WO2015171017A1

WO2015171017A1 - Surgical fastening element

Info

Publication number: WO2015171017A1
Application number: PCT/RU2015/000221
Authority: WO
Inventors: Аркадий Вениаминович ДУБРОВСКИЙ
Original assignee: Аркадий Вениаминович ДУБРОВСКИЙ
Priority date: 2014-05-05
Filing date: 2015-04-08
Publication date: 2015-11-12

Abstract

Proposed is a surgical fastening element for mechanically suturing biological tissues, said element being made of a biocompatible, bioabsorbable material. The fastening element has a tubular portion (1) with an expansion (2) on the proximal end thereof, and with a rigid sharpened rod (3) located inside the tube and easily retrieved from within same following suturing. The securing of the distal end of the tubular portion (1) following the suturing of tissues, and the removal of the rigid rod (3) are carried out at any level of the tubular portion with the help of a securing portion (4), which is also made of a biologically-compatible material which is resorbable within a specified amount of time, and which is positioned on the opposite side of the tissues to be sutured. The securing portion is in the form of a continuous securing strip or in the form of individual discs provided with means for securing the distal end of the tubular portion which is inserted into an opening in the securing portion (4).

Description

SURGICAL FIXING ELEMENT

Technical field

This utility model relates to medical equipment and more specifically relates to a surgical fastening element intended for use in staplers, mainly for stitching biological tissues, but can also be used in other areas.

State of the art

The main element of all staplers, except for devices adapted for stitching with threads, is the bracket. For the first time in 1908, the Hungarian surgeon N. Hultl and the engineer V. Fischer created a stapler, which imposed 4 rows of staple stitches with dissection of tissues between them. Already in this first stapler, a U-shaped metal bracket was used. The sharp ends of the brackets after stitching fell into the corresponding holes of the stapler, twisted and the U-shaped clip turned into a B-shaped one. Over the past century, this principle of fixing brackets has not changed much. The material of the wire for the bracket has changed. In 1921, Von Petz used silver wire for brackets. In the 50s of the last century in the USSR, where the first modern staplers were designed and put into production, tantalum wire was used, and then 40 KNXM alloy. Since the 60s of the last century, Auto-Suture (USSC) has been using titanium for brackets.

Initially, the brackets were made of wire, now they are made of flat tape. Reinforcing faces, various notches are proposed, their shape has slightly changed. However, the essence remains the same - a metal bracket is retained, which has a number of advantages: inertness, strength and reliability of the connection, as well as ease of use. Pressing one handle or tightening one screw of a modern stapler leads to stitching of fabrics with brackets and bending of the ends of the staples in the corresponding holes. The bracket from the U-shaped turns into a B-shaped. This provides a reliable fixation of stitched fabrics.

However, the main drawback of the metal bracket remains - foreign bodies remain in the tissues after flashing. The body is delimited from inert foreign bodies by the formation of a connective tissue capsule, which leads to an expansion of the zone of development of scar tissue in a functioning organ. Using an X-ray examination of patients, it was found that over time, as a rule, there is a migration of brackets, for example, in the lung tissue, especially in a growing organism. Patients operated on with metal brackets cannot be examined on nuclear magnetic resonance devices. Even clips made of titanium interfere with MRI scans.

The advantage of a thin metal bracket is the ability to create a thin seam on stitched fabrics. However, the pressure exerted by a thin bracket on the stitched fabric plays a negative role in certain cases. Cases of teething by brackets are sometimes observed. In the stomach and intestines, erupted braces are thrown out by the body to the outside, and in the bronchi this leads to the development of hemoptysis and the formation of fistulas. Brackets can penetrate some altered tissues, they can not be applied to emphysema areas of the lung tissue, to parenchymal organs (liver, spleen). Therefore, the latest models of stapling tools use flat brackets. But even with these brackets you cannot flash parenchymal organs and emphysematous sections of the lungs.

At the same time, in medicine, biocompatible materials that are absorbable at specific times are currently being used.

