Implants and instruments with flexible features
11596525 · 2023-03-07
Assignee
Inventors
- Jennifer Anne Moore (Leesburg, VA, US)
- Todd M. Wallenstein (Ashburn, VA, US)
- Clint Boyd (Leesburg, VA, US)
- Jordan Floyd (Westlake, OH, US)
- Patrick Ayerle (Severna Park, MD, US)
Cpc classification
A61F2/4455
HUMAN NECESSITIES
A61F2/447
HUMAN NECESSITIES
International classification
Abstract
According to one embodiment of the disclosure, an implant includes a body having a surface with a flexible pattern defined by a plurality of material segments including a first material segment and a second material segment. The first material segment abuts the second material segment. Further, the first material segment includes a first non-linear shape extending between a first end and a second end while the second material segment includes a second non-linear shape extending between a first end and a second end. The two material segments are interconnected such that one of the first end and the second end of the first non-linear shape is interconnected with one of the first end and the second end of the second non-linear shape.
Claims
1. An intervertebral implant comprising: an upper endplate, a lower endplate opposite the upper endplate and an intermediate support connecting the upper endplate and the lower endplate, the upper endplate and the lower endplate defining a void therebetween, wherein the upper and lower endplates are both adapted to contact a vertebral body of a spine; and a first portion on one of the upper endplate and the lower endplate, the first portion including a first flexible surface with a plurality of segments that define a plurality of slits, the plurality of slits including a first slit and a second slit, the first slit crossing the second slit between first and second ends of the second slit, wherein the first portion inclusive of each of the plurality of segments is monolithic, and wherein the first flexible surface has a surface contour that changes as a function of force borne by the first flexible surface such that when the intervertebral implant is disposed between vertebral bodies, the first flexible surface deforms to adapt to the contours of a bone surface bearing thereon.
2. The intervertebral implant of claim 1, wherein the first flexible surface is flexible in a direction transverse to a plane that is approximately aligned with the first flexible surface.
3. The intervertebral implant of claim 1, wherein the first slit has a length extending from a first enclosed end to a second enclosed end opposite the first enclosed end.
4. The intervertebral implant of claim 1, wherein the plurality of segments include a first segment, a second segment, a third segment and a fourth segment, each segment extending radially from a first location and each segment being oriented differently relative to the first location than the other segments.
5. The intervertebral implant of claim 4, wherein the plurality of segments are positioned such that a first axis passing through a first midpoint of a first length of the first segment and a second midpoint of a second length of the second segment is orthogonal to a second axis passing through the first midpoint of the first segment and a third midpoint of a third length of the third segment.
6. The intervertebral implant of claim 1, wherein the plurality of segments interconnect to form rows and columns.
7. The intervertebral implant of claim 4, wherein each of the first, second, third and fourth segments have the same shape.
8. The intervertebral implant of claim 1, further comprising a second flexible surface with a second plurality of slits, the second flexible surface being different from the first flexible surface.
9. The intervertebral implant of claim 4, wherein the first segment includes a first portion, a second portion and a third portion, the first portion being linear and oriented in a first direction, the second portion being linear and oriented in a second direction different from the first direction, and the third portion being linear and oriented in a third direction different from the second direction.
10. The intervertebral implant of claim 1, further comprising at least one non-flexible surface.
11. The intervertebral implant of claim 1, wherein each of the plurality of slits extend entirely through the one of the upper endplate and the lower endplate of the intervertebral implant.
12. The intervertebral implant of claim 11, wherein the plurality of slits include at least two slits that are oriented at different angles relative to the first flexible surface.
13. A method of using an intervertebral implant comprising: providing the intervertebral implant, the intervertebral implant including a first endplate having a flexible surface, the flexible surface including a first slit with a first length extending between a first enclosed end and a second enclosed end and a second slit with a second length extending between a third enclosed end and a fourth enclosed end, the second slit intersecting the first slit between the first and second enclosed ends, wherein the flexible surface is a monolithic surface; inserting the intervertebral implant into a final operative location within a patient such that the first endplate abuts a first vertebral body and a second endplate of the intervertebral implant abuts a second vertebral body, and deforming the first endplate of the intervertebral implant based on force applied to the flexible surface by the first vertebral body, the force causing a uniform surface contour of the flexible surface to become a non-uniform surface contour, wherein before, during and after the deformation, the first, second, third and fourth enclosed ends remain enclosed such that each enclosed end remains a terminal end of a respective slit in the flexible surface.
14. The method of claim 13, wherein deforming the endplate of the intervertebral implant occurs while the intervertebral implant is being disposed in the final operative location, the flexible surface conforming to a shape of a surface that applies force to the flexible surface.
15. The method of claim 13, wherein deforming occurs only in the flexible surface and a peripheral surface of the first endplate retains its shape before and after being subject to force.
