WO2018133868A1 - Stent - Google Patents

Abstract

A stent, comprising: a bone supporting component (1), internally provided with a tunnel (12); a proximal connector (2), connecting to a tail end of the bone supporting component (1) and internally provided with a tunnel (12); and a distal connector (3), connecting to a tail end of the proximal connector (2) and internally provided with a tunnel (12). When the bone supporting component (1), the proximal connector (2) and the distal connector (3) are connected to form the stent, the tunnels (12) therein are through-connected with each other. The number of the tunnels (12) is at least two. The tunnels (12) exit the distal connector (3) at the bottom thereof. A top end or a side part of a top portion of the bone supporting component (1) has a recess that forms a window. The tunnels (12) are connected in the recess. The stent can be co-transplanted with blood vessels for the treatment of femoral head avascular necrosis.

Description

Bracket Technical field

The present invention relates to medical devices. More specifically, it relates to a medical stent.

Background technique

Femoral head necrosis, also known as avascular necrosis of the femoral head, is a common and refractory disease in the field of orthopedics. It is a kind of lesion that causes partial ischemia of the femoral head due to various reasons, which causes further ischemia, necrosis, trabecular bone fracture and collapse of the femoral head. If not treated effectively, about 80% of patients will have femoral head collapse within 1-4 years, secondary joint dysfunction, and eventually patients have to undergo artificial joint replacement, the high cost of artificial joint replacement to patients and society There is a huge economic burden, and because of the certain life span of artificial joints, the joint replacement of young and middle-aged patients often faces problems of joint loosening. The difficulty and risk of artificial joint revision surgery is high, and artificial joint revision will further aggravate patients. The economic burden and significantly reduce the quality of life of patients. Recent studies have shown that the incidence of femoral head necrosis has been increasing year by year in recent years, and its age of onset is younger. Therefore, early treatment of femoral head necrosis, in order to preserve the patient's own joints, has been receiving much attention.

Early removal of lesions, use of implant materials to fill the defect area and promote bone regeneration is one of the hotspots of current research and clinical treatment. In the previous material research, stem cell therapy, autologous bone/artificial bone material filling treatment and crow bar implantation treatment were adopted, but no satisfactory therapeutic effect was obtained. Because the main cause of femoral head necrosis is damage or interruption of blood supply in the lesion area, although these materials have biomechanical support or promote osteogenic properties, it is difficult to reconstruct the microcirculatory system of the lesion area, so it is impossible to inject stem cells or The new bone tissue provides the necessary nutrients and removes metabolic waste, making it impossible to achieve the desired therapeutic effect.

Therefore, an effective treatment for early femoral head necrosis needs to solve the following three problems: biomechanical support of the bone defect area after the lesion is removed, reconstruction of the local microcirculation system, and promotion of bone tissue regeneration and repair.

In addition, in the past, for the treatment of femoral head necrosis, if the artificial joint replacement is needed due to the progress of the disease, due to the presence of metal crowbar in the femoral neck osteotomy area, it is not possible to directly cut the bone. The rod is taken out; since the porous crowbar has bone ingrowth, it cannot be directly unscrewed by means of screw rotation.

Drilling with a trephine to separate the stent from the bone is one of the possible ways, but the removal process is often extremely difficult. The trephine often cuts the stent, causing a large amount of metal wear debris, which is difficult to clean; and it is easy to cause stent fracture or local fracture ( Such as large trochanter fractures, etc., thereby increasing the difficulty of surgery and leading to a decrease in the stability of the prosthesis after joint replacement, which significantly affects the surgical outcome.

Summary of the invention

According to the problems in the prior art, the present invention proposes a stent and develops an associated device associated therewith.

The stent of the present invention includes a stent body and a plurality of cells, wherein the plurality of cells extend through the body of the stent, and the sides of the top or top of the stent body have depressions to form a fenestration in which the channels (12) communicate.

Optionally, the number of the channels is at least two, and the holes pass through at the bottom of the body of the bracket and communicate with each other at the top or side of the body of the bracket.

Optionally, the sides of the top or top of the stent body have depressions to form a fenestration in which the channels communicate.

