Method for manufacturing medical implants and device for suturing tubular medical implant walls

FIELD: medical engineering.

SUBSTANCE: method involves mounting implant on supporting platform. The platform is turned and moved about and along its longitudinal axis to enable one to arrange needle in any given position on implant surface. The needle is controllable in a way that the first thread is brought through the implant wall from the first side of the wall. The first loop is formed from the first loop on the second implant wall. The thread is brought through the loop. The loop is tightened to produce a stitch. The stage the thread is passed through the loop is carried out by means of device movable back and forth along longitudinal implant axis. The device additionally has at least one driving mechanism for turning and moving transplant platform about and along its longitudinal axis to enable one to arrange needle in any given position on implant surface and additional driving mechanism for passing thread through the loop back and forth along longitudinal implant axis. Main device head piece is movable into any required position as a result of implant-carrying cylinder rotation or axial displacement on implant surface.

EFFECT: wide range of functional applications; enabled fitting of anatomical tubes of different diameters in several points arranged on an axis.

11 cl, 7 dwg

 

The present invention relates to a method and device for flashing thread wall of a tubular medical implant, in particular to a method and apparatus for suturing thread of the wall of the graft, for example, to create a tubular graft-stent.

Because tubular grafts are usually attached to the metal construction of the stent manually, this process takes a long time. Another problem is the difficulty of monitoring the quality and cost of the finished product.

In the application WO 99/37242 (on behalf of the applicant of this application) proposed an alternative solution, according to which for the manufacture of flat devices, which then give a tubular shape, use computerized stitching. This approach solved many of the problems complicating manual manufacture, however, it appears the seam and it becomes impossible to make a solid structure.

In the British patent 2165559 (University College London) described another device for flashing substrate, for example one of the tissues of the body during surgical procedures. In order for a bent piece of the substrate was between needle and hook, it is sucked into another device. Then with a needle thread is passed through a bent section of the substrate so about the time, to see its other end, and hook the thread hook. Stitched device is moved along the substrate and repeatedly performs this operation, due to which the substrate is bound. This stitched device cannot be used for flashing thread wall of the tubular graft, because the graft is not sufficiently elastic, so that it bent piece could be pulled into another device.

In U.S. patent 4 241 681 (Porter) describes another device for flashing series of spaced reinforcing rings on a long flexible tube made of non combustible material. The device has a long tubular support, which is similar to sleeve put on the workpiece. A fixed mechanism flashing capable of forming a single chain weld on the workpiece and pull the mechanism for advancing the workpiece on the support as the formation therein of a seam.

In the patent 4 414 908 (Janome Sewing Machine Co., Limited) describes another device for suturing on dissected tissues or organs of the patient. The device has a needle holder (mainly tongs and holder dropship, mounted on the needle holder slidable. Thus, the needle cannot move independently of the Shuttle nor at what degrees of freedom. Alternatively implemented the I invention, the needle can rotate around the circumference of the Shuttle. The device is not designed for flashing a tubular implant.

In accordance with the first embodiment of the invention, a method for suturing thread of the wall of a tubular medical implant, the implementation of which the implant is placed at the pole, turn and move support implant around and along its longitudinal axis in order to position the needle in any given position on the implant surface, control the needle thus, to apply the first thread through the wall of the implant from the first side wall formed from a first thread of the first loop to the second side wall of the implant, pass the thread through this loop and pull the specified loop to form a stitch, at this stage of passing the thread through specified loop is performed using means for passing thread through this loop, and the tool is moved forward and backward along the longitudinal axis of the implant.

This method allows you to form on the wall of the graft single chain stitch due to the fact that the first thread again passed through the wall of the graft to form a second loop, and before tightening the first loop is passed through it the specified second loop. Then through the second loop pass the third loop of the first thread and then repeat this operation, h is usually used to form a single chain stitch.

Alternatively, through the first loop of the first thread miss the second thread, then pass the second thread through the loop of the first thread, which have been passed through the wall of the graft to form on the wall of the graft closed seam.

