CN116616887A - Female stress urinary incontinence radio frequency ablation electrode - Google Patents

Female stress urinary incontinence radio frequency ablation electrode Download PDF

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Publication number
CN116616887A
CN116616887A CN202310403761.0A CN202310403761A CN116616887A CN 116616887 A CN116616887 A CN 116616887A CN 202310403761 A CN202310403761 A CN 202310403761A CN 116616887 A CN116616887 A CN 116616887A
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CN
China
Prior art keywords
needle
sub
urinary incontinence
needle shaft
ablation electrode
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202310403761.0A
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Chinese (zh)
Inventor
王洪奎
徐鸣
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Weihai Hongyuan Medical Technology Co ltd
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Individual
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Priority to CN202310403761.0A priority Critical patent/CN116616887A/en
Publication of CN116616887A publication Critical patent/CN116616887A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1477Needle-like probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14Probes or electrodes therefor
    • A61B18/1485Probes or electrodes therefor having a short rigid shaft for accessing the inner body through natural openings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505Urinary tract
    • A61B2018/00517Urinary bladder or urethra
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00505Urinary tract
    • A61B2018/00523Treatment of incontinence
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00553Sphincter
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00571Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for achieving a particular surgical effect
    • A61B2018/00577Ablation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636Sensing and controlling the application of energy
    • A61B2018/00773Sensed parameters
    • A61B2018/00791Temperature

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Otolaryngology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention provides a female stress urinary incontinence radiofrequency ablation electrode, comprising: a needle shaft having a proximal end for manipulation and a distal end for insertion into the urethra of a patient; a positioning balloon provided at a distal end of the needle shaft, capable of being inserted into the urethra to a certain depth along with the distal end of the needle shaft; the sub-needles are provided with a plurality of sub-needles and distributed at the proximal end of the positioning air bag; each of the sub-needles is provided with an insulating coating near the needle bar; a handle disposed at a proximal end of the needle shaft; the distal end of the handle is connected with the proximal end of the needle bar; one end of the inflation tube is arranged on the handle, and the other end of the inflation tube is communicated with the positioning air bag; the positioning balloon can be inflated through the inflation tube, thereby increasing the diameter of the positioning balloon. The invention can be used for treating stress urinary incontinence, and has obvious effect, thorough cure and less adverse reaction.

