A drug-loaded balloon dilation system

Abstract

The application provides a drug-loaded balloon expansion system, which comprises an inner tube, an intermediate tube, an outer sheath tube and a control handle; the intermediate tube is provided with a first balloon and a second balloon, and the first balloon and the second balloon both have an expansion state and a contraction state; the inner tube is inserted into and passes through the intermediate tube, a stent is sleeved on the inner tube, a first end of the stent is connected to an end of the intermediate tube, and a second end of the stent is connected to the inner tube; the outer sheath tube is sleeved on the intermediate tube; the control handle is connected to the intermediate tube to drive the intermediate tube to move relative to the inner tube, and the control handle is connected to the outer sheath tube to drive the outer sheath tube to move relative to the intermediate tube. In the operation process of the expansion system, general anesthesia is not needed for a patient, a surgery room is not needed to enter, and treatment can be completed in an outpatient clinic; it is possible that reciprocating actions of rubbing the urethra of the patient are hidden in the outer sheath tube, the urethra of the patient is little stimulated, the patient is less uncomfortable, the urethra of the patient is not easily damaged, complications are less, and safety is higher.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to a drug-loaded balloon dilation system. Background Technology

[0002] The prostate gland is located directly below the bladder and surrounds the urethra. It begins to enlarge during puberty under the influence of testosterone and continues to do so until old age. Prostatic hyperplasia (BPH) can compress the urethra, potentially causing urethral stricture and affecting normal urination.

[0003] Benign prostatic hyperplasia (BPH) leads to elongation, compression, deformation, and stricture of the posterior urethra, as well as increased urethral resistance, causing high bladder pressure and related voiding symptoms. With increasing bladder pressure, compensatory hypertrophy of the detrusor muscle occurs, leading to detrusor instability and related storage symptoms. If the obstruction is not relieved for a prolonged period, the detrusor muscle loses its compensatory capacity. Upper urinary tract changes secondary to BPH, such as hydronephrosis and renal impairment, are primarily caused by increased intrabladder pressure.

[0004] The main treatments for benign prostatic hyperplasia (BPH) currently include:

[0005] 1. Drug treatment

[0006] The short-term goal of drug treatment for benign prostatic hyperplasia (BPH) is to relieve lower urinary tract symptoms, while the long-term goal is to slow disease progression and prevent complications. Maintaining a high quality of life for patients while minimizing drug side effects is the overall objective of BPH drug treatment.

[0007] 2. Surgical treatment

[0008] Patients with benign prostatic hyperplasia (BPH) whose quality of life is significantly affected may choose surgical treatment, especially those who do not respond well to or refuse medication. Surgical treatments include: transurethral resection of the prostate (TURP), transurethral holmium laser enucleation of the prostate, and open prostatectomy.

[0009] The existing technology has the following technical problems:

[0010] 1. Drug treatment cannot fundamentally resolve urethral stricture caused by benign prostatic hyperplasia and may be accompanied by side effects.

[0011] 2. Prostate surgery carries the following risks: during the procedure, there may be unexpected bleeding, nerve damage, etc.; postoperative complications may include difficulty urinating, urinary incontinence, urethral stricture, etc. Some patients may require a second surgery to resolve these issues.

[0012] 3. Existing instruments for treating benign prostatic hyperplasia require patients to be under general anesthesia and need ultrasound assistance for instrument positioning, which greatly prolongs the operation time. Summary of the Invention

[0013] This invention aims to at least partially solve one of the technical problems in related technologies. To this end, this invention provides a drug-loaded balloon dilation system, comprising: an inner tube, a middle tube, an outer sheath, and a control handle;

[0014] The intermediate tube is provided with a first balloon and a second balloon, both of which have an inflated state and a contracted state.

[0015] The inner tube is inserted into and passes through the intermediate tube. A bracket is fitted on the inner tube. The first end of the bracket is connected to the end of the intermediate tube, and the second end of the bracket is connected to the inner tube. The intermediate tube can move axially relative to the inner tube and drive the bracket to switch between an expanded state and a contracted state.