Although the invention is described as applied to a tubular medical implant, which may be a graft, a stent, a graft-stent device for fixation of the graft, the device for strengthening the eye sockets, ring support, heart valve, venous implants, supports venous valve, or any other tubular medical implant, the method and the device according to the invention can be equally applied for flashing any surface of the tubular form.

In accordance with the second embodiment of the invention, an apparatus for suturing thread of the wall of a tubular medical implant having a support for the implant needle to the filing of the first thread through the wall of the implant with its first side to form a second wall of the implant of the first loop, and means for passing thread through this loop from the second side wall of the implant, the device additionally has at least one drive mechanism, turning and moving prop Tr is spuntata around and along its longitudinal axis with the to position the needle in any given position on the surface of the implant, and an additional drive mechanism that moves the tool to pass the thread through this loop forward and backward along the longitudinal axis of the implant.

In case you need to flash the graft from the inside toward the outside of the needle may be mounted on the elongated element, through which it is controlled from the outside, and works from the inside of the graft. If you need to flash the wall of the graft from outside to inside, alternatively, can be used a regular needle, and pass the thread through the loops on the inner side of the graft is provided an elongated element that is managed outside of the graft. The elongated element is preferably an elongated spool or Shuttle.

In a preferred embodiment of the invention, the device additionally has a means of turning the graft around its longitudinal axis relative to the needles and means to move the graft along the specified axis relative to the needle. Bearing graft preferably is a hollow drum, on which the graft is based one of the ends.

In the invention preferably has a special device with a numerical control or panel is the pressure from the computer, performing the operation flashing the surface of the cylinder and providing a range of products, which was previously impossible to manufacture with the appropriate quality, reliability and price restrictions.

Particularly preferably, the device has the following main components:

the hollow drum to which one end rests tubular implant;

two actuating mechanism for controlling the angular and axial position of the drum;

the nozzle stitched device designed for flashing a narrow tube from the outside in.

Thus, due to the axial movement or rotation of the cylinder, which is based on the implant, the attachment to another device can be placed in any desired position on the surface of the implant. Implant is likely to be a truncated cone, i.e. has a different diameter at the ends, but can be used implants with parallel walls. If necessary to comply with specific anatomic criteria are made of tubes having different diameters at different points along their axis.

In this case, there can be used conventional stitched device, since the inner diameter and length of the implants are too small for conventional coil can pass through the lumen of the implant and to be opposite needle stitched device. Diameter and is of plantation is from 3 mm to 45 mm, preferably in the range from 10 mm to 30 mm Length implants up to 500 mm, preferably 250 mm

In one of the embodiments of the invention applied to another device for flashing single chain stitch in which to lock a single thread passing through the needle, use a simple mechanism located beneath the cloth. Then in the next stitch geared thread then stretch, resulting from a single thread receives a continuous chain stitches. Single chain stitch has a tendency to wear out or come apart at the seams. In the programme of work to another device can be laid paving the lines in the reverse of the promotion materials or other operation for the purpose of securing stitch. To strengthen the threads can also be applied glue.

There are other ways of stabilizing single bead chain, such as chain stitch using a second thread. In one embodiment, the chain seam with two strands of alternating threads form the alternating loops. In another embodiment, the second strand stretch through the loops to hold them in place. In an additional embodiment, to stabilize the chain seam form a single chain stitch and removing the needle, after which the seam is turned at a distance of from half to five times in order to ensure that the twisting of the thread. Such twisting tackle the duty to regulate wear single chain stitch.

In an alternative embodiment of the invention applied to another device for flashing a closed seam, which uses a special coil design. In this case, the second thread closed seam use a long, thin coil. The thread can be wound on the coil around the circumference of either of the two ends, and for pulling thread from the spool, using the appropriate socket. This design is feasible for this application devices, because each device makes a small number of stitches in comparison with sewing machines used in the garment industry. In addition, given the small size of the implants does not require high speed flashing, so you can use longer and heavier coils than would have been possible for ordinary sewing machines. To move the coil through the loop formed by the needle, it is necessary that the coil is preferably operated mechanical impulse, compressed air, energy of a spring, magnetic repulsion, or similar means acting along the axis of the implant.

