JPS63502886A - Vascular prosthetic device and its manufacturing method - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

[Detailed description of the invention] Vascular prosthetic device and its manufacturing method Background of the invention The present invention relates to vascular prostheses and in particular, to the detriment of their other properties. To prevent the device from fraying, the sutures should be removed so that they can withstand both fall and expansion. The present invention relates to stabilizing the prosthetic device.

Description of prior art Vascular prostheses or grafts are available for approximately 1 to 3Q years for artery replacement and replacement. It has been used in surgery for intermittent canal. Such prostheses generally have a tubular shape; Polyester, especially polyethylene terephthalate (e.g. Dacron (I) ac ron): registered trademark) is made of Teflon (registered trademark), especially Polytetra. Constructed from trafluoroethylene material; woven or knitted; and also Provides resistance to wear and tear, and provides surgeons with the flexibility they need at critical times during surgery. It is crimped to allow for some elongation or tension.

Such tubular prostheses come in several shapes, typically straight, branched, etc. and has a tapered configuration.

A comprehensive description of vascular prostheses on the market can be found in the Spring 3rd issue of Medical Magazine. Logless through technology (Medical Progr@mm Through gh Teebc+1ogy) S page 2/7 to page 226, M ・Mepuru, King (M, W, King), R No Gaitoy (R, G, Guidoin), K.R. Gunasegara (K, R, Gt +nas*to*ra) and Shi Gosselin (c.

Goiselin) “Planning for future polyester vascular prostheses (Desi gning Po1y@5ter VameularProsth@ses f or the Future) J, and this article is It is included herein for all purposes.

The typical woven construction used is a warp/weft tube interlaced, unadulterated ( plain) fabrics, plush fabrics known as velor fabrics (in which #i transfer To add flange-like naps to one or both of the inner and outer surfaces of the explant. , special intersecting @ or “floating” in opposite orientation or direction on a number of threads. yarn or filament) and knitted fabrics (in which an orderly lattice) (in the form of a pattern, interlaced with one or more threads about itself) ing. The threads or filaments used in the construction of the vascular prosthesis are flat Kw The cross section was round and trilobed, with single or multiple twists.

The tube dimensions of artificial vascular grafts based on textile fabrics range from approximately 33 m in inner diameter to approximately 33 m in diameter. It changes with The "porosity" (actually expressed as water permeability) of those grafts is , for woven grafts at about jO~/j001Ll/min/cm2 Yes, and approximately /000-II-00011+7 for organized grafts /ml n7cm2”t’h; b.

The nominal wall thickness of these materials is approximately 0. It varies from 　j　m to about tj■. crimp Crimping dimensions are approximately 2.0 for some knitted grafts. m to dimensions less than 0, jsxm for some textile grafts.

Crimp processing is usually presented in the form of a helical or spiral pattern or a circular pattern. Served.

Although the above matters do not necessarily apply in all cases, they are generally offered to the market. This covers most of the artificial graft products currently available that are based on woven fabrics.

Some conventional vascular prostheses also suffer from whitening, especially of the tubular material! lfc means turn back Anticipate use and thereby avoid any entanglement or compaction that may occur to the material. 1. Contains reinforcing # wire and annular rings or loops where hazards occur. These rings or loops slide over the outer surface of the tube. those rings or the loop has considerable dimensions, usually on the order of 0.6 to 2 cm in diameter, and in the form of individual rings spaced apart along the length or in the form of a spiral It is applied in the form of a loop consisting of windings and may be permanently and securely fixed to the tube. Yes, you don't have to. The number of rings or helical loops used is 12 or more fins per linear finch, regardless of the number of Although there can be fibers, there are usually only two per linear inch of pipe and rings or loops. Conventionally used rings like this also loops are used for crimped and non-crimped prostheses. It has been used in both orthotics.

The previously used 7'CJfn lumen prostheses have three related drawbacks. for use In some cases, materials that are available in relatively long forms are cut and torn for certain applications. Rimmed. When this is done, especially the ends of the tubular material are cut into pieces At times, its edges often become torn. Regarding this tendency to get tired just by handling it, Additionally, when sewing material near the cut end of the tube, avoid especially #1 leaks or pullouts. The tendency to pullout increases. child Because of this tendency, one surgeon may choose not to suture close to the distal end, which he or she would otherwise choose. stomach. Finally, traditional braided grafts may expand in one or multiple directions over time. or had a tendency to gradually open or swell. The origin of this tendency It may also invite.

