Patent Application
20240299173
The present invention is generally directed to an implant for sacroiliac (SI) Joint fixation. Specifically, the present invention is generally directed to an implant for SI Joint fixation comprising a pair of anchor members connected to one another by an adjustable connector assembly.
Sacroiliac joints may be affected by arthritis, traumatic injury, pregnancy, infection, and other conditions, including systemic inflammatory conditions. Movement of such sacroiliac joints can be a major source of pain. In some scenarios, fixating the sacroiliac joint has been shown to alleviate such pain. Traditionally, dowels or wedges made from cadaveric bone have been used as an implant to help fixate the joint. In such instances, the implant is configured to be inserted from an inferior-posterior approach, and generally hammered into a space between the sacrum and ilium.
More recently, catamaran styled implants have been developed, for example, by companies such as Tenon Medical (https://tenonmed.com/catamaran/, hereinafter the “Tenon Medical Implant”). The Tenon Medical Implant is configured to stretch across an SI Joint in order to fixate it. However, the Tenon Medical Implant is a single, monolithic piece. Such a configuration may limit the ability to manipulate the anatomy of pelvic bones or sacroiliac joints and/or make revisions or adjustments to same.
The present invention is configured to provide an adjustable implant configured, for example, to distract or compress a sacroiliac joint. In some examples, a dual anchor assembly may be inserted into the sacroiliac joint, a first anchor member into the sacrum, a second anchor member into the ilium, with an adjustable connector assembly holding the pair of anchor members together and enabling the anchors to separate to distract a sacroiliac joint. These and other features and advantages of the present invention will be explained and will become obvious to one skilled in the art through the summary of the invention that follows.
The present invention relates generally to an SI joint implant for at least partial to full fixation SI joints. In particular, the present invention encompasses an implant with a pair of anchor members and an adjustable connector adapted to support fixation of an SI joint.
It is an object of the present invention to provide an implant configured to be inserted into a sacral-iliac joint.
It is another object of the present invention to provide an SI joint implant for partial to full fixation of SI joints.
It is another object of the present invention to provide an SI joint implant with an integrated adjustable connector assembly.
It is another object of the present invention to provide an SI joint implant with arm members slidably integrated within anchor member shafts.
It is another object of the present invention to provide an SI joint implant comprising a first anchor member configured to be implanted into the sacrum, and a second anchor member configured to be implanted contralateral of the SI Joint, into the ilium with respect to the first anchor member.
It is another object of the present invention to provide an SI joint implant having a pair of anchor members configured to be relatively close to one another during insertion (e.g., a collapsed state), and, to be expanded once the implant is suitably positioned in the SI joint.
It is another object of the present invention to provide an SI joint implant configured to transfix SI joints.
It is another object of the present invention to provide an SI joint implant that is more easily insertable into an SI joint in its collapsed state than SI implants of the prior art.
It is another object of the present invention to provide an SI joint implant comprising anchor members configured to move apart laterally to expand the SI joint and/or fixate the SI joint in an expanded position.
Accompanying this written specification is a collection of drawings of exemplary embodiments of the present invention. One of ordinary skill in the art would appreciate that these are merely exemplary embodiments, and additional and alternative embodiments may exist and still be within the spirit of the invention as described herein.
In accordance with embodiments of the present invention, an implant for partial to full fixation of a sacroiliac (SI) joint may comprise a pair of anchor members connected together by an adjustable connector assembly. In some embodiments, the adjustable connector assembly may comprise a pair of arm members configured to pivot about one or more axes to move the implant from a first position to a second position, for example, from a partially or fully collapsed position to a partially or fully expanded position.
In accordance with embodiments of the present invention, the anchor members may be elongated components with anti-migration features running generally perpendicular to the long axis on the exterior of an anchor member. The anti-migration features may be teeth, threads, a roughened surface, or any other similar textured or roughened surface suitable for preventing migration of an implanted implant. The anchor members may be generally cylindrical, but could also be a conical, triangular, rectangular or any other similarly suitable shape for implantation. In some embodiments, a slot may run axially along an axis of the anchor. The slot may extend from the top (superior) side to the bottom (inferior) side of the anchor. A pivot point may also extend from the top (superior) side to the bottom (inferior) side of the anchor member. In some embodiments, the slot may be positioned in a location generally near the rear (posterior) end of the anchor member, and the pivot point may be positioned in a location generally near the front (anterior) of the anchor member. A posterior cavity may extend axially along the anchor from the rear (posterior) face to at least the slot feature. An elongate lateral opening or slot may extend axially along the side (medial) wall of the anchor member. The pair of anchor members may be oriented in such a way so that the lateral openings face each other.
