MIS beveled driver for implanting IBS bone compression screws

The MIS beveled driver with a beveled sleeve and radio marker aligns the screw flush with the bone surface, addressing soft tissue irritation and facilitating bone fusion in minimally invasive procedures.

WO2025155566A1PCT designated stage expired Publication Date: 2025-07-24IN2BONES USA LLC
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Patent Information

Application Number
PCT/US2025/011593
Authority / Receiving Office
WO · WO
Patent Type
Applications
Current Assignee / Owner
Priority Date
2024-01-17
Filing Date
2025-01-14
Publication Date
2025-07-24

AI Technical Summary

Technical Problem

Conventional IBS bone compression and fully threaded screws require deep insertion to countersink heads, causing irritation to surrounding soft tissue, and there is a need for a minimally invasive solution without a fusion bone plate.

Method used

An MIS beveled driver with a beveled sleeve and marks ensures the screw is aligned flush with the bone surface, using a Torx driver shaft and radio marker for fluoroscopic guidance.

Benefits of technology

Minimizes soft tissue irritation and facilitates bone fusion with minimal invasive surgery by ensuring the screw head is flush with the bone surface, enabling precise alignment and visualization.

✦ Generated by Eureka AI based on patent content.

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Abstract

An MIS beveled driver and methods are provided for implanting beveled IBS bone compression and fully threaded screws to encourage bone fusion. The driver includes an elongated driver shaft extending from a shaped distal end to a proximal handle, a beveled sleeve having an angled distal-most surface adjacent to the shaped distal end that couples with the bone screw, and beveled marks on the driver shaft to indicate an orientation of the sleeve. The sleeve is affixed to the driver shaft such that the angle of the distal-most surface remains aligned with the beveled marks. The sleeve ensures that the bone screw only assembles with the driver in an orientation that enables aligning a proximal head portion of the bone screw to be flush with the surrounding bone surface. The sleeve includes a radio marker to enable observation of the bone screw by way of fluoroscopy.
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Description

MIS BEVELED DRIVER FOR IMPLANTING IBS BONE COMPRESSION SCREWSPRIORITY

[0001] This application claims the benefit of and priority to U.S. Provisional Application, entitled “MIS Beveled Driver For Implanting IBS Bone Compression Screws,” filed on lanuary 17, 2024, and having application serial number 63 / 621,992, the entirety of said application being incorporated herein by reference.FIELD

[0002] Embodiments of the present disclosure generally relate to securing bones together. More specifically, embodiments of the disclosure relate to an apparatus and methods for a Minimally Invasive Surgery beveled driver for implanting IBS bone compression and fully threaded screws.BACKGROUND

[0003] A fusion bone plate implant may be utilized in conjunction with one or more fasteners so as to generate compression and stability at a bone interface. An implant coupled with fasteners generally serves to stabilize bones, or bone parts, relative to one another so as to promote bone fusion. In many applications, bone plates and fasteners are used to fuse bones, or bone parts, of the human body, such as bones in the foot, the ankle, the hand, the wrist, as well as various other portions of the body. Furthermore, during the course of certain medical procedures, a surgeon may immobilize one or more bones or the bone fragments by stabilizing the bones together in a configuration which approximates the natural anatomy. To this end, the surgeon may use fasteners to attach the bones to a bone plate implant so as to hold the bones in alignment with one another while they fuse together.

