main seat 11 to move the first distance, the push rod 611 contacts the second trigger member 168; under the deformation action of the second elastic member 162, the support block 151 moves at least the first distance and hits the push block 5 to provide power to extend the steam needle assembly 2.
[0094] The eject button 61 pushes the linkage plate 152 to move via the abutment surface 612 on its back, and the eject button 61 pushes the second trigger member 168 to move via the push rod 611. During the movement of the eject button 61, it first contacts the sliding main seat 11, and then contacts the second trigger member 168 after pushing the sliding main seat 11 to move a first distance.
[0095] When the steam needle assembly 2 is retracted, the sliding main seat 11 and the support block 151 are in contact. The eject button 61 pushes the sliding main seat 11 a first distance, stretching the second elastic member 162 by the first distance. At this point, the eject button 61 continues to move, causing the second trigger member 168 to release the second stopper 165, releasing the support block 151. Under the action of the second elastic member 162, the support block 151 rapidly moves toward the sliding main seat 11 and strikes the push block 5 in the sliding slot 113, ejecting the steam needle assembly 2.
[0096] The eject button 61 can also be replaced by a motor or a magnetic component. For example, an incomplete gear can be installed on the motor, and the linkage plate 152 can be set as a rack. The rotation of the gear drives the linkage plate 152 to move, pushing the sliding main seat 11 to move. Alternatively, a magnetic component can be used to push the linkage plate 152.
[0097] According to one embodiment of the present application, Figure 1 and Figure 2 As shown, the steam gun also includes a guide sheath 3, the fixed end of the guide sheath 3 is connected to the steam gun body 6, and the free end of the guide sheath 3 is provided with a side wall opening 31; a mirror sheath 32 and a steam needle assembly 2 are provided in the guide sheath 3, and the free end of the steam needle assembly 2 extends from the side wall opening 31; the mirror sheath 32 is used to provide a channel for the flushing liquid; of course, the mirror sheath 32 can also be used as a guide structure as described above.
[0098] In practical applications, the steam needle assembly 2 can be installed in the guide tube 34 , and the guide tube 34 and the scope sheath 32 are installed together in the guide sheath 3 .
[0099] The integrated design of the guide sheath 3 and the scope sheath 32 creates a precise puncture and thermal damage protection system. The fixed end of the guide sheath 3 is rigidly connected to the steam gun body 6, while the sidewall opening 31 at the free end provides a precise exit channel for the steam needle assembly 2, ensuring a stable puncture trajectory. The coolant circulation system within the scope sheath 32 immediately removes excess heat generated by steam ablation, preventing thermal damage to surrounding tissues due to high temperatures.
[0100] The rigid positioning of the guide sheath 3 ensures that the steam needle 21 extends along the preset path, improving puncture accuracy; the guiding structure of the side wall opening 31 reduces the deviation of the steam needle 21 when it is extended, and cooperates with the coolant protection of the mirror sheath 32 to form a dual safety mechanism of "precise puncture + thermal damage protection"; the continuous circulation of the coolant can maintain the controllability of the temperature field in the ablation area, ensuring the effective inactivation of hyperplastic tissue and preventing damage to normal tissue by heat diffusion, significantly improving the safety of surgical operations and the controllability of the treatment process.
[0101] According to one embodiment of the present application, Figure 4 、 Figure 8 、 Figure 9 and Figure 10 As shown, the clamping assembly 4 is provided with a through hole, and the mirror sheath 32 passes through the through hole, so that the clamping assembly 4 is sleeved on the outside of the mirror sheath 32.
[0102] The clamping assembly 4 is sleeved on the outside of the mirror sheath 32, and the through hole forms a precise fit with the mirror sheath 32, which not only plays a fixed supporting role for the mirror sheath 32 to prevent the coolant passage from shaking during surgery, but also provides a guide track for the clamping assembly 4 to move axially along the mirror sheath 32.
[0103] The coaxial fit of the through hole ensures that when the clamping assembly 4 drives the outer sheath tube 22 or the steam needle assembly 2 to move, it maintains a precise relative position with the mirror sheath 32 to avoid deviation of the puncture trajectory; the rigid sleeve structure ensures that the mirror sheath 32 is stably fixed, maintains the reliability of the coolant circulation path, and prevents cooling failure due to shaking of the instrument.
