Prostate steam ablation system and application method thereofTechnical Field
The invention relates to the technical field of minimally invasive treatment of prostate, in particular to a system for treating benign prostatic hyperplasia by using steam transmitted to the prostate and an application method thereof.
Background
Along with the continuous improvement of life and medical conditions, the pursuit of people on the quality of life is also continuously promoted, the aging of population is continuously aggravated at the present stage, and senile diseases are increasingly highlighted, wherein benign prostatic hyperplasia is one of common diseases of aged men, and the quality of life of the aged is seriously influenced.
The incidence rate of prostatic hyperplasia of aged men over 60 years is more than 60%, 10% of which need surgical treatment, and 600 ten thousand aged men need surgical treatment according to a conservative estimation. The prostatic hyperplasia is an aging disease, and patients often have complications such as heart, lung, brain, hypertension, renal insufficiency or diabetes, and the like, and have high requirements on anesthesia and perioperative management.
Early in life, the prostate has the size and shape of a walnut, weighing about 20 grams before hypertrophy is caused by BPH (benign prostatic hyperplasia). Enlargement of the prostate appears to be a normal process. With age, the size of the prostate increases gradually to twice or more of its normal size. After the gland reaches a certain size, the fibromuscular tissue of the outer prostate capsule restricts expansion. Due to this restriction on expansion, the intracapsular tissue will press against and restrict the prostatic urethra, thereby causing resistance to urine flow.
In the male genitourinary anatomy, the prostate gland is positioned below the bladder and bladder neck. The bladder wall can expand and contract to cause urine to flow through the urethra that extends from the bladder through the prostate and penis. The portion of the urethra surrounded by the prostate gland is called the prostatic urethra. The prostate also encloses an ejaculatory duct that has an open termination in the prostatic urethra. During sexual stimulation, the vas deferens sperm from the testes to the prostate, which provides fluid in combination with sperm to form semen during ejaculation. The vas deferens and seminal vesicles are joined on each side of the prostate to form a single tube called the ejaculatory duct. Thus, each ejaculatory duct delivers seminal vesicle secretions and sperm into the prostatic urethra.
The prostate gland structure can be divided into three regions, a peripheral region, a transition region and a central region. The peripheral zone PZ comprises about 70% of the volume of the prostate gland of young men. The lower part of the envelope behind the prostate gland surrounds the distal urethra and 70-80% of cancers originate in peripheral zone tissue. The central zone CZ surrounds the ejaculatory duct and comprises about 20-25% of the prostate volume. The central region is usually the site of the inflammatory process. The transition zone TZ is the site in which benign prostatic hyperplasia develops and includes about 5-10% by volume of glandular elements in normal prostate, but may constitute up to 80% of this volume in the case of BPH. The transition zone includes two lateral prostatic lobes and periurethral gland regions. Around the transition zone there is a natural barrier, namely the prostatic urethra, the anterior fibromuscular stroma and the fiber plane between the transition zone and the peripheral zone. The pre-fibromuscular stroma or fibromuscular region is predominantly fibromuscular tissue.
BPH is generally diagnosed when patients complain of troublesome urination difficulties seeking medical treatment. The main symptoms of BPH are urinary frequency and urgency, and a significant drop in flow rate during urination. BPH may also cause urine to reside in the bladder, which in turn may lead to Lower Urinary Tract Infection (LUTI). In many cases, the LUTI may then rise into the kidney and cause chronic pyelonephritis, ultimately possibly leading to renal insufficiency. BPH may also lead to sexual dysfunction associated with sleep disorders or psychological anxiety caused by severe urination difficulties. Thus, BPH may significantly alter quality of life as the male population ages.
BPH is the result of an imbalance between continuous production of glandular cells of the prostate gland and natural death (apoptosis). Overproduction of these cells results in an increase in the size of the prostate, most notably in the transition zone across the prostatic urethra.
In the early cases of BPH, drug treatment may alleviate some symptoms. For example, alpha-blockers treat BPH by relaxing smooth muscle tissue found in the prostate and bladder neck, which also allows urine to more easily flow out of the bladder. Such drugs can prove to be effective before the glandular element causes extreme cell growth in the prostate.
