En bloc distractor and method of using same
Patent Information
- Authority / Receiving Office
- WO · WO
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2026-02-05
- Publication Date
- 2026-08-13
Smart Images
Figure US2026014079_13082026_PF_FP_ABST
Abstract
Description
EN BLOC DISTRACTOR AND METHOD OF USING SAMECROSS REFERENCES TO RELATED APPLICATIONS
[0001] The following application claims priority under 35 U.S.C. § 119 (e) to U.S. Provisional Patent Application Serial No. 63 / 754,832 filed February 6, 2025 entitled EN BLOC DISTRACTOR. The above-identified application is incorporated herein by reference in its entirety for all purposes.TECHNICAL FIELD
[0002] The present disclosure generally relates to an en bloc distractor and method of using same, and more particularly to an en bloc distractor for distraction and / or compression during a spinal fusion surgery and method of using same.BACKGROUND
[0003] Scoliosis is an abnormal lateral LAT curvature of the spine. In persons with scoliosis curvature of the spine occurs in at least one of a lumbar region, a thoracic region and / or a thoracic region of the spine 302. During spinal surgery to correct scoliosis or other spinal deformities or injuries, towers 310, 320 are often attached to pedicle screws 316, 326 to allow access to a pedicle screw- tulip head 312, 322 (see FIG. 1). The towers 310, 320 helps eliminate any challenges that may occur in placing rods 318 into a surgical exposure to engage with the pedicle screw- tulip heads 312, 322. The towers 310, 320 and tulip and screws 312, 322, 316, 326 are especially important in deeper wounds with minimal exposure as well as deformity correction surgery, such as scoliosis surgery-. Current distraction techniques place an applied force AF on aPage 1 of 29NCH-032840.F WO ORDsingle pedicle screw tulip head 312, 322 with a distractor device to distract the spine 302 relative to the rod 318, potentially compromising fixation and causing implant failure.SUMMARY
[0004] One aspect of the present disclosure comprises an en bloc distraction system. The en bloc distraction system comprising a first en bloc distractor, the first en bloc distractor having a first peripheral thickness and a lateral thickness, the first en bloc distractor having a first saddle coupled to a first handle, the first saddle defining a first seat for interacting with a rod coupled to a plurality of tulip heads and screws, said screws embedded in a vertebrae of a spine and a second en bloc distractor, the second en bloc distractor having a second peripheral thickness and the lateral thickness, the second en bloc distractor having a second saddle coupled to a second handle, the second saddle defining a second seat for interacting with the rod. The system further includes a coupler for coupling the first handle to the second handle when the first and second en bloc distractors are placed on the rod and between adjacent tulip heads.
[0005] Another aspect of the present disclosure comprises a method of using an en bloc distraction system. The method includes selecting a first en bloc distractor based upon a first distance between adjacent first and second tulip heads and screws and a first peripheral thickness of said first en bloc distractor, wherein said first distance is greater than said first peripheral thickness. Wherein, the screws are embedded in a vertebrae of a spine, and wherein the first en bloc distractor has the first peripheral thickness and a lateral thickness, the first en bloc distractor having a first saddle coupled to a first handle, the first saddle defining a first seat for interacting with a rod coupled to the first and second tulip heads. The method further includes placing the first en bloc distractor between the first and second tulip heads such that the first seat envelops a portion of the rod therebetween. The method also includes selecting a second en bloc distractorPage 2 of 29NCH-032840.F WO ORDbased upon a second distance between adjacent second and third tulip heads and screws and a second peripheral thickness of said second en bloc distractor. Wherein said second distance is greater than said second peripheral thickness, and wherein the second en bloc distractor has the second peripheral thickness and the lateral thickness. Further, the second en bloc distractor having a second saddle coupled to a second handle, the second saddle defining a second seat for interacting with the rod, the rod coupled to the second and third tulip heads. The method additionally includes placing the second en bloc distractor between the second and third tulip heads such that the second seat envelops a portion of the rod therebetween and applying a force to the first pedicle screw, causing the first, second, and third tulip heads to come into contact with the first and second en bloc distractors residing therebetween, respectively.
