Femoral neck support structure, system, and method of use

Abstract

A device for repairing a femoral fracture is disclosed. The device comprises a hollow rod (262) having a first end that can be inserted into a hole (120'') of the greater trochanter (206) and positioned in a flare (201) of the greater trochanter, and a second end (267) with at least one opening (266) that can be positioned in the femoral head (205); an unfolding element (110) that can be inserted into the hollow rod (262); and a traction device (268) for pushing the unfolding element (110) toward the second end (267) while simultaneously pulling the hollow rod (262) toward the traction device (268).

Description

Cross - reference to related applications

[0001] This application is a PCT application claiming priority to Application No. 18 / 208,401, filed on June 12, 2023. The details of that application are hereby incorporated by reference in their entirety for all appropriate purposes. Identification of related parties

[0002] The applicant for this intellectual property matter is MJP Innovations, Inc. of Colorado, USA. The inventor of the invention described in this patent document is Marc Joseph Philippon of Colorado, USA. At the time of filing, John B. Moetteli and Da Vinci Partners LLC of Switzerland served as the applicant's agents. Copyright and legal notice

[0003] Some of the materials disclosed in this patent document are subject to copyright protection. The applicant has no objection to third - party facsimile reproduction of the patent documents disclosed as patents in the records of the Patent and Trademark Office, but in all other cases reserves all copyrights. Also, third - party patents or articles described in this application should not be considered as an admission that the present invention has no right to precede such materials on the grounds of prior invention.

Technical Field

[0004] Aspects of the present invention generally relate to medical devices. In particular, without limitation, aspects of the present invention relate to femoral neck support devices, systems, and methods of operating them.

Background Art

[0005] Fractures within the hip joint can cause debilitating and life - threatening conditions. Statistically, 50% of people over 50 years old who have suffered a hip bone fracture die within the first year. One area where hip fractures often occur is the femoral neck. The femoral neck is part of the femur that integrates the main body of the femur extending from the knee joint and the femoral head that fits within the socket (acetabulum) of the hip joint.

[0006] The femoral neck is particularly prone to fracture in people suffering from osteoporosis, a condition characterized by decreased bone density. Furthermore, conditions such as (but not limited to) diseased trabeculae in the Ward's triangle region of the femoral neck can also increase the risk of femoral neck fracture. Common approaches to reducing femoral neck fractures include strengthening the femoral neck by increasing bone density.

[0007] One way to increase bone density in the femoral neck is through the use of medication. However, the increase in femoral neck bone density from medication is considered relatively small. For example, one study showed that the increase in femoral neck bone density from medication was only about 6%. (See Uri A. Liberman, MD, Ph.D., et al., Effect of Oral Alendronate on Bone Mineral Density and the Incidence of Fractures in Postmenopausal Osteoporosis, The New England Journal of Medicine, Nov. 30, 1995). Other studies have shown that the increase in femoral neck bone density from medication is considerably less, so this increase is likely the maximum increase in bone density. Furthermore, the use of medication can cause serious side effects such as chest pain, dysphagia or pain during swallowing, flushing, joint pain, blood clots, and stomach or esophageal ulcers.

[0008] The general prevention of hip fractures through the use of medical devices has also been mentioned in the prior art. For example, U.S. Patent No. 7,261,720 ('720) describes a balloon embodiment adapted to support the upper femoral region. However, the balloon embodiment described in the '720 patent does not provide adequate support and reinforcement to the femoral neck.

[0009] Therefore, there is a need for a system and method for installing a femoral neck bone reinforcement that is effectively fixed to the cancellous bone and allows at least a portion of the load from the femoral neck bone to be transmitted to the support structure.

[0010] Therefore, devices and methods for reinforcing bone are needed. Furthermore, devices and methods for repairing fractures are needed. [Overview of the project]

[0011] The present invention relates to a device for repairing a femoral fracture according to claim 1. Preferred embodiments of the present invention are defined in the appended dependent claims.

[0012] The exemplary embodiments of the present invention shown in the drawings are summarized below. These and other embodiments are described in more detail in the detailed description section. However, it should be understood that the present invention is not intended to be limited to the forms described in the abstract or detailed description of the invention. Those skilled in the art will recognize that there are numerous modifications, equivalents, and alternative configurations that fall within the spirit and scope of the invention as expressed in the claims.

[0013] According to one embodiment, a device for reinforcing the femoral tibia, which is also used in the case of fracture, includes a support structure that can be deployed from a first substantially contracted position to a second substantially expanded position, the support structure being adapted to displace at least a portion of the cancellous bone region, and when deployed to the second substantially expanded position, the support structure structurally interacts with at least a portion of the cortical bone region.

[0014] According to other embodiments, a method for reinforcing the femoral neck includes creating a hole near at least one of Ward's triangle and the greater trochanter (even if the femoral neck is fractured), creating at least one cavity in the cancellous region of the femoral neck, inserting a substantially contracted support structure into the cavity through the hole, expanding the support structure, and allowing at least a portion of the load from the femoral neck to be transmitted to the support structure.

