CN112674912A

CN112674912A - Long bone lengthening prosthesis

Info

Publication number: CN112674912A
Application number: CN202011627208.8A
Authority: CN
Inventors: 王彩梅
Original assignee: Beijing AK Medical Co Ltd
Current assignee: Beijing AK Medical Co Ltd
Priority date: 2020-12-30
Filing date: 2020-12-30
Publication date: 2021-04-20
Anticipated expiration: 2040-12-30
Also published as: CN112674912B

Abstract

The invention provides a long bone lengthening prosthesis. The long bone lengthening prosthesis comprises a first sleeve having a first receiving cavity; the second sleeve is positioned above the first sleeve and is at least partially arranged in the first sleeve, the second sleeve and the first sleeve are relatively movably arranged, the second sleeve is provided with a second accommodating cavity, and the first accommodating cavity is communicated with the second accommodating cavity; the elastic piece is arranged in the first accommodating cavity and/or the second accommodating cavity, the elastic piece is of a spiral structure, the spiral structure is provided with a hollow cavity, and the first sleeve is provided with an injection port communicated with the hollow cavity; the elastic piece is made of one-way memory alloy materials and can be arranged in an extensible mode, and when fluid with preset temperature is injected into the hollow cavity, the elastic piece can extend. The technical scheme of the application effectively solves the problems that the prosthesis can be prolonged to need a larger incision, the operation times are more and complications are easy to generate in the related technology.

Description

Long bone lengthening prosthesis

Technical Field

The invention relates to the technical field of medical instruments, in particular to a long bone lengthening prosthesis.

Background

The extendable prosthesis can better solve the problem that the limbs of the child are unequal after limb protection, but the currently widely adopted extendable prosthesis needs to be operated every time of extension, a cut with a certain length is cut to expose an extension screw, and the prosthesis is extended by using a mechanical driving device. And each extension has a limited length (the vascular nerve cannot tolerate traction, and multiple operations can increase the infection probability and tissue scarring.

Thus, the invasive extension prostheses currently employed by physicians greatly increase the number of surgeries and the chances of postoperative complications for pediatric patients. This frequent surgical procedure will last ten years or even longer, with a considerable pain and economic burden on the patient.

Disclosure of Invention

The invention mainly aims to provide a long bone lengthening prosthesis, which aims to solve the problems that a lengthening prosthesis needs a larger incision, the operation frequency is more and complications are easy to generate in the related art.

In order to achieve the above object, the present invention provides a long bone extension prosthesis comprising: a first sleeve having a first receiving cavity; the second sleeve is positioned above the first sleeve and is at least partially arranged in the first sleeve, the second sleeve and the first sleeve are relatively movably arranged, the second sleeve is provided with a second accommodating cavity, and the first accommodating cavity is communicated with the second accommodating cavity; the elastic piece is arranged in the first accommodating cavity and/or the second accommodating cavity, the elastic piece is of a spiral structure, the spiral structure is provided with a hollow cavity, and the first sleeve is provided with an injection port communicated with the hollow cavity; the elastic piece is made of one-way memory alloy materials and can be arranged in an extensible mode, and when fluid with preset temperature is injected into the hollow cavity, the elastic piece can extend.

Further, the first end of the elastic piece is provided with a first opening communicated with the injection port, and the second end of the elastic piece is provided with a second opening communicated with the first containing cavity and/or the second containing cavity.

Further, the elastic piece is made of nickel-titanium alloy; and/or the elastic piece is formed by 3D printing.

Further, the sprue is arranged on the side wall of the first sleeve, the long bone extension prosthesis further comprises an injection part, the injection part is arranged in the first accommodating cavity, and an injection channel of the injection part is communicated with the sprue and the hollow cavity of the elastic part.

Further, a silica gel plugging piece is arranged at the injection port.

Further, the long bone extension prosthesis further comprises a sealing ring, wherein the sealing ring is sleeved on the periphery of the second sleeve and sealed at the end part of the first sleeve.

Furthermore, the sealing ring is made of PEEK material; or the sealing ring is made of PEKK material; or the sealing ring is made of PE material.

Furthermore, the end, far away from the second sleeve, of the first sleeve is provided with a first inserting portion, and the end, far away from the first sleeve, of the second sleeve is provided with a second inserting portion.

Further, the fluid is medical paraffin.

Further, the elastic member is maintained in an initial state by cold pressing.