If the diameter stitched graft is small, the size of the loop formed by the needle, may be so small that the coil does not pass through the loop. This problem can be solved through the use of a curved needle, because what is between the needle and thread provides the specified gap. As an additional alternative, use a needle that pierced the wall of the graft at an oblique angle relative to its axis, the length of the thread, which involve in the transplant, also not limited to its diameter. Typically, in this embodiment, the angle between the needle and the axis of the graft is controlled automatically, providing the perpendicular position of the needle relative to the axis of the graft at the beginning and end of the stitch and, consequently, the formation of loops in a predetermined position.

In an alternative embodiment, another device which is capable of piercing the surface of the tube, the position of the above-described structural elements rotated, causing the needle is located inside the graft, and the hook or coil - the outside of the tube. In this embodiment, the needle may be based on the corresponding narrow roller. Roller and needle are moved relative to the wall of the graft, due to which the needle is pierced through the wall. When flashing single chain stitch for loop from the thread that pulls the needle, the hook may be located outside of the graft. When flashing a closed seam coil can be installed on the outside of the graft, which allows the use of coils of larger size. In this case, to increase the loop, which passes through the coil, which can be used outside of the graft additional Shuttle.

In all variants of implementation stitched device may preferably be applied bearing ("foot"), holding the cloth in her flashing needle. Such support may take the form of a cylinder, the wall of which there is a hole located under the needle. Alternatively, the entire length of the wall of the cylinder can pass slot. There are many possible embodiments of a support, in particular under the needle may be placed in a partial or complete ring.

In all variants of implementation stitched device has the ability to spread the width of the elements located inside the graft, in case of change in cross-sectional shape of the graft to the tubular at the oval. In case of combination of the main axis of the graft with an oval cross-sectional shape with the needle in the lumen of the graft tighten longer piece of thread, which facilitated the passage of the coil. Alternatively, in the case of alignment with the needle of the minor axis of the graft can be applied more widely and more flat coil.

Despite the fact that the wire and the other suture material used for flashing transplant, may be temporarily fixed using pins, basting stitches, glue or similar means, stitched device preferably has a holder, hold the living suture near the graft. Such a holder may be a cylindrical or conical tube, preferably having a slot in the wall and made of a material with sufficient elasticity to ensure that the tube can be open and wrap around the specified suture material and graft.

In any of the preferred embodiments stitched device forming stitches on the surface of the cylinder is entirely managed by a computer or similar device with numerical control. Such management can be fully pre-programmed either by using an appropriate sensor, such as sensor vision system or optical key, the trajectory of the seam may be set so that it followed existing on the surface of the graft markup or schema. That you are carrying out a series of operations known in the textile industry:

the ends of the tubes sew stikova connection;

tube form, be bound seam edge of the whole sheet material, folded into a tube;

the stitches of the filamentary material are laid on the surface of the tube in any direction;

the surface of the tube stitch and attach to the material. Such material may be a solid filamentary material, such as wire,which is attached with single stitches or groups of stitches, located on both sides of the wire. Larger pieces of material, such as rags, attach, be bound around the perimeter. Larger pieces of material can be a tube, capable of conducting fluid in other parts of the device, or tube, which stiffen, creating excessive pressure;

in tubular form create pseudocroup, be bound by the thread of the substrate, which is then removed by a method of dissolving or other process of decomposition. After this operation the sewn thread remains in place;

the pre-formed structure, such as a wire stent, is placed on the tube, attach them to the fabric tube and using the claimed invention devices have stitches around elements of the stent.

In the example of a graft-stent, to strengthen the textile tube to the surface sew the wire. In the simplest case, the wire is wrapped around the tube in a spiral trajectory, while the wire previously not give any form except that it is nominally straight or curved and has a large radius of curvature. In this case, after the wire by means of stitches secured around the tubular graft, the wire creates a preliminary voltage. The resulting implant is t has the properties of the textile tube, however, it differs substantially greater radial rigidity, ability to expand in the radial direction after compression, for example, after passing through the catheter and in General the ability to lean back and fold in half, not bending and not splosives.

