Controllable operation-free take-out ureteral stent with degradable coating
20240000558 ยท 2024-01-04
Assignee
Inventors
- Jiahao JIN (Jiaxing, CN)
- Weiwen YU (Jiaxing, CN)
- Dahong ZHANG (Jiaxing, CN)
- Gonghui LI (Jiaxing, CN)
- Fuqing TAN (Jiaxing, CN)
- Jun LU (Jiaxing, CN)
- Guohai XIE (Jiaxing, CN)
- Xiang HE (Jiaxing, CN)
Cpc classification
A61M2205/0238
HUMAN NECESSITIES
A61L2430/22
HUMAN NECESSITIES
A61M27/008
HUMAN NECESSITIES
A61F2/04
HUMAN NECESSITIES
International classification
A61F2/04
HUMAN NECESSITIES
A61M27/00
HUMAN NECESSITIES
Abstract
A controllable operation-free take-out ureteral stent with a degradable coating includes a ureteral stent, a traction wire, a discharged body, and a degradable fixture, where the discharged body is fixed on one end of the traction wire, and the degradable fixture fixes the discharged body on the other end of the traction wire and is arranged close to one end of the ureteral stent within a limited period of time; the ureteral stent comprises a nondegradable base layer and a degradable coating which are sequentially arranged from inside to outside; the problem of bacterial adhesion on the surface of the ureteral stent caused by long indwelling time or patients' special allergies can be solved by automatic degradation and peeling off of the degradable coating on the surface of the ureteral stent within a certain period of time.
Claims
1. A controllable operation-free take-out ureteral stent with a degradable coating, comprising: a ureteral stent, a traction wire, a discharged body, and a degradable fixture, wherein the discharged body is fixed on a first end of the traction wire, and the degradable fixture fixes the discharged body on a second end of the traction wire and is arranged adjacent to an end of the ureteral stent within a limited period of time; the ureteral stent comprises a nondegradable base layer and the degradable coating, wherein the nondegradable base layer and the degradable coating are sequentially arranged from an inside to an outside.
2. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 1, wherein the nondegradable base layer is made of polyurethane or silica gel, and the degradable coating layer is made of a degradable material selected from polylactic acid, polyglycolic acid, polylactic-glycolic acid copolymer, chitosan, alginate-based material, polyhydroxyalkanoate, and polydioxanone.
3. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 2, wherein a hydrophilic coating is arranged between the nondegradable base layer and the degradable coating, and the hydrophilic coating is made of one of polyacrylamide, polyvinylpyrrolidone, polyoxyethylene, hydrogel, and sodium hyaluronate.
4. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 1, wherein the ureteral stent comprises a stent body and a forward J-shaped tube, wherein the stent body is tubular and a first end of the stent body far from the discharged body is connected to the forward J-shaped tube; a drainage channel runs through between the stent body and the forward J-shaped tube, the drainage channel is located in the nondegradable base layer and runs through a front and a back, and a plurality of drainage holes communicating with an outside and the drainage channel are respectively arranged on the stent body and the forward J-shaped tube.
5. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 4, wherein a second end of the stent body adjacent to the discharged body is further provided with a bladder retaining structure, wherein the bladder retaining structure is a flared tube, an elliptical tube, or an inverted J-shaped tube, and a ring size of the inverted J-shaped tube is smaller than a ring size of the forward J-shaped tube.
6. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 5, wherein the other end of the bladder retaining structure is connected to an end of an anti-reflux water-retaining soft sleeve, and a length of the anti-reflux water-retaining soft sleeve is greater than or equal to twice a width of the bladder retaining structure.
7. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 5, wherein a plurality of marking scales for a length measurement are arranged outside the stent body, and a hardness of the forward J-shaped tube, the stent body and the bladder retaining structure gradually becomes softer, and diameters of the forward J-shaped tube and the stent body gradually become smaller.
8. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 1, wherein the degradable fixture is one or more of a degradable wire, a degradable perforated module, and a medical glue; the degradable wire and the degradable perforated module are binary copolymers formed by a polymerization of glycolide and lactide, terpolymers or alginate polymers formed by a polymerization of glycolide, lactide, and caprolactone, and the medical glue is a-cyanoacrylate.
9. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 8, wherein a length of the traction wire is longer than a length of a human urethra, the traction wire is a non-absorbent and nondegradable wire, and some points on a line segment of the traction wire are simultaneously fixed by the degradable wire and/or the medical glue to be folded.