[0015] These and other embodiments are described in further detail herein. [Brief explanation of the drawing]

[0016] Various purposes and advantages, and a more complete understanding of the present invention, will become apparent and easier to understand by referring to the following “Detailed Description” and the appended claims, which are considered in conjunction with the accompanying drawings. [Figure 1A] This is a side view of a femoral neck support structure that expands into the femoral neck. [Figure 1B] This is a side view of one embodiment of a folded femoral neck support structure. [Figure 2A] This is a lateral view of an example of the femoral body, neck, and head. [Figure 2B] This is a cross-sectional view of the femoral neck along line AA in Figure 1A, showing the expanded support structure positioned within it. [Figure 3A] This is a side view of an actuator having a notch near the actuator head, and a magnified view of the side of the notch in the actuator head. [Figure 3B] This is a side view showing the working device and supporting structure within the cross-section of the femoral head and neck. [Figure 3C] This is a side view showing how the movement of the trigger mechanism is applied to a part of the support structure. [Figure 3D] This is a side view of the cutout portion of the working device head, showing two lumens. [Figure 4]Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 5] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 6A] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 6B] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 7] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 8] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 9] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 10] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 11] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 12] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 13] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 14] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 15] Various embodiments of a femoral neck support structure configured according to an aspect of the present invention. [Figure 16A] A side view of a perforation of the Ward's triangle, an actuating device, a pair of actuators, and a support structure according to an embodiment of a device configured according to an aspect of the present invention. [Figure 16B] A plurality of views of an accordion-like support structure according to an embodiment of a device configured according to an aspect of the present invention. [Figure 16C]This is a side view of the perforation and cavity of the Ward triangle, in which three support structures and filler material are placed. [Figure 17A] This is a side view of a pair of rotatable and deployable support structure portions according to one embodiment of a device configured according to an aspect of the present invention. [Figure 17B] This is a side view of a retractable support structure according to one embodiment of a device configured according to an aspect of the present invention. [Figure 18] This is a side view of a femoral neck support structure adapted to unfold from a greater trochanteric perforation, according to one embodiment of a device configured according to aspects of the present invention. [Figure 19A] This is a side view of a device comprising a sheath and a support structure, according to one embodiment of a device configured according to an aspect of the present invention. [Figure 19B] This is a side view of a device comprising a sheath and a support structure, according to one embodiment of a device configured according to an aspect of the present invention. [Figure 20] This is a cross-sectional view of another embodiment of the femoral neck support structure. [Figure 21A] Another embodiment of the femoral neck support structure and a cross-sectional view of the femoral head, neck, and part of the body. [Figure 21B] This is a top view showing the arrangement of femoral neck support structures within the femoral head. [Figure 22] This is one embodiment of a method for reinforcing the femoral neck. [Figure 23] This is another embodiment of a method for reinforcing the femoral neck. [Figure 24] This is yet another embodiment of a method for reinforcing the femoral neck. [Figure 25A] This is a top view of the femoral neck, which has a perforation in the anterior Ward's triangle, within which a femoral neck support structure is positioned. [Figure 25B] This is a lateral view of the femoral neck with a perforation in the anterior Ward's triangle. [Figure 26A] This is a schematic diagram of a further embodiment of a device for repairing fractures. [Figure 26B]Figure 26A is an exploded view of a device for repairing fractures. [Figure 27] This is a schematic diagram of a further embodiment of a device for repairing fractures. [Figure 28A] This is a schematic diagram of a further embodiment of a device for repairing fractures. [Figure 28B] Figure 28A is a schematic diagram detailing an embodiment of the device. [Modes for carrying out the invention]

[0017] Referring to the drawings, the same or similar elements are appropriately denoted by the same reference numerals throughout the drawings, and in particular, referring to Figures 1A to 2B, a device 100 for reinforcing the bone of the femoral neck 102 is shown and described. As shown in Figure 2A, the femoral neck 202 is part of the femur 204, located between the greater trochanter 206 and the femoral head 205, and connects the femoral body 203 to the femoral head 205 located within the hip joint. The device 100 is fitted to be positioned inside the bone of the femoral neck 202, thereby reinforcing the femoral neck 202 from the inside.

[0018] In one embodiment, the device 100 comprises a support structure 110, as shown in Figure 1A. One support structure 110 may be able to unfold from a first substantially folded position shown in Figure 1B to a second substantially extended position shown in Figure 1A. In one embodiment, the folded position is used to allow the structure 110 to be inserted into the femoral neck 102. For example, the folded support structure 110 may enter the femoral neck 102 through at least one of the holes 120' in the Ward's triangle and the holes 120'' in the greater trochanter, and then expand within the femur 102.

[0019] To expand, one embodiment may consist of a stent 112 and a balloon 114. Expansion of the structure 110 into the femoral neck 102 can be actuated by expanding the balloon 114 from a position adjacent to the holes 120', 120'' into the internal region of the femoral neck 102. Other expansion techniques known in the art that do not use balloons are also conceivable. For example, the stent 112 may be actuated to expand from a folded position to an expanded position by applying at least one of a lateral force 111 and a longitudinal force 113 to the structure 110, as shown in Figure 1B. Such forces 111, 113 can be used in devices that do not have a balloon 114. However, similar forces can also be used in devices that have one or more balloons 114. Furthermore, some embodiments may consist of one or more stents 112 or balloons 114. Embodiments comprising one or more devices 100 are also conceivable.

