CN110215321B - A device for implanting a prostate stent - Google Patents

A device for implanting a prostate stent Download PDF

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Publication number
CN110215321B
CN110215321B CN201910623363.3A CN201910623363A CN110215321B CN 110215321 B CN110215321 B CN 110215321B CN 201910623363 A CN201910623363 A CN 201910623363A CN 110215321 B CN110215321 B CN 110215321B
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Prior art keywords
prostate
stent
endoscope
seat
support
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CN201910623363.3A
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CN110215321A (en
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唐义
徐梦婷
唐世豪
吴依
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Shanghai Xinghuo Medical Technology Co ltd
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Shanghai Xinghuo Medical Technology Co ltd
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Endoscopes (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention discloses an implantation device of a prostate stent, wherein the prostate stent and the implantation device are both made of a shape memory alloy material, and the implantation device comprises a first stent seat; the implantation device utilizes an endoscope to convey the prostate stent; when the prostate stent is conveyed, the first stent seat and the prostate stent are sleeved on the endoscope in parallel, and the proximal end of the prostate stent is propped against the distal end of the first stent seat; the prostate support can be fastened and fixed on the endoscope in a hooping way when the temperature is lower than the phase change point of the prostate support, and can be expanded and loosened from the endoscope when the temperature is higher than the phase change point of the prostate support; the first bracket seat can be fastened and fixed on the endoscope when the temperature is higher than the phase change point of the first bracket seat, and can be expanded and released from the endoscope when the temperature is lower than the phase change point of the first bracket seat. The invention has no long sheath tube which can be blocked with the endoscope completely, and is safe to use.

