Patent Application
20240130726
The present disclosure relates to strategies for effecting a reduced position between bone segments, including carpometacarpal repair.
Osteoarthritis (OA) of the thumb trapeziometacarpal (TMC) joint is a common disabling condition. Trapeziectomy may be used used for decreasing pain and improving hand use and function in patients with carpometacarpal joint osteoarthritis. In order to obtain long-term stability at the base of the thumb after trapeziectomy, it may be advisable to perform ligament reconstruction. This is commonly achieved using the ligament reconstruction and tendon interposition (LRTI) procedure. Using this approach, piece of tendon from one of the wrist muscles (the flexor carpi radialis) is cut, and part of the cut tendon is used to reconstruct the ligament that used to connect the metacarpal bone to the trapezium. The remaining portion of the tendon is then folded and used to fill the space formerly occupied by the trapezium.
A further approach for stabilizing the relative positions of the first and second metacarpals is suture suspension arthroplasty (SSA). This technique uses a single incision, trapeziectomy, and an intra-articular suture suspension sling anchored into the insertions of the flexor carpi radialis (FCR) and abductor pollicis longus (APL), which serves to stabilize the base of the thumb metacarpal, correct subluxation deformity, and maintain arthroplasty space.
Both the LRTI and SSA procedures can involve harvesting all or part of the FCR tendon, which has implications for the complexity of the reparative procedure and for the length of the post-operative recovery period.
Provided herein are methods for positioning a first bone segment relative to a second bone segment within a subject's body comprising securing at least a part of a middle portion of a suture construct to the second bone segment, wherein the suture construct further includes a loop arm and a free arm positioned such that the middle portion extends from the loop arm to the free arm, and a suture loop at a terminal end of the loop arm; passing one of the free arm and the loop arm through a hole in the first bone segment; passing the free arm through the suture loop of the loop arm; and sliding the suture loop along the free arm toward the first bone segment so as to draw together the first bone segment and the second bone segment to establish a reduced position of the first bone segment and the second bone segment.
Also provided are suture constructs for positioning a first bone segment relative to a second bone segment within a subject's body comprising a loop arm, a free arm, and a middle portion that extends from the loop arm to the free arm, the loop arm comprising a suture loop at the terminal end of the loop arm, and a sliding joint positioned at a juncture between the suture loop and a linear portion of the loop arm.
Also disclosed are kits for securing a position of a first bone segment relative to a second bone segment within a subject's body comprising a suture construct according to the preceding embodiment; and, an interposition material for attachment to the suture construct by threading the loop arm or the free arm through the interposition material.
The presently disclosed inventive subject matter may be understood more readily by reference to the following detailed description taken in connection with the accompanying figures and examples, which form a part of this disclosure. It is to be understood that these inventions are not limited to the specific products, methods, conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed inventions.
The entire disclosures of each patent, patent application, and publication cited or described in this document are hereby incorporated herein by reference.
As employed above and throughout the disclosure, the following terms and abbreviations, unless otherwise indicated, shall be understood to have the following meanings.
In the present disclosure the singular forms “a,” “an,” and “the” include the plural reference, and reference to a particular numerical value includes at least that particular value, unless the context clearly indicates otherwise. Thus, for example, a reference to “an anchor” is a reference to one or more of such anchors and equivalents thereof known to those skilled in the art, and so forth. Furthermore, when indicating that a certain element “may be” X, Y, or Z, it is not intended by such usage to exclude in all instances other choices for the element.
When values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment. As used herein, “about X” (where X is a numerical value) preferably refers to ±10% of the recited value, inclusive. For example, the phrase “about 8” preferably refers to a value of 7.2 to 8.8, inclusive; as another example, the phrase “about 8%” preferably refers to a value of 7.2% to 8.8%, inclusive. Where present, all ranges are inclusive and combinable. For example, when a range of “1 to 5” is recited, the recited range should be construed as optionally including ranges “1 to 4”, “1 to 3”, “1-2”, “1-2 & 4-5”, “1-3 & 5”, and the like. In addition, when a list of alternatives is positively provided, such a listing can also include embodiments where any of the alternatives may be excluded. For example, when a range of “1 to 5” is described, such a description can support situations whereby any of 1, 2, 3, 4, or 5 are excluded; thus, a recitation of “1 to 5” may support “1 and 3-5, but not 2”, or simply “wherein 2 is not included.” The phrase “at least about x” is intended to embrace both “about x” and “at least x”. It is also understood that where a parameter range is provided, all integers within that range, and tenths thereof, are also provided by the invention. For example, “2-5 hours” includes 2 hours, 2.1 hours, 2.2 hours, 2.3 hours, etc., up to 5 hours.