Optionally, the fenestration is provided with a cover for covering the fenestration.

Optionally, there is a septum between the channels.

Optionally, the bottom or side of the tail of the stent body has a recess, a recess or a raised structure.

Optionally, the outer periphery of the tail of the bracket body has a threaded region in which a recess, a recess or a raised structure is located.

Optionally, the stent body is a porous structure.

Optionally, the bracket body is cylindrical, and the top of the bracket body is curved.

Optionally, the stent body has a diameter of 5-18 mm, the diameter of the tunnel is 1-8 mm, the column width of the stent body is 100-1000 um, the pore diameter is 100-3000 um, and the porosity of the stent body 11 is 40-90%.

Optionally, the material for preparing the stent is titanium alloy, tantalum, titanium-niobium alloy, nickel-titanium alloy, pure titanium, cobalt alloy, magnesium alloy, calcium phosphate, hydroxyapatite, polylactic acid, lactic acid-glycolic acid copolymer, poly Acetate lactone, coral or bioceramic.

Optionally, the bracket body is cylindrical.

The beneficial effect of the stent is that it can treat the femoral head necrosis in combination with vascular transplantation, repair the local biomechanical strength after the lesion is removed, reconstruct the local microcirculation system, and promote the regeneration and repair of the bone tissue. The curved design at the top of the stent facilitates reconstruction of the local biomechanical strength and avoids the compression of the surrounding bone by the surrounding bone. The fenestration structure formed by the depression of the top or the top side of the stent facilitates the smooth implantation of the vascular bundle into the pore of the porous stent.

In another aspect, the present invention also provides a stent comprising: a bone support member having a bore therein; a proximal connector, the proximal connector connecting the tail of the bone support, the proximal connector having a bore; and the distal end; The end connector, the distal connector is connected to the tail of the proximal connector, and the distal connector has a hole. The bone support, the proximal connector and the distal connector form a bracket connection, and the inner holes thereof penetrate each other. The number is at least two, the channels are passed out at the bottom of the distal connector, and the sides of the top or top of the bone support have depressions to form a fenestration in which the channels communicate.

Optionally, the number of channels is at least two, the channels are passed out at the bottom of the distal connector and communicate with each other at the top or side of the bone support.

Optionally, the sides of the top or top of the bone support have depressions to form a fenestration in which the channels communicate.

Optionally, the fenestration is provided with a cover for covering the fenestration.

Optionally, there is a septum between the channels.

Optionally, the bottom end or side of the tail of the distal connector has a recess, a recess or a raised configuration.

Optionally, the proximal connector is integral with the bone support.

Optionally, the distal end of the distal connector has a threaded region in which the recess, recess or raised structure is located.

Optionally, the proximal connector has a threaded structure for attachment, the proximal end of the distal connector having a threaded structure for attachment, the proximal connector and the distal connector being screwed into each other by a connecting thread structure for matching combination.

Optionally, the bone support is a porous structure, the proximal connector is a solid or small aperture structure, and the distal connector is a solid, non-porous structure.

The beneficial effect of the stent is that it can be combined with vascular grafting to treat femoral head necrosis, repair local biomechanical strength after lesion removal, reconstruct local microcirculation system, and promote regeneration and repair of bone tissue. Moreover, if the femoral head necrosis collapses later, when the joint replacement surgery is required, since the proximal part has bone ingrowth, the distal part is a solid structure without bone ingrowth, the distal part can be screwed out, and then the femoral neck The femoral neck was cut off, and there was no interference from the stent in the osteotomy area.

DRAWINGS

Figure 1 is a schematic view of an embodiment of the composite stent of the present invention after being split;

Figure 2 is a perspective view of the assembled bracket of Figure 1 after assembly;

Figure 3 is a perspective view of one embodiment of the fenestration of the top of the stent of the present invention;

Figure 4 is a perspective view of another embodiment of the fenestration of the top of the stent of the present invention;

Figure 5 is a perspective view of still another embodiment of the fenestration of the top of the stent of the present invention;

Figure 6 is a perspective view of an embodiment of a stent tail of the present invention;

Figure 7 is a perspective view of still another embodiment of the stent tail of the present invention;

Figure 8 is a perspective view of still another embodiment of the stent tail of the present invention;

Figure 9 is a perspective view of one embodiment of a stent fenestration top cover of the present invention.