[0020] As shown in Figure 1A, the femur 104 may be composed of cortical bone 107 and cancellous bone 108. In patients with osteoporosis or other diseases, cancellous bone 108 may have lower bone density or be relatively malleable compared to the portion of cortical bone 107, which can be healthier and more rigid bone material. One structure 110 is adapted to expand within the cancellous bone 108. In one embodiment, as the support structure 110 expands into the femoral neck 202 (or femoral head), a cavity 209 is formed, as shown in Figure 2B. In one embodiment, the cavity 209 is formed by the expansion of the structure 210 itself. However, in other embodiments, the cavity 209 may be formed before the expansion of the structure 210. For example, the cavity can be drilled, tapped, or punched into the cancellous bone 208, and the folded structure 210 may be placed into the cavity 209 and then expanded. In one embodiment, the cancellous bone 208 may be compressed, such that the structure 210 forms a cavity 209. The cancellous bone 208 may also be removed from the femoral neck 202 by drilling or the like. As shown in Figure 2B, the cancellous bone 208 may be compressed between the support structure 210 and the cortical bone 207. In one embodiment, a balloon 214 may be inflated to compress the cancellous bone 208, and then a stem 212 may be inserted into the cavity 209 formed by the balloon 214 and expanded.

[0021] As shown in Figures 1A and 2B, when deployed to a second substantially extended position, the support structure 210 may be further adapted to interact with the cortical bone 207. For example, in one embodiment, one or more staples 215, or other similar mechanisms, may be used to bond the structure 210 to the cortical bone 207 or compressed cancellous bone 208. However, the structure 210 may also interact with the cortical bone 207 in one or more other embodiments. For example, as shown in Figures 1A and 2B, one embodiment may be configured to have an outer shape that generally conforms to the inner surface of the cortical bone 107, so that the support structure fits snugly within the healthy cortical bone 207. By adapting the shape of the structure 110 to resemble the shape of the cortical bone 107 within the femoral neck 202, interaction between the structure 110 and the cortical bone 107 is enabled. Interaction occurs when an external load, such as (but not limited to) a peak walking load 135 or a lateral fall load 130, is applied to the femoral neck 102. In such cases, the load is transmitted from the cortical bone 107 to the structure 110, allowing the structure 110 to reinforce the femoral neck 202. In at least one embodiment, the load is transmitted to the structure 110 through contact between the cortical bone 107 and the structure, but in other embodiments, the interaction between the cortical bone 107 and the structure 110 may occur through compressed cancellous bone 108 or bone cement.

[0022] It should be noted that the hole 120' in the Ward's triangle, as shown in Figure 1A and others, may include the hole 2520' in the anterior Ward's triangle located in the femoral neck 2502, as shown in Figures 25A and 25B. All embodiments discussed herein can be accessed through the hole 2520' in the anterior Ward's triangle. One such embodiment may include a support structure 2510 having a portion containing one or more holes 2527. The support structure section 2729 may be released into the cancellous bone 2508 through at least one hole 2527. Once released from the hole 2527, the support structure section 2729 may expand. Furthermore, the filler 2595 may be released into the cancellous bone 2508 from the hole 2527. In one embodiment, the filler 2595 may enter the cancellous bone 2508 directly, or it may enter the cancellous bone 2508 together with the support structure section 2529, as shown in Figure 25A.

[0023] Referring to Figures 3A-3C, one embodiment of the femoral neck support structure 310 may further include an actuation device 340. The actuation device 340 is adapted to deliver the support structure 310 to the femoral neck 302. For example, the actuation device 340 may consist of a tubular body adapted to substantially surround the compressed support structure 310. The actuation device 340 may be maneuverable so that the actuation device head 342 can be positioned near the hole 320 in the femoral neck. In some embodiments, the actuation device head 342 may also be adapted to be positioned within the hole 320, the cortical bone 307, or the cancellous bone 308.

[0024] When the actuation device head 342 is positioned correctly, the support structure 310 can be deployed. The actuation device 340 may deploy the support structure 310 via a trigger mechanism 344. The trigger mechanism 344 may be adapted to maneuverably release the separated support structure sections into separate regions of the femoral neck 302. For example, as shown in Figures 3A and 3B, the support structure 310 may consist of a first section 346, a second section 347, and a third section 348. When the trigger mechanism 344 is activated, the first, second, and third sections 346, 347, and 348 are released from the tube to separate regions of cancellous bone 308. The trigger mechanism may be adapted to receive one or more pushing, pulling, or twisting actions to actuate the release of the support structure 310.

[0025] The first section 346 may be designed to bend toward the greater trochanter 306 when released from the actuation device 340, and the third section 348 may be designed to bend toward the femoral head 305. Structural sections 346, 348 can be adapted to bend in a particular direction by attaching an elastomer band of a first length to one side of the section and an elastomer band of a longer second length to the opposite side of the section, thereby bending the section toward the side with the shorter elastomer band. Bending the individual support structural sections 346, 347, 348 to the appropriate internal position of the femoral neck can also occur through an action applied to the trigger mechanism 344. For example, as shown in Figure 3C, a pulling motion applied to the trigger mechanism 344 is transmitted to the side 349 of the first structural section 346, allowing section 346 to bend toward the pulled side 349.

