WO2020013786A2

WO2020013786A2 - A surgical sheath

Info

Publication number: WO2020013786A2
Application number: PCT/TR2019/050475
Authority: WO
Inventors: Lutfi TUNC
Original assignee: Tunc Lutfi
Priority date: 2018-06-22
Filing date: 2019-06-20
Publication date: 2020-01-16
Also published as: WO2020013786A3; TR201808899A2

Abstract

The present invention relates to a surgical sheath (1) which is covered onto manual tools used at morcellation stage during HoLEP surgery and wherein an inflatable balloon (3) is located on its one end.

Description

A SURGICAL SHEATH Technical Field

The present invention relates to a surgical sheath which is covered onto manual tools used at morcellation stage during HoLEP surgery and wherein an inflatable balloon is located on its one end.

Background of the Invention

BPH (benign prostatic hyperplasia) is a frequent disease for over middle-aged men and HoLEP (holmium laser enucleation of the prostate) surgery is a method used for surgical treatment of this disease. At the first stage of the HoLEP surgery, the enlarged prostate tissue is resected from the prostate capsule by means of laser and then it is discarded into the bladder. Being discarded into the bladder, the prostate tissue is disintegrated from the bladder and taken out by means of a special tool called as morcellator at the final stage of surgery.

The morcellation stage is the most significant step in HoLEP surgery. Bladder mucosa is damaged when it is not possible to be careful because the range of vision reduces due to bleeding originating from the prostatic part. The morcellation stage takes a long time because of these considerations. In order that the morcellation operation takes a shorter time by improving the vision quality at the morcellation stage, it is required to prevent transition of the bleeding to the bladder side and to continue the morcellation operation during the prevention operation. Stopping the transition of the bleeding, which arises from the prostatic part, to the prostatic part will improve the vision quality and ensure that the HoLEP surgery is performed much more safely and quickly. Therefore, a surgical application which will both reduce and/or stop bleeding and also enable to continue the morcellation operation and have an attachable/detachable structure for the tools to be used for morcellation, is needed considering the present applications in the prior art.

The European patent document no. EP2810613 discloses an invasive device of minimal size used for the treatment of prostate diseases. In the said device, the prostatic tissue is resected and it is enabled to fix the shaft by inflating a balloon located on the upper part of the shaft in order to remove the resected tissue. Transaction of tissue debulking is performed by inflating the balloon between the bladder and the prostate and fixing the shaft. The device, which is mentioned in the European patent document no. EP2810613 and receives the tissue around the urethra and debulks it, is particularly used for treatment of BPH and prostatic carcinoma.

The Einited States patent document no. US20080262477 discloses a catheter structure having a balloon suitable for use in suprapubic prostatectomy. The said catheter includes a tube having a plurality of lumens in order to facilitate passage of fluid. The lumens comprise a plurality of outlet openings in order to facilitate passage of fluid out of the urinary bladder. An expandable balloon is located on one of the plurality of lumens, preferably on the distal end. By applying pressure on the walls of the prostatic capsule by means of the balloon, it is enabled to keep the bleeding under control and to provide fluid flow from other lumens on the other hand.

As can also be seen in the documents in the prior art; although balloon structures are available in the medical sector, there is no surgical sheath whereby both the bleeding is stopped, reduced by inflating the balloon upon it is covered onto the manual tool used at morcellation stage at HoLEP surgery and also the disintegration and evacuation operation is continued after the manual tool used for morcellation operation passes through the inflated balloon. disintegrated from the bladder and taken out by means of a special tool called as morcellator at the final stage of surgery

Summary of the Invention

An objective of the present invention is to realize a sheath which is covered onto manual tools such as morcellator used at morcellation stage during HoLEP surgery; wherein an inflatable balloon is located on its one end; and which stops, reduces the bleeding passing from the prostatic part to the bladder.

Another objective of the present invention is to realize a sheath which reduces the bleeding upon being placed between the bladder and the prostate after the balloon is inflated before the morcellation operation is started; and ensures that the morcellation operation is realized in an environment with high vision quality by stopping the passage of blood to the bladder.

A further objective of the present invention is to realize a sheath which enables to realize a much safer and faster HoLEP surgery in a more clear vision obtained by preventing the passage of bleeding from the prostatic part to the bladder.

Detailed Description of the Invention

“A Surgical Sheath” realized to fulfil the objectives of the present invention is shown in the figures attached, in which:

Figure 1 is a perspective view of the inventive surgical sheath wherein its balloon is non-inflated;

Figure 2 is a perspective view of the inventive surgical sheath wherein its balloon is inflated; Figure 3 is a detailed perspective view of the apparatus which acts as a valve located at the end of the inventive surgical sheath.

