WO2022039699A1

WO2022039699A1 - An advanced secure tissue tunnel opener

Info

Publication number: WO2022039699A1
Application number: PCT/TR2021/050789
Authority: WO
Inventors: Orhan Seyfi Aksakal
Original assignee: Orhan Seyfi Aksakal
Priority date: 2020-08-17
Filing date: 2021-08-10
Publication date: 2022-02-24
Also published as: TR202012933A2

Abstract

The present invention relates to an advanced tunnel opener intended for use in surgical procedure of the trans obturator tape applications. It has been developed to solve the problems encountered both in the needle tip (3) and the system elements that control the movement of the needle from outside regarding the trans obturator tape applications.

Description

An Advanced Secure Tissue Tunnel Opener

TECHNICAL FIELD

The present invention is related to an advanced tunnel opener intended for use in the surgical procedure of trans obturator tape applications.

BACKGROUND OF THE INVENTION

The invention is a tissue tunnel opener that performs tunneling in order to surgically pass a suspension strip through the obturator hole in the pubis bone, one of the pelvic bones, in order to correct urinary incontinence that may occur in humans. In order to facilitate the application of trans obturator tape in the tissue, the needle and counter system with its movement structure have advanced structural features.

In the background of the technique, the needle, which is also used in surgical devices used to correct this problem in the human body, can be stuck in the pubis bone while it is in the process of passing through the hole in these surgeries, which must be done completely under the skin and in a way that does not allow visual correction, and the damage may occur on the bone tissue between the needle and the opposite tip. This situation also causes stress on the surgeon. Another problem encountered in this surgery is that due to the elasticity of the soft tissues in the area that the needle has to pass through, it cannot penetrate them and drag it along instead. In this case, the surgeon can pass through the elastic tissue accumulated in layers, which the needle cannot pierce and drag with it, by having to apply a great instantaneous force. This is, at the very least, an unpleasant situation in practice. This sudden movement may adversely affect the mental coordination of surgeon.

The device which is the subject of the patent document TR 2015 03286 B may be shown as an example of the current situation.

AIM OF THE INVENTION

The aim of the present invention is to realize an advanced intra-tissue tunnel opener which will allow the surgeon to work more comfortably and more confidently to achieve positive results. TECHNICAL PROBLEMS AIMED TO BE SOLVED BY THE INVENTION

The present invention designed to overcome the problems of the existing systems by arrangements made in the said tunnel opener and especially in the needle and the needle counter thus making, the surgical operation easier for the surgeon.

BRIEF DESCRIPTION OF THE FIGURES

The advanced tunnel opener realized to achieve the objectives of the present invention is illustrated in the attached figures as follows:

Figure 1 : In the current system, depicts the position of the bone - the shaded triangle region - being compressed between the needle and the needle counter (the thick black arrow indicates contact direction of the needle tip to the bone)

Figure 2: Comparison of the needle tip in the contact area with the bone (left view) and the invented system (right view) (thick black arrows indicate needle tip movement)

Figure 3: Side view of the flat rail system

Figure 4: Perspective view of the monorail system composed of combination of circular and special shaped rails

Figure 5: Progressed embodiment of the needle tip in a monorail system composed of combination of the circular and special shaped rails

Figure 6: Left hand side; depicts side view of the needle and sled, (flexion of the needle tip section indicated in dashed line.). Right hand side; depicts perspective view of the needle and sled

Figure 7: Illustrates needle and sled assembled together

Figure 8: Perspective view of the flexible needle tip, which has sharp point on the opposite side of the bone, the contact area with the bone is flat and slightly thinner

Figure 9: Front view of the needle tip with the needle inserted between the flexible comb ends in the needle counter ( black colored triangle is the cross section of the needle tip. The flexible comb teeth in the needle counter are in open position being pushed on both sides by the needle) Figure 10: Illustrates two unconnected rails (circular rails) on the left and special shaped rail system on the right (white spots of the dark area are rails, black dots are sled feet.)

Figure 11 : Side view of the monorail system composed of combination of the circular and special shaped rails

Figure 12: Illustrates the needle movement in the monorail system composed of combination of the circular and special shaped rails (the movement path indicated by letter D at the needle tip indicates the circular path in the existing systems. The movement indicated by letter E indicates the linear movement path of the subject invention)

Figure 13: Illustrates the embodiment where the rail is mounted to the sled instead of body

Figure 14: Perspective view of the embodiment with the rail on the sled

Figure 15: Side view of the embodiment in which the front foot of the sled moves on the rail opened inside the body and the rear foot is connected to the pusher arm.