By applying the technical scheme of the invention, a first sleeve with a first accommodating cavity and a second sleeve with a second accommodating cavity are arranged, and the second sleeve is positioned above the first sleeve and is at least partially arranged in the first sleeve. So that the first accommodating cavity and the second accommodating cavity are communicated to form a closed cavity. Meanwhile, the second sleeve and the first sleeve are relatively movably arranged. The elastic part is of a spiral structure, and the spiral structure is arranged in a closed cavity formed by the first accommodating cavity and the second accommodating cavity. The elastic element is made of one-way memory alloy material, and the one-way memory alloy material can stretch after being heated by hot fluid. The spiral structure is provided with a hollow cavity, and the first sleeve is provided with an injection port communicated with the hollow cavity. When the long bone lengthening prosthesis needs to be lengthened, fluid with preset temperature can be injected into the hollow cavity of the spiral structure through the injection port, so that the elastic part is lengthened. In the extension process of the elastic part, the two ends of the elastic part push the first sleeve and the second sleeve, so that the first sleeve and the second sleeve are away from each other, the long bone extension prosthesis can be extended, and the effect of extending limbs is achieved. The arrangement of the structure can realize the extension of the long bone extension prosthesis only by injecting fluid with preset temperature into the hollow cavity of the spiral structure, the wound is small, the operation is simple, and the problems that the extension prosthesis needs a large incision, the operation frequency is high and complications are easy to generate in the related technology are effectively solved.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the invention and, together with the description, serve to explain the invention and not to limit the invention. In the drawings:

FIG. 1 shows a schematic perspective view of an embodiment of a long bone lengthening prosthesis according to the invention;

FIG. 2 shows a schematic cross-sectional view of the long bone extension prosthesis of FIG. 1;

FIG. 3 shows a schematic perspective view of the elastomeric member and injection portion of the long bone lengthening prosthesis of FIG. 1;

FIG. 4 shows a schematic cross-sectional view of the elastomeric member and injection section of FIG. 3;

FIG. 5 shows a schematic perspective view of a first sleeve and a sealing ring of the long bone lengthening prosthesis of FIG. 1; and

fig. 6 shows a schematic cross-sectional view of the first sleeve and the sealing ring of fig. 5.

Wherein the figures include the following reference numerals:

10. a first sleeve; 11. a first insertion part; 12. a first accommodating chamber; 13. an injection port; 14. a silica gel block; 20. a second sleeve; 21. a second insertion part; 22. a second accommodating chamber; 30. an elastic member; 31. a hollow cavity; 40. an injection part; 50. and (5) sealing rings.

Detailed Description

It should be noted that the embodiments and features of the embodiments in the present application may be combined with each other without conflict. The present invention will be described in detail below with reference to the embodiments with reference to the attached drawings.

The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all of the embodiments. The following description of at least one exemplary embodiment is merely illustrative in nature and is in no way intended to limit the invention, its application, or uses. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It is noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of example embodiments according to the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, and it should be understood that when the terms "comprises" and/or "comprising" are used in this specification, they specify the presence of stated features, steps, operations, devices, components, and/or combinations thereof, unless the context clearly indicates otherwise.

The relative arrangement of the components and steps, the numerical expressions and numerical values set forth in these embodiments do not limit the scope of the present invention unless specifically stated otherwise. Meanwhile, it should be understood that the sizes of the respective portions shown in the drawings are not drawn in an actual proportional relationship for the convenience of description. Techniques, methods, and apparatus known to those of ordinary skill in the relevant art may not be discussed in detail but are intended to be part of the specification where appropriate. In all examples shown and discussed herein, any particular value should be construed as merely illustrative, and not limiting. Thus, other examples of the exemplary embodiments may have different values. It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, further discussion thereof is not required in subsequent figures.

As shown in fig. 1 and 2, the long bone extension prosthesis of the present embodiment includes: a first sleeve 10, a second sleeve 20 and a resilient member 30. A first sleeve 10, the first sleeve 10 having a first receiving cavity 12. And the second sleeve 20 is positioned above the first sleeve 10, the second sleeve 20 is at least partially arranged in the first sleeve 10, the second sleeve 20 and the first sleeve 10 are relatively movably arranged, the second sleeve 20 is provided with a second accommodating cavity 22, and the first accommodating cavity 12 is communicated with the second accommodating cavity 22. The elastic member 30 is disposed in the first accommodating cavity 12 and the second accommodating cavity 22, the elastic member 30 is a spiral structure, the spiral structure has a hollow cavity 31, and the first sleeve 10 is provided with an injection port 13 communicated with the hollow cavity 31. The elastic member 30 is made of one-way memory alloy material, the elastic member 30 is arranged to be extendable, and when fluid with preset temperature is injected into the hollow cavity 31, the elastic member 30 can extend.