Description

Female stress urinary incontinence radio frequency ablation electrode
Technical Field
The invention relates to a radio frequency ablation electrode, in particular to a radio frequency ablation electrode for treating female stress urinary incontinence, and belongs to the technical field of minimally invasive interventional medical instruments.
Background
Female stress incontinence refers to the involuntary leakage of urine when there is a sudden increase in abdominal pressure (e.g., coughing, sneezing). Female stress incontinence has a high incidence, almost 40% of adult women.
Methods for treating female stress urinary incontinence mainly include drug therapy, pelvic floor laser therapy, and transvaginal middle section suspension. Wherein, the drug treatment mainly relieves symptoms and has limited treatment effect. The recurrence rate of pelvic floor laser treatment is high, most patients need repeated treatment, and a synthetic mesh sheet is needed to be placed through the incision of the anterior wall of the vagina in the middle section of the vagina in the suspension operation, so that adverse reactions possibly occur more. Thus, there is a need in the art for a device and method for treating stress urinary incontinence that is effective, cures thoroughly, and has fewer adverse effects.
Disclosure of Invention
The invention aims to provide a safe, effective and easy-to-implement tool for treating stress urinary incontinence, which can improve the operation efficiency and the operation effect.
The technical scheme of the invention is as follows.
A stress urinary incontinence radiofrequency ablation electrode comprising:
a needle shaft having a proximal end for manipulation and a distal end for insertion into the urethra of a patient;
a positioning balloon provided at a distal end of the needle shaft, capable of being inserted into the urethra to a certain depth along with the distal end of the needle shaft;
the sub-needles are provided with a plurality of sub-needles and distributed at the proximal end of the positioning air bag; each of the sub-needles is provided with an insulating coating near the needle bar;
a handle disposed at a proximal end of the needle shaft; the distal end of the handle is connected with the proximal end of the needle bar;
one end of the inflation tube is arranged on the handle, and the other end of the inflation tube is communicated with the positioning air bag; the positioning balloon can be inflated through the inflation tube, thereby increasing the diameter of the positioning balloon.
Preferably, the patient is female and the length of the needle shaft is such that the distal end of the needle shaft is inserted into the urethra by about 10 cm.
Preferably, the positioning balloon has a volume of about 10 milliliters; when the positioning balloon is inflated by about 10 ml, its diameter can be increased to press it against the patient's body tissue, thereby preventing the needle shaft from moving in the urethra.
Preferably, the sub-needle is connected to an operating means by a transmission means, having a first condition in which it is deployed outwardly relative to the needle shaft to be in contact with the tissue to be treated, and a second condition in which it is retracted inwardly relative to the needle shaft to be disengaged from the tissue to be treated; the sub-needle can be switched between the first state and the second state by operating the operating means.
Preferably, the operating means is provided on the handle.
Preferably, the needle outlet direction of the sub-needle when being unfolded outwards forms an obtuse angle with the insertion direction of the needle bar.
Preferably, the tip of the sub-needle is provided with a temperature sensor.
Preferably, there are 5 sub-needles distributed around the shank at 8, 10, 12, 2 and 4 o' clock positions.
Preferably, the number of the sub-needles is 3, and the sub-needles are uniformly distributed around the needle bar.
Preferably, the proximal end of the handle is curved downwardly.
Through the technical scheme, the invention can obtain the following beneficial technical effects.
The radiofrequency ablation electrode realizes radiofrequency ablation of the tissue of the urethral sphincter by combining the positioning air bag and the sub-needle with the large-angle needle outlet direction so as to treat the stress urinary incontinence.
The temperature sensor is arranged at the distal end of the sub-needle of the radiofrequency ablation electrode, so that the temperature inside the tissue at the position receiving the radiofrequency ablation treatment can be directly measured, an operator is allowed to accurately control the temperature of the tissue at the ablation point in the treatment process, and damage to body tissues beyond the treatment position is avoided while the treatment is completed.
Drawings
FIG. 1 is a schematic diagram of a female stress urinary incontinence radiofrequency ablation electrode of the present invention;
FIG. 2 is a view showing the sub-needle distribution part in FIG. 1;
FIG. 3 is a schematic view of the sub-pin cable connection of FIG. 1;
fig. 4 is a schematic view of the positioning balloon of fig. 1.
The meaning of the individual reference numerals in the figures is as follows:
1. positioning the air bag; 2. a sub-needle; 3. a scale tube; 4. a handle; 5. push-pull button; 6. a knob; 7. a plug; 8. an inflation tube; 9. and (3) a cable.
Description of the embodiments
As shown in fig. 1 to 4, a stress urinary incontinence radiofrequency ablation electrode according to the present invention comprises: needle shaft, positioning air bag 1, sub needle 2, handle 4, inflation tube 8, and cable 9.
The needle shaft has a proximal end for manipulation and a distal end for insertion into the urethra of the patient. The distal end of the needle shaft is capable of reaching the treatment site through the patient's urethra while undergoing treatment.
The positioning balloon 1 is arranged at the distal end of the needle bar and can be inserted into the urethra to a certain depth along with the distal end of the needle bar. The needle shaft further comprises a scale tube 3 on which a scale indicating the depth of insertion of the distal end of the needle shaft is marked.