Therefore, the present invention has no appreciable loss in handling porosity. Reduces the tendency of the tubular segments to fray and increases the suture retention ability of the prosthesis. The tubular segment to improve and substantially reduce harmful dilation of the tube A vascular prosthesis containing an elongated series (in-line) tie that is firmly fixed in the gap between the There are K places that provide the ingredients.

Another feature of the invention is that the tubular material can be Improved hemocontains an integrated exterior structure that reduces the tendency of the tubular material to fray Provide ductal prostheses. It's there.

Another feature of the present invention is that the tubular material can be used at any location without fraying of the edges. over a considerable length, usually over its entire length, so that the material can be cut and trimmed. According to a preferred manufacturing method having a structure that does not cause #1 tangle over A very thin polypropylene monofilament coated with gold is wrapped around the base of the tube. A vascular prosthesis is provided that is woven and crimped in a spiral or helical shape. The monofilament has a diameter smaller than the diameter from the base to the top of the material. has. It melts or burns the substrate or base tubular material. is heated to a temperature sufficient to soften the monofilament without The monofilament material becomes fused with the outer fibers of the tubular material. Therefore, the model Nofilaments can be covered with a single layer or with an integrated elongated wire binder. Become. The monofilament is completely confined within the helical groove of the crimp. The feel of the outside of the tube remains unchanged. Furthermore, the softened monofilament The addition does not interfere with the elongation or elasticity provided by the crimp process. Moreover, there is no appreciable negative effect on porosity. surface K To provide a structure similar to the above, which is covered and contained within, and does not cause fraying. Alternatives to fused monofilament are also available, such as KFi, spraying and gluing. can do.

Another embodiment of the invention uses an elongated line of bonding material that is not associated with the crimped structure. and this is annularly crimped rather than helical crimped. It is particularly useful for tubular vascular grafts that are fabricated, which are often combined with knitted grafts. used together. The elongated linear bonding material is used prior to crimping or Axially, helically, ″ or with respect to the graft that remains unlimped. Can be placed on a double vine rewinder. In any of these cases, The resulting elongated linear bond is not necessarily confined to the crimp groove, but rather The method should be small enough so that it does not appreciably change the feel or appearance of the knitted surface. Sai. This is because the surfaces of knitted fabrics and velor are rougher and more porous than those of regular woven fabrics. It should be noted that it is more lenient in this respect.

monofilament) can also be included as an integral part of the textile fabric. . i.e. monofilament in the ply of yarn when weaving or knitting the material 7 or more than 2 plies can be included. When it comes to textile structure, 1 or 2 of the above in either or both of the warp and Fi weft (fill) It can contain more than a book of plies.

Then, as mentioned for the monofilament above, the monofilament is made by heating. The filament is softened to combine it with the subnutrate material.

Description of preferred embodiments Referring to the drawings and first to Figure 1, a typical vascular prosthesis or or a tubular segment of the graft IO. Such segments are typically can be part of a long tubular material or bifurcated or branched It can be part of a more complex structure, such as a split structure. In this specification, tubes (tubes) When referring to tubular segments, it refers to any of such structures. It means. This construction typically consists of one crimp as shown. /2 is helical-shaped and connected to the fabric structure. Main departure Although it is not decisive for Ming, there are about 72 cracks per inch. It is normal to have rips, and these crimps can be selectively pulled if necessary. To provide a tubular structure that can be stretched and bent.

The prosthetic device is drawn in a curved shape. The bending of the prosthesis 10 is achieved by crimping the tubular material. Note that K does not cause tangles due to the construction.

Referring now to Figure ≠, Figure 1 illustrates a typical textile pattern. This diagram The solution is the actual filament used in each yarn bundle. Or individual plies are shown enlarged.

Each warp bundle/44 consists of a plurality of individual thread filaments (thrsad). filem・nt).

This thread filament is typically a polyester thread, most obviously a It is a polyethylene terephthalate thread such as Kron(R). Teflon Other polymers are also used, especially polytetrafluoroethylene. It was done. A bundle 16 of weft threads (i.e. fills: rttt) and a plurality of individual threads Overlapping bundles that are similarly bundled from filaments or zorai (overlapping bundle) It is intersected with (andru).