[0004] In some instances, however, a bone plate may be impractical for implantation in a portion of the body that requires treatment. In some instances, IBS bone compression and fully threaded screws may be used to stabilize a fracture or an osteotomy bone cut. A drawback to conventional IBS compression and fully threaded screws, however, is they often must be driven deeply into the bones to countersink heads of the screws so as to minimize irritation to surrounding soft tissue. What is needed, therefore, is an MIS beveled driver and beveled compression and fullythreaded screws configured to fuse bones in absence of a fusion bone plate and minimize irritation to surrounding soft tissue.SUMMARY

[0005] An MIS beveled driver and methods are provided for implanting beveled IBS bone compression and fully threaded screws to encourage bone fusion. The driver includes an elongated driver shaft extending from a shaped distal end to a proximal handle, a beveled sleeve having an angled distal-most surface adjacent to the shaped distal end that couples with the bone screw, and beveled marks on the driver shaft to indicate an orientation of the sleeve. The sleeve is affixed to the driver shaft such that the angle of the distal-most surface remains aligned with the beveled marks. The sleeve ensures that the bone screw only assembles with the driver in an orientation that enables aligning a proximal head portion of the bone screw to be flush with the surrounding bone surface. The sleeve includes a radio marker on a proximal beveled surface to enable observation of the bone screw by way of fluoroscopy.

[0006] In an exemplary embodiment, an MIS beveled driver for implanting a beveled screw into bone comprises: an elongated driver shaft that extends from a shaped distal end to a proximal handle; a beveled sleeve including an angled distal -most surface adjacent to the shaped distal end; and one or more beveled marks disposed on the driver shaft to indicate an orientation of the beveled sleeve.

[0007] In another exemplary embodiment, the shaped distal end comprises a Torx driver shaft configured to couple with a Torx-shaped opening in the beveled screw. In another exemplary embodiment, the beveled sleeve is configured to ensure that the beveled screw can only be assembled with the shaped distal end in a single orientation. In another exemplary embodiment, the single orientation comprises a proximal head portion of the beveled screw being aligned with the one or more beveled marks.

[0008] In another exemplary embodiment, the beveled screw includes a proximal head portion that is disposed at an angle that mates with an angle of the distal-most surface. In another exemplary embodiment, the angle of the proximal head portion and the angle of the distal-most surface are configured to ensure that the beveled screw can only be assembled with the shaped distal end in a single orientation. In another exemplary embodiment, the single orientation isconfigured to enable implanting the beveled screw such that the proximal head portion is flush with the surrounding bone surface.

[0009] In another exemplary embodiment, the beveled sleeve is affixed to the driver shaft such that the angle of the distal-most surface remains aligned with the one or more beveled marks. In another exemplary embodiment, the beveled sleeve includes a radio marker on a beveled surface that is disposed about 1mm proximal of the distal-most surface. In another exemplary embodiment, the radio marker is configured to enable observation of the position and orientation of the beveled screw by way of fluoroscopy.

[0010] In an exemplary embodiment, a method for an MIS beveled driver for implanting a beveled screw into bone comprises: forming an elongated driver shaft that extends from a shaped distal end to a proximal handle; configuring a beveled sleeve including an angled distal-most surface adjacent to the shaped distal end; and disposing one or more beveled marks on the driver shaft to indicate an orientation of the beveled sleeve.

[0011] In another exemplary embodiment, forming the elongated driver shaft includes configuring the shaped distal end to comprise a Torx driver shaft to couple with a Torx-shaped opening in the beveled screw. In another exemplary embodiment, configuring the beveled sleeve includes ensuring that the beveled screw can only be assembled with the shaped distal end in a single orientation. In another exemplary embodiment, configuring the beveled sleeve includes ensuring that a proximal head portion of the beveled screw can only be aligned with the one or more beveled marks.

[0012] In another exemplary embodiment, configuring the beveled sleeve includes disposing the angled distal-most surface and at an angle that mates with the beveled screw. In another exemplary embodiment, disposing the angled distal-most surface includes ensuring that the beveled screw can only be assembled with the shaped distal end in a single orientation. In another exemplary embodiment, disposing the angled distal-most surface includes configuring the single orientation to enable implanting the beveled screw such that the proximal head portion is flush with the surrounding bone surface.

