Bracket for treating benign prostatic hyperplasia and implantation system
By designing a wrap-around prostate hyperplasia stent with nickel-titanium alloy material and combining with the traction device, the existing stent has solved the problems of obvious edges and angles, complex molding and discomfort in implantation, and the round shape of the stent is realized, simplified structure and convenient implantation and removal process.
Patent Information
- Application Number
- CN202421644121.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2024-07-12
- Publication Date
- 2025-06-13
- Estimated Expiration
- 2034-07-12
AI Technical Summary
The existing prostate hyperplasia stent has obvious edges and corners after being released, which leads to discomfort in the patient, and is complex in forming and setting, and has a greater discomfort during implantation and removal.
A stent for treating prostate hyperplasia was designed, using nickel-titanium alloy material, formed by wrapping a single stent wire, including multiple stent rings and transition tendons, combining traction beads, traction wires and implantation devices to improve the shaping shape and structure and simplify the implantation and removal process.
The improved stent has a round and smooth body shape, without sharp corners and convex points, which reduces discomfort during implantation, simplifies the structure and processing difficulty of the stent, and is adapted to surgical channels and laminoscopic instrument channels to facilitate the correct placement and subsequent removal of the stent.
Smart Images
Figure CN222968702U_ABST
Abstract
Description
Technical Field
[0001] The utility model belongs to the field of medical devices, in particular to a stent and an implantation system for treating prostatic hyperplasia. Background Art
[0002] The prostate is a walnut-shaped gland that surrounds the urethra, and urine is discharged from the bladder through it. Although the gland is initially small, it has a tendency to enlarge as a man ages. An overly enlarged prostate can lead to a disease called benign prostatic hyperplasia (BPH). Benign prostatic hyperplasia (BPH) refers to an abnormal but non-malignant (non-cancerous) growth of the prostate that is commonly observed in older men. BPH is a chronic condition and is associated with the development of urinary flow obstruction or luminal stenosis in the prostatic urethra. Bladder outlet obstruction (BOO) refers to an obstruction at the base of the bladder that reduces or prevents urine from flowing into the urethra and may be secondary to BPH. A series of related conditions collectively referred to as lower urinary tract symptoms (LUTS) can lead to including sexual dysfunction, frequent urination, difficulty urinating, urinary retention, urinary incontinence, and urinary and bladder infections, and this situation will worsen as the prostate hypertrophies and develops due to abnormal growth.
[0003] Currently, the common treatment options for BPH mainly include drug treatment, classical surgery, laser treatment, vapor ablation, stent implantation, prostate urethral lift (PUL therapy), etc. Among them, "stent implantation" can avoid damaging the prostate tissue, aiming to enlarge the diameter of the prostatic urethra without removing tissue from the prostate. Prostate implant stent is a surgical procedure in which a urologist inserts a small device into the prostatic urethra narrowed by the enlarged prostate tissue. Once placed in position, the implant stent is designed to expand and help keep the urethra open by pushing aside tissue lobules, while preventing the enlarged prostate tissue from being fully affected and opening the urethra. Ideally, prostate implants eliminate the need for surgical removal of prostate tissue and can reduce the risks of infection, sexual dysfunction, and urinary incontinence. Since the removable implant stent may need to be removed in the future for additional surgical treatment, this surgical method is also designed to be reversible. Therefore, an implant delivery and placement system is needed so that doctors can perform surgical procedures in the outpatient clinic using a standard cystoscope and urological techniques commonly used to examine the obstruction and the degree of BPH in the prostatic urethra. After confirming that the implant is placed in the correct position, the delivery system will need to release the implant. So the problems to be solved now are that after the stent is released, there are obvious edges and corners, which are easy to cause discomfort to patients; the molding and shaping are complex; and the implantation and removal of the stent are improved to reduce the discomfort during implantation. Summary of the Invention
[0004] In view of the deficiencies of the prior art, the present utility model provides a stent and an implantation system for treating benign prostatic hyperplasia, which improve the shape of the stent body after deployment, cooperate with the implantation device, improve the implantation and removal of the stent body, and reduce the discomfort during implantation, thus solving the problems mentioned in the above background art.
[0005] The present utility model provides the following technical solutions: The present utility model provides a stent for treating benign prostatic hyperplasia, including a stent body, which is formed by winding a single stent wire. The stent body includes N stent rings, where N is an integer greater than 1. Adjacent two stent rings are connected by a transition rib. The distal end of the stent body is connected with a top bead, and the proximal end of the stent body is connected with a traction bead. A traction wire is connected to the traction bead. The stent body has two forms including deployed and linear.