EXPLANATION OF THE REFERENCES IN THE FIGURES:

1 . Needle

2. Flat area at the bottom of the needle tip that helps sliding over the bone surface

3. Pointed end of the needle/needle tip

4. Flexible and flat area at the needle tip

5. Sled

6. Rail

7. Body

8. Straight Rail

9. Pusher Arm

10. Circular Rail

11 . Special Shaped Rail

12. Sled Front Foot

13. Sled Rear Foot

14. Needle Counter

15. Flexible Comb Tips of the Needle Counter

16. Thread hole

17. Finger hole

18. Thumb hole

19. Pusher DESCRIPTION OF THE INVENTION

The heuristic steps of the subject invention, which has more than one embodiment, are explained in the following three main sections, sub-clauses and paragraphs thereof:

I. Shaping the Needle According to the Wav of Progress in the Body:

In the first embodiment, having an advanced structural feature adapted to the edge of the bone and preventing the needle tip from getting stuck in the bone ensures that the needle tip (3) moves straight, not circularly, in the contact area with the bone (Figures 2, 3, 5, 12).

There is also another embodiment that can only be pushed on a straight line (straight rail) to ensure that the needle goes straight in the contact area with the bone (Figure 3). In this embodiment the needle (Figures 6, 7) mounted on a sled with protrusions on both sides, is pushed forward or pulled back with the thumb (Figure 3).

In the second embodiment of the tunnel opener where, by turning from a rotation point (18) on the body (7) pushes the sled (5), thus the needle 5 (Figure 7) which is mounted on it (Figures 4, 5, 14, 15). In this case, a rail system suitable for this movement pattern is required for the needle to make the required movements - in a pattern with defined inclinations - (Figures 10, 11 , 14). After all, while the slide protrusions advance on these rail/s, the tip of the needle mounted on the sled, at the end of the movement, slides over this bone without getting stuck in the pubis bone towards the counter (Figure 12 - E route). That is, there are separate rail embodients (Figure 10) for the front (12) and rear (13) feet of the sled (5), as well as single, that is, combined rail (6), (11 ) embodiments. The aim here is to provide the surgeon with the opportunity to make and arrange the body (7), sled (5), rail (6) elements located at the bottom of this device to be used in the said tunneling process, with more than one option, by providing the options in the figures (Figures 4, 5, 10, 11 , 14, 15) are shown and briefly explained in the figure references. The movement of the sled on the rails can be with pins or similar projections that we call the feet (12, 13) in the front and back that protrude from the sled to the sides (Figures 6, 7, 10, 11 , 12); pins and similar elements that serve only as feet can be placed inside the body of the rail (Figures 13, 14). In this case, while the front feet (12) of the sled move on the rail, the rear feet can be articulated directly to the pusher arm (9) (Figure 15).

The needle and sled should be loose enough to easily allow back and forth movement in the body from both sides, but should be tight enough to move forward without wobbling- contraction during movement. In this way, the needle tip (3) can move towards the needle counter without wobbling or jamming the sled (5).

Or, while the front feet (12) of the sled move on the rail (6), the rear feet may be connected directly to the pusher arm (9) (Figure 15). The needle and the sled are tightly wound on both sides to allow back and forth movement within the body, but without much of a space. In this way, the needle tip may advance towards the needle counter without wobbling.

II. Needle Tip Features: a. Soft contact with the bone is provided thanks to the fact that the end part of the needle that is in contact with the bone (2), (3), (4) is made of flexible material and in conformity with the lower, side and tip parts (Figures 6, 7, 8, 9). b. Thanks to the fact that the lower surface of the needle tip that contacts the bone is wide, slippery and having an upward-curved form, allows the sharp end of the needle to slide over the bone without sinking or getting stuck (Figures 6, 7, 8, 9).

III. Structural Feature of Needle Counter:

As far as body of the patient during the operation is concerned, It is the characteristic of the needle counter (14) that meets the needle tip (3), which slides over the pubis bone, under this bone in the body. Thanks to the needle counter with flexible teeth (15), the structural feature of the needle counter is that the needle tip (3) easily pierces the combshaped teeth of the needle counter on both sides, without dragging along the elastic tissues while passing through them thus preventing, forward movement of the same.. The number of these flexible comb structures is sufficient to ensure that even if the needle tip flexes sideways, it is necessary to face it. If the structure of the needle does not allow stretching to the sideways then, at the point where the needle tip reaches the needle counter (14) thus ensuring , the needle tip to pass through, only two each are sufficient. If the structure of the needle tip allows stretching to the side ways, it is necessary to increase the number of these parts in order to align the tip (3) between the two flexible combs (15). Regarding the illustrative embodiments shown in the figures, they are arranged four each in number.

