Filling block for orthopedic implant

By designing a filler block for orthopedic implants, the problem of the gap between the proximal end of the stem prosthesis and the femur in traditional hip replacement surgery was solved, achieving greater stability and osseointegration, and reducing the risk of subsidence and fracture.

CN121335680APending Publication Date: 2026-01-13MERIL HEALTHCARE PVT LTD
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Patent Information

Application Number
CN202480038084.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-06-07
Filing Date
2024-06-07
Publication Date
2026-01-13

AI Technical Summary

Technical Problem

In traditional hip replacement surgery, an undesirable gap exists between the proximal end of the stem prosthesis and the femur, leading to the risk of implant failure and/or fracture, and existing solutions such as the use of adhesives are not ideal.

Method used

Design a filler block for orthopedic implants, comprising elongated and transverse members, manufactured by 3D printing or machining. The filler block is placed tightly between the implant and the inner surface of the bone to reduce gaps, enhance support and osseointegration, and is secured using a fastening mechanism.

Benefits of technology

It effectively reduces the gap between the implant and the bone, lowers the incidence of subsidence, improves the stability and osseointegration of the implant, and reduces the risk of implant failure and fracture.

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Abstract

The invention relates to a filling block (100) for an implant (10). The fill block includes an elongate member (110) and a cross member (130). The elongate member is placed in a gap between a bone and the implant. The elongate member includes a curvature corresponding to a curvature of the implant. The transverse member is connected to the elongated member for placement on top of the implant. The cross member is disposed at a predetermined angle to the elongate member.
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Description

Technical Field

[0001] This invention relates to a filler block for orthopedic implants. More specifically, this invention discloses a filler block for orthopedic implants used to increase the contact area with autologous bone. Background Technology

[0002] Patients with deteriorating hip joints undergo hip replacement surgery. In hip replacement surgery, the hip joint is completely or partially replaced with an artificial implant.

[0003] The hip joint includes the femur (thigh bone), which connects to the pelvis via a ball-and-socket joint. In hip replacement surgery, a stemmed prosthesis (or implant) is placed in the femur to strengthen the hip joint.

[0004] Traditional stem prostheses consist of an axially extending stem and a neck angled relative to the stem. The stem prosthesis is inserted into the cavity of the femur. The neck indirectly connects the stem to the pelvis.

[0005] Traditionally, available stem prostheses are either monolithic or modular. As the name suggests, a monolithic stem prosthesis is a one-piece structure with a neck and stem. Monolithic stem prostheses are easy to insert and have no risk of breakage. However, monolithic stem prostheses have drawbacks such as a higher rate of subsidence and the inability to restore soft tissue tension.

[0006] In contrast, modular stem prostheses have a neck that is detachably attached to the stem. Modular stem prostheses are relatively more resistant to subsidence and offer better soft tissue balance. However, they are more cumbersome to insert into the bone, and the connection point between the stem and neck is prone to breakage, especially if there is no bone support at the proximal end of the stem prosthesis.

[0007] In approximately 30% of cases, an undesirable gap was observed between the proximal end of the stem prosthesis and the femur after insertion, resulting in a lack of support for the proximal end of the stem prosthesis. If these gaps are not addressed, implant failure and / or femoral fracture can easily occur.

[0008] Traditionally, surgeons may not be able to close undesirable gaps between implants and bone, or at most they may use some adhesive to fill them, which is not a suitable solution.

[0009] Therefore, a system / device is needed to address the aforementioned shortcomings. Summary of the Invention

[0010] Specific embodiments of the invention are described below with reference to the accompanying drawings. However, it should be understood that the disclosed embodiments are merely examples of the invention, which can be embodied in various forms. To avoid obscuring the invention with unnecessary detail, well-known functions or structures are not described in detail. Therefore, the specific structural and functional details disclosed in this invention should not be construed as limiting, but rather serve as the basis for the claims and as a representative basis for teaching those skilled in the art to use the invention in various ways in virtually any reasonably detailed structure.

[0011] This invention relates to a filler block for an implant. The filler block includes an elongated portion and a transverse member. The elongated portion and the transverse member form an integral structure. The elongated portion is placed in a cavity defined between bone and the implant, and includes a curvature corresponding to the curvature of the implant. The transverse member of the filler block forms a predetermined angle. The transverse member is placed on top of the implant and connected to the elongated member. Attached Figure Description

[0012] The following detailed description of the above overview and exemplary embodiments can be better understood when read in conjunction with the assigned accompanying drawings. The drawings illustrate exemplary constructions of the invention for illustrative purposes. However, the invention is not limited to the specific methods and tools disclosed herein. Furthermore, those skilled in the art will understand that the drawings are not drawn to scale.