[0016] The outer sheath is fitted onto the intermediate tube and is axially movable relative to the intermediate tube;

[0017] The control handle is connected to the intermediate tube to drive the intermediate tube to move relative to the inner tube, and the control handle is connected to the outer sheath to drive the outer sheath to move relative to the intermediate tube.

[0018] The drug-loaded balloon dilation system of the present invention does not require general anesthesia or an operating room for the patient during operation, and can be completed on an outpatient basis; the reciprocating motion that may rub against the patient's urethra is hidden in the outer sheath, which minimizes irritation to the patient's urethra, reduces patient discomfort, is less likely to damage the patient's urethra, has fewer complications, and is safer.

[0019] Optionally, the control handle includes a handle housing, a rotary handwheel, a limit switch, a slider, and a transmission assembly;

[0020] The transmission assembly is located inside the handle housing, the rotating handwheel is located outside the handle housing and connected to the transmission assembly, the transmission assembly is connected to the intermediate tube to drive the intermediate tube to move relative to the inner tube, and the transmission assembly is connected to the outer sheath tube to drive the outer sheath tube to move relative to the intermediate tube.

[0021] The limit switch is located outside the handle housing and connected to the slider. The limit switch can drive the slider to move and limit the rotation of the rotary handwheel through the slider.

[0022] Optionally, the transmission assembly includes a first rack, a second rack, a third rack, a first gear, and a second gear;

[0023] The first rack is connected to the intermediate tube, the second rack is connected to the outer sheath tube, the third rack is fixed on the second rack, the first gear is located between the first rack and the third rack, the first rack and the third rack are driven by the first gear, the rotating handwheel is connected to the second gear, and the second gear meshes with the second rack;

[0024] The slider is provided with a limiting tooth at its end. The slider engages with the second gear through the limiting tooth to restrict the rotation of the second gear, thereby restricting the rotation of the rotary handwheel.

[0025] Optionally, the handle housing is provided with a handle marking line, and the rotating handwheel is provided with a first marking line. When the rotating handwheel is rotated until the handle marking line is aligned with the first marking line, the bracket is released from the outer sheath, and the first gear simultaneously meshes with the first rack and the third rack.

[0026] Optionally, the rotating handwheel has a second marking line. When the rotating handwheel is rotated until the handle marking line is aligned with the second marking line, the bracket is squeezed into an expanded state by the intermediate tube and the inner tube.

[0027] Optionally, the rotating handwheel has a third marking line. When the rotating handwheel is rotated until the handle marking line is aligned with the third marking line, the first and second balloons are released from the outer sheath, and the first gear disengages from the third rack.

[0028] Optionally, the handle housing has multiple slots, which are evenly spaced along the axial direction of the inner tube; the limit switch is provided with a locking block, a spring, and a pushing member; the spring force causes the locking block to engage in the slot, preventing the slider from moving; pressing the limit switch overcomes the spring force, causing the locking block to disengage from the slot, allowing the slider to move.

[0029] Optionally, the handle housing is provided with a first Luer connector, which is in communication with both the first balloon and the second balloon. The first Luer connector is used to deliver saline solution to the first balloon and the second balloon to inflate the first balloon and the second balloon.

[0030] The handle housing is provided with a second Luer connector, which is connected to the inner tube and is used to inject anesthetic drugs into the body through the inner tube.

[0031] Optionally, it also includes a Y-valve and a flexible cystoscope; the Y-valve is detachably connected to the second Luer connector, and the flexible cystoscope is inserted into the inner tube through the Y-valve.

[0032] Optionally, the first balloon and the second balloon are connected, and in the inflated state, the first balloon is larger than the second balloon, and both the first balloon and the second balloon are drug-loaded balloons; in the inflated state, the first balloon and the second balloon are circular or elliptical; the surface of the outer sheath is coated with a hydrophilic coating and anesthetic drugs.