The wire gives shape to a place with a strong current or a similar tool heat to its cross-section just before the wire attached to the implant. This ensures local annealing of wire, which in the process of sewing attach the appropriate form.

Among the preferred materials from which to fabricate the wire comprises a Nickel-titanium alloy with shape memory effect, stainless steel, Elgiloy and similar high-strength alloys.

As an alternative to the implant surface sew the wire, which was previously given some form. The wire, which is attached to the tubular implant, can be given a zigzag form, as described in the application WO 99/37242, thereby provide the above advantages, coupled with the resistance to axial compression.

If another device of the multi-needle thread can be used yarns with different properties. The threads give elasticity using them from which otopleniya elastomers, polymers and copolymers, such as polysiloxane. In the threads that stitch the implant surface, also add fabric glue. This creates a zone in which is provided a highly efficient sealing of the intimal surface of the vessel, which was implanted device.

According to the third variant embodiment of the invention the claimed method of forming a medical implant (e.g., transplant), the implementation of which is stitched with thread soluble substrate having the form of an implant or a predecessor of which may be formed implant, dissolve the substrate, leaving the implant or the precursor formed from the specified thread, and form of the precursor to the implant. Stage flashing thread soluble substrate preferably carry out the claimed invention method.

The substrate preferably consists of a light fabric, such as gauze, or may be soluble. In any case, using the above-described another device create a tubular implant, in which the textile fibers are distributed in such a way as to correspond to the mechanical and physiological properties of the implant. So, may be provided fenestration, allowing blood to enter through the walls of the implant in the lateral artery. At the same time excluded op the risk of abrasion of the holes on the sides. Similarly, can be provided with reinforcing sections, the implant does not add any separate components. The walls of the implant can be reinforced with wire, if necessary, hidden from both the intimal and visceral surface of the implant. Through the use of the above materials, the implant may have an elastic areas, areas containing tissue adhesive, reinforced areas, areas with holes. Can be used threads, releasing drugs or other pharmacological agents on the surface of the implant.

The following describes some preferred embodiments of the invention with reference to the drawings, in which:

on figa schematically shows a perspective of the device according to the invention,

on FIGU shows the end view of the device illustrated in figa,

figure 2 schematically shows a single chain stitch, passing through the wall of the graft,

figure 3 schematically shows the closed seam, which to the wall of the graft attached material

figure 4 schematically shows the closed seam, located on the wall of the graft,

on figa shows a perspective coil used in the invention,

on FIGU shows a perspective coils alternative forms used in the invention,

figure 6 shows the graft-stent in perspective and in partial section, obtained by the process according to the invention,

7 shows a top view of the graft, with different scopes created according to the invention.

On figa shown a drum 1 mounted on the rotor 2, which is driven by the node 3 of the actuator. The transplant 4 relies on the drum 1. In the nozzle 6 to another device over a graft 4 comes with needle 1.

In the process, the node 3 of the actuator rotates the rotor 2, the drum 1 and the transplant 4 around the longitudinal axis of the graft 4 in the direction indicated by the arrow 8. Node 3 of the drive is also able to move the transplant 4 forward and backward along the longitudinal axis in the direction indicated by the arrow 9.

A drive device (not shown) stitched device moves the nozzle 6 up and down relative to the graft 4 in the direction indicated by the arrow 7. By combining these movements of the needle 5 can move along the surface of the graft 4, as shown by the dashed line 10.

On FIGU shows the end view of the device illustrated in figure 1. Under the needle 5 on the inside of the graft is the coil 11. In operation, the drive device (not shown) stitched device moves the coil 11 forward and backward along the longitudinal axis of the graft 4, so she ran across the loop, formed from yarn needle 5.

Figure 2 shows the wall 20 of the graft and the trajectory passing through the filament 21 through the wall 20 in the process of forming a single-chain seam 22.

Figure 3 shows the wall 30 of the graft and the material 31, which was sewn to the wall 30 by flashing material upper thread 32 and the transmission of the lower thread 33 through the loops formed from the upper thread 32, the result of which was formed by the closed seam.