Numerous fastening elements from absorbable polymeric materials have been developed. Basically, these are U-shaped staples with sharp ends twisting at different levels (US Pat. No. 8,365,976) or (lance-shaped) arrow-shaped ends, snapping at a predetermined level on the counterpart (US 5222963). Covidien created the linear seam units Poly GIA ТМ 75 and ТА Premium devices with fastening elements from absorbable (bioabsorbable) material Lactomer or Polysorb (polymer of lactic and glycolic acids). These fastening elements are essentially in the form of U-shaped brackets. The sharp ends of these elements are swept in shape and snap into the mating holding part at a strictly defined height. The mating holding portion also has a U-shape. There are three sizes of fastening elements - for thin, medium and thick fabrics. Accordingly, the gap of the fastening element in the closed state is 1.5 mm for thin fabrics, 4.3 mm for medium fabrics and 5.0 mm for thick fabrics. This causes certain difficulties, as it is always difficult to determine in advance the thickness of the stitched fabric in a compressed state. In addition, it is extremely rare that all fabric sewn by the machine (40 mm, 60 mm or more) has an equal thickness. Metal brackets can compensate to some extent by bending over different heights. In recent designs of staplers, for example, in the apparatus disclosed in US Pat. The quality of the seam depends on this. This prevents excessive compression of some areas, resulting in tissue necrosis, or insufficient compression of other areas, which may result in leakage of the suture or bleeding.

In addition, the dimensions of the polymer fastening elements exceed the dimensions of the metal brackets. Given all this, polymer clips can not yet compete with metal brackets and are used only in gynecology and urology. There is no data on the possibility of piercing with polymer clips of dense tissues, such as bronchi of various diameters.

A brief description of the essence of the utility model

The utility model is based on the task of developing a fastening element made of modern biocompatible materials that are absorbable at a certain time, which could be used in staplers to create an airtight seam on any fabrics with a large range of thicknesses of stitched fabrics.

The problem is solved by creating a surgical fastening element from a biocompatible bioabsorbable material for mechanical flashing of biological tissues using a stapler. The fastening element contains a stitching and reciprocal fixing part located one opposite the other on different sides of the stitched fabric. According to the proposed utility model, the flashing part has a tubular shape with expansion at the proximal end. A rigid rod with a pointed end protruding beyond the distal end of the tube is mounted with the possibility of extraction in the channel of the tube. In the mating fixing portion adapted to receive the distal end of the tube, there is means for fixing the end of the tube at any preferred level after removing the rigid rod.

The outer surface of the tubular part may be smooth or ribbed with at least two ribs, or faceted, for example,

trihedral or polyhedral shape.

The counter, fixing part is preferably in the form of a “washer” with a channel for receiving the distal end of the tube, and protrusions are formed on the surface of the channel having flexibility that allows the tubular part to advance in the flashing direction and prevent it from moving in the opposite direction. It is possible that the protrusions have the shape of triangular petals, bent in the direction of stitching.

It is also possible that on the outer surface of the distal end of the tube, narrowing protrusions bent in the direction of flashing are made.

It is advisable that the response fixing part is made in the form of a three-layer tape, easily pierced by a fastening element with a rigid sharpened rod, while it is desirable that the middle layer of the tape be installed with the possibility of forced longitudinal displacement relative to the outer layers.

In this case, the middle layer of the fixing tape may be a thread with loops located respectively stitching tubular elements.

It is also possible that the mating fixing part was made in the form of two coaxial tubes located along the seam, easily pierced by flashing tubular elements with a rigid pointed rod, while the inner tube should be mounted with the possibility of forced longitudinal displacement relative to the outer one.

In some cases, it is desirable to perform the response fixing part in the form of a tube filled with bioabsorbable adhesive, while the wall of the tube must be thick enough to pierce the wall with the pointed end of the rigid rod and insert the distal end of the tubular stitching part of the fastening element into the adhesive mass.