Description

Device for placing prostate support
Technical Field
The invention relates to the technical field of urological medical equipment, in particular to an imbedding device of a prostate support.
Background
The prostatic hyperplasia is a common disease of old men, is a progressive disease, can cause urethral stricture, urination disorder and even complete occlusion, increases the incidence rate year by year along with the aging development of population, is counted by domestic related data, and has the prostatic hyperplasia of about 35-50% of men over 50 years old. At present, transurethral prostatectomy is mainly adopted for treating the prostatic hyperplasia, and the proportion of the prostatic hyperplasia to be treated in developed countries is 60-90 percent due to the characteristics of no trauma on the body surface and quick recovery, so that the method still belongs to a traumatic operation, is highly influenced by the proficiency of an operator and the physical condition of a patient, and has long learning curve and high price.
Urethral stent (or prostate stent) implantation has been greatly developed in recent years. The current method commonly used clinically is to place a urethral stent at the urethral stricture to prop open the urethral stricture or obstruction. The support is made of stainless steel, synthetic fiber silica gel or nickel-titanium alloy, can be placed on the narrow part of the urethra through a cystoscope, so that the back urethra which is closed by the original narrow part is expanded, and most patients with difficult urination can recover the urination function after placing the urethra support.
The nickel-titanium alloy is a shape memory alloy, can automatically restore plastic deformation of the nickel-titanium alloy to an original shape at a certain temperature, has better corrosion resistance than the best medical stainless steel at present, can meet the application requirements of various projects and medicine, and is a very excellent functional material.
As an emerging alternative therapy, nitinol urethral stents may be wound in a spring-like fashion from nitinol wires, with one or both ends being machined slightly thicker than the stent body, e.g., designed in a flare-like fashion, for assisting in positioning. The urethral stent of the nickel-titanium memory alloy has a temperature memory function, can deform and shrink at low temperature (generally 0-10 ℃), and can recover the shape at a specific temperature. The stent can be cooled by coolant to shrink on the delivery sheath for delivery from urethra to the lesion. Hot water is injected after the catheter is delivered to the focus to expand the urethra so as to lead the urinary tract to be unobstructed, and the catheter can be taken out or implanted in the body for a long time after the treatment course is finished, thereby realizing the treatment with no wound, no pain and more convenient operation process.
The nickel-titanium memory alloy prostate bracket is arranged on a conveying system in the market at present, the conveying system is sleeved on an endoscope for use, the existing endoscope system is utilized, the matching is convenient, the defect is that when the nickel-titanium memory alloy prostate bracket is sleeved on a hard endoscope for use, the damage of the hard endoscope to tissues is large, and when the nickel-titanium memory alloy prostate bracket is matched with a soft endoscope, the rigidity of the endoscope is increased by a sheath tube of the conveying system, the risk of damaging tissues is increased, the diameter of the soft endoscope is large, the outer surface skin of the soft endoscope is made of a soft material, the friction coefficient between the soft endoscope and the sheath tube is large, lubricating oil such as silicone oil must be smeared to sleeve the conveying system on the soft endoscope, and once the parts of the soft endoscope are in a leaking coating state, the conveying system and the soft endoscope are blocked easily, so that the conveying system is extremely troublesome to dismount, and even the damage to the endoscope occurs.
Disclosure of Invention
The invention aims to overcome the defects of the prior art and provide an imbedding device of a prostate support, which cannot be blocked with an endoscope.
In order to achieve the above object, the present invention provides an implanting device for a prostate stent, wherein the prostate stent and the implanting device are made of shape memory alloy materials, and the implanting device comprises a first stent holder; the implanting device utilizes an endoscope to convey the prostate stent; when the prostate stent is conveyed, the first stent seat and the prostate stent are sleeved on the endoscope in parallel, and the proximal end of the prostate stent is propped against the distal end of the first stent seat; the prostate support can be fastened and fixed on the endoscope in a hooping way when the temperature is lower than the phase change point of the prostate support, and can be expanded and loosened from the endoscope when the temperature is higher than the phase change point of the prostate support; the first bracket seat can be fastened and fixed on the endoscope when the temperature is higher than the phase change point of the first bracket seat, and can be expanded and released from the endoscope when the temperature is lower than the phase change point of the first bracket seat.
Preferably, the phase transition point of the prostate support is 37-60 ℃.