[0013] Figure 1 A cross-section of a femur 1 having an implant 10 and a filler block 100 according to an embodiment of the present invention is shown.

[0014] Figure 2 A filling block 100 for an implant 10 according to an embodiment of the present invention is shown.

[0015] Figure 3 An implant 10 according to an embodiment of the present invention is shown.

[0016] Figure 4 A longitudinal cross-section of a femur 1 having an implant 10 and a filler block 100 according to an embodiment of the present invention is shown. Detailed Implementation

[0017] Before describing the invention in detail, the words or phrases used in this patent document are defined as follows: the terms “comprising” and “including” and their derivatives mean including but not limited to; the term “or” is inclusive, meaning and / or; the phrases “connected” and “associated” and their derivatives may mean including, comprising, interconnecting, containing, enclosing, linking, coupling, communicating, cooperating, intertwining, juxtaposing, proximate, binding, having attributes, etc. This patent document provides definitions of words and phrases, and those skilled in the art will understand that these definitions are applicable to use in many (if not most) situations now and in the future.

[0018] In this specification, references to "an embodiment," "embodiment," or similar language mean that a particular feature, structure, or characteristic associated with that embodiment is included in at least one embodiment. Therefore, unless expressly stated otherwise, the phrases "in one embodiment," "in an embodiment," and similar language in this specification may, but do not necessarily, refer to the same embodiment, but rather to "one or more, but not all, embodiments." Unless expressly stated otherwise, the terms "comprising," "including," "having," and variations thereof mean "including, but not limited to," "including," or "with." Unless expressly stated otherwise, the enumerated objects do not imply that any or all objects are mutually exclusive and / or mutually inclusive. Unless expressly stated otherwise, the terms "described," "explained," and "the" also mean "one or more."

[0019] While exemplary embodiments of the disclosed methods may be described in a specific order for ease of presentation, it should be understood that the disclosed embodiments may include an order of operations other than the specific order disclosed. For example, in some cases, the operations described in sequence may be rearranged or performed simultaneously. Moreover, the descriptions and disclosures provided in connection with a particular embodiment are not limited to that embodiment and can be applied to any embodiment disclosed herein. Furthermore, for simplicity, the accompanying drawings may not show the various ways in which the disclosed systems, methods, and apparatuses can be used in conjunction with other systems, methods, and apparatuses.

[0020] Furthermore, the features, advantages, and characteristics of the described embodiments can be combined in any suitable manner. Those skilled in the art will recognize that the embodiments can be practiced without one or more specific features or advantages of a particular embodiment. In other cases, it will be recognized that additional features and advantages in some embodiments may not be present in all embodiments. These features and advantages of the embodiments will become more apparent from the following description and allocated claims, or may be learned through practice of the embodiments described below.

[0021] In the context of this invention, a gap refers to the space between the bone and the implant after insertion. The term "cavity" refers to a reshaped or redefined gap in which a filler block is inserted. Typically, the size of the cavity corresponds to the size of the filler block.

[0022] This invention discloses a filler block for orthopedic implants (or implants). The filler block is tightly placed within the cavity between the implant and the inner surface of the bone. Therefore, the filler block minimizes the gap between the implant and the inner surface of the bone and maintains the maximum implant-bone contact area. Furthermore, the incidence of sinking is substantially reduced.

[0023] The filler block of the present invention is designed to be installed in the patient's femur during surgery. However, it is anticipated that, with some appropriate adjustments, the filler block can be used in conjunction with a humeral implant for shoulder surgery. In these embodiments, the configuration of the filler block can be substantially as described below, but the overall size and shape of the filler block will be configured to allow its installation in the humerus rather than the femur. It is also anticipated that at least some embodiments of the invention can be modified for use with a femoral (distal) implant or a tibial implant for knee surgery. Again, in these embodiments, the configuration of the implant can be substantially as described below, but the overall size and shape of the filler block will be configured to allow its installation in the distal femur or tibia rather than the proximal femur.

