CN112826563A - Medical implant and method of making the same - Google Patents
- ️Tue May 25 2021
CN112826563A - Medical implant and method of making the same - Google Patents
Medical implant and method of making the same Download PDFInfo
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Publication number
- CN112826563A CN112826563A CN202110232048.5A CN202110232048A CN112826563A CN 112826563 A CN112826563 A CN 112826563A CN 202110232048 A CN202110232048 A CN 202110232048A CN 112826563 A CN112826563 A CN 112826563A Authority
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- 2021-03-02 Legal status (The legal status 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 status listed.)
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- 239000007943 implant Substances 0.000 title claims abstract description 151
- 238000004519 manufacturing process Methods 0.000 title claims abstract description 11
- 239000000463 material Substances 0.000 claims abstract description 75
- 239000011295 pitch Substances 0.000 claims description 42
- 238000000034 method Methods 0.000 claims description 28
- 238000004804 winding Methods 0.000 claims description 25
- 230000008569 process Effects 0.000 claims description 10
- 229910045601 alloy Inorganic materials 0.000 claims description 8
- 239000000956 alloy Substances 0.000 claims description 8
- 229910052751 metal Inorganic materials 0.000 claims description 8
- 239000002184 metal Substances 0.000 claims description 8
- 229920000642 polymer Polymers 0.000 claims description 6
- 238000012856 packing Methods 0.000 abstract description 18
- 206010002329 Aneurysm Diseases 0.000 description 26
- 230000010102 embolization Effects 0.000 description 12
- 230000003902 lesion Effects 0.000 description 12
- 208000027418 Wounds and injury Diseases 0.000 description 11
- 201000011066 hemangioma Diseases 0.000 description 9
- 206010028980 Neoplasm Diseases 0.000 description 7
- 201000008450 Intracranial aneurysm Diseases 0.000 description 6
- 230000000694 effects Effects 0.000 description 6
- 230000008093 supporting effect Effects 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 230000015572 biosynthetic process Effects 0.000 description 3
- 238000005553 drilling Methods 0.000 description 3
- 230000005484 gravity Effects 0.000 description 3
- 230000002093 peripheral effect Effects 0.000 description 3
- 238000004904 shortening Methods 0.000 description 3
- 239000007787 solid Substances 0.000 description 3
- 206010055031 vascular neoplasm Diseases 0.000 description 3
- 208000005189 Embolism Diseases 0.000 description 2
- KDLHZDBZIXYQEI-UHFFFAOYSA-N Palladium Chemical compound [Pd] KDLHZDBZIXYQEI-UHFFFAOYSA-N 0.000 description 2
- 230000009471 action Effects 0.000 description 2
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- 210000004204 blood vessel Anatomy 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- 238000011161 development Methods 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000002349 favourable effect Effects 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 150000002739 metals Chemical class 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 230000007704 transition Effects 0.000 description 2
- 208000032851 Subarachnoid Hemorrhage Diseases 0.000 description 1
- 230000002411 adverse Effects 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000001627 detrimental effect Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 238000007917 intracranial administration Methods 0.000 description 1
- 230000002601 intratumoral effect Effects 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
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- WFKWXMTUELFFGS-UHFFFAOYSA-N tungsten Chemical compound [W] WFKWXMTUELFFGS-UHFFFAOYSA-N 0.000 description 1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
- A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/1214—Coils or wires
- A61B17/12145—Coils or wires having a pre-set deployed three-dimensional shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B2017/00526—Methods of manufacturing
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- Health & Medical Sciences (AREA)
- Surgery (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Molecular Biology (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Neurosurgery (AREA)
- Surgical Instruments (AREA)
Abstract
The invention relates to a medical implant and a manufacturing method thereof, wherein the medical implant comprises at least two spring ring units which are connected end to end, the material coverage rate of the unit area of the at least two spring ring units is different, and the spring ring unit with high material coverage rate of the unit area is used for being arranged in the spring ring unit with low material coverage rate of the unit area; thereby improving the basket forming performance and packing performance of the medical implant and reducing the economic burden of the patient.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a medical implant and a manufacturing method thereof.
Background
Intracranial aneurysms are the leading cause of subarachnoid hemorrhage. The endovascular embolization technology is a novel technology which is developed along with the development of interventional science, and has the advantages of small wound, quick recovery, low fatality rate and the like. With the rapid development of neuroimaging, embolization materials and techniques, the endovascular embolization technique is becoming mature for the treatment of intracranial aneurysms, and embolization materials are also emerging in many ways. Due to the advantages of convenient operation, stable implantation, safety, effectiveness and the like, the spring ring is increasingly emphasized by clinicians and scientific researchers, and gradually becomes a mainstream means for clinically treating intracranial aneurysm. On the one hand, the ideal coil needs to have better basket forming and positioning performance, and can stably exist in the aneurysm after being implanted into the aneurysm and form a basket-shaped framework, so that the subsequent coil can be conveniently embolized continuously. In addition, the packing performance of the spring ring is the same as the key, and the spring ring with excellent packing performance can improve the intratumoral packing density.
Currently, clinically used spring rings are mostly of a single configuration, namely a basket ring alone (3D configuration) or a filled ring alone (2D configuration). For a spring ring with a single configuration, for example, a 3D spiral formed basket ring can well form a space frame in a tumor, can be stably supported in the aneurysm, has a three-dimensional shape well covering a wide area and is not easy to displace, but the spring ring with a basket ring structure alone is weak in drilling and emptying capacity, is not compact in filling of a small space, and is not easy to block blood flow in a large-range blank in the spring ring, especially in a high blood flow volume. The filling ring of the 2D structure has better drilling empty capacity, is more convenient to fill in space, but cannot be well fixed, is easy to displace, and seriously causes part of the filling ring to fall off to a parent artery, thereby causing operation failure.
Based on this, the current clinician performs coil embolization of aneurysms by first selecting a basket-like ring of comparable size to the aneurysm, forming a stable framework structure within the aneurysm, and then gradually selecting a packing ring of decreasing size gradient to continue to fill the remaining space within the aneurysm to eventually form a dense embolization of the aneurysm. In the whole embolization process, due to the selection of the specification and the size of the spring ring, the dense embolization of one aneurysm can be completed only by using 5-8 spring rings in one operation on average, so that the economic burden of a patient is increased, the operation time is prolonged, and the health of doctors and patients is also adversely affected.
Disclosure of Invention
In order to solve the above problems, it is an object of the present invention to provide a medical implant having the effects of stable basket formation and dense filling.
In order to achieve the above object, the present invention provides a medical implant, comprising at least two spring coil units connected end to end, wherein the material coverage per unit area of at least two spring coil units is different;
the medical implant has a first configuration and a second configuration; when the medical implant is in the first shape, at least two spring coil units are arranged side by side and do not overlap with each other; when the medical implant is in the second configuration, the high material coverage per unit area coil unit is disposed within the low material coverage per unit area coil unit.
