CN215273072U - Medical implant - Google Patents

Abstract

The utility model relates to a medical implant, which comprises at least two spring ring units connected end to end, wherein 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

Medical implant

Technical Field

The utility model relates to the technical field of medical equipment, in particular to medical implant.

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.

SUMMERY OF THE UTILITY MODEL

In order to solve the above technical problem, the present invention provides a medical implant, which has 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 blood vessels, 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, the medical implant is mainly used for hemangioma embolism, including but not limited to intracranial blood vessels, and also 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 structural view of a first medical implant according to an embodiment of the present invention in a first configuration;

FIG. 2 is a schematic structural view of a first medical implant in a second configuration according to an embodiment of the present invention;

FIGS. 3a to 3c are schematic views of 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 a first medical implant according to an embodiment of the present invention in an open position;

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 according to a second embodiment of the present invention in a second configuration;

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. 8 a-8 c are front views of three coil units in a second medical implant according to a second embodiment of the present invention in open position, respectively;

FIG. 9 is a schematic view of a third medical implant according to a third embodiment of the present invention in a first configuration;

FIG. 10 is a schematic view of a third medical implant according to a third embodiment of the present invention in a second configuration;

FIGS. 11a to 11c are schematic views of the winding of three coil units in a third medical implant according to an embodiment of the present invention;

figure 12 is a front view of a third medical implant according to a third embodiment of the present invention.

Detailed Description

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of 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 implant 10 in a first embodiment of the present invention in a first configuration and a second configuration, respectively, and fig. 3 a-3 c are schematic structural views of a first coil unit 1, a second coil unit 2 and a third coil unit 3 in a first embodiment of the present invention, respectively.

In particular, the present embodiment provides a first medical implant 10 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 implant 10 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 implant 10 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 the coil units is determined according to the number of the coil units actually needed in one operation, so that the utility model has no special requirement on the number of the coil units.

The following description illustrates three coil units as an example of the first medical implant 10 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 implant 10 comprises a first spring coil unit 1, a second spring coil unit 2 and a third spring coil unit 3 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 implant 10 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 unit 1 is connected to one end of the body in the second coil unit 2, the other end of the body in the second coil unit 2 is connected to one end of the body in the third coil unit 3, 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 implant 10 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 implant 10 is in the second configuration, the second coil unit 2 is disposed inside the first coil unit 1, and the third coil unit 3 is disposed inside the second coil unit 2. In particular, the material coverage per unit area of the first coil unit 1, the material coverage per unit area of the second coil unit 2, and the material coverage per unit area of the third coil unit 3 increase in this order.

When implanted, the first coil unit 1 is the distal-most end of the first medical implant 10, i.e., enters the lesion first, and the third coil unit 3 is the proximal-most end of the first medical implant 10, i.e., enters the lesion last. In the case of an aneurysm, the first coil unit 1 first enters the aneurysm, the second coil unit 2, and the third coil unit 3, and finally fills the aneurysm in the second configuration shown in fig. 2. When the first medical implant 10 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 unit 1 being at the outermost portion, the second coil unit 2 being inside the first coil unit 1 (i.e., the second coil unit 2 is located between the first coil unit 1 and the third coil unit 3, and defined as an intermediate position), and the third coil unit 3 being inside the second coil unit 2 (i.e., the third coil unit 3 being at the innermost portion).

In addition, the present invention does not particularly limit the size of the first coil unit 1, and the size of the lesion site of the embolism may be generally set as required. 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 unit 1 is preferably 5mm to 30mm, more preferably the maximum outer diameter D1 of the first coil unit 1 is 8mm to 24mm, and still more preferably the maximum outer diameter D1 of the first coil unit 1 is 10mm to 16 mm.

Further, when the first medical implant 10 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 implant 10 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 unit 1 is preferably 1.2 to 1.5 times the maximum outer diameter D2 of the second spring coil unit 2; as shown in FIGS. 4b to 4c, the maximum outer diameter D2 of the second spring coil unit 2 is preferably 1.2 to 1.5 times the maximum outer diameter D3 of the third spring coil unit 3. 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 unit 1 is formed by connecting a plurality of first basic units 11 distributed circumferentially in sequence. The first coil unit 1 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 units 11 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 unit 2 is formed by connecting a plurality of second basic units 21 distributed circumferentially one after another. Since the second spring coil unit 2 serves as the intermediate spring coil unit, the number of the second base units 21 is not particularly limited as long as it is larger than the number of the first base units 11.

As shown in fig. 3c, the third spring ring unit 3 is formed by connecting a plurality of third basic units 31 distributed circumferentially in sequence. Since the third coil unit 3 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 units 31 is not particularly limited as long as it is larger than the number of the second base units 21.

