WO2024005757A1 - A uterine manipulator - Google Patents

A uterine manipulator Download PDF

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Publication number
WO2024005757A1
WO2024005757A1 PCT/TR2023/050593 TR2023050593W WO2024005757A1 WO 2024005757 A1 WO2024005757 A1 WO 2024005757A1 TR 2023050593 W TR2023050593 W TR 2023050593W WO 2024005757 A1 WO2024005757 A1 WO 2024005757A1
Authority
WO
WIPO (PCT)
Prior art keywords
shaft
uterine
uterine manipulator
cervical
uterus
Prior art date
Application number
PCT/TR2023/050593
Other languages
French (fr)
Inventor
Salih TASKIN
Batuhan ASLAN
Original Assignee
T.C. Ankara Universitesi Rektorlugu
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from TR2022/010828 external-priority patent/TR2022010828A1/en
Application filed by T.C. Ankara Universitesi Rektorlugu filed Critical T.C. Ankara Universitesi Rektorlugu
Publication of WO2024005757A1 publication Critical patent/WO2024005757A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B17/4241—Instruments for manoeuvring or retracting the uterus, e.g. during laparoscopic surgery
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/0482—Needle or suture guides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0813—Accessories designed for easy sterilising, i.e. re-usable

Definitions

  • the invention relates to a uterine manipulator which enters the uterus and allows the uterus to be optimally moved for diagnostic or therapeutic purposes and is used to facilitate the surgical procedure and reduce the risk of complications during a laparoscopic hysterectomy (closed hysterectomy).
  • uterine manipulators provide better visualization of the female pelvis, allow the uterus to be moved, allow fluids to be injected through the uterus, and maintain pneumoperitoneum. As one of the most important instruments used in this procedure, uterine manipulators provide accurate and optimum tissue tension for anatomical surgery. In addition, they minimize the risk of injury by allowing the mobilization of the uterus and removing adjacent organs such as the bladder and ureter from the surgical site.
  • uterine manipulators are used as an indispensable instrument of this operation as laparoscopic hysterectomy, that is, closed uterine removal surgery, has become a popular method used quite frequently worldwide.
  • uterine manipulators used in gynecology and obstetrics.
  • Existing uterine manipulators have difficulty in installation and use during surgery.
  • the complex configuration of uterine manipulators may create difficulties in placing the manipulator in the cervix. In this case, improper use of the uterine manipulator, especially in the learning phase, and inappropriate movements can lead to adverse conditions such as uterine perforation.
  • the uterine manipulators do not contain structures that will prevent air escape from the outside during the separation of the uterus and the vagina.
  • the air escape situation leads to a decrease in the pressure in the abdomen, which should be at a certain level, and the surgical procedure cannot be continued until the pressure is restored. For this reason, laparoscopic views and procedures become impossible. It is also known that sudden pressure losses increase the risk of surgical complications.
  • uterine manipulators which are in another state of the art and are used during laparoscopic hysterectomy (closed hysterectomy), are generally disposable. Said uterine manipulators are used separately for each patient and do not contain a structure that allows the uterine manipulator used in the procedure to be used on another patient. This situation causes great economic waste and environmental damage.
  • the uterine manipulator comprises a shaft, a handle, an end assembly, and a cutting assembly.
  • the shaft comprises a first end and a second end, and the handle is connected to the first end and is rotatable about a first axis relative to the first end.
  • the end assembly is coupled to the second end and rotatable relative to the second end along a second axis parallel to the first axis and adapted for insertion into the uterus.
  • the cutting device is assembled around the shaft and a structure is provided to receive the cervix when the end device is placed in the uterus.
  • the application numbered 2021/008385 in the literature is a uterine manipulator for laparoscopic hysterectomy surgeries.
  • the uterine manipulator produced to effectively guide the uterus in laparoscopic hysterectomy surgeries consists of five parts: a single structure consisting of an intracavitary shaft, cervical cap, and main shaft, two cone-shaped silicone valves to completely prevent gas leakage, and a handle and handle fixing screw to facilitate power transfer. With the intervention and observation windows in the cervical head, it is ensured that the cervical placement process is easy and rapid.
  • the present invention relates to a uterine manipulator for eliminating the above-mentioned disadvantages and bringing new advantages to the relevant technical field.
  • An object of the invention is to provide a uterine manipulator that prevents air escape during surgery and aims to reduce the risk of perforation of the uterus with the effect of the manipulator end, and also provides convenience to people who are in the learning stage with its easy installation and practical use.
  • Another object of the invention is to provide a uterine manipulator that contributes to the country's economy due to the high number of hysterectomy surgical procedures performed annually and the frequent use of uterine manipulators.
  • the present invention is a uterine manipulator having at least one shaft member which, by entering the uterus, enables the uterus to be optimally moved for diagnostic or therapeutic purposes. Accordingly, its novelty comprises that a balloon member positioned at another end of the shaft member and in a way to grasp the shaft all around has a feature that said balloon member can be removed and reinstalled when necessary.
  • the uterine manipulator is replaced by the balloon member instead of the complete replacement of the uterine manipulator for each user, providing both an economic and a sterile uterine manipulator.
  • a possible embodiment of the invention is characterized in that the shaft member has a curved form.