Optionally, the medical implant comprises at least three spring ring units connected end to end in sequence, and the material coverage rate per unit area of the at least three spring ring units is increased in sequence; when the medical implant is in the second state, the coil unit with high material coverage per unit area is disposed inside the coil unit with low material coverage per unit area in any two adjacent coil units.
Optionally, the number of the spring ring units is three, and the spring ring units are respectively a first spring ring unit, a second spring ring unit and a third spring ring unit; the first spring ring unit, the second spring ring unit and the third spring ring unit are sequentially connected end to end; the secondary coil unit is disposed within the primary coil unit and the tertiary coil unit is disposed within the secondary coil unit when the medical implant is in the second configuration.
Optionally, the at least three spring ring units have the same shape, and are all spheres, polyhedrons or spindles, or the at least three spring ring units have different shapes and are a combination of spheres, polyhedrons and spindles.
Optionally, when the shape of at least three spring coil units is different from each other and the medical implant is in the second configuration, the outermost spring coil unit is a polyhedron, the middle at least one spring coil unit is a sphere, and the innermost spring coil unit is a spindle.
Optionally, at least two of the spring ring units have different shapes or are identical to each other.
Optionally, each of the coil units is sequentially connected to form a polyhedron from a plurality of basic units, and the outermost coil unit is sequentially connected to form a polyhedron from at least four basic units when the medical implant is in the second configuration, or each of the coil units is sequentially connected to form a sphere from a plurality of basic units, and the outermost coil unit is sequentially connected to form a sphere from at least three basic units when the medical implant is in the second configuration; wherein:
when the medical implant is in the second configuration, the number of base units of the internal coil unit is greater than the number of base units of its external adjacent coil units.
Optionally, when each of the spring coil units is a polyhedron, the shape of the basic unit in each spring coil unit is at least partially different.
Optionally, each spring ring unit comprises a C-shaped base unit and an Ω -shaped base unit, and the Ω -shaped base unit is an open ring having an opening curvature smaller than that of the C-shaped base unit.
Optionally, the medical implant comprises at least three spring coil units which are connected end to end in sequence, and the number of basic units of the at least three spring coil units is increased in sequence;
the coil unit with the larger number of base units is adapted to be disposed inside the coil unit with the smaller number of base units, among any two adjacent coil units, when the medical implant is in the second configuration.
Optionally, when each of the coil units is a sphere, and the medical implant is in the second configuration, the number of the basic units of the outermost coil unit is 3 to 8;
when each of the coil units is polyhedral and the medical implant is in the second configuration, the number of the basic units of the outermost coil unit is 4 to 8.
Optionally, when the spring coil units are polyhedrons, the ratio of the length, the height, and the width of any one spring coil unit is 1.
Optionally, the maximum cross-sectional area of the outer spring coil unit is 1.2 to 1.5 times the maximum cross-sectional area of its inner adjacent spring coil unit when the medical implant is in the second configuration.
Optionally, the outermost spring coil unit has a maximum cross-sectional width of 5-30 mm when the medical implant is in the second configuration.
Optionally, the number of the spring ring units is 2 to 5.
Optionally, each spring ring unit is formed by spirally winding a body, and each spring ring unit is a spindle body with two small ends and a large middle part; wherein: when the medical implant is in the second configuration, the helical pitch of the internal coil unit is less than the helical pitch of its external adjacent coil units.
Optionally, when the medical implant is in the second configuration, the helical pitch of the external spring coil unit is 1.5-2 times the helical pitch of its internal adjacent spring coil unit.
Optionally, the ratio of the height to the maximum width of each spring ring unit is 1-1.5.
Optionally, the maximum cross-sectional area of each spring ring unit is 2-3 times of the minimum cross-sectional area.
Optionally, when the medical implant is in the second configuration, the minimum cross-sectional area of the outer coil unit is 1-1.5 times the maximum cross-sectional area of its inner adjacent coil unit.
Optionally, the number of the spring ring units is three, and the spring ring units are respectively a first spring ring unit, a second spring ring unit and a third spring ring unit; the first spring ring unit, the second spring ring unit and the third spring ring unit are sequentially connected end to end; when the medical implant is in the second configuration, the secondary coil unit is disposed within the primary coil unit, and the tertiary coil unit is disposed within the secondary coil unit; wherein:
the spiral pitch of the first spring ring unit is 3-5 times of the outer diameter of the body; the spiral pitch of the second spring ring unit is 2-2.5 times of the outer diameter of the body; the spiral pitch of the third spring ring unit is 1-1.2 times of the outer diameter of the body.
Optionally, each spring ring unit is formed by winding a primary coil, and the primary coil is formed by spirally winding a metal, alloy or polymer wire.
In order to achieve the above object, the present invention also provides a method for manufacturing a medical implant, for preparing any of the medical implants, the method comprising:
providing a body;
the body is made to run according to a mold, so that at least two spring ring units connected end to end are formed in the mold in a winding mode, the material coverage rate of the unit area of the spring ring units is different in at least two spring ring units in the winding process, and the spring ring units with high material coverage rate of the unit area can be arranged in the spring ring units with low material coverage rate of the unit area.
Optionally, in the winding process, the body is sequentially wound on the die to form a plurality of basic units, and the basic units are sequentially connected to form at least two spring ring units, wherein the number of the basic units of the at least two spring ring units is different.
Optionally, a plurality of the basic units are connected in sequence to form at least two polyhedrons, each polyhedron forms a spring ring unit, or a plurality of the basic units are connected in sequence to form at least two spheres, and each sphere forms a spring ring unit.
Optionally, in the winding process, the body is spirally wound on the die to form at least two spindles, each of the spindles forms a spring ring unit, and the at least two spindles have different spiral pitches.
Optionally, the body is wound on the die to form at least three spring ring units connected end to end, and the material coverage rate of the at least three spring ring units per unit area is sequentially increased; in any two adjacent spring coil units, the spring coil unit with high material coverage per unit area can be arranged inside the spring coil unit with low material coverage per unit area.
Optionally, the body is a primary coil, and the primary coil is formed by spirally winding a metal, an alloy or a polymer wire.
To achieve the above object, the present invention also provides a method for treating hemangioma, wherein the neck of the hemangioma is open to a blood vessel, the method comprising:
firstly, placing a spring ring unit with low material coverage per unit area in the hemangioma;
the spring coil units with high material coverage per unit area are then placed inside the spring coil units with low material coverage per unit area.