The thread structure illustrated in Figure 1 is representative of the structure commonly used for vascular prostheses. We have to be careful that this is a typical sequence. Other common structures are flat woven due to material construction (not including overlapping thread bundles) and interlocking pattern. An organizational structure that uses a single composite thread bundle that is interlaced with itself. Ru. However, this knitting structure is not limited to one specific 0-knit pattern.

It should also be noted that the illustration in Figure 1 is significantly enlarged. As shown in Fig. A typical thread bundle used in a woven structure is reproduced here. Referring to Figure 1 and Figure 1, the helical crimp shown is 0 for material thickness. j = 2.0　Dimension from the base to the top of the wm level It is noteworthy that it gives Very thin linear monofila of polypropylene 2Q A ment 20 is placed at the base of the crimp of the vascular prosthesis 20. monofilament The diameter of the crimp from the base to the top of the crimp can be felt in its surface structure. do not have.

The monofilament is designed to provide a controlled amount of heat to the monofilament. Therefore, it fuses into the gap between the tubes. Such heat obviously soften the bonding agent without enough #1 to melt or burn the surface of the substrate material. The heat is suitable for oxidation. 1 monofilament as shown in Figure 5 The threads 20 have contact between the warp threads, weft threads and monofilaments and these threads. intersects said monofilament, including overlapping threads where It is fused with all the threads of the underlying substrate.

The structure just described consists of a monofilament thin linear binder and this thin linear Although heat is used to bond the binder to all materials, the thin wire The binder can be bonded by adhering to the binder't-surface. . Instead of heat sealing or gluing suitable polypropylene polypropylene in the form of a fine jet spray to create the same structure shown in Long thin linear bonds by spraying with pyrene or other suitable material The agent can be applied to the surface.

The above description suggests that the helical tie be used before securing the elongated linear binder to the external surface of the vascular prosthesis. The present invention relates to a vascular prosthesis including a limp. As stated in the prior art section above The vascular prosthesis tube is knitted or woven into a spiral helical shape. Form a crimp in an annular shape or do not apply any crimp processing. You can also do it. To obtain the benefits of a thin linear bonded construction as previously mentioned. It is not necessary to wrap the base of each annular crimp. About such a structure The other embodiments shown in FIGS. 6, 79, and 2 can be used.

The substrate or base tube shown in Figures 6 and 7 is This is a tube 22 that has been removed.

This tube is wrapped with two pieces of suitable monofilament as shown in Figure 6. The appropriate monofilaments 26 and 21r shown in Figure 7 are also included in the pattern. Wrapped in a double helix pattern. The monofilament 26 is wound in the first direction. On the other hand, 2g of monofilament is wrapped in one direction, and this Such a winding involves the same monophragm moving first in one direction and then in the return direction. This can be conveniently accomplished by wrapping the filament thread around the tube. I can do it.

Following the wrapping shown in Figures 6 or 7, the tube is crimping by methods well known in the art for crimping the ribbon. Processed. -! Is this technique called crimp processing? Chew not treated at all It could also be applied to

The position of the elongated linear bonding material in Figures 6 and 7 has no relation to the position of the crimp process. so that the monofilament line placed on top reaches the top of the crimp and this Naturally, it is expected that there may be cases in which it exceeds t.

The surface pattern of the entire tube has a structure placed and attached in this way The long thin linear binder cannot be easily detected by touch or appearance. It has a similar surface pattern.

Referring now to Diagram 1, the axial direction of the monofilament tube for the vascular prosthesis tube is shown. The structure in which the ment line 3θ is located is shown. around the surface if desired Additional monofilament lines 32 can be placed at separate locations. this Overlays can be accomplished before or after crimping, as desired. Ru.

Referring again to Diagram No. 1, we can overlay the tube in any number of ways. Alternatively, 1gA or more warp bundles, weft (fill) bundles dollar, or overlapping bundle for woven tubing, or knitted tubing. Yarn bundles used for knitting bundles (spread bundle wood, poly 1 of plies/j of propylene or other suitable elongated linear binder material It can contain a book or more than one filament. Then apply controlled heat. By using such an elongated linear binder, it is possible to subsubstrate in the same manner as described above. Adhere to tray or substrate material.