[0026] Referring to Figures 4–15, various embodiments of the femoral neck support structure 110 (typically deployed within the femoral head) with various stent configurations 112 are shown and described. It should be understood that the support structures described herein are not intended to be limited to the various configurations shown in Figures 4–15 or other drawings. Figures 4 and 15 include exemplary embodiments of truss or strut support structures 410 and 1510. Figure 5 includes one embodiment of a mesh support structure 510, Figures 6A, 6B and 7 include embodiments of tubular support structures 610 and 710, and Figures 8, 10 and 11 include embodiments of biasing device support structures such as spring support structures 810, 1010 and 1110. Figures 9 and 12 include embodiments of coiled or spring structures 910 and 1210. Figures 13 and 14 show extended support structures 1310 and 1410 adapted to receive fillers 1395 and 1495 (e.g., bone cement), but each structure in Figures 4–15 may also include an expandable support structure adapted to receive fillers 1395 and 1495. Furthermore, it should be understood that each structure in Figures 4–15 may be similar to the structures described in Figures 1A–1B in some embodiments.

[0027] The stent 112 described herein may be made of 316L stainless steel or nickel-titanium alloy. However, other materials known in the art may also be used. For example, in some embodiments, polymer materials may be used for the stent 112 and / or balloon 114.

[0028] As shown in Figures 6A and 6B, one embodiment may consist of one or more single devices 600. A single device 600 may consist of an integrated head portion 680, a distal neck portion 682, and a proximal neck portion 684. The single device 600 may be further compressible. For example, the single device 600 may be a substantially hollow device having a substantially hourglass shape, made substantially of an elastomer or malleable material. During expansion, the single device 600 may be adapted to be subsequently filled with a filler.

[0029] Referring to Figures 16A–16C, it is shown that one or more compressed accordion devices 1650 are inserted into the hole 1620' of the Ward's triangle, and then the devices 1650 are expanded within the cavity 1609. One accordion device 1650 may expand as it is inserted through the hole 1620' of the Ward's triangle by using a pair of actuators 1649, as shown in Figure 16A. Each actuator 1649 may be adapted to move the accordion device 1650 away from the actuating device head 1642 and position the device within the cavity 1609. Once inside the cavity 1609, a first actuator 1649' may drive one end of the device 1650 in a first direction, and a second actuator 1649'' may drive the opposite end of the device 1650 in a second direction. The second direction may be substantially opposite to the first direction. These movements may occur sequentially or simultaneously. However, embodiments adapted to use more or fewer actuators 1649 than two, or to extend in two or more directions, are also conceivable. Furthermore, as shown in Figure 16C, two or more structures 1610 may be placed within the cavity 1609. A filler material may also be used within the cavity 1609, and in one embodiment, the filler material 1695 may hold one or more structures 1610 in appropriate positions within the cavity 1609. As shown in Figures 16A-16C, one embodiment may also involve interaction with bone cement or other filler material 2095 instead of cortical bone 107 or cancellous bone 108 shown in Figure 1A.

[0030] Referring to Figure 17A, additional devices adapted to expand with or without actuator 1649 may include a telescopic support structure 1710, as shown in Figure 17B, and a rotatable device 1760, as shown in Figure 17A. The telescopic and rotatable devices 1710 and 1760 may be adapted to expand unidirectionally or bidirectionally from either the greater trochanter hole 120'' or the Ward triangle hole 120''. A further embodiment adapted to expand bidirectionally from the insertion position of the greater trochanter hole 120'' is shown in Figure 18. As shown, a single pulling motion applied to actuator 1849 causes the structure 1810 to expand bidirectionally. Other devices are also possible.

[0031] Now, we focus on Figures 19A-19B, which show a device 1900 including a sheath 1970 and a support structure 1910. As shown in Figure 19A, in one embodiment, the sheath 1970 is fitted to substantially enclose the compressed support structure 1910. As shown in Figure 19B, the sheath 1970 is fitted to be subsequently removed to expose the support structure 1910. For example, when the sheath 1970 is removed by sliding it in a direction substantially parallel to the longitudinal axis of the structure (such as, but not limited to, the longitudinal axis 417 shown in Figure 4), the support structure 1910 is fitted to expand. The support structure 1910 may be fitted to expand bidirectionally laterally when the sheath 1970 is removed, but the structure may be fitted to expand in one direction or in two or more directions.

[0032] For example, as shown in Figure 19B, the support structure 1910 may consist of biasing devices such as (but not limited to) one or more compression springs 1919 that expand the stent 1914 when the sheath 1970 is removed. Other designs of the compressed or coiled support structure 1910 can also be used with the sheath 1970. Furthermore, it is conceivable that an accordion device 1650 may be used with the sheath 1970. In one embodiment, the sheath 1970 may be part of the actuation device 340 shown and described in Figures 3A-3C.

[0033] Figure 20h includes a structure 2010 that is in many respects similar to the structure 210 shown in Figure 2B. It should be understood that one embodiment of the support structure 2010 may have a variety of material properties, including but not limited to viscoelastic properties. Furthermore, one embodiment may include a structure 2010 having time-dependent or temperature-dependent properties. For example, a stent or filler 2095 used in a cavity (similar to the cavity 209 shown in Figure 2B) may become rigid after a certain period of time, or harden in the cavity when a specific temperature is reached, or when irradiated with light of a specific wavelength. The filler 2095 may also, in one embodiment, consist of a gelatinous material, or it may consist of bone growth chemomotors, such as hyaluronic acid or glycosaminoglycans, etc. The bone growth chemomotors may be growth factors adapted to locally promote and increase bone density and / or promote inward growth into the structure 2010. Many growth factors, such as IGF-I, IGF-BP-3, and the TGF-beta family, can stimulate overall positive levels of bone formation in vivo. Other methods and embodiments adapted to increase bone density are also conceivable, including the inclusion of osteoblasts from allogeneic or autologous grafts. Locally promoting bone growth may result in higher bone density than that obtained through systemic drug use. The filler 2095 may also consist of materials such as cement, glue, adhesive, and foaming agents, or a combination of one or more of these, or other materials. The support structure and filler are adapted together to support and reinforce the femoral neck 2002 and / or femoral head.