Optionally, the method further comprises:
providing at least three spring coil units connected end to end;
firstly, placing the spring ring unit with the lowest coverage rate of the material in unit area in the hemangioma;
and then the spring coil units with the unit area material coverage rate sequentially increased are sequentially placed in the spring coil units with the unit area material coverage rate lower.
In the above medical implant and the method for manufacturing the same, the medical implant is mainly used for hemangioma embolization, which includes but is not limited to intracranial blood vessels, and also can be peripheral blood vessels. In addition, the medical implant comprises at least two spring coil units which are connected end to end, wherein one spring coil unit can be arranged in the other spring coil unit, and the spring coil unit with high material coverage per unit area is arranged in the spring coil unit with low material coverage per unit area; by the structure, the spring ring unit with low material coverage rate per unit area at the farthest end (namely the outermost end) can be used as a basket ring (good in supporting performance), the spring ring unit with high material coverage rate per unit area can fill the spring ring unit with high material coverage rate per unit area into the basket ring to play a role in filling the basket ring, and the spring ring unit with high material coverage rate per unit area has good drilling empty capacity, so that space filling can be conveniently carried out, stable and compact filling is finally formed, the filling performance and basket forming performance are good, the spring rings with different specifications and configurations can be prevented from being selected for multiple times in a doctor operation, the operation in the operation is reduced, the operation time is shortened, and the economic burden of a patient is relieved.
Drawings
FIG. 1 is a schematic view of a first medical implant in a first configuration according to one embodiment of the present invention;
FIG. 2 is a schematic structural view of a first medical implant in a second configuration in accordance with one embodiment of the present invention;
FIGS. 3a to 3c are schematic views showing three coil units in a first medical implant according to an embodiment of the present invention;
FIGS. 4a to 4c are front views of three coil units in an open position in a first medical implant according to an embodiment of the present invention;
FIG. 5 is a schematic structural view of a second medical implant according to a second embodiment of the present invention in a first configuration;
FIG. 6 is a schematic structural view of a second medical implant in a second configuration according to a second embodiment of the present invention;
FIGS. 7a to 7c are schematic views of three coil units in a second medical implant according to a second embodiment of the present invention;
FIGS. 8a to 8c are front views of three coil units in an open position in a second medical implant according to a second embodiment of the present invention;
FIG. 9 is a schematic structural view of a third medical implant according to a third embodiment of the invention in a first configuration;
FIG. 10 is a schematic structural view of a third medical implant according to a third embodiment of the invention in a second configuration;
FIGS. 11 a-11 c are schematic views of the winding of three coil units in a third medical implant according to a third embodiment of the present invention;
FIG. 12 is a front view of a third medical implant according to a third embodiment of the invention.
Detailed Description
To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming the embodiments of the present invention.
As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "plurality" is generally employed in a sense that it includes two or more, unless the content clearly dictates otherwise. The term "plurality" is generally employed in a sense including an indefinite amount unless the content clearly dictates otherwise.
As used in this specification, the term "proximal" generally refers to the end near the operator of the medical implant, and "distal" generally refers to the end of the medical implant that enters the body first, unless the context clearly dictates otherwise. As used in this specification, "circumferential" refers to a direction about an axis; "axial" refers to a direction parallel to the axis; "transverse" refers to a direction perpendicular to the axis.
Example one
Referring to fig. 1-2 and fig. 3 a-3 c, fig. 1 and 2 are schematic structural views of a first
medical implant10 in a first embodiment of the invention in a first configuration and a second configuration, respectively, and fig. 3 a-3 c are schematic structural views of a
first coil unit1, a
second coil unit2 and a
third coil unit3, respectively, in a first embodiment of the invention.
In particular, the present embodiment provides a first
medical implant10 for use in the occlusion treatment of a vascular tumor, including, but not limited to, an intracranial aneurysm, and also a peripheral aneurysm. In addition, the first
medical implant10 of the present embodiment uses an integrated multi-level coil for embolization, which avoids the need for multiple selection of coils of different sizes and configurations during the operation of the physician, thereby reducing the number of operations during the operation, shortening the operation time, and reducing the number of coils used in one operation, thereby reducing the economic burden on the patient.
The first
medical implant10 includes at least two spring coil units connected end to end, and optionally, the number of the spring coil units is 2 to 5. It should be understood that the number of coil units is determined primarily by the number of coil units actually required for a procedure, and thus the number of coil units is not particularly required in the present invention.
The following description illustrates three coil units as an example of the first
medical implant10 that can improve basket formation and packing, but those skilled in the art will appreciate that the number of coil units in the present embodiment may be two or more than three.
Preferably, the first
medical implant10 comprises a first
spring coil unit1, a second
spring coil unit2 and a third
spring coil unit3 which are connected end to end, and each spring coil unit is a sphere formed by winding a body, and is preferably a standard sphere. Preferably, the body is a primary coil, and the primary coil is formed by spirally winding a metal, alloy or polymer wire. The structure of the wire is not particularly limited, and may be a strand formed of a single wire or a plurality of single wires. A "single wire" is a single wire having a circular or other cross-section and extending in a linear fashion. The material of the wire rod is not particularly limited, and the material may be a material opaque to X-rays, such as any one of platinum, rhodium, rhenium, palladium, or tungsten, or an alloy of these metals, or a combination of at least two of these metals or alloys. The "standard sphere" is a round sphere having a substantially constant outer diameter, but is not limited thereto, and the sphere may be a spheroid or the like. Because the spheroid is favorable to reducing the camber of the body of connecting two adjacent spring coil units especially standard spheroid, makes the body gently pass through to next spring coil unit from preceding spring coil unit to reduce the degree of curvature of the body of transition department with the pressure that reduces to the tumor wall, reduce the risk that hemangioma bursts. It will be appreciated here that if the curvature of the body at the transition is large, it is likely to form a tip, causing excessive pressure on the wall of the aneurysm, which tends to cause the aneurysm to rupture.
The first
medical implant10 has a first configuration (i.e., a preformed shape) as shown in fig. 1 and a second configuration (i.e., a packed shape or a free state after removal from a sheath) as shown in fig. 2. The second form refers to the final shape imparted to the first form shown in fig. 1. In more detail, one end of the body in the
first coil unit1 is connected to one end of the body in the
second coil unit2, the other end of the body in the
second coil unit2 is connected to one end of the body in the
third coil unit3, and the body here is usually a primary coil, i.e., a primary coil is wound in the first form shown in fig. 1. When the first
medical implant10 is in the first configuration, the three coil spring units are arranged side by side and do not overlap with each other; when the first
medical implant10 is in the second configuration, the
second coil unit2 is disposed inside the
first coil unit1, and the
third coil unit3 is disposed inside the
second coil unit2. In particular, the material coverage per unit area of the
first coil unit1, the material coverage per unit area of the
second coil unit2, and the material coverage per unit area of the
third coil unit3 increase in this order.