[0033] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0034] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0035] Figure 1 This is a schematic diagram of an embodiment of the present invention in which the outer sheath completely covers the inner tube and the intermediate tube;

[0036] Figure 2 This is a schematic diagram of the external sheath releasing the stent, the first balloon, and the second balloon according to an embodiment of the present invention;

[0037] Figure 3 This is a schematic diagram of an embodiment of the present invention, showing the external sheath releasing the stent, the first balloon, and the second balloon, with the stent in an expanded state.

[0038] Figure 4 This is a partial top view of a control handle according to an embodiment of the present invention;

[0039] Figure 5 This is a partial bottom view of the control handle according to an embodiment of the present invention;

[0040] Figure 6 yes Figure 4 Sectional view along AA;

[0041] Figure 7 yes Figure 4 A cross-sectional view along BB;

[0042] Figure 8 and Figure 9 This is a schematic diagram for measuring the length of the prostatic urethra;

[0043] Figure 10 and Figure 11 This is a state view of the drug-loaded balloon dilation system in the second step of one embodiment of the present invention;

[0044] Figure 12 and Figure 13 This is a state view of the drug-loaded balloon dilation system in the third step of an embodiment of the present invention;

[0045] Figure 14 and Figure 15 This is a state view of the drug-loaded balloon dilation system in the fourth step of an embodiment of the present invention;

[0046] Figure 16 and Figure 17 This is a state view of the drug-loaded balloon dilation system in step five of an embodiment of the present invention;

[0047] Figure 18 and Figure 19 This is a state view of the drug-loaded balloon dilation system in step six of an embodiment of the present invention;

[0048] Figure 20 This is a state view of the drug-loaded balloon dilation system in step seven of an embodiment of the present invention.

[0049] Figure label:

[0050] 1-Bladder wall; 2-Bladder neck; 3-Prostate; 4-Urethra; 5-Penis tip; 6-First landmark; 7-Second landmark;

[0051] 10-Inner tube; 11-Support;

[0052] 20 - Intermediate tube; 21 - First balloon; 22 - Second balloon;

[0053] 30 - Outer sheath;

[0054] 40-Control handle; 41-Handle housing; 411-Handle marking line; 412-First Luer connector; 413-Second Luer connector; 414-Slot; 42-Rotating handwheel; 421-First marking line; 422-Second marking line; 423-Third marking line; 43-Limit switch; 431-Clamping block; 432-Spring; 433-Pushing element; 44-Slider; 45-First rack; 46-Second rack; 47-Third rack; 48-First gear; 49-Second gear;

[0055] 50 - Y valve; 51 - Locking knob;

[0056] 60 - Flexible cystoscope; 61 - Flexible cystoscope tube. Detailed Implementation

[0057] The technical solution of the present invention will be further described in detail below with reference to specific embodiments. It should be understood that the following embodiments are merely illustrative and explanatory of the present invention, and should not be construed as limiting the scope of protection of the present invention. All technologies implemented based on the above content of the present invention are covered within the scope of protection intended by the present invention.

[0058] See Figures 1-20This embodiment provides a drug-loaded balloon dilation system (hereinafter referred to as the dilation system), comprising: an inner tube 10, a middle tube 20, an outer sheath 30, and a control handle 40; a first balloon 21 and a second balloon 22 are disposed on the middle tube 20, both the first balloon 21 and the second balloon 22 having an inflated state and a contracted state; the inner tube 10 is longer than the middle tube 20, the inner tube 10 is inserted into and passes through the middle tube 20, and a support 11 is sleeved on the inner tube 10, the first end of the support 11 is connected to the end of the middle tube 20, and the second end of the support 11 is connected to the inner tube 10; the middle tube 20 can move axially relative to the inner tube 10, thereby causing the support 11 to switch between the inflated state and the contracted state; specifically, by moving the middle tube 20 relative to the inner tube 10, the inner tube 10 and the middle tube 20 compress the support 11, thereby changing the support 11 from the contracted state to the inflated state. In the contracted state, the support 11 is attached to the outer surface of the inner tube 10, and in the inflated state, the support 11 is circular or elliptical.