16. The method of claim 13, wherein providing the intervertebral implant includes providing the first endplate such that the first endplate including an entirety of the flexible surface is monolithic.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
(1) Various embodiments of the present disclosure are described herein below with reference to the drawings, wherein:
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DETAILED DESCRIPTION
(53) Various embodiments will now be described in detail with reference to the drawings, wherein like reference numerals identify similar or identical elements. Additionally, in the drawings and in the description that follows, terms such as front, rear, upper, lower, top, bottom, and the similar directional terms are used simply for convenience of description and are not intended to limit the disclosure attached hereto.
(54) In the drawings and in the description that follows, the term “proximal” refers to the portion of the device that is closest to the operator, while the term “distal” refers to the portion of the device that is furthest from the operator. Additionally, in the drawings and in the description that follows, terms such as front, rear, upper, lower, top, bottom, and the similar directional terms are used simply for convenience of description and are not intended to limit the disclosure attached hereto. In addition, the term “cephalad” is used to indicate a direction toward a patient's head, whereas the term “caudad” indicates a direction toward the patient's feet. Further still, the term “medial” indicates a direction toward the middle of the body of the patient, whilst the term “lateral” indicates a direction toward a side of the body of the patient (i.e., away from the middle of the body of the patient). The term “posterior” indicates a direction toward the patient's back, and the term “anterior” indicates a direction toward the patient's front. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
(55) Flexible Interbody
(56) In one aspect, the present disclosure is directed an interbody comprising at least one surface with a flexible pattern, wherein the flexible pattern includes a continuous line of material. The flexibility of a surface can be determined by various techniques including determining the stiffness of a surface, i.e., the resistance of a surface to elastic deformation. Stiffness is a measure of the applied force divided by the deflection of the surface. Variables associated with the flexible pattern can alter the stiffness of the surface. By selecting certain variables, a specific stiffness can be achieved in response to a given load. The flexible pattern can provide a stiffness to a surface that can be measured, for example, using a compressive load. The stiffness of a surface including a flexible pattern relative to another surface without the flexible pattern can vary from about 25% to about 100%, for example, from about 35% to about 90%, and as a further example from about 50% to about 80%.
(57) Referring now to
(58) The body 102 can be configured such that the top and bottom vertebral engaging surfaces 112a, 112b intersect the side surfaces 162a, 162b, respectively, to provide a substantially quadrilateral cross-section with rounded corners 140, as illustrated in
(59) In another aspect, the body 102 can be configured such that the top and bottom vertebral engaging surfaces 112a, 112b intersect posts 106, to provide support to the body 102 with minimal structural elements, as illustrated in
(60) The body 102 can also be configured such that the top and bottom vertebral engaging surfaces 112a, 112b have a convex profile, as illustrated in
(61) In an aspect, the top and bottom vertebral engaging surfaces 112a, 112b can be the same or different. In particular, each of the top and bottom vertebral engaging surfaces 112a, 112b can independently have a smooth configuration or a plurality of protrusions 122 in a particular configuration. A smooth configuration is shown in
(62) The interbody 100 can comprise at least one surface with a flexible pattern 200, in which the flexible pattern 200 includes a continuous line of material. As discussed herein, the interbody 100 can include top and bottom vertebral engaging surfaces 112a, 112b, post 106, side surfaces 162a, 162b, first end 104, and second end 108. The interbody 100 can include at least two surfaces each with a flexible pattern 200, as shown in
(63) Each surface of the interbody 100 can be independent from any other surface of the interbody 100 in terms of variables, such as degree of flexibility, degree of rigidity, density of the flexible pattern 200, form of the flexible pattern 200, thickness of the surface including the flexible pattern 200, and etc. One of these variables may impact another variable. For example, a thick top surface 112a with a flexible pattern 200 can have a higher degree of rigidity as compared to a thin bottom surface 112b with a flexible pattern 200 within the same interbody 100.
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(65) As another example, of how one variable of the flexible pattern 200 can effect another variable of the flexible pattern 200, an end surface 108 can have a dense flexible pattern 200 including curved line as shown in
(66) As shown in
(67) In another aspect as shown in
(68) In another aspect as shown in
(69) The flexible pattern 200 can flex under application of a force. In an aspect, a first area of the flexible pattern 200 can move in a direction relative to a second area of the flexible pattern 200 under an applied force.
(70) As shown in
(71) Other examples of flexible patterns with continuous lines of material are shown in
(72) In
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(74) The continuous line of material can be any biocompatible material, such as a metal, an alloy, a polymer, and combinations thereof, such as a blend of a metal and a polymer. The continuous line of material can have a uniform width. In an aspect, a width of the continuous line of material can vary. In an aspect, the continuous line of material can include straight areas and/or curved areas.
(75) In yet another arrangement, a flexible pattern includes a plurality of concentric cut outs as shown in
(76) In an aspect, the gaps, also referred to herein as cut outs, in the interbody 100 that define the flexible pattern can be oriented at an acute angle relative to a surface of the interbody 100, as shown in
(77) In any of the contemplated embodiments, cut outs that define the flexible pattern may be formed entirely through a thickness of the body of the implant. Alternatively, the cut outs may be formed through only a portion of the thickness of the body. In further alternatives, some flexible patterns may be defined by cut outs entirely through the thickness while others are formed through only a portion of the thickness. In still further alternatives, any one flexible pattern may include a first portion with cut outs through the thickness of the body and a second portion with cut outs through only part of a thickness of the body.