  • a uterine manipulator that also has the ability to reduce the pressure exerted on the uterine wall and prevent uterine injuries is introduced.
  • Another possible embodiment of the invention is characterized in that it comprises at least one cervical container positioned to move freely on the shaft.
  • a uterine manipulator is introduced to help separate the cervix and uterus from the vagina and physically move the incision site away from nearby ureters.
  • Another possible embodiment of the invention is characterized in that the stopper is seated on said cervical container surface.
  • a uterine manipulator is introduced with a stabilizer system that allows the restriction of cervical container mobility when necessary.
  • Figure 1 shows a representative overview of a uterine manipulator of the invention.
  • Figure 2 shows a representative balloon member of a uterine manipulator according to the invention.
  • Figure 3 shows a representative stopper member of a uterine manipulator of the invention.
  • Figure 4 shows a representative cervical container member of a uterine manipulator of the invention.
  • Figure 5 shows a side view of a representative balloon member of a uterine manipulator of the invention.
  • Figure 6 shows a side view of a cervical container member representative of a uterine manipulator of the invention.
  • Uterine manipulators are traditionally used in laparoscopic hysterectomies to activate and position the uterus, to allow better visualization to facilitate the separation of the vagina and cervix, and to remove the uterus after a colpotomy.
  • the present invention relates to uterine manipulators, and more particularly to a uterine manipulator having an adjustable, size- changeable cervical container (20) feature accessible to the operator, i.e., located outside the outer opening of the vagina, positional against the cervix or the outer end of the cervical canal.
  • the uterine manipulator of the invention comprises a detachable part of the device with a long handle that receives and firmly grasps a catheter section, positioned against the cervix or the external opening of the cervical canal.
  • the members that make up the uterine manipulator are preset, the structure and components of the uterine manipulator include a structure that can adapt to differences within the body.
  • the cervical container (20) can be placed around the cervix and pressed inward against the vaginal fornix.
  • Figure 2 shows the shaft (10) member.
  • the shaft (10) member Considering the uterine placement and shape of the shaft (10), it is seen that it contains a curve (40) to be suitable for manipulation ergonomics. It is intended to eliminate the puncture of the uterus during the surgery due to the curve (40) provided on the shaft (10).
  • One end holding part and another end of the shaft (10) member may be referred to as the end part.
  • the holding part is fixed in the configuration.
  • the cervical container (20) and the stopper (50) located behind it can also be separated from the shaft (10).
  • it is designed to be in the form of a hollow tube of the shaft (10) and to permit fluid passage through it.
  • a balloon member (30) connected to one end of the shaft (10).
  • the balloon member (30) prevents the escape of air during the separation of the uterus and the vagina.
  • the balloon member (30) is connected to the shaft (10) in a circumferential manner.
  • the balloon member (30) has a pear-like shape with a narrow bottom and expanding towards the top.
  • the balloon member (30) located at one end of the shaft (10) contains an inflatable structure.
  • the balloon member (30) can be renewed during each operation and can increase the duration of use of the uterine manipulator.
  • the shaft (10) and the balloon member (30) are connected to each other with the screwing system.
  • the hole at the end of the screwing system is located in the balloon member (30) and helps to transfer the fluid passing through the shaft (10) into the balloon member (30).
  • the economic benefit of the invention is enormous, as a complete replacement of the uterine manipulator is not required for every user.
  • the balloon member (30) is interchangeable during each process, it is ensured that a sterile process is performed for each user.
  • the balloon member (30) is developed according to the current art and has an ability to reduce the pressure applied to the uterine wall with its curved (40) shape and to prevent uterine injuries.
  • the cervical container (20) in the uterine manipulator configuration is provided on the shaft (10) in a way that it can move freely.
  • the cervical container (20) expands from the sides in the form of a cone, its base is closed in a circular manner and is limited to a hole that can only pass through the center of the shaft (10). It is aimed to provide process ergonomics by replacing the cone size with a piece suitable for the cervical diameter of the patient with the dimensions with increasing and decreasing widths.
  • the holes in the conical lateral surfaces of the piece are used to pass the cervical sutures to be applied and to contribute to the piece connection during the removal of the uterus.
  • the stopper (50) sits on the circular surface of the part cervical container (20) and restricts the mobility of the fixing system and the cervical container (20).
  • a uterine manipulator of the invention can be inserted seamlessly into the cervical canal. It provides optimum tension to the uterus and ensures that it is safely kept away from the bladder. With the said invention, it is aimed to use a uterine manipulator that is longer-lasting, reusable, easy to repair if damaged, reduces the possibility of air escape, and provides ergonomic ease of use. Considering the population of the country and the number of annual hysterectomies and surgical procedures using the uterine manipulator, it is aimed to contribute to the country's economy with domestic production.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Reproductive Health (AREA)
  • Pregnancy & Childbirth (AREA)
  • Engineering & Computer Science (AREA)
  • Gynecology & Obstetrics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Endoscopes (AREA)