The process of forming a closed seam in the wall 30 of the graft is illustrated in more detail in figure 4. As follows from figure 4, the needle 5 and threaded through her upper thread 32 pass through the wall 30 of the graft to form a loop 40 on the inside of the graft. After that, the coil 9 (not shown) through the loop 40 in the direction indicated by the arrow 41, passed the lower thread 33 (not shown). Then the needle 5 is removed to close the loop 40 and form a closed-seam stitch.

On figa and 5B are shown alternative embodiments of the elongated coil used according to the present invention for forming a closed seam. On figa illustrated mounted on the axis 52 of the cylindrical coil 51, around which is wound the thread 50, forming the coils 53. According to the illustrated figv alternative implementation coil has a strap 54, mounted on rollers 55 and FPIC is BNY to move forward and backward along the longitudinal axis of the coil. Due to this, the thread 50, forming the coils 53, wound on the coil at both ends.

Figure 6 shows the graft-stent 60, in which the tubular graft reinforced with wire 61, sewn in a spiral (the stitches are not shown). By changing the spiral path formed region 62 in which the reinforcing wire is tight, and the area 63 where the wire is less tightly. Thus, the region 62 has a larger gain than the area 63, and thereby provides greater support than the area 63. However, the region 63 with a less dense arrangement of the wire provides the ability of the graft-stent to bend, forming an angle.

7 shows the graft-stent 70, manufactured by the method according to the invention. The graft-stent 70 has many different regions, namely region 71 fixation, dense region 72, region 73 with holes, less dense region 74, the area 75, which establish various supporting elements, and region 76, which set the spikes (not shown).

1. The method of flashing thread wall of a tubular medical implant, the implementation of which the implant is placed on a support, characterized in that the bearing implant rotate and move around and along its longitudinal axis in order to position the needle in any given position on the surface and the implant, control the needle thus, to apply the first thread through the wall of the implant from the first side wall formed from a first thread of the first loop to the second side wall of the implant, pass the thread through this loop and pull the specified loop to form a stitch, at this stage of passing the thread through this loop is performed using the device according to claim 7, which is moved forward and backward along the longitudinal axis of the implant.

2. The method according to claim 1, characterized in that thread, which is passed through the first loop is the second loop of the first thread, which was filed through the wall of the implant, through the specified second loop then pass the third loop of the first thread to form on the wall of the implant single chain stitch.

3. The method according to claim 1, characterized in that thread, which is passed through this loop represents the second thread, which is then passed through subsequent loops of the first thread, which was filed through the wall of the implant, to form on the wall of the implant closed seam.

4. The method according to any of the preceding claims 1 to 3, characterized in that the first side wall of the implant is an outer surface of the implant, and the second side of the inner surface of the implant.

5. The method according to claim 4, characterized in that the specified thread is passed through the said first loop using the inside of the implant to the elongated element, managed outside of the implant.

6. The method according to claim 5, characterized in that the elongated element is an elongated spool or Shuttle.

7. The device for flashing thread wall of a tubular medical implant having a support for the implant needle to the filing of the first thread through the wall of the implant with its first side to form a second wall of the implant of the first loop, and means for passing thread through this loop from the second side wall of the implant, the device additionally has at least one drive mechanism, turning and moving the support transplant around and along its longitudinal axis in order to position the needle in any given position on the surface of the implant, and an additional drive mechanism that moves the tool to pass the thread through specified loop forward and backward along the longitudinal axis of the implant.

8. The device according to claim 7, characterized in that the first side wall of the implant is an outer surface of the implant, and the second side of the inner surface of the implant.

9. The device according to claim 8, characterized in that it has an elongated element with which the specified thread is passed through the said first loop, with the specified element is controlled on the outside of the implant is the same.

10. The device according to claim 9, characterized in that the elongated element is an elongated spool or Shuttle.

11. Device according to any one of claims 7 to 10, characterized in that the bearing implant is a hollow drum to which one end rests implant.



 

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