Referring to FIG. 3, elongated linear binders may be provided by any of the methods previously discussed. A vascular prosthesis 10 is shown in use and protected against fraying. I understand that. In order to stitch the vascular prosthesis exactly in place as desired by the surgeon, Surgical tool 31A is shown inserting the suture near its distal end.

Suture the It is very important to locate the thread as close to the end as possible. elongated linear bond by providing suture retention while providing protection from fraying. This position is as shown in the diagram, where the first pull is completely near the end without any dropout. can be done. In fact, the retention by such elongated linear binders, While allowing the prosthetic device to be trimmed to a desired size, the very manual operation To enable the prosthetic device to be handled over a wide range without causing wear and tear. 1 more The presence of a linear binder does not interfere with its sutability, elongation properties, or flexibility; and its presence exclusively reduces its tendency to fray and makes it easier to remove the suture. The resistance to oxidation is enhanced, and the resistance to expansion is also enhanced.

The term "stability" is used herein to refer to one or more of these enhanced properties. to refer to strengthening the tube in the aforementioned manner to provide two or more It is used. an elongated linear bond placed on a surface relative to the material involved Due to the highly elongated nature of the agent, the appearance and feel of the entire suture area is virtually invisible. does not change. In addition to improving material stability, the porosity or permeability of the material Treatment with any of the above methods does not substantially reduce the winding of the double helical wire shown in FIG. Depending on the size, the reduction will probably be much smaller than 70~/j.

monofilament) or other methods mentioned above. It is of course obvious that the method of immobilizing the binder can be easily automated.

It is common practice to provide tubular material which is protected from fraying throughout by the method described above. Although it is common knowledge, if you wish, part of it or fc can only be segmented like this: It can also be protected. In any case, stability is added, integrated, Moreover, a structure substantially similar to the structure before processing is obtained as a result.

Identifies and describes certain embodiments of the invention and discusses modifications or alternatives thereof. However, a modified sequence can be easily created by a person skilled in the art and is not a problem for a person skilled in the art. It is clear that the present invention is not limited to these spinning machines or examples. You will understand.

Brief description of the drawing The features, advantages and objects of the invention as set forth above, as well as other matters, will be apparent. These are illustrated in the drawings to help you understand them in detail. The invention briefly summarized above will be further described below with reference to embodiments of the invention described above. Although described in detail, these drawings constitute a part of this specification. But long The attached drawings merely illustrate preferred embodiments of the invention. Therefore, there is no intention to limit the scope of the present invention, and the present invention extends to other similar applications. It should be noted that valid implementations are also acceptable.

in the drawing FIG. 1 is a top view of a straight tubular vascular prosthesis according to a preferred embodiment of the present invention.

FIG. 2 is a nine-sided view of the embodiment shown in FIG. 1 in a bent position; .

FIG. 3 is a torso view of the tubular vascular prosthesis of the present invention in the state of being sewn together.

Figure ψ shows a vascular prosthesis according to an embodiment of the present invention before the elongated linear binder is placed. FIG. 2 is an enlarged view of a typical woven structure.

Figure 5 is an enlarged view showing the part of the vascular prosthesis in Figure 5 with the elongated linear binder placed on it. It is.

FIG. 6 shows the twisting of the vine to cover the slender linear binder over the vascular prosthesis of the present invention. A pictorial diagram showing the machine; FIG. 7 shows a double vine for covering an elongated linear binder over the vascular prosthesis of the present invention. 1 is a pictorial diagram showing a rewinder; FIG.

FIG. This is a pictorial diagram showing the situation.