(78) The at least one surface including a flexible pattern 200 can be formed by known manufacturing methods, such as additive layer manufacturing, e.g., three-dimensional printing, chemical etching, photo etching, laser cutting, water jet cutting, and traditional machining, etc. Examples of additive layer manufacturing (ALM) techniques include electron beam melting, selective laser sintering (SLS), selective laser melting (SLM), and other three-dimensional (3-D) processes. When employing these technologies, articles are produced in layer-wise fashion from a laser-fusible powder that is dispensed one layer at a time. The powder is sintered in the case of SLS technology and melted in the case of SLM technology, by the application of laser energy that is directed in raster-scan fashion to portions of the powder layer corresponding to a cross section of the article. After the sintering or melting of the powder on one particular layer, an additional layer of powder is dispensed, and the process repeated, with sintering or melting taking place between the current layer and the previously laid layers until the article is complete. In one example, a high energy beam is emitted from a beam-generating apparatus to heat metal powder sufficiently to sinter and preferably to at least partially melt or fully melt the metal powder. High energy beam equipment for manufacturing such structures may be one of many commercially available. The beam generation equipment may also be a custom-produced laboratory device. Detailed descriptions of the SLS technology may be found in U.S. Pat. Nos. 4,863,538, 5,017,753, 5,076,869, and 4,944,817, the entire disclosures of which are incorporated by reference herein. Similarly, a detailed description of the use of SLM technology may be found in U.S. Pat. No. 7,537,664 (“the '664 patent”), the disclosure of which is incorporated by reference herein. The SLM and SLS technologies enable direct manufacture of solid or porous three-dimensional articles of high resolution and dimensional accuracy from a variety of materials including wax, metal and metal alloys, metal powders with binders, polycarbonate, nylon, other plastics and composite materials, such as polymer-coated metals and ceramics.
(79) Other non-powder based additive manufacturing technologies are also known to produce high resolution and dimensionally accurate articles. For example, in fused filament fabrication (FFF) or Plastic Jet Printing (PJP), strands of molten material are extruded from a nozzle to form layers onto a substrate in which the material hardens upon extrusion. Using digital light processing (DLP), photosensitive resin plastic is cured by light and built layer by layer from the bottom-up or a vat of liquid polymer is exposed to balanced levels of ultraviolet light and oxygen to produce a part often from the top-down. In inkjet 3D printing, a liquid binding material is selectively deposited across a thin layer of a powder and the process is repeated in which each new layer is adhered to the previous layer.
(80) As shown in
(81) The flexible pattern 200 can transition from a perimeter to an interior so that the perimeter is more flexible than the interior and vice versa. For example, the flexible pattern 200 can transition from a less dense, i.e., farther apart, pattern at a perimeter to a more dense, i.e., closer together, pattern at an interior of the at least one surface. As a further example, the flexible pattern 200 can transition from a more dense, i.e., closer together, pattern at a perimeter to a less dense, i.e., farther apart, pattern at an interior of the at least one surface. The transition of the flexible pattern 200 can be equivalent from a perimeter to an interior and vice versa. The transition of the flexible pattern 200 can be graduated so that there are gradient zones of varying flexibility across the at least one surface.
(82) The at least one surface can include alternating sections. For example, a first section of the at least one surface can be more rigid. A second section can be adjacent to the first section and can be more flexible. The number of alternating rigid and flexible sections can vary. The at least one surface can be more rigid depending upon variables, such as the density of the pattern and/or the thickness of the material used to form the pattern. Similarly, the at least one surface can be more flexible with, for example, a less dense pattern and/or a thinner material used to form the pattern. In another aspect, the at least one surface can include an alternating section of a first section with a flexible pattern 200 and a second section without a flexible pattern 200.
(83) The at least one surface can have a uniform thickness, such as shown in the top engaging surface 112a in
(84) Notwithstanding the presence of the flexible pattern 200, the at least one surface can be smooth or include the plurality of projections 122. A smooth surface can be even and regular, i.e., it does not include any projections 122 from the at least one surface. An array of projections 122 can inhibit movement of the interbody 102 when positioned in place. In an aspect, the interbody 100 has at least one smooth surface. In another aspect, the interbody 100 has at least one smooth surface with a flexible pattern. In another aspect, the interbody 100 has a least one surface with a flexible pattern and a plurality of projections. In another aspect, the interbody has at least one surface with a plurality of projections.
(85) In an aspect, the interbody 100 can be symmetric. For example, the interbody 100 can be symmetric with respect to two surfaces each with a flexible pattern 200, e.g., can have the exact same surface and flexible pattern 200 opposite one another, such as a top surface 112a with a flexible pattern 200 that is exactly the same in all variables as a bottom surface 112b with a flexible pattern 200.
(86) In another aspect, the interbody 100 can be asymmetric. For example, the interbody 100 can be asymmetric with respect to two surfaces with a flexible pattern 200, e.g., can have a different surface with a flexible pattern 200 opposite one another, such as a top surface 112a that is different with respect to one variable as a bottom surface 112b.