[0059] The expansion and contraction principle of the stent 11: One end of the stent 11 is fixed to the inner tube 10, and the other end is fixed to the intermediate tube 20. When the inner tube 10 remains stationary, that is, the left end of the stent 11 remains stationary, and the intermediate tube 20 is pushed forward, that is, the right end of the stent 11 moves to the left, the stent 11 will expand.

[0060] The outer sheath 30 is fitted onto the intermediate tube 20 and can move axially relative to the intermediate tube 20; the outer sheath 30 can completely cover the inner tube 10, the support 11 and the entire intermediate tube 20, thereby reducing the stimulation of the urethra 4 when passing through the urethra 4.

[0061] The control handle 40 is connected to the intermediate tube 20 to drive the intermediate tube 20 to move relative to the inner tube 10, thereby controlling the state of the stent 11. The control handle 40 is also connected to the outer sheath 30 to drive the outer sheath 30 to move relative to the intermediate tube 20, thereby releasing the stent 11, the first balloon 21, and the second balloon 22.

[0062] The above-mentioned procedure does not require general anesthesia or an operating room for the patient and can be completed on an outpatient basis. The outer sheath 30 in the above-mentioned procedure can be coated with a hydrophilic coating, which hides the reciprocating motion that may rub against the patient's urethra within the outer sheath 30, minimizing irritation to the patient's urethra, reducing patient discomfort, reducing the risk of urethral damage, resulting in fewer complications and higher safety.

[0063] In some embodiments, the control handle 40 includes a handle housing 41, a rotary handwheel 42, a limit switch 43, a slider 44, and a transmission assembly. The transmission assembly is located inside the handle housing 41, the rotary handwheel 42 is disposed outside the handle housing 41 and connected to the transmission assembly, the transmission assembly is connected to the intermediate tube 20 to drive the intermediate tube 20 to move relative to the inner tube 10, and the transmission assembly is connected to the outer sheath tube 30 to drive the outer sheath tube 30 to move relative to the intermediate tube 20. The limit switch 43 is disposed outside the handle housing 41 and connected to the slider 44. The limit switch 43 can drive the slider 44 to move and limit the rotation of the rotary handwheel 42 through the slider 44. The rotation of the rotary handwheel 42 can drive the transmission assembly, thereby controlling the movement of the intermediate tube 20 and the outer sheath tube 30.

[0064] Specifically, the transmission assembly includes a first rack 45, a second rack 46, a third rack 47, a first gear 48, and a second gear 49; the first rack 45 is connected to the intermediate tube 20, the second rack 46 is connected to the outer sheath tube 30, the third rack 47 is fixed on the second rack 46, the first gear 48 is located between the first rack 45 and the third rack 47, and the first rack 45 and the third rack 47 are driven by the first gear 48; the rotating handwheel 42 is connected to the second gear 49, and the second gear 49 meshes with the second rack 46; the end of the slider 44 is provided with a limiting tooth, and the slider 44 meshes with the second gear 49 through the limiting tooth to limit the rotation of the second gear 49, thereby limiting the rotation of the rotating handwheel 42.

[0065] In some embodiments, a handle marking line 411 is provided on the handle housing 41, and a first marking line 421 is provided on the rotating handwheel 42. When the rotating handwheel 42 is rotated until the handle marking line 411 is aligned with the first marking line 421, the bracket 11 is released from the outer sheath tube 30, and the first gear 48 simultaneously meshes with the first rack 45 and the third rack 47.

[0066] The first gear 48 is always engaged with the first rack 45, and the first gear 48 is engaged with the third rack 47 in certain states. The second gear 49 is always engaged with the second rack 46.

