Drug-loaded balloon dilatation system

Abstract

The invention provides a drug-loaded balloon dilatation system. The drug-loaded balloon dilatation system comprises an inner tube, a middle tube, an outer sheath tube and a control handle, a first balloon and a second balloon are arranged on the middle tube, and both the first balloon and the second balloon have an expansion state and a contraction state; the inner pipe is inserted into and penetrates through the middle pipe and sleeved with a support, the first end of the support is connected with the end of the middle pipe, and the second end of the support is connected with the inner pipe. The outer sheath tube is sleeved on the middle tube; the control handle is connected with the middle tube to drive the middle tube to move relative to the inner tube, and the control handle is connected with the outer sheath tube to drive the outer sheath tube to move relative to the middle tube. According to the expansion system, the patient does not need to be subjected to general anesthesia in the operation process and does not need to enter an operating room, and treatment can be completed in an outpatient service; reciprocating actions possibly rubbing the urethra of a patient are hidden in the outer sheath tube, so that stimulation to the urethra of the patient is small, discomfort of the patient is relieved, the urethra of the patient is not prone to being damaged, complications are fewer, and safety is higher.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular, to a drug-coated balloon dilation system. Background Art

[0002] The prostate is located directly below the bladder and surrounds the urethra. It continues to grow under the influence of testosterone from puberty until old age. After the prostate hyperplasia, it will occupy the space of the urethra, easily causing urethral stricture and affecting normal urination.

[0003] Prostate hyperplasia causes the posterior urethra to elongate, be compressed and deformed, become stenotic, and increase urethral resistance, resulting in high bladder pressure and related micturition symptoms. As the bladder pressure increases, compensatory hypertrophy of the detrusor muscle, detrusor instability, and related storage symptoms occur. If the obstruction is not relieved for a long time, the detrusor muscle will lose its compensatory ability. The upper urinary tract changes secondary to prostate hyperplasia, such as hydronephrosis and renal function impairment, are mainly caused by the increased pressure in the bladder.

[0004] Benign prostatic hyperplasia (BPH) is a common chronic disease mainly characterized by urinary disorders in middle-aged and elderly men. Since this disease is not fatal and patients have extraordinary endurance, the number of patients seeking medical treatment is relatively small. Therefore, the update of BPH treatment technology in China is very slow.

[0005] Currently, the main treatment methods for benign prostatic hyperplasia are as follows:

[0006] 1. Drug treatment

[0007] The short-term goal of drug treatment for patients with prostate hyperplasia is to relieve the lower urinary tract symptoms of patients, and the long-term goal is to delay the clinical progression of the disease and prevent the occurrence of complications. The overall goal of drug treatment for prostate hyperplasia is to maintain a high quality of life for patients while reducing the side effects of drug treatment.

[0008] 2. Surgical treatment

[0009] Patients with prostate hyperplasia who are significantly affected in their quality of life can choose surgical treatment, especially those with poor drug treatment effects or those who refuse to accept drug treatment. Surgical treatments include: transurethral resection of the prostate (TURP), transurethral holmium laser enucleation of the prostate, and open prostatectomy.

[0010] The prior art has the following technical problems:

[0011] 1. Drug treatment cannot fundamentally solve the urethral stricture caused by prostate hyperplasia and is accompanied by side effects.

[0012] 2. Prostate surgery may pose the following risks: unexpected bleeding, nerve damage, etc. may occur during the operation; complications such as difficulty in urination, urinary incontinence, urethral stricture, etc. may occur after the operation, and some patients may need to undergo another operation to solve these problems.

[0013] 3. Existing instruments for treating benign prostatic hyperplasia require the patient to be under general anesthesia during operation and need to use ultrasound to assist in positioning the instrument, which greatly prolongs the operation time. Summary of the Invention

[0014] The present invention aims to solve at least one of the technical problems in the related art to some extent. For this purpose, the present invention provides a drug-loaded balloon dilation system, comprising: an inner tube, an intermediate tube, an outer sheath tube and a control handle;

[0015] A first balloon and a second balloon are provided on the intermediate tube, and both the first balloon and the second balloon have a dilated state and a contracted state;

[0016] The inner tube is inserted 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, a second end of the stent is connected to the inner tube, and the intermediate tube can move axially relative to the inner tube and drive the stent to switch between a dilated state and a contracted state;

[0017] The outer sheath tube is sleeved on the intermediate tube and can move axially relative to the intermediate tube;

[0018] 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.