The above exemplary descriptions of the invention are given for better understanding of the subject, and do not limit the scope of the invention.

In all of the embodiments, the process is started by passing the thread through the thread hole (16) at the tip of the needle, which is used to pull the material known as the sling, which will treat urinary incontinence. In the embodiment where the rail (6) is completely straight, the fingers are inserted into the finger hole (17) and the thumbs are inserted into the thumb hole (18), and the tool is prepared for use by first pulling these fingers away from each other to the end. The needle counter (14) is then advanced into the body and under the bone. Then, the thumb and other fingers are brought close to each other to the last point, and the needle (1 ) enters the body, firstly passes through the subcutaneous tissues and reaches the obturator hole formed by the pubis bone. At this point, the needle tip comes into contact with the bone and then, after it slides over the pubic bone, the needle tip (3) approaches to the needle counter.

As regards the not fully straight rail embodiment, first of all the fingers are placed in the corresponding holes (17, 18) and moved away from each other. And in the same way, the needle counter (14) is placed under the bone in the body and the needle (1 ) is inserted into the body by bringing the fingers closer. As described in the paragraph above, the pusher arm (9) turns from the pusher (19) and pushes the sled (5) on which it is mounted from the rear foot (13) and the mounted needle (1) forward in the direction of the rail (6, 8, 10, 11 ). The needle tip (3), which passes through the necessary spaces and tissues of the body, is brought up to the needle counter (14).

After the needle tip (3) passes the flexible comb ends (15) of the needle counter (14) and exits, the thread previously passed to the needle tip (3) has passed the channel path in the body. When the needle (1 ) comes out after passing through and/or over various tissues in the body, the gaps between the needle counter (14) are narrower than the needle tip, and there are flexible comb tips (15) that help the needle to pierce and pass through these tissues thus enabling, the attachment of the elastic tissues dragged along with the needle. These are flexible elements like comb teeth, the intervals of which are thin enough for the needle tip to pass through.

After that, the sling strap attached to one of the two ends of the thread by the surgeon performing the operation is passed through the tunnel opened by the needle (1), and the function of the tunnel opener is completed.

INDUSTRIAL APPLICATION OF THE INVENTION

Successfully solve the above mentioned technical problem, the invention can be produced like other tunnel openers and widely used in the related field.

The parts of the invented device can be easily manufactured.

Claims

1. The advanced secure tissue tunnel opener comprising of the needle (1), flat area (2), needle pointed (3), flexible and flat area at the needle tip (4), slide (5), rail/s (6, 8, 11 ), body (7), pusher lever (9), sled front legs (12), sled rear legs (13), needle counter (14), needle counter's flexible comb ends (15), thread hole (16), finger holes (17, 18), and pusher (19).

2. The secure tissue tunnel opener as in Claim 1 wherein; the needle (1) moves in a circular, curvilinear and linear manner without getting stuck to the bone.

3. The secure tissue tunnel opener as in Claim 2 whereas; providing the structural elements of the body (7), straight rail (8), slide front legs (12), slide rear legs (13), finger holes (17,18) and the pusher (19) to ensure linear advancement of the needle (1 )-

4. The secure tissue tunnel opener according to Claim 2 whereas; providing the structural elements of the sled (5), rail (6), body (7), pusher arm (9), circular rail (10), specially shaped rail (11 ), sled front legs (12), rear legs (13), finger holes (17, 18) and the pusher (19) to ensure both curvilinear and circular advancement of the needle (1 )

5. The secure tissue tunnel opener according to Claim 4 wherein; the lower part of the needle tip (2) and the right-left side parts (4) of the needle tip are shaped in a flat, flexible and slippery structure so that the needle (1 ) does not pierce the bone to be faced while moving through the body.

6. The secure tissue tunnel opener according to Claim 4 or Claim 5 wherein; the needle (1 ) is prevented from being stuck to the bone to be faced while moving through the body, by means of the needle pointed tip (3) which is in the form of an upward curve.

7. The secure tissue tunnel opener as per any one of the proceeding Claims 1 -6 wherein; the needle counter (14) that meets the needle (1 ) after passing through and/or over various body tissues, provides flexible comb tips (15) which help the

7 needle to pierce and pass through the tissues by ensuring attachment of the elastic tissues dragged along by the needle.

8. The secure tissue tunnel opener as per any one of the above claims wherein; the needle counter (14) that meets the needle tip (3) easily comes off without stretching and forcing the body tissues, by means of the thin and flexible intervals of the comb ends (15) allowing passing through of the needle tip.

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