Implantable medical devices having microporous surface layers and method for reducing foreign body response to the same
AssigneeHealionics Corporation
InventorsAndrew J. Marshall, Michel Alvarez, Max Maginness
Life of this patent
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Abstract
This disclosure provides implantable devices coated with microporous surface layers with macrotopographic features that improve bio-integration at the interface of the implantable devices and the surrounding tissue.
Claims45
A microporous biomaterial with macrotopographic surface features and a plurality of pores, wherein substantially all the pores are each interconnected to at least 2 other pores, a mean diameter of the pores is between about 5 and about 100 micrometers, and any two adjacent pores are connected by a throat, a mean throat diameter of the throats being between about 5 micrometers and about 50 micrometers, and wherein the macrotopography is defined by a plurality of peaks and valleys, wherein each peak is porous and has a height of between about 100 micrometers and about 2000 micrometers, and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured.
An implantable device comprising:
- a device body;
- and
- a microporous biomaterial overlying the device body wherein the microporous biomaterial has macrotopographic surface features and a plurality of pores, and wherein substantially all the pores are each interconnected to at least 2 other pores, a mean diameter of the pores is between about 5 and about 100 micrometers, and any two adjacent pores are connected by a throat, a mean throat diameter of the throats being between about 5 micrometers and about 50 micrometers, and wherein the macrotopography is defined by a plurality of peaks and valleys, wherein each peak is porous and has a height of between about 100 micrometers and about 2000 micrometers, and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured.
(canceled)
An implantable device comprising:
- a device body;
- and
- a textured surface layer overlying the device body, wherein the textured surