Intercostal spacer device and method for use in correcting a spinal deformity

Abstract

An intercostal spacer device for placement between two adjacent ribs, includes a spacer member and at least one pair of arms that extend from a first end of the spacer member and at least one pair of arms that extend from a second end of the spacer member. The intercostal spacer device may also include a flexible, fillable container for containing an injectable material that is compressible following implantation. The container is impermeable to the material it will be filled with. A structural mesh, for example, made of PET fabric and interwoven shape-memory alloy wire, provides structure for and containment of the container, as well as shape control of the intercostal spacer device. The material can be injected into the container through a conduit. The intercostal spacer device is sized and configured to allow for placement into the intercostal space to produce a force for correcting a spinal deformity.

1 . An intercostal spacer device for use in correcting a spinal deformity comprising:
 a spacer member comprising a first end and a second end;   a first pair of arms extending from the first end of the spacer member and a second pair of arms extending from the second end of the spacer member; and   wherein the spacer member, first pair of arms and second pair of arms are sized and configured to allow for placement of the intercostal spacer device between two adjacent ribs of a patient to dynamically produce a force for correcting a spinal deformity of the patient.   
   
   
       2 . The intercostal spacer device of  claim 1 , wherein the first pair of arms includes a first anterior arm and a first posterior arm, the first anterior arm and the first posterior arm being substantially parallel to each other and forming a first channel therebetween, and wherein the first channel is sized to receive a first rib of the two adjacent ribs, and wherein the second pair of arms includes a second anterior arm and a second posterior arm, with the second anterior arm and the second posterior arm extending substantially parallel to each other and forming a second channel therebetween, wherein the second channel is sized to receive a second rib of the two adjacent ribs of the patient. 
   
   
       3 . The intercostal spacer device of  claim 2 , wherein the first and second posterior arms are configured for positioning along a posterior side of the first and second ribs and the first and second anterior arms are configured for positioning along an anterior side of the first and second ribs. 
   
   
       4 . The intercostal spacer device of  claim 1 , wherein the spacer member comprises a central axis extending between the first end and the second end thereof, with the first pair of arms disposed at the first end and the second pair of arms disposed at the second end each being centered about the central axis. 
   
   
       5 . The intercostal spacer device of  claim 1 , wherein at least one of the first pair of arms and the second pair of arms is offset in a lateral direction relative to the central axis of the spacer member, and wherein at least one of the first pair of arms and the second pair of arms is offset in a medial direction relative to the central axis of the spacer member. 
   
   
       6 . The intercostal spacer device of  claim 1 , further comprising at least one additional pair of arms extending from the first end of the spacer member. 
   
   
       7 . The intercostal spacer device of  claim 6 , wherein the at least one additional pair of arms disposed at the first end of the spacer member is offset in the lateral direction relative to the central axis and the first pair of arms disposed at the first end of the spacer member is offset in the medial direction relative to the central axis, and wherein the second pair of arms at the second end of the spacer member is centered about the central axis. 
   
   
       8 . The intercostal spacer device of  claim 1 , further comprising at least one connector, wherein the at least one connector is configured to secure the intercostal spacer device between the first and second ribs of the patient. 
   
   
       9 . The intercostal spacer device of  claim 8 , wherein the spacer member includes at least one bore extending therethrough between an anteriorly oriented side and a posteriorly oriented side of the spacer member when positioned between the first and second ribs and the at least one connector extends through the at least one bore when employed to couple the intercostal spacer device to the first and second ribs. 
   
   
       10 . The intercostal spacer device of  claim 8 , wherein the first pair of arms and the second pair of arms each include at least one bore extending therethrough between an anteriorly oriented side and a posteriorly oriented side thereof, with the at least one bore disposed within the first pair of arms extending in a direction substantially parallel to a direction of the at least one bore disposed within the second pair of arms, wherein the at least one connector is multiple connectors, and wherein a first connector of the multiple connectors extends through the at least one bore in the first pair of arms and a second connector of the multiple connectors extends through the at least one bore in the second pair of arms when employed to couple the intercostal spacer device to the first and second ribs. 
   