[0006] Yet another aspect of the present disclosure comprises an en bloc distraction system. The en bloc distraction system includes a first en bloc distractor, the first en bloc distractor having first and second lateral walls coupled together and spaced by first and second peripheral walls, the first and second peripheral walls having a first peripheral thickness and the first and second lateral walls having a first lateral thickness, the first en bloc distractor having a first saddle coupled to a first handle, the first saddle defining a first seat for interacting with a rod coupled to a plurality of tulip heads and screws, said screws embedded in a vertebrae of a spine. The system also includes a second en bloc distractor, the second en bloc distractor having first and second lateral walls coupled together and spaced by first and second peripheral walls, the first and second peripheral walls having a second peripheral thickness and the first and second lateral walls having a second lateral thickness, the second en bloc distractor having a second saddle coupled to a second handle, the second saddle defining a second seat for interacting with the rod, the first and second seat configured to have a seat diameter that is larger than a rod. The system further includes a coupler for coupling the first handle to the second handle when the first and second en blocPage 3 of 29NCH-032840.F WO ORDdistractors are placed on the rod and between adjacent tulip heads, the coupler maintaining the spacing of the first and second en bloc distractors relative to each other.BRIEF DESCRIPTION OF THE DRAWINGS
[0007] The foregoing and other features and advantages of the present disclosure will become apparent to one skilled in the art to which the present disclosure relates upon consideration of the following description of the disclosure with reference to the accompanying drawings, wherein like reference numerals, unless otherwise described refer to like parts throughout the drawings and in which:
[0008] FIG. 1 is a prior art example of a spinal deformity correction;
[0009] FIG. 2 illustrates a top perspective view of a plurality of En Bloc Distractors, in accordance with one example embodiment of the present disclosure;
[0010] FIG. 3 illustrates a left elevation view of an En Bloc Distractor, in accordance with a second example embodiment of the present disclosure;
[0011] FIG. 4 illustrates a right elevation view of an En Bloc Distractor, in accordance with a second example embodiment of the present disclosure;
[0012] FIG. 5 illustrates a left elevation view of an En Bloc Distractor seated over a rod, in accordance with a second example embodiment of the present disclosure;
[0013] FIG. 6 illustrates a left elevation view of a second embodiment of an En Bloc Distractor, in accordance with a second example embodiment of the present disclosure;
[0014] FIG. 7 illustrates a right elevation view of a second embodiment of an En Bloc Distractor, in accordance with a second example embodiment of the present disclosure;Page 4 of 29NCH-032840.F WO ORD
[0015] FIG. 8 illustrates a left elevation view of a second embodiment of an En Bloc Distractor seated over a rod, in accordance with a second example embodiment of the present disclosure;
[0016] FIG. 9 illustrates a portion of a spine including pedicle screws, tulips, and a rod, in accordance with a second example embodiment of the present disclosure;
[0017] FIG. 10 illustrates a portion of a spine including pedicle screws, tulips, and a rod and cross sections lines A-A and B-B, in accordance with a second example embodiment of the present disclosure;
[0018] FIG. 10A illustrates a side view of a pedicle screw, tulip, and a rod taken along cross sections lines A-A, in accordance with a second example embodiment of the present disclosure;
[0019] FIG. 10B illustrates a side view of a pedicle screw, tulip, and a rod taken along cross sections lines B-B, in accordance with a second example embodiment of the present disclosure;
[0020] FIG. 11 illustrates a plurality of En Bloc Distractors interacting with pedicle screws, tulips, and a rod, in accordance with a second example embodiment of the present disclosure;
[0021] FIG. 12 illustrates a plurality En Bloc Distractor clamped together interacting with pedicle screws, tulips, and a rod, in accordance with a second example embodiment of the present disclosure;
[0022] FIG. 13 illustrates a method of utilizing a plurality of En Bloc Distractors, in accordance with one example embodiment of the present disclosure;
[0023] FIG. 14 illustrates a left elevation view of a third embodiment of an En Bloc Distractor, in accordance with a second example embodiment of the present disclosure;Page 5 of 29NCH-032840.F WO ORD
[0024] FIG. 15 illustrates a left elevation view of a fourth embodiment of an En Bloc Distractor, in accordance with a second example embodiment of the present disclosure;
[0025] FIG. 16 illustrates a top plan view of a fourth embodiment of an En Bloc Distractor seated over a rod, in accordance with a second example embodiment of the present disclosure;
[0026] FIG. 17 illustrates a right perspective view of a fourth embodiment of En Bloc Distractors, in accordance with a second example embodiment of the present disclosure;
[0027] FIG. 18 illustrates a right perspective view of a fourth embodiment of En Bloc Distractors, in accordance with a second example embodiment of the present disclosure;
[0028] FIG. 19 illustrates a top perspective view of a plurality of En Bloc Distractors, in accordance with another example embodiment of the present disclosure;
[0029] FIG. 20 illustrates a top perspective view of a plurality7of En Bloc Distractors, in accordance w ith yet another example embodiment of the present disclosure;
[0030] FIG. 21 illustrates a right perspective view of an embodiment of En Bloc Distractors, in accordance with a second example embodiment of the present disclosure;
[0031] FIG. 22 illustrates a left perspective view of an embodiment of En Bloc Distractors, in accordance with a second example embodiment of the present disclosure;
[0032] FIG. 23 illustrates a right perspective view of a fourth embodiment of En Bloc Distractors, in accordance with a second example embodiment of the present disclosure; and
[0033] FIG. 22 illustrates a left perspective view of a fourth embodiment of En Bloc Distractors, in accordance with a second example embodiment of the present disclosure.
[0034] Skilled artisans will appreciate that elements in the figures are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the dimensions Page 6 of 29NCH-032840.F WO ORDof some of the elements in the figures may be exaggerated relative to other elements to help to improve understanding of embodiments of the present disclosure.
[0035] The apparatus and method components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein.DETAILED DESCRIPTION
[0036] Referring now to the figures generally wherein like numbered features shown therein refer to like elements throughout unless otherwise noted. The present disclosure generally relates to an en bloc distractor and method of using same, and more particularly to an en bloc distractor for distraction and / or compression during a spinal fusion surgery' and method of using same.
[0037] Illustrated in the example embodiment of FIGS. 2-5 are a plurality of goose neck en bloc distractors 100 having a handle 102 coupled to a saddle portion 104. In one example embodiment, the plurality of goose neck en bloc distractors 100 comprise at least one of stainless steel, titanium, cobalt chrome, or the like. In one example embodiment, at least a portion of the handle 102 is coated or covered w ith silicone or similar autoclavable materials.