(87) In an aspect, the interbody 100 can include at least one surface and at least one post 106. For example, the at least one post 106 can be positioned under a center of the interior of the at least one surface, as shown in
(88) The interbody 100 can include at least one surface having a radius of curvature forming a curved surface. The curved surface can be a smooth surface or a surface having an array of projections 122. The curved surface can also be at least one surface with a flexible pattern 200. The curved surface can have a radius of curvature defining a convex surface. The curved surface can have a radius of curvature defining a concave surface. If the interbody 100 includes two or more curved surfaces, each curved surface may be the same or different. For example, the radius of curvature can be the same or different for each curved surface.
(89) In another aspect, the interbody 100 can be distractible. Distractible interbodies are described in the following U.S. patents, the entirety of their disclosures are hereby incorporated by reference: U.S. Pat. Nos. 8,303,663; 8,932,302; 8,636,746; 8,771,360; 9,358,125; 9,474,626; and 9,498,270.
(90) The interbody 100 can be filled with a bone support matrix. As used herein, a “bone support matrix” is a material that facilitates osteogenesis. Suitable bone support matrices can be resorbable or nonresorbable and osteoconductive or osteoinductive. Non-limiting examples of suitable bone support matrices include synthetic materials, bone morphogenic proteins (BMPs), and heterologous, homologous, or autologous bone and derivatives thereof. The bone support matrix may be radiolucent on x-rays.
(91) In another aspect, the flexible interbody 100 is included in a method of placing an implant between vertebrae in a spine.
(92) Through the inclusion of a flexible pattern on an interbody, engagement of the interbody with adjacent vertebrae is improved. In particular, surfaces of the interbody deform to adapt to the contours of the bone surfaces so that a close fit is obtained.
(93) Fixation Member
(94) In another aspect, the present disclosure is directed to a fixation member 300, including a head 312, and at least one surface with a flexible pattern 400, wherein the flexible pattern includes a continuous line of material. The flexibility of a surface can be determined by various techniques including determining the stiffness of a surface, i.e., the resistance of a surface to elastic deformation. Stiffness is a measure of the applied force divided by the deflection of the surface. Variables associated with the flexible pattern can alter the stiffness of the surface. By selecting certain variables, a specific stiffness can be achieved in response to a given load. The flexible pattern can provide a stiffness to a surface that can be measured, for example, using a compressive load. The stiffness of a surface including a flexible pattern relative to another surface without the flexible pattern can vary from about 25% to about 100%, for example, from about 35% to about 90%, and as a further example from about 50% to about 80%.
(95) As shown in
(96) The head 312 can extend from a proximal end of the fixation member 300 into a body 314. The body 314 can extend from the head 312 to a distal end 316 of the fixation member 300. In an aspect, the body 314 can include a consistent diameter throughout a length of the body. In another aspect, the body 314 can taper from the head 312 to the distal end 316 of the fixation member 300. The body 314 of the fixation member 10 can include an exterior helical thread with surfaces that can engage with osseous tissue. The exterior helical thread of the body 314 may be same or different from the exterior helical thread of the head 312. For example, the exterior helical thread of the head 312 may form a tighter, denser helix as compared to the exterior helical thread of the body 314 or vice versa. Alternatively, the body 314 can include a smooth surface.
(97) The body 314 of the fixation member 300 can include a surface with a flexible pattern 400. The flexible pattern 400 can extend at least a quarter of a length of the fixation member 300. In another aspect, the flexible pattern 400 can extend at least a half of a length of the fixation member 300. The fixation member 300 can be configured and dimensioned to bend and/or flex when under stress, such as an applied force.
(98) The distal end 316 of the fixation member 300 can have a blunt end or a pointed end. The distal end 316 can also include any exterior helical thread that extends from the body 314. In another aspect, the distal end 316 can include a non-flexible surface, e.g., a surface absent the flexible pattern 400.
(99) The fixation member 300 can include at least one surface with a flexible pattern 400, in which the flexible pattern 400 includes a continuous line of material.
(100) The fixation member 300 may be varied in many ways. As shown in
(101) The flexible pattern of material on the fixation member may be varied in many ways, such as those shown in
(102) In another aspect as shown in
(103) As shown in
(104) The continuous line of material can be any biocompatible material, such as a metal, an alloy, a polymer, and combinations thereof, such as a blend of a metal and a polymer. The continuous line of material can have a uniform width. In an aspect, a width of the continuous line of material can vary. In an aspect, the continuous line of material can include straight areas and/or curved areas.
(105) In further variations, the flexible pattern may also be as shown in
(106) The flexible pattern 400 can flex under application of a force or stress. In an aspect, a first area of the flexible pattern 400 can move in a direction relative to a second area of the flexible pattern 400 under an applied force, as shown in
(107) The fixation member 300 can be formed by known manufacturing methods, such as additive layer manufacturing, e.g., three-dimensional printing, chemical etching, photo etching, laser cutting, water jet cutting, and traditional machining, etc. Additive layer manufacturing may be performed in any of the ways described above, for example.