In addition, the mating retaining part can be made in the form of two opposite to each other tapes having curly protrusions located on facing each other surfaces, which ensure that the tapes interlock with each other and fix the distal ends of the tubular flashing parts inserted into the space between ribbons

In another embodiment, the mating retaining part can be made in the form of a clamping device having a housing with an opening for accommodating the distal end of the tubular stitching part, and a movable element mounted with

the ability to move in the hole of the housing and fixing the distal end of the tubular part.

According to this proposal, the fastening element from the proximal end has an extension, preferably in the form of a flat wide "hat" of round or oblong shape, the distal end is sharp.

The presence of a wide cap from the proximal end and a separate rather wide fixing part in the form of a “washer” or a wide soft fixing tape with the distal end of the fastening element allows you to create a sealed seam in any biological tissue. This greatly expands the possibilities of using a mechanical staple seam in surgery.

There are several options for fixing after flashing the distal end of the fastening element.

If there are protrusions of various shapes on the faces of the tubular part that impede its reverse movement, fixing in the fixing tape or separate clips located on the opposite side of the seam is carried out at any desired level immediately after piercing and removing the rigid rod.

However, the preferred option is to use a fastening element with a smooth tubular part. In this embodiment, a fixing element with a channel can be used, on the surface of which flexible protrusions are formed that impede the reverse movement after flashing the distal end of the tubular part from the retainer.

The distal part of the paper clip extending beyond the fixing tape or retainer is cut off after flashing.

Also convenient in operation and reliable are the clamps, squeezing the distal end of the tubular part of the fastening element, caught in the clamp after removing the metal rod.

Detailed disclosure of utility model

In the future, the utility model is illustrated by a description of the preferred options for its implementation and the accompanying drawings, on which, according to this proposal:

Figure 1 depicts a surgical fastening element with elastic protrusions in the latch channel, a longitudinal section;

Figure 2 is the same as in FIG. 1, but with flexible petals in the latch channel;

Fig. 3 - the same as in figure 1, but with an elastic membrane in the channel of the latch;

Figa - the same as in Fig.1, but with a latch consisting of two parts;

FIG. 46 is a movable portion of the latch of FIG. 4a, cross section;

Figa, b - the same as in figa, b, but on the inner surface of the fixed part of the channel of the latch there are additional protrusions.

Fig. 7, 8a, b, c - embodiments of the fastening element with a lock in the form of a washer, equipped with a clamping device; Fig.9 is a fastening element with flexible protrusions on the outer surface of the tubular part, a longitudinal section, a fixing element is conventionally shown in top view;

Figure 10 is the same as in figure 9, but the tubular part is additionally provided with ribs;

Figure 1 1 is the same as in figure 9, but the tubular part is a trihedral shape;

Figa - fastening element with a three-layer tape retainer in the position of flashing, a longitudinal section;

Fig. 126 is the same as in Fig. 12a, but in the locked position;

Fig - fastening element with a latch of two coaxial tubes, in the locked position, a longitudinal section;

Figa - fastening element with a snap tape retainer, a longitudinal section;

Fig.146 is the same as in fig. 14a, the transverse section, after fixing, is enlarged.

FIG. 14c is the same as in FIG. 14a, the transverse section, after fixing, is enlarged.

Figure 1 shows a surgical fastening element (hereinafter referred to as a clip) containing a tubular part 1 having an extension 2 (a “hat”) at its proximal end. A rigid shaft 3 with a sharp distal end protruding beyond the tubular end is located in the channel of the tubular part 1 parts 1. The rod 3 can easily be removed from the channel of the paper clip after sewing tissue. The mating clip fixing part 4 is for gripping and securing the distal end of the tubular part 1 after flashing. It has the shape of a rounded or multifaceted "washer" and is located on the other sponge of the stapler (not shown in the drawing), on the other side of the stitched fabric.

In the embodiment shown in FIG. 1, on the walls of the channel “washers” there are protrusions 5 directed by their pointed ends in the distal direction and having flexibility allowing the distal end of the tubular part 1 to advance

direction of flashing and preventing it from moving in the opposite direction.