Abstract

The invention relates to a uterine manipulator having at least one shaft (10) member which, by entering the uterus, enables the uterus to be optimally moved for diagnostic or therapeutic purposes, characterized in that said shaft (10) comprises a balloon member (30) positioned at a further end of said shaft (10) so as to encircle it, said balloon member (30) being removable and reinsertable when required, said shaft (10) having a curved form (40), comprising at least one cervical container (20) positioned to move freely on said shaft (10), comprising a stopper (50) seated on the surface of said cervical container (20).

Description

A UTERINE MANIPULATOR
TECHNICAL FIELD
The invention relates to a uterine manipulator which enters the uterus and allows the uterus to be optimally moved for diagnostic or therapeutic purposes and is used to facilitate the surgical procedure and reduce the risk of complications during a laparoscopic hysterectomy (closed hysterectomy).
BACKGROUND
Today, uterine manipulators provide better visualization of the female pelvis, allow the uterus to be moved, allow fluids to be injected through the uterus, and maintain pneumoperitoneum. As one of the most important instruments used in this procedure, uterine manipulators provide accurate and optimum tissue tension for anatomical surgery. In addition, they minimize the risk of injury by allowing the mobilization of the uterus and removing adjacent organs such as the bladder and ureter from the surgical site.
The general principles and methods of applying uterine manipulators are known by gynecologists and obstetricians, and uterine manipulators are often used by these physicians. Uterine manipulators are used as an indispensable instrument of this operation as laparoscopic hysterectomy, that is, closed uterine removal surgery, has become a popular method used quite frequently worldwide.
In the present art, there are various uterine manipulators used in gynecology and obstetrics. Existing uterine manipulators have difficulty in installation and use during surgery. The complex configuration of uterine manipulators may create difficulties in placing the manipulator in the cervix. In this case, improper use of the uterine manipulator, especially in the learning phase, and inappropriate movements can lead to adverse conditions such as uterine perforation.
In the state of the art, it is seen that the uterine manipulators do not contain structures that will prevent air escape from the outside during the separation of the uterus and the vagina. The air escape situation leads to a decrease in the pressure in the abdomen, which should be at a certain level, and the surgical procedure cannot be continued until the pressure is restored. For this reason, laparoscopic views and procedures become impossible. It is also known that sudden pressure losses increase the risk of surgical complications.
It is seen that uterine manipulators, which are in another state of the art and are used during laparoscopic hysterectomy (closed hysterectomy), are generally disposable. Said uterine manipulators are used separately for each patient and do not contain a structure that allows the uterine manipulator used in the procedure to be used on another patient. This situation causes great economic waste and environmental damage.
Application US10722266B2 in the literature, is a uterine manipulator that can be used to separate the uterus and cervix from the vagina. The uterine manipulator comprises a shaft, a handle, an end assembly, and a cutting assembly. The shaft comprises a first end and a second end, and the handle is connected to the first end and is rotatable about a first axis relative to the first end. The end assembly is coupled to the second end and rotatable relative to the second end along a second axis parallel to the first axis and adapted for insertion into the uterus. The cutting device is assembled around the shaft and a structure is provided to receive the cervix when the end device is placed in the uterus.
The application numbered 2021/008385 in the literature, is a uterine manipulator for laparoscopic hysterectomy surgeries. The uterine manipulator produced to effectively guide the uterus in laparoscopic hysterectomy surgeries consists of five parts: a single structure consisting of an intracavitary shaft, cervical cap, and main shaft, two cone-shaped silicone valves to completely prevent gas leakage, and a handle and handle fixing screw to facilitate power transfer. With the intervention and observation windows in the cervical head, it is ensured that the cervical placement process is easy and rapid.
As a result, all the above-mentioned problems have made it imperative to innovate in the relevant technical field.
BRIEF DESCRIPTION OF THE INVENTION
The present invention relates to a uterine manipulator for eliminating the above-mentioned disadvantages and bringing new advantages to the relevant technical field.
An object of the invention is to provide a uterine manipulator that prevents air escape during surgery and aims to reduce the risk of perforation of the uterus with the effect of the manipulator end, and also provides convenience to people who are in the learning stage with its easy installation and practical use.
Another object of the invention is to provide a uterine manipulator that contributes to the country's economy due to the high number of hysterectomy surgical procedures performed annually and the frequent use of uterine manipulators.
In order to fulfill all the aforementioned objects and those which will arise from the detailed description below, the present invention is a uterine manipulator having at least one shaft member which, by entering the uterus, enables the uterus to be optimally moved for diagnostic or therapeutic purposes. Accordingly, its novelty comprises that a balloon member positioned at another end of the shaft member and in a way to grasp the shaft all around has a feature that said balloon member can be removed and reinstalled when necessary. Thus, the uterine manipulator is replaced by the balloon member instead of the complete replacement of the uterine manipulator for each user, providing both an economic and a sterile uterine manipulator.
A possible embodiment of the invention is characterized in that the shaft member has a curved form. In this way, a uterine manipulator that also has the ability to reduce the pressure exerted on the uterine wall and prevent uterine injuries is introduced.
Another possible embodiment of the invention is characterized in that it comprises at least one cervical container positioned to move freely on the shaft. In this way, a uterine manipulator is introduced to help separate the cervix and uterus from the vagina and physically move the incision site away from nearby ureters.