[0034] Figure 20 shows a femoral neck support system 2090. The femoral neck support system may consist of a support structure 2010. The support structure 2010 used within the support system 2090 is similar to the support structures described elsewhere in this specification. For example, the support structure 2010 may consist of at least one balloon 2014, or at least one spring, similar to the multiple springs shown in Figure 19B. Similar to the support structure 2010 previously described, the femoral neck support system 2090 defines at least one internal cavity. For example, as shown in Figure 2B, the expanded balloon 214 defines an internal space containing a cavity 209. Furthermore, the support structure 2010 may consist of an internal support beam 2092 and an external support beam 2094. The internal support beam 2092 may extend through the cavity, and the external support beam 2094 may extend along the edge of the cavity. Although shown vertically in Figure 20, some internal and external support beams may not be vertically positioned. The filler material 2095 is adapted to fill the space between opposing external support beams 2094 and around the internal support beams 2092.

[0035] The actuation device 340 shown in Figures 3A-3B may be adapted to deliver the filler material 395 into the internal cavity. For example, as shown in Figure 3D, the actuation device 340 may comprise at least one lumen 351 adapted to deliver the filler material 395 into the cavity and at least one other lumen 351 adapted to deliver the structure 310. Lumens 351 may also have other support system components, such as (but not limited to) the sheath 1970 shown in Figures 19A and 19B.

[0036] Referring to Figures 1A, 4, and 20, embodiments of the support structures 110, 410, and 2010 having the filler 2095 may be oriented along the longitudinal axis 417 while receiving a maximum peak walking load 135 or a lateral fall load 130. One lateral fall load 130 is also called the first load, and one peak walking load 135 is also called the second load. In one embodiment, the filler 2095 and the structure 410 may be adapted to receive a maximum peak walking load 135 of about 7 kN before plastic deformation or structural failure occurs. One peak walking load 135 may be applied substantially parallel to the longitudinal axis 417. However, as discussed herein, it is understood that the loads 130 and 135 applied to the femoral neck 102, the support structures 410, 110, and 2010, and the filler 2095 may vary with time, direction, and location. Therefore, the loads 130 and 135 in Figure 1A are merely general representative examples of peak walking and lateral fall loads on the device 100. For example, one peak walking load 135 may be applied at a 13-degree angle from the vertical plane and may have its center at a different location on the femoral head 105 than shown in Figure 1A. Similarly, it should be understood that the direction of the lateral fall load 130 may be applied at a 30-degree angle from the horizontal plane and at a different location than shown in Figure 1A. In one embodiment, the maximum lateral fall load 130 that can be adapted so that a single support structure 2010, 410, 110 and filler 2095 can withstand without plastic deformation or structural failure is about 12 kN. The lateral fall load 130 may also be applied substantially perpendicular to the longitudinal axis 417 of the support structure 410.

[0037] As shown in Figures 21A-21B, a further embodiment may consist of at least one guidewire 2197 and a plurality of support blocks 2199. The support blocks 2199 and the guidewire 2197 may be delivered to the femoral neck 2102 through an actuation device 340 as described in Figures 3A-3D. In one embodiment, the guidewire 2197 may be inserted into one or more cavities formed within the femoral neck 2102. For example, a balloon or other device may form a first cavity 2109', a second cavity 2109'', and a third cavity 2109''''. Once the guidewire 2197 is inserted into cavities 2109', 2109'', and 2109'''', the support blocks 2199 may be delivered into the cavities along the guidewire 2199. Each support block 2199 may be fitted to connect with each adjacent support block 2199. After correctly positioning the support block 2199, a filler material 2095 may be introduced into the cavity as shown in Figure 20, and the guide wire may be removed from the cavity. In one embodiment, once positioned, the support block 2199 may form a roughly cross shape as shown in Figure 21B.

[0038] Referring to Figure 22 of the priority application, and together with Figures 1A and 2A, a method for reinforcing the femoral neck 102 is shown. This method begins at 2200. At 2205, a hole is formed near at least one of the Ward's triangle and the greater trochanter 206. At least one hole can be formed with a drill (but not limited to) such as a coring drill, or with other devices (but not limited to) such as a chisel or pick, and is used to access the cancellous bone 108 within the femoral neck 202. At 2210, a compressed femoral support structure 110 (as shown in Figure 1B) is positioned near at least one of the holes 120' in the Ward's triangle and the hole 120'' in the greater trochanter. Correct positioning of the device can be done through the use of an actuation device 340 as shown in Figure 3A. Specifically, a maneuverable actuation device 340 may be used. At 2215, at least one cavity is formed in the cancellous bone 108 of the femoral head. However, at least one cavity may be formed in the cancellous region of the greater trochanter 206 and / or the femoral head 208. At least one cavity may be formed by expanding the balloon 114 and compressing a portion of the cancellous bone 108 of the femoral head. The balloon 114 may also be positioned correctly by the actuation device 340. In 2220, the femoral support structure 110 may be expanded. In one method, the expansion may be performed through the expansion of the balloon 114. When a load is applied to the femoral neck 102 as shown in 2225 to reinforce the femoral neck, at least a portion of the load is then transmitted from the bone of the femoral neck to the femoral support structure 110 as shown in 2230.