[0019] During the operation of the drug-loaded balloon dilation system of the present invention, general anesthesia is not required for the patient, there is no need to enter the operating room, and the treatment can be completed in the outpatient clinic; reciprocating movements that may rub the patient's urethra are all hidden in the outer sheath tube, causing little irritation to the patient's urethra, reducing the patient's discomfort, not easily damaging the patient's urethra, having fewer complications and higher safety.

[0020] Optionally, the control handle includes a handle housing, a rotary handwheel, a limit switch, a slider and a transmission component;

[0021] The transmission component is located inside the handle housing, the rotary handwheel is arranged outside the handle housing and is connected to the transmission component, the transmission component is connected to the intermediate tube to drive the intermediate tube to move relative to the inner tube, and the transmission component is connected to the outer sheath tube to drive the outer sheath tube to move relative to the intermediate tube;

[0022] The limit switch is arranged outside the handle housing and is connected to the slider. The limit switch can drive the slider to move and limit the rotation of the rotary handwheel through the slider.

[0023] Optionally, the transmission assembly includes a first rack, a second rack, a third rack, a first gear, and a second gear;

[0024] 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 rotary handwheel is connected to the second gear, and the second gear meshes with the second rack;

[0025] A limit tooth is arranged at the end of the slider. The slider engages with the second gear through the limit tooth to limit the rotation of the second gear, and further limit the rotation of the rotary handwheel.

[0026] Optionally, a handle marking line is arranged on the handle housing, and a first marking line is on the rotary handwheel. When the rotary handwheel rotates until the handle marking line is aligned with the first marking line, the bracket is released from the outer sheath tube, and the first gear meshes with the first rack and the third rack at the same time.

[0027] Optionally, a second marking line is on the rotary handwheel. When the rotary handwheel rotates 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.

[0028] Optionally, a third marking line is on the rotary handwheel. When the rotary handwheel rotates until the handle marking line is aligned with the third marking line, the first balloon and the second balloon are released from the outer sheath tube, and the first gear disengages from the third rack.

[0029] Optionally, a plurality of card slots are formed on the handle housing, and the plurality of card slots are equally spaced along the axial direction of the inner tube; a clamping block, a spring, and a pushing member are arranged on the limit switch; the elastic force of the spring causes the clamping block to be stuck in the card slot so that the slider cannot move; by pressing the limit switch to overcome the elastic force of the spring, the clamping block is disengaged from the card slot so that the slider can move.

[0030] Optionally, a first Luer connector is arranged on the handle housing, and the first Luer connector is communicated with both the first balloon and the second balloon. The first Luer connector is used to convey physiological saline to the first balloon and the second balloon to expand the first balloon and the second balloon;

[0031] A second Luer connector is provided on the handle housing. The second Luer connector is in communication with the inner tube and is used for injecting anesthetic drugs into the body through the inner tube.

[0032] Optionally, it further includes a Y valve and a flexible cystoscope. The Y valve can be detachably connected to the second Luer connector, and the flexible cystoscope is inserted into the inner tube through the Y valve.

[0033] Optionally, the first balloon and the second balloon are in communication. In the expanded state, the first balloon is larger than the second balloon. Both the first balloon and the second balloon are drug-loaded balloons. In the expanded state, the first balloon and the second balloon are circular or elliptical. The surface of the outer sheath tube is coated with a hydrophilic coating and anesthetic drugs.

[0034] Additional aspects and advantages of the present invention will be given in part in the following description, become apparent in part from the following description, or be learned through the practice of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The accompanying drawings herein are incorporated into the specification and constitute a part of the specification, showing embodiments consistent with the present invention and, together with the specification, are used to explain the principles of the present invention.