In accordance with embodiments of the present invention, the anchor members may be connected together by an adjustable connector assembly. The adjustable connector assembly may be configured to adjust (e.g., decrease or increase) the distance between the anchor members and may comprise a pair of arm members in pivotal communication with one another. In accordance with embodiments of the present invention, the arm members may be able to pivot and move along various axis points, for example, about a series or set of one or more pivotable fasteners (or one or more pairs of pivotable fasteners), for example, posts, pins, screws, or any other similarly suitable pivotable fasteners. In some examples, portions of the arm members may be received inside the lateral openings of the anchor members. For example, a first arm member may have its first end received in a lateral opening of a first anchor member and a second end received in a lateral opening of a second anchor member, and a second arm member may have its first end received in the lateral opening of the second anchor member and its second end received in the lateral opening of the first anchor member.
In accordance with embodiments of the present invention, the arm members may comprise a central pivot point, rear (posterior) pivot point, and a front (anterior) pivot point. A rear (posterior) pin may extend through the slot of the anchor member and into the rear (posterior) pivot point of the arm member. The arm member may pivot about the rear (posterior) pin. Also, the rear (posterior) pin may slide within the guide slot of the anchor member. This may allow the rear (posterior) pin, and the arm member, to translate front to rear (e.g., anterior-posterior) along the central axis of the anchor member. A front (anterior) pin may extend through the pivot point of the anchor member and into the front (anterior) pivot point of the arm member. The arm member may then pivot about the front (anterior) pin. Similarly, a central pin may be received within the central pivot point of the arm members, allowing the arm members to pivot at the central pivot point with respect to each other.
In accordance with an exemplary usage scenario, an implant in accordance with embodiments of the present invention may be inserted into the sacral-iliac joint. A first anchor member may be implanted into a first bone, for example, the sacrum, while the second anchor member may be implanted into a second bone, for example, the ilium (e.g., contralateral of the SI Joint) with respect to the first anchor member. In some scenarios, during insertion, the pair of anchors may be relatively close to one another, with the posterior pins being positioned in a rear (e.g., posterior) position, for example, in a position farthest from the front (anterior) pins. In some embodiments, once the implant is positioned (e.g., seated) in the SI joint, the implant may be expanded. For example, the arm members may be pressed forward with a tool (e.g., an inserting or expanding tool) through the rear (posterior) cavity. In some examples, forcing a rear (posterior) portion of the arm members forward (e.g., sliding the arm members within the anchor member shafts) directs the arm members to pivot about the front (anterior) pin and the central pin. Such an action may move (e.g., force) the anchor members apart laterally, expanding the SI joint and/or fixating the SI joint in an expanded position. In some examples, the arm members may be secured (e.g., locked) in an expanded position. In some embodiments, one or more fasteners may be utilized to secure (e.g., lock) the arm members in an expanded position. The fasteners may be set screws, pins, nails or other similarly suitable fastening implements. For example, the posterior openings may be formed with threads or threaded portions configured to engage with threaded set screw(s) to secure the set screws to the assembly and maintain the arm members in their forward (e.g., expanded implant) position. In an illustrative example, a set screw may be configured to abut a posterior (rear) end of the arm members to hold the arm members in a second position wherein the implant is expanded.
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In accordance with an exemplary usage scenario, an implant 10 in accordance with embodiments of the present invention may be inserted into the sacral-iliac joint. A first anchor member 20 may be implanted into the sacrum, while the second anchor member 20 may be implanted contralateral of the SI Joint into the ilium with respect to the first anchor member 20. In some scenarios, during insertion, the pair of anchors 20 may be relatively close to one another, with the rear (posterior) pins 50 being positioned in a rear (e.g., posterior) position, for example, in a position farthest from the front (anterior) pins 40. In some embodiments, once the implant 10 is positioned (e.g., seated) in the SI joint, the implant 10 may be expanded. For example, the arm members 30 may be pressed forward with a tool (e.g., an inserting or expanding tool) through the rear (posterior) cavity 23. In some examples, forcing a rear (posterior) portion of the arm members 30 forward directs the arm members 30 to pivot about the front (anterior) pin 40 and the central pin 60. Such an action may move (e.g., force) the anchor members 20 apart laterally, expanding the SI joint and/or fixating the SI joint in an expanded position.
In another exemplary usage scenario, a tool may be inserted into the interior area of the anchor members through their rear (posterior) openings 23 to support a transition of the implant 10 from a collapsed position (as shown for example in
In the Summary above and in this Detailed Description, and the Claims below, and in the accompanying drawings, reference is made to particular features of various embodiments of the invention. It is to be understood that the disclosure of embodiments of the invention in this specification includes all possible combinations of such particular features. For example, where a particular feature is disclosed in the context of a particular aspect or embodiment of the invention, or a particular claim, that feature can also be used—to the extent possible—in combination with and/or in the context of other particular aspects and embodiments of the invention, and in the invention generally.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from this detailed description. The invention is capable of myriad modifications in various obvious aspects, all without departing from the spirit and scope of the present invention. Accordingly, the drawings and descriptions are to be regarded as illustrative in nature and not restrictive.
It should be noted that the features illustrated in the drawings are not necessarily drawn to scale, and features of one embodiment may be employed with other embodiments as the skilled artisan would recognize, even if not explicitly stated herein. Descriptions of well-known components and processing techniques may be omitted so as to not unnecessarily obscure the embodiments.