[0013] In another exemplary embodiment, configuring the beveled sleeve includes affixing the beveled sleeve to the driver shaft such that the angle of the distal-most surface remains aligned with the one or more beveled marks. In another exemplary embodiment, configuring the beveled sleeve includes configuring a radio marker on a beveled surface that is disposed about 1mm proximal of the distal-most surface. In another exemplary embodiment, configuring the radio marker includes configuring the radio marker to enable observation of the position and orientation of the beveled screw by way of fluoroscopy.

[0014] These and other features of the concepts provided herein may be better understood with reference to the drawings, description, and appended claims.BRIEF DESCRIPTION OF THE DRAWINGS

[0015] The drawings refer to embodiments of the present disclosure in which:

[0016] Figure 1 illustrates an isometric view of an exemplary embodiment of an MIS beveled driver and beveled screw, according to the present disclosure;

[0017] Figure 2 illustrates a side view of an exemplary embodiment of a beveled driver in accordance with the present disclosure;

[0018] Figure 3 illustrates a side view of an exemplary embodiment of a beveled sleeve and driver shaft comprising a beveled driver, according to the present disclosure;

[0019] Figure 4 illustrates a side view of an exemplary embodiment of a beveled screw and a beveled driver that includes beveled marks in accordance with the present disclosure;

[0020] Figure 5 illustrates a side view of an exemplary embodiment of a beveled screw coupled with a beveled driver that includes beveled marks in accordance with the present disclosure;

[0021] Figure 6 illustrates a close-up view of an exemplary embodiment of a beveled screw coupled with a beveled driver, according to the present disclosure;

[0022] Figure 7 illustrates an exemplary-use environment wherein a K-wire is inserted across an osteotomy cut in bone, according to the present disclosure;

[0023] Figure 8 illustrates an exemplary-use environment wherein a depth gauge is used to determine bone screw length, according to the present disclosure;

[0024] Figure 9 illustrates an exemplary -use environment wherein a cannulated drill is used to drill a bone hole across the osteotomy cut in accordance with the present disclosure;

[0025] Figure 10 illustrates an exemplary -use environment wherein a cannulated countersink is used to prepare the bone hole to a screw head in accordance with the present disclosure;

[0026] Figure 11 illustrates a side view of an exemplary embodiment of a beveled IBS bone screw coupled with an exemplary embodiment of an MIS beveled driver, according to the present disclosure;

[0027] Figure 12 illustrates an exemplary-use environment wherein the beveled IBS bone screw of Fig. 11 has been implanted in a bone hole by way of the MIS beveled driver of Fig. 11 in accordance with the present disclosure;

[0028] Figure 13 illustrates an exemplary -use environment wherein a beveled IBS bone screw of Fig. 12 has been implanted in the bone hole such that the screw head is flush with the sounding bone surface, according to the present disclosure;

[0029] Figure 14 illustrates an exemplary -use environment wherein an exemplary embodiment of a beveled IBS bone screw is being implanted across a bone fracture by way of an exemplary embodiment of an MIS beveled driver, according to the present disclosure; and

[0030] Figure 15 illustrates the exemplary -use environment of Fig. 14 after the MIS beveled driver has been removed, showing that the screw head of the beveled IBS bone screw is flush with the sounding bone surface in accordance with the present disclosure.

[0031] While the present disclosure is subject to various modifications and alternative forms, specific embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. The present disclosure should be understood to not be limited to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.DETAILED DESCRIPTION

[0032] In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present disclosure. It will be apparent, however, to one of ordinary skill in the art that the MIS beveled driver and methods disclosed herein may be practiced without these specific details. In other instances, specific numeric references such as “first screw,” may be made. However, the specific numeric reference should not be interpreted as a literal sequential order but rather interpreted that the “first screw” is different than a “second screw.” Thus, the specific details set forth are merely exemplary. The specific details may be varied from and still be contemplated to be within the spirit and scope of the present disclosure. The term “coupled” is defined as meaning connected either directly to the component or indirectly to the component through another component. Further, as used herein, the terms “about,” “approximately,” or “substantially” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein.