However, the advanced stages of BPH can only be treated by surgical or minimally invasive heat removal device intervention. Various methods have been developed that utilize electrosurgery or mechanical tissue aspiration (extraction) and thermal or cryoablation of intracapsular prostate tissue. In many cases, such interventions provide only temporary relief, and these treatments often result in significant preoperative and post-operative discomfort and morbidity.
Current thermal vapor treatment devices utilize pulse energy to heat sterile distilled water to 103 ℃, and the thermal vapor is injected into the proliferated prostate tissue by piercing with a disposable thermal vapor prostate treatment device, and the thermal vapor diffuses through the interstitial convection to release thermal energy, raising the tissue temperature in the treatment area by about 70 ℃ in 9s, thereby causing cell membrane denaturation and cell death. Necrotic tissue is absorbed by the body, which reduces the volume of prostate tissue adjacent to the urinary tract and relieves LUTS. In addition, thermal energy can cause vascular collapse in the treatment area, ensuring that there is substantially no bleeding during surgery.
The prior steam thermal ablation device Rezum (namely the steam elimination system disclosed in CN 113855214A and the system for treating the prostate disclosed in CN 105816237A) on the market needs to be matched with a cystoscope with a lens of 4mm/30 degrees/30 cm for use, the cystoscope needs to be matched with a light source and an image display device, a plurality of cables are connected with external equipment, a front needle head needs to be penetrated into the prostate tissue before steam delivery and release, the prior steam thermal ablation device Rezum adopts a magnetic device to provide the motion power of the needle, whether the needle head penetrates into the correct position cannot be effectively judged, and in addition, in order to maintain a clear operation observation field during the prostate ablation operation, the prior steam thermal ablation device Rezum needs to be flushed with sterile saline from time to time, and the prior steam thermal ablation device Rezum cannot well meet the operation requirement because the structure limits the endoscope and the sterile saline flushing to share 1 channel.
Therefore, the system for prostate steam ablation, which is reasonable in design and convenient to operate, has great practical significance.
Disclosure of Invention
Due to the defects in the prior art, the invention provides a prostate steam ablation system which is reasonable in design and convenient to operate, and the defects that a cystoscope is required to be matched, the observation is inconvenient and potential safety hazards exist in operation in the existing steam thermal ablation equipment are overcome.
In order to achieve the above object, the present invention provides the following technical solutions:
A system for steam ablation of the prostate comprising a guide sheath for transurethral access to a patient, a handle coupled to the guide sheath, a steam generator disposed in the handle and configured to generate condensable steam, a steam delivery needle in communication with the steam generator and slidably disposed within the guide sheath, and a miniature servo-cylinder attached to the steam delivery needle for driving the steam delivery needle;
The saline solution outlet channel in the guide tube sheath is communicated with a liquid outlet positioned at the end of the guide tube sheath, far away from the handle, and the other end of the saline solution outlet channel is communicated with a physiological saline solution outlet pipe;
The guide tube sheath is far away from the handle end and is provided with a guide tube sheath front camera aligned with the front end of the guide tube sheath, a guide tube sheath rear camera aligned with the needle head of the steam delivery needle and an ultrasonic probe module, and the liquid inlet is aligned with the guide tube sheath rear camera.
The steam generator is used for vaporizing the sterile distilled water, the sterile distilled water is fed by a peristaltic pump of a host, and the peristaltic pump of the host is connected with a sterile distilled water bag.
Compared with the prior art, the prostate steam ablation system provided by the invention has the following advantages:
(1) The integrated design is adopted, a separate matched cystoscope is not needed, a front camera and a rear camera (a front camera of the guide tube sheath and a rear camera of the guide tube sheath) are arranged on the guide tube sheath, and the rear camera of the guide tube sheath aligned with the needle head of the steam delivery needle can observe the firing and withdrawing conditions of the delivery needle and the treatment position, so that an operator can conveniently perform operation;
(2) The added ultrasonic probe module not only can assist in positioning the puncture needle, but also can determine the operation effect through the ultrasonic probe in operation;
(3) Compared with the magnetic driving piece in the prior art, the miniature servo electric cylinder is adopted to drive the steam conveying needle, the stroke precision is high (the delivery stroke precision reaches +/-0.03 mm), the force sensor embedded in the miniature servo electric cylinder can feed back the puncture force to the miniature servo electric cylinder, the miniature servo electric cylinder can control the steam conveying needle according to the puncture force, the steam conveying needle can be prevented from penetrating the capsule wall to cause serious injury to a patient in the operation process to the greatest extent, compared with the traditional method which only relies on the experience of operators to judge the puncture depth of the steam conveying needle, the reliability is good, and a safety guarantee is added for the operation safety of the patient;
(4) Compared with the prior art that the endoscope and the flushing channel share the same channel, the special liquid inlet and outlet channel for normal saline is arranged in the guide tube sheath, so that flushing and cleaning of the visual field in the operation process are facilitated, and pollution can be avoided due to the existence of the special channel;
(5) The steam delivery needle, the saline liquid inlet channel in the guide tube sheath and the saline liquid outlet channel in the guide tube sheath are integrated together, so that the diameter of the guide tube sheath can be reduced (can be reduced to 6 mm), and further the operation burden of a patient is reduced.
