Joint spacers
11458018 · 2022-10-04
Assignee
Inventors
Cpc classification
A61F2/30907
HUMAN NECESSITIES
A61F2002/30579
HUMAN NECESSITIES
A61F2002/30062
HUMAN NECESSITIES
A61F2002/30754
HUMAN NECESSITIES
A61F2002/30912
HUMAN NECESSITIES
International classification
Abstract
An apparatus including a joint spacer for treatment of a joint of a human subject. The joint spacer includes a bioresorbable stent having compressed and expanded configurations and a covering that covers an external surface of the stent. The joint spacer is configured to be inserted into a space of the joint, and is shaped, when the bioresorbable stent is in the expanded configuration, to provide mechanical support to the joint until the bioresorbable stent resorbs into a body of the subject. Treating a joint of a human subject includes inserting a joint spacer into a space of the joint while a bioresorbable stent of the joint spacer is in a compressed configuration, and transitioning the bioresorbable stent to an expanded configuration within the joint, such that the joint spacer provides mechanical support to the joint until the bioresorbable stent resorbs into a body of the subject.
Claims
1. An apparatus comprising a joint spacer for treatment of a joint of a human subject, the joint spacer comprising: a bioresorbable structure having a plurality of struts defining a plurality of openings, the bioresorbable structure having compressed and expanded configurations; and a covering that covers an external surface of the bioresorbable structure, wherein the joint spacer is configured to be inserted into a space of the joint, and is shaped, when the bioresorbable structure is in the expanded configuration, to provide mechanical support to the joint until the bioresorbable structure resorbs into a body of the subject, wherein the covering is bioresorbable, the bioresorbable structure being configured to resorb into the body of the subject before the covering resorbs into the body of the subject.
2. The apparatus according to claim 1, wherein the covering is fluid-permeable and blood-permeable.
3. The apparatus according to claim 1, wherein the covering is tissue-permeable.
4. The apparatus according to claim 1, wherein the covering defines a non-tubular lumen therethrough when the joint spacer is unconstrained and the bioresorbable structure is in the expanded configuration, at least immediately upon placement within the joint.
5. The apparatus according to claim 1, wherein the covering is sachet-shaped at least immediately upon placement within the joint.
6. The apparatus according to claim 1, wherein the covering is rectangular at least immediately upon placement within the joint.
7. The apparatus according to claim 1, wherein the apparatus further comprises a delivery tube, in which the joint spacer is removably disposed for delivery in a radially-compressed configuration with a central longitudinal axis thereof parallel to a longitudinal axis of the delivery tube.
8. The apparatus according to claim 1, wherein the bioresorbable structure is a stent shaped generally as an elliptical cylinder, and wherein the length of the major axis of the elliptical cylinder equals at least 200% of the length of the minor axis of the elliptical cylinder when the bioresorbable structure is in the expanded configuration.
9. The apparatus according to claim 1, wherein the bioresorbable structure is configured to resorb into the body of the subject between 3 and 36 months after placement in the joint.
10. A method for treating a joint of a human subject, the method comprising: inserting a joint spacer into a space of the joint while a bioresorbable structure of the joint spacer is in a compressed configuration, the bioresorbable structure having a plurality of struts defining a plurality of openings, wherein a covering of the joint spacer covers an external surface of the bioresorbable structure, the covering being bioresorbable and configured to absorb into a body of the subject after the bioresorbable structure absorbs into the body of the subject; and transitioning the bioresorbable structure to an expanded configuration within the joint, such that the joint spacer provides mechanical support to the joint, wherein the joint spacer is a subacromial spacer, and wherein inserting the joint spacer comprises inserting the subacromial spacer into a subacromial space of a shoulder joint.
11. The method according to claim 10, wherein the covering is shaped as a pouch within which the bioresorbable structure is disposed, at least immediately upon placement within the joint.
12. The method according to claim 10, wherein the bioresorbable structure is shaped as a partially-flattened tube when the joint spacer is unconstrained and the bioresorbable structure is in the expanded configuration.
13. The method according to claim 12, wherein inserting the joint spacer comprises inserting the joint spacer while it is removably disposed in a delivery tube in a radially-compressed configuration with a central longitudinal axis of the joint spacer parallel to a longitudinal axis of the delivery tube.
14. A method for treating a joint of a human subject, the method comprising: inserting a joint spacer into a space of the joint while a bioresorbable structure of the joint spacer is in a compressed configuration, the bioresorbable structure having a plurality of struts defining a plurality of openings, wherein a covering of the joint spacer covers an external surface of the bioresorbable structure, the covering being bioresorbable and configured to absorb into a body of the subject after the bioresorbable structure absorbs into the body of the subject; and transitioning the bioresorbable structure to an expanded configuration within the joint, such that the joint spacer provides mechanical support to the joint, wherein the joint spacer is a glenohumeral spacer, and wherein inserting the joint spacer comprises inserting the glenohumeral spacer into a glenohumeral joint.