When implanted, the
first coil unit1 is the distal-most end of the first
medical implant10, i.e., enters the lesion first, and the
third coil unit3 is the proximal-most end of the first
medical implant10, i.e., enters the lesion last. In the case of an aneurysm, the
first coil unit1 first enters the aneurysm, the
second coil unit2, and the
third coil unit3, and finally fills the aneurysm in the second configuration shown in fig. 2. When the first
medical implant10 is applied only by gravity (in a free state, i.e., not constrained by the sheath, nor occluding the lesion), the structure is in the form of the
first coil unit1 being at the outermost portion, the
second coil unit2 being inside the first coil unit 1 (i.e., the
second coil unit2 is located between the
first coil unit1 and the
third coil unit3, and defined as an intermediate position), and the
third coil unit3 being inside the second coil unit 2 (i.e., the
third coil unit3 being at the innermost portion).
In the present invention, the size of the
first coil unit1 is not particularly limited, and may be generally set according to the size of a lesion to be embolized. In the case of an aneurysm, as shown in fig. 4a, the maximum outer diameter D1 (i.e., the maximum cross-sectional width) of the
first coil unit1 is preferably 5mm to 30mm, more preferably the maximum outer diameter D1 of the
first coil unit1 is 8mm to 24mm, and still more preferably the maximum outer diameter D1 of the
first coil unit1 is 10mm to 16 mm.
Further, when the first
medical implant10 is in the second configuration, the maximum outer diameter of the outer coil unit is preferably 1.2 to 1.5 times the maximum outer diameter of its inner adjacent coil units, i.e., equivalently, when the first
medical implant10 is in the first configuration, the maximum outer diameter of the distal coil unit is preferably 1.2 to 1.5 times the maximum outer diameter of the proximal coil unit in any two adjacent coil units. As shown in fig. 4a to 4b, the maximum outer diameter D1 of the first
spring coil unit1 is preferably 1.2 to 1.5 times the maximum outer diameter D2 of the second
spring coil unit2; as shown in FIGS. 4b to 4c, the maximum outer diameter D2 of the second
spring coil unit2 is preferably 1.2 to 1.5 times the maximum outer diameter D3 of the third
spring coil unit3. The advantage of so configuring the outer diameters of two adjacent spring ring units is that one spring ring unit of any two adjacent spring ring units is conveniently and smoothly plugged into the other spring ring unit, the plugging performance is good, meanwhile, compact plugging is conveniently formed, materials are saved, and the cost is reduced.
In this embodiment, each spring ring unit is formed by connecting a plurality of basic units in sequence, the plurality of basic units are uniformly or non-uniformly arranged along the circumferential direction of the spring ring unit, the shapes and sizes of the basic units in the same spring ring unit are preferably the same, and the shapes of the basic units in different spring ring units can be the same or different without special requirements as long as the plurality of basic units are connected in sequence to form a sphere.
As shown in fig. 3a, the first
spring ring unit1 is formed by connecting a plurality of first
basic units11 distributed circumferentially in sequence. The
first coil unit1 is the outermost coil unit in the second form (i.e., the most distal coil unit in the first form), and generally, the number of the
first base units11 is not less than 3, preferably 3 to 8, such as 3, 4, 5, 6, 7, or 8.
As shown in fig. 3b, the second
spring coil unit2 is formed by connecting a plurality of second
basic units21 distributed circumferentially one after another. Since the second
spring coil unit2 serves as the intermediate spring coil unit, the number of the
second base units21 is not particularly limited as long as it is larger than the number of the
first base units11.
As shown in fig. 3c, the third
spring ring unit3 is formed by connecting a plurality of third
basic units31 distributed circumferentially in sequence. Since the
third coil unit3 serves as the innermost coil unit in the second form (i.e., the most proximal coil unit in the first form), the number of the
third base units31 is not particularly limited as long as it is larger than the number of the
second base units21.
In an embodiment, the first
medical implant10 is configured to: the number of the first
basic units11 is 4, the number of the second
basic units21 is 6, and the number of the third
basic units31 is 8. In another embodiment, the first
medical implant10 is configured to: the number of the first
basic units11 is 3, the number of the second
basic units21 is 5, and the number of the third
basic units31 is 7.
It is to be understood that the combination of the above-described basic elements is merely a preferred example and is not intended as a limitation of the present invention. In the present embodiment, in order to make the material coverage of the three spring coil units different from each other, the number of the basic units of the three spring coil units is configured to be different from each other, that is, the number of the first
basic unit11, the second
basic unit21, and the third
basic unit31 is sequentially increased, so that a structure in which the material coverage is from thin to dense is formed, and thus, not only is the basket forming effect good, but also the packing performance is more excellent, and therefore, the basket forming and packing performance can be simultaneously considered, and finally, a dense plug in a tumor is formed, and the plug is not easily displaced, and has good support performance. It will also be appreciated that the above definition of dimensions is based on the dimensions in the first configuration.
Example two
Referring to fig. 5-6 and 7 a-7 c, fig. 5 and 6 are schematic structural views of a second
medical implant20 in a second embodiment of the present invention in a first configuration and a second configuration, respectively, and fig. 7 a-7 c are schematic structural views of a
first coil unit1, a
second coil unit2 and a
third coil unit3, respectively, in a second embodiment of the present invention.
Specifically, the present embodiment provides a second
medical implant20 for use in the occlusion treatment of a vascular tumor, including, but not limited to, intracranial aneurysm, and also peripheral vascular tumor. In addition, the second
medical implant20 of the present embodiment uses an integrated multi-level coil for embolization, which avoids the need for multiple selection of coils of different sizes and configurations during the operation of the physician, thereby reducing the number of intraoperative procedures, shortening the operation time, and reducing the number of coils used in a single operation, thereby reducing the economic burden on the patient.
The second
medical implant20 includes at least two spring coil units connected end to end, and optionally, the number of the spring coil units is 2 to 5. It should be understood that the number of spring coil units in this embodiment is also determined by the number of spring coil units actually required for a single operation.
The following description illustrates three coil units as an example of the improvement in basket formation and packing performance of the second
medical implant20, but those skilled in the art will recognize that the number of coil units in the present embodiment may be two or more than three.
Preferably, the second
medical implant20 comprises a
first coil unit1, a
second coil unit2 and a
third coil unit3 which are connected end to end, each coil unit is a spindle body formed by spirally winding a body, and the structure of the body is the same as that of the first embodiment and will not be described in detail. Different from the first embodiment, this embodiment designs every spring coil unit as the spindle, because the spindle has the characteristics that both ends are little, the centre is big for this kind of structure has good location support nature, becomes basket performance good, also is favorable to connecting the body of adjacent spring coil unit department and gently transiting to next spring coil unit by preceding spring coil unit.