(108) The flexible pattern 400 can be the same or different and/or can be present or absent across the at least one surface of the fixation member 300. In an aspect, the flexible pattern 400 can be present across the entire surface or can be present in sections, as shown in
(109) The flexible pattern 400 can transition from a less dense, i.e., farther apart, pattern at a proximal end of the body 314 to a denser, i.e., closer together, pattern at a distal end of the body 314. The transition of the flexible pattern 400 along a length of the body 314 can be equivalent from a proximal end to a distal end of the body 314 and vice versa. The transition of the flexible pattern 400 can also be graduated so that there are gradient zones of varying flexibility across the body 314 of the fixation member 300.
(110) A method of using the fixation member 300 includes, forming an insertion hole in osseous tissue, such as a vertebra. For example, a user can use a drill or probe to form the insertion hole. Alternatively, a user can probe the osseous tissue using the fixation member 300 itself using a driver (not shown). The fixation member 300 can be inserted into the insertion hole. In an aspect, the fixation member 300 can be inserted into the insertion hole until the head 312 is within the vertebra. A user can then affix a driver (not shown) into the head 312 of the fixation member 300 and apply a force to the driver. The applied force can rotate the fixation member 300 about its longitudinal axis so that the exterior helical threads of the body 314 and/or the head 312 engage with the osseous tissue. If the fixation member 300 experiences stress, for example, by the distal end 316 abutting the osseous tissue, the fixation member 300 will flex/bend under the force, as shown in
(111) Through the inclusion of a flexible pattern on a fixation member, the fixation member is advantageous as it provides a greater number of possibilities for an insertion angle and ultimately reduces the size of incision required to implant the fixation member.
(112) Flexible Instrument
(113) In one aspect, the present disclosure is directed to a flexible instrument 500 comprising at least one surface with a flexible pattern 600, wherein the flexible pattern 600 includes a continuous line of material. The flexible instrument 500 can be any instrument with the at least one surface with a flexible pattern 600, such as a retractor blade. The flexibility of a surface can be determined by various techniques including determining the stiffness of a surface, i.e., the resistance of a surface to elastic deformation. Stiffness is a measure of the applied force divided by the deflection of the surface. Variables associated with the flexible pattern 600 can alter the stiffness of the surface. By selecting certain variables, a specific stiffness can be achieved in response to a given load. The flexible pattern 600 can provide a stiffness to a surface that can be measured, for example, using a compressive load. The stiffness of a surface including a flexible pattern 600 relative to another surface without the flexible pattern can vary from about 25% to about 100%, for example, from about 35% to about 90%, and as a further example from about 50% to about 80%.
(114) The flexible instrument 500 can include an arm 512, and an elongated portion 514, as shown in
(115) The elongated portion 514 can extend from the arm 512. The elongated portion 514 can include any height and width so long as the elongated portion 514 does not inhibit a view of a surgical field. In an aspect, the height and width of the elongated portion 514 should be configured and dimensioned to improve retraction of tissue in a surgical field.
(116) In an aspect, the elongated portion 514 can include a distal end 516. The distal end 516 can include a curved surface. In an aspect, the curved surface of the distal end 516 can be configured and dimensioned to engage with tissue. For example, the distal end 516 can include a plurality of teeth 520.
(117) The elongated portion 514 of the flexible instrument 500 can have at least one surface including a flexible pattern 600. In an aspect, the flexible pattern 600 can be present across the entire surface of the elongated portion 514, as shown in
(118) The flexible pattern 600 can extend at least a quarter of a length of the elongated portion 514. In another aspect, the flexible pattern 600 can extend at least a half of a length of the elongated portion 514. In an aspect, the flexible pattern 600 can extend an entire length of the elongated portion 514, such as from the arm 512 to the distal end 516. The flexible instrument 500 can be configured and dimensioned to bend and/or flex when under stress, such as an applied force.
(119) In an aspect, the flexible instrument 500 can include an elongated portion 514 with a non-flexible surface 518 that extends up to 25% of a length of the elongated portion 514 and the remainder of the length (75%) of the elongated portion 514 can include the flexible pattern 600.
(120) In another aspect not shown, the flexible instrument 500 can include an elongated portion 514 with a flexible pattern 600 near the arm 512 and the distal end 516, and a non-flexible surface in between the flexible pattern 600. In a further aspect, the flexible instrument 500 can include an elongated portion 514 with a non-flexible surface 518 near the arm 512 and the distal end 516, and a flexible pattern 600 in between the non-flexible surface 518 areas, as shown in
(121) The flexible pattern of material on the flexible instrument may be varied in many ways, such as those shown in
(122) In another aspect as shown in
(123) Also shown in
(124) The continuous line of material can be any biocompatible material, such as a metal, an alloy, a polymer, and combinations thereof, such as a blend of a metal and a polymer. The continuous line of material can have a uniform width. In an aspect, a width of the continuous line of material can vary. In an aspect, the continuous line of material can include straight areas and/or curved areas.