Another possible embodiment of the invention is characterized in that the stopper is seated on said cervical container surface. In this way, a uterine manipulator is introduced with a stabilizer system that allows the restriction of cervical container mobility when necessary.
BRIEF DESCRIPTION OF THE FIGURE
Figure 1 shows a representative overview of a uterine manipulator of the invention.
Figure 2 shows a representative balloon member of a uterine manipulator according to the invention. Figure 3 shows a representative stopper member of a uterine manipulator of the invention.
Figure 4 shows a representative cervical container member of a uterine manipulator of the invention.
Figure 5 shows a side view of a representative balloon member of a uterine manipulator of the invention.
Figure 6 shows a side view of a cervical container member representative of a uterine manipulator of the invention.
DETAILED DESCRIPTION OF THE INVENTION
In this detailed description, a uterine manipulator of the invention is described only by way of examples which have no limiting effect on a better understanding of the subject matter.
Uterine manipulators are traditionally used in laparoscopic hysterectomies to activate and position the uterus, to allow better visualization to facilitate the separation of the vagina and cervix, and to remove the uterus after a colpotomy. The present invention relates to uterine manipulators, and more particularly to a uterine manipulator having an adjustable, size- changeable cervical container (20) feature accessible to the operator, i.e., located outside the outer opening of the vagina, positional against the cervix or the outer end of the cervical canal.
The uterine manipulator of the invention comprises a detachable part of the device with a long handle that receives and firmly grasps a catheter section, positioned against the cervix or the external opening of the cervical canal. Although the members that make up the uterine manipulator are preset, the structure and components of the uterine manipulator include a structure that can adapt to differences within the body. In order to separate the cervix and uterus from the vagina and physically remove the incision site from the nearby ureters, as well as to provide an observable or tangible sign of the incision point, the cervical container (20) can be placed around the cervix and pressed inward against the vaginal fornix.
Figure 2 shows the shaft (10) member. Considering the uterine placement and shape of the shaft (10), it is seen that it contains a curve (40) to be suitable for manipulation ergonomics. It is intended to eliminate the puncture of the uterus during the surgery due to the curve (40) provided on the shaft (10). One end holding part and another end of the shaft (10) member may be referred to as the end part. The holding part is fixed in the configuration. Also, when the end part is removed, the cervical container (20) and the stopper (50) located behind it can also be separated from the shaft (10). In addition, it is designed to be in the form of a hollow tube of the shaft (10) and to permit fluid passage through it.
In the uterine manipulator of the invention, there is a balloon member (30) connected to one end of the shaft (10). The balloon member (30) prevents the escape of air during the separation of the uterus and the vagina. The balloon member (30) is connected to the shaft (10) in a circumferential manner. The balloon member (30) has a pear-like shape with a narrow bottom and expanding towards the top. The balloon member (30) located at one end of the shaft (10) contains an inflatable structure.
The balloon member (30) can be renewed during each operation and can increase the duration of use of the uterine manipulator. The shaft (10) and the balloon member (30) are connected to each other with the screwing system. The hole at the end of the screwing system is located in the balloon member (30) and helps to transfer the fluid passing through the shaft (10) into the balloon member (30).
Furthermore, the economic benefit of the invention is enormous, as a complete replacement of the uterine manipulator is not required for every user. In addition, thanks to the fact that the balloon member (30) is interchangeable during each process, it is ensured that a sterile process is performed for each user. The balloon member (30) is developed according to the current art and has an ability to reduce the pressure applied to the uterine wall with its curved (40) shape and to prevent uterine injuries.
The cervical container (20) in the uterine manipulator configuration is provided on the shaft (10) in a way that it can move freely. The cervical container (20) expands from the sides in the form of a cone, its base is closed in a circular manner and is limited to a hole that can only pass through the center of the shaft (10). It is aimed to provide process ergonomics by replacing the cone size with a piece suitable for the cervical diameter of the patient with the dimensions with increasing and decreasing widths. The holes in the conical lateral surfaces of the piece are used to pass the cervical sutures to be applied and to contribute to the piece connection during the removal of the uterus. In addition, the stopper (50) sits on the circular surface of the part cervical container (20) and restricts the mobility of the fixing system and the cervical container (20). The level of the cervical container (20) does not change during manipulation. A uterine manipulator of the invention can be inserted seamlessly into the cervical canal. It provides optimum tension to the uterus and ensures that it is safely kept away from the bladder. With the said invention, it is aimed to use a uterine manipulator that is longer-lasting, reusable, easy to repair if damaged, reduces the possibility of air escape, and provides ergonomic ease of use. Considering the population of the country and the number of annual hysterectomies and surgical procedures using the uterine manipulator, it is aimed to contribute to the country's economy with domestic production.
The protection scope of the invention is specified in the appended claims and cannot be strictly limited to those explained in this detailed description for illustrative purposes. It is evident that a person skilled in the art may exhibit similar embodiments in light of the foregoing without departing from the main theme of the invention.
REFERENCE NUMBERS GIVEN IN THE FIGURES
10 Shaft
20 Cervical Container 30 Balloon Member
40 Curve
50 Stopper