[0006] The stent body starts from the first point of the stent wire, takes the stent axis as the center, and starts circular winding along the first direction to the second point to form the first stent ring. The material of the stent wire is nitinol alloy material.
[0007] The first transition rib smoothly passes through the arc-shaped first vertex from the second point to the third point.
[0008] The stent wire continues to circularly wind along the second direction with the stent axis as the center to the fourth point to form the second stent ring.
[0009] Then it bends downward along the first direction, passes through the arc-shaped second vertex to the fifth point to form the second transition rib; and continues to wind clockwise with the stent axis as the center to the sixth point to form the third stent ring.
[0010] The arc-shaped first vertex and the arc-shaped second vertex need to be on the outer circle of the stent to ensure that the whole is round, smooth, without sharp corners and convex points; the above stent rings can be increased or decreased as needed.
[0011] The above first direction and second direction can be the clockwise direction and the counterclockwise direction respectively, and it is not limited that the first direction is clockwise.
[0012] The traction wire passes through the through hole on the traction bead and is knotted and fixed.
[0013] An implantation system for treating benign prostatic hyperplasia. The system includes the stent for treating benign prostatic hyperplasia according to any one of the above, and an implantation device. The implantation device includes an introducer sheath. A sheath lumen is provided in the introducer sheath for accommodating the linearly contracted stent body to reduce the diameter of the stent body implanted into the introducer sheath. An inner push rod is inserted into the proximal end of the introducer sheath. A push rod inner channel is provided in the inner push rod for passing through the traction wire.
[0014] Compared with the prior art, the utility model has the following beneficial effects: improving the forming shape and structure of the stent body, simplifying the stent structure, reducing the processing difficulty, reducing the diameter of the stent body implanted into the introducer sheath, adapting to the surgical channel established during the operation and the instrument channel of the endoscope, and facilitating the implantation and removal of the stent body through the cooperation of the traction beads, traction lines and the implantation device, and repositioning the stent body in case of misplacement of the stent body. BRIEF DESCRIPTION OF THE DRAWINGS
[0015] Figure 1 FIG. 7 is a schematic three-dimensional structure diagram of the stent for treating benign prostatic hyperplasia in the first specific embodiment of the utility model;
[0016] Figure 2 FIG. 11 is a schematic front view structure diagram of the stent for treating benign prostatic hyperplasia in the first specific embodiment of the utility model;
[0017] Figure 3 FIG. 15 is a schematic left view structure diagram of the stent for treating benign prostatic hyperplasia in the first specific embodiment of the utility model;
[0018] Figure 4 FIG. 19 is a schematic top view structure diagram of the stent for treating benign prostatic hyperplasia in the first specific embodiment of the utility model;
[0019] Figure 5 FIG. 23 is a schematic pre-assembled structure diagram of the stent and the implantation device for treating benign prostatic hyperplasia in the first specific embodiment of the utility model;
[0020] Figure 6 FIG. 27 is a schematic diagram of the stent implantation for treating benign prostatic hyperplasia in the first specific embodiment of the utility model;
[0021] Figure 7 FIG. 31 is a schematic diagram after the stent for treating benign prostatic hyperplasia in the first specific embodiment of the utility model is implanted.
[0022] In the figure: 1. stent; 11. stent body; 12. top bead; 13. traction bead; 14. traction line; 11a. first point; 11b. second point; 11d. third point; 11e. fourth point; 11g. fifth point; 11h. sixth point; 11j. seventh point; 11k. eighth point; 11A. first stent ring; 11B. second stent ring; 11C. third stent ring; 11D. fourth stent ring; 11c. first arc vertex; 11f. second arc vertex; 11i. third arc vertex; 11X. first transition rib; 11Y. second transition rib; 11Z. third transition rib; 2. introducer sheath; 21. sheath lumen; 3. inner push rod; 31. inner channel of the push rod. DETAILED DESCRIPTION OF THE EMBODIMENTS
[0023] Next, the technical solutions in the embodiments of the present invention will be clearly and completely described in conjunction with the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative efforts shall fall within the protection scope of the present invention.
[0024] Specific Embodiment 1: Please refer to Figures 1-7 , this stent 1 is processed by winding with a nickel-titanium alloy material. This material is a special alloy that can automatically recover its plastic deformation under a certain temperature. Its expansion rate is greater than 20%, the fatigue life is 1×10 to the 7th power, the damping characteristic is 10 times that of an ordinary spring, and the corrosion resistance is better than the best current medical stainless steel. Therefore, it can meet the application requirements of various engineering and medical fields and is a very excellent functional material. For the convenience of description, the distal end refers to the end farther from the medical staff operator, and the proximal end is the end closer to the medical staff operator.