   
       11 . The intercostal spacer device of  claim 8 , wherein the at least one connector comprises at least one of a tether, cable, wire, band, screw, lock pin, rivet, staple and press-fit pin. 
   
   
       12 . The intercostal spacer device of  claim 1 , wherein the intercostal spacer device is fabricated from a flexible material. 
   
   
       13 . The intercostal spacer device of  claim 1 , wherein the intercostal spacer device is capable of resisting a compressive load with a stiffness of about 10 N/mm to about 300 N/mm. 
   
   
       14 . An intercostal spacer device for use in correcting a spinal deformity comprising:
 a flexible container for containing an injectable material, the flexible container being substantially impermeable to the injectable material and being compressible following implantation between two adjacent ribs of a patient;   a conduit coupled to the flexible container for injecting the injectable material into the flexible container;   a structure for at least part of the flexible container; and   wherein the structure controls at least part of a shape of the intercostal spacer device, and wherein the structure is sized and configured for placement of the intercostal spacer device between two adjacent ribs of a patient to produce a force for correcting a spinal deformity of the patient.   
   
   
       15 . The intercostal spacer device of  claim 14 , wherein the injectable material is flowable during filling of the flexible container. 
   
   
       16 . The intercostal spacer device of  claim 14 , wherein the conduit comprises a one-way valve. 
   
   
       17 . The intercostal spacer device of  claim 14 , wherein the flexible container is situated inside the structure. 
   
   
       18 . The intercostal spacer device of  claim 14 , wherein the flexible container is situated outside the structure. 
   
   
       19 . The intercostal spacer device of  claim 14 , wherein the flexible container is integral with the structure. 
   
   
       20 . The intercostal spacer device of  claim 14 , wherein the structure comprises a shape memory alloy. 
   
   
       21 . The intercostal spacer device of  claim 20 , wherein the shape memory alloy is body temperature activated. 
   
   
       22 . The intercostal spacer device of  claim 20 , wherein the shape memory alloy is elastic. 
   
   
       23 . The intercostal spacer device of  claim 20 , wherein the shape memory alloy is coupled to an inside of the structure. 
   
   
       24 . The intercostal spacer device of  claim 20 , wherein the shape memory alloy is coupled to an outside of the structure. 
   
   
       25 . The intercostal spacer device of  claim 24 , wherein the structure comprises a plurality of interlocking links, and wherein the plurality of interlocking links comprise the shape memory alloy. 
   
   
       26 . The intercostal spacer device of  claim 20 , wherein the structure comprises a structural mesh, and wherein the shape memory alloy comprises at least one shape memory alloy wire within the structural mesh. 
   
   
       27 . The intercostal spacer device of  claim 14 , wherein the structure has at least a partially preformed shape. 
   
   
       28 . The intercostal spacer device of  claim 14 , wherein the container and the structure together comprise a layer of rubber thick enough to roughly maintain a desired shape. 
   
   
       29 . The intercostal spacer device of  claim 14 , wherein the container comprises at least one of silicone, rubber, polyurethane, polyethylene terephthalate (PET), polyolefin, polycarbonate urethane, and silicone copolymer. 
   
   
       30 . The intercostal spacer device of  claim 14 , wherein the injectable material comprises at least one of a curable polymer and an adhesive. 
   
   
       31 . The intercostal spacer device of  claim 14 , wherein the structure comprises at least one of PET fabric, polypropylene fabric, polyethylene fabric and metal wire. 
   
   
       32 . The intercostal spacer device of  claim 14 , wherein the intercostal spacer device is capable of resisting a compressive load with a stiffness of about 10 N/mm to about 300 N/mm. 
   
   
       33 . The intercostal spacer device of  claim 14 , wherein the structure is at least partially permeable. 
   
   
       34 . A method of controlling at least part of a shape of an intercostal spacer device, the intercostal spacer device comprising a flexible container for containing an injectable material, the container being substantially impermeable to the injectable material, and a structure for at least part of the flexible container, the method comprising creating the structure with at least one material for controlling at least part of a shape of the intercostal spacer device with the intercostal spacer device being sized and configured for placement between two adjacent ribs of a patient to dynamically produce a force for correcting a spinal deformity of the patient, and with the flexible container being compressible following implantation between the two adjacent ribs of the patient. 
   