[0024] Now refer to the attached diagram, Figure 1 A cross-section of a femur 1 having an implant 10 and a filler block 100 is shown. The filler block 100 minimizes the gap between the implant 10 and the femur 1, thereby minimizing the incidence of implant failure and / or femoral fracture. The filler block 100 is mounted on the implant 10 in the femur 1. The filler block 100 may extend at least partially within the femur 1 along the surface of the implant 10.

[0025] The filler block 100 includes an elongated member 110 and a transverse member 130, the details of which are as follows: Figure 2 As shown. The elongated member 110 includes two opposing faces. Once mounted on the implant 10, the elongated member 110 of the filler block 100 is positioned along the longitudinal axis of the body 13 of the implant 10. One face of the elongated member 110 contacts the implant 10, while the other face of the elongated member 110 contacts the inner surface of the femur 1. A transverse member 130 is used to attach to the top of the shoulder 15 of the implant 10, as described below, to properly secure the filler block 100 to the implant 10.

[0026] Therefore, the filler block 100 provides support for the implant 10 by filling the gap between the body 13 and the inner surface of the femur 1.

[0027] Figure 2 A filler block 100 for the implant 10 is shown to reduce the gap between the implant 10 and the inner surface of the femur 1. Essentially, the filler block 100 is attached to the shoulder 15 of the implant 10 to reduce / eliminate the gap between the implant 10 and the inner surface of the femur 1.

[0028] The filler block 100 is made of a porous material, including but not limited to titanium, cobalt-chromium, and other metals or alloys thereof. The filler block 100 is manufactured by 3D printing or machining. In one exemplary embodiment, the filler block 100 is manufactured by 3D printing using a titanium alloy (Ti-6Al-4V-ELI). The filler block 100 helps support the body 13 (and shoulder 15) of the implant 10, thereby reducing the risk of subsidence. Furthermore, the filler block 100 helps enhance osseointegration of the implant 10, thereby providing further resistance to subsidence. In the event of poor trochanteric bone quality or fracture, the filler block 100 also helps to secure the trochanteric fragments to the body 13 of the implant 10.

[0029] As described above, the filler block 100 includes an elongated member 110 and a transverse member 130. In an exemplary embodiment, the elongated member 110 and the transverse member 130 form an integral structure.

[0030] The elongated member 110 includes a plate-like body, which optionally has curvature. In an exemplary embodiment, the radius of curvature of the elongated member 110 corresponds to the radius of the body 13 to which a filler block 100, such as the body of a handle, is attached. The edges of the plate-like body may be smooth, chamfered, rounded, etc. The distal end of the elongated member 110 may be tapered or rounded. Alternatively, the distal end of the elongated member 110 may be straight. The length of the elongated member 110 is at least 5 mm.

[0031] The elongated member 110 and the transverse member 130 may have predefined thicknesses. In an exemplary embodiment, the elongated member 110 and the transverse member 130 have the same thickness. Alternatively, the elongated member 110 and the transverse member 130 may have different thicknesses. In an exemplary embodiment, the thickness of the elongated member 110 (e.g., at least 1 mm) corresponds to the width of the cavity defined by reaming the gap between the body 13 of the implant 10 and the inner surface of the femur 1. The thickness of the gap between the body 13 and the inner surface of the femur 1 varies based on the anatomy of the femur 1. The minimum thickness of the elongated member 110 is 1 mm. The minimum thickness of the transverse member 130 is 1 mm.

[0032] In one embodiment, the thickness of the elongated member 110 and the thickness of the lateral member 130 vary along their respective surfaces. For example, the thickness of the elongated member 110 toward its edge and the thickness of the lateral member 130 toward its edge may be less than the thickness around their respective centers. Alternatively, the thickness of the elongated member 110 and the thickness of the lateral member 130 may vary as needed to provide support to the implant 10, all of which are within the scope of the invention.

[0033] The shape and surface of the filler block 100 are crucial for enhancing osseointegration of the implant 10. In an exemplary embodiment, the filler block 100 includes a textured, rough, or meshed surface to promote inward bone growth or osseointegration.

[0034] The transverse member 130 may define a predetermined angle with the elongated member 110. The predetermined angle between the elongated member 110 and the transverse member 130 may correspond to the anatomical structure of the femur 1. In an exemplary embodiment, the predetermined angle between the elongated member 110 and the transverse member 130 is 90°, which corresponds to an inverted L shape.