[0104] According to one embodiment of the present application, the output holes 211 are arranged in 2 to 6 rows along the circumferential direction of the steam needle 21 ; and in 4 to 8 rows along the axial direction of the steam needle 21 .
[0105] For example, the output holes 211 can be arranged in three rows along the circumference of the steam needle 21, and in five rows along the axial direction. This structure, through a matrix design of three circumferential rows and five axial rows of output holes 211, creates a multi-dimensional steam energy distribution system. The three circumferential rows of output holes 211 ensure uniform thermal coverage of the prostate tissue, avoiding the ablation blind spots caused by traditional single-hole or dual-hole structures. The five axial rows create a gradient energy release zone along the length of the steam needle 21, ensuring precise ablation of hyperplastic tissue of varying sizes.
[0106] In practice, the outer sheath 22 and steam needle 21 can be combined to expose four rows of holes: the hot steam holes (i.e., output holes 211) have a diameter of 0.35 to 0.38 mm, with a spacing of 1.05 to 1.10 mm. The distance from the tip to the center of the nearest hole is approximately 2.21 mm, and the tip angle is approximately 40°. The maximum penetration depth is approximately 11.5 mm, with the deepest steam hole reaching a depth of 9.5 mm and the hole closest to the urethra (the shallowest) reaching a depth of 4.5 mm. The outer sheath 22 covers the unexposed fifth steam hole to prevent hot steam from entering tissue within 4 mm of the urethral wall, thereby preventing burns. If a larger ablation area is desired, the user can adjust the penetration depth of the steam needle 21, allowing the hole closest to the tip to penetrate deeper into the tissue while leaving the fifth steam hole neatly exposed near the urethral wall to ensure effective ablation of tissue near the urethral wall. On the contrary, when the tissue to be ablated is smaller, the insertion depth can be reduced so that the outer sheath 22 can cover and block more steam holes, but the protection range of the outer sheath 22 will ensure that there are no steam holes within 4 mm of the urethra wall.
[0107] The arrangement of the output holes 211 of the steam needle 21 may also be in other forms. For example, the output holes 211 of the steam needle 21 may be designed to be arranged in a spiral so that the steam covers a cylindrical space with a radius of the steam ejection distance.
[0108] In addition to the aforementioned "clamping assembly 4 includes a first clamping block 41 + blocking member 134 includes a first blocking ring 135" mode, the specific structure of the clamping assembly 4 and the blocking member 134 can also be adjusted, and the adjustment knob 131 can be adjusted accordingly, such as Figure 11 and Figure 12 Another structure of the clamping assembly 4, the blocking member 134 and the adjusting knob 131 is described below.
[0109] According to one embodiment of the present application, Figure 11 and Figure 12As shown, the clamping assembly 4 includes a first clamping member 43 and a second clamping member 44. The fixed end of the outer sheath tube 22 is clamped and fixed on the first clamping member 43, and one end of the steam needle 21 is clamped and fixed on the second clamping member 44; the second clamping member 44 can push the first clamping member 43 to move, and the second clamping member 44 is connected to the pushing block 5.
[0110] The first clamping member 43 clamps the rear end of the outer sheath 22, while the second clamping member 44 clamps the rear end of the steam needle 21. The push block 5 pushes the second clamping member 44 to move. After the second clamping member 44 moves a certain distance L, it pushes the first clamping member 43 to move with it. By clamping the outer sheath 22 and steam needle 21 separately, the maximum puncture depth of the outer sheath 22 and steam needle 21 can be controlled separately, making it easier to adjust the number of output holes 211 covered by the outer sheath 22, and thus the ablation range.
[0111] According to one embodiment of the present application, Figure 11 and Figure 12 As shown, the second clamping member 44 includes a guide plate 441, a connecting plate 442, a clamping plate 443, and a second push post 444. The guide plate 441 and the clamping plate 443 are respectively arranged at both ends of the connecting plate 442 to form a U-shaped structure, and the first clamping member 43 is located in the opening of the U-shaped structure; one end of the second push post 444 is connected to the connecting plate 442, and the other end is connected to the push block 5. The second clamping member 44 can be a split structure, with the guide plate 441, the connecting plate 442, the clamping plate 443, and the second push post 444 connected and fixed to form the second clamping member 44; the second clamping member 44 can also be a single-piece component.