[0067] Furthermore, there is a second marking line 422 on the rotating handwheel 42. When the rotating handwheel 42 is rotated until the handle marking line 411 is aligned with the second marking line 422, the bracket 11 is squeezed into an expanded state by the intermediate tube 20 and the inner tube 10.

[0068] Furthermore, there is a third marking line 423 on the rotating handwheel 42. When the rotating handwheel 42 is rotated until the handle marking line 411 is aligned with the third marking line 423, the first balloon 21 and the second balloon 22 are released from the outer sheath tube 30, and the first gear 48 disengages from the third rack 47.

[0069] See Figure 5 and Figure 6The handle housing 41 has multiple slots 414, which are evenly spaced along the axial direction of the inner tube 10; see reference. Figure 7 The limit switch 43 is equipped with a locking block 431 and a spring 432; the elastic force of the spring 432 causes the locking block 431 to be locked into the slot 414, so that the slider 44 cannot move; by pressing the limit switch 43, the elastic force of the spring 432 is overcome, so that the locking block 431 is disengaged from the slot 414, so that the slider 44 can move.

[0070] Specifically, when the limit switch 43 is pressed, the block 431 disengages from the slot 414, and the pusher 433 on the limit switch 43 is pushed, the slider 44 can move back and forth.

[0071] In some embodiments, a first Luer connector 412 is provided on the handle housing 41. The first Luer connector 412 is in communication with both the first balloon 21 and the second balloon 22. The first Luer connector 412 is used to deliver saline solution to the first balloon 21 and the second balloon 22 so as to inflate the first balloon 21 and the second balloon 22.

[0072] Furthermore, a second Luer connector 413 is provided on the handle housing 41. The second Luer connector 413 is connected to the inner tube 10 and is used to inject anesthetic drugs into the body through the inner tube 10.

[0073] In some embodiments, the drug-loaded balloon dilation system further includes a Y-valve 50 and a flexible cystoscope 60; the Y-valve 50 is detachably connected to a second Luer connector 413, and the flexible cystoscope 60 is inserted into the inner tube 10 through the Y-valve 50.

[0074] In some embodiments, the first balloon 21 and the second balloon 22 are connected, and in the inflated state, the first balloon 21 is larger than the second balloon 22. Both the first balloon 21 and the second balloon 22 are drug-loaded balloons. In the inflated state, the first balloon 21 and the second balloon 22 are circular or elliptical. The surface of the outer sheath 30 is coated with a hydrophilic coating and anesthetic drugs.

[0075] Based on the above description of various embodiments, the operation mode of the drug-loaded balloon dilation system in this embodiment will be described below.

[0076] Step 1: Measure the length of the prostatic urethra

[0077] See Figure 8 Insert the flexible cystoscope 60 into the urethra 4. Observe the position of the flexible cystoscope tip in the urethra 4 under visualization. When the flexible cystoscope tip reaches the bladder neck 2, make the first mark 6 on the flexible cystoscope at the tip of the penis 5. See reference. Figure 9The flexible cystoscope 60 is moved outwards, and its position within the urethra 4 is observed through it. When the tip of the flexible cystoscope reaches between the verumontanum and the external sphincter, a second mark 7 is made on the flexible cystoscope at the distal end of the penis 5. The distance between the first mark 6 and the second mark 7 is measured, which is the length of the prostatic urethra. This measurement is repeated multiple times, and this is used as the basis for selecting the balloon model.

[0078] Step Two:

[0079] See Figure 10 and Figure 11 The drug-loaded balloon dilation system includes an outer sheath 30 coated with a hydrophilic coating and anesthetic drugs, an intermediate tube 20 carrying a stent 11 and a balloon, an inner tube 10, a rotating handwheel 42, and a gear and rack structure. Anesthetic drugs can be injected into the body through the inner tube 10 via a second Luer connector 413. The flexible cystoscope 60's cystoscope tube 61 is inserted into the inner tube 10 via a Y-valve 50. When the tip of the flexible cystoscope reaches the distal outlet of the dilation system, the Y-valve 50 is locked by the locking knob 51, thus fixing the relative position of the flexible cystoscope 60 and the dilation system. The dilation system and the flexible cystoscope are then inserted together into the urethra 4 through the urethral opening and into the bladder. Real-time observation is performed through the flexible cystoscope 60. Insertion is stopped when the distal end of the dilation system approaches the bladder wall 1. At this time, the gear and rack structure is as follows: Figure 10 As shown, the rotating handwheel 42 is connected to the second gear 49, and the second gear 49 is locked by the slider 44 and cannot rotate.