Removal of the trapezium (trapeziectomy) for can be effective for addressing osteoarthritis at the base of the thumb (trapeziometacarpal osteoarthritis). However, trapeziectomy partly disrupts the constraints of the scaphotrapeziotrapeziod (STT) joint, which has been suggested to potentially cause a carpal instability pattern that has been termed as non-dissociative. In dissociative carpal instability, there is a disruption of intrinsic intercarpal ligaments causing instability between bones within the same carpal row. It has presently been discovered that a suture-based approach as described herein can be used to effect a reduced position between bone segments, including metacarpal members, in order to increase the stability of the relative positions of such segments.
Accordingly, provided herein are methods for positioning a first bone segment relative to a second bone segment within a subject's body comprising securing at least a part of a middle portion of a suture construct to the second bone segment, wherein the suture construct further includes a loop arm and a free arm positioned such that the middle portion extends from the loop arm to the free arm, and a suture loop at a terminal end of the loop arm; passing one of the free arm and the loop arm through a hole in the first bone segment; passing the free arm through the suture loop of the loop arm; and sliding the suture loop along the free arm toward the first bone segment so as to draw together the first bone segment and the second bone segment to establish a reduced position of the first bone segment and the second bone segment.
Pursuant to the present methods, the first bone segment and the second bone segment may be of the same bone. In other words, the method may be for positioning a first bone segment that represents a first portion of a bone relative to a second bone segment that represents a second portion of the same bone. Such a process may be used, for example, in the situation in which a bone has been fractured and it is desirable to establish a reduced position between portions of the bone that were separated as a result of the fracture.
In other embodiments, the first bone segment and the second bone segment are of different bones. For example, it may be desirable to reduce the distance between respective bones that, under normal physiological circumstances, are in a particular position relative to one another, but that have deviated from this position, or to maintain the positions of the respective bones relative to one another if they have not yet deviated from the correct physiological positioning but there is a risk that they could do so. In certain embodiments, the bone segments are both bones within the human hand, such as a situation in which the first bone segment and the second bone segment are both metacarpals. For example, the first bone segment may be the first metacarpal bone, and the second bone segment may be the second metacarpal bone.
The suture construct that is used in the present methods includes a loop arm and a free arm that are respectively positioned such that a middle portion of the suture construct extends from the loop arm to the free arm. The suture construct further includes a suture loop at a terminal end of the loop arm.
The suture construct may be formed from suture thread, suture tape, cable, or any combination thereof. In certain embodiments, the suture construct is formed from suture thread. One or more of the loop arm, free arm, and middle portion can comprise, one, two, or more than two suture strands.
At least a part of the middle region of the suture construct is secured to the second bone segment pursuant to the present methods. As shown in
The securing step may be performed prior to or following a step in which either the free arm or the loop arm of the suture construct is passed through a hole in the first bone segment.
After the free arm or the loop arm is passed through a hole in the first bone segment, the free arm is passed through the suture loop of the loop arm.
After the free arm is passed through the suture loop of the loop arm, the suture loop is slid along the free arm toward the first bone segment. Doing so draws together the first bone segment and the second bone segment in order to establish a reduced position of the first bone segment and the second bone segment. In some embodiments, as shown in
The present methods may further comprise a step of securing the first bone segment relative to the second bone segment in the reduced position. In some embodiments, this can include forming a knot using the free arm proximate to a location where the suture loop engages the free arm.
As described previously herein, the ligament reconstruction and tendon interposition (LRTI) procedure involves folding a portion of the flexor carpi radialis (FCR) tendon in order to fill the void space formerly occupied by the trapezium. In accordance with the present disclosure, as an alternative to the use of the FCR tendon, a portion of the suture construct may be threaded through an interposition material that can serve to occupy at least a portion of a space that results from the excision of a trapezium bone. The interposition material is intended to provide the structural support and enable the positioning among the remaining bones of the hand in the manner provided by the trapezium before its removal. In this sense, the interposition material can eliminate the need for a K-wire fixation process. The interposition material preferably includes elements that promote the formation of scar tissue at the location of the material. Exemplary interposition materials that can be used in accordance with the present disclosure are described in U.S. Provisional Application No. 63/66,563, filed on Jun. 17, 2022, which is incorporated herein by reference in its entirety. As noted above, one of the free arm or the loop arm is passed through a hole that is formed through the first bone segment, and, pursuant to embodiments in which an interposition material is used, the other of the free arm or the loop arm (i.e., the portion of the suture construct that is not passed through the hole in the first bone segment) can be threaded through the interposition material in order to secure the latter at a desired location within the space formerly occupied by the trapezium. Optionally, the arm may be threaded through the interposition material prior to securing the middle portion of the suture construct to the second bone segment, or may be threaded through the interposition material after securing the middle portion of the suture construct to the second bone segment.