[0039] Additional methods may include variations of each of the above steps, and may include further steps such as bonding the support structure to healthy bone material. For example, the support structure may be bonded to healthy cortical bone or structurally active compressed cancellous bone using bone cement, clips, or staples. Other methods of bonding the support structure to healthy cortical bone include through friction between the device and the bone, or through compressive force between the device and the bone. Filling material may be introduced into the cavity. At least a portion of the load applied to the femoral neck may then be transferred to the support structure and filling component. Finally, it is conceivable to introduce fluid into the cavity. However, any fluid introduced into the cavity is likely to be contained and surrounded by a fluid containment structure, such as (but not limited to) a balloon.

[0040] Some of these steps, and others, are shown in Figure 23. In one embodiment, the start of the method in Figure 23 (2300) begins from the end of the method in Figure 22. Additional steps include inserting one or more guidewires into the cancellous bone region at 2240. This may include inserting polymer or 316L stainless steel wires into cavities formed in the cancellous bone of the femur. Once the wires are in place, the method continues to 2245, where one or more support blocks are fed along the wires into the cancellous bone region. Upon reaching the correct position, one or more support blocks may be positioned at 2250 in a configuration adapted to support the femoral neck. One support position may be a common cruciate position as shown in Figure 21B, but other support block positions are also possible. At 2255, filler is placed in at least one cavity, which conforms to the shape of at least one cavity and then hardens. Finally, at 2260, in addition to the load transfer to the support structure at 2230, a portion of the load is transferred to the filler.

[0041] Referring to Figure 24, another method for reinforcing the femoral neck is shown, and in one embodiment, the start of the method in Figure 24 (2400) begins from the end of the method in Figure 22. At 2465, the femoral support structure is enclosed in a sheath. This may include enclosing a compressed support structure, such as (but not limited to) the compressed support structure shown in Figure 1B. At 2470, the sheath is removed, and at 2475, the femoral support structure is expanded. For example, the sheath may be fitted to keep the support structure in a compressed position, and when removed, the support structure may be fitted to expand. Finally, at 2480, a substantially rigid support structure is positioned near at least one of healthy femoral cortical bone, compressed cancellous bone, or bone cement placed within the femur. In one embodiment, the substantially rigid support structure is created upon removal of the sheath and expansion of the structure. In another embodiment, expansion of the support structure may also occur through twisting, pulling, and pushing of an actuation device.

[0042] In a further embodiment, the greater trochanter hole 120'' (Figure 1A) is used to introduce a support structure 110 and fix the support structure to bones 205, 206 in the event of a fracture of the femoral neck. The support structure 110 may then be positioned according to the position shown in Figure 1A, which is generally oriented axially with respect to the femoral neck. The support structure 110 fixed thereto may be used to fix a portion of the femoral head 205 onto it, and therefore to the greater trochanter 206, in the event of a fracture of the femoral neck between the greater trochanter 206 and the femoral head 205. For example, when a fracture occurs between the femoral head 205 and the greater trochanter 206, the femoral head 205 can be fixed to the greater trochanter 206 (see Figure 2A). Therefore, the support structure 110 may further include an arm-shaped bone plate that can be positioned within the greater trochanter hole 120'' compared to the embodiment shown in Figure 1A, and optionally include one or more fixing elements that can be fixed to the surface of the greater trochanter 206 near the entrance region of the greater trochanter hole 120''.

[0043] Referring to Figures 26A and 28A, the further device 261 for repairing the fracture includes a threaded hollow rod 262 insertable into the hole 120'' of the greater trochanter, deployment elements 110, 110', 1650, 1760, and a traction device 268. The deployment elements 110, 110', 1650, 1760 may be at least partially formed from a material whose stiffness increases upon irradiation with light of a specific wavelength. Alternatively, the deployment elements 110, 110', 1650, 1760 may be at least partially formed from a material whose stiffness increases upon application of a specific temperature, preferably body temperature. The traction device 268 may be a screw including a traction thread 268' for connecting with the threads 265 of the threaded hollow rod 262. The fracture repair device 261 comprises at least one fixation element 264 for fixing the device 261 to the greater trochanter 206, preferably the flare (protrusion) 201 of the greater trochanter, and optionally includes a bone plate 263 that can be fixed to the greater trochanter 206. The flare 201 of the greater trochanter 206 is represented by the concave surface between the greater trochanter 206 and the femoral shaft bone 203, in other words, the concave surface where the greater trochanter 206 widens toward the femoral shaft 203. The more fixation elements 264 there are, the more stably the bone plate 263, and by extension the device 261, can be fixed to the greater trochanter 206. The bone plate 263 may be fixable to the greater trochanter 206 with the help of a traction device 268. The fixation elements 264 may be bone screws, nails, anchors, etc. The threaded hollow rod 262 is advantageously rod-shaped for insertion into the greater trochanter hole 120'' and includes threads 265 at its first end. Preferably, the threads 265 are aligned toward the center of the threaded hollow rod 262 and / or positioned in the flare 201 of the greater trochanter hole 120'' when inserted into the greater trochanter hole 120''. The threaded hollow rod 262 has an opening 266 at its second end 267 opposite the first end.The unfolding elements 110, 110', 1650, and 1760 are adapted to extend into the cancellous region of the femoral head 205 at the second end 267 of the threaded hollow rod 262, and optionally, in a manner similar to those shown in Figures 3A–D, in which elongated bodies or barbs (also known as individual support structure sections 346, 347, and 348) enter the cancellous bone.