The second
medical implant20 has a first configuration (i.e., a preformed shape) as shown in fig. 5 and a second configuration (i.e., a packed shape or a free state after removal from the sheath) as shown in fig. 6. The second form refers to the final shape imparted to the first form shown in fig. 5. In more detail, one end of the body of the
first coil unit1 is connected to one end of the body of the
second coil unit2, and the other end of the body of the
second coil unit2 is connected to one end of the body of the
third coil unit3, and the body here is generally a primary coil, that is, a primary coil is wound in the first form shown in fig. 5, similarly to the embodiment. When the second
medical implant20 is in the first configuration, the three coil spring units are arranged side by side and do not overlap with each other; when the second
medical implant20 is in the second form, the
second coil unit2 is disposed inside the
first coil unit1, and the
third coil unit3 is disposed inside the
second coil unit2. Further, as in the first embodiment, the material coverage per unit area of the
first coil unit1, the material coverage per unit area of the
second coil unit2, and the material coverage per unit area of the
third coil unit3 of the present embodiment are sequentially increased.
When implanted, the
first coil unit1 is the distal-most end of the second
medical implant20, i.e., enters the lesion first, and the
third coil unit3 is the proximal-most end of the second
medical implant20, i.e., enters the lesion last. In the case of an aneurysm, the
first coil unit1 first enters the aneurysm, the
second coil unit2, and the
third coil unit3, and finally fills the aneurysm in the second configuration shown in fig. 6. When the second
medical implant20 is only under the action of gravity (in a free state, i.e., not constrained by the sheath, nor occluding the lesion), the structure is presented in the form of the
first coil unit1 being at the outermost portion, the
second coil unit2 being inside the
first coil unit1, and the
third coil unit3 being inside the second coil unit 2 (i.e., the
third coil unit3 being at the innermost portion).
In addition, the size of the
first coil unit1 in this embodiment is also set according to the size of the lesion site to be embolized. In the case of an aneurysm, as shown in fig. 7a and 8a, the maximum outer diameter D1 (i.e., the maximum cross-sectional width) of the
first coil unit1 of the present embodiment is preferably 5mm to 30mm, more preferably 8mm to 24mm, and still more preferably 10mm to 16 mm.
Furthermore, the maximum cross-sectional area of each spring ring unit is preferably 2-3 times of the minimum cross-sectional area, so that the spring ring units are configured to form a spindle body structure with small two ends and large middle, the forming stability is good, the support performance is good, and the spring ring units are not easy to crush when being filled in a tumor. Specifically, the maximum outer diameter D1 of the first
spring ring unit1 is 2-3 times of the minimum outer diameter D1, the maximum outer diameter D2 of the second
spring ring unit2 is preferably 2-3 times of the minimum outer diameter D2, and the maximum outer diameter D3 of the third
spring ring unit3 is 2-3 times of the minimum outer diameter D3.
Further, when the second
medical implant20 is in the second configuration, the minimum cross-sectional area of the outer coil unit is preferably 1 to 1.5 times the maximum cross-sectional area of its inner adjacent coil unit, i.e., equivalently, when the second
medical implant20 is in the first configuration, the minimum cross-sectional area of the distal coil unit is preferably 1 to 1.5 times the maximum cross-sectional area of the proximal coil unit in any two adjacent coil units. For example, the minimum outer diameter D1 of the first
spring coil unit1 is 1 to 1.5 times the maximum outer diameter D2 of the second
spring coil unit2, and the minimum outer diameter D2 of the second
spring coil unit2 is 1 to 1.5 times the maximum outer diameter D3 of the third
spring coil unit3. The arrangement is convenient for the spring coil unit to smoothly fill and enter another spring coil unit.
Further, in order to make the material coverage rates per unit area of the three spring coil units different from each other, the present embodiment configures the spiral pitches of the three spring coil units to be different from each other, that is, the spiral pitch P1 of the first
spring coil unit1, the spiral pitch P2 of the second
spring coil unit2, and the spiral pitch P3 of the third
spring coil unit3 are sequentially decreased, it is also understood that the spiral pitch of the inner spring coil unit is smaller than the spiral pitch of the outer adjacent spring coil unit thereof, or in any two adjacent spring coil units, the spiral pitch of the proximal spring coil unit is smaller than the spiral pitch of the distal spring coil unit. Preferably, the spiral pitch of the external spring coil unit is 1.5-2 times of the spiral pitch of the internal adjacent spring coil unit. Specifically, the spiral pitch P1 of the first
spring ring unit1 is 1.5-2 times of the spiral pitch P2 of the second
spring ring unit2, and the spiral pitch P2 of the second
spring ring unit2 is 1.5-2 times of the spiral pitch P3 of the third
spring ring unit3. Thus, by adjusting the helical pitch, the second
medical implant20 of the present embodiment is formed with a structural feature from thin to dense material coverage from outside to inside. It should be understood that the spiral pitch of the spring coil unit does not refer to the spiral pitch of the primary coil, but refers to the pitch when the primary coil is re-spirally wound.
Furthermore, in order to make the material coverage rate per unit area of the first
spring ring unit1 low, the spiral pitch P1 of the first
spring ring unit1 is preferably 3-5 times of the outer diameter of the primary coil, so that the first
spring ring unit1 can achieve both the support property and the packing property; if the spiral pitch P1 is too large, the material coverage rate is small, the structure is softer, and the supporting performance is weak; if the helical pitch P1 is too small, the material coverage is high, but the structure is relatively stiff and detrimental to packing of subsequent spring coil units. Since the
primary coil unit1 mainly functions to form a support skeleton, the support effect is better, and therefore, in order to balance the support and the packing performance, the spiral pitch P1 of the
primary coil unit1 is designed to be 3-5 times of the outer diameter of the primary coil. Furthermore, the ratio of the height H1 of the first
spring ring unit1 to the maximum outer diameter D1 (i.e. the maximum width) is preferably 1-1.5, and the supporting effect in the tumor is good.
Further, in order to make the material coverage rate of the unit area of the second
spring coil unit2 higher, the spiral pitch P2 of the second
spring coil unit2 is preferably 2-2.5 times of the outer diameter of the primary coil, so that the spring coil unit with higher material coverage rate can be obtained, and the packing effect is ensured. In addition, the ratio of the height H2 of the second
spring ring unit2 to the maximum outer diameter D2 (namely, the maximum width) is preferably 1-1.5, and the supporting effect in the tumor is good.
Further, in order to make the material coverage rate per unit area of the third
spring coil unit3 higher, the spiral pitch P3 of the third
spring coil unit3 is preferably 1-1.2 times of the outer diameter of the primary coil, so that the spring coil unit with higher material coverage rate can be obtained, and the packing density is further improved. In addition, the ratio of the height H3 of the third
spring ring unit3 to the maximum outer diameter D3 (i.e. the maximum width) is 1-1.5, so as to further improve the support property in the tumor.