   
       35 . The method of  claim 34 , wherein the creating comprises adding a shape memory alloy to the structure. 
   
   
       36 . The method of  claim 35 , wherein the structure comprises a structural mesh, and wherein the creating comprises adding at least one shape-memory alloy wire to the structural mesh. 
   
   
       37 . The method of  claim 35 , wherein the creating comprises coupling the at least one shape memory alloy to the structure. 
   
   
       38 . The method of  claim 34 , wherein the creating comprises adding a layer of rubber thick enough to roughly maintain a desired shape. 
   
   
       39 . An intercostal spacer system, the intercostal spacer system comprising:
 a plurality of intercostal spacer devices, the plurality of intercostal spacers including:
 a first intercostal spacer device comprising a spacer member including a first end and a second end, and a first pair of arms extending from the first end and a second pair of arms extending from the second end, wherein the spacer member, first pair of arms and second pair of arms of the first intercostal spacer device are sized and configured for placement between a first rib and an adjacent second rib of a patient; 
 a second intercostal spacer device, comprising a spacer member including a first end and a second end, and a first pair of arms extending from the first end and a second pair of arms extending from the second end, wherein the spacer member, first pair of arms and second pair of arms of the second intercostal spacer device are sized and configured for placement between adjacent second rib and a third rib of the patient; and 
 wherein the first intercostal spacer and the second intercostal spacer cooperate to dynamically produce a force for correcting a spinal deformity of the patient. 
   
   
   
       40 . The intercostal spacer system of  claim 39 , wherein for each of the intercostal spacer devices, the first pair of arms includes a first anterior arm and a first posterior arm, with the first anterior arm and the first posterior arm being substantially parallel to each other and forming a first channel therebetween, and wherein the first channel is sized to receive a first rib of the patient, and wherein the second pair of arms includes a second anterior arm and a second posterior arm, with the second anterior arm and the second posterior arm extending substantially parallel to each other and forming a second channel therebetween, wherein the channel is sized to receive an adjacent second rib of the patient. 
   
   
       41 . The intercostal spacer system of  claim 40 , wherein for each of the intercostal spacer devices, the first and second posterior arms of the first pair of arms and the second pair of arms are each positionable along a posterior side of the first and second ribs and the first and second anterior arms in the first pair of arms and the second pair of arms is positionable along an anterior side of the first and second ribs. 
   
   
       42 . The intercostal spacer system of  claim 39 , wherein for each of the intercostal spacer devices, the spacer member comprises a central axis extending between the first end and the second end thereof, with the first pair of arms disposed at the first end and the second pair of arms disposed at the second end each being centered about the central axis. 
   
   
       43 . The intercostal spacer system of  claim 39 , wherein the first intercostal spacer device is positioned between the first rib and the second rib and the second intercostal spacer device is positioned between the second rib and the third rib, wherein the first intercostal spacer device is positioned offset relative to the second intercostal spacer device. 
   
   
       44 . The intercostal spacer system of  claim 42 , wherein for each of the intercostal spacer devices, at least one of the first pair of arms and the second pair of arms is offset in a lateral direction relative to the central axis of the spacer member, and wherein at least one of the first pair of arms and the second pair of arms is offset in a medial direction relative to the central axis of the spacer member. 
   
   
       45 . The intercostal spacer system of  claim 44 , wherein the first intercostal spacer device is positioned between the first rib and the second rib of the patient and the second intercostal spacer device is positioned between the second rib and the third rib of the patient, wherein when implanted, the first intercostal spacer device is positioned for close approximation relative to the second intercostal spacer device to produce a force for correcting a spinal deformity of the patient. 
   
   
       46 . The intercostal spacer system of  claim 39 , wherein for each of the intercostal spacer devices, the intercostal spacer device further comprising at least one additional pair of arms extending from the first end of the spacer member. 
   