[0044] The threaded hollow rod 262 is inserted into or can be inserted into the hole 120'' of the greater trochanter. In one embodiment, the deployment element 110 is inserted into the threaded hollow rod 262 at its first end and then advanced to the second end 267 of the threaded hollow rod 262. The elongated bodies 110', 346, 347, 348 of the deployment element 110 are fitted to contact the cam surface or deflection surface 262a of the second end 267 of the threaded hollow rod 262. As the deployment element 110 is further advanced when it is positioned in the opening 266 of the threaded hollow rod 262, the elongated bodies of the deployment element 110 expand through the opening 266 of the threaded rod 262 into the cancellous region of the femoral head 205. Advantageously, the elongated portions 110, 346, 347, 348, and 349 of the device 261 can control the rotation within the femoral head 205 relative to the femur.

[0045] Optionally, the traction device 268 can also function as the sole fixing screw, for example, if the screw head of the fixing screw covers the flare 201 of the greater trochanter 206. Thus, screwing in the traction device 268 causes the aforementioned expansion of the elongated body. The device 261 is thus fixed inside the greater trochanter 206 and the femoral head 205, thereby firmly fixing the deployment element 110 within the femoral head 205.

[0046] Note that the dashed line 263a in Figures 26A to 27 shows a relocated wall 263a (moved from position 263 to the position of dashed line 263a) to represent an alternative embodiment in which there is no external screw 264 and only one screw 268'. Advantageously, the single-screw embodiment minimizes screw cutout (protrusion) and minimizes damage to the lateral epiphyseal vessels.

[0047] An optional configuration that extends into the bone through the opening 266 is described in PCT application no. PCT / IB2013 / 002066 (WO 2014 / 045103), in particular in Figures 10A and 10B and Figures 3A to 3D and their associated text, the contents of which are incorporated herein by reference and relied upon. At least one optional fixation element 264 is fixed to the flare 201 of the greater trochanter 206. Furthermore, as already stated, the device 261 includes a traction device 268 having threads 268' that fit into the threads 265 of a threaded hollow rod 262. The traction device 268 is adapted to fix the bone plate 263 to the greater trochanter 206 and further pull the femoral head 205 toward the greater trochanter 206 by screwing the traction device 268 onto the threaded hollow rod 262, thereby closing any fracture site. The threads 268' of the traction device 268 are adapted to interact with the threads 265 of the threaded hollow rod 262 in order to pull the anchored deployment element 110 toward the greater trochanter 206, thereby tightening the femoral head 205 toward the greater trochanter 206. In other words, screwing in the traction device 268 should result in a natural connection between the femoral head 205 and the greater trochanter 206 with high surface contact. Natural bone growth will allow the fracture between the greater trochanter 206 and the femoral head 205 to heal.

[0048] Referring next to Figure 26B, the device 261 according to Figure 26A, including a bone plate 263, is shown. The deployment element 110 of the device 261 may include an expansion section 230 having at least one elongated body 234 (shown here in an undeformed state), and optionally a spacer rod 235 for inserting the deployment element 110 and / or for helping to hold the deployment element 110 in place. After the deployment element 110 is advanced within the threaded hollow rod 262 to the second end 267 of the threaded hollow rod 262, the elongated body 230(234) expands into the cancellous bone region of the femoral head 205. Then, when the fastening means is screwed into the threads of the threaded hollow rod 262 (see Figure 26), the spacer pushes the deployment element 110, spreading (deforming) the elongated body 234 into the cancellous bone. In this way, the threaded hollow rod 262 fixes the expandable portion 230 within the femoral head 205 by pulling the expandable portion 230 toward the greater trochanter 206.

[0049] Referring to Figure 28B, further details of the device 261 shown in Figure 26A are provided. The fracture repair device 261 includes a traction device 268 in the flare 201 of the greater trochanter 206 along axis 299, thereby positioning the traction device 268 in contact with the unfolding elements 110, 110'. The traction device 268 comprises a thread 268', a screw head 268'', and a centering device 268'''. The cross-sectional area of ​​the screw head 268'' perpendicular to the axial direction of the traction device 268 is substantially larger than the diameter of the hole 120'' in the greater trochanter 206. Therefore, a bone plate 263 as shown in Figures 26A and 26B is unnecessary. The screw head 268'' may have any other arbitrary shape, for example, to provide a continuous surface of the greater trochanter 206 in the flare 201 of the greater trochanter 206. The centering device 268'' of the traction device 268 offers the advantage of being able to position the fracture repair device 261 in the correct location within the bones 205, 206.

[0050] Referring to Figure 27, further embodiments of the device 261 are adapted to repair fractures, including alternative unfolding elements 110. The unfolding elements 110, 1650, and 1760 are adapted to unwind (relax) a tightly wound configuration that allows a cannula to pass through when positioned at the second end 267 of the threaded hollow rod 262 (or to unwind in an accordion-like manner as shown in Figure 16B or as shown in Figure 17A), and after the threaded hollow rod 262 is pushed through, they become a larger, looser configuration at the final position of the second end 267 through its lateral opening 266. The device 261 may also include further features shown in Figure 27, although these are not specifically mentioned. It may also include the use of adjacent unfolding elements 110, 1650, and 1760 unfolding from opposing lateral openings 266 of the shaft 267 to counteract lateral forces. Advantageously, in this embodiment, no axial load is applied to the bone when the deployment element 110 is deployed, because all forces are applied laterally with respect to the axis 299. This prevents the separation of bone fragments when the device 261 is fixed.