The sub-needles 2 are distributed at the proximal end of the positioning balloon 1. Each of the sub-needles 2 is provided with an insulating coating near the needle shaft. The tip of the sub-needle 2 is capable of delivering rf ablated current to tissue at the treatment site.
The handle 4 is arranged at the proximal end of the needle shaft. The distal end of the handle 4 is connected to the proximal end of the needle shaft and both are coaxially arranged. The proximal end of the handle 4 is curved downwards and in a preferred embodiment the proximal end of the handle 4 is curved in the 6 o' clock direction.
One end of the inflation tube 8 is arranged on the handle 4, and the other end is communicated with the positioning air bag 1. The positioning balloon 1 can be inflated through the inflation tube 8, whereby the diameter of the positioning balloon 1 is increased, thereby achieving positioning within the patient. In the non-inflated state, the diameter of the positioning balloon 1 is the same as the diameter of the graduated tube 3 or smaller than the diameter of the graduated tube 3.
In a preferred embodiment, the patient is a female, and the length of the needle shaft is adapted to the length of the female's urethra. In a more preferred embodiment, the length of the needle shaft is such that the distal end of the needle shaft is inserted into the urethra by about 10 cm.
In a preferred embodiment, the sub-needle is coupled to an operating means by a transmission means having a first state in which it is deployed outwardly relative to the needle shaft to contact the tissue to be treated, and a second state in which it is retracted inwardly relative to the needle shaft to disengage from the tissue to be treated; the sub-needle can be switched between the first state and the second state by operating the operating means.
In a preferred embodiment, the operating device is arranged on the handle.
In a preferred embodiment, the operating device is a push-pull button or a rotary button.
In a preferred embodiment, there are 5 sub-needles 2 distributed around the shank at 8, 10, 12, 2 and 4 o' clock positions, as shown in figure 2.
In another preferred embodiment, there are 3 sub-needles 2, evenly distributed around the shank at 8, 12 and 4 o' clock positions. Each sub-needle is provided with a small section of insulating coating near the needle bar. .
Fig. 3 shows a schematic diagram of the connection of the sub-needle 2 and the cable 9 of the radiofrequency ablation electrode according to the invention. A guide tube is arranged in the needle bar. The sub-needle 2 is disposed in a guide tube and is slidable therein so that the distal end of the sub-needle 2 is extended or retracted from the distal end of the guide tube. The proximal end of the sub-needle 2 extends outwardly from the proximal end of the guide tube and is connected to one end of a cable 9. The other end of the cable 9 is connected with a plug 7. Those skilled in the art will appreciate that the plug 7 can be connected to any suitable device known in the art capable of providing rf ablation current.
In a preferred embodiment, the distal end of the sub-needle 2 is preformed in a shape bent at a large angle, so that the needle-out direction of the distal end of the sub-needle 2 forms an obtuse angle with the insertion direction of the needle shaft when the sub-needle 2 is protruded from the guide tube. In a more preferred embodiment, the distal end of the sub-needle 2 is preformed in the shape of a circular arc.
In a preferred embodiment, the tip of the sub-needle 2 is equipped with a temperature sensor for measuring the temperature of the tissue at the site of receiving the radio frequency ablation treatment, thereby enabling the operator to precisely control the temperature of the radio frequency ablation. The temperature sensor is connected to the cable 9 via a wire in the sub-needle 2, so that a temperature measurement signal is transmitted.
In a preferred embodiment, the positioning balloon 1 has a volume of about 10 ml. When the positioning balloon 1 is inflated by about 10 ml, its diameter can be increased to cause it to press against the patient's body tissue to exert a force, thereby preventing the needle shaft from moving in the urethra, as shown in fig. 4.
The use of the radiofrequency ablation electrode of the present invention is described below. The invention relates to a minimally invasive interventional therapy, which comprises the following treatment processes.
The patient is placed in the lithotomy position and inserted into the urethra about ten centimeters using the radiofrequency ablation electrode of the invention.
The positioning balloon was inflated by an inflation tube by about 10 ml and the needle was pulled outward to a resistance stop.
The sub-needle is deployed and the radiofrequency ablation electrode is connected to the radiofrequency ablation generator.
The radiofrequency ablation current is output using a radiofrequency ablation generator, and the radiofrequency ablation current is applied to a selected location of the urethral sphincter via a radiofrequency ablation electrode. When the rf ablation electrode used comprised 5 sub-needles, the urethral sphincter was set to 5 thermal freezing points (8, 10, 12, 2, 4 o' clock) and two layers of 10 thermal freezing points. If 3 sub-needles of ablation electrodes are used, two layers of 6 ablation points are made. In the radio frequency ablation process, the temperature of the urethral sphincter at the radio frequency ablation treatment position is monitored through the temperature sensor.
After the radio frequency ablation operation is finished, the sub-needle is retracted, and the gas filled in the positioning air bag is extracted.
Subsequently, the radiofrequency ablation electrode is removed from the patient's urethra.
After operation, the annular sphincter of the urethra is thickened and shortened along with the growth recovery of the tissue at the ablation point, so that the resistance of the urethra is increased. Thus, symptoms of stress incontinence are treated and relapse is less likely.
While the invention has been described and illustrated in detail in the foregoing description with reference to specific embodiments thereof, it should be noted that various equivalent changes and modifications could be made to the above described embodiments without departing from the spirit of the invention as defined by the description and drawings.