It will also be appreciated that the above definitions of the outer diameter, the helical pitch and the aspect ratio are based on the dimensions of the first form.
EXAMPLE III
Referring to fig. 9 to 10, and fig. 11a to 11c and 12, fig. 9 is a schematic view showing a third medical implant according to a third embodiment of the present invention in a first configuration, fig. 10 is a schematic view showing a third medical implant according to a third embodiment of the present invention in a second configuration, fig. 11a to 11c are schematic views showing respective coil units wound in the third medical implant according to a third embodiment of the present invention, and fig. 12 is a front view showing the third medical implant according to a third embodiment of the present invention.
In particular, the present embodiment provides a third
medical implant30 for use in the occlusive treatment of hemangiomas, including, but not limited to, intracranial aneurysms, and also peripheral hemangiomas. In addition, the third
medical implant30 of the present embodiment uses an integrated multi-level coil for embolization, which avoids the need for multiple selection of coils of different sizes and configurations during the operation of the physician, thereby reducing the number of intraoperative procedures, shortening the operation time, and reducing the number of coils used in a single operation, thereby reducing the economic burden on the patient.
The third
medical implant30 includes at least two end-to-end connected spring coil units, and optionally, the number of the spring coil units is 2 to 5. The number of spring coil units in this embodiment is also determined by the number of spring coil units actually required for a single operation.
The following description illustrates three coil units as an example of the ability of the third
medical implant30 to improve basket and packing performance, but those skilled in the art will appreciate that the number of coil units in the present embodiment may be two or more than three.
Preferably, the third
medical implant30 includes a
first coil unit1, a
second coil unit2 and a
third coil unit3 connected end to end, each coil unit is a polyhedron wound from a body, which is referred to as the first embodiment and will not be described in detail. In this embodiment, the polyhedron is at least a tetrahedron, and each spring coil unit is formed by connecting a plurality of basic units in sequence, and the basic units are respectively distributed in different planes. The polyhedron has better supporting force, and the stability of the spring coil unit can be ensured.
The third
medical implant30 has a first configuration shown in fig. 9 and a second configuration shown in fig. 10. The second form refers to the final shape imparted to the first form shown in fig. 9. In more detail, one end of the body in the
first coil unit1 is connected to one end of the body in the
second coil unit2, the other end of the body of the
second coil unit2 is connected to one end of the body of the
third coil unit3, and the body is generally a primary coil, i.e., a primary coil is wound in the first form shown in fig. 9. When the third
medical implant30 is in the first configuration, the three coil spring units are arranged side by side and do not overlap with each other; when the third
medical implant30 is in the second configuration, the
secondary coil unit2 is disposed inside the
primary coil unit1, and the
tertiary coil unit3 is disposed inside the
secondary coil unit2. Also, as in the first embodiment, the material coverage per unit area of the
first coil unit1, the material coverage per unit area of the
second coil unit2, and the material coverage per unit area of the
third coil unit3 of the present embodiment are sequentially increased.
When implanted, the
first coil unit1 is the distal-most end of the third
medical implant30, i.e., enters the lesion first, and the
third coil unit3 is the proximal-most end of the third
medical implant30, i.e., enters the lesion last. In the case of an aneurysm, the
first coil unit1 first enters the aneurysm, the
second coil unit2, and the
third coil unit3, and finally fills the aneurysm in the second configuration shown in fig. 10. When the third
medical implant30 is only under the action of gravity (in a free state, i.e., not constrained by the sheath, nor occluding the lesion), the structure is in the form of the
first coil unit1 being at the outermost portion, the
second coil unit2 being inside the
first coil unit1, and the
third coil unit3 being inside the second coil unit 2 (i.e., the
third coil3 being at the innermost portion).
In addition, the size of the
first coil unit1 in this embodiment is also set according to the size of the lesion site to be embolized. In the case of an aneurysm, as shown in fig. 12, the maximum outer diameter D1 (i.e., the maximum cross-sectional width) of the
first coil unit1 of the present embodiment is preferably 5mm to 30mm, more preferably the maximum outer diameter D1 of the
first coil unit1 is 8mm to 24mm, and still more preferably the maximum outer diameter D1 of the
first coil unit1 is 10mm to 16 mm. Preferably, the ratio of the length, the height and the width (the size of each plane) of each spring coil unit is 1, namely, the spring coil unit is similar to a cubic structure, and the positioning performance of the structure is good.
Preferably, the maximum cross-sectional area of the outer coil unit is 1.2 to 1.5 times the maximum cross-sectional area of its inner adjacent coil unit when the third
medical implant30 is in the second configuration, i.e., the maximum cross-sectional area of the distal coil unit is 1.2 to 1.5 times the maximum cross-sectional area of the proximal coil unit in any two adjacent coil units when the third
medical implant30 is in the first configuration. For example, the maximum outer diameter D1 of the first
spring coil unit1 is 1.2-1.5 times the maximum outer diameter D2 of the second
spring coil unit2, and the maximum outer diameter D2 of the second
spring coil unit2 is 1.2-1.5 times the maximum outer diameter D3 of the third
spring coil unit3; therefore, one spring ring unit can conveniently enter the other spring ring unit smoothly, compact packing is conveniently formed, materials can be saved, and cost is reduced.
In this embodiment, the winding method of the spring coil unit is preferably as shown in fig. 11a to 11 c.
As shown in fig. 11a, for the first
spring coil unit1, the
primary coil40 is prepared, then the
primary coil40 starts to wind from the starting point, first a first basic unit is wound on the
first plane11, then a second basic unit is continuously wound on the
second plane12, then a third basic unit is continuously wound on the
third plane13, and finally a fourth basic unit is wound on the
fourth plane14, thereby obtaining a tetrahedron. Wherein the
first plane11 is adjacent to the
second plane12, the
third plane13 is adjacent to the
second plane12 and parallel to the
first plane11, and the
fourth plane14 is parallel to the
second plane12. As shown in fig. 11b, the secondary
spring coil unit2 is a pentahedron formed by winding the
primary coil40 in five planes in sequence. As shown in fig. 11c, the
third coil unit3 is a hexahedron formed by winding the
primary coil40 on six faces in sequence.