[0080] Step 3:

[0081] See Figure 12 and Figure 13 Keeping the dilation system and cystoscope still, move the pusher 433 to separate the slider 44 from the second gear 49. Rotate the rotating handwheel 42 counterclockwise, and the outer sheath 30 begins to move outward. Stop rotating when the first marking line 421 is aligned with the handle marking line 411. At this time, the support 11 is released from the outer sheath 30.

[0082] Step 4:

[0083] See Figure 14 and Figure 15 Continue to rotate the handwheel 42 counterclockwise. Through the combined action of all gears and racks, the first gear 48 meshes with the first rack 45 and the third rack 47 at the same time. As a result, the outer sheath tube 30 retracts and moves forward along with the middle tube 20. The tail end of the bracket 11 begins to be released from the outer sheath tube 30. The bracket 11 gradually expands. When the second marking line 422 aligns with the handle marking line 411, it indicates that the bracket 11 is fully expanded.

[0084] Step 5:

[0085] See Figure 16and Figure 17 Pressing the limit switch 43 and moving the pusher 433 causes the slider 44 to engage the second gear 49, preventing the handwheel 42 from rotating and keeping the gear and rack structure fixed. The flexible cystoscope and dilation system are pulled outwards as a whole until resistance is encountered. Observation using the flexible cystoscope 60 indicates that the stent 11 is located at the bladder outlet. At this point, the first balloon 21 and the second balloon 22 have reached the prostate 3.

[0086] Step 6:

[0087] See Figure 18 and Figure 19 Keeping the system as a whole stationary, the slider 44 and the second gear 49 are separated by the pusher 433. The rotating handwheel 42 is then turned, and the outer sheath 30 continues to retract. During the rotation of the handwheel 42, the intermediate tube 20 remains stationary, meaning the shape of the support 11 is unaffected. When the third indicator line 423 aligns with the handle indicator line 41, it indicates that the first balloon 21 and the second balloon 22 have been completely released from the outer sheath 30. The second gear 49 is then locked to restrict the rotation of the handwheel 42. The reason why the first balloon 21 and the second balloon 22 are released last from the outer sheath 30 is because the surface of the outer sheath 30 is coated with a hydrophilic coating, allowing the outer sheath 30 to move back and forth in the urethra as much as possible. Therefore, in the fourth step, when the entire dilation system is pulled outwards, because the first balloon 21 and the second balloon 22 are inside the outer sheath 30, the irritation to the urethra is minimal.

[0088] Step 7:

[0089] See Figure 20 Keeping the system stationary, inject saline solution through the first Luer connector 412 to inflate the first balloon 21 and the second balloon 22, thereby completing the dilation of the urethral stricture caused by benign prostatic hyperplasia and releasing the medication coated on the balloon surface into the tissue, thus completing the treatment.

[0090] Step 8:

[0091] Controlling the contraction of the first balloon 21 and the second balloon 22 pushes the pusher 433, causing the slider 44 to separate from the second gear 49. Rotating the handwheel 42 clockwise advances the outer sheath 30. When the second indicator line 422 aligns with the handle indicator line 411, it indicates that the first balloon 21 and the second balloon 22 are retracted into the sheath 30. Push the entire device inwards, observing in real-time with the aid of a flexible cystoscope 60. Continuing to rotate the handwheel 42 clockwise causes the stent 11 to begin contracting, and the outer sheath 30 continues to advance. The stent 11 gradually retracts into the outer sheath 30. When the handwheel 42 can no longer be rotated clockwise, it indicates that the stent 11 is fully retracted into the outer sheath 30. The entire dilation system is then withdrawn from the urethra, ending the treatment.