In an embodiment, the first medical implant 10 is configured to: the number of the first basic units 11 is 4, the number of the second basic units 21 is 6, and the number of the third basic units 31 is 8. In another embodiment, the first medical implant 10 is configured to: the number of the first basic units 11 is 3, the number of the second basic units 21 is 5, and the number of the third basic units 31 is 7.

It should be understood that the combination of the above-described basic elements is only a preferred example and not intended as a limitation on 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 unit 11, the second basic unit 21, and the third basic unit 31 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 fig. 7 a-7 c, fig. 5 and 6 are schematic structural views of a second medical implant 20 in a first configuration and a second configuration, respectively, according to a second embodiment of the present invention, and fig. 7 a-7 c are schematic structural views of a first coil unit 1, a second coil unit 2 and a third coil unit 3, respectively, according to a second embodiment of the present invention.

Specifically, the present embodiment provides a second medical implant 20 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 implant 20 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 implant 20 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 implant 20, 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 implant 20 comprises a first coil unit 1, a second coil unit 2 and a third coil unit 3 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 implant 20 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 unit 1 is connected to one end of the body of the second coil unit 2, and the other end of the body of the second coil unit 2 is connected to one end of the body of the third coil unit 3, 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 implant 20 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 implant 20 is in the second form, the second coil unit 2 is disposed inside the first coil unit 1, and the third coil unit 3 is disposed inside the second coil unit 2. Further, as in the first embodiment, the material coverage per unit area of the first coil unit 1, the material coverage per unit area of the second coil unit 2, and the material coverage per unit area of the third coil unit 3 of the present embodiment are sequentially increased.

When implanted, the first coil unit 1 is the distal-most end of the second medical implant 20, i.e., enters the lesion first, and the third coil unit 3 is the proximal-most end of the second medical implant 20, i.e., enters the lesion last. In the case of an aneurysm, the first coil unit 1 first enters the aneurysm, the second coil unit 2, and the third coil unit 3, and finally fills the aneurysm in the second configuration shown in fig. 6. When the second medical implant 20 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 unit 1 being at the outermost portion, the second coil unit 2 being inside the first coil unit 1, and the third coil unit 3 being inside the second coil unit 2 (i.e., the third coil unit 3 being at the innermost portion).

In addition, the size of the first coil unit 1 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 unit 1 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 unit 1 is 2-3 times of the minimum outer diameter D1, the maximum outer diameter D2 of the second spring ring unit 2 is preferably 2-3 times of the minimum outer diameter D2, and the maximum outer diameter D3 of the third spring ring unit 3 is 2-3 times of the minimum outer diameter D3.

Further, when the second medical implant 20 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 implant 20 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 unit 1 is 1 to 1.5 times the maximum outer diameter D2 of the second spring coil unit 2, and the minimum outer diameter D2 of the second spring coil unit 2 is 1 to 1.5 times the maximum outer diameter D3 of the third spring coil unit 3. 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 unit 1, the spiral pitch P2 of the second spring coil unit 2, and the spiral pitch P3 of the third spring coil unit 3 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 unit 1 is 1.5-2 times of the spiral pitch P2 of the second spring ring unit 2, and the spiral pitch P2 of the second spring ring unit 2 is 1.5-2 times of the spiral pitch P3 of the third spring ring unit 3. Thus, by adjusting the helical pitch, the second medical implant 20 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 unit 1 low, the spiral pitch P1 of the first spring ring unit 1 is preferably 3-5 times of the outer diameter of the primary coil, so that the first spring ring unit 1 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 unit 1 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 unit 1 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 unit 1 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 unit 2 higher, the spiral pitch P2 of the second spring coil unit 2 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 unit 2 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 unit 3 higher, the spiral pitch P3 of the third spring coil unit 3 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 unit 3 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 structural view of a third medical implant in a first form according to an embodiment of the present invention, fig. 10 is a schematic structural view of a third medical implant in a second form according to an embodiment of the present invention, fig. 11a to 11c are schematic winding diagrams of each spring coil unit in the third medical implant according to an embodiment of the present invention, and fig. 12 is a front view of the third medical implant according to an embodiment of the present invention.

In particular, the present embodiment provides a third medical implant 30 for use in the occlusive treatment of hemangiomas, including, but not limited to, intracranial aneurysms, and also peripheral hemangiomas. In addition, the third medical implant 30 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 implant 30 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 implant 30 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 implant 30 includes a first coil unit 1, a second coil unit 2 and a third coil unit 3 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 implant 30 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 unit 1 is connected to one end of the body in the second coil unit 2, the other end of the body of the second coil unit 2 is connected to one end of the body of the third coil unit 3, 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 implant 30 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 implant 30 is in the second configuration, the secondary coil unit 2 is disposed inside the primary coil unit 1, and the tertiary coil unit 3 is disposed inside the secondary coil unit 2. Also, as in the first embodiment, the material coverage per unit area of the first coil unit 1, the material coverage per unit area of the second coil unit 2, and the material coverage per unit area of the third coil unit 3 of the present embodiment are sequentially increased.