As a preferable technical scheme:
according to the prostate steam ablation system, the saline liquid inlet channel in the guide tube sheath and the saline liquid outlet channel in the guide tube sheath are respectively connected with the normal saline liquid inlet pipe and the normal saline liquid outlet pipe through the water separator;
the front camera of the guiding tube sheath is arranged at the end of the guiding tube sheath far away from the handle end.
The system for prostate steam ablation comprises a physiological saline liquid inlet pipe and a physiological saline liquid outlet pipe which penetrate out from the bottom of the handle;
the free end of the physiological saline liquid inlet pipe is provided with a physiological saline liquid inlet Guan Luer joint, and the free end of the physiological saline liquid outlet pipe is provided with a physiological saline liquid outlet Guan Luer joint. The quick connection of the pipeline can be realized through the luer connector.
In the system for steam ablation of the prostate, the steam generator is connected with a sterile distilled water inlet pipe away from the steam delivery needle end, and the sterile distilled water inlet pipe penetrates out from the bottom of the handle.
A system for steam ablation of the prostate as described above, wherein the introducer sheath is secured to the handle by a knob and the introducer sheath is rotatable about the handle.
The system for prostate steam ablation is characterized in that a video/ultrasonic signal cable channel in the guide tube sheath is further arranged in the guide tube sheath, a video/ultrasonic signal cable used for connecting a rear camera of the guide tube sheath, a front camera of the guide tube sheath and an ultrasonic probe module is arranged in the video/ultrasonic signal cable channel in the guide tube sheath, and the video/ultrasonic signal cable penetrates into the handle and then penetrates out of the bottom of the handle.
The system for prostate steam ablation comprises a control cable, a steam generator and a miniature servo electric cylinder, wherein the control cable penetrates into the handle from the bottom of the handle and is respectively connected with the steam generator and the miniature servo electric cylinder through signals;
the miniature servo electric cylinder is embedded with a force sensor, the force sensor can timely feed back the puncture force, and the puncture of the capsule wall is avoided to the greatest extent;
the steam generator is a pulse heater which converts electric energy into heat energy to heat and convert sterile distilled water into sterile distilled water steam.
A system for steam ablation of the prostate as described above, wherein the handle is provided with firing buttons for controlling the steam generator and the micro-servo electric cylinder.
The invention also provides an application method of the prostate steam ablation system, which comprises the following steps:
(1) Inserting a guide tube sheath of a prostate steam ablation system into a patient through urethra to reach the prostate of the patient, wherein the current position of the guide tube sheath can be determined through a front camera of the guide tube sheath in the insertion process;
(2) The system for controlling the steam ablation of the prostate can convey steam into the prostate through the steam conveying needle, the state of the needle head of the steam conveying needle can be obtained through the rear camera of the guide tube sheath and the state of the treatment part of a patient can be observed when the steam is conveyed, and the operation part and the rear camera of the guide tube sheath are flushed through the normal saline liquid inlet tube in operation.
As a preferable technical scheme:
the application method as described above further comprises:
(3) After the operation is completed, the steam delivery needle is retracted and the steam generator is turned off, and the introducer sheath is withdrawn transurethral from the prostate.
The above technical solution is only one possible technical solution of the present invention, the protection scope of the present invention is not limited thereto, and a person skilled in the art can reasonably adjust the specific design according to the actual requirements.