Figure 2 shows an embodiment of the mating locking part, in which the inner channel of the "washer" is closed by flexible petals 5 'forming a funnel.

The top of the funnel is directed along the stitching part 1. The stitching part 1 with a rigid rod 3 inside easily deflects the petals 5 'in only one direction.

The deviation of the petals 5 'in the opposite direction is impossible. After removing the rigid rod 3, the petals 5 'tightly compress the soft walls of the tubular part 1 and

prevent its reverse movement. The petals can be replaced by a 5 ”elastic funnel-shaped membrane (FIG. 3). The top of the membrane is also directed along the stitching tubular part 1. This allows the 5” membrane to be pierced freely and the stitching part 1 can pass through it with the rigid shaft 3 only in one direction. After removing the rigid rod 3, an elastic funnel-shaped membrane tightly compresses the soft walls of the tubular part 1 and prevents its reverse movement.

On figa, b shows an embodiment of the locking element,

formed by two rounded details 6 and 7 of the U-shaped cross-section,

entering one another. In this case, the cavity of the lower part 7 has a narrowing downward in the direction of flashing, and the walls of the upper part 6 are made with vertical slots and can spring. When pressure is applied to the lower part 7, this part

it is mounted on the upper part 6. The walls of the channel of the upper part 6 come together, reducing the clearance of the channel of the part 6. At the same time, the distal end of the tubular part located in the "washer" is compressed and the rigid rod is removed from it.

In FIG. 5 a, b depicts the same embodiment as in FIG. 4a, b, but on the walls of the channel of the upper part 6, pointed protrusions 8 are made, which increase the reliability of fixing the distal end of the tubular part 1 after flashing.

In the embodiment shown in figa, b, the "washer" also consists of two parts 9 and 10, equipped with a Central channel and mounted with the possibility of moving one relative to the other in the vertical direction with simultaneous displacement in the horizontal plane. The interacting side walls of the parts 9 and 10 are made inclined and there are pointed notches 11 that engage when moving the parts 9 and 10. At the same time, after pressing the rigid rod 3 onto the lower part 3, it is pressed against the part 10 due to displacement in

In the horizontal direction of the central channel of the lower part 10 relative to the channel of the upper part 9, a corresponding displacement of the distal end of the tubular part 1 occurs and its fixation in the washer. The notches 11, snapping together, prevent the lower part 10 from slipping out of the upper.

In FIG _. 7, a circular “washer” is shown in cross-sectional top view in which the parts 12 and 13 can be moved horizontally relative to each other so that the clamping device 14 snaps into place. The distal part of the paper clip 1 caught between the parts 12 and 13 after flashing and removing the rigid rod it is compressed and reliably after squeezing parts 12 and 13 until the clamping device 14 clicks into place. On figa, b, c presents three more embodiments of the fixing part, each of which contains a housing 15 with a hole 16 and a movable part 17 mounted in the hole 16 with the possibility of movement relative to the housing 15. In addition, the locking part is equipped with a clamping device 18 to fix the position of the movable part 17. The distal end of the tubular part of the paper clip with a rigid rod pierce the housing 15 and enter it into the channel formed in the housing, remove the rigid rod, then move the movable part 17 to preload the tube the distal end of the paper clip to the wall of the hole 16 and snap the clamping device 18.

In the embodiment shown in FIG. 8a, the movable part 17 has a cylindrical shape with cone-shaped extensions at the end, and corresponding conical circular grooves are made in the walls of the holes 16 of the housing 15 to accommodate and advance the movable part 17. The conical extensions and grooves on the part 17 and in the hole 16 respectively form a clamping device 18 and with

interaction lead to fixing the position of the part 17 relative to the housing 15. The distal end of the tubular part of the paper inserted into the opening 16 of the housing 15 is pressed by the end of the movable part 17 to the wall of the housing 15 and is held there from reverse movement.