[0036] Figure 1 is a schematic diagram showing the outer sheath tube of an embodiment of the present invention completely covering the inner tube and the intermediate tube;

[0037] Figure 2 is a schematic diagram showing the outer sheath tube of an embodiment of the present invention releasing the stent, the first balloon and the second balloon;

[0038] Figure 3 is a schematic diagram showing the outer sheath tube of an embodiment of the present invention releasing the stent, the first balloon and the second balloon, and the stent being in an expanded state;

[0039] Figure 4 is a partial top view schematic diagram of the control handle of an embodiment of the present invention;

[0040] Figure 5 is a partial bottom view schematic diagram of the control handle of an embodiment of the present invention;

[0041] Figure 6 is Figure 4 a cross-sectional view along A-A;

[0042] Figure 7 is Figure 4 a cross-sectional view along B-B;

[0043] Figure 8 and Figure 9 is a schematic diagram for measuring the length of the prostatic urethra;

[0044] Figure 10 and Figure 11 are the state views of the drug - loaded balloon dilation system in the second step in one embodiment of the present invention;

[0045] Figure 12 and Figure 13 are the state views of the drug - loaded balloon dilation system in the third step in one embodiment of the present invention;

[0046] Figure 14 and Figure 15 are the state views of the drug - loaded balloon dilation system in the fourth step in one embodiment of the present invention;

[0047] Figure 16 and Figure 17 are the state views of the drug - loaded balloon dilation system in the fifth step in one embodiment of the present invention;

[0048] Figure 18 and Figure 19 are the state views of the drug - loaded balloon dilation system in the sixth step in one embodiment of the present invention;

[0049] Figure 20 are the state views of the drug - loaded balloon dilation system in the seventh step in one embodiment of the present invention.

[0050] Reference numerals:

[0051] 1 - bladder wall; 2 - bladder neck; 3 - prostate; 4 - urethra; 5 - penile tip; 6 - first marker; 7 - second marker;

[0052] 10 - inner tube; 11 - stent;

[0053] 20 - intermediate tube; 21 - first balloon; 22 - second balloon;

[0054] 30 - outer sheath tube;

[0055] 40 - control handle; 41 - handle housing; 411 - handle marking line; 412 - first Luer connector; 413 - second Luer connector; 414 - card slot; 42 - rotary handwheel; 421 - first marking line; 422 - second marking line; 423 - third marking line; 43 - limit switch; 431 - locking block; 432 - spring; 433 - pushing member; 44 - slider; 45 - first rack; 46 - second rack; 47 - third rack; 48 - first gear; 49 - second gear;

[0056] 50 - Y - valve; 51 - locking knob;

[0057] 60 - flexible cystoscope; 61 - flexible cystoscope tube. Detailed implementation manners

[0058] The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments. It should be understood that the following embodiments are only for exemplarily illustrating and explaining the present invention, and should not be construed as limiting the protection scope 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.

[0059] Referring to Figures 1 - 20 , this embodiment provides a drug-coated balloon dilation system (hereinafter referred to as the dilation system), including: an inner tube 10, an intermediate tube 20, an outer sheath tube 30, and a control handle 40; a first balloon 21 and a second balloon 22 are provided on the intermediate tube 20, and both the first balloon 21 and the second balloon 22 have a dilated state and a contracted state; the length of the inner tube 10 is greater than that of the intermediate tube 20, the inner tube 10 is inserted through and passes through the intermediate tube 20, a stent 11 is sleeved on the inner tube 10, the first end of the stent 11 is connected to the end of the intermediate tube 20, the second end of the stent 11 is connected to the inner tube 10, and the intermediate tube 20 can move axially relative to the inner tube 10 and drive the stent 11 to switch between the dilated state and the contracted state; specifically, by moving the intermediate tube 20 relative to the inner tube 10, the inner tube 10 and the intermediate tube 20 squeeze the stent 11, so that the stent 11 changes from the contracted state to the dilated state. The stent 11 adheres to the outer surface of the inner tube 10 in the contracted state, and the stent 11 is circular or elliptical in the dilated state.