[0038] In one example embodiment, each goose neck en bloc distractor 100 defines a first and second lateral walls 106a. 106b coupled together and spaced by first and second peripheral walls 108a, 108b. In this example embodiment, the goose neck en bloc distractor 100 have a length of between 8 cm to about 12cm as measured from a an end of the handle 102 that is furthest from the saddle portion 104, and an end of the saddle portion that is furthest Page 7 of 29NCH-032840.F WO ORDfrom the handle. In this example embodiment, the peripheral walls 108a, 108b have a peripheral wall thickness 118. In this example embodiment, the peripheral wall thickness 118 is a uniform thickness of the goose neck en bloc distractor 100. In one example embodiment, each of the plurality' of goose neck en bloc distractors 100a, 100b, 100c, lOOd have an individual peripheral wall thickness 118a, 118b, 118c, 118d. In one example embodiment, a first peripheral wall thickness 118a is approximately 30 mm. In one example embodiment, a second peripheral wall thickness 118b is approximately 15 mm. In one example embodiment, a third peripheral wall thickness 118c is approximately 7.5 mm. In one example embodiment, a fourth peripheral wall thickness 118d is approximately 3.75 mm. In one example embodiment, the respective first and second peripheral walls 108a, 108b, have the same peripheral wall thicknesses 18a, 118b, 118c, 118d.
[0039] In one example embodiment, the plurality of goose neck en bloc distractors 100a, 100b, 100c, lOOd have an increasing lateral wall thickness, from a first lateral wall thickness 116a to a second lateral wall thickness 116b. In one example embodiment, the first and second lateral walls 106a, 106b, have the same first and second lateral wall thicknesses 116a, 116b.
[0040] In one example embodiment, the first lateral wall thickness 116a is a peripheral wall thickness measured at first end of the handle 102, wherein the first end is coupled to the saddle portion 104, and the second lateral wall thickness 116b is a peripheral wall thickness measured at second end of the handle 102, wherein the second end is opposite the saddle portion 104. In one example embodiment, a first lateral wall thickness 116a is between 6 mm to about 10 mm, and a second lateral wall thickness 116b is between 3 mm to about 6 mm. In this example embodiment, both the first and second lateral wall thicknesses 116a, 116b remainPage 8 of 29NCH-032840.F WO ORDconsistent over the plurality of goose neck en bloc distractors 100a, 100b, 100c, lOOd, while the individual peripheral wall thicknesses 118a, 118b, 118c, 118d are variable.
[0041] In this example embodiment, the saddle portion 104 includes a continuation of the first and second lateral walls 106a, 106b. In this example embodiment, both the first and second lateral wall thicknesses 116a, 116b of the saddle portion 104 remain consistent. In one example embodiment, the saddle 104 defines a seat 110. The seat 110 defines a u-shaped channel 112. In one example embodiment, the seat 110 defines a semi-circle that extends into parallel sidewalls. In one example, the semi-circle of the seat 110 defines a diameter 119. In one example, the diameter 119 is between 6 mm to about 7 mm. In another example, the diameter 119 is greater than a diameter of the rod 318. In this example embodiment, the seat 110 terminates in first and second extension portions 114a, 114b. Further, in this example embodiment, at least one of the first or second extension portions 114a, 114b extend a grip distance 215. In one example embodiment, the grip distance 115 is between 3 mm to about 6 mm.
[0042] Referring to FIGS. 2, 6-8 a plurality of raised neck en bloc distractors 200 are provided according to another example embodiment of the present disclosure. The plurality' of goose neck en bloc distractors 100 in FIG. 2-5 are substantially similar to the plurality of raised neck en bloc distractors 200 in FIGS. 2, 6-8 with shared features being identified by the same numeral increased by 100. That is, in the second embodiment illustrated in FIGS. 2, 6-8, the plurality of raised neck en bloc distractors 200 comprises all of the features of the plurality of goose neck en bloc distractors 100 except that the saddle 204 is a raised neck saddle that will be described in greater detail below.
[0043] In this example embodiment, the saddle portion 204 includes a continuation of the first and second lateral walls 206a, 206b. In this example embodiment, both the first andPage 9 of 29NCH-032840.F WO ORDsecond lateral wall thicknesses 216a, 216b of the saddle portion 204 remain consistent. In one example embodiment, the saddle 204 defines a seat 210. The seat 210 defines a u-shaped channel 212, wherein a corresponding partially u-shaped protrusion 210a extends away from the first peripheral wall 208a, defining a raised neck. In one example embodiment, the partially u-shaped protrusion 210a extends a raised distance 215a from the first peripheral wall 208a. In one example embodiment, the raised distance 215a is between 1 mm to about 3 mm. In this example embodiment, at least one of the first or second extension portions 214a, 214b extend a grip distance 215. In one example embodiment, the grip distance 215 is between 1 mm to about 3 mm.
[0044] Illustrated in the example embodiment of FIG. 14 is a rounded en bloc distractors 400 having a handle 402 coupled to a saddle portion 404. In one example embodiment, the rounded neck en bloc distractors 400 comprise at least one of stainless steel, titanium, cobalt chrome, or the like. In one example embodiment, at least a portion of the handle 402 is coated or covered with silicone or similar autoclavable materials.