In FIG. 86, the movable part 17, in contrast to the above, as well as the channel in the housing 15 has a conical shape, which ensures the reliability of fixing the tubular part of the paper clip after flashing.

In the embodiment of FIG. 8c, the locking element is formed by two L-shaped parts: a fixed part-housing 15 and a movable part 17, capable of moving relative to the housing 15 in the horizontal direction. The clamping device 18 in this case is made in the form of two pins with

conical extensions at the ends, mounted on the movable part 17 and directed towards the housing 15, in the body of which there are two sockets for receiving and snapping the ends of the pins and fixing the position of the movable part 17 relative to the housing 15 with compression of the distal end of the tubular part of the paper clip between the movable Part 17 and Case 15.

Figure 9 shows the tubular part 1 of the paper clip, having on its outer surface, in its distal part, elastic protrusions 19 directed by sharp ends in the proximal direction. The protrusions 19 allow the tubular part 1 to freely pass through the stitched fabrics and enter the hole of the fixing part 4 in only one direction, but do not allow its reverse movement. On the surface of the tubular part 1 of the clip shown in FIG. 10, thin ribs 20 are additionally made to make the tubular part more durable. The ribs 20 may be two, three, as shown in figure 10, or more, depending on the thickness and density of the stitched fabrics.

In Fig.1 to 1, in contrast to the above presents a variant of the paper clip

trihedral shape, which allows to increase the rigidity of the design of the paper clip. The fixation of the distal clip is similar to the previous version. This option

the implementation of the paper clip taking into account the increased rigidity of the structure in some cases can be applied without the use of a rigid rod.

On figa, b shows a clip, in which the fixing part is made in the form of a tape having three layers 22A, 226 and 22B, and the middle layer 226 is made with the possibility of longitudinal forced movement relative to the outer layers 22A and 22B. After flashing the tape with the tubular parts 1 of the staples and removing the rigid rods 3 from them, the middle layer 226 is displaced, which leads to squeezing and some curvature of the tubular parts 1 of the staples in this section, thereby eliminating their movement in the opposite direction. A clip 23 is provided at the end of the tape to fix the offset position of layer 226 relative to layers 22a and 22b.

The middle layer 226 can be made in the form of threads from bioabsorbable material with loops located exactly along the stitching staples, or in the form of two parallel threads with jumpers between them. Jumpers should be spaced equal to or a multiple of the distance between the staples.

On Fig presents another embodiment of the fixing part, in which it contains two coaxial tubes 24A, 246, and the inner tube 246 is installed with the possibility of forced longitudinal movement relative to the outer tube 14a. A slight displacement of the inner tube 246 after piercing it with staples and removing the rigid rods results in a strong fixation of the distal ends of the staples. A clamp 23 is provided at the end of the tubes to prevent reverse movement of the tube 246 after flashing. This provides reliable fixation of staples.

It is also possible to use a fixing part containing only one tube (not shown in the drawings) filled with biocompatible

absorbable after a certain period of time glue. After piercing the tube with paper clips, they are glued together with the tube.

On figa, b, c, shows another variant of the fixing part of the fastening element of the tape type. In this case, the fixing part is made in the form of two facing one another tapes 25a and 256, in the interval between which the distal ends of the tubular parts 1 of the paper clips are inserted. After flashing and removing the hard rods, the tapes 25a and 256 are connected by a mechanism 26, which easily moves along their length. The surfaces of the tapes 25a facing each other. 256 are equipped with means for ensuring their strong adhesion to each other. These can be protrusions of various configurations adapted to interact with each other. On Fig presents one of the possible embodiments of the means of adhesion of the tapes.

The protrusions 27 are in the form of rods with rounded heads. Being latched among themselves, they squeeze and deform the tubular part of a paper clip located between them.

The heads can be conical in shape, providing a more reliable grip when snapping.

The protrusions may also be in the form of rough villi, providing strong adhesion of the tapes and fixing the clips located between them.