15. The method according to claim 14, wherein the covering is shaped as a pouch within which the bioresorbable structure is disposed, at least immediately upon placement within the joint.
16. The method according to claim 14, wherein the bioresorbable structure is shaped as a partially-flattened tube when the joint spacer is unconstrained and the bioresorbable structure is in the expanded configuration.
17. The method according to claim 16, wherein inserting the joint spacer comprises inserting the joint spacer while it is removably disposed in a delivery tube in a radially-compressed configuration with a central longitudinal axis of the joint spacer parallel to a longitudinal axis of the delivery tube.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
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DETAILED DESCRIPTION
(10) Embodiments of the present disclosure provide a joint spacer 10 for treatment of a joint of a human subject.
(11) Reference is made to
(12) Joint spacer 10 includes: a bioresorbable stent 30 having a compressed configuration, such as shown in
(13) Joint spacer 10 is configured to be inserted into a space of the joint, and is shaped, when bioresorbable stent 30 is in the expanded configuration, to provide mechanical support to the joint until bioresorbable stent 30 resorbs into a body of the subject while new tissue is remodeled. For some applications, joint spacer 10 may simulate at the size or shape of a natural bursa.
(14) For some applications, joint spacer 10 is a subacromial spacer and the joint is a shoulder joint, and the subacromial spacer is shaped and sized so as to be insertable into a subacromial space of the shoulder joint to provide support to the shoulder joint until bioresorbable stent 30 resorbs into the body of the subject. For example, the subacromial spacer may be used for treating a rotator cuff injury. For other applications, joint spacer 10 is a glenohumeral spacer and the joint is a glenohumeral joint, and the glenohumeral spacer is shaped and sized so as to be insertable into the glenohumeral joint to provide support to the glenohumeral joint until bioresorbable stent 30 resorbs into the body of the subject for treating glenohumeral arthritis. Alternatively, joint spacer 10 is shaped and sized to be inserted into another joint, such as knee, hip, ankle, or hand (e.g., CMC1) joint.
(15) Typically, bioresorbable stent 30 is configured to resorb into the body of the subject between 3 and 36 months after placement in the joint, such as between 6 and 18 months after placement in the joint, e.g., about one year after placement in the joint. This period of time may allow soft tissue to grow into the space defined and structurally supported by joint spacer 10 while bioresorbable stent 30 resorbs into the body, thereby providing long-term treatment to the joint without the long-term presence of a prosthetic implant.
(16) For some applications, bioresorbable stent 30 includes a metal selected from the group of metals consisting of: magnesium, a magnesium alloy, calcium, a calcium alloy, iron, and an iron alloy other than steel.
(17) For some applications, covering 32 is shaped as a pouch 36 within which bioresorbable stent 30 is disposed, at least immediately upon placement within the joint. (For applications in which covering 32 is bioresorbable, such as described herein, covering 32 ceases to be shaped as pouch 36 at some point during the bioresorption of covering 32; the same is true of many of the other features described herein.) For some applications, pouch 36 is shaped so as to define a closed space therewithin at least immediately upon placement within the joint. For some applications, pouch 36 is not shaped so as to define any openings that have a cross-sectional area greater than 3 mm.sup.2 at least immediately upon placement within the joint.
(18) Typically, covering 32 is fluid-permeable and blood-permeable. For applications in which covering 32 is bioresorbable, such as described herein, covering 32 is typically fluid-permeable and blood-permeable until resorbing into the body of the subject. Typically, covering 32 is tissue-permeable. For applications in which covering 32 is bioresorbable, such as described herein, covering 32 is typically tissue-permeable until resorbing into the body of the subject.
(19) For some applications, covering 32 is bioresorbable. For some applications, bioresorbable covering 32 is configured to resorb into the body of the subject between 3 and 36 months after placement in the joint, such as between 6 and 18 months after placement in the joint, e.g., about one year after placement in the joint. For some applications, covering 32 includes a material selected from the group consisting of: a bioresorbable polymer, a biological tissue (e.g., bovine or equine fascia lata), and collagen. For some applications in which the material is the bioresorbable polymer, the bioresorbable polymer includes one or more polymers selected from the group of polymers consisting of: a polylactic acid (PLA) polymer, a PLA/GA polymer, a polyglycolic acid (PGA) polymer, a polycaprolactone (PCL) polymer, a polydioxanone (PDO) polymer, and a copolymer of any of these polymers.