[0051] Referring to Figure 22 of this application, a modified method for reinforcing the femoral neck 102 using embodiments of Figures 26A–28B includes all the steps of Figure 22 of the priority application, except that step 2205 is reinterpreted as “creating a hole along the axis 299 of the femoral neck,” and steps 2210 and 2215 are replaced by a single step 2212 which “positions compressed deployable elements 110, 1650, 1760 within a hollow rod 262 and displaces them to a lateral opening 266 for deployment, thereby forming at least one cavity in the cancellous bone of the femoral head.” This method begins at 2200. At 2205, a hole is formed along the longitudinal axis 299 of the femoral neck. The hole can be formed with a drill, such as but not limited to a coring drill, or with other devices, such as a chisel or pick, and is used to cross the cancellous bone 108 within the femoral neck 202 to the proximal region of the femoral head. At 2210, the compressed femoral support structure 110 (as shown in Figures 1B and 26A-28B) is positioned. Correct positioning of the device can be achieved through the use of an actuation device 340, as shown in Figure 3A. Specifically, a maneuverable actuation device 340 may be used. At 2215, at least one cavity is formed in the cancellous bone 108 of the femur. At least one cavity may be formed in the cancellous region of the greater trochanter 206 and / or the femoral head 208. At least one cavity may be formed by expanding a balloon 114 and compressing a portion of the cancellous bone 108 of the femoral head. The balloon 114 may also be positioned correctly by the actuation device 340. At 2220, the femoral support structure 110 may be expanded. Expansion in one method may be achieved through the expansion of the balloon 114. When a load is applied to the femoral neck 102 as shown in 2225 to reinforce the femoral neck, at least a portion of the load is subsequently transmitted from the bone of the femoral neck to the femoral support structure 110 as shown in 2230.

[0052] Those skilled in the art will readily recognize that numerous variations and substitutions are possible in the present invention, its uses, and its configuration to achieve substantially the same results as those achieved by the embodiments described herein. Therefore, there is no intention to limit the present invention to the exemplary forms disclosed. Many variations, modifications, and alternative structures are included within the scope and spirit of the disclosed invention.

Claims

1. A femoral fracture repair device (261), - A hollow rod (262) fitted to be insertable into a hole (120'') of the greater trochanter (206), the hole (120'') of the greater trochanter extending substantially axially through the femoral neck from the flare (201) of the greater trochanter to the femoral head (205), the hollow rod (262) characterized by a first end fitted to be configurable into the flare (201) of the greater trochanter and at least one opening (266) at a second end (267), the second end (267) being the end of the hollow rod (262) opposite to the first end, the second end (267) being fitted to be configurable into the femoral head (205), - A deployment element (110) adapted to be insertable into the hollow rod (262), - A traction device (268) adapted to push the deployment element (110) toward the second end (267) while simultaneously pulling the hollow rod (262), Includes, A fracture repair device wherein the unfolding element (110) is displaced toward the second end (267) of the hollow rod (262) and then adapted to expand into the cancellous region of the femoral head (205) through the at least one opening (266) of the hollow rod (262).

2. The fracture repair device according to claim 1, wherein the traction device (268) is preferably a screw having a traction thread (268'), and the hollow rod (262) has a threaded portion (265) at the first end so that the traction thread (268') and the threaded portion (265) interlock with each other.

3. The fracture repair device according to claim 1, comprising a bone plate (263), preferably a flat washer, fitted to be fixed to the greater trochanter flare (201), wherein the bone plate (263) is fitted to be positionable on the greater trochanter flare (201) to stabilize the device (261) when fixed to the greater trochanter (206).

4. The fracture repair device according to claim 3, wherein the bone plate (263) is fitted to the greater trochanter (206) so as to be fixable by at least one fastening element (264), preferably a bone screw, nail, or anchor.

5. The fracture repair device according to claim 1, wherein the unfolding element (110) is adapted to enclose a filler material.

6. The fracture repair device according to claim 5, wherein the filler is bone cement.

7. The fracture repair device according to claim 5, wherein the filler material comprises a gelatinous material.

8. The fracture repair device according to claim 5, wherein the filler material comprises a material selected from one of the group consisting of glue, adhesive, and foaming agent.

9. The fracture repair device according to claim 5, wherein the filler comprises a bone growth chemical regulator, the bone growth chemical regulator is preferably selected from the group consisting of hyaluronic acid and glycosaminoglycans.

10. The fracture repair device according to claim 1, wherein the unfolding element (110) is at least partially formed of a material whose rigidity increases when irradiated with light of a specific wavelength.

11. The fracture repair device according to claim 1, wherein the unfolding element (110) is at least partially formed of a material whose rigidity increases upon application of a specific temperature, preferably body temperature.

12. The fracture repair device according to claim 1, wherein the elongated body (110') of the unfolding element (110) is adapted to control rotation within the femoral head.

13. The fracture repair device according to claim 1, which minimizes screw cutout (protrusion) and damage to the lateral epiphyseal vessel by using only one screw (268, 268', 268'').

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