In cross section, each tape 24a, 246 may have any shape, however, it is preferable to use tapes of the L-shaped profile, as shown in Fig. 146. The horizontal part of the tape is smooth, adjacent to the stitched fabrics. Vertical part - adjacent to stitching staples and has a surface equipped with

means of adhesion to the vertical part of the second tape.

The mechanism 27 connecting the two tapes can be supplemented with a knife that cuts off the ends of the tubular parts of the clips protruding beyond the limits of the fixing tape.

Thus, a number of options are presented that allow you to use

a fastening element made of biocompatible materials, absorbable at specific times, for flashing biological tissues and firmly fixing the distal portion of the clip. Moreover, fixing is possible at any level of paper clips. Therefore, it is possible to use one size of paper clips for fabrics of different thicknesses.

The presence of expansion at the proximal end in the form of a "hat" and execution

the fixing part of the fastening element in the form of a “washer” or fixing tape makes the seam airtight and prevents the eruption of any biological tissues. This technical solution will allow the use of a mechanical suture in any sections of surgery, including during operations on all parenchymal organs. The use of biocompatible absorbable materials creates the most

favorable conditions for tissue healing, in which after the operation there are no foreign bodies left. Yu

Claims

USEFUL MODEL FORMULA

1 Surgical staple for mechanical stitching

biological tissues using a stapler, made of a biocompatible bioabsorbable material, containing stitching and mating fixing parts located one opposite the other on opposite sides

stitching fabric, characterized in that the stitching part (1) has a tubular shape with an extension (2) at the proximal end, a rigid shaft (3) with a pointed end protruding beyond the distal end of the tube is installed with the possibility of extraction, and in the return the fixing part (4),

adapted to receive the distal end of the tube, there is a means for fixing the end of the tube at any preferred level after removing the rigid rod (3).

2. The surgical fastening element according to claim 1, characterized in that the outer surface of the tubular part is ribbed with at least two ribs (20).

3. The surgical fastening element according to claim 1, characterized in that the mating retaining part has the form of a “washer” with a channel for receiving the distal end of the tube, and protrusions (5) are formed on the surface of the channel, having the flexibility to allow the advancement of the tubular part (1) in the direction of flashing and

preventing it from moving in the opposite direction.

4. A surgical fastening element according to claim 3, characterized in that the protrusions are in the form of triangular petals (5 ¹ ), bent in the direction of stitching.

5. The surgical fastening element according to claim 1, characterized in that on the outer surface of the distal end of the tube made narrowing protrusions, bent in the direction of flashing.

6. Surgical fastening element according to claim 1, characterized in that the mating fixing part (4) is made in the form of a three-layer tape, easily pierced by a fastening element with a rigid pointed rod (3), the middle layer (226) connected with the outer layers with the possibility of forced longitudinal displacement relative to them.

7. The surgical fastening element according to claim 6, characterized in that the middle layer of the fixing tape is a thread with loops located respectively stitching the fastening elements.

8. The surgical fastening element according to claim 1, characterized in that the mating fixing part is made in the form of two coaxial tubes (24a, 24b),

located along the seam, easily pierced by fastening elements with a rigid pointed rod, while the inner tube is mounted with the possibility of forced longitudinal displacement relative to the outer.

9. The surgical stapling element according to claim 1, characterized in that the mating fixing part is made in the form of a tube filled with bioabsorbable adhesive, the wall of the tube having a thickness allowing piercing of the wall with the pointed end of the rigid rod and introducing the distal end of the tubular stitching part of the fastening element into adhesive mass.

10. The surgical fastening element according to claim 1, characterized in that the reciprocal fixing part is made in the form of two ribbons located opposite one another, having curly protrusions on facing each other surfaces, which are arranged to ensure the adhesion of the belts to each other and the distal fixation the ends of the tubular flashing parts inserted into the space between the tapes.

1 1. The surgical fastening element according to claim 1, characterized in that the mating fixing part is made in the form of a clamping device having a housing with an opening for accommodating the distal end of the tubular stitching part, and a movable element mounted to move in the housing opening and fix the distal end of the tubular part.