Claims (10)

1. A stress urinary incontinence radiofrequency ablation electrode, comprising:
a needle shaft having a proximal end for manipulation and a distal end for insertion into the urethra of a patient;
a positioning balloon provided at a distal end of the needle shaft, capable of being inserted into the urethra to a certain depth along with the distal end of the needle shaft;
the sub-needles are provided with a plurality of sub-needles and distributed at the proximal end of the positioning air bag; each of the sub-needles is provided with an insulating coating near the needle bar;
a handle disposed at a proximal end of the needle shaft; the distal end of the handle is connected with the proximal end of the needle bar;
one end of the inflation tube is arranged on the handle, and the other end of the inflation tube is communicated with the positioning air bag; the positioning balloon can be inflated through the inflation tube, thereby increasing the diameter of the positioning balloon.
2. The radiofrequency ablation electrode for stress urinary incontinence of claim 1, wherein said patient is female, and wherein said needle shaft has a length such that said distal end of said needle shaft is inserted into the urethra by about 10 cm.
3. The radiofrequency ablation electrode for stress urinary incontinence as claimed in claim 1, wherein the volume of said positioning balloon is about 10 milliliters; when the positioning balloon is inflated by about 10 ml, its diameter can be increased to press it against the patient's body tissue, thereby preventing the needle shaft from moving in the urethra.
4. A stress urinary incontinence radio frequency ablation electrode as claimed in claim 1, wherein said sub-needle is connected to an operating means by transmission means having a first condition in which it is deployed outwardly relative to said needle shaft to contact tissue to be treated and a second condition in which it is retracted inwardly relative to said needle shaft to disengage from the tissue to be treated; the sub-needle can be switched between the first state and the second state by operating the operating means.
5. A stress urinary incontinence radiofrequency ablation electrode as claimed in claim 4, wherein said operating means is provided on said handle.
6. A radiofrequency ablation electrode for stress urinary incontinence as claimed in claim 4 or claim 5, wherein the needle exit direction of the sub-needle when deployed outwardly is at an obtuse angle to the insertion direction of the needle shaft.
7. The radiofrequency ablation electrode for stress urinary incontinence of claim 4, wherein the tip of said sub-needle is equipped with a temperature sensor.
8. The radiofrequency ablation electrode for stress urinary incontinence of claim 4 wherein said sub-needles are 5 and are distributed around said needle shaft at 8, 10, 12, 2 and 4 o' clock positions.
9. The radiofrequency ablation electrode for stress urinary incontinence of claim 4, wherein said number of sub-needles is 3, evenly distributed around said needle shaft.
10. A stress urinary incontinence radio frequency ablation electrode as claimed in claim 1, wherein the proximal end of the handle is curved downwardly.
CN202310403761.0A 2023-04-16 2023-04-16 Female stress urinary incontinence radio frequency ablation electrode Pending CN116616887A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202310403761.0A CN116616887A (en) 2023-04-16 2023-04-16 Female stress urinary incontinence radio frequency ablation electrode

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202310403761.0A CN116616887A (en) 2023-04-16 2023-04-16 Female stress urinary incontinence radio frequency ablation electrode

Publications (1)

Publication Number Publication Date
CN116616887A true CN116616887A (en) 2023-08-22

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Family Applications (1)

Application Number Title Priority Date Filing Date
CN202310403761.0A Pending CN116616887A (en) 2023-04-16 2023-04-16 Female stress urinary incontinence radio frequency ablation electrode

Country Status (1)

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CN (1) CN116616887A (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101496738A (en) * 2009-02-27 2009-08-05 夏丽华 Equipment for treating relaxation of anal sphincter with trace radio frequency electrode
CN104510532A (en) * 2013-09-30 2015-04-15 王新 Conformal radio frequency ablation electrode
CN105434040A (en) * 2016-01-11 2016-03-30 王洪奎 Umbrella-shaped radiofrequency ablation electrode needle for endoscopes
CN206548600U (en) * 2016-12-02 2017-10-13 申小青 A kind of petal-shaped multi-pole rf ablating electrode pin with air bag

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101496738A (en) * 2009-02-27 2009-08-05 夏丽华 Equipment for treating relaxation of anal sphincter with trace radio frequency electrode
CN104510532A (en) * 2013-09-30 2015-04-15 王新 Conformal radio frequency ablation electrode
CN105434040A (en) * 2016-01-11 2016-03-30 王洪奎 Umbrella-shaped radiofrequency ablation electrode needle for endoscopes
CN206548600U (en) * 2016-12-02 2017-10-13 申小青 A kind of petal-shaped multi-pole rf ablating electrode pin with air bag

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Effective date of registration: 20231228

Address after: B611, No.213-3 Torch Road, Torch High tech Industrial Development Zone, Weihai City, Shandong Province, 264209

Applicant after: Weihai Hongyuan Medical Technology Co.,Ltd.

Address before: 16 Zhongxing South Road, Yinghai, Daxing District, Beijing 100076

Applicant before: Wang Hongkui