[0045] In this example embodiment, the rounded en bloc distractor 400 defines first and second lateral walls 106 coupled together and spaced by first and second peripheral walls 108. In this example embodiment, the rounded en bloc distractor 400 has a length of between 140mm to about 185 mm as measured from an end of the handle 402 that is furthest from the saddle portion 404, and an end of the saddle portion that is furthest from the handle. In this example embodiment, the rounded en bloc distractor 400 has a length of 177.57mm.
[0046] In this example embodiment, the peripheral walls 108 have a peripheral wall thickness 422. In one example embodiment, the peripheral wall thickness 422 is a uniform thickness of the rounded en bloc distractor 400. In one example embodiment, the peripheral wall thickness 422 is between approximately 1mm to about 25 mm. In one examplePage 10 of 29NCH-032840.F WO ORDembodiment, the rounded en bloc distractors 400 have a lateral wall thickness 444. In one example embodiment, the lateral wall thickness 444 is between 3 mm to about 7 mm. In one example embodiment, the lateral wall thickness 444 is 7mm.
[0047] In one example embodiment, the saddle 404 defines a seat 410. The seat 410 defines a u-shaped channel 412 defining a radius of between 9mm to about 11mm. In one example embodiment, the radius is 10mm. In another example embodiment, the u-shaped channel 412 defines a diameter of between 3mm to about 7mm. In this example embodiment, the diameter 6.35mm. In one example embodiment, the seat 410 terminates in first and second extension portions 401a, 401b. In one example embodiment, the first and second extension portions 401a, 401b are substantially rounded. In this example embodiment, the rounding of the first and second extension portions 401a, 401b decrease a likelihood puncturing tissue near the spine 302.
[0048] Further, in this example embodiment, at least one of the first or second extension portions 401a, 401b extend a grip distance 407. In one example embodiment, the grip distance 407 is between 5 mm to about 9 mm. In one example embodiment, the grip distance 407 is 9mm. In one example embodiment, a round neck 405 extends between the handle 402 and the first and second extension portions 401a, 401b. In this example the round neck 405 extends a neck distance 409. In one example embodiment, the neck distance 409 is between 10. mm to about 15 mm. In one example embodiment, the neck distance 409 is 14.19mm.
[0049] In this example embodiment, a round head neck 452 extends between the handle 402 and a front head 454. In this example embodiment, the round head neck 452 extends a head neck distance 450. In one example embodiment, the head neck distance 450 is between 9 mm to about 13 mm. In one example embodiment, the head neck distance 450 is 11.87mm. In this example embodiment, the front head 454 extends between the round head neck 452 andPage 11 of 29NCH-032840.F WO ORDthe first and second extension portions 401a, 401b. In this example embodiment, the front head 454 extends a front distance 411. In one example embodiment, the front distance 411 is between 4 mm to about 6 mm. In one example embodiment, the front distance 411 is 4.87mm. In one example embodiment, a proximal end 446 of the handle 402 has a width and / or height of 2mm to about 3mm. In one example embodiment, the proximal end 446 of the handle 402 has a width and / or height of 2mm. Further, the rounded neck en bloc distractor 400 alters an angle 448 of the saddle 404 relative to the handle 402 as compared to the en bloc distractors 100, 200. In this example embodiment, the angle 448 is between 0° to about 90°. In one example embodiment, the angle 448 is 30°. The angle 448 is configured to allow space between the spine 302 and a user. In this example embodiment, the variability of the configuration of the en bloc distractors 100, 200, 400 allows for different uses and advantages. In one example embodiment, an extended length of the handle 104, 204, 404 allows for a user to grip from comfortable distance away from spine 302. Increasing a size of the u-shaped channel 112, 212, 412 allow for interaction with largest rods 318 used for pediatric scoliosis surgery. Increasing a size of the u-shaped channel 112, 212, 412 allow the channel to fit more securely on the rod 318. The configuration of the round head neck 452, the front head 454, and the round neck 405 improve ease of machinability of the en block distractors. A decreased width 422 of the handle 402 decreases an overall weight of an en block distractor.
[0050] Referring to FIGS. 15-18, the rounded neck en bloc distractors 400 in FIG. 14 are substantially similar to the plurality of rounded neck en bloc distractors 500 in FIGS. 15-18 with shared features being identified by the same numeral increased by 100. That is, in the fourth embodiment illustrated in FIGS. 15-18, the rounded neck en bloc distractors 500 comprises all of the features of the rounded neck en bloc distractors 400 except that the handlePage 12 of 29NCH-032840.F WO ORD502 defines an indented and extended feature 526, 534 that will be described in greater detail below.
[0051] In one example embodiment, the extended feature 534 is substantially rectangular and supports a rectangular extension in a first lateral sidewall 506a. In one example embodiment, the extended feature 534 extends an extension distance 530 away from the first lateral sidewall 506a. In one example embodiment, the extension distance 530 is between 3mm to about 4mm. In one example embodiment, the extension distance 530 is 3mm. In this example embodiment, the extended feature 534 extends an extension length 532 along the first lateral sidewall 506a. In one example embodiment, the extension distance 530 is between 30mm to about 40mm. In one example embodiment, the extension distance 530 is 40mm. In another example embodiment, other geometric shapes of the extended feature 534 are contemplated.