FIG. 2 FIG. 7 international search report ANNEXτO’hHE INTERNATIONAL 5EARCHREPO RT ON

Claims (26)

[Claims] 1. at least one tubular segment constructed of interlaced threads; of the tubular segment to substantially improve the stability of the tubular segment. an elongated linear binder secured to the interstices of said tubular segment at least near the distal end; , A vascular prosthesis consisting of. 2. The vascular prosthesis of claim 1, wherein the vessel segment is fibrous. 3. The vascular prosthesis of claim 1, wherein the tubular segment is velor fabric. Ingredients. 4. The vascular prosthesis of claim 1, wherein the tubular segment is knitted. 5. 3. The claim 1, wherein the elongate linear bonding agent rests on the outside of the tubular segment. The vascular prosthesis according to item 1 above. 6. The elongated linear binder melts and fuses with the outer fibers of the tubular segment. The claimed invention is a polypropylene monofilament coated on said outer surface. The vascular prosthesis according to scope 5. 7. The tubular segment carrying the bonding agent is crimped into a helical shape. ,and The elongated linear bonding material resting on the outside of the tubular segment forms a helical bond. located at the base of the The vascular prosthesis according to claim 5. 8. The dimension from the base to the top of the helical crimp is the length of the elongated linear bonding agent. The vascular prosthesis according to claim 6, which has a large thickness. 9. the tubular segment bearing the bonding agent is not crimped; The vascular prosthesis according to claim 5. 10. the elongate linear bonding material extends axially through at least a majority of the tubular segment; The vascular prosthesis according to claim 1, wherein the vascular prosthesis is placed in a vascular prosthesis according to claim 1. 11. the elongated linear binder is placed in a helical shape on the outer surface of the tubular segment; The vascular prosthesis according to claim 1. 12. the elongated linear binder is in the form of a double helical winding about the tubular segment; 2. The vascular prosthesis of claim 1, wherein the vascular prosthesis is placed in a vascular prosthesis. 13. The elongated linear binder is assembled with the substrate while creating an interlaced thread structure. The vascular prosthesis according to claim 1, wherein the vascular prosthesis is combined with the vascular prosthesis of claim 1. 14. The blood vessel of claim 1, wherein the tubular segment is polyenitel. Prosthetics. 15. Claim 1, wherein the tubular segment is polyethylene terephthalate. The vascular prosthesis according to item 1. 16. Claim 1, wherein said tubular segment is polytetrafluoroethylene. The vascular prosthesis according to item 1. 17. Blood is applied to a pickpocket containing at least one tubular segment made up of interlaced threads. Assemble the tubular prosthesis, apply a helical crimp to the tubular segment, and do the tubular segment such that an elongated linear bonding agent adheres to the outer fibers of the tubular segment; the elongated line at least near the end of the segment and at the base of the helical crimp; A method for manufacturing a vascular prosthesis comprising steps in which a bonding agent is fixed. 18. The height of the elongated linear bonding agent is from the root to the top of the helical crimp. 18. The method for manufacturing a vascular prosthesis according to claim 17, wherein the dimension up to the top is also small. 19. the elongated linear binder is a polypropylene thread, and The fixing includes placing the polypropylene thread at the base of the helical crimp; and heating the yarn until it fuses with the outer fibers of the tubular segment. including each stage, A method for manufacturing a vascular prosthesis according to claim 17. 20. The elongated rim bonding agent is adhered to the base of the helical crimp. A method for manufacturing a vascular prosthesis according to item 17. 21. A blood vessel comprising at least/tubular segments having an interlaced configuration. Assemble the prosthesis and connect the tubular segment at least to the left near the distal end of the tubular segment. An elongated linear bonding agent is fixed to a pickpocket that adheres to the outer fibers of the crimping the tubular segment containing the elongated linear binder; A method for manufacturing a vascular prosthesis consisting of each step. 22. the elongated linear binder in the axial direction of at least a majority of the tubular segment; 22. The method for manufacturing a vascular prosthesis according to claim 21. 23. Claims: The elongated linear binder is placed in a helical manner on the tubular segment. 22. A method for manufacturing a vascular prosthesis according to item 21. 24. the elongated linear binder in a double helical winding about the tubular segment; Claim 21. A method for manufacturing the vascular prosthesis described in Section 1. 25. The vascular prosthetic device according to claim 21, wherein the crimping process is performed in an annular shape. manufacturing method. 26. comprising a bundle of plies including at least one ply of elongated linear binder material; let me, Using said bundle for at least one component of the intersecting components, intersecting The vascular prosthesis is assembled into a vascular prosthesis including at least one tubular segment having a configuration. stand up, and Heating the tubular segment in a controlled manner to form the elongated linear binder material adhering a material to the fibers of the tubular segment; A method for manufacturing a vascular prosthesis consisting of each step.