   
       47 . The intercostal spacer system of  claim 46 , wherein for each of the intercostal spacer devices, the additional pair of arms disposed at the first end of the spacer member is offset in the lateral direction relative to the central axis and the first pair of arms disposed at the first end of the spacer member is offset in the medial direction relative to the central axis, and wherein the second pair of arms extending from the second end of the spacer member is centered about the central axis. 
   
   
       48 . The intercostal spacer system of  claim 47 , wherein the plurality intercostal spacer devices are shaped and dimensioned to allow for close association in use between adjacent ribs of a patient, wherein the positioning of the plurality of intercostal spacer devices facilitate the correction of a spinal deformity in the patient. 
   
   
       49 . The intercostal spacer system of  claim 39 , for each of the intercostal spacer devices, the intercostal spacer device further comprises at least one connector, wherein the at least one connector is configured to secure the intercostal spacer device between the first and second ribs of the patient. 
   
   
       50 . The intercostal spacer system of  claim 39 , wherein the intercostal spacer system further comprising at least one connector, wherein the at least one connector is configured to couple each of the plurality of intercostal spacer devices together. 
   
   
       51 . The intercostal spacer system of  claim 49 , wherein for each of the intercostal spacer devices, the spacer member includes at least one bore extending therethrough between an anteriorly oriented side and a posteriorly oriented side of the spacer member when positioned between the first and second ribs and the at least one connector extends through the at least one bore when employed to couple the intercostal spacer device to the first and second ribs. 
   
   
       52 . The intercostal spacer system of  claim 49 , wherein for each of the intercostal spacer devices, the first pair of arms and the second pair of arms each include at least one bore extending therethrough between an anteriorly oriented side and a posteriorly oriented side thereof, with the at least one bore disposed within the first pair of arms extending in a direction substantially parallel to a direction of the at least one bore disposed within the second pair of arms, wherein the at least one connector is multiple connectors, and wherein a first connector of the multiple connectors extends through the at least one bore in the first pair of arms and a second connector of the multiple connectors extends through the at least one bore in the second pair of arms when employed to couple the intercostal spacer device to the first and second ribs. 
   
   
       53 . The intercostal spacer system of  claim 49 , wherein for each of the intercostal spacer devices, the at least one connector comprises at least one of a tether, cable, wire, band, screw, lock pin, rivet, staple and press-fit pin. 
   
   
       54 . The intercostal spacer system of  claim 39 , wherein for each of the intercostal spacer devices, the intercostal spacer device is fabricated from a flexible material. 
   
   
       55 . The intercostal spacer system of  claim 39 , wherein each of the intercostal spacer devices are capable of resisting a compressive load with a stiffness of about 10 N/mm to about 300 N/mm. 
   
   
       56 . A method for correcting a spinal deformity, the method comprising:
 providing at least one intercostal spacer device comprising a spacer member having a first end and a second end, and at least one first pair of arms extending from the first end and a second pair of arms extending from the second end, wherein the spacer member, the at least one first pair of arms and the second pair of arms of the at least one intercostal spacer device are sized and configured for placement between a first rib and an adjacent second rib of a patient; and   positioning the at least one intercostal spacer device between the first rib and the adjacent second rib of the patient, with the first rib disposed between the at least one first pair of arms and the second rib disposed between the second pair of arms, thereby facilitating securing the at least one intercostal spacer device between the first rib and adjacent second rib and producing a force for correcting a spinal deformity of the patient.   
   
   
       57 . A method for correcting a spinal deformity, the method comprising:
 providing an intercostal spacer device, the intercostal spacer device comprising:
 a flexible container for containing an injectable material, the flexible container being substantially impermeable to the injectable material and being compressible following implantation between two adjacent ribs of a patient; 
 a conduit coupled to the flexible container for injecting the injectable material into the flexible container; and 
 a structure for at least part of the flexible container, the structure has a shape of the intercostal spacer device, with the intercostal spacer device being sized and configured for placement between two adjacent ribs of a patient; 
   implanting the intercostal spacer device between the two adjacent ribs of the patient; and   injecting the injectable material into the flexible container through the conduit so that the shape of the structure is achieved, thereby producing a force for correcting a spinal deformity of the patient.