[0112] The guide plate 441 may be provided with a through hole for the outer sheath 22 to pass through, so as to prevent the outer sheath 22 from affecting the movement of the second clamping member 44. At the same time, the outer sheath 22 may also play a certain guiding role for the second clamping member 44. The clamping plate 443 is used to fix and clamp the steam needle 21.
[0113] According to one embodiment of the present application, Figure 11 and Figure 12 As shown, the blocking member 134 includes a first blocking column 136 and a second blocking column 137, and the adjusting knob 131 includes an outer sheath adjusting knob 133 and a steam needle adjusting knob 132; the outer sheath adjusting knob 133 is rotated to adjust the axial position of the first blocking column 136 to limit the maximum extension length of the outer sheath 22; the steam needle adjusting knob 132 is rotated to adjust the axial position of the second blocking column 137 to limit the maximum extension length of the steam needle 21.
[0114] The outer sheath adjustment knob 133 is disposed at the front end of the steam needle adjustment knob 132 .
[0115] The first blocking column 136 is used to limit the maximum displacement of the first clamping member 43, thereby achieving the effect of limiting the maximum extension length of the outer sheath tube 22; the second blocking column 137 is used to limit the maximum displacement of the second clamping member 44, thereby achieving the effect of limiting the maximum extension length of the steam needle 21.
[0116] It should be understood that a linkage structure may be provided between the outer sheath adjustment knob 133 and the steam needle adjustment knob 132, such as Figure 12 As shown, that is, when the steam needle adjusting knob 132 is rotated, the outer sheath adjusting knob 133 will rotate together, so that the relative position of the outer sheath 22 and the steam needle 21 remains fixed; when the outer sheath adjusting knob 133 is rotated, the steam needle adjusting knob 132 does not move to adjust the relative position between the outer sheath 22 and the steam needle 21.
[0117] In addition to the above structure, the steam gun can also be provided with a handle body, a hot steam module 65, a flushing button 63, an ablation button 64 and other structures. When the operator grips the handle with his hand, the base of his palm will press against the flushing button 63 to activate the flushing function. The sterile water used for flushing enters the sheath 32 from the outside through the pipeline via a peristaltic pump, and can be used to flush tissue or dirt blocking the steam needle 21 or the endoscope; it can also be kept cool during the hot steam delivery process. Considering that hot steam needs to completely fill an entire peek steam pipe to ensure timely steam output during treatment, even if the flushing button 63 is not pressed during the working process, the system will continue to inject sterile water at a small flow rate for cooling. During the treatment process, the flushing button 63 will be interlocked with the ablation button 64 on the electronic component to ensure that there is enough sterile water flowing through the guide sheath 3 during the steam ablation process to cool the area near the ablation site and avoid steam burns to the urethra. Pressing the eject button 61 of the steam needle 21 will cause the steam needle 21 to pop out; pressing the ablation button 64 will activate the hot steam module 65 to release steam; a rebound button is provided at the front end for retracting the ejected steam needle 21.
[0118] The hot steam module 65 may include an RF heating coil, a fluid connector, and piping. The tail end of the piping transports the liquid, which enters the heating coil and is heated to form a continuous vapor. This vapor enters the steam needle 21 through the fluid connector and is then continuously discharged from the orifice of the steam needle 21. The hot steam module 65 utilizes its own component features to mate with corresponding features on the handle body, enabling it to function as a position limiter, foolproof, and quick-release device. The hot steam module 65 is designed to be quick-release and replaceable as a consumable. The piping within the hot steam module 65 controls the energy consumption of the hot steam and may utilize at least one three-way connection for real-time monitoring of steam pressure. While treatment methodology recommends ablating proximal (less porous) tissue first and then distal (more porous) tissue to ensure a steady increase in steam pressure and avoid repeated increases and decreases in pressure, a pressure relief valve may be added to the detection end to release accumulated steam pressure from the device in special circumstances to mitigate operational errors and unexpected events. Furthermore, the steam detection module can also facilitate self-detection of steam port blockages.
[0119] The steam gun may also be equipped with a fluid delivery control device for controlling the energy of steam delivery to better control steam generation and delivery. The fluid delivery control device can precisely control the steam delivery rate within a range of 0.1 to 5 ml / min. At the beginning of the procedure, the fluid delivery control device can set a higher steam delivery rate to speed up the ablation process; toward the end of the ablation, the steam delivery rate can be reduced to avoid excessive ablation and damage to normal tissue.