10. The controllable operation-free take-out ureteral stent with the degradable coating according to claim 9, wherein a surface of the discharged body is smooth and provided with a plurality of through holes, a density of the discharged body is higher than a density of water; the traction wire and the degradable wire are configured to pass through the plurality of through holes to bind the discharged body, and a largest through hole of the plurality of through holes has a hole size allowing a loach guide wire or a zebra guide wire to pass through.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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[0056] In the figures: 1Ureteral stent, 11Stent body, 12Forward Jtube, 13Nondegradable base, 14Degradable coating, 15Hydrophilic coating, 16Drainage channel, 17Drainage hole, 18Bladder retaining structure, 2Traction wire, 3Discharged body and 31Through hole.
DETAILED DESCRIPTION OF THE EMBODIMENTS
Embodiment 1
[0057] Referring to
[0058] The nondegradable base layer 13 is made of polyurethane or silica gel, and the degradable coating layer 14 is made of a degradable material selected from polylactic acid, polyglycolic acid, polylactic acid-glycolic acid copolymer, chitosan, alginate-based material, polyhydroxyalkanoate and polydioxanone.
[0059] The degradable coating 14 is also mixed with one of hydrophilic substances, antibacterial and anti-inflammatory substances and anticoagulant substances, wherein the hydrophilic substance is one of polyvinylpyrrolidone, sodium hyaluronate and hydrogel; the antibacterial and anti-inflammatory substance is one of triclosan, silver sulfadiazine salt, sirolimus and rifampicin; and the anticoagulant substance is heparin sodium, so as to reduce the stimulation of the ureteral stent 1 to human bodies and further avoid impurities such as calculus scale or bacterial biofilm on the surface of the ureteral stent 1.
[0060] The ureteral stent 1 includes a stent body 11 and a forward J-shaped tube 12. The stent body 11 is tubular, and one end far from the discharged body 3 is connected with the forward J-shaped tube 12. A drainage channel 16 runs through the stent body 11 and the forward J-shaped tube 12, and the drainage channel 16 is located in the nondegradable base layer 13 and runs through the front and back. There are also several drainage holes 17 on the stent body 11 and the forward J-shaped tube 12 to communicate with the outside and the drainage channel 16. Among them, the drainage channel 16 and the drainage hole 17 can fully drain urine in the renal pelvis and ureter 6, so as to play a role in drainage and dredging.
[0061] There are several marking scales for length measurement outside the stent body 11. The hardness of the forward J-shaped tube 12 and the stent body 11 gradually becomes softer, and the diameters of the forward J-shaped tube 12 and the stent body 11 gradually decrease. Wherein, the forward J-shaped tube 12 is located at the renal pelvis side of human body, while the other end of the stent body 11 is located at the bladder side of human body, that is, the hardness of the ureteral stent 1 gradually softens from the renal pelvis end to the bladder end, so that the ureteral stent 1 can be pushed through the guide wire without wrinkling on the premise of ensuring the stable fixation of the forward J-shaped tube 12 located in the renal pelvis, and at the same time, the stent body 11 has the maximum softness, and further increases the natural space of the ureter after the ureteral stent is placed, which is beneficial to the natural drainage of the ureter. Specifically, the forward J-shaped tube 12 can be made of polyurethane with a hardness of 95, and the stent body 11 can be made of softer polyurethane or silica gel. The diameter of the J-shaped head at the end of renal pelvis is F8-F10, and gradually tapers down to F4-F5. For the marking scale, a first positioning ring is arranged at the joint of the stent body 11 and the forward J-shaped tube 12, a second positioning ring is arranged at a distance of 15 cm from the first positioning ring, and then the next positioning ring is arranged every 5 cm, and a ruler scale can be arranged every 1 cm between two adjacent positioning rings. At least one of the ring number, ring width or ring color of each positioning ring is different. With this design, when the ureteral stent 1 is implanted, it can avoid too many marking rings, which are too complicated and difficult to see. In addition, it can cooperate with the guide wire that can measure the length of ureter during operation, which is convenient for individualized selection of ureteral stent 1 with appropriate length. At the same time, the implantation depth of the ureteral stent 1 can be accurately known under direct vision during operation, and the end of the straight opening of the ureteral stent 1 is ensured to be above the bladder opening of the ureter 6.