(125) In further variations, the flexible pattern may also be as shown in
(126) The flexible instrument 500 can be formed by known manufacturing methods, such as additive layer manufacturing, e.g., three-dimensional printing, chemical etching, photo etching, laser cutting, water jet cutting, and traditional machining, etc. Additive layer manufacturing may be performed in any of the ways described above, for example.
(127) The flexible pattern 600 can transition from a less dense, i.e., farther apart, pattern near the arm 512 of the elongated portion 514 to a denser, i.e., closer together, pattern at a distal end 516 of the elongated portion 514. The transition of the flexible pattern 600 along a length of the elongated portion 514 can be equivalent from near the arm 512 to a distal end 16 and vice versa. The transition of the flexible pattern 600 can also be graduated so that there are gradient zones of varying flexibility along a length of the elongated portion 514 of the flexible instrument 500.
(128) As shown in
(129) The flexible pattern 600 can transition from a perimeter to an interior so that the perimeter is more flexible than the interior and vice versa. For example, the flexible pattern 600 can transition from a less dense, i.e., farther apart, pattern at a perimeter to a denser, i.e., closer together, pattern at an interior of the at least one surface. As a further example, the flexible pattern 600 can transition from a denser, i.e., closer together, pattern at a perimeter to a less dense, i.e., farther apart, pattern at an interior of the at least one surface. The transition of the flexible pattern 600 can be equivalent from a perimeter to an interior and vice versa. The transition of the flexible pattern 600 can be graduated so that there are gradient zones of varying flexibility across the at least one surface.
(130) The at least one surface can include alternating sections. For example, a first section of the at least one surface can be more rigid. A second section can be adjacent to the first section and can be more flexible. The number of alternating rigid and flexible sections can vary. The at least one surface can be more rigid depending upon variables, such as the density of the pattern and/or the thickness of the material used to form the pattern. Similarly, the at least one surface can be more flexible with, for example, a less dense pattern and/or a thinner material used to form the pattern. In another aspect, the at least one surface can include an alternating section of a first section with a flexible pattern 600 and a second section with a non-flexible surface 118.
(131) The at least one surface can have a uniform thickness, such as shown in the elongated portion 514 in
(132) In particular,
(133) In another aspect, flexible instrument 500 may be used in a method of retraction to create or modify a portal to a surgical site within a patient. Increased flexural properties on customized areas of the instrument provide a final retracted space for use in access to the surgical site that is closer to a desired size than would be possible without the flexural properties provided by the flexible regions.
(134) One reason flexible instrument 500 is advantageous is that the inclusion of a flexible pattern surface provides the instrument with increased versatility, reducing surgical steps requiring both hands of a surgeon and otherwise minimizing a size of incision required for use of the instrument.
(135) Flexible Rod
(136) In one aspect, the present disclosure is directed to rod 700 including a first end 712, a second end 716, and a body 714 with a flexible pattern 800, wherein the flexible pattern 800 includes a continuous line of material. The flexibility of a surface can be determined by various techniques including determining the stiffness of a surface, i.e., the resistance of a surface to elastic deformation. Stiffness is a measure of the applied force divided by the deflection of the surface. Variables associated with the flexible pattern can alter the stiffness of the surface. By selecting certain variables, a specific stiffness can be achieved in response to a given load. The flexible pattern can provide a stiffness to a surface that can be measured, for example, using a compressive load. The stiffness of a surface including a flexible pattern relative to another surface without the flexible pattern can vary from about 25% to about 100%, for example, from about 35% to about 90%, and as a further example from about 50% to about 80%.
(137) As shown in
(138) The rod 700 can have a body 714 with a surface including a flexible pattern 800. In an aspect, the flexible pattern 800 can be present across the entire surface of the body 714 or can be present in sections, as shown in
(139) The flexible pattern 800 can extend at least a quarter of a length of the body 714. In another aspect, the flexible pattern 800 can extend at least a half of a length of the body 714, as shown in
(140) In an aspect, the rod 700 can include a body 714 with a non-flexible surface 718 that extends up to 25% of a length of the body 714 and the remainder of the length (75%) of the body 714 can include the flexible pattern 800, as shown in
(141) In another aspect, the rod 700 can include a body 714 with a flexible pattern 800 near the first end 712 and the second end 716, and a non-flexible surface 718 in between the flexible pattern 800, as shown in
(142) As shown in
(143) The rod 700 can include a surface with a flexible pattern 800, in which the flexible pattern 800 includes a continuous line of material, as shown in
(144) In another aspect as shown in
(145) As shown in
(146) The continuous line of material can be any biocompatible material, such as a metal, an alloy, a polymer, and combinations thereof, such as a blend of a metal and a polymer. The continuous line of material can have a uniform width. In an aspect, a width of the continuous line of material can vary. In an aspect, the continuous line of material can include straight areas and/or curved areas.
(147) In further variations, the flexible pattern may also be as shown in
(148) The rod 700 can be formed by known manufacturing methods, such as additive layer manufacturing, e.g., three-dimensional printing, chemical etching, photo etching, laser cutting, water jet cutting, and traditional machining, etc. Additive layer manufacturing may be performed in any of the ways described above, for example.