[0060] Principle of expansion and contraction 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 leftward, the stent 11 will expand.

[0061] The outer sheath tube 30 is sleeved on the intermediate tube 20 and can move axially relative to the intermediate tube 20; the outer sheath tube 30 can cover the inner tube 10, the stent 11, and the entire intermediate tube 20, so as to reduce the irritation to the urethra 4 when passing through the urethra 4.

[0062] 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, so as to achieve the purpose of controlling the state of the stent 11. The control handle 40 is connected to the outer sheath tube 30 to drive the outer sheath tube 30 to move relative to the intermediate tube 20, so as to release the stent 11, the first balloon 21, and the second balloon 22.

[0063] During the operation of the above solution, general anesthesia is not required for the patient, and there is no need to enter the operating room, and the treatment can be completed in the outpatient clinic; a hydrophilic coating can be covered on the outer side of the outer sheath tube 30 in the above solution, and all reciprocating movements that may rub the patient's urethra are hidden in the outer sheath tube 30, with very little irritation to the patient's urethra, reducing the discomfort of the patient, not easily damaging the patient's urethra, having fewer complications, and higher safety.

[0064] 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 within 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, and 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.

[0065] 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 to 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 rotary handwheel 42 is connected to the second gear 49, and the second gear 49 meshes with the second rack 46; a limit tooth is provided at the end of the slider 44, and the slider 44 engages with the second gear 49 through the limit tooth to limit the rotation of the second gear 49, thereby limiting the rotation of the rotary handwheel 42.

[0066] 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 rotary handwheel 42. When the rotary handwheel 42 rotates 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 meshes with both the first rack 45 and the third rack 47 simultaneously.

[0067] Among them, the first gear 48 is always engaged with the first rack 45, the first gear 48 is engaged with the third rack 47 in certain states, and the second gear 49 is always engaged with the second rack 46.

[0068] Further, a second marking line 422 is provided on the rotary handwheel 42. When the rotary handwheel 42 rotates 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.

[0069] Further, a third marking line 423 is provided on the rotary handwheel 42. When the rotary handwheel 42 rotates 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.

[0070] Refer to Figure 5 and Figure 6, a plurality of card slots 414 are formed on the handle housing 41, and the plurality of card slots 414 are equally spaced along the axial direction of the inner tube 10; referring to Figure 7 , a clamping block 431 and a spring 432 are arranged on the limit switch 43; the elastic force of the spring 432 causes the clamping block 431 to be clamped into the card slot 414, so that the slider 44 cannot move; by pressing the limit switch 43 to overcome the elastic force of the spring 432, the clamping block 431 is disengaged from the card slot 414, so that the slider 44 can move.

[0071] Specifically, when the limit switch 43 is pressed, the clamping block 431 is disengaged from the card slot 414, and the pushing member 433 on the limit switch 43 is pushed, so that the front-back movement of the slider 44 can be realized.

[0072] In some embodiments, a first luer connector 412 is arranged on the handle housing 41, and the first luer connector 412 is communicated with both the first balloon 21 and the second balloon 22. The first luer connector 412 is used to convey physiological saline to the first balloon 21 and the second balloon 22, so that the first balloon 21 and the second balloon 22 expand;

[0073] Furthermore, a second luer connector 413 is arranged on the handle housing 41, and the second luer connector 413 is communicated with the inner tube 10. The second luer connector 413 is used to inject anesthetic drugs into the body through the inner tube 10.

[0074] In some embodiments, the drug-loaded balloon dilation system further 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.

[0075] In some embodiments, the first balloon 21 and the second balloon 22 are communicated. In the expanded state, the first balloon 21 is larger than the second balloon 22, and both the first balloon 21 and the second balloon 22 are drug-loaded balloons; in the expanded state, the first balloon 21 and the second balloon 22 are circular or elliptical; the surface of the outer sheath tube 30 is coated with a hydrophilic coating and anesthetic drugs.

[0076] Based on the introduction of the above embodiments, the operation method of the drug-loaded balloon dilation system in this embodiment is introduced below.