Figure 10 is a perspective view of a tail portion of still another embodiment of the stent of the present invention.

Figure 11 is a cross-sectional view of the inner bore of the bracket of Figure 10.

Figure 12 is a perspective view of a tail portion of still another embodiment of the stent of the present invention.

Figure 13 is a perspective view of a tail portion of still another embodiment of the stent of the present invention.

Figure 14 is a perspective view of still another embodiment of the stent of the present invention.

Reference numeral

1-bone support; 11-bracket body; 12-channel; 13-threaded zone; 14-groove; 15--aperture; 16-raised structure; 17-cap; 18-external connecting thread structure; - built-in connection thread structure; 113-threaded zone; 114-groove; 115-recessed hole; 116-raised structure; 117-cap; 2- proximal connector; 3- distal connector.

detailed description

Embodiments of the present invention are described below with reference to the accompanying drawings, in which the same parts are denoted by the same reference numerals. In this context, the so-called proximal end refers to the end of the bone first, and the opposite end is called the distal end. The so-called tip refers to the end of the bone first, and the opposite end is called the tail.

The split structure and assembled structure of the composite stent of the present invention are shown in Figures 1-2. The combination stent of the present invention comprises a bone support 1, a proximal connector 2 and a distal connector 3, wherein the so-called proximal end refers to the end of the bone first, and the opposite end is referred to as the distal end.

The bone support member 1 is a porous stent, which can be implanted into a cavity formed by the avascular necrosis of the avascular necrosis of the femoral head, which plays a role in biomechanical support and promotes the growth of blood vessels and bone tissues.

The bone support 1 can be prepared by 3D printing techniques, and of course by non-3D printing techniques (such as powder metallurgy, vapor deposition or sintering, etc.). The bone support member 1 of the present invention is a porous titanium alloy stent. Of course, the material of the stent may also be tantalum, titanium-niobium alloy, nickel-titanium alloy, pure titanium, cobalt alloy, magnesium alloy, calcium phosphate, hydroxyapatite, poly Lactic acid (PLA), lactic acid-glycolic acid copolymer (PLGA), polyacetal lactone (PCL), coral, bioceramics and other materials. The bone support 1 can be processed into any other shape as needed.

In one embodiment, as shown in Figures 1-2, the bone support 1 is of a porous structure, the proximal connector 2 is a solid or small aperture structure, and the distal connector 3 is a solid, non-porous structure. These three parts together form the main body of the bracket, and each has a through-hole 12 therethrough. The bone support 1 of the stent is illustrated as a cylindrical shape having a diameter of 5-18 mm, and the top of the bone support 1 is hemispherical or curved to better maintain the mechanical support of the stent tip. The hemispherical curvature can be adjusted as needed.

Optionally, the overall length of the bone support 1 is 40-200 mm, the column width of the bone support 1 is 100-1000 um (median 300 um), the aperture is 100-3000 um (median 1000 um), and the bone support The porosity of the part 1 is 40-90%.

After the stent assembly is completed, the tunnel 12 runs through the entire stent. The tunnel 12 runs longitudinally inside the assembled bracket, and the diameter of the tunnel 12 is 1-8 mm.

Alternatively, the number of the tunnels 12 is two, and the two tunnels pass through at the trailing end of the distal end connector 3 and communicate with each other at the top of the bone support 1. Implantation of blood vessels: by transplanting blood vessels (such as large/small saphenous veins, small arteriovenous bundles in adjacent or other parts, artificial blood vessels or artificial blood vessels combined with autologous blood vessels, etc.) into two holes communicating with each other in the stent In the tract, and with the blood supply system (such as the lateral femoral arteriovenous system) around the hip joint, the vascularization of the stent is achieved to promote the growth of blood vessels in the stent and the lesion area, and to realize the reconstruction of the microcirculatory system in the lesion area. Provides the necessary stem cells, oxygen, nutrients, growth factors and localized metabolic waste for the new bone tissue. The stent can be directly used after being implanted into the vascular bundle, or a growth factor (such as BMP-2/VEGF, etc.) or stem cells can be loaded inside the porous structure to further enhance its ability to promote bone regeneration.