By applying the technical solution of the embodiment, a first sleeve 10 having a first accommodating cavity 12 and a second sleeve 20 having a second accommodating cavity 22 are provided, the second sleeve 20 is located above the first sleeve 10 and at least partially disposed in the first sleeve 10, so that the first accommodating cavity 12 and the second accommodating cavity 22 are communicated to form a closed cavity. Meanwhile, the second sleeve 20 and the first sleeve 10 are relatively movably disposed. The elastic member 30 has a spiral structure, and the spiral structure is disposed in the closed cavity formed by the first accommodating chamber 12 and the second accommodating chamber 22. The elastic member 30 is made of a one-way memory alloy material that is elongated when heated by a hot fluid. The spiral structure has a hollow cavity 31, and the first sleeve 10 is provided with an injection port 13 communicated with the hollow cavity 31. When the long bone extension prosthesis needs to be extended, a fluid of a predetermined temperature may be injected into the hollow cavity 31 of the helical structure through the injection port 13, so that the elastic member 30 is extended. In the extending process of the elastic member 30, the two ends of the elastic member 30 push the first sleeve 10 and the second sleeve 20, so that the first sleeve 10 and the second sleeve 20 are away from each other, and the long bone extension prosthesis can be extended, thereby realizing the effect of limb extension. Due to the arrangement of the structure, the long bone extension prosthesis can be extended only by injecting fluid with preset temperature into the hollow cavity 31 of the spiral structure, the wound is small, the operation is simple, and the problems that the extension prosthesis needs a large incision, the operation frequency is high and complications are easy to generate in the related art are effectively solved.

The long bones are mainly present in four limbs, the upper limbs include humerus, ulna, etc., and the lower limbs include femur, tibia, fibula, etc.

In the present embodiment, the elastic member 30 is made of a one-way memory alloy material, which belongs to a temperature-driven memory alloy, and may be a nickel-Titanium (TINI) memory alloy. The one-way memory alloy material elongates upon heating by the hot fluid. Specifically, the memory alloy may be compressed to a certain length below the phase transition temperature thereof, largely deformed and maintained in a deformed state, and when heated by a high-temperature fluid (e.g., water, air, etc.) as a heat source, the memory alloy may be restored to an original shape. The degree of shape recovery is related to the amount of heat applied, and the resilient member 30 can be extended in several increments if heat is applied in increments during use.

The one-way memory alloy has a shape memory effect, the alloy deforms at a lower temperature, and can restore the shape before deformation after heating, namely, the alloy deforms only in the heating process. When the fluid of the predetermined temperature is injected, the elastic member 30 is extended, and the elastic member 30 can be maintained in the extended state due to the one-way memory effect after the injection is completed, and is not deformed by the cooling of the fluid.

The elongation process of the elastic member 30 is as follows:

in this embodiment, the elastic member 30 is compressed to an initial state of a length size required by the patient under a low temperature condition of about 0 degree, and during the growth of the patient, hot paraffin of 50 degrees ± 5 degrees is injected into the hollow cavity 31 of the elastic member 30, so that the elastic member 30 is extended compared to the initial state. When the hot paraffin is injected, the heat Q meeting the requirement that the elastic part 30 extends to the longest state can be injected at one time, so that the elastic part 30 extends to the longest state, the whole heat Q is divided into a plurality of groups, and the heat Q is injected in a plurality of times, so that the elastic part 30 extends for a plurality of times, and finally the longest state is reached. Since the temperature of the thermal paraffin is higher than the body temperature of the human body, the body temperature does not affect the elongation of the elastic member 30.

The elongation of the elastic member 30 to inject the fluid to be switched from the initial state to the longest state is smaller than the overlapping amount of the first sleeve 10 and the second sleeve 20 in the initial state, so that the long bone extension prosthesis can be elongated and the second sleeve 20 is not released from the first sleeve 10. The provision of the elastic member 30 allows the surgeon to control the amount of fluid injected and thus the elongation of the long bone lengthening prosthesis according to the actual needs of the patient.