[0077] The first step: Measure the length of the prostatic urethra

[0078] Referring to Figure 8 , insert the flexible cystoscope 60 into the urethra 4, observe the position of the distal end of the flexible cystoscope in the urethra 4 under visualization. When the distal end of the flexible cystoscope reaches the bladder neck 2, make a first mark 6 on the flexible cystoscope at the penile end 5. Referring to Figure 9, move the flexible cystoscope 60 in the direction of the outside of the body, observe the position of the distal end of the flexible lens in the urethra 4 through the flexible cystoscope 60. When the distal end of the flexible lens reaches between the seminal colliculus and the external sphincter, make a second mark 7 on the flexible cystoscope at the end of the penis 5. Measure the distance between the first mark 6 and the second mark 7, which is the length of the prostatic urethra. Measure multiple times repeatedly and use this as the basis for selecting the balloon model.

[0079] Step 2:

[0080] Refer to Figure 10 and Figure 11 , the drug-loaded balloon dilation system includes an outer sheath 30 coated with a hydrophilic coating and an anesthetic drug, an intermediate tube 20 carrying a stent 11 and a balloon, an inner tube 10, a rotating handwheel 42, a rack and pinion structure, etc.; an anesthetic drug can be injected into the body through the inner tube 10 via the second Luer connector 413; insert the flexible cystoscope tube 61 of the flexible cystoscope 60 into the inner tube 10 through the Y-valve 50. When the distal end of the flexible cystoscope reaches the distal outlet of the dilation system, lock the Y-valve 50 through the locking knob 51. At this time, the relative position of the flexible cystoscope 60 and the dilation system is fixed; insert the combined dilation system and flexible cystoscope into the urethra 4 from the urethral orifice and reach the inside of the bladder. Through real-time observation by the flexible cystoscope 60, when the distal end of the dilation system approaches the bladder wall 1, stop inserting. At this time, the state of the rack and pinion is as Figure 10 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.

[0081] Step 3:

[0082] Refer to Figure 12 and Figure 13 , keep the dilation system and the flexible cystoscope stationary, 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 starts to move in the direction of the outside of the body. Stop rotating when the first marking line 421 aligns with the handle marking line 411. At this time, the stent 11 is released from the outer sheath 30.

[0083] Step 4:

[0084] Refer to Figure 14 and Figure 15 , continue to rotate the rotating handwheel 42 counterclockwise. Through the combined action of all the racks and pinions, at this time, the first gear 48 meshes with the first rack 45 and the third rack 47 at the same time, so that the outer sheath 30 retracts and the intermediate tube 20 advances. The tail end part of the stent 11 starts to be released from the outer sheath 30, and the stent 11 gradually expands. When the second marking line 422 aligns with the handle marking line 411, it indicates that the stent 11 is fully expanded.

[0085] Step 5:

[0086] Refer to Figure 16and Figure 17 Press the lower limit switch 43, move the pusher 433, the slider 44 catches the second gear 49, and the rotary handwheel 42 cannot rotate, and the rack and pinion structure remains fixed. The cystoscope and the dilation system are pulled outward as a whole until the pulling is blocked, and the cystoscope 60 is used for auxiliary observation, indicating that the stent 11 is located at the bladder outlet at this time. At this time, the first balloon 21 and the second balloon 22 reach the prostate 3 position.

[0087] Sixth step:

[0088] Refer to Figure 18 and Figure 19 Keep the system as a whole stationary, separate the slider 44 and the second gear 49 through the pusher 433, rotate the rotary handwheel 42, and the outer sheath tube 30 continues to be withdrawn backward. During the rotation of the rotary handwheel 42, the intermediate tube 20 remains stationary, that is, the shape of the stent 11 will not be affected. When the third marking line 423 aligns with the handle marking line 41, it indicates that the first balloon 21 and the second balloon 22 are completely released from the outer sheath tube 30. Lock the second gear 49 to restrict the rotation of the rotary handwheel 42. The purpose of releasing the first balloon 21 and the second balloon 22 from the outer sheath tube 30 last is that the surface of the outer sheath tube 30 is coated with a hydrophilic coating, and the outer sheath tube 30 is allowed to move back and forth in the urethra as much as possible. Therefore, in the fourth step, when the dilation system is pulled outward as a whole, because the first balloon 21 and the second balloon 22 are inside the outer sheath tube 30, the stimulation to the urethra is very small.