[0120] The adjusting knob 131 , the mounting sleeve 66 , the steam needle assembly 2 , the blocking assembly 13 , the clamping assembly 4 , the mirror sheath 32 , etc. can be treated as a whole and individually used as consumables and can be replaced at any time.
[0121] In the specific use of the steam gun: First, adjust the two knobs: the steam needle adjustment knob 132 adjusts the steam needle 21 , and the outer sheath adjustment knob 133 adjusts the outer sheath 22 .
[0122] A treatment plan is designed based on the diagnosis, and the ablation range required by the patient is confirmed, so as to provide the required insertion "gear" (corresponding to the insertion depth and the number of steam output holes 211) required for the ablation. After each insertion into the tissue, the steam system obtains the gear information and automatically adjusts the amount of hot steam for ablation.
[0123] There are three buttons distributed on the handle of the handle body, and a flushing button 63 is provided on the back of the handle. When the handle is gripped, the palm will press the button to activate the peristaltic pump to inject liquid. The liquid is drawn from the pipeline by the peristaltic pump and flows through the hot steam module 65 to the mirror sheath 32 in the guide sheath 3, and finally flows out from the guide rounded head 33.
[0124] A steam needle 21 pop-up button 61 is provided at the front of the handle. When the steam needle 21 pop-up button 61 is pressed, the transmission component inside the handle body will be activated. The transmission component is connected to the ejection module 1 through the guide push mechanism 12. When the transmission component is activated, the guide push mechanism 12 drives the steam needle 21 and the tail end of the outer sheath tube 22 to pop out. The pop-up distance is determined according to the length value adjusted by the adjustment knob 131.
[0125] The adjustment knob 131 of the steam needle 21 has an adjustment range of 8.5 to 15 mm. The outer sheath 22 maintains a constant penetration depth (4 mm to ensure safety within a 4 mm radius of the urethral wall), with a minimum of three holes exposed, and a maximum of all holes exposed, depending on the design. The adjustment range of the outer sheath 22 starts at the midpoint between the first and second holes on the head of the steam needle 21 and moves 8 mm toward the fourth hole. This range defines the outer sheath 22's adjustment range. When the adjustment knob 131 is at the 0 scale, the steam needle 21 exposes the first hole. As the outer sheath 22 moves toward the fourth hole, it gradually exposes the second, third, and fourth holes, thereby controlling the range of steam output.
[0126] After the steam needle 21 penetrates the tissue, the ablation button 64 is pressed, activating the hot steam module 65. Steam enters the steam needle 21 through the pipeline and is discharged through the output hole 211. The hot steam module 65 includes an RF heating coil, input pipelines, output pipelines, steam pressure monitoring pipelines, and connectors. The input pipeline of the hot steam module 65 is connected to the linear propulsion module in the external mainframe. The linear propulsion module contains a plunger-type container filled with liquid, which is connected to the end of the RF heating coil in the hot steam module 65 through a pipeline. The RF heating coil is made of a hollow capillary tube with a spiral bend. The entire heating coil is 33 mm long and 11 mm in diameter. The capillary tube has an outer diameter of 1.25 mm and an inner diameter of 0.8 mm. The other end is connected to a flexible tube with a connector that connects to the corresponding connector of the steam gun. When heating begins, the RF heating coil is activated, and the linear propulsion module in the external mainframe is controlled to move linearly, pushing the plunger container, causing the liquid in the container to enter the pipeline and flow into the RF heating coil at a uniform speed. Water is heated to a vapor state in the RF heating coil. As the linear propulsion module continues to advance, the water is continuously pushed into the RF heating coil, propelling the initially heated vapor water forward until it reaches the steam needle 21 and escapes through the output port 211, causing high-temperature ablation of the treated tissue. To ensure smooth control of the hot steam, the control signal for the RF coil has a default minimum output, maintaining a small amount of steam flowing to the steam delivery port. This prevents the transient volume collapse during gas-liquid conversion, which could cause low pressure and draw fluid back into the steam ablation needle, blocking the steam port. After steam injection is complete, the steam needle 21 retracts into the outer sheath 22. The sealing properties of the outer sheath 22 ensure positive pressure inside the steam delivery needle 21, preventing the possibility of external liquid being drawn back into the steam ablation needle. Excessive pressure is discharged through a pressure relief valve. In addition to controlling the electrical signal, the steam flow is also controlled by the pressure relief valve; excessive pressure is discharged through the pressure relief valve.