Preferably, the phase change point of the first support seat is 10-20 ℃.
Preferably, the first support seat is a tubular woven structure or a hollow structure engraved by laser.
Preferably, the implanting device further comprises: a second bracket base made of a shape memory alloy material; the second bracket seat can be fastened and fixed on the endoscope when the temperature is higher than the phase change point of the second bracket seat, and can be expanded and loosened from the endoscope when the temperature is lower than the phase change point of the second bracket seat; when the prostate stent is conveyed, the second stent holder hoop is fastened and fixed on the endoscope, and the proximal end of the second stent holder abuts against the distal end of the prostate stent.
Preferably, the phase change point of the second bracket seat is 10-20 ℃.
Preferably, the second support seat is a tubular woven structure or a hollow structure engraved by laser.
Preferably, the first support seat and the second support seat are made of nickel-titanium alloy.
Preferably, the prostate support is helically wound into a spring-like structure.
Preferably, one or both ends of the prostate support are in a horn mouth structure.
Compared with the prior art, the invention has the following beneficial effects:
(1) The device for placing the prostate stent has simple structural design;
(2) The implanting device of the invention utilizes the endoscope to convey the prostate support, so that the bending rigidity of the endoscope is not greatly increased;
(3) The invention has no long sheath tube which is possibly blocked with the endoscope, thus greatly facilitating the operation process and reducing the risk of damaging tissues.
Drawings
Fig. 1 is a schematic view illustrating a usage state of an implanting device according to a first embodiment of the present invention.
Fig. 2 is a schematic diagram of a phase change process of the first bracket seat.
FIG. 3 is a schematic view illustrating a usage state of an implanting device according to a second embodiment of the present invention.
Detailed Description
The technical scheme of the invention is further described below with reference to the accompanying drawings and examples.
In the present invention, when the endoscope is used, the end far from the operator is the "distal end", and the end close to the operator is the "proximal end", but the direction is not intended to limit the present invention.
The insertion device of the present invention utilizes an endoscope to deliver the prostatic stent to the urethra. The prostate support is made of shape memory alloy material and can be designed into a spring-shaped structure.
As shown in fig. 1, the prostate stent 1 is strapped to the endoscope 2 during delivery. The implanting device according to the first embodiment of the present invention includes: the first support seat 3 is made of a shape memory alloy material, and the first support seat 3 is tubular. When the endoscope 2 is used for conveying the prostate support 1 forwards, the first support seat 3 and the prostate support 1 are sleeved on the endoscope 2 in parallel, and the proximal end of the prostate support 1 abuts against the distal end of the first support seat 3. The prostate support 1 can be fastened to the endoscope 2 by means of a band when the temperature is below its phase transition point, and can be inflated and released from the endoscope 2 when the temperature is above its phase transition point. The first bracket seat 3 can be fastened to the endoscope 2 by a clip when the temperature is higher than the phase transition point, and can be expanded and released from the endoscope 2 when the temperature is lower than the phase transition point.
The proximal end of the prostate support 1 abuts against the distal end of the first support seat 3, and the prostate support 1 coated on the outer side of the endoscope 2 is ensured not to shift during the conveying process.
The prostate support 1 and the imbedding device are inserted into the urethra by utilizing the endoscope 2, the position of the lesion is observed by the endoscope 2, after the positioning is finished, hot water with the temperature higher than the phase change point of the prostate support 1 and the first support seat 3 is injected into the urethra, the prostate support 1 can be heated and expanded, the endoscope 2 is loosened, and the prostate support is fixed at the lesion. Since the temperature of the hot water is also higher than the phase transition point of the first stent holder 3, the first stent holder 3 maintains a state in which the band is fastened to the endoscope 2, at which time the endoscope 2 can be withdrawn from the inflated prostate stent 1, and the prostate stent 1 remains at the lesion for dilating the urethra. After the positioning is finished, the prostate support 1 is released, the endoscope 2 is extracted, and then the first support seat 3 is disassembled and discarded, so that the operation can be finished. Compared with the existing conveying system, the bending rigidity of the endoscope 2 is not greatly increased, and a long sheath tube which is possibly blocked with the endoscope 2 completely does not exist, so that the surgical process can be greatly facilitated, and the risk of damaging tissues is reduced. When the first mount 3 is to be detached, the endoscope 2 is drawn out by immersing it in a liquid having a temperature lower than the phase transition point of the first mount 3 to expand it.