[0035] The transverse member 130 may be provided with one or more holes 130a. The number of holes 130a corresponds to the number of recesses 15a in the shoulder portion 15. The filler block 100 is secured to the shoulder portion 15 of the implant 10 using a fastening mechanism, including but not limited to snap-fit ​​engagement, tapered locking, fasteners, etc. The fastening mechanism passes through the holes 130a of the filler block 100 and enters the recesses 15a of the implant 10, thereby securing the filler block 100 and the implant 10. In an exemplary embodiment, a fastener 130b is used to secure the filler block 100 relative to the implant 10 in a desired orientation. Other functionally equivalent devices are within the scope of the teachings of this invention.

[0036] Before describing the assembly of the filler block 100 and the implant 10, Figure 3 An exemplary implant is shown. It should be noted that the filler block 100 can be used with [other components]. Figure 3 This can be used with any implant, including the exemplary embodiments described herein. The implant 10 is used for insertion into a cavity of bone to strengthen the bone (and / or adjacent joints). In an exemplary embodiment, the implant 10 is inserted into a cavity defined in the femur 1 to strengthen the hip joint.

[0037] In one exemplary embodiment, as described in Indian Patent Application No. 202321039103, the implant 10 is inserted into the cavity of the femur 1 using an implant applicator.

[0038] The implant 10 has a proximal end 10a and a distal end 10b. Further, the implant 10 includes a stem 11, a body 13, a shoulder portion 15, and a neck portion 17. The stem 11 is disposed toward the distal end 10b of the implant 10 such that the distal tip of the stem 11 defines the distal end 10b of the implant 10.

[0039] The handle 11 can be tubular, conical, cylindrical, or any other suitable shape. As shown, the handle 11 is cylindrical. In an exemplary embodiment, as... Figure 1As shown, the stem 11 tapers at least partially toward the distal end 10b. That is, the diameter of the middle section of the stem 11 is larger than the diameter of the distal section. The distal end of the stem 11 may be pointed. Alternatively, the distal end of the stem 11 may be any other shape, including but not limited to curved, round, bullet-shaped, etc., to facilitate the insertion of the implant 10 into the bone. The tapering structure of the stem 11 increases the usability of the implant 10 by facilitating a more efficient implant insertion process, thereby minimizing surgical time and the workload of the surgeon.

[0040] Alternatively or additionally, the handle 11 may have a plurality of ribs 11a on its outer surface. The ribs 11a may be circumferentially distributed on the outer surface of the handle 11. The ribs 11a may extend at least partially along the axis of the handle 11 (or in the longitudinal direction) on the outer surface of the handle 11. In one embodiment, the ribs 11a extend longitudinally from the distal end to the proximal end on the outer surface of the handle 11.

[0041] In one embodiment, the ligament 11a has a textured surface that facilitates frictional engagement between the implant 10 and the surrounding bone after the implant 10 is inserted into the bone cavity. The ligament 11a may include various patterns, including but not limited to straight lines, serrated lines, wavy lines, etc. In an exemplary embodiment, the ligament 11a has a straight line pattern on the surface of the handle 11. The ligament 11a provides rotational resistance to the implant 10 within the bone cavity and increases the total contact area with autologous bone.

[0042] The main body 13 is disposed toward the proximal end 10a of the handle 11. In an exemplary embodiment, the main body 13 and the handle 11 form an integral structure. Alternatively, the main body 13 may be detachably connected to the handle 11.

[0043] Alternatively or additionally, the body 13 is provided with one or more holes 13a. In an exemplary embodiment, the holes 13a in the central region of the body 13 allow the user to attach a wire to the rotor fragment (not shown). The rotor fragment functions as an artificial replacement for the autologous trochanteric bone, an anatomical structure located in the upper part of the femur. The rotor fragment is used for fixation when the trochanteric bone is of poor quality or fractured.

[0044] The main body 13 includes an outer surface that, once implanted into the femur 1, maintains direct contact with the femur 1 (or bone). The outer surface of the main body 13 may be provided with at least one coating. In an exemplary embodiment, the outer surface of the main body 13 is provided with a coating, including but not limited to hydroxyapatite (HA), titanium coating, etc. The coating has chemical similarity to the minerals of autologous bone, thus contributing to enhanced bone-implant integration between the implant 10 and the femur 1 after the implant 10 is inserted into the cavity of the femur 1. The coating further promotes bone tissue regeneration, thereby improving the bone integration rate.

