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WO2018133868A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2018133868A1
WO2018133868A1 PCT/CN2018/073669 CN2018073669W WO2018133868A1 WO 2018133868 A1 WO2018133868 A1 WO 2018133868A1 CN 2018073669 W CN2018073669 W CN 2018073669W WO 2018133868 A1 WO2018133868 A1 WO 2018133868A1
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WO
WIPO (PCT)
Prior art keywords
stent
connector
bracket
distal
recess
Prior art date
Application number
PCT/CN2018/073669
Other languages
English (en)
Chinese (zh)
Inventor
李波
张国伟
徐保东
赵国栋
Original Assignee
北京形梦信息技术有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 北京形梦信息技术有限公司 filed Critical 北京形梦信息技术有限公司
Publication of WO2018133868A1 publication Critical patent/WO2018133868A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/28—Bones

Definitions

  • the present invention relates to medical devices. More specifically, it relates to a medical stent.
  • Femoral head necrosis also known as avascular necrosis of the femoral head
  • Femoral head necrosis 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • the sides of the top or top of the stent body have depressions to form a fenestration in which the channels communicate.
  • the fenestration is provided with a cover for covering the fenestration.
  • the bottom or side of the tail of the stent body has a recess, a recess or a raised structure.
  • 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.
  • the stent body is a porous structure.
  • the bracket body is cylindrical, and the top of the bracket body is curved.
  • 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%.
  • 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.
  • 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.
  • 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.
  • 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.
  • the sides of the top or top of the bone support have depressions to form a fenestration in which the channels communicate.
  • the fenestration is provided with a cover for covering the fenestration.
  • the bottom end or side of the tail of the distal connector has a recess, a recess or a raised configuration.
  • the proximal connector is integral with the bone support.
  • the distal end of the distal connector has a threaded region in which the recess, recess or raised structure is located.
  • 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.
  • the bone support is a porous structure
  • the proximal connector is a solid or small aperture structure
  • 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.
  • 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.
  • proximal end refers to the end of the bone first, and the opposite end is called the distal end.
  • 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.
  • 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.
  • the bone support 1 is of a porous structure
  • the proximal connector 2 is a solid or small aperture structure
  • the distal connector 3 is a solid, non-porous structure.
  • 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.
  • 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)
  • the bone support The porosity of the part 1 is 40-90%.
  • 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.
  • 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.
  • 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.
  • 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.
  • a growth factor such as BMP-2/VEGF, etc.
  • 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.
  • the top of the bone support 1 can also be a fully covered porous structure (no window).
  • 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.
  • the two channels 12 can be accompanied by or without a septum.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
  • the proximal connector 2 has a bore therein for abutting the bore of the bone support 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • a growth factor such as BMP-2/VEGF, etc.
  • 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.
  • the top of the stent body 11 may also be a fully covered porous structure (no window).
  • 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.
  • the two channels 12 can be accompanied by or without a septum.
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Un stent, comprenant : un composant de support d'os (1), pourvu intérieurement d'un tunnel (12); un connecteur proximal (2), se raccordant à une extrémité de queue du composant de support d'os (1) et pourvu intérieurement d'un tunnel (12); et un connecteur distal (3), se raccordant à une extrémité de queue du connecteur proximal (2) et pourvu intérieurement d'un tunnel (12). Lorsque le composant de support d'os (1), le connecteur proximal (2) et le connecteur distal (3) sont reliés pour former le stent, les tunnels (12) à l'intérieur de celui-ci sont reliés l'un à l'autre. Le nombre des tunnels (12) est d'au moins deux. Les tunnels (12) sortent du connecteur distal (3) au niveau de sa partie inférieure. Une extrémité supérieure ou une partie latérale d'une partie supérieure du composant de support d'os (1) a un évidement qui forme une fenêtre. Les tunnels (12) sont reliés dans l'évidement. Le stent peut être co-transplanté avec des vaisseaux sanguins pour le traitement de la nécrose avasculaire de la tête fémorale.
PCT/CN2018/073669 2017-01-23 2018-01-22 Stent WO2018133868A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN201710049581 2017-01-23
CN201710057121.3 2017-01-23
CN201710049581.1 2017-01-23
CN201710057121 2017-01-23

Publications (1)

Publication Number Publication Date
WO2018133868A1 true WO2018133868A1 (fr) 2018-07-26

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PCT/CN2018/073669 WO2018133868A1 (fr) 2017-01-23 2018-01-22 Stent

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WO (1) WO2018133868A1 (fr)

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003043543A1 (fr) * 2001-11-22 2003-05-30 Eska Implants Gmbh & Co. Endoprothese du col du femur destinee a une articulation de hanche artificielle
CN101317790A (zh) * 2008-05-16 2008-12-10 北京天新福医疗器材有限公司 一种用于股骨头坏死的金属骨支撑器
CN102028566A (zh) * 2010-12-06 2011-04-27 北京畅想天行医疗技术有限公司 一种股骨头内支撑架
US20140012392A1 (en) * 2009-09-01 2014-01-09 Concept, Design And Development, Llc Neck sparing total hip implant system
CN103767807A (zh) * 2014-01-10 2014-05-07 中国医学科学院整形外科医院 一种新型血管化组织工程骨及其构建方法
CN204364501U (zh) * 2014-12-02 2015-06-03 中国人民解放军第四军医大学 一种具有仿生骨小梁结构的多孔钛合金股骨头支撑棒
CN104814814A (zh) * 2015-03-17 2015-08-05 苏州瑞华医院有限公司 一种用于治疗股骨头坏死的支撑装置
CN106798601A (zh) * 2017-01-23 2017-06-06 北京形梦信息技术有限公司 一种支架
CN106798600A (zh) * 2017-01-23 2017-06-06 北京形梦信息技术有限公司 一种组合支架

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003043543A1 (fr) * 2001-11-22 2003-05-30 Eska Implants Gmbh & Co. Endoprothese du col du femur destinee a une articulation de hanche artificielle
CN101317790A (zh) * 2008-05-16 2008-12-10 北京天新福医疗器材有限公司 一种用于股骨头坏死的金属骨支撑器
US20140012392A1 (en) * 2009-09-01 2014-01-09 Concept, Design And Development, Llc Neck sparing total hip implant system
CN102028566A (zh) * 2010-12-06 2011-04-27 北京畅想天行医疗技术有限公司 一种股骨头内支撑架
CN103767807A (zh) * 2014-01-10 2014-05-07 中国医学科学院整形外科医院 一种新型血管化组织工程骨及其构建方法
CN204364501U (zh) * 2014-12-02 2015-06-03 中国人民解放军第四军医大学 一种具有仿生骨小梁结构的多孔钛合金股骨头支撑棒
CN104814814A (zh) * 2015-03-17 2015-08-05 苏州瑞华医院有限公司 一种用于治疗股骨头坏死的支撑装置
CN106798601A (zh) * 2017-01-23 2017-06-06 北京形梦信息技术有限公司 一种支架
CN106798600A (zh) * 2017-01-23 2017-06-06 北京形梦信息技术有限公司 一种组合支架

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