[0033] In some instances, a bone plate may be impractical for implantation in a portion of the body that requires treatment. In such instances, IBS bone compression and fully threaded screws may be used to stabilize bone fractures or an osteotomy bone cut. A drawback to conventional IBS compression and fully threaded screws, however, is they often must be driven deeply into the bones to countersink heads of the screws so as to minimize irritation to surrounding soft tissue. Provided herein are embodiments and methods for an MIS beveled driver and beveled IBS compression and fully threaded screws configured to fuse bones in absence of a fusion bone plate and minimize irritation to surrounding soft tissue.

[0034] Figure 1 illustrates an exemplary embodiment of an MIS beveled driver 100 (hereinafter “beveled driver 100”) and a beveled IBS bone compression screw 104 (hereinafter, “beveled screw 104”), according to the present disclosure. It should be borne in mind that the beveled screw 104 is not limited to being bone compression screws, and thus the beveled screw 104 can be fully threaded bone screws, in some embodiments. The beveled driver 100 comprises a generally elongated driver shaft 108 that extends from a shaped distal end 1 12 to a proximal handle 116. The driver shaft 108 is coupled with a beveled sleeve 120 that ensures that the beveled screw 104 can only be assembled in a single orientation with the beveled screw 104.

[0035] Figures 2-3 illustrate an exemplary embodiment of a beveled driver 100 in accordance with the present disclosure. In the illustrated embodiment, the shaped distal end 112 comprises a Torx driver shaft configured to couple with a Torx-shaped opening in the beveled screw 104. The Torx driver shaft and the beveled sleeve 120 are dedicated to implant IBS-B (i.e., bevel headed) screws, such as the beveled screw 104 shown in Fig. 1, in a way that the beveled head of the screw 104 is flush to the bone surface. This provides a minimally invasive surgery (MIS) when the skin incision is minimal making visualization of the screw 104 limited.

[0036] Figures 4-5 illustrate assembly of an exemplary embodiment of a beveled screw 104 onto an exemplary embodiment of a beveled driver 100. As shown in Fig. 4, the beveled screw 104 has a proximal head portion 124 that is disposed at an angle that mates with the angle of a distal-most surface 128 of the beveled sleeve 120. The angles of the proximal head portion 124 and the distal-most surface 128 ensure that the beveled screw 104 can be installed onto the beveled driver 100 in one orientation, as shown in Fig. 5.

[0037] One or more beveled marks 132 may be disposed on the beveled driver 100 to provide a visual indication of the orientation of the angle of the proximal head portion 124 during implantation of the beveled screw 104. It is contemplated that the sleeve 120 is welded, or otherwise, affixed to the driver shaft 108 such that the angle of the distal-most surface 128 remains aligned with the beveled marks 132. It is further contemplated that in case of the beveled driver 100 disengaging from the screw 104, the unique orientation between the screw 104 and beveled driver 100 enables the surgeon to reassemble the beveled driver 100 onto the screw 104 by automatically finding the correct angulation for assembly, without necessarily needing to see the end of the beveled driver 100, such as may occur during percutaneous procedures.

[0038] Figure 6 is a close-up view of an exemplary embodiment of a beveled screw 104 that is coupled with a beveled driver 100, according to the present disclosure. In the illustrated embodiment, the beveled sleeve 120 includes a radio marker 136 on a beveled surface that is disposed about 1mm proximal of the distal-most surface 128. As such, when the proximal head portion 124 is adjacent to the distal-most surface 128, the radio marker 136 is about 1mm proximal of the proximal head portion 124. It is contemplated that the radio marker 136 enables the surgeonto observe the position and orientation of the screw 104 under fluoroscopic check. Further, the 1mm gap may allow the surgeon to implant the screw 104 farther as needed.