The present disclosure also provides suture constructs for positioning a first bone segment relative to a second bone segment within a subject's body, comprising a loop arm, a free arm, and a middle portion that extends from the loop arm to the free arm, the loop arm comprising a suture loop at the terminal end of the loop arm, and a sliding joint positioned at a juncture between the suture loop and a linear portion of the loop arm. Any one or more of the characteristics of the suture constructs described supra in connection with the present methods may be included with respect to the inventive constructs.
Also provided herein are kits for securing a position of a first bone segment relative to a second bone segment within a subject's body comprising a suture construct according to any one of the embodiments described in the present disclosure; and, an interposition material as described supra for attachment to the suture construct by threading the loop arm or the free arm through the interposition material.
The present disclosure also pertains to and includes at least the following aspects:
The present invention is further defined in the following Examples. It should be understood that these examples, while indicating preferred embodiments of the invention, are given by way of illustration only, and should not be construed as limiting the appended claims. From the above discussion and these examples, one skilled in the art can ascertain the essential characteristics of this invention, and without departing from the spirit and scope thereof, can make various changes and modifications of the invention to adapt it to various usages and conditions.
A suture construct formed from a double strand of suture thread and comprising a loop arm, a free arm, a middle portion extending from the loop arm to the free arm, and a suture loop at a terminal end of the loop arm is secured to the second metacarpal facet of the second metacarpal bone of a female subject, aged 70, who has undergone trapeziectomy. In particular, the free arm of the suture construct is drawn through the eyelet of a suture anchor, such that the middle portion of the suture construct is positioned within the eyelet of the suture anchor. Using an orthopedic drill bit, a hole is drilled laterally into the lower portion of the second metacarpal bone at the location of the second metacarpal facet. The suture anchor is then driven into the second metacarpal facet, thereby securing the suture construct to the subjects second metacarpal bone.
A hole is formed through first metacarpal bone of the subject, whereby the hole extends from a first side of the first metacarpal bone to an opposed second side of the first metacarpal bone. The free arm of the suture construct is passed through the hole on the side of the first metacarpal bone that is anatomically proximate to the second metacarpal bone, and the free arm is then drawn out from the hole on the opposed side of the second metacarpal bone.
The free arm is passed through the suture loop of the loop arm, and the suture loop is then contracted around the free arm. The contracted suture loop is then slid along the free arm towards the first metacarpal until it contacts the first metacarpal. The contracted suture loop is slid further in the direction of the first metacarpal bone in order to urge the first metacarpal towards the second metacarpal, until the first metacarpal is in a position relative to the second metacarpal that is determined by the surgeon as representing the appropriate final positional relationship.
The strands of the free arm are formed into a series of half-hitch knots that secures the first metacarpal in the desired position relative to the second metacarpal, and the loose strands of the free arm are thereafter cut.
In the same manner as in Example 1, a suture construct is used to position a first metacarpal relative to a second metacarpal as deemed appropriate by a surgeon. However, following the step of passing the free arm through the hole in the first metacarpal and prior to the step of passing the free arm through the suture loop of the loop arm, the free arm is threaded through an interposition material. The interposition material, which comprises elements that allow infiltration of blood components, such as platelets, pursuant to the formation of scar tissue, is emplaced within the void space that resulted from the excision of the trapezium from the subject. After the free arm is threaded through the interposition material, the free arm is passed through the suture loop of the loop arm, and the remainder of the procedure for positioning the first metacarpal relative to the second metacarpal is the same as in Example 1. The interposition material, which is secured by the suture construct within the space formerly occupied by the subject's trapezium, is resorbed over the course of about six weeks.
The present application claims the benefit of priority to U.S. Provisional Application No. 63/380,621, filed Oct. 24, 2022, the entire contents of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 63380621 | Oct 2022 | US |