[0092] In summary, the drug-eluting balloon dilation system in this embodiment does not require other auxiliary positioning equipment, such as ultrasound. Doctors can treat patients using the system's built-in positioning function and with the assistance of a flexible cystoscope. This embodiment allows for real-time observation of the instrument's position within the body via a flexible cystoscope. This embodiment is very convenient to operate; doctors only need to rotate the handwheel to complete multiple treatment steps, and a limit switch prevents misoperation caused by handwheel rotation. This embodiment uses a support for positioning, resulting in more precise positioning and preventing instrument movement during use. This embodiment integrates the surgical process into a single system, reducing doctor training time and making it easy to learn. The outer sheath of this embodiment contains anesthetic drugs, which can be injected into the body via a delivery system, reducing patient discomfort.

[0093] In the description of this invention, it should be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," and "circumferential" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and simplifying the description, and are not intended to indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention.

[0094] Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one of that feature. In the description of this invention, "a plurality of" means at least two, such as two, three, etc., unless otherwise explicitly specified.

[0095] In this invention, unless otherwise explicitly specified and limited, the terms "installation," "connection," "linking," and "fixing," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between them; they can refer to a direct connection or an indirect connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise explicitly limited. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0096] In this invention, unless otherwise explicitly specified and limited, "above" or "below" the second feature can mean that the first feature is in direct contact with the second feature, or that the first feature is in indirect contact with the second feature through an intermediate medium. Furthermore, "above," "over," and "on top" of the second feature can mean that the first feature is directly above or diagonally above the second feature, or simply that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature can mean that the first feature is directly below or diagonally below the second feature, or simply that the first feature is at a lower horizontal level than the second feature.

[0097] In this invention, the terms "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., refer to a specific feature, structure, material, or characteristic described in connection with that embodiment or example, which is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples. Moreover, without contradiction, those skilled in the art can combine and integrate the different embodiments or examples described in this specification, as well as the features of different embodiments or examples.

[0098] Although embodiments of the present invention have been shown and described above, it is understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those skilled in the art can make changes, modifications, substitutions and variations to the above embodiments within the scope of the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A drug-loaded balloon dilation system, characterized in that, include: Inner tube (10), intermediate tube (20), outer sheath tube (30) and control handle (40); The intermediate tube (20) is provided with a first balloon (21) and a second balloon (22), both of which have an expanded state and a contracted state; The inner tube (10) is inserted into and passes through the intermediate tube (20). A bracket (11) is fitted on the inner tube (10). The first end of the bracket (11) is connected to the end of the intermediate tube (20), and the second end of the bracket (11) is connected to the inner tube (10). The intermediate tube (20) can move axially relative to the inner tube (10) and drive the bracket (11) to switch between an expanded state and a contracted state. The outer sheath (30) is sleeved on the intermediate tube (20) and can move axially relative to the intermediate tube (20); The control handle (40) includes a handle housing (41), a rotary handwheel (42), a limit switch (43), a slider (44), and a transmission assembly; the transmission assembly is located inside the handle housing (41), and the rotary handwheel (42) is located outside the handle housing (41); the transmission assembly includes a first rack (45), a second rack (46), a third rack (47), a first gear (48), and a second gear (49), the first rack (45) being connected to the intermediate tube (20) to drive the intermediate tube (20) relative to the inner tube (10). The second rack (46) is connected to the outer sheath tube (30) to drive the outer sheath tube (30) to move relative to the intermediate tube (20). The third rack (47) is fixed on the second rack (46). The first gear (48) is located between the first rack (45) and the third rack (47). The first rack (45) and the third rack (47) are driven by the first gear (48). The rotating handwheel (42) is connected to the second gear (49). The second gear (49) meshes with the second rack (46). Rotating the handwheel causes the second rack to drive the outer sheath to move outward, thereby releasing the stent from the outer sheath. Continuing to rotate the handwheel causes the first gear to mesh with both the first and third racks simultaneously, causing the second rack to drive the outer sheath backward and the first rack to drive the intermediate tube forward, thereby releasing the tail end of the stent from the outer sheath until the stent is fully expanded.