[0052] In one example embodiment, the indented feature 526 is substantially rectangular and supports a rectangular void in a second lateral sidewall 506b. In one example embodiment, the indented feature 526 extends an indent depth 525 into the second lateral sidewall 506b. In one example embodiment, the indent depth 525 is between 0.25m to about 0.40mm less than the extension distance 530. In one example embodiment, the indented feature 526 extends an indent length 528 within the second lateral sidewall 506b. In one example embodiment, the indent length 528 is between 0.25m to about 0.40mm less than the extension length 532. In this example embodiment, the extension distance and length 530, 532 and the indent depth and length 525, 528 are configured such that the extension feature 534 is housed within the indented feature 526. In one example embodiment, the extension distance and length 530, 532 and the indent depth and length 525, 528 are configured such that the extension feature 534 is housed and frictionally and removably retained within the indented feature 526. In one example embodiment, the extension distance 534 and the indent depth 525 are dependent uponPage 13 of 29NCH-032840.F WO ORDperipheral wall thickness 522, wherein the extension distance 534 and the indent depth 525 are less than the peripheral wall thickness 522.
[0053] Referring to FIG. 19, a plurality of neck block goose neck en bloc distractors 600 having a neck block 650 are provided according to another example embodiment of the present disclosure. The plurality of en bloc distractors 100 in FIG. 2-5 are substantially similar to the plurality of neck block goose neck en bloc distractors 600 in FIG. 19 with shared features being identified by the same numeral increased by 500. That is, in the embodiment illustrated in FIG. 19, the plurality of neck block goose neck en bloc distractors 600 comprises all of the features of the plurality of goose neck en bloc distractors 100 except that the neck block 650 is attached to the en block distractor that will be described in greater detail below. In the example embodiment of FIG. 19, the neck block 650 is supported on the second peripheral walls 108b. In this example embodiment, the neck block 650 extends partially from the saddle 104 and the handle 102, wherein the neck block 650 has a width less than the peripheral wall thicknesses 118a, 118b, 118c, 118d.
[0054] Referring to FIG. 19. a plurality of neck block raised neck en bloc distractors 700 having a neck block 750 are provided according to another example embodiment of the present disclosure. The plurality of raised neck en bloc distractors 200 in FIG. 2, 6-8 are substantially similar to the plurality of neck block raised neck en bloc distractors 700 in FIG.19 with shared features being identified by the same numeral increased by 500. That is, in the embodiment illustrated in FIG. 19, the plurality' of neck block raised neck en bloc distractors 700 comprises all of the features of the plurality of goose neck en bloc distractors 200 except that the neck block 750 is attached to the en block distractor that will be described in greater detail below. In the example embodiment of FIG. 19, the neck block 750 is supported on the second peripheral walls 208b. In this example embodiment, the neck block 750 extendsPage 14 of 29NCH-032840.F WO ORDpartially from the saddle 204 and the handle 202 and has a width that is less than peripheral wall thicknesses, 218a, 218b, 218c, 218d.
[0055] Referring to FIG. 20, a plurality of neck block goose neck en bloc distractors 800 having a neck block 850 are provided according to another example embodiment of the present disclosure. The plurality of en bloc distractors 100 in FIG. 2-5 are substantially similar to the plurality of neck block goose neck en bloc distractors 800 in FIG. 20 with shared features being identified by the same numeral increased by 700. That is, in the embodiment illustrated in FIG. 20, the plurality of neck block goose neck en bloc distractors 800 comprises all of the features of the plurality of goose neck en bloc distractors 100 except that the neck block 850 is attached to the en block distractor that will be described in greater detail below. In the example embodiment of FIG. 20, the neck block 850 extends the second peripheral walls 108b. In this example embodiment, the neck block 850 extends partially from the saddle 104 and the handle 102, wherein the neck block 850 has a width that is substantially the same as the peripheral wall thicknesses 118a, 118b, 118c, 118d.
[0056] Referring to FIG. 20. a plurality of neck block raised neck en bloc distractors 900 having a neck block 950 are provided according to another example embodiment of the present disclosure. The plurality of raised neck en bloc distractors 200 in FIG. 2, 6-8 are substantially similar to the plurality of neck block raised neck en bloc distractors 900 in FIG.20 with shared features being identified by the same numeral increased by 700. That is, in the embodiment illustrated in FIG. 20, the plurality' of neck block raised neck en bloc distractors 900 comprises all of the features of the plurality of goose neck en bloc distractors 200 except that the neck block 950 is attached to the en block distractor that will be described in greater detail below. In the example embodiment of FIG. 20, the neck block 950 is supported on the second peripheral walls 208b. In this example embodiment, the neck block 950 extendsPage 15 of 29NCH-032840.F WO ORDpartially from the saddle 204 and the handle 202 and has a width that is substantially as the peripheral wall thicknesses, 218a, 218b, 218c, 218d.
[0057] As described herein, the indented feature 525 and the extended feature 534 are contemplated all the en bloc distractors 100, 200, 400, 500, 600, 700, 800, 900 disclosed herein.