[0089] Seventh step:

[0090] Refer to Figure 20 Keep the system stationary, inject normal saline through the first Luer connector 412 to expand the first balloon 21 and the second balloon 22, complete the dilation of the urethral stricture segment caused by benign prostatic hyperplasia, and release the drug coated on the balloon surface into the tissue to complete the treatment.

[0091] Eighth step:

[0092] Control the contraction of the first balloon 21 and the second balloon 22, push the pusher 433 to separate the slider 44 from the second gear 49, rotate the rotary handwheel 42 clockwise, the outer sheath tube 30 advances. When the second marking line 422 aligns with the handle marking line 411, it indicates that the first balloon 21 and the second balloon 22 are retracted into the sheath tube 30. Push the whole instrument inward, and observe in real time with the cystoscope 60. Continue to rotate the rotary handwheel 42 clockwise, the stent 11 begins to contract, the outer sheath tube 30 continues to advance, and the stent 11 gradually retracts into the outer sheath tube 30. When the rotary handwheel 42 cannot continue to rotate clockwise, it indicates that the stent 11 is completely retracted into the outer sheath tube 30. Withdraw the dilation system as a whole from the urethra, and the treatment is over.

[0093] In summary, the drug-loaded balloon dilatation system in this embodiment does not require the use of other auxiliary positioning equipment, such as ultrasound, etc. The doctor can treat the patient according to the positioning function of the system and the assistance of the cystoscope; this embodiment can observe the position of the instrument in the human body in real time through the cystoscope. This embodiment is very convenient to operate. The doctor only needs to turn the rotating handwheel to complete multiple treatment steps, and there is a limit switch to prevent misoperation caused by turning the rotating handwheel. This embodiment uses the bracket for positioning, which is more accurate and can prevent the doctor from moving the instrument during use. This embodiment integrates the surgical process into a system, reduces the doctor's learning time, and is easy to use. In this embodiment, there is anesthetic on the surface of the outer sheath, and the anesthetic can be injected into the body through the delivery system to reduce patient discomfort.

[0094] In the description of the present invention, it is to be understood that the terms “center”, “longitudinal”, “lateral”, “length”, “width”, “thickness”, “up”, “down”, “front”, “back”, “left”, “right”, “vertical”, “horizontal”, “top”, “bottom”, “inside”, “outside”, “clockwise”, “counterclockwise”, “axial”, “radial”, “circumferential”, etc., indicating orientations or positional relationships based on the orientations or positional relationships shown in the accompanying drawings, are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the referred device or element must have a specific orientation, be constructed and operated in a specific orientation, and therefore should not be understood as limiting the present invention.

[0095] In addition, the terms "first" and "second" are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of the indicated technical features. Therefore, the features defined as "first" and "second" may explicitly or implicitly include at least one of the features. In the description of the present invention, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0096] In the present invention, unless otherwise clearly specified and limited, the terms "installed", "connected", "connected", "fixed" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral one; it can be a mechanical connection, an electrical connection, or communication with each other; it can be a direct connection, or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0097] In the present invention, unless otherwise clearly specified or limited, a first feature being "on" or "under" a second feature may mean that the first and second features are in direct contact, or the first and second features are indirectly in contact via an intermediate medium. Moreover, a first feature being "above", "over" and "on top of" a second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the horizontal height of the first feature is higher than that of the second feature. A first feature being "under", "below" and "beneath" a second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the horizontal height of the first feature is less than that of the second feature.

[0098] In the present invention, the terms "an embodiment", "some embodiments", "example", "specific example", or "some examples", etc. mean that the specific features, structures, materials, or characteristics described in connection with the embodiment or example are included in at least one embodiment or example of the present invention. 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 may be combined in any one or more embodiments or examples in a suitable manner. In addition, without contradiction, those skilled in the art may combine and combine the different embodiments or examples described in this specification and the features of the different embodiments or examples.