[0062] The degradable fixture 4 is a degradable wire, which is a binary copolymer formed by the polymerization of glycolide and lactide, and the time-limited fixation of the discharged body 3 and the time-limited folding of the traction wire 2 are completed by the degradable wire alone. Specifically, when the degradable wire is used, it is in the form of a knot, on the one hand, the discharged body 3 is bound and fixed on the end of the traction wire 2 close to the ureteral stent 1, and on the other hand, the traction wire is bound into a folded shape. Wherein, the binary copolymer formed by the polymerization of glycolide and lactide may be Vicryl Rapide, Polyglactin 910 produced by Johnson & Johnson Company, which is a copolymer of 90% glycolide and 10% L-lactide, with a suture tension maintained for 5 days, an absorption time in vivo being 42 days, which can make discharge time of the discharged body 3 in the bladder be 30-45 days approximately. Moreover, because this suture is a multi-strand braided wire, it is 10-30 strands after splitting, which is 10-50 zeros, so one of them can be used to bind the traction wire 2 and the discharged body 3, so that the discharged body 3 can be discharged in the bladder for about 15-30 days. This method can meet the needs of most clinical surgical patients. In addition, the degradable fixing wire 4 has 10-50 zeros and a length of 1-4 cm, which is thinner than the hair, and produces few degradation products in the bladder, which is easy to be discharged with urine and has no great discomfort to human body. It should also be emphasized that the user can further control the degradation time of the degradable wire in urine by adjusting the thickness of the degradable wire, the distribution of different components in the degradable material (such as increasing the content of glycolide), the molecular weight and other factors. At the same time, it is believed that with the further research of degradable materials, the degradation time of the degradable wire can be more accurate, and then the time of taking out the ureteral stent 1 without surgery can be more accurate. In addition, the traction wire 2 is bound in a 6-strand shape, and the folded traction wire 2 is 3-4 cm, which can effectively improve the convenience of surgical placement and effectively avoid discomfort caused by the traction wire 2 being discharged into the posterior urethra in advance in the bladder.
[0063] The length of the traction wire 2 is longer than the length of the human urethra (20-30 cm for men and 8-15 cm for women), so as to meet the requirement of discharging the discharged body 3 smoothly. The traction wire 2 is non-absorbent and nondegradable, and some points on the line segment of the traction wire 2 are simultaneously fixed by degradable wires and/or medical glue to be folded. The traction wire 2 can be made of unattractive materials such as polypropylene, and the surface of the traction wire 2 can also be provided with an antibacterial coating.
[0064] The surface of the discharged body 3 is smooth and provided with two communicating through holes 31, the density of the discharged body 3 is higher than that of water, both the traction line 2 and the degradable wire can pass through a smaller through hole to bind the discharged body 3, and the aperture size of the other through hole 31 can also be used for the loach guide wire (a model of 038/150) or zebra guide wire to pass through. In this way, the discharged body 3 and the ureteral stent 1 can pass through the guide wire together during surgical placement, and then be implanted into the body through the push rod, thus effectively improving the convenience of operation. Wherein, the discharged body 3 can take various shapes, preferably a spherical shape without obvious foreign body sensation in the body. Specifically, the discharged body 3 is a small round ball with holes made of 304 stainless steel, which has little influence on human body, and its outer diameter is 2-5 mm.
[0065] The Work Process of the Present Application:
[0066] Referring to
[0067] Referring to
Embodiment 2
[0068] Referring to
[0069] The hydrophilic coating 15 was composed of one of polyacrylamide, polyvinylpyrrolidone, polyoxyethylene, hydrogel and sodium hyaluronate. The added hydrophilic coating 15 could make the surface of the ureteral stent 1 still have good hydrophilicity after the degradable coating 14 was degraded, thereby improving the implantation comfort of the ureteral stent 1.
[0070] Others were the same as in Embodiment 1.
Embodiment 3
[0071] Referring to
[0072] Others were the same as in Embodiment 1.
Embodiment 4
[0073] Referring to
[0074] Others were the same as in Embodiment 1.
Embodiment 5
[0075] Referring to
[0076] Others were the same as in Embodiment 1.
Embodiment 6
[0077] Referring to
[0078] The other end of the bladder retaining structure 18 was also connected with one end of the anti-reflux water-retaining soft sleeve 6, and the length of the anti-reflux water-retaining soft sleeve 6 was not less than twice the width of the bladder retaining structure 18.