The components illustrated in the figures are individually numbered, where the numbers refer to the following:

1. Surgical sheath

2. Body

3. Balloon

4. Cannula

5. Apparatus

The inventive surgical sheath (1) which is positioned on a manual tool used at morcellation stage in HoLEP surgery comprises:

- at least one hollow body (2) which is covered onto the tool used during surgery and allows the tool to perform its function;

- at least one balloon (3) which is located on one end of the body (2); has an inflatable-deflatable structure; both reduces, stops the bleeding and prevents the bleeding from proceeding to the bladder upon being placed between the bladder and the prostatic part;

- at least one cannula (4) which is located on the body (2); whereby the fluid necessary for inflating the balloon (3) is given to the balloon (3) and the fluid is withdrawn for deflating the balloon (3) upon being connected to the balloon (3) from its one end; and

- at least one apparatus (5) which is located on the other end of the cannula (4) wherein the balloon (3) is not present; whereby the fluid enters and exits; and which acts as a valve.

In the inventive surgical sheath (1), the body (2) is positioned between the bladder and the prostatic part over its end where the balloon (3) is located. After the balloon (3) is inflated, the body (2) is pulled backwards and placed to the joint of the bladder and the prostate.

In a preferred embodiment of the inventive surgical sheath (1), the body (2) is located on the bladder part of the body (2) and it has an inflatable-deflatable structure on demand. Being located on the end part of the body (2) before the morcellation stage begins, the balloon (3) is placed between the bladder and the prostate by being inflated and both reduces the bleeding and prevents the blood from passing from the prostate to the bladder by buffering the small vessels bleeding in that area. The balloon (3) located on the end part of the body (2) is 1 cm wide while it is deflated. Liquid or gas is used for inflating the balloon (3).

In a preferred embodiment of the invention, the end of the cannula (4) connected to the balloon (3) is adjacent to body (2) whereas the end thereof connected to the apparatus (5) is located in a position apart from the body (2). The end of the cannula (4) reaching the apparatus (5) by moving away from the balloon (3) departs from the body (2) after a certain point on the body.

In the inventive surgical sheath (1), the apparatus (5) is a piece which acts as a valve and allows the passage of the fluid required for inflating the balloon (3). The apparatus (5) controls the passage of the fluid to be given to the cannula (4) or pulled through the balloon (3) and makes contact with the inflator or fluid withdrawing structures such as syringe.

The inventive surgical sheath (1) is covered onto manual tools such as morcellator, resectoscope which are used at morcellation stage in HoLEP surgeries, over the hollow body (2). After the balloon (3) located on the end of the body (2) reaching the bladder is inflated, the sheath (1) is withdrawn a little and it is placed between the bladder and the prostate. Thereby, the morcellation operation is continued with the manual tool passing through the hollow body (2) and tissues are disintegrated and taken out and also it is ensured that a clear vision -which is required for quick and safe execution of these transactions- is provided by preventing the bleeding from reaching the bladder by means of the balloon (3).

The inventive surgical sheath (1) act as a buffer in order to reduce the bleeding by placing the balloon (3) between the bladder and the prostate after it is inflated before the morcellation operation is initiated and it is enabled to realize the morcellation operation in an environment with high vision quality by stopping the passage of the blood to the bladder. In addition, a much safer and quicker HoLEP surgery is obtained in the more clear vision obtained by preventing the passage of the bleeding from the prostatic part to the bladder.

Within these basic concepts; it is possible to develop various embodiments of the inventive“A Surgical Sheath (1)”; the invention cannot be limited to the examples disclosed herein and it is essentially according to the claims.

Claims

1. A surgical sheath (1) which is positioned on a manual tool used at morcellation stage in HoLEP surgery; characterized by:

2. A surgical sheath (1) according to Claim 1; characterized by the body (2) which is positioned between the bladder and the prostatic part over its end where the balloon (3) is located.

3. A surgical sheath (1) according to Claim 1 or 2; characterized by the body (2) which is pulled backwards and placed to the joint of the bladder and the prostate after the balloon (3) is inflated.

4. A surgical sheath (1) according to any of the preceding claims; characterized by the balloon (3) which is located on the end part of the body (2) before the morcellation stage begins; placed between the bladder and the prostate by being inflated and both reduces the bleeding and prevents the blood from passing from the prostate to the bladder by buffering the small vessels bleeding in that area.

5. A surgical sheath (1) according to any of the preceding claims; characterized by the balloon (3) which is 1 cm wide while it is deflated, on the end part of the body (2).

6. A surgical sheath (1) according to any of the preceding claims; characterized by the cannula (4) the end of which connected to the balloon (3) is adjacent to body (2) whereas the end thereof connected to the apparatus (5) is located in a position apart from the body (2).

7. A surgical sheath (1) according to any of the preceding claims; characterized by the cannula (4) the end of which reaching the apparatus (5) by moving away from the balloon (3) departs from the body (2) after a certain point on the body.

8. A surgical sheath (1) according to any of the preceding claims; characterized by the apparatus (5) which is a piece acting as valve and allowing the passage of the fluid required for inflating the balloon (3).

9. A surgical sheath (1) according to any of the preceding claims; characterized by the apparatus (5) which controls the passage of the fluid to be given to the cannula (4) or pulled through the balloon (3) and makes contact with the inflator or fluid withdrawing structures such as syringe.