[0127] When ablation is completed, pressing the rebound button will trigger the transmission structure inside the steam needle 21, causing the guide pushing mechanism 12 to bring the steam needle 21 and the outer sheath tube 22 back to the starting point at the same time.
[0128] For example, the steam needle 21 is made of PEEK material, has a length of 20 cm, an outer diameter of 2 mm, and an output hole 211 arranged in a 3*4 pattern with a hole diameter of 0.2 mm. The guide sheath 3 is entirely made of stainless steel and includes a mirror sheath 32 and a cylindrical cavity for guiding the outer sheath tube 22 and the steam needle 21. The front end cross-section of the guide rounded head 33 has an arc for guidance. After the arc is bent, the vertical steam needle 21 and the outer sheath tube 22 are guided and bent. The guide sheath 3 is composed of the mirror sheath 32 and the space where the steam needle 21 is located in the outer sheath tube 22. The steam needle 21 and the outer sheath tube 22 are axially displaced in the guide sheath 3. The outer sheath tube 22 and the steam needle 21 are bound and connected to the guide push mechanism 12. The guide push mechanism 12 has a circular through hole in the middle with a diameter equal to the mirror sheath diameter. The guide push mechanism 12 moves axially along the mirror sheath 32, using the mirror sheath 32 as a guide mechanism. In addition, a separate guide mechanism can be provided without using the mirror sheath 32 for guidance. The guide push mechanism 12 is provided with a cylindrical feature (i.e., the first push post 42), which connects to the transmission mechanism inside the handle to transmit motion. The cylindrical feature can be replaced by other features, such as a hole here and a raised feature inside the handle; any feature that can connect the two mechanisms will be acceptable. The sliding main seat 11 is provided with a sliding groove 113, in which the push block 5 slides.
[0129] The ejection module 1 can be designed to manually apply force for transmission. Alternatively, a motor and associated electronic sensors can be used to output torque to control transmission. Furthermore, a motor and gears can be used to replace the transmission method between the ejection button 61 and the linkage rod. The linkage rod can be equipped with a rack or designed as a part with rack features, and can be used in conjunction with the motor's gear or gear mechanism to push the rod. The gear in the gear mechanism responsible for pushing the rack can be designed as a half-turn gear. When it rotates to a specific angle, it no longer generates thrust. At this point, the sliding main seat 11 is in the working position, and the support block 151 has been released and ejected.
[0130] The steam gun provided by this application can not only determine the ablation range by controlling the penetration depth of the hot steam needle assembly 2 and the amount of steam used during treatment, but also the output holes 211 of the steam needle 21 are arranged in multiple rows, and a sheath is provided on the outside of the steam needle 21. By controlling the relative distance between the steam needle 21 and the outer sheath 22, the number of steam needle 21 delivery holes exposed in the tissue can be controlled. This application can adjust the ablation range according to the degree of prostate hyperplasia of the patient, thereby improving the adaptability and accuracy of the treatment. This application can adopt equal output of hot steam energy, directly control it, and improve the treatment effect.
[0131] The steam gun provided in this application can flexibly adjust the ablation range according to the patient's degree of prostate hyperplasia by controlling the penetration depth of the steam needle assembly 2 and the amount of steam used during treatment, thereby improving the adaptability and precision of the treatment and avoiding the problem of poor treatment effect caused by the fixed ablation range in the prior art. The output holes 211 of the steam needle 21 are arranged in a multi-hole arrangement, and an outer sheath 22 is located outside the steam needle 21. By controlling the relative distance between the steam needle 21 and the outer sheath 22, the number of steam output holes 211 exposed after penetration into the tissue can be controlled, making the adjustment of the ablation range more flexible and precise. It can also further combine imaging data to determine the preoperative and intraoperative three-dimensional models of the target patient's prostate, improving the accuracy and reliability of the models and providing a basis for precise control of the ablation range. The steam delivery rate can also be further controlled to better control the generation and delivery of steam, improving the safety and effectiveness of the treatment. The spatial position of the steam delivery needle within the tissue can be precisely navigated and planned, further improving the accuracy of the ablation range control and ensuring the treatment effect. The operation is highly safe, and the module that is inserted into the human body can be disassembled and assembled at any time, allowing for more detailed control over the surgical process.