Said invention has the following advantages or beneficial effects:
(1) The prostate steam ablation system disclosed by the invention is reasonable in structural design, does not need to be matched with a cystoscope alone, is integrally designed, is provided with a guide tube sheath front camera and a guide tube sheath rear camera, can be used for observing the urethra tissue environment in real time, and can be used for observing the firing and withdrawal conditions of a delivery needle and observing a treatment part;
(2) According to the prostate steam ablation system, the ultrasonic probe module is added to the guide tube sheath, so that the positioning of the puncture needle position can be assisted, and the operation effect can be determined through the ultrasonic probe in an operation;
(3) Compared with a magnetic driving piece, the system for steam ablation of the prostate has high stroke precision, and the steam delivery needle is driven by a miniature servo electric cylinder, so that the puncture of the capsule wall is avoided to the greatest extent;
(4) According to the prostate steam ablation system, the guide tube sheath is also provided with the special liquid inlet and outlet channel for normal saline, so that flushing and cleaning of a visual field in a surgical process are facilitated, pollution can be avoided due to the existence of the special channel, and surgical operation is facilitated;
(5) According to the prostate steam ablation system, the steam delivery needle, the saline liquid inlet channel in the guide tube sheath and the saline liquid outlet channel in the guide tube sheath are integrated, so that the diameter of the guide tube sheath can be reduced, the operation burden of a patient is further reduced, and the application prospect is good.
Drawings
The invention and its features, aspects and advantages will become more apparent from the detailed description of non-limiting embodiments with reference to the following drawings. Like numbers refer to like parts throughout. The drawings are not drawn to scale, emphasis instead being placed upon illustrating the principles of the invention.
Fig. 1 is a perspective view of a system for steam ablation of the prostate of the present invention;
FIG. 2 is a schematic cross-sectional view of an introducer sheath;
FIG. 3 is a schematic view of an introducer sheath tip;
fig. 4 is a front perspective view of a system for steam ablation of the prostate of the present invention;
FIG. 5 is a schematic view of a system for prostate steam ablation of the present invention with the handle and housing removed;
The device comprises a handle 1, a normal saline liquid inlet pipe 2, a normal saline liquid outlet pipe 3, a sterile distilled water liquid inlet pipe 4, a video/ultrasonic signal cable 5, a control cable 6, a steam generator 7, a water distributor 8, a miniature servo electric cylinder 9, a knob 10, a firing button 11, a guide tube sheath 12, a steam conveying needle 13, a saline liquid inlet channel 14 in the guide tube sheath 15, a saline liquid outlet channel 16 in the guide tube sheath, a video/ultrasonic signal cable channel 17 in the guide tube sheath, a front camera 18 in the guide tube sheath, a rear camera 19 in the guide tube sheath, a normal saline liquid inlet Guan Luer connector 20 in the guide tube sheath Guan Luer connector, an ultrasonic probe module 21, a liquid inlet 22 and a liquid outlet 23.
Detailed Description
The structure of the present invention will be further described with reference to the accompanying drawings and specific examples, which are not intended to limit the invention.
Example 1
A system for steam ablation of the prostate, as shown in fig. 1-4, comprising an introducer sheath 12 for transurethral access to a patient, a handle 1 coupled to the introducer sheath 12 (the introducer sheath 12 is secured to the handle 1 by a knob 10 and the introducer sheath 12 is rotatable about the handle 1), a steam generator 7 (pulse heater) disposed in the handle 1 and configured to generate condensable steam, a steam delivery needle 13 in communication with the steam generator 7 and slidably disposed within the introducer sheath 12, and a micro-servo-cylinder 9 attached to the steam delivery needle 13 for driving the steam delivery needle 13;
The end, far away from the steam conveying needle 13, of the steam generator 7 is connected with a sterile distilled water inlet pipe 4, the sterile distilled water inlet pipe 4 penetrates out from the bottom of the handle 1, a control cable 6 penetrates into the handle 1 from the bottom of the handle and is respectively connected with the steam generator 7 and the micro servo electric cylinder 9 in a signal manner, a force sensor is embedded in the micro servo electric cylinder 9, and a firing button 11 for controlling the steam generator 7 and the micro servo electric cylinder 9 is arranged on the handle 1;