[0058] A method 1300 of utilizing the en bloc distractors 100, 200, is illustrated in FIG.13. Herein, the en bloc distractor refers to any en bloc distractor 100. 200, 400. 500, 600, 700, 800, 900 described herein. At 1302. a first en bloc distractor 100a, 200a of the plurality of en bloc distractors 100, 200 is selected based upon a first distance 320 between a first and second pedicle screw tulip 312a. 312b. (see FIGS. 9-10). In this example embodiment, a first en bloc distractor 100, 200 is selected based upon a peripheral wall thicknesses 118a, 118b, 118c, 118d, 218a. 218b, 218c, 218d. In one example embodiment, the peripheral wall thicknesses 118a, 118b, 118c, 118d, 218a, 218b, 218c. 218d of the first en bloc distractor 100a, 200a is selected to be between 1mm to 2mm less than the first distance 320. Stated another way, the peripheral wall thicknesses 118a, 118b, 118c, 118d, 218a, 218b, 218c, 218d of the first en bloc distractor 100a, 200a is selected such that the first lateral wall 106a, 206b is a first distance 120a from a first sidewall 324a of the first pedicle screw tulip 312a and a second distance 120b from a first sidewall 324b of the second pedicle screw tulip 312b. In one example embodiment, the first distance 120a is between 0.05mm to about 1.5mm and the second distance 120b is between 0.05mm to about 1.5mm.
[0059] At 1304, prior to distraction, the first en bloc distractor 100a, 200a is placed on the rod between the first and second first and second pedicle screw tulip 312a, 312b. (see FIG.11). In this example embodiment, the u-shaped channel 110, 210 of the seat 104, 204 this placed over the rod 318, as illustrated in FIGS. 5 and 8. In this example embodiment, the u-shaped channel 110, 210 at least partially envelopes the rod 318.Page 16 of 29NCH-032840.F WO ORD
[0060] At 1306, a second en bloc distractor 100b. 200b of the plurality of en bloc distractors 100, 200 is selected based upon a second distance 322 between a second and third pedicle screw tulip 312b, 312c. (see FIGS. 9-10). In this example embodiment, a second en bloc distractor 100b. 200b is selected based upon a peripheral wall thicknesses 118a, 118b, 118c, 118d, 218a, 218b, 218c, 218d. In one example embodiment, the peripheral wall thicknesses 118a, 118b, 118c, 118d, 218a, 218b, 218c, 218d of the second en bloc distractor 100b. 200b is selected to be between 1mm to 2mm less than the second distance 322 and / or to be the first distance from an adjacent sidewall of the second pedicle screw tulip 312b and the second distance from an adjacent sidewall of the third pedicle screw tulip 312c, as described above with regard to the first and second pedicle screw tulips. At 1308, prior to distraction, the second en bloc distractor 100b, 200b is placed on the rod between the second and third second pedicle screw tulip 312b, 312c. (see FIG. 11).
[0061] At 1310, an optional third en bloc distractor (not shown) of the plurality of en bloc distractors 100, 200 is selected based upon a distance between the third pedicle screw tulip 312c and a fourth pedicle screw tulip (not shown). In this example embodiment, a third en bloc distractor is selected based upon a peripheral wall thicknesses 118a, 118b, 118c, 118d, 218a, 218b, 218c, 218d. In one example embodiment, the peripheral wall thicknesses 118a, 118b, 118c, 118d, 218a, 218b, 218c, 218d of the third en bloc distractor is selected to have a thickness that is less than 1mm to about 2mm of a distance between the third and fourth pedicle screws, and / or to have respective distances from sidewalls of the third and fourth pedicle screws, as described above with regard to the first and second en bloc distractors 100a, 200a, 100b, 200b. At 1308, prior to distraction, the third en bloc distractor is placed on the rod between the third and fourth second pedicle screw tulip 312c. It is contemplated that additionalPage 17 of 29NCH-032840.F WO ORDen bloc distractors can be selected as described at steps 1302, 1306, and 1310, and applied to the rod 318 as described at 1304, 1308, 1312.
[0062] At 1314, the first, second, and optional third en bloc distractors 100a, 200a, 100b, 200b are coupled together via a coupler 130. In one example embodiment, the coupler 130 couples to the handles 102. 202 of the respective en bloc distractors 100a, 200a, 100b, 200b to statically couple the distractors together. In one example embodiment, the coupler 130 attaches via a friction coupling. In another example embodiment, the coupler 130 attaches via a rigid or flexible coupling. In one example embodiment, the coupler 130 comprises a same material as the en bloc distractors 100, 200. In another example embodiment, the coupler 130 is at least partially coated or covered with an autoclavable griping material.
[0063] At 1316, applied force AF is applied to one of the first pedicle screw 312a to distract the spine 302. It would be understood that the applied force AF can be applied to the spine 302 directed to the head or the sacrum, and the first pedicle screw 312a is the pedicle screw that is directly adjacent to the first en bloc distractor 100a, 200b, wherein the applied force AF is applied to the pedicle screw on a surface opposite the first en bloc distractor.
[0064] In this example embodiment, during distraction the first and second lateral walls 106a, 206a, 106b, 206b interact with the first and second sidewalls 224a, 224b of the first and second pedicle screw tulip 312a, 312b, wherein additional lateral walls of en bloc distractors that are included, also interact with adjacent sidewalls of respective pedicle screws. In this example embodiment, the applied force AF is be shared among all the pedicle screws 312 adjacent to en bloc distractors 100a, 200a, and thus shared among all screws 316 coupled to those pedicle screws 312 rather than the force being applied to a single tulip head, and thus a single pedicle screw.Page 18 of 29NCH-032840.F WO ORD
[0065] The en bloc distractors described herein can be use at least in en bloc distraction, en bloc compression, segmental distraction, segmental compression, posterior spinal distraction, posterior spinal compression, intersegmental spacers during posterior spinal correction, fracture fixation, osteotomies - to aid with provisional correction and fixation, foot deformity correction, upper extremity deformity correction, lower extremity deformity correction.