Optionally, there is a depression on the side of the top or top of the bone support 1 forming a fenestration in which the two channels 12 communicate. The fenestration allows for vessel implantation and avoids compression of blood vessels. The fenestration may be located on one or the top of the top of the bone support 1, and the size, shape and position of the fenestration may be adjusted as needed. In addition, the top of the bone support 1 can also be a fully covered porous structure (no window).

Alternatively, as shown in FIG. 5, in one embodiment, the fenestration is located on the side of the top of the bone support 1. The range of the side opening window can be floated up and down. On the inside of the window opening, in the bone support member 1, the two channels 12 can be accompanied by or without a septum. Optionally, as shown in FIGS. 6-8, in one embodiment, the periphery of the tail of the distal connector 3 is designed with a threaded zone 13 having a length of 4-50 mm, and the stent portion inside the threaded zone is non-porous. Structure (solid structure with two vascular channels).

In addition, the bottom end of the distal end of the distal connector 3 is provided with a recess 14 for connection with an external connector for screwing in the bracket. The groove 14 can also be located on the side of the tail of the distal connector 3.

Alternatively, as shown in Fig. 7, in one embodiment, the bottom end of the distal end of the distal connector 3 is designed with a recess 15 for attachment to an external connector for screwing in the bracket. The recess 15 can also be located on the side of the tail of the distal connector 3.

Alternatively, as shown in Figure 8, in one embodiment, the bottom end of the distal end connector 3 is designed with a raised structure 16 for attachment to an external connector for screwing in the bracket. The raised structure 16 can also be located on the side of the tail of the distal connector 3.

Alternatively, as shown in Figure 9, in one embodiment, the fenestration cover 17 shown in Figures 3-5 can be provided.

The proximal connector 2 of the combination stent of the present invention is coupled to the distal end of the bone support 1, and the proximal connector 2 and the bone support 1 are of unitary construction. The proximal connector 2 has an external connecting thread structure 18 having a diameter smaller than the diameter of the femoral support 1. The proximal connector 2 can vary depending on the shape of the distal end of the bone support 1. The diameter of the distal connector 3 coincides with the diameter of the bone support 1, and the proximal end of the distal connector 3 has a built-in connecting thread structure 19 which can be screwed into the external connecting thread structure of the proximal connector 2. The matching combination of the brackets is realized, and after the combination is completed, the inner channels can be completely butted and mutually penetrated.

As shown in Fig. 1, the proximal connector 2 has a bore therein for abutting the bore of the bone support 1.

In the embodiment shown in Figure 1, the proximal connector 2 of the combination stent is coupled to the distal end of the bone support 1, the proximal connector 2 being integral with the bone support 1. The proximal connector 2 has an external connecting thread structure 18 having a diameter smaller than the diameter of the femoral support 1. The proximal connector 2 can vary depending on the shape of the distal end of the bone support 1. The diameter of the distal connector 3 coincides with the diameter of the bone support 1, and the proximal end of the distal connector 3 has a built-in connecting thread structure 19 which can be screwed into the external connecting thread structure of the proximal connector 2. The matching combination of the brackets is realized, and after the combination is completed, the inner channels can be completely butted and mutually penetrated.

After the combination is completed as shown in FIGS. 6-8, the tail end of the bracket (ie, the tail end of the distal connector 3) has a structure of a groove 14, a recess 15 or a protrusion 16 for the bracket and the external connector. Connect to achieve screwing in the bracket. The shape, size, position, etc. of the grooves, recesses, and protrusions can be adjusted and changed as needed. Optionally, the bone support 1 and the proximal connector 2 are of unitary structure, wherein the proximal connector 2 is solid or may be a small hole structure.