The present invention does not specifically require the shape of the base unit in each spring coil unit, and it is preferable that the base unit in each spring coil unit is at least partially different in shape. Further, for any one spring coil unit, the base unit may be a combination of at least two of a C-shaped unit, an O-shaped unit, and an Ω -shaped unit, and preferably, each spring coil unit includes a C-shaped base unit and an Ω -shaped base unit, and the Ω -shaped base unit is an open loop having an opening curvature smaller than that of the C-shaped base unit. The O-ring unit in this application includes but is not limited to a circular, but also oval or irregular closed ring, and those skilled in the art will recognize that "closed ring" means no opening as viewed along the axial direction of the ring, and does not mean an end-to-end closed ring structure. The C-shaped unit in the present application includes, but is not limited to, circular arcs, and may be an elliptical arc, a circular arc with different curvatures, or an open loop such as a "concave" shape including a partial straight line and a partial arc. An omega-shaped element in this application refers to an open loop with an opening arc less than the opening arc of a C-shape, which again includes but is not limited to a circular arc. The stability of the omega-shaped unit is good, so that the stability of the spring coil unit can be maintained. At the same time, at least two C-shaped units are preferably arranged in two adjacent planes and are sequentially connected to form a three-dimensional S-shaped structure. The three-dimensional S-shaped structure has better turning capability and compressibility, so that the spring coil unit has better compliance. Constructed in this way, the spring coil unit can simultaneously meet the requirements of stable basket forming and flexible packing, thereby being beneficial to the spring coil unit to conform to aneurysms with different shapes and sizes and further obtaining better compact packing. The C-shaped elements may be more compressible than the omega-shaped elements. In the embodiment, the arc length of the omega-shaped unit is greater than or equal to 75% of the circumference and less than 100% of the circumference, so that the omega-shaped unit is difficult to compress and good in stability, and the stability of the whole spring ring unit can be maintained. Preferably, the arc length of the C-shaped unit is greater than or equal to 50% and less than 75% of the circumference, which is easily compressed and compliant. Therefore, the spring ring unit adopting the two basic units has good stability and better compliance.
Therefore, in the present embodiment, in order to make the material coverage per unit area of the three spring coil units different from each other, the number of the basic units of the three spring coil units is configured to be different from each other, that is, the number of the basic units of the first
spring coil unit1 is smaller than the number of the basic units of the second
spring coil unit2, and the number of the basic units of the second
spring coil unit2 is smaller than the number of the third
spring coil unit2, thereby forming a structure in which the material coverage is from thin to dense from outside to inside.
It is to be understood that the number of basic units of the first
spring coil unit1 is at least 4, preferably 4 to 8. While the number of the base units of the second
spring coil unit2 is not limited to 5 as long as it is larger than the number of the base units of the first
spring coil unit1, the number of the base units of the third
spring coil unit3 is not limited to 6 as long as it is larger than the number of the second
spring coil unit2, for example, the number of the base units of the second
spring coil unit2 may also be 6, 8 or more, and the number of the base units of the third
spring coil unit2 may also be 8 or more.
Example four
The present embodiment provides a method for manufacturing a medical implant for use in an occlusion treatment of a hemangioma, the method comprising:
providing a body; preferably, the body is a primary coil formed by spirally winding a metal, alloy or polymer wire;
the body is made to run according to the mold, so that at least two spring ring units connected end to end are formed in the mold in a winding mode, the material coverage rate of the unit area of the spring ring units is different in at least two winding processes, and the spring ring units with high material coverage rate of the unit area can be arranged in the spring ring units with low material coverage rate of the unit area.
Furthermore, in the winding process, the body is sequentially wound on the die to form a plurality of basic units, the basic units are sequentially connected to form at least two spring ring units, and the number of the basic units of the at least two spring ring units is different. Furthermore, at least two polyhedrons are formed by connecting a plurality of the basic units in sequence, and each polyhedron forms a spring coil unit, or at least two spheres are formed by connecting a plurality of the basic units in sequence, and each sphere forms a spring coil unit.
In other embodiments, during the winding process, the body is spirally wound on the die to form at least two spindles, each spindle forms a spring coil unit, and at least two spindles have different spiral pitches.
In a preferred embodiment, when the medical implant is prepared, the body is wound on the die to form at least three spring coil units which are connected end to end, and the material coverage rate of the unit area of the at least three spring coil units is increased in sequence; in any two adjacent spring coil units, the spring coil unit with high material coverage per unit area can be arranged inside the spring coil unit with low material coverage per unit area.
It should be understood that any of the medical implants provided in the first to third embodiments can be prepared and molded by a mold, and the wiring grooves and the legs of the primary coil can be prepared according to the size and specification requirements of the medical implant, and the primary coil is wound and then subjected to mold binding and subsequent heat treatment according to the wiring grooves, so as to prepare the medical implant with the first form. Further, the mold comprises a mandrel, the structure of which is designed according to the structure of the medical implant to be wound, for example, in order to prepare a plurality of spindles connected end to end, the mandrel may be designed to have a plurality of spindle-shaped solid portions on which the primary coil is wound, or the mandrel may be designed to have a plurality of spherical solid portions, or the mandrel may be designed to have a plurality of cubic solid portions. And after the primary coil is wound and formed, heating, curing and forming. The structure of the mold is not particularly limited in the present invention, and it is designed according to the structure of the medical implant to be prepared at the time of actual manufacturing.
In summary, the medical implant provided by the embodiment of the invention is an integrated multi-stage series structure, and has double effects of basket forming and filling, the farthest end is a basket forming ring with low material coverage rate per unit area, after embolism, the spring frame with a prefabricated structure is formed at first, and the outer diameter gradient of the unit structure of the subsequent secondary and tertiary spring rings is reduced, so that the spring frame can be inserted into the space inside the basket forming ring to play a role in filling the ring. The integrated embolism mass is formed after the three-stage structure is completely embolized, can be kept stable in the aneurysm, forms compact stuffing and has good stuffing effect.
In addition, it should be understood that the coil units in any one of the medical implants provided by the present invention may have different or same shapes, such as the coil units in the first embodiment or the second embodiment have the same shape, such as the coil units in the third embodiment have different polyhedral shapes (e.g., a combination of tetrahedrons, pentahedrons, and hexahedrons), and the medical implant may be formed by connecting coil units of different shapes in series, such as at least three coil units, which are different from each other when the medical implant is formed by the coil units, and the at least three coil units may be a combination of spheres, polyhedrons, and spindles, preferably, the outermost coil unit is a polyhedron, at least one coil unit in the middle is a sphere, and the innermost coil unit is a spindle. Here, when the medical implant is in the second configuration, "outermost" refers to the outermost one of the coil units, i.e., the distal-most one of the coil units in the first configuration; "intermediate" means a number of spring coil units located between the outermost and innermost layers; "innermost" means the innermost coil unit, i.e., the proximal-most coil unit in the second configuration.
The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention.