[0132] According to a second aspect of the present application, a steam ablation system includes a steam source, an irrigation liquid source, and the aforementioned steam gun, wherein the steam source and the irrigation liquid source are respectively connected to the steam gun; The steam gun also includes an electronic controller configured to control the generation of steam from the steam source and its delivery to the steam needle assembly, as well as to control the delivery of the flushing liquid.
[0133] According to a third aspect of the present application, a steam ablation system includes an imaging device and the aforementioned steam gun, wherein the imaging device is communicatively connected to the steam gun. Automatic or manual adjustment of the ablation range to accommodate varying hyperplasia volumes can be achieved through an adaptive imaging system, such as transrectal ultrasound.
[0134] The steam gun also includes an imaging interface that can be connected to an MRI (Magnetic Resonance Imaging) or CT device. Before surgery, the patient undergoes an MRI or CT scan to obtain prostate imaging data. Dedicated software reconstructs a three-dimensional model of the patient's prostate based on this imaging data and transmits this 3D model to the ablation gun's control unit. During surgery, the control unit uses the 3D model to guide the surgeon in real-time navigation and planning of the steam needle's position within the tissue, directing ablation of the prostate lesion. Imaging equipment not only performs preoperative testing, such as imaging with MRI or CT, but also provides real-time guidance during the steam gun puncture. During the puncture, conventional color ultrasound equipment (color ultrasound diagnostic equipment) equipped with a specialized ultrasound probe can be used for prostate ultrasound, transabdominal ultrasound, or transrectal ultrasound (TRUS). Real-time imaging monitoring during surgery, combined with the endoscope, ensures surgical safety by preventing excessive puncture depth that could damage the rectal wall or affect the patient's sexual function.
[0135] By integrating imaging equipment with the steam gun, a visual precision ablation system is constructed. The imaging equipment acquires real-time 3D images of prostate tissue, sharing data with the steam gun via a communication link to enable visual guidance of puncture path planning and ablation areas.
[0136] During the specific operation, real-time image guidance is used to ensure that the steam needle 21 accurately punctures along the preset trajectory to avoid nerve and blood vessel damage caused by blind puncture; imaging data is linked with the depth adjustment and energy output parameters of the steam gun to dynamically adjust the ablation range according to the boundary of the proliferative tissue, adapting to the individualized treatment needs of bilateral asymmetric hyperplasia.
[0137] According to one embodiment of the present application, the imaging device is a magnetic resonance imaging device, a computer tomography scanner or a color ultrasound diagnostic device.
[0138] Based on the patient's imaging data such as MRI, CT, etc., the three-dimensional model of the patient's prostate is determined, and the spatial position of the steam needle 21 in the tissue is accurately navigated and planned to guide the implementation of the ablation surgery and improve the accuracy of ablation range control.
[0139] Finally, it should be noted that the above embodiments are intended only to illustrate the present application and are not intended to limit the present application. Although the present application has been described in detail with reference to the embodiments, those skilled in the art will appreciate that various combinations, modifications, or equivalent substitutions of the technical solutions of the present application do not depart from the spirit and scope of the technical solutions of the present application and are intended to be encompassed by the claims of the present application.
Claims
1. A steam gun, characterized in that: include: A steam gun body (6) and a steam needle assembly (2), wherein the fixed end of the steam needle assembly (2) is connected to the steam gun body (6), and the steam needle assembly (2) is movable relative to the steam gun body (6) so as to extend or retract the steam needle assembly (2) from the steam gun body (6); The steam needle assembly (2) comprises an outer sheath tube (22) and a steam needle (21); a plurality of output holes (211) are provided at the free end of the steam needle (21); the outer sheath tube (22) is sleeved on the outside of the steam needle (21), and the outer sheath tube (22) is movable relative to the steam needle (21) to adjust the number of the output holes (211) covered by the outer sheath tube (22).