In one embodiment, the bone support 1 has a diameter of 5-18 mm and a length of 5-50 mm. The proximal connector 2 has a length of 5-50 mm, and the bone support 1 and the proximal connector 2 are of an integrated structure having a total length of 20-100 mm. The distal connector 3 has a length of 20-150 mm.

In use, after the stent is implanted into the bone tunnel after removal of the femoral head necrotic core decompression lesion, the position of the proximal end of the proximal connector 2 is higher than the position of the femoral neck osteotomy line in the normal hip replacement, ie, after implantation The connection zone is located at the proximal and/or middle of the femoral neck.

Advantages of the combined stent of the present invention: if the femoral head necrosis collapses in the later stage, when a joint replacement operation is required, since the proximal porous portion (bone support 1) has bone ingrowth, the distal portion is a solid structure (distal connection) 3) Without bone ingrowth, the distal end can be unscrewed and the femoral neck can be cut off at the femoral neck, and the osteotomy area no longer interferes with the stent, so it does not interfere with the normal operation of hip replacement.

The invention also provides a stent, the stent 1 is a porous structure, can be implanted into the cavity formed by the avascular necrosis of the avascular necrosis of the femoral head, and plays a role in biomechanical support and promotes the growth of blood vessels and bone tissue. effect.

The stent 1 can be prepared by 3D printing techniques, but can of course also be prepared by non-3D printing techniques (such as vapor deposition or sintering). The stent 1 of the present invention is a porous titanium alloy stent. Of course, the material of the stent may also be tantalum, titanium-niobium alloy, nickel-titanium alloy, pure titanium, cobalt alloy, magnesium alloy, calcium phosphate, hydroxyapatite, polylactic acid ( PLA), lactic acid-glycolic acid copolymer (PLGA), polyacetic acid lactone (PCL), coral, bioceramics and other materials. The bracket 1 can be processed into any other shape as needed. The stent 1 can be made by additive manufacturing (3D printing) or equivalent manufacturing (powder metallurgy) technology.

In one embodiment, as shown in FIGS. 3-5, the stent 1 includes a stent body 11 and a channel 12. The stent body 11 has a porous structure, which is cylindrical in shape and has a diameter of 5-18 mm. The top of the stent body 11 is hemispherical or curved to better maintain the mechanical support of the stent tip. The hemispherical curvature can be adjusted as needed.

Optionally, the overall length of the stent body 11 is 40-200 mm, the column width of the hole of the stent body 11 is 100-1000 um (median 300 um), the aperture is 100-3000 um (median 1000 um), and the stent body 11 The porosity is 40-90%.

The tunnel 12 extends through the bracket body 11. The tunnel 12 runs longitudinally inside the stent body 11, and the diameter of the tunnel 12 is 1-8 mm.

Alternatively, the number of the tunnels 12 is two, and the two tunnels pass through at the bottom of the bracket main body 11 and communicate with each other at the top of the bracket main body 11. Implantation of blood vessels: by transplanting blood vessels (such as large/small saphenous veins, small arteriovenous bundles in adjacent or other parts, artificial blood vessels or artificial blood vessels combined with autologous blood vessels, etc.) into two holes communicating with each other in the stent In the tract, and with the blood supply system (such as the lateral femoral arteriovenous system) around the hip joint, the vascularization of the stent is achieved to promote the growth of blood vessels in the stent and the lesion area, and to realize the reconstruction of the microcirculatory system in the lesion area. Provides the necessary stem cells, oxygen, nutrients, growth factors and localized metabolic waste for the new bone tissue. The stent 1 can be directly used after being implanted into the vascular bundle, or a growth factor (such as BMP-2/VEGF, etc.) or stem cells can be loaded inside the porous structure to further enhance its ability to promote bone regeneration.

Optionally, the top of the stent body 11 has a depression forming a fenestration in which the two channels 12 communicate (as shown in Figure 3). The fenestration allows for vessel implantation and avoids compression of blood vessels. The fenestration may be located on one side or the top of the top of the stent body 11, and the size, shape and position of the fenestration may be adjusted as needed. In addition, the top of the stent body 11 may also be a fully covered porous structure (no window).