[0066] Advantageously, the use of one or more en bloc distractors 100a. 200b allows the applied force AF is be shared among all the pedicle screws 312 adjacent the to en bloc distractors 100a, 200a, and thus shared among all screws 316 coupled to those pedicle screws 312 rather than the force being applied to a single tulip head, and thus a single pedicle screw.
[0067] This shared applied force allows for less tension on a single vertebrae of the spine 302, and thus less potential for fracture or break of the vertebrae from the distraction.
[0068] In the foregoing specification, specific embodiments have been described. However, one of ordinary skill in the art appreciates that various modifications and changes can be made without departing from the scope of the disclosure as set forth in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present teachings.
[0069] The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements of any or all the claims. The disclosure is defined solely by the appended claims including any amendments made during the pendency of this application and all equivalents of those claims as issued.Page 19 of 29NCH-032840.F WO ORD
[0070] Moreover in this document, relational terms such as first and second, top and bottom, and the like may be used solely to distinguish one entity or action from another entity or action without necessarily requiring or implying any actual such relationship or order between such entities or actions. The terms "comprises," "comprising," “has’', “having,’" “includes”, “including,” “contains”, “containing” or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a process, method, article, or apparatus that comprises, has, includes, contains a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. An element proceeded by “comprises ... a”, “has ... a”, “includes ... a”, “contains ... a” does not, without more constraints, preclude the existence of additional identical elements in the process, method, article, or apparatus that comprises, has, includes, contains the element. The terms “a” and “an” are defined as one or more unless explicitly stated otherw ise herein. The terms “substantially”, “essentially”, “approximately”, “about” or any other version thereof, are defined as being close to as understood by one of ordinary skill in the art. In one nonlimiting embodiment the terms are defined to be within for example 100%, in another possible embodiment within 5%, in another possible embodiment within 1%, and in another possible embodiment within 0.5%. The term “coupled” as used herein is defined as connected or in contact either temporarily or permanently, although not necessarily directly and not necessarily mechanically. A device or structure that is “configured” in a certain way is configured in at least that way. but may also be configured in ways that are not listed.
[0071] To the extent that the materials for any of the foregoing embodiments or components thereof are not specified, it is to be appreciated that suitable materials w ould be known by one of ordinary skill in the art for the intended purposes.Page 20 of 29NCH-032840.F WO ORD
[0072] The Abstract of the Disclosure is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. In addition, in the foregoing Detailed Description, it can be seen that various features are grouped together in various embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the claimed embodiments require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separately claimed subject matter.Page 21 of 29NCH-032840.F WO ORD
Claims
CLAIMSWhat is claimed is:
1. An en bloc distraction system, the en bloc distraction system comprising:a first en bloc distractor, the first en bloc distractor having a first penpheral thickness and a lateral thickness, the first en bloc distractor having a first saddle coupled to a first handle, the first saddle defining a first seat for interacting with a rod coupled to a plurality of tulip heads and screws, said screws embedded in a vertebrae of a spine:a second en bloc distractor, the second en bloc distractor having a second peripheral thickness and the lateral thickness, the second en bloc distractor having a second saddle coupled to a second handle, the second saddle defining a second seat for interacting with the rod; anda coupler for coupling the first handle to the second handle when the first and second en bloc distractors are placed on the rod and between adjacent tulip heads.
2. The en bloc distractor system of claim 1, wherein the first en bloc distractor having first and second lateral walls is coupled together and spaced by first and second peripheral walls and the second en bloc distractor having first and second lateral walls coupled together and spaced by first and second peripheral walls.
3. The en bloc distractor system of claim 2, wherein the first en bloc distractor defines an indented feature within the first lateral wall and the second en bloc distractor supports an extended feature extending from the second lateral wall.Page 22 of 29NCH-032840.F WO ORD4. The en bloc distractor system of claim 2, wherein the first en bloc distractor defines an extended feature within the second lateral wall and the second en bloc distractor supports an indented feature extending from the first lateral wall.
5. The en bloc distractor system of claim 2, wherein the extended feature of the first en bloc distractor is housed within the indented feature of the second en bloc distractor.
6. The en bloc distractor system of claim 2, wherein the extended feature of the first en bloc distractor is complementary' shaped relative to the indented feature of the second en bloc distractor.
7. The en bloc distractor system of claim 1, wherein the first en bloc distractor has an increasing lateral wall thickness, from a first lateral wall thickness at a first end of the first en bloc distractor to a second lateral wall thickness at a second end of the first en bloc distractor, the first end opposite the saddle and the second end.
8. The en bloc distractor system of claim 1 , wherein the first en bloc distractor has an continuous lateral wall thickness.