The inside of the guide tube sheath 12 is also provided with a guide tube sheath saline inlet channel 14, a guide tube sheath saline outlet channel 15 and a guide tube sheath inner video/ultrasonic signal cable channel 16, one end of the guide tube sheath saline inlet channel 14 is communicated with a liquid inlet 22 positioned at the end of the guide tube sheath far away from the handle, the other end of the guide tube sheath saline inlet channel is communicated with a physiological saline inlet pipe 2, the guide tube sheath saline outlet channel 15 is communicated with a liquid outlet 23 positioned at the end of the guide tube sheath far away from the handle, the other end of the guide tube sheath saline inlet channel is communicated with the physiological saline outlet pipe 3, the physiological saline inlet pipe 2 and the physiological saline outlet pipe 3 penetrate out of the bottom of the handle 1, a physiological saline inlet pipe luer connector 19 is arranged at the free end of the physiological saline inlet pipe 2, a physiological saline outlet Guan Luer connector 20 is arranged at the free end of the physiological saline outlet pipe 3, the guide tube sheath saline inlet channel 14 and the guide tube sheath inner saline outlet channel 15 are respectively connected with the physiological saline inlet pipe 2 and the physiological saline outlet pipe 3 through a water separator 8, the guide tube inner video/ultrasonic signal cable channel 16 is internally provided with a video/ultrasonic signal cable for connecting a guide tube 18, a guide tube 17 and an ultrasonic camera head 17 penetrates out of the bottom of the handle 1, and a front camera head 21 penetrates out of the handle 1;
The end of the guiding tube sheath 12 far away from the end of the handle 1 is provided with a guiding tube sheath front camera 17 aligned with the front end of the guiding tube sheath 12, the guiding tube sheath 12 is also provided with a guiding tube sheath rear camera 18 aligned with the needle head of the steam delivery needle 13, and the liquid inlet 22 is aligned with the guiding tube sheath rear camera 18.
The application method of the prostate steam ablation system comprises the following steps:
(1) Inserting a guide tube sheath of a prostate steam ablation system into a patient through urethra to reach the prostate of the patient, wherein the current position of the guide tube sheath can be determined through a front camera of the guide tube sheath in the insertion process;
(2) The system for controlling the steam ablation of the prostate conveys steam into the prostate through the steam conveying needle, the state of the needle head of the steam conveying needle can be obtained through the rear camera of the guide tube sheath when the steam is conveyed, the state of a treatment part of a patient is observed, and the operation part and the rear camera of the guide tube sheath are flushed through the normal saline liquid inlet tube in operation;
(3) After the operation is completed, the steam delivery needle is retracted and the steam generator is turned off, and the introducer sheath is withdrawn transurethral from the prostate.
The system for prostate steam ablation is verified to be reasonable in structural design, does not need to be matched with a cystoscope alone, is integrally designed, is provided with a front camera of the guide tube sheath and a rear camera of the guide tube sheath, the front camera of the guide tube sheath can be used for observing the urethra tissue environment in real time, the rear camera of the guide tube sheath can observe the firing and retracting conditions of a delivery needle and can observe a treatment position, the ultrasonic probe module on the guide tube sheath can assist in positioning the position of the puncture needle and can also determine the operation effect through the ultrasonic probe in operation, the steam delivery needle is driven by a micro servo electric cylinder, compared with a magnetic driving piece, the system is high in stroke precision, the bag wall is prevented from being punctured to the greatest extent, the guide tube sheath is also provided with a special saline inlet and outlet channel, flushing and cleaning fields in the operation process are facilitated, the special channel can be prevented from being polluted, the operation is convenient, the steam delivery needle, the saline inlet channel in the guide tube sheath and the saline outlet channel in the guide tube sheath are integrated together, the diameter (the diameter can be 6 mm) of the guide tube sheath can be reduced, and the application prospect is good.
Those skilled in the art will understand that the skilled person can implement the modification in combination with the prior art and the above embodiments, and this will not be repeated here. Such modifications do not affect the essence of the present invention, and are not described herein.
The preferred embodiments of the present invention have been described above. It is to be understood that the invention is not limited to the particular embodiments described above, in which the apparatus and structures not described in detail are to be understood as being embodied in a manner commonly understood in the art, and that many possible variations and modifications may be made to the technical solution of the invention by any person skilled in the art using the methods and techniques disclosed above, or modified to equivalent embodiments without departing from the spirit of the invention. Therefore, any simple modification, equivalent variation and modification of the above embodiments according to the technical substance of the present invention still fall within the scope of the technical solution of the present invention.