Alternatively, as shown in FIG. 5, in one embodiment, the fenestration is located on the side of the top of the stent body 11. The range of the side window opening can be floated up and down. On the inside of the window, in the bracket body 11, the two channels 12 can be accompanied by or without a septum.

Optionally, as shown in FIG. 10-11, in one embodiment, the periphery of the tail portion of the bracket body 11 is designed with a threaded area 113, the length of the thread: 4-50 mm, and the bracket portion inside the threaded area may be a porous structure or Non-porous structures (such as solid structures with two vascular channels).

In addition, the bottom end of the bracket body 11 is provided with a recess 114 for connection with an external connector to effect screwing of the bracket. The groove 114 may also be located on the side of the tail of the stent body 11.

Alternatively, as shown in FIG. 12, in one embodiment, the bottom end of the bracket body 11 is provided with a recessed hole 115 for connection with an external connector to effect screwing of the bracket. The recess 115 may also be located on the side of the tail of the bracket body 11.

Alternatively, as shown in FIG. 13, in one embodiment, the bottom end of the bracket body 11 is provided with a raised structure 116 for connection with an external connector to effect screwing of the bracket. The raised structure 116 can also be located on the side of the tail of the stent body 11.

Alternatively, as shown in FIG. 14, in one embodiment, the fenestration cover 117 shown in FIG. 5 may be provided. The embodiments described above are only preferred embodiments of the present invention, and the usual changes and substitutions made by those skilled in the art within the scope of the present invention are included in the scope of the present invention.

Claims (13)

A combination bracket characterized by comprising: a bone support member (1) having a hole (12) in the bone support member (1); a proximal connector (2), a proximal connector (2) connecting the tail of the bone support (1), and a proximal channel (12) having a channel (12); a distal connector (3), a distal connector (3) connected to the tail of the proximal connector (2), and a distal channel (12) having a channel (12) therein. After the bone support (1), the proximal connector (2) and the distal connector (3) form a bracket connection, the inner tunnels (12) penetrate each other. The number of the channels (12) is at least two, the channels (12) are pierced at the bottom of the distal connector (3), and the sides of the top or top of the bone support (1) are recessed to form a window, a hole ( 12) Connected in the recess. The combination bracket according to claim 1, wherein The fenestration is provided with a cover (17) for covering the fenestration. The combination bracket according to claim 1, wherein There is a septum between the tunnels (12). The combination bracket according to claim 1, wherein The bottom end or side of the tail of the distal connector (3) has a recess (14), a recess (15) or a raised structure (16). The combination bracket according to claim 4, wherein The distal end of the distal connector (3) has a threaded region (13) in which a recess (14), a recess (15) or a raised structure (16) is located. The combination bracket according to claim 5, wherein The proximal connector (2) has a threaded structure (18) for attachment, the proximal end of the distal connector (3) has a threaded structure (19) for attachment, and the proximal connector (2) is connected to the distal end The piece (3) is screwed into each other by the connecting thread structure (18, 19) to achieve a matching combination. The combination bracket according to claim 1, wherein The bone support (1) is of a porous structure, the proximal connector (2) is a solid or small-porous structure, and the distal connector (3) is a solid non-porous structure. A bracket characterized by comprising: a bracket body (11) and a plurality of tunnels (12), wherein the plurality of tunnels (12) extend through the bracket body (11), and a side of the top end or the top of the bracket body (11) has a recess to form a window, the tunnel (12) ) communicating in the recess. A stand according to claim 8 wherein: The fenestration is provided with a cover (117) for covering the fenestration. A stent according to claim 8, characterized in that the channels (12) are accompanied by a septum. A stand according to claim 8 wherein: The bottom end or side of the tail of the bracket body (11) has a groove (114), a recessed hole (115) or a raised structure (116). A stand according to claim 11 wherein: The periphery of the tail of the bracket body (11) has a threaded area (113) in which the recess (114), the recessed hole (115) or the raised structure (16) is located. A stand according to claim 8 wherein: The stent body (11) has a porous structure.

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