[0079] There were several marking scales for length measurement outside the stent body 11. The hardness of the forward J-shaped tube 12, the stent body 11 and the bladder retaining structure 18 gradually became soft, and the diameters of the forward J-shaped tube 12 and the stent body 11 gradually decreased. The diameter of the J-shaped head at the end of renal pelvis was F8-F10, and gradually tapered down to F4-F5. With this design, the stent body 11 can be guaranteed to have the maximum flexibility, and at the same time, the natural space of the ureter after the ureteral stent was indwelled is further increased, which was beneficial to the natural drainage of the ureter and reduced discomfort.
[0080] Others were the same as in Embodiment 1.
[0081] Under normal circumstances, the bladder, as a urine storage organ, has a receptive relaxation function, and its internal pressure is stable at 0-15 cm water column. In a certain volume range, the bladder has no detrusor contraction and the internal pressure is stable, while the normal renal pelvis pressure is less than 15 cm water column. In addition, the ureter 6 is a muscular tubular structure, and its function is to transport urine. After the traditional ureteral stent is placed, because the bladder does not contract during the urine storage period, the urine produced by the kidney can be smoothly discharged into the bladder from the renal pelvis, the ureteral stent and the ureter 6, so that the patient has no discomfort of waist swelling except the stimulation of the ureteral stent itself. However, when urinating, the bladder pressure will increase, generally reaching 40 cm water column or even 70-100 cm water column. At this time, due to the pressure increase, urine easily flows back to the renal pelvis through the ureteral stent and ureter 6, and the corresponding pressure in the bladder will also be transmitted to the renal pelvis, which will lead to pain and discomfort in the affected side of the patient.
[0082] For this embodiment, during the urine storage period, the anti-reflux water-retaining soft sleeve 6 was in a free state, while during urination, the bladder pressure rose, and the anti-reflux water-retaining soft sleeve 6 could cover the orifice of the flared tube under the action of the bladder pressure, so that the inner space of the ureteral stent 1 was completely separated from the inner space of the bladder, thereby preventing the urine from flowing back.
Embodiment 7
[0083] Referring to
[0084] The other end of the bladder retaining structure 18 was also connected with one end of the anti-reflux water-retaining soft sleeve 6, and the length of the anti-reflux water-retaining soft sleeve 6 was not less than twice the width of the bladder retaining structure 18.
[0085] There were several marking scales for length measurement outside the stent body 11. The hardness of the forward J-shaped tube 12, the stent body 11 and the bladder retaining structure 18 gradually became soft, and the diameters of the forward J-shaped tube 12 and the stent body 11 gradually decreased.
[0086] Others were the same as in Embodiment 1.
[0087] During the urine storage period, the anti-reflux water-retaining soft sleeve 6 was in a free state, while during urination, the bladder pressure rose, and the anti-reflux water-retaining soft sleeve 6 could cover the orifice of the elliptical tube under the action of the bladder pressure, so that the space in the tube of the ureteral stent 1 was completely separated from the space in the bladder, thereby preventing the urine from flowing back.
Embodiment 8
[0088] Referring to
[0089] The other end of the bladder retaining structure 18 was also connected with one end of the anti-reflux water-retaining soft sleeve 6, and the length of the anti-reflux water-retaining soft sleeve 6 was not less than twice the width of the bladder retaining structure 18.
[0090] There were several marking scales for length measurement outside the stent body 11. The hardness of the forward J-shaped tube 12, the stent body 11 and the bladder retaining structure 18 gradually became soft, and the diameters of the forward J-shaped tube 12 and the stent body 11 gradually decreased.
[0091] Others were the same as in Embodiment 1.
[0092] During the urine storage period, the anti-reflux water-retaining soft sleeve 6 was in a free state, while during urination, the bladder pressure rises, and the anti-reflux water-retaining soft sleeve 6 could cover the orifice of the forward J-shaped tube 12 under the action of the bladder pressure, so that the inner space of the ureteral stent 1 was completely separated from the inner space of the bladder, thereby preventing the urine from flowing back.
Embodiment 9
[0093] Referring to
[0094] Others were the same as in Embodiment 1.
[0095] The above embodiment is an explanation of the present application, not a limitation of the present application, and any solution after simple transformation of the present application belongs to the protection scope of the present application.