In the present disclosure, various features may be described as being optional, for example, through the use of the verb “may;”, or, through the use of any of the phrases: “in some embodiments,” “in some implementations,” “in some designs,” “in various embodiments,” “in various implementations,”, “in various designs,” “in an illustrative example,” or “for example;” or, through the use of parentheses. For the sake of brevity and legibility, the present disclosure does not explicitly recite each and every permutation that may be obtained by choosing from the set of optional features. However, the present disclosure is to be interpreted as explicitly disclosing all such permutations. For example, a system described as having three optional features may be embodied in seven different ways, namely with just one of the three possible features, with any two of the three possible features or with all three of the three possible features. In various embodiments. elements described herein as coupled or connected may have an effectual relationship realizable by a direct connection or indirectly with one or more other intervening elements.
In the present disclosure, the term “any” may be understood as designating any number of the respective elements, i.e. as designating one, at least one, at least two, each or all of the respective elements. Similarly, the term “any” may be understood as designating any collection(s) of the respective elements, i.e. as designating one or more collections of the respective elements, a collection comprising one, at least one, at least two, each or all of the respective elements. The respective collections need not comprise the same number of elements.
While various embodiments of the present invention have been disclosed and described in detail herein, it will be apparent to those skilled in the art that various changes may be made to the configuration, operation and form of the invention without departing from the spirit and scope thereof. In particular, it is noted that the respective features of embodiments of the invention, even those disclosed solely in combination with other features of embodiments of the invention, may be combined in any configuration excepting those readily apparent to the person skilled in the art as nonsensical. Likewise, use of the singular and plural is solely for the sake of illustration and is not to be interpreted as limiting.
In the present disclosure, all embodiments where “comprising” is used may have as alternatives “consisting essentially of,” or “consisting of.” In the present disclosure, any method or apparatus embodiment may be devoid of one or more process steps or components. In the present disclosure, embodiments employing negative limitations are expressly disclosed and considered a part of this disclosure.
Certain terminology and derivations thereof may be used in the present disclosure for convenience in reference only and will not be limiting. For example, words such as “upward,” “downward,” “left,” and “right” would refer to directions in the drawings to which reference is made unless otherwise stated. Similarly, words such as “inward” and “outward” would refer to directions toward and away from, respectively, the geometric center of a device or area and designated parts thereof. References in the singular tense include the plural, and vice versa, unless otherwise noted.
The term “comprises” and grammatical equivalents thereof are used herein to mean that other components, ingredients, steps, among others, are optionally present. For example, an embodiment “comprising” (or “which comprises”) components A, B and C can consist of (i.e., contain only) components A, B and C, or can contain not only components A, B, and C but also contain one or more other components.
Where reference is made herein to a method comprising two or more defined steps, the defined steps can be carried out in any order or simultaneously (except where the context excludes that possibility), and the method can include one or more other steps which are carried out before any of the defined steps, between two of the defined steps, or after all the defined steps (except where the context excludes that possibility).
The term “at least” followed by a number is used herein to denote the start of a range beginning with that number (which may be a range having an upper limit or no upper limit, depending on the variable being defined). For example, “at least 1” means 1 or more than 1. The term “at most” followed by a number (which may be a range having 1 or 0 as its lower limit, or a range having no lower limit, depending upon the variable being defined). For example, “at most 4” means 4 or less than 4, and “at most fastener %” means fastener % or less than fastener %. When, in this specification, a range is given as “(a first number) to (a second number)” or “(a first number)-(a second number),” this means a range whose limit is the second number. For example, 25 to 100 mm means a range whose lower limit is 25 mm and upper limit is 100 mm.
Many suitable methods and corresponding materials to make each of the individual parts of embodiment apparatus are known in the art. According to an embodiment of the present invention, one or more of the parts may be formed by machining, 3D printing (also known as “additive” manufacturing), CNC machined parts (also known as “subtractive” manufacturing), and injection molding, as will be apparent to a person of ordinary skill in the art. Metals, wood, thermoplastic and thermosetting polymers, resins and elastomers as may be described herein-above may be used. Many suitable materials are known and available and can be selected and mixed depending on desired strength and flexibility, preferred manufacturing method and particular use, as will be apparent to a person of ordinary skill in the art.
Any element in a claim herein that does not explicitly state “means for” performing a specified function, or “step for” performing a specific function, is not to be interpreted as a “means” or “step” clause as specified in 35 U.S.C. § 112 (f). Specifically, any use of “step of” in the claims herein is not intended to invoke the provisions of 35 U.S.C. § 112 (f).
A number of implementations have been described. Nevertheless, it will be understood that various modifications may be made. For example, advantageous results may be achieved if the steps of the disclosed techniques were performed in a different sequence, or if components of the disclosed systems were combined in a different manner, or if the components were supplemented with other components. Accordingly, other implementations are contemplated within the scope of the following claims.