2. The drug-loaded balloon dilation system according to claim 1, characterized in that, The limit switch (43) is located outside the handle housing (41) and connected to the slider (44). The limit switch (43) can drive the slider (44) to move and limit the rotation of the rotary handwheel (42) through the slider (44).

3. The drug-loaded balloon dilation system according to claim 2, characterized in that, The end of the slider (44) is provided with a limiting tooth. The slider (44) meshes with the second gear (49) through the limiting tooth to restrict the rotation of the second gear (49), thereby restricting the rotation of the rotating handwheel (42).

4. The drug-loaded balloon dilation system according to claim 3, characterized in that, The handle housing (41) is provided with a handle marking line (411), and the rotating handwheel (42) has a first marking line (421). When the rotating handwheel (42) is rotated until the handle marking line (411) is aligned with the first marking line (421), the bracket (11) is released from the outer sheath (30), and the first gear (48) simultaneously meshes with the first rack (45) and the third rack (47).

5. The drug-loaded balloon dilation system according to claim 4, characterized in that, The rotating handwheel (42) has a second marking line (422). When the rotating handwheel (42) is rotated to the point where the handle marking line (411) is aligned with the second marking line (422), the bracket (11) is squeezed into an expanded state by the intermediate tube (20) and the inner tube (10).

6. The drug-loaded balloon dilation system according to claim 5, characterized in that, The rotating handwheel (42) has a third marking line (423). When the rotating handwheel (42) is rotated until the handle marking line (411) is aligned with the third marking line (423), the first balloon (21) and the second balloon (22) are released from the outer sheath (30), and the first gear (48) disengages from the third rack (47).

7. The drug-loaded balloon dilation system according to claim 2, characterized in that, The handle housing (41) has multiple slots (414) that are evenly spaced along the axial direction of the inner tube (10). The limit switch (43) is provided with a block (431), a spring (432), and a pusher (433). The spring force of the spring (432) causes the block (431) to engage in the slot (414), so that the slider (44) cannot move. By pressing the limit switch (43), the spring force of the spring (432) is overcome, so that the block (431) disengages from the slot (414), so that the slider (44) can move.

8. The drug-loaded balloon dilation system according to claim 2, characterized in that, The handle housing (41) is provided with a first Luer connector (412), which is connected to both the first balloon (21) and the second balloon (22). The first Luer connector (412) is used to deliver saline solution to the first balloon (21) and the second balloon (22) to inflate the first balloon (21) and the second balloon (22). The handle housing (41) is provided with a second Luer connector (413), which is connected to the inner tube (10). The second Luer connector (413) is used to inject anesthetic drugs into the body through the inner tube (10).

9. The drug-loaded balloon dilation system according to claim 8, characterized in that, It also includes a Y-valve (50) and a flexible cystoscope (60); The Y valve (50) can be detachably connected to the second Luer connector (413), and the flexible cystoscope (60) is inserted into the inner tube (10) through the Y valve (50).

10. The drug-loaded balloon dilation system according to claim 1, characterized in that, The first balloon (21) and the second balloon (22) are connected. The first balloon (21) is located at the proximal end of the second balloon (22). In the inflated state, the first balloon (21) is larger than the second balloon (22). Both the first balloon (21) and the second balloon (22) are drug-loaded balloons. In the inflated state, the first balloon (21) and the second balloon (22) are circular or elliptical. The surface of the outer sheath (30) is coated with a hydrophilic coating and anesthetic drugs.

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