[0099] Although the embodiments of the present invention have been shown and described above, it can be understood that the above embodiments are exemplary and should not be construed as limiting the present invention. Those of ordinary skill 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 principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A drug - loaded balloon dilation system, characterized in that, Comprising: an inner tube (10), an intermediate tube (20), an outer sheath tube (30), and a control handle (40); a first balloon (21) and a second balloon (22) are provided on the intermediate tube (20), and both the first balloon (21) and the second balloon (22) have an expanded state and a contracted state; the inner tube (10) is inserted through and passes through the intermediate tube (20), a stent (11) is sleeved on the inner tube (10), a first end of the stent (11) is connected to an end of the intermediate tube (20), a second end of the stent (11) is connected to the inner tube (10), the intermediate tube (20) can move axially relative to the inner tube (10), and drives the stent (11) to switch between an expanded state and a contracted state; the outer sheath tube (30) is sleeved on the intermediate tube (20) and can move axially relative to the intermediate tube (20); 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), and the control handle (40) is connected to the outer sheath tube (30) to drive the outer sheath tube (30) to move relative to the intermediate tube (20).

2. The drug-loaded balloon dilation system according to claim 1, wherein, 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 provided outside the handle housing (41) and is 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 provided outside the handle housing (41) and is 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, wherein 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 to 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 rotary handwheel (42) is connected to the second gear (49), and the second gear (49) meshes with the second rack (46); a limit tooth is provided at an end of the slider (44), and the slider (44) engages with the second gear (49) through the limit tooth to limit the rotation of the second gear (49), thereby limiting the rotation of the rotary handwheel (42).

4. The drug-loaded balloon dilation system according to claim 3, wherein, A handle marking line (411) is provided on the handle housing (41). There is a first marking line (421) on the rotary handwheel (42). When the rotary handwheel (42) rotates to align the handle marking line (411) with the first marking line (421), the bracket (11) is released from the outer sheath tube (30), and the first gear (48) meshes with the first rack (45) and the third rack (47) simultaneously.

5. The drug-loaded balloon dilation system according to claim 4, wherein There is a second marking line (422) on the rotary handwheel (42). When the rotary handwheel (42) rotates to align the handle marking line (411) 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, There is a third marking line (423) on the rotary handwheel (42). When the rotary handwheel (42) rotates to align the handle marking line (411) 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).

7. The drug-loaded balloon dilation system according to claim 2, wherein, A plurality of card slots (414) are formed on the handle housing (41). The plurality of card slots (414) are equidistantly spaced along the axial direction of the inner tube (10). A latch block (431), a spring (432), and a pushing member (433) are provided on the limit switch (43). The elastic force of the spring (432) causes the latch block (431) to be engaged in the card slot (414), so that the slider (44) cannot move. By pressing the limit switch (43) to overcome the elastic force of the spring (432), the latch block (431) is disengaged from the card slot (414), so that the slider (44) can move.

8. The drug-loaded balloon dilation system according to claim 2, wherein A first Luer connector (412) is provided on the handle housing (41). The first Luer connector (412) is communicated with both the first balloon (21) and the second balloon (22). The first Luer connector (412) is used to convey physiological saline to the first balloon (21) and the second balloon (22) to expand the first balloon (21) and the second balloon (22). A second Luer connector (413) is provided on the handle housing (41). The second Luer connector (413) is communicated with 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, wherein, It further includes a Y valve (50) and a flexible cystoscope (60). The Y valve (50) can be detachably connected to the second Luer connector (413). 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, wherein, The first balloon (21) and the second balloon (22) are in communication. In the expanded state, the first balloon (21) is larger than the second balloon (22). Both the first balloon (21) and the second balloon (22) are drug-coated balloons. In the expanded state, the first balloon (21) and the second balloon (22) are circular or oval in shape. The surface of the outer sheath tube (30) is coated with a hydrophilic coating and an anesthetic drug.

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