2. The steam gun according to claim 1, characterized in that The steam gun body (6) comprises an ejection module (1), an ejection button (61) and a retraction button (62), and the fixed end of the steam needle assembly (2) is connected to the ejection module (1); The ejection button (61) and the retraction button (62) are respectively connected to the ejection module (1), and the ejection module (1) controls the steam needle assembly (2) to extend or retract based on the action of the ejection button (61) or the retraction button (62).
3. The steam gun according to claim 2, characterized in that The ejection module (1) comprises a sliding main seat (11) and a guide push mechanism (12), and the ejection button (61) and the retraction button (62) are respectively connected to the sliding main seat (11); The sliding main seat (11) is connected to the guide pushing mechanism (12), and the fixed end of the steam needle assembly (2) is fixed on the guide pushing mechanism (12); The sliding main seat (11) and the guide push mechanism (12) transmit the actions of the eject button (61) and the retract button (62) to the steam needle assembly (2).
4. The steam gun according to claim 3, characterized in that The guide pushing mechanism (12) comprises a connected clamping assembly (4) and a pushing block (5), and the fixed end of the outer sheath tube (22) is clamped and fixed on the clamping assembly (4); A sliding groove (113) is provided on the sliding main seat (11), and the pushing block (5) is slidably installed in the sliding groove (113).
5. The steam gun according to claim 4, characterized in that The clamping assembly (4) comprises a first clamping block (41), the fixed end of the outer sheath tube (22) is clamped and fixed on the first clamping block (41), and the first clamping block (41) is connected to the pushing block (5); A first push column (42) is provided on the first clamping block (41), and the first push column (42) is connected to the pushing block (5).
6. The steam gun according to claim 4, characterized in that The clamping assembly (4) comprises a first clamping member (43) and a second clamping member (44), the fixed end of the outer sheath tube (22) is clamped and fixed on the first clamping member (43), and one end of the steam needle (21) is clamped and fixed on the second clamping member (44); The second clamping member (44) can push the first clamping member (43) to move, and the second clamping member (44) is connected to the pushing block (5).
7. The steam gun according to claim 6, characterized in that The second clamping member (44) comprises a guide plate (441), a connecting plate (442), a clamping plate (443) and a second push column (444), wherein the guide plate (441) and the clamping plate (443) are respectively arranged at two ends of the connecting plate (442) to form a U-shaped structure, and the first clamping member (43) is located in an opening of the U-shaped structure; One end of the second push column (444) is connected to the connecting plate (442), and the other end is connected to the pushing block (5).
8. The steam gun according to claim 3, characterized in that The ejection module (1) further includes a blocking component (13); Along the extension direction of the steam needle assembly (2), the blocking assembly (13) is arranged in front of the guide pushing mechanism (12) to limit the maximum extension length of the steam needle assembly (2).
9. The steam gun according to claim 8, characterized in that The blocking assembly (13) comprises an adjusting knob (131) and a blocking member (134); the adjusting knob (131) is sleeved on the outside of the steam needle assembly (2); the adjusting knob (131) and the blocking member (134) cooperate to transmit; The adjusting knob (131) rotates along the circumference of the steam needle assembly (2) to adjust the position of the blocking member (134) in the axial direction of the steam needle assembly (2).
10. The steam gun according to claim 9, characterized in that The blocking member (134) comprises a first blocking ring (135), the first blocking ring (135) being sleeved on the outside of the steam needle assembly (2), and the adjusting knob (131) being rotated to adjust the axial position of the first blocking ring (135) to limit the maximum extension length of the steam needle assembly (2); or, The blocking member (134) includes a first blocking column (136) and a second blocking column (137); the adjusting knob (131) includes an outer sheath adjusting knob (133) and a steam needle adjusting knob (132); the outer sheath adjusting knob (133) is rotated to adjust the axial position of the first blocking column (136) to limit the maximum extension length of the outer sheath (22); the steam needle adjusting knob (132) is rotated to adjust the axial position of the second blocking column (137) to limit the maximum extension length of the steam needle (21).
11. The steam gun according to claim 4, characterized in that The ejection module (1) further includes a housing (14), a first elastic member (161), and a second elastic member (162); One end of the first elastic member (161) is connected to the housing (14), and the other end is connected to the sliding main seat (11); the first elastic member (161) provides power for the steam needle assembly (2) to retract; One end of the second elastic member (162) is connected to the housing (14) or the linkage assembly (15), and the other end is connected to the sliding main seat (11); the second elastic member (162) provides power for extending the steam needle assembly (2).