The elastic member 30 is a spiral structure, i.e., a spring. As shown in fig. 2 to 4, a first end of the elastic member 30 has a first opening communicating with the injection port 13, and a second end of the elastic member 30 has a second opening communicating with the first receiving chamber 12 and the second receiving chamber 22. The first opening of the elastic member 30 is communicated with the injection port 13, when the long bone extension prosthesis needs to be extended, fluid with preset temperature can be injected into the hollow cavity 31 of the elastic member 30 through the injection port 13, and the fluid heats the elastic member 30 when flowing through the hollow cavity 31, so that the elastic member 30 can be switched to the extension state from the initial state. The second opening of the elastic member 30 is communicated with the first accommodating chamber 12 and the second accommodating chamber 22, and when the injected fluid is filled in the hollow cavity 31 of the elastic member 30, the fluid can directly flow into the second opening and be stored in the cavity formed by the first accommodating chamber 12 and the second accommodating chamber 22, and the fluid does not need to be pumped out.

Meanwhile, when the elastic element 30 extends to push the first sleeve 10 and the second sleeve 20 away from each other to extend the long bone extension prosthesis, the volume of the cavity formed by the first accommodating cavity 12 and the second accommodating cavity 22 is increased, so that the pressure inside the cavity is reduced, the low air pressure inside the whole device during extension can be compensated by the injection of the fluid, and the resistance of the long bone extension prosthesis during extension is reduced.

As shown in fig. 1 to 4, the injection port 13 is disposed on a sidewall of the first sleeve 10, the long bone lengthening prosthesis further includes an injection part 40, the injection part 40 is disposed in the first accommodating chamber 12, and an injection passage of the injection part 40 communicates the injection port 13 and the hollow cavity 31 of the elastic member 30. The injection part 40 is disposed in the first cavity between the elastic member 30 and the end surface of the first cavity. The injection part 40 communicates the injection port 13 disposed on the sidewall of the first sleeve 10 and the hollow cavity 31 of the elastic member 30, so that fluid can flow into the hollow cavity 31 of the elastic member 30 through the injection port 13 and the injection passage of the injection part 40, and further the elastic member 30 is switched from the initial state to the extended state.

As shown in fig. 5 and 6, a silicone packing 14 is provided at the injection port 13. When the elongation of the long bone extension prosthesis is required, fluid can be injected into the hollow cavity 31 of the elastic member 30 from the injection port 13. After the injection is completed, the injection hole is automatically sealed under the action of the elasticity of the silica gel plugging piece 14 (similar to a sealing rubber plug of an infusion bottle), so that the sealing of the inner cavity of the long bone extension prosthesis is realized, and the fluid can not flow out from the injection hole.

As shown in fig. 5 and 6, the long bone extension prosthesis further comprises a sealing ring 50, wherein the sealing ring 50 is sleeved on the periphery of the second sleeve 20 and sealed at the end of the first sleeve 10. The open end of first sleeve 10 is provided with the stair structure, and sealing washer 50 sets up in stair structure department and overlaps and establish in the periphery of second sleeve 20, realizes the sealed of first sleeve 10 and second sleeve 20 for the fluid of pouring into elastic component 30 finally can be sealed inside long bone extension prosthesis, can not flow into the musculature of fixed long bone extension prosthesis, has guaranteed the security of long bone extension prosthesis.

In the present embodiment, the sealing ring 50 is made of PEEK material; alternatively, the seal ring 50 is made of PEKK material; alternatively, the sealing ring 50 is made of PE material. The parts made of the materials have the advantages of high precision, small thermal expansion coefficient and good dimensional stability. In the using process, the sealing ring 50 is not deformed or denatured due to the injection of the high-temperature liquid, has a stable structure, and has a good sealing effect.

As shown in fig. 1 and fig. 2, an end of the first sleeve 10 away from the second sleeve 20 is provided with a first insertion portion 11, and an end of the second sleeve 20 away from the first sleeve 10 is provided with a second insertion portion 21. In use, the long bone lengthening prosthesis is implanted into muscles of two diaphysis, the first insertion part 11 is inserted into the medullary cavity of the upper diaphysis, and the second insertion part 21 is inserted into the medullary cavity of the lower diaphysis and fixed with the diaphysis in a biological or bone cement manner, so as to play a role in connecting the disconnected diaphysis.

In the present embodiment, the elastic member 30 is formed by 3D printing, and the elastic member 30 is hollow, and the height is the height of the elastic member 30 in the longest state. The 3D printing and forming technology has the advantages of material saving, high precision and the like.

The elastic member 30 is compressed and maintained in an initial state by means of cold pressing. The method specifically comprises the following steps: the height of the elastic member 30 molded by 3D printing is compressed from the height of the longest state to the height of the initial state (height before non-extension) and is always maintained in the initial state before the fluid is injected.