[0039] Turning, now, to Fig. 7, an exemplary-use environment wherein a K-wire 140 is inserted across an osteotomy cut 144 in a bone 148 is illustrated, according to the present disclosure. As shown, a wire guide 152 is inserted into a drill guide 156, which in turn is inserted into a soft tissue protector sleeve 160, to place appropriately sized K-wires, then removed prior to measuring and drilling. The wire guide 152 has a tapered body that will press-fit into the drill guide 156 with light manual pressure.

[0040] Figure 8 illustrates an exemplary -use environment wherein a depth gauge 164 is used to determine a required length of the compression screw, according to the present disclosure. The wire guide 152 has been removed, leaving the drill guide 156 and the K-wire 140 in place. The depth gauge 164 slides over the K-wire 140 into the drill guide 156 until depth gauge 164 contacts the cortical surface 168. The length of the compression screw can be determined by measuring the length of the K-wire 140 inside the depth gauge 164. It is contemplated that the depth gauge 164 is selected based on length of the K-wire 140.

[0041] Figure 9 illustrates an exemplary -use environment wherein a cannulated drill 172 is used to drill a bone hole across the osteotomy cut 144 in accordance with the present disclosure. As will be appreciated, in some instances, drilling the bone hole may be an optional step performed in preparation for implanting the compression bone screw into the bone 148. Once the depth gauge 164 of Fig. 8 has been removed, an appropriately sized cannulated drill 172 may be passed over the K-wire 140 to the cortical surface 168. The bone hole may then be drilled to a desired depth into the bone 148. The cannulated drill 172 and the drill guide 156 may then be removed from the patient. Next, an appropriately sized cannulated countersink 176 may be passed over the K-wire 140 to prepare the bone hole for the screw head, as shown in Fig. 10.

[0042] Figure 11 illustrates a side view of an exemplary embodiment of a beveled IBS bone compression screw 180 coupled with the MIS beveled driver 100, according to the present disclosure. As shown in Fig. 11, the beveled IBS compression screw 180 includes an angled proximal head portion 124 that mates with the distal-most surface 128 of the beveled sleeve 120 and thus ensures that the beveled IBS compression screw 180 is properly installed onto the beveleddriver 100. Further, the beveled marks 132 disposed on the beveled driver 100 provide a visual indication of the orientation of the angle of the proximal head portion 124 during implantation of the beveled IBS bone compression screw 180.

[0043] Figure 12 illustrates an exemplary-use environment wherein the beveled IBS bone compression screw 180 has been implanted in the bone hole by way of the MIS beveled driver 100 in accordance with the present disclosure. As shown in Fig. 12, the beveled IBS bone compression screw 180 and the beveled driver 100 may be inserted through the soft tissue protection sleeve 160 and implanted into the bone hole until the proximal head portion 124 is flush with the surrounding cortical surface 168. As shown in Fig. 13, the proximal head portion 124 being flush with the cortical surface 168 can be confirmed by using fluoroscopy to verify that a gap of about 1mm exists between the cortical surface 168 and the radio marker 136 (see Fig. 6). As mentioned herein, the 1mm gap may allow the surgeon to insert the screw farther as needed.

[0044] Figure 14 illustrates an exemplary -use environment wherein an exemplary embodiment of a beveled IBS bone compression screw 180 is being implanted across a bone fracture 184 by way of an exemplary embodiment of an MIS beveled driver 100, according to the present disclosure. As shown in Fig. 14, the beveled IBS bone compression screw 180 has been implanted into the bone 148 until the proximal head portion 124 is flush with the surrounding bone surface. That the proximal head portion 124 is flush with the cortical surface 168 is confirmed by using fluoroscopy to verify that a gap of about 1mm exists between the bone surface and the radio marker 136 (see Fig. 6). As shown in Fig. 15, once the beveled driver 100 is removed from the patient, the beveled IBS bone compression screw 180 fixates the bone fracture 184 while the proximal head portion 124 remains flush with the surrounding bone surface.