[0025] The present invention provides a stent 1 for treating prostate hyperplasia, including a stent body 11. The stent body 11 is formed by winding a single stent wire. The stent body 11 includes N stent rings, where N is an integer greater than 1. Adjacent two stent rings are connected by a transition rib. The distal end of the stent body 11 is connected with a tip bead 12, the proximal end of the stent body 11 is connected with a traction bead 13, a traction wire 14 is connected to the traction bead 13, and the stent body 11 has two forms including expanded and linear. In this specific embodiment, N is 4, that is, 4 stent rings.
[0026] The stent body 11 starts from the first point 11a of the stent wire, takes the stent axis as the center, and starts circular winding along the first direction. In this specific embodiment, the first direction is clockwise, that is, starting from the first point 11a of the stent wire, taking the stent axis as the center, and circularly winding clockwise to the second point 11b to form the first stent ring 11A. The material of the stent wire is a nickel-titanium alloy material.
[0027] The first transition rib 11X smoothly passes through the arc-shaped first vertex 11c from the second point 11b to the third point 11d.
[0028] The stent wire continues to circularly wind along the second direction with the stent axis as the center to the fourth point 11e to form the second stent ring 11B. In this specific embodiment, the second direction is counterclockwise, that is, the stent wire continues to circularly wind counterclockwise with the stent axis as the center to the 11e point to form the second stent ring 11B.
[0029] Then it is bent downward along the first direction, that is, clockwise (in the reverse direction), passing through the arc-shaped second vertex 11f to the fifth point 11g to form the second transition rib 11Y; and continuing to wind clockwise around the stent axis to the sixth point 11h to form the third stent ring 11C.
[0030] Finally, it is bent downward counterclockwise, passing through the arc-shaped third vertex 11i to the seventh point 11j to form the third transition rib 11Z; and continuing to wind counterclockwise around the stent axis to the eighth point 11k to form the fourth stent ring 1D.
[0031] The arc-shaped first vertex 11c, the arc-shaped second vertex 11f, and the arc-shaped third vertex 11i should be on the outer circle of the stent 1. Ensure that the whole is round, smooth, without sharp corners and convex points; the above stent rings can be increased or decreased as needed. The overall structure of this structure is round and smooth, without obvious edges and corners, and will not stimulate the surrounding tissues when implanted into the patient's body, causing discomfort to the patient. Simplify the structure of the stent 1, reduce the processing difficulty and processing cost.
[0032] After that, the top bead 12 and the traction bead 13 are respectively welded to both ends of the wire of the stent body 11, and the traction wire 14 can pass through the through hole on the traction bead 13 and be knotted and fixed. The connection method between the traction wire 14 and the through hole on the traction bead 13 is not limited to the knotting and fixing in this embodiment.
[0033] An implant system for treating benign prostatic hyperplasia. The system includes the stent 1 for treating benign prostatic hyperplasia described in any one of the above, and an implant device. The implant device includes an introducer sheath 2. A sheath lumen 21 is provided in the introducer sheath 2 for accommodating the linearly contractible stent body 11. An inner push rod 3 is inserted into the proximal end of the introducer sheath 2. A push rod inner channel 31 is provided in the inner push rod 3 for passing through the traction wire 14.
[0034] Compared with the prior art, the utility model has the following beneficial effects: improving the forming shape and structure of the stent body 11, simplifying the structure of the stent 1, reducing the processing difficulty, reducing the diameter of the stent body 11 implanted into the introducer sheath 2, adapting to the surgical channel and the instrument channel of the endoscope established during the operation, and facilitating the implantation and removal of the stent body 11 through the cooperation of the traction bead 13, the traction wire 14 and the implant device. The stent body 11 can be repositioned in case of misplacement.
[0035] After the prostate is pathologically hyperplastic, the urethra covered by the gland is compressed, which can lead to a series of diseases including sexual dysfunction, frequent urination, dysuria, urinary retention, urinary incontinence, and urinary tract and bladder infections. Therefore, the prostate stent 1 can be implanted to ensure the normal life and treatment of the patient.
[0036] When in use, such as Figure 5, first, thread the traction wire 14 into the introducer sheath 2, and pull the traction wire 14 to "straighten" the stent body 11 and insert it into the sheath lumen 21, ensuring that the tip bead 12 is immersed. Then, the traction wire 14 continues to pass through the inner push rod 3 into the inner channel 31 of the push rod until the end face of the inner push rod 3 abuts against the end face of the traction bead 13, completing the pre-assembly of the stent 1.