When implanted, the first coil unit 1 is the distal-most end of the third medical implant 30, i.e., enters the lesion first, and the third coil unit 3 is the proximal-most end of the third medical implant 30, i.e., enters the lesion last. In the case of an aneurysm, the first coil unit 1 first enters the aneurysm, the second coil unit 2, and the third coil unit 3, and finally fills the aneurysm in the second configuration shown in fig. 10. When the third medical implant 30 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 unit 1 being at the outermost portion, the second coil unit 2 being inside the first coil unit 1, and the third coil unit 3 being inside the second coil unit 2 (i.e., the third coil 3 being at the innermost portion).

In addition, the size of the first coil unit 1 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 unit 1 of the present embodiment is preferably 5mm to 30mm, more preferably the maximum outer diameter D1 of the first coil unit 1 is 8mm to 24mm, and still more preferably the maximum outer diameter D1 of the first coil unit 1 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 implant 30 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 implant 30 is in the first configuration. For example, the maximum outer diameter D1 of the first spring coil unit 1 is 1.2-1.5 times the maximum outer diameter D2 of the second spring coil unit 2, and the maximum outer diameter D2 of the second spring coil unit 2 is 1.2-1.5 times the maximum outer diameter D3 of the third spring coil unit 3; 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 unit 1, the primary coil 40 is prepared, then the primary coil 40 starts to wind from the starting point, first a first basic unit is wound on the first plane 11, then a second basic unit is continuously wound on the second plane 12, then a third basic unit is continuously wound on the third plane 13, and finally a fourth basic unit is wound on the fourth plane 14, thereby obtaining a tetrahedron. Wherein the first plane 11 is adjacent to the second plane 12, the third plane 13 is adjacent to the second plane 12 and parallel to the first plane 11, and the fourth plane 14 is parallel to the second plane 12. As shown in fig. 11b, the secondary spring coil unit 2 is a pentahedron formed by winding the primary coil 40 in five planes in sequence. As shown in fig. 11c, the third coil unit 3 is a hexahedron formed by winding the primary coil 40 on six faces in sequence.

The utility model discloses do not have special requirements to the shape of the basic unit in every spring coil unit, preferably the shape of the basic unit in every spring coil unit is at least partly inequality. 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 unit 1 is smaller than the number of the basic units of the second spring coil unit 2, and the number of the basic units of the second spring coil unit 2 is smaller than the number of the third spring coil unit 2, 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 unit 1 is at least 4, preferably 4 to 8. While the number of the base units of the second spring coil unit 2 is not limited to 5 as long as it is larger than the number of the base units of the first spring coil unit 1, the number of the base units of the third spring coil unit 3 is not limited to 6 as long as it is larger than the number of the second spring coil unit 2, for example, the number of the base units of the second spring coil unit 2 may also be 6, 8 or more, and the number of the base units of the third spring coil unit 2 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 utility model discloses do not do specific restriction to the structure of mould, when actually making according to treat the medical implant's of preparation structure design can.

To sum up, the embodiment of the utility model provides a multistage series connection structure of medical implant formula as an organic whole possesses the dual effect of one-tenth basket and packing, and the farthest end is the lower one-tenth basket circle of unit area material coverage, at first forms the spring frame of prefabricated type structure behind the embolism, and follow-up second grade and tertiary spring coil unit structure external diameter gradient diminish, can embolia into the inside space of one-tenth basket circle, play the effect of packing the circle. 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.

Furthermore, it should be understood that the present invention provides any one of the medical implants wherein the coil units have different shapes or are the same as each other, for example, the coil units in the first embodiment or the second embodiment have the same shape, for example, the coil units in the third embodiment have different polyhedral shapes (such as a combination of tetrahedron, pentahedron and hexahedron), and the medical implant can also be formed by connecting coil units of different shapes in series, for example, when at least three coil units form the medical implant, the coil units are different from each other, at least three coil units can be a combination of sphere, polyhedron and spindle, preferably, the outermost coil unit is polyhedron, at least one coil unit in the middle is sphere, and the innermost coil unit is 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 preferred embodiment of the present invention, and not for any limitation of the scope of the present invention, and any modification and modification made by those skilled in the art according to the above disclosure all belong to the protection scope of the present invention.

Claims (22)

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, wherein each of the spring coil units is spirally wound from a body, and each of the spring coil units is a spindle 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.

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