Claims (28)
1. A medical implant comprising at least two spring coil units connected end to end, at least two of said spring coil units having different material coverage per unit area;
the medical implant has a first configuration and a second configuration; when the medical implant is in the first shape, at least two spring coil units are arranged side by side and do not overlap with each other; when the medical implant is in the second configuration, the high material coverage per unit area coil unit is disposed within the low material coverage per unit area coil unit.
2. The medical implant of claim 1, comprising at least three coil units connected end to end in series, the at least three coil units having sequentially increasing material coverage per unit area; when the medical implant is in the second state, the coil unit with high material coverage per unit area is disposed inside the coil unit with low material coverage per unit area in any two adjacent coil units.
3. The medical implant of claim 2, wherein the number of coil units is three, being a first coil unit, a second coil unit, and a third coil unit; the first spring ring unit, the second spring ring unit and the third spring ring unit are sequentially connected end to end; the secondary coil unit is disposed within the primary coil unit and the tertiary coil unit is disposed within the secondary coil unit when the medical implant is in the second configuration.
4. The medical implant of claim 2 or 3, wherein at least three of the coil units are identical in shape and are each a sphere, polyhedron or spindle, or are different in shape and are a combination of a sphere, polyhedron and spindle.
5. The medical implant of claim 4, wherein when at least three of the coil units are shaped differently from each other and the medical implant is in the second configuration, the outermost one of the coil units is a polyhedron, the middle at least one of the coil units is a sphere, and the innermost one of the coil units is a spindle.
6. The medical implant of claim 1 or 2, wherein at least two of the spring coil units are shaped differently from each other or from each other.
7. The medical implant of claim 1 or 2, wherein each of the coil units is connected sequentially from a plurality of base units to a polyhedron, and the outermost coil unit is connected sequentially from at least four base units to a polyhedron when the medical implant is in the second configuration, or each of the coil units is connected sequentially from a plurality of base units to a sphere, and the outermost coil unit is connected sequentially from at least three base units to a sphere when the medical implant is in the second configuration; wherein:
when the medical implant is in the second configuration, the number of base units of the internal coil unit is greater than the number of base units of its external adjacent coil units.
8. The medical implant of claim 7, wherein the shape of the base unit in each coil unit is at least partially different when each coil unit is polyhedral.
9. The medical implant of claim 8, wherein each spring coil unit comprises a C-shaped base unit and an omega-shaped base unit, the omega-shaped base unit being an open loop having an opening arc less than the opening arc of the C-shaped base unit.
10. The medical implant of claim 7, comprising at least three coil units connected end to end, the number of basic units of the at least three coil units increasing sequentially;
when the medical implant is in the second configuration, the coil unit with the larger number of base units is disposed inside the coil unit with the smaller number of base units, among any two adjacent coil units.
11. The medical implant of claim 10, wherein when each of the coil units is a sphere, and the medical implant is in the second configuration, the number of base units of the outermost coil unit is 3 to 8;
when each of the coil units is polyhedral and the medical implant is in the second configuration, the number of the basic units of the outermost coil unit is 4 to 8.
12. The medical implant of claim 7, wherein when each of the coil units is polyhedral, the ratio of the length, height, and width of any one coil unit is 1.
13. The medical implant of claim 1 or 2, wherein the maximum cross-sectional area of an external coil unit is 1.2 to 1.5 times the maximum cross-sectional area of its internal adjacent coil unit when the medical implant is in the second configuration.
14. The medical implant of claim 1 or 2, wherein the outermost coil unit has a maximum cross-sectional width of 5-30 mm when the medical implant is in the second configuration.
15. The medical implant of claim 1 or 2, wherein the number of spring coil units is 2 to 5.
16. The medical implant of claim 1 or 2, wherein each of the spring coil units is spirally wound from a body, and each of the spring coil units is a spindle body with small ends and a large middle; wherein: when the medical implant is in the second configuration, the helical pitch of the internal coil unit is less than the helical pitch of its external adjacent coil units.
17. The medical implant of claim 16, wherein the helical pitch of an external coil unit is 1.5-2 times the helical pitch of its internal adjacent coil units when the medical implant is in the second configuration.
18. The medical implant of claim 16, wherein the ratio of the height to the maximum width of each spring coil unit is 1-1.5.
19. The medical implant of claim 16, wherein the maximum cross-sectional area of each spring coil unit is 2-3 times the minimum cross-sectional area.
20. The medical implant of claim 16, wherein the minimum cross-sectional area of an external coil unit is 1-1.5 times the maximum cross-sectional area of its internal adjacent coil units when the medical implant is in the second configuration.
21. The medical implant of any of claims 16-20, wherein the number of coil units is three, being a first coil unit, a second coil unit, and a third coil unit; the first spring ring unit, the second spring ring unit and the third spring ring unit are sequentially connected end to end; when the medical implant is in the second configuration, the secondary coil unit is disposed within the primary coil unit, and the tertiary coil unit is disposed within the secondary coil unit; wherein:
the spiral pitch of the first spring ring unit is 3-5 times of the outer diameter of the body; the spiral pitch of the second spring ring unit is 2-2.5 times of the outer diameter of the body; the spiral pitch of the third spring ring unit is 1-1.2 times of the outer diameter of the body.
22. The medical implant of claim 1 or 2, wherein each spring coil unit is wound from a primary coil that is helically wound from a metal, alloy or polymer wire.
23. A method of manufacturing a medical implant for preparing a medical implant according to any of claims 1-22, the method comprising:
providing a body;
the body is made to run according to a mold, so that at least two spring ring units connected end to end are formed in the mold in a winding mode, the material coverage rate of the unit area of the spring ring units is different in at least two spring ring units in the winding process, and the spring ring units with high material coverage rate of the unit area can be arranged in the spring ring units with low material coverage rate of the unit area.
24. The method of claim 23, wherein the body is wound sequentially into a plurality of base units on the mold during the winding process, and the plurality of base units are sequentially connected to form at least two spring coil units, wherein at least two spring coil units have different numbers of base units.
25. The method of manufacturing a medical implant according to claim 24, wherein at least two polyhedrons, each constituting one coil unit, are formed by connecting a plurality of the basic units in sequence, or at least two spheres, each constituting one coil unit, are formed by connecting a plurality of the basic units in sequence.
26. The method of claim 23, wherein the body is helically wound on the mold to form at least two spindles, each of the spindles forming a spring coil unit, and at least two of the spindles having different helical pitches during the winding process.
27. The method of manufacturing a medical implant according to any of claims 23-26, wherein the body is wound on the mold to form at least three end-to-end connected spring coil units, the at least three spring coil units having sequentially increasing material coverage per unit area; in any two adjacent spring coil units, the spring coil unit with high material coverage per unit area can be arranged inside the spring coil unit with low material coverage per unit area.
28. The method of any one of claims 23-26, wherein the body is a primary coil formed by helically winding a metal, alloy or polymer wire.
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