(149) The flexible pattern 800 can transition from a less dense, i.e., farther apart, pattern at a first end of the body 714 to a denser, i.e., closer together, pattern at a second end of the body 714. The transition of the flexible pattern 800 along a length of the body 714 can be equivalent from a first end to a second end of the body 714 and vice versa. The transition of the flexible pattern 800 can also be graduated so that there are gradient zones of varying flexibility along a length of the body 714 of the rod 700.
(150) In another aspect, the rod 700 may be used in a method of spinal alignment correction as an element to interconnect bone anchors on adjacent vertebrae. During adjustment of the rod during a procedure, the rod may bend to render adjustment simpler. With the rod, less force is required to adjust the rod relative to a rod without flexible regions.
(151) One advantage of the flexible rod is its versatility during use in surgery. In particular, adjustment of the rod position to accommodate anchor placement is less difficult in view of the flexible regions on the rod.
(152) Corpectomy
(153) In one aspect, the present disclosure is directed an adjustable cage device 900 comprising at least one surface 915 with a flexible pattern 1000, wherein the flexible pattern 1000 includes a continuous line of material. The adjustable cage device 900 can be a foldable cage, such as shown in
(154)
(155) The at least one endplate 920 can include an exterior surface that can be smooth (not shown) or can include a plurality of projections 922, as shown in
(156) In an aspect, the adjustable cage device 900 has an endplate 920 including at least one smooth surface. In another aspect, the adjustable cage device 900 has an endplate 920 including at least one smooth surface with a flexible pattern 1000. In another aspect, the adjustable cage device 900 has an endplate 920 including a least one surface with a flexible pattern 1000 and a plurality of projections 922, as shown in
(157) The endplate 920 can include an interior surface that includes a channel 930 that extends along an inner edge of the endplate 920. For example, as shown in
(158) The endplate 920 can vary in dimension. In an aspect, the endplate 920 can be any shape, such as a circle, a square, a triangle, or any other polygon. In another aspect, the endplate 920 can be any size. The adjustable cage device 900 can range from about 10 mm to about 60 mm, for example from about 12 mm to about 20 mm. The adjustable cage device 900 can also be a rectangular size ranging from about 11 mm×11 mm to about 45 mm×50 mm, such as from about 12 mm×14 mm to about 17 mm×20 mm. During an operation, a user can select from various sized endplates 920 and from various surfaces including the flexible pattern 1000 to make a suitable adjustable cage device 900 for the patient.
(159) As shown in
(160)
(161) As shown in
(162) In an aspect, an initial height of the adjustable cage device 900 can range from about 12 mm to about 130 mm. One of ordinary skill in the art will appreciate that the initial height of an adjustable cage device 900 can be based in part upon the initial footprint of the adjustable cage device 900. For example, an adjustable cage device 900 with a smaller footprint will likely have a smaller initial height. The initial height of the adjustable cage device 900 can be increased by, for example, an additional 4 mm. One of ordinary skill in the art will understand that the height of the adjustable cage device 900 can be increased in any increment from 0 mm and 16 mm, such as for example from about 0.5 mm to about 15.5 mm, from about 1.0 mm to about 14.0 mm, and as another example from about 2.0 mm to about 13.0 mm.
(163) In an aspect, an angle of the top surface 970 of the adjustable cage device 900 can also be adjusted. In an aspect, an initial angle of the top surface 970 of the adjustable cage device 900 can be 0° with respect to an x-axis, as shown in
(164) The adjustable cage device 900 can be filled with a bone support matrix.
(165) The housing 950 can include an elongate body and defining a longitudinal passage (not shown). The longitudinal passage can be dimensioned and configured to receive at least a portion of the support member 960. For example, a wall of the longitudinal passage can include a helical thread dimensioned and configured to engage with an external helical thread present on the support member 960.
(166) The adjustable cage device 900 can include at least one surface that can include a flexible pattern 1000, wherein the flexible pattern 1000 includes a continuous line of material. As shown in
(167) The flexible pattern 1000 can be present on an entire surface, as shown in
(168) The flexible pattern of material on the adjustable cage device may be varied in many ways, such as those shown in
(169) In another aspect as shown in
(170) In another aspect as shown in
(171) As shown in
(172) The continuous line of material can be any biocompatible material, such as a metal, an alloy, a polymer, and combinations thereof, such as a blend of a metal and a polymer. For example, the continuous line of material may be made of polyetheretherketone (PEEK), titanium, stainless steel, cobalt chrome, polymeric materials, a combination thereof, or any other suitable material. The continuous line of material can have a uniform width. In an aspect, a width of the continuous line of material can vary. In an aspect, the continuous line of material can include straight areas and/or curved areas.
(173) In further variations, the flexible pattern may also be as shown in
(174) The at least one surface including a flexible pattern 1000 can be formed by known manufacturing methods, such as additive layer manufacturing, e.g., three-dimensional printing, chemical etching, photo etching, laser cutting, water jet cutting, and traditional machining, etc. Additive layer manufacturing may be performed in any of the ways described above, for example.