In some embodiments, the phase transition point of the prostate support 1 is 37-60 ℃, and the phase transition point of the first support seat 3 is 10-20 ℃.
The prostate support 1, the first support seat 3 and the second support seat 4 can be made of a two-way memory alloy. Some alloys recover the shape of the high temperature phase when heated and the shape of the low temperature phase when cooled, known as the two-way memory effect. The two-way memory alloy can automatically recover to a certain shape when the temperature is raised and lowered.
As shown in fig. 2, the phase change process of the first bracket holder 3 is illustrated. At 0 ℃, the temperature is lower than the phase change point of the first support seat 3, the first support seat 3 expands, and at 15 ℃, the temperature is higher than the phase change point of the first support seat 3, and the first support seat 3 contracts. The temperature drops to 0 ℃ again, and the volume of the first bracket seat 3 expands again.
In the invention, the phase change point of the first bracket seat 3 is lower than the body temperature, and the first bracket seat 3 can keep a tightening and fixing state in the process of conveying the prostate bracket 1. The phase transition point of the prostate stent 1 is high in temperature, and hot water is added to expand the stent.
As shown in fig. 3, the implanting device according to the second embodiment of the present invention further includes: a second bracket seat 4 made of a shape memory alloy material. The second support seat 4 has the same structure as the first support seat 3. The second support seat 4 can be fastened and fixed on the endoscope 2 when the temperature is higher than the phase change point of the second support seat, and the second support seat 4 can be expanded and separated from the endoscope 2 when the temperature is lower than the phase change point of the second support seat. When the prostate support 1 is conveyed forwards, the second support seat 4 is fastened and fixed on the endoscope 2, the proximal end of the second support seat 4 is abutted against the distal end of the prostate support 1, namely, the two sides of the prostate support 1 are respectively provided with the first support seat 3 and the second support seat 4.
The distal end of the prostate support 1 is provided with the second support seat 4, which is favorable for further limiting the prostate support 1, and ensures that the prostate support 1 cannot be wound untight when the prostate support 1 is retracted in the repeated positioning process.
The phase change point of the second bracket seat 4 is 10-20 ℃.
In the above two embodiments, the materials of the first support seat 3 and the second support seat 4 are nickel-titanium alloy, and are two-way nickel-titanium memory alloy woven structures or hollow structures engraved by laser. The manufacturing process is as follows: firstly, weaving a memory alloy wire or carving a memory alloy tube by laser, performing heat treatment at 600 ℃ for shaping after the memory alloy wire or the memory alloy tube is manufactured, then, stretching a bracket seat from the center, soaking in water at 0 ℃, then, loosening the bracket seat, soaking in water at room temperature, and repeating the soaking for 50-150 times.
The prostate stent 1 is also made of nickel-titanium memory alloy, the Ni content is 55-56%, and the surface is covered with a biocompatible coating or a polymer film for preventing tissue proliferation or stone formation in the gaps of the stent.
The prostate support 1 is spirally wound into a spring-like structure, wherein one or both ends of the spring-like structure can be processed to be slightly thicker than the main body of the prostate support 1, for example, the spring-like structure is designed into a horn shape for auxiliary positioning.
The application method of the implanting device of the invention is exemplified as follows: the first support seat is soaked in ice water to expand, then is sleeved on the endoscope, and waits for the temperature of the endoscope to return, or is soaked in water at normal temperature to return the temperature, and at the moment, the support seat can shrink and is hooped on the endoscope. The spring-shaped prostate support is also sleeved into the endoscope and is propped against the first support seat. According to clinical requirements, a second bracket seat can be installed at the distal end of the endoscope. The whole system is inserted into the urethra, the position of the lesion is observed through the endoscope, after the positioning is finished, hot water with the temperature of 40-60 ℃ is injected into the urethra, and the hot water can be injected through a pipeline of the endoscope. The prostate stent expands when heated and is fixed at the lesion. The endoscope with the stent holder is withdrawn (the second stent holder passes through the inflated prostate stent when withdrawn) and soaked in ice water, so that the stent holder is inflated again and detached, and the operation is completed.
While the present invention has been described in detail through the foregoing description of the preferred embodiment, it should be understood that the foregoing description is not to be considered as limiting the invention. Many modifications and substitutions of the present invention will become apparent to those of ordinary skill in the art upon reading the foregoing. Accordingly, the scope of the invention should be limited only by the attached claims.