[0045] While the MIS beveled driver and methods have been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the MIS beveled driver is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the MIS beveled driver. Additionally, certain of the steps may be performed concurrently in a parallel process, when possible, as well as performedsequentially as described above. To the extent there are variations of the MIS beveled driver, which are within the spirit of the disclosure or equivalent to the MIS beveled driver found in the claims, it is the intent that this patent will cover those variations as well. Therefore, the present disclosure is to be understood as not limited by the specific embodiments described herein, but only by scope of the appended claims.

Claims

CLAIMSWhat is claimed is:

1. An apparatus for an MIS beveled driver for implanting a beveled screw in bone, comprising: an elongated driver shaft that extends from a shaped distal end to a proximal handle; a beveled sleeve including an angled distal-most surface adjacent to the shaped distal end; and one or more beveled marks disposed on the driver shaft to indicate an orientation of the beveled sleeve.

2. The apparatus of claim 1, wherein the shaped distal end comprises a Torx driver shaft configured to couple with a Torx-shaped opening in the beveled screw.

3. The apparatus of claim 1 , wherein the beveled sleeve is configured to ensure that the beveled screw can only be assembled with the shaped distal end in a single orientation.

4. The apparatus of claim 3, wherein the single orientation comprises a proximal head portion of the beveled screw being aligned with the one or more beveled marks.

5. The apparatus of claim 1, wherein the beveled screw includes a proximal head portion that is disposed at an angle that mates with an angle of the distal-most surface.

6. The apparatus of claim 5, wherein the angle of the proximal head portion and the angle of the distal-most surface are configured to ensure that the beveled screw can only be assembled with the shaped distal end in a single orientation.

7. The apparatus of claim 6, wherein the single orientation is configured to enable implanting the beveled screw such that the proximal head portion is flush with the surrounding bone surface.

8. The apparatus of claim 1, wherein the beveled sleeve is affixed to the driver shaft such that the angle of the distal-most surface remains aligned with the one or more beveled marks.

9. The apparatus of claim 1, wherein the beveled sleeve includes a radio marker on a beveled surface that is disposed about 1mm proximal of the distal-most surface.

10. The apparatus of claim 9, wherein the radio marker is configured to enable observation of the position and orientation of the beveled screw by way of fluoroscopy.

11. A method for an MIS beveled driver for implanting a beveled screw into bone, comprising: forming an elongated driver shaft that extends from a shaped distal end to a proximal handle; configuring a beveled sleeve including an angled distal-most surface adjacent to the shaped distal end; and disposing one or more beveled marks on the driver shaft to indicate an orientation of the beveled sleeve.

12. The method of claim 11, wherein forming the elongated driver shaft includes configuring the shaped distal end to comprise a Torx driver shaft to couple with a Torx-shaped opening in the beveled screw.

13. The method of claim 11, wherein configuring the beveled sleeve includes ensuring that the beveled screw can only be assembled with the shaped distal end in a single orientation.

14. The method of claim 13, wherein configuring the beveled sleeve includes ensuring that a proximal head portion of the beveled screw can only be aligned with the one or more beveled marks.

15. The method of claim 11, wherein configuring the beveled sleeve includes disposing the angled distal-most surface and at an angle that mates with the beveled screw.

16. The method of claim 15, wherein disposing the angled distal -most surface includes ensuring that the beveled screw can only be assembled with the shaped distal end in a single orientation.

17. The method of claim 16, wherein disposing the angled distal -most surface includes configuring the single orientation to enable implanting the beveled screw such that the proximal head portion is flush with the surrounding bone surface.

18. The method of claim 11, wherein configuring the beveled sleeve includes affixing the beveled sleeve to the driver shaft such that the angle of the distal -most surface remains aligned with the one or more beveled marks.

19. The method of claim 11, wherein configuring the beveled sleeve includes configuring a radio marker on a beveled surface that is disposed about 1mm proximal of the distal-most surface.

20. The method of claim 19, wherein configuring the radio marker includes configuring the radio marker to enable observation of the position and orientation of the beveled screw by way of fluoroscopy.

Citation Information

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