(20) For some applications, bioresorbable stent 30 and bioresorbable covering 32 are configured such that bioresorbable stent 30 resorbs into the body of the subject before bioresorbable covering 32 resorbs into the body of the subject. As a result, bioresorbable covering may protect the joint from direct exposure to bioresorbable stent 30 until bioresorbable stent 30 resorbs.
(21) For other applications, covering 32 is non-bioresorbable. For some of these applications, covering 32 includes polyethylene terephthalate (PET).
(22) For some applications, covering 32 is configured to promote tissue growth thereon and/or therethrough, into the space defined by the spacer. For example, covering 32 may be coated with a tissue-growth-promoting material, e.g., selected from the group consisting of: collagen, chondrocytes, and hydroxylapatite.
(23) Typically, unlike endovascular stent-grafts, joint spacer 10 is not shaped so as to allow directional blood flow therethrough, at least immediately upon placement within the joint. Typically, unlike endovascular stent-grafts, covering 32 does not define a tubular lumen therethrough when joint spacer 10 is unconstrained and bioresorbable stent 30 is in the expanded configuration, at least immediately upon placement within the joint. Typically, unlike endovascular stent-grafts, bioresorbable stent 30 does not include any circular cylindrical portions when joint spacer 10 is unconstrained and bioresorbable stent 30 is in the expanded configuration, at least immediately upon placement within the joint.
(24) Reference is made to
(25) For some applications, bioresorbable stent 130 is shaped generally as an elliptical cylinder. For example, the length L1 of the major axis of the elliptical cylinder may equal at least 200% of the length L2 of the minor axis of the elliptical cylinder when joint spacer 110 is unconstrained and bioresorbable stent 130 is in the expanded configuration. For some applications, bioresorbable stent 130 is shaped generally as an oval or elliptic cylinder, and the distance between the axes of the oval cylinder equals at least 200% of the radii of the oval cylinder when joint spacer 110 is unconstrained and bioresorbable stent 130 is in the expanded configuration.
(26) Reference is still made to
(27) Reference is made to
(28) For some applications, such as shown in
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(30) For some applications, bioresorbable stent 230 is shaped generally as an ovoid when joint spacer 210 is unconstrained and bioresorbable stent 230 is in the expanded configuration.
(31) For some applications, bioresorbable stent 230 is shaped generally as an ellipsoid when joint spacer 210 is unconstrained and bioresorbable stent 230 is in the expanded configuration. For some applications, bioresorbable stent 230 is shaped generally as a spheroid when joint spacer 210 is unconstrained and bioresorbable stent 230 is in the expanded configuration. For some applications, bioresorbable stent 230 is shaped generally as an oblate spheroid 270 when joint spacer 210 is unconstrained and bioresorbable stent 230 is in the expanded configuration. For some applications, wires 260 cross one another within 3 mm of a first pole 272A of oblate spheroid 270 and within 3 mm of a second pole 272B of oblate spheroid 270 when joint spacer 210 is unconstrained and bioresorbable stent 230 is in the expanded configuration. For some applications, the length of each of the semi-axes of oblate spheroid 270 equals at least 200% of the length of the symmetry axis of the oblate spheroid when joint spacer 210 is unconstrained and bioresorbable stent 230 is in the expanded configuration.
(32) Reference is made to
(33) For some applications, such as shown in
(34) Reference is now made to
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(45) Reference is now made to
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(51) A bioresorbable stent 530 of joint spacer 510 defines first and second poles 572A and 572B, which together define an axis 580 of bioresorbable stent 530. Typically, wires 260 cross one another within 3 mm of first pole 572A and within 3 mm of a second pole 572B when joint spacer 510 is unconstrained and bioresorbable stent 530 is in the expanded configuration. Optionally, anchor 322 is disposed at one of first and second poles 572A and 572B. Optionally, a central longitudinal axis of anchor 322 is coaxial with axis 580 of bioresorbable stent 530.
(52) Bioresorbable stent 530 is disposed eccentrically about axis 580 when joint spacer 510 is unconstrained and bioresorbable stent 530 is in the expanded configuration. When joint spacer 510 is removably disposed in delivery tube 50 for delivery, joint spacer 510 is collapsed asymmetrically. For example, joint spacer 510 may be compressed on axis 580.
(53) The scope of the present disclosure includes embodiments described in the following applications. In some embodiments, techniques and apparatus described in one or more of the following applications are combined with techniques and apparatus described herein:
(54) U.S. Pat. No. 8,753,390 to Shohat
(55) U.S. Pat. No. 8,894,713 to Shohat et al.
(56) PCT Publication WO 2008/111073 to Shohat
(57) PCT Publication WO 2010/097724 to Shohat
(58) PCT Publication WO 2012/017438 to Shohat et al.
(59) PCT Publication WO 2013/057566 to Shohat
(60) It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein. Rather, the scope of the present disclosure includes both combinations and subcombinations of the various features described herein, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.