12. The steam gun according to claim 11, characterized in that The ejection module (1) further comprises a first limiting member (163), a first limiting portion (111) being provided on the sliding main seat (11), and the first limiting member (163) cooperates with the first limiting portion (111) to provide limiting after the steam needle assembly (2) extends to a preset position.
13. The steam gun according to claim 12, characterized in that The first limiting member (163) is movable in a direction perpendicular to the extension direction of the steam needle assembly (2); the ejection module (1) further comprises a first trigger member (167); The first limiting member (163) is provided with a first matching portion (164) corresponding to the first trigger member (167), and the first trigger member (167) presses the first matching portion (164) to move the first limiting member (163), thereby releasing the limiting effect of the first limiting member (163).
14. The steam gun according to claim 11, wherein One end of the second elastic member (162) is connected to the linkage assembly (15); the ejection module (1) further comprises a linkage assembly (15), the linkage assembly (15) comprises a support block (151) and a linkage plate (152), and the support block (151) is slidably mounted on the linkage plate (152); The linkage plate (152) is fixedly connected to the sliding main seat (11), and the eject button (61) pushes the linkage plate (152) and the sliding main seat (11) to move; One end of the second elastic member (162) is connected to the support block (151), and the other end is connected to the sliding main seat (11); the support block (151) is configured to push the push block (5) to slide in the sliding groove (113) under the action of the second elastic member (162).
15. The steam gun according to claim 14, characterized in that The ejection module (1) further comprises a second limiting member (165), a second limiting portion (1511) being provided on the support block (151), and the second limiting member (165) cooperates with the second limiting portion (1511) to provide limiting after the steam needle assembly (2) is retracted to a preset position.
16. The steam gun according to claim 15, characterized in that The second limiting member (165) is movable in a direction perpendicular to the extension direction of the steam needle assembly (2), and the ejection module (1) further comprises a second trigger member (168); The second limiting member (165) is provided with a second matching portion (166) corresponding to the second trigger member (168), and the second trigger member (168) presses the second matching portion (166) to move the second limiting member (165), thereby releasing the limiting effect of the second limiting member (165).
17. The steam gun according to claim 16, characterized in that A push rod (611) is provided on the eject button (61), and when the eject button (61) abuts against the linkage plate (152) and continues to push the sliding main seat (11) to move a first distance, the push rod (611) contacts the second trigger member (168); Under the deformation action of the second elastic member (162), the support block (151) moves at least a first distance and strikes the push block (5), thereby providing power to extend the steam needle assembly (2).
18. The steam gun according to claim 4, wherein The steam gun further comprises a guide sheath (3), a fixed end of the guide sheath (3) being connected to the steam gun body (6), and a free end of the guide sheath (3) being provided with a side wall opening (31); A mirror sheath (32) and the steam needle assembly (2) are arranged in the guide sheath (3), and the free end of the steam needle assembly (2) extends from the side wall opening (31); the mirror sheath (32) is used to provide a channel for flushing liquid.
19. The steam gun according to claim 18, characterized in that The clamping assembly (4) is provided with a through hole, and the mirror sheath (32) passes through the through hole, so that the clamping assembly (4) is sleeved on the outside of the mirror sheath (32).
20. The steam gun according to any one of claims 1 to 19, characterized in that Along the circumferential direction of the steam needle (21), the output holes (211) are arranged in 2 to 6 rows; along the axial direction of the steam needle (21), the output holes (211) are arranged in 4 to 8 rows.
21. A steam ablation system, characterized in that: comprising a steam source, a flushing liquid source, and a steam gun according to any one of claims 1 to 20, wherein the steam source and the flushing liquid source are respectively connected to the steam gun; The steam gun further comprises an electronic controller configured to control the generation of steam from the steam source and the delivery of steam in the steam needle assembly (2), as well as the delivery of flushing liquid.
22. A steam ablation system, characterized in that: The invention comprises an imaging device and a steam gun according to any one of claims 1 to 20, wherein the imaging device is in communication with the steam gun.
23. The steam ablation system according to claim 22, characterized in that: The imaging device is a magnetic resonance imaging device, a computer tomography scanner or a color ultrasound diagnostic device.
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Hot steam treatment instrument and hot steam treatment equipment
CN121129413A