[0037] As Figure 6 , during implantation, the pre-assembled stent body 11 can be delivered to the prostate through the instrument channel on the ureteral guiding sheath or cystoscope. After confirming the implantation position, keep the inner push rod 3 stationary and withdraw the introducer sheath 2 outward to release the stent body 11. After the stent body 11 leaves the sheath lumen 21, it resumes its initial shape and snaps into the inner wall of the urethra to support the urethra and ensure its patency.
[0038] After the implantation is completed, the traction wire 14 can be left in the patient's urethra to facilitate the subsequent removal of the stent 1.
[0039] When removing the stent 1, the traction wire 14 can be threaded through the instrument channel of the sheath or cystoscope, and the traction wire 14 is pulled to immerse the stent body 11 into the tube, and then the sheath or cystoscope can be withdrawn from the patient's body. Reduce the diameter of the stent 1 implantation sheath to fit the surgical channel established during the operation and the instrument channel of the endoscope. In the case where the stent body 11 is mispositioned, the stent body 11 can be repositioned through relatively simple operations using the traction wire 14, the introducer sheath 2, the inner push rod 3, and the inner channel 31 of the push rod. Specific Embodiment
[0040] The difference between this specific embodiment and Specific Embodiment 1 is that the first direction and the second direction can be the clockwise direction and the counterclockwise direction respectively, without restricting the first direction to be clockwise. In this specific embodiment, the first direction is counterclockwise and the second direction is clockwise.
[0041] In the description of the present utility model, it should be noted that the orientation or positional relationship indicated by the terms "center", "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present utility model and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation to the present utility model; the terms "first", "second", "third" are only used for descriptive purposes and cannot be construed as indicating or implying relative importance. In addition, unless otherwise clearly defined and limited, the terms "installed", "connected", "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present utility model can be understood according to specific circumstances. Moreover, the terms "include", "comprise" or any other variation thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements not only includes those elements, but also includes other elements not expressly listed, or further includes elements inherent to such process, method, article or device.
[0042] Although the embodiments of the present utility model have been shown and described, for those of ordinary skill in the art, it can be understood that various changes, modifications, substitutions and variations can be made to these embodiments without departing from the principles and spirit of the present utility model. The scope of the present utility model is defined by the appended claims and their equivalents.
Claims
1. A stent for treating prostatic hyperplasia, characterized in that: It includes a stent body, which is formed by winding a single stent wire. The stent body includes N stent rings, where N is an integer greater than 1. Two adjacent stent rings are connected by transition ribs. The distal end of the stent body is connected to a top bead, the proximal end of the stent body is connected to a traction bead, and the traction bead is connected to a traction wire. The stent body has two forms including unfolded and linear.
2. The stent for treating prostate hyperplasia according to claim 1, characterized in that: The stent body is circularly wound along a first direction with the first point of the stent wire as the starting point and the stent axis as the center, to form a first stent ring at a second point. The stent wire is made of nickel-titanium alloy.
3. The stent for treating prostatic hyperplasia according to claim 2, characterized in that: The first transition rib smoothly and roundly passes through the first vertex of the arc from the second point to the third point.
4. The stent for treating prostatic hyperplasia according to claim 3, characterized in that: The stent wire continues to be circularly wound along the second direction to a fourth point with the stent axis as the center to form a second stent ring.
5. The stent for treating prostate hyperplasia according to claim 4, characterized in that: Then it bends downward along the first direction, passes through the second vertex of the arc to the fifth point, forming a second transition rib; and continues to wind clockwise around the axis of the support to the sixth point, forming a third support ring.
6. The stent for treating prostatic hyperplasia according to claim 5, characterized in that: The first vertex of the arc and the second vertex of the arc must be on the outer circle of the bracket.
7. The stent for treating prostate hyperplasia according to claim 1, characterized in that: The traction line passes through the through hole on the traction bead and is knotted and fixed.
8. An implant system for treating prostate hyperplasia, characterized in that: The system includes a stent for treating prostate hyperplasia according to any one of claims 1 to 7, and an implantation device, wherein the implantation device includes an introduction sheath, a sheath cavity is provided in the introduction sheath for accommodating a linearly contracted stent body, an inner push rod is inserted into the proximal end of the introduction sheath, and an inner push rod channel is provided in the inner push rod for passing the traction wire.