9. A method of using an en bloc distraction system, the method comprising:selecting a first en bloc distractor based upon a first distance between adjacent first and second tulip heads and screws and a first peripheral thickness of said first en bloc distractor, wherein said first distance is greater than said first peripheral thickness, said screws embedded in a vertebrae of a spine, wherein the first en bloc distractor has the firstPage 23 of 29NCH-032840.F WO ORDperipheral thickness and a lateral thickness, the first en bloc distractor having a first saddle coupled to a first handle, the first saddle defining a first seat for interacting with a rod coupled to the first and second tulip heads;placing the first en bloc distractor between the first and second tulip heads such that the first seat envelops a portion of the rod therebetween;selecting a second en bloc distractor based upon a second distance between adjacent second and third tulip heads and screws and a second peripheral thickness of said second en bloc distractor, wherein said second distance is greater than said second peripheral thickness, wherein the second en bloc distractor has the second peripheral thickness and the lateral thickness, the second en bloc distractor having a second saddle coupled to a second handle, the second saddle defining a second seat for interacting with the rod, the rod coupled to the second and third tulip heads;placing the second en bloc distractor between the second and third tulip heads such that the second seat envelops a portion of the rod therebetween; andapplying a force to the first pedicle screw, causing the first, second, and third tulip heads to come into contact with the first and second en bloc distractors residing therebetween, respectively.
10. The method of claim 9, the placing the first en bloc distractor between the first and second tulip heads comprises placing a u-shaped portion of a saddle portion of the first en block distractor on the rod.Page 24 of 29NCH-032840.F WO ORD11. The method of claim 9, the placing the second en bloc distractor between the second and third tulip heads comprises placing a u-shaped portion of a saddle portion of the second en block distractor on the rod.
12. The method of claim 9, the selecting the second en bloc distractor based upon the second distance between adjacent second and third tulip heads, comprising combining an extended feature en bloc distractor with an indented feature en bloc distractor to create the second en bloc distractor having the second peripheral thickness, the extended feature en bloc distractor supporting an extended feature on a second lateral wall of the extended feature en bloc distractor, the extended feature en bloc distractor having first and second lateral walls is coupled together and spaced by first and second peripheral walls, and the indented feature en bloc distractor defining an indented feature on a first lateral wall of the indented feature en bloc distractor, the indented feature en bloc distractor having first and second lateral walls is coupled together and spaced by first and second peripheral walls, the indented feature housing the extended feature to couple the extended feature en bloc distractor to the indented feature en bloc distract or.
13. The method of claim 9, further comprising coupling a first handle of the first en bloc distractor to a second handle of the second en bloc distractor.
14. The method of claim 9, the placing the first en bloc distractor between the first and second tulip heads comprises placing a first u-shaped portion of a first saddle portion of the first en block distractor on the rod. and the placing the second en bloc distractor between thePage 25 of 29NCH-032840.F WO ORDsecond and third tulip head comprises placing a second u-shaped portion of a second saddle portion of the second en block distractor on the rod.
15. The method of claim 14, further comprising coupling a first handle of the first en bloc distractor to a second handle of the second en bloc distractor, wherein the first handle is coupled to the first saddle portion and the second handle is coupled to the second handle portion.
16. An en bloc distraction system, the en bloc distraction system comprising:a first en bloc distractor, the first en bloc distractor having first and second lateral walls coupled together and spaced by first and second peripheral walls, the first and second peripheral walls having a first peripheral thickness and the first and second lateral walls having a first lateral thickness, the first en bloc distractor having a first saddle coupled to a first handle, the first saddle defining a first seat for interacting with a rod coupled to a plurality of tulip heads and screws, said screws embedded in a vertebrae of a spine;a second en bloc distractor, the second en bloc distractor having first and second lateral walls coupled together and spaced by first and second peripheral walls, the first and second peripheral walls having a second peripheral thickness and the first and second lateral walls having a second lateral thickness, the second en bloc distractor having a second saddle coupled to a second handle, the second saddle defining a second seat for interacting with the rod, the first and second seat configured to have a seat diameter that is larger than a rod; and a coupler for coupling the first handle to the second handle when the first and second en bloc distractors are placed on the rod and between adjacent tulip heads, the coupler maintaining the spacing of the first and second en bloc distractors relative to each other.Page 26 of 29NCH-032840.F WO ORD17. The en bloc distractor system of claim 16, wherein the first en bloc distractor defines an indented feature within the first lateral wall and supports an extended feature extending from the second lateral wall.18 The en bloc distractor system of claim 16 wherein the first en bloc distractor includes a combined extended feature en bloc distractor and an indented feature en bloc distractor, wherein the extended feature en bloc distractor supports an extended feature on a second lateral wall of the extended feature en bloc distractor, the extended feature en bloc distractor having first and second lateral walls coupled together and spaced by first and second peripheral walls, and the indented feature en bloc distractor defines an indented feature on a first lateral wall of the indented feature en bloc distractor, the indented feature en bloc distractor having first and second lateral walls is coupled together and spaced by first and second peripheral walls, the indented feature housing the extended feature to couple the extended feature en bloc distractor to the indented feature en bloc distractor.
19. The en bloc distractor system of claim 16, wherein the first en bloc distractor has an increasing lateral wall thickness, from a first lateral wall thickness at a first end of the first en bloc distractor to a second lateral wall thickness at a second end of the first en bloc distractor, the first end opposite the saddle and the second end.
20. The en bloc distractor system of claim 16, wherein the first en bloc distractor has an continuous lateral wall thickness.Page 27 of 29NCH-032840.F WO ORDNCH-032840.F WO ORD