Claims

CLAIMS The invention relates to a uterine manipulator having at least one shaft (10) member which, by entering the uterus, enables the uterus to be optimally moved for diagnostic or therapeutic purposes, characterized in that said shaft (10) comprises a balloon member (30) positioned at a further end of said shaft (10) so as to encircle it, said balloon member (30) having a feature of being removable and reinsertable when required. A uterine manipulator according to Claim 1 , characterized in that the shaft (10) member has a curved (40) shape. A uterine manipulator according to Claim 1 , characterized in that it comprises at least one cervical container (20) positioned to move freely on the shaft (10). A uterine manipulator according to Claim 1 , characterized in that it comprises a stopper (50) seated on the surface of the said cervical container (20).
PCT/TR2023/050593 2022-06-30 2023-06-20 A uterine manipulator WO2024005757A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2022010828 2022-06-30
TR2022/010828 TR2022010828A1 (en) 2022-06-30 A UTERINE MANIPULATOR

Publications (1)

Publication Number Publication Date
WO2024005757A1 true WO2024005757A1 (en) 2024-01-04

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PCT/TR2023/050593 WO2024005757A1 (en) 2022-06-30 2023-06-20 A uterine manipulator

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106580408A (en) * 2016-12-12 2017-04-26 朱滔 Disposable balloon uterine manipulator
WO2019164613A2 (en) * 2018-02-20 2019-08-29 Conmed Corporation Uterine manipulator
WO2021257789A1 (en) * 2020-06-18 2021-12-23 Conmed Corporation Uterine manipulator with balloon occluder

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN106580408A (en) * 2016-12-12 2017-04-26 朱滔 Disposable balloon uterine manipulator
WO2019164613A2 (en) * 2018-02-20 2019-08-29 Conmed Corporation Uterine manipulator
WO2021257789A1 (en) * 2020-06-18 2021-12-23 Conmed Corporation Uterine manipulator with balloon occluder

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