POROUS DEVICES AND PROCESSES FOR PRODUCING SAME
A method for making a polymer with a porous layer from a solid piece of polymer is disclosed. In various embodiments, the method includes heating a surface of a solid piece of polymer to a processing temperature and holding the processing temperature while displacing a porogen layer through the surface of the polymer to create a matrix layer of the solid polymer body comprising the polymer and the porogen layer. In at least one embodiment, the method also includes removing at least a portion of the layer of porogen from the matrix layer to create a porous layer of the solid piece of polymer.
1 . A method for determining tissue ingrowth into a medical device, the method comprising:
(a) visualizing a medical device in a patient using an electromagnetic-imaging technique, wherein the medical device comprises:
a porous surface; and
at least one marker for detecting the medical device in a radiograph, wherein a top of the marker is a known distance relative to a top of the porous surface;
(b) measuring a position of an edge of a tissue and a position of an edge of the at least one marker; and
(c) comparing a distance between the edge of the tissue and the edge of the at least one marker, thereby determining the tissue ingrowth of the patient's tissue into the medical device.
2 . The method of claim 1 , wherein the top of the marker is below the top of the porous surface.
3 . The method of claim 1 , wherein the top of the marker is flush with the top of the porous surface.
4 . The method of claim 1 , further comprising measuring a baseline level of tissue ingrowth immediately following or shortly after implantation of the medical and measuring tissue ingrowth at a later time.
5 . The method of claim 1 , wherein the at least one marker comprises a radiolucent material.
6 . The method of claim 5 , further comprising a radiopaque material.
7 . The method of claim 1 , wherein the at least one marker comprises a radiopaque metal.
8 . The method of claim 7 , wherein the radiopaque metal is tantalum.
9 . The method of claim 1 , wherein the at least one marker is substantially cylindrical, rectangular, triangular, or conical.
10 . The method of claim 9 , wherein the at least one marker is substantially cylindrical.
11 . A method for determining tissue ingrowth into a medical device, the method comprising:
(a) visualizing a medical device in a patient using an electromagnetic-imaging technique, wherein the medical device comprises:
a porous surface; and
at least one marker for detecting the medical device in a radiograph, wherein a top of the marker is a known distance below a top of the porous surface;
(b) measuring a distance between the patient's tissue and the top of the at least one marker; and
(c) comparing the distance between the patient's tissue and the top of the at least one marker and the known distance of the top of the marker below the top of the porous surface, thereby determining the tissue ingrowth of the patient's tissue into the medical device.
12 . The method of claim 0 , wherein the at least one marker comprises a radiolucent material.
13 . The method of claim 12 , further comprising a radiopaque material.
14 . The method of claim 0 , wherein the at least one marker comprises a radiopaque metal.
15 . The method of claim 14 , wherein the radiopaque metal is tantalum.
16 . The method of claim 0 , wherein the at least one marker is substantially cylindrical, rectangular, triangular, or conical.
17 . The method of claim 16 , wherein the at least one marker is substantially cylindrical.
18 . The method of claim 17 , wherein the substantially cylindrical marker can be inserted into a portion of the medical device.
19 . The method of claim 0 , wherein substantially cylindrical marker can be inserted into a portion of the medical device and extends vertically through the medical device.
20 . A method for determining tissue ingrowth into a medical device, the method comprising:
(a) visualizing a medical device in a patient using an electromagnetic-imaging technique, wherein the medical device comprises:
a thermoplastic body defining a porous surface formed from a plurality of pores, each of the pores extending from a top face into the body; and
at least one marker for detecting the medical device in a radiograph, wherein a top of the marker is approximately flush with the top face of the porous surface; and
(b) measuring the distance between the patient's tissue and the top of the at least one marker, thereby determining the tissue ingrowth of the patient's tissue into the medical device.
21 . The method of claim 20 , wherein an interconnectivity between the plurality of pores is at least 99%; and an interfacial shear strength between the porous surface and the body is at least about 17 MPa.
22 . The method of claim 20 , wherein the at least one marker comprises a radiolucent material.
23 . The method of claim 22 , wherein the at least one marker further comprises a radiopaque material.
24 . The method of claim 20 , wherein the at least one marker comprises a radiopaque metal.
25 . The method of claim 24 , wherein the radiopaque metal is tantalum.
26 . The method of claim 20 , wherein the at least one marker is substantially cylindrical, rectangular, triangular, or conical.
27 . The method of claim 26 , wherein the at least one marker is substantially cylindrical.
28 . The method of claim 27 , wherein the substantially cylindrical marker can be inserted into a portion of the body.
29 . The method of claim 20 , wherein substantially cylindrical marker can be inserted into a portion of the body and extends vertically through the body.
30 . The method of claim 20 , wherein the body comprises polyetheretherketone (PEEK).