[0045] A shoulder portion 15 is disposed at the proximal end 10a of the implant 10. The shoulder portion 15 is provided with at least one recess 15a. The recess 15a can be circular, semi-circular, elliptical, or any other desired shape. Furthermore, the walls of the recess 15a can be threaded, partially threaded, or unthreaded. The recess 15a extends at least partially along the length of the body 13. Further, the recess 15a can be aligned with the center of the shoulder portion 15, or can be offset from the center by a predetermined distance.

[0046] The recess 15a facilitates the user in connecting the filler block 100 to the implant 10 using a connection mechanism including but not limited to fasteners, rivets, etc. In an exemplary embodiment, the recess 15a connects the filler block 100 to the shoulder portion 15 of the implant 10. The connection mechanism includes, but is not limited to, fasteners 130b (such as...). Figure 2 (As shown), press fit, tapered fit, etc. Fastener 130b can be made of any biocompatible material, including but not limited to titanium, cobalt-chromium, and other metals or alloys thereof. In an exemplary embodiment, fastener 130b is made of titanium.

[0047] The neck 17 extends away from the body 13 of the implant 10. The neck 17 forms a predetermined angle with the axis of the stem 11. This angle is based on the orientation of the femur and the adjacent pelvis. The neck 17 indirectly forms a ball-and-socket joint with the pelvis. In an exemplary embodiment not shown, the neck 17 is provided with a ball that connects to the acetabulum of the pelvis or an implant disposed on the pelvis, forming a ball-and-socket joint that replicates the movement of the autologous joint.

[0048] Figure 4 An exemplary exploded view of the assembly is shown. First, the implant 10 is inserted into the femur 1. For this purpose, the stem 11 of the implant 10 is first inserted. After the stem 11 of the implant 10 is accurately positioned in the bone 1, the gap between the implant 10 and the cavity of the bone is analyzed. The gap is reamed to obtain a cavity with a suitable thickness. Once the cavity is formed, a filler block of appropriate thickness is selected.

[0049] Next, the filler block 100 is installed on the implant 10. Specifically, the elongated member 110 of the filler block 100 is inserted into the cavity between the implant and the bone. The filler block 100 is pushed until the transverse member 130 of the filler block 100 is positioned on the shoulder 15 of the implant 10. The filler block 100 and the implant 10 are then connected using fasteners 130b.

[0050] The scope of this invention is limited only by the appended patent claims. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described in this invention are exemplary, and actual parameters, dimensions, materials, and / or configurations will depend on the specific application using the teachings of this invention.

Claims

1. A filler block (100) for an implant (10), characterized in that, include: a. An elongated member (110) for placement in a cavity defined between bone 1 and said implant (10); as well as b. A transverse member (130) connected to the elongated member (110) for placement on top of the implant (10); The transverse member (130) and the elongated member (110) are arranged at a predetermined angle; The elongated member (110) includes a curvature corresponding to the curvature of the implant (10).

2. The filling block (100) according to claim 1, characterized in that, At least one of the elongated member (110) and the transverse member (130) has a smooth or chamfered edge.

3. The filling block (100) according to claim 1, characterized in that, The thickness of the elongated member (110) is variable.

4. The filling block (100) according to claim 1, characterized in that, The transverse member (130) includes a hole 130a to allow the connecting mechanism to pass through.

5. The filling block (100) according to claim 4, characterized in that, The hole 130a is threaded, partially threaded, or unthreaded.

6. The filling block (100) according to claim 4, characterized in that, The connecting mechanism includes fastener 130b.

7. The filling block (100) according to claim 1, characterized in that, The elongated member (110) and the transverse member (130) form an integral structure.

8. The filling block (100) according to claim 1, characterized in that, The filler block (100) is 3D printed or machined.

9. The filling block (100) according to claim 1, characterized in that, The filler block (100) is made of titanium alloy.

10. The filling block (100) according to claim 9, characterized in that, The fill block (100) includes a textured or rough surface.

11. The filling block (100) according to claim 1, characterized in that, The predetermined angle between the elongated member (110) and the transverse member (130) is 90°, which is equivalent to an inverted L-shape.

Citation Information

Patent Citations

  • Anti-loosening fastening assembly with one-way bearing structure

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