In this embodiment, the fluid is medical grade paraffin. The medical paraffin is directly injected into the elastic part 30, the temperature is controllable, and the operation is convenient. The medical paraffin has the advantages of low heavy metal content and high heating efficiency. When it is desired to lengthen the long bone lengthening prosthesis, medical wax is injected from the bottom of the elastic member 30, and the elastic member 30 is heated to elongate the elastic member 30. After the injected fluid fills the hollow cavity 31 of the elastic member 30, the fluid may flow out from the top of the elastic member 30 into the first receiving chamber 12 and the second receiving chamber 22. The medical paraffin is harmless to human and simple and convenient to operate. In the embodiment, the medical paraffin can be injected percutaneously, an external magnetic field is not needed, and the use is simple and convenient.

Spatially relative terms, such as "above … …," "above … …," "above … …," "above," and the like, may be used herein for ease of description to describe one device or feature's spatial relationship to another device or feature as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is turned over, devices described as "above" or "on" other devices or configurations would then be oriented "below" or "under" the other devices or configurations. Thus, the exemplary term "above … …" can include both an orientation of "above … …" and "below … …". The device may be otherwise variously oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

It should be noted that the terms "first", "second", and the like are used to define the components, and are only used for convenience of distinguishing the corresponding components, and the terms have no special meanings unless otherwise stated, and therefore, the scope of the present invention should not be construed as being limited.

The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention, and various modifications and changes may be made by those skilled in the art. Any modification, equivalent replacement, or improvement made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims

1. A long bone lengthening prosthesis, comprising:

a first sleeve (10), said first sleeve (10) having a first housing cavity (12);

a second sleeve (20), wherein the second sleeve (20) is positioned above the first sleeve (10) and is at least partially arranged in the first sleeve (10), the second sleeve (20) and the first sleeve (10) are relatively movably arranged, the second sleeve (20) is provided with a second accommodating cavity (22), and the first accommodating cavity (12) and the second accommodating cavity (22) are communicated;

the elastic piece (30) is arranged in the first accommodating cavity (12) and/or the second accommodating cavity (22), the elastic piece (30) is of a spiral structure, the spiral structure is provided with a hollow cavity (31), and the first sleeve (10) is provided with an injection port (13) communicated with the hollow cavity (31);

the elastic piece (30) is made of a one-way memory alloy material, the elastic piece (30) can be arranged in an extensible mode, and when fluid with preset temperature is injected into the hollow cavity (31), the elastic piece (30) can extend.

2. The long bone lengthening prosthesis according to claim 1, characterized in that a first end of the elastic element (30) has a first opening communicating with the injection port (13) and a second end of the elastic element (30) has a second opening communicating with the first receiving chamber (12) and/or the second receiving chamber (22).

3. The long bone lengthening prosthesis according to claim 1, characterized in that said elastic element (30) is made of nitinol; and/or the elastic piece (30) is formed by 3D printing.

4. The long bone lengthening prosthesis according to any of claims 1 to 3, characterized in that the injection port (13) is provided on a side wall of the first sleeve (10), the long bone lengthening prosthesis further comprising an injection part (40), the injection part (40) being provided in the first accommodation cavity (12), an injection passage of the injection part (40) communicating the injection port (13) and the hollow cavity (31) of the elastic member (30).

5. The long bone lengthening prosthesis according to claim 4, characterized in that a silicone closure (14) is provided at the injection opening (13).

6. The long bone extension prosthesis according to any of claims 1 to 3, further comprising a sealing ring (50), said sealing ring (50) being fitted around the outer circumference of the second sleeve (20) and sealing at the end of the first sleeve (10).

7. The long bone lengthening prosthesis according to claim 6, characterized in that said sealing ring (50) is made of PEEK material; or the sealing ring (50) is made of PEKK material; or the sealing ring (50) is made of PE material.

8. The long bone lengthening prosthesis according to any one of claims 1 to 3, characterized in that an end of the first sleeve (10) remote from the second sleeve (20) is provided with a first plug-in part (11), and an end of the second sleeve (20) remote from the first sleeve (10) is provided with a second plug-in part (21).

9. A long bone lengthening prosthesis according to any one of claims 1 to 3, wherein said fluid is medical paraffin.

10. The long bone extension prosthesis according to any of claims 1 to 3, characterized in that the elastic element (30) is kept in an initial state by means of cold pressing.