Claims (8)

1. An arrangement for the implantation of a prostate stent, characterized in that:
the prostate support and the imbedding device are both made of shape memory alloy materials, and the imbedding device comprises a first support seat and a second support seat;
the implanting device utilizes an endoscope to convey the prostate stent; when the prostate stent is conveyed, the first stent seat and the prostate stent are sleeved on the endoscope in parallel, and the proximal end of the prostate stent is propped against the distal end of the first stent seat;
the prostate support can be fastened and fixed on the endoscope in a hooping way when the temperature is lower than the phase change point of the prostate support, and can be expanded and loosened from the endoscope when the temperature is higher than the phase change point of the prostate support;
the first bracket seat can be fastened and fixed on the endoscope when the temperature is higher than the phase change point of the first bracket seat, and can be expanded and loosened from the endoscope when the temperature is lower than the phase change point of the first bracket seat;
the second bracket seat can be fastened and fixed on the endoscope when the temperature is higher than the phase change point of the second bracket seat, and can be expanded and loosened from the endoscope when the temperature is lower than the phase change point of the second bracket seat; when the prostate stent is conveyed, the second stent holder hoop is fastened and fixed on the endoscope, and the proximal end of the second stent holder abuts against the distal end of the prostate stent; the first support seat and the second support seat are made of nickel-titanium alloy.
2. The prostate stent placement apparatus according to claim 1, wherein the phase transition point of the prostate stent is 37-60 ℃.
3. The prostate stent placement apparatus of claim 1 wherein said first stent scaffold has a phase transition point of between 10 ℃ and 20 ℃.
4. The prostate stent placement apparatus of claim 1, wherein said first stent holder is a tubular woven structure or a laser engraved hollow structure.
5. The prostate stent placement apparatus of claim 1 wherein said second stent holder has a phase transition point of 10-20 ℃.
6. The prostate stent placement apparatus of claim 1, wherein said second stent holder is a tubular woven structure or a laser engraved hollow structure.
7. The prostate stent insertion device of claim 1, wherein said prostate stent is helically wound into a spring-like structure.
8. The prostate stent placement apparatus of claim 1, wherein one or both ends of said prostate stent are configured in a horn-like configuration.
CN201910623363.3A 2019-07-11 2019-07-11 A device for implanting a prostate stent Active CN110215321B (en)

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114391802A (en) * 2022-03-04 2022-04-26 江阴市人民医院 Damage-preventing cystoscope feeding device for urethral prostate operation
CN115920200B (en) * 2023-03-14 2023-06-16 中国科学院深圳先进技术研究院 A sheath with continuously adjustable stiffness, its stiffness adjustment method, and surgical equipment

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CN101401752A (en) * 2008-10-31 2009-04-08 东北大学 Apparatus for taking out metal stent in vascular or non-vascular cavity channel
CN101578078A (en) * 2006-11-22 2009-11-11 印斯拜尔Md有限公司 Optimized stent jacket
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CN210749682U (en) * 2019-07-11 2020-06-16 上海星伙医疗科技有限公司 Prostate stent imbedding device
CN114391802A (en) * 2022-03-04 2022-04-26 江阴市人民医院 Damage-preventing cystoscope feeding device for urethral prostate operation

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Publication number Priority date Publication date Assignee Title
CN2088876U (en) * 1991-04-02 1991-11-20 北京中医学院东直门医院 Marmen holder for urethra and prostate
CN2128887Y (en) * 1992-06-24 1993-03-31 李硕 Memory alloy support for dilating prostate section of urethra
CN2152563Y (en) * 1992-09-16 1994-01-12 东南大学 Titanium-Nickel Shape Memory Alloy Extended Stent for Lower Urinary Tract
US6514285B1 (en) * 1993-03-11 2003-02-04 Medinol Ltd. Stent
CN1201381A (en) * 1995-11-01 1998-12-09 生物相容有限公司 Braided stent
CN101578078A (en) * 2006-11-22 2009-11-11 印斯拜尔Md有限公司 Optimized stent jacket
CN101011304A (en) * 2007-02-12 2007-08-08 西安理工大学 Double-direction shape memory alloy plane-helical microwave thermotherapy antenna with water capsule
CN101401752A (en) * 2008-10-31 2009-04-08 东北大学 Apparatus for taking out metal stent in vascular or non-vascular cavity channel
CN104523305A (en) * 2014-12-30 2015-04-22 武汉唐济科技有限公司 Special sheath for prostate endoscopic surgical instrument
CN210749682U (en) * 2019-07-11 2020-06-16 上海星伙医疗科技有限公司 Prostate stent imbedding device
CN114391802A (en) * 2022-03-04 2022-04-26 江阴市人民医院 Damage-preventing cystoscope feeding device for urethral prostate operation

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