(175) The flexible pattern 1000 can flex under application of a force. In an aspect, a first area of the flexible pattern 1000 can move in a direction relative to a second area of the flexible pattern 1000 under an applied force.
(176) Each surface of the adjustable cage device 900 can be independent from any other surface of the adjustable cage device 900 in terms of variables, such as degree of flexibility, degree of rigidity, density of the flexible pattern 1000, form of the flexible pattern 1000, thickness of the surface including the flexible pattern 1000, and etc. One of these variables may impact another variable. For example, a thick housing 950 with a flexible pattern 1000 can have a higher degree of rigidity as compared to a thin top plate 970 with a flexible pattern 1000 within the same adjustable cage device 900.
(177) In
(178) As another example, of how one variable of the flexible pattern 1000 can effect another variable of the flexible pattern 1000, a housing 950, as shown in
(179) As shown in
(180) The flexible pattern 200 can transition from a perimeter to an interior so that the perimeter is more flexible than the interior and vice versa. For example, the flexible pattern 200 can transition from a less dense, i.e., farther apart, pattern at a perimeter to a denser, i.e., closer together, pattern at an interior of the at least one surface. As a further example, the flexible pattern 200 can transition from a denser, i.e., closer together, pattern at a perimeter to a less dense, i.e., farther apart, pattern at an interior of the at least one surface. The transition of the flexible pattern 200 can be equivalent from a perimeter to an interior and vice versa. The transition of the flexible pattern 200 can be graduated so that there are gradient zones of varying flexibility across the at least one surface.
(181) The at least one surface can include alternating sections. For example, a first section of the at least one surface can be more rigid. A second section can be adjacent to the first section and can be more flexible. The number of alternating rigid and flexible sections can vary. The at least one surface can be more rigid depending upon variables, such as the density of the pattern and/or the thickness of the material used to form the pattern. Similarly, the at least one surface can be more flexible with, for example, a less dense pattern and/or a thinner material used to form the pattern. In another aspect, the at least one surface can include an alternating section of a first section with a flexible pattern 200 and a second section without a flexible pattern 200.
(182) The at least one surface can have a uniform thickness. In another aspect, the at least one surface can have a thickness that varies. The thickness can vary by sections. For example, the at least one surface can have a first section that is thin adjacent to a second section that is thick (compared to the first section). The thin/thick sections can alternate across the at least one surface and can affect the flexibility of the at least one surface. In another aspect, the thickness can vary along a gradient of the at least one surface, such as from thick to thin or vice versa. It is expected that a section of the at least one surface that is thicker than another section will also be more rigid. Similarly, it is expected that a section of the at least one surface that is thinner than another section will also be more flexible, as shown in
(183) In another aspect, the adjustable cage device 900 is used in a method of performing a corpectomy.
(184) The adjustable cage device 900 is advantageous in that the flexible regions on the device are adaptable to natural and varying curvature and dimensions of a spine of a patient. For example, upper and lower surfaces of the device adapt to conform to a bone surface of a vertebra opposite a device surface when the device is positioned within the spine. This reduces or eliminates problems associated with gaps between a cage device and adjacent vertebral bodies.
(185) Other Implant Structures
(186) In one aspect, the present disclosure relates to a flexible interbody 1100 as shown in
(187) In another aspect, the present disclosure relates to a plate 1300 as illustrated in
(188) In yet another aspect, the present disclosure relates to a plate 1500 shown in
(189) In another aspect, the present disclosure relates to a knee implant system 1700 that includes a femoral component 1710 and a tibial component 1750. Femoral component 1710 includes a condyle portion 1712, a contact portion 1714 and an anterior portion 1716. In this arrangement, each angulation on an interior surface of femoral component 1710 includes a surface with a flexible pattern thereon. Specifically, and as shown in
(190) As with other aspects of the disclosure described above, the cut outs of the flexible pattern of each implant may all be perpendicular to a surface with the flexible pattern, some may be at an acute angle relative to the surface, or the cut outs may be any combination of orientations as described above. Further, the cut outs may be partially or entirely through a thickness of the structure, such as an outer wall structure, as described above. Further, the implants may be formed by known manufacturing methods, such as additive layer manufacturing, e.g., three-dimensional printing, chemical etching, photo etching, laser cutting, water jet cutting, and traditional machining, etc. Additive layer manufacturing may be performed in any of the ways described above, for example.
(191) In another aspect, the present disclosure relates to an interbody implant 1900 shown in
(192) Each opening includes unique flexible features to allow engagement with an element inserted therein. Within opening 1922 is a continuous strip of material 1950 over a portion of opening perimeter, as shown in
(193) In any one of the above embodiments, a single structure with flexible surface regions may have two or more types of flexible patterns. Any combination of patterns described or otherwise contemplated herein may be included in these combinations.
(194) In another aspect, the present disclosure relates to a flexible surface that includes a flexible pattern. The material of the surface may be any contemplated for use in a surgical procedure. In one embodiment, the flexible pattern is as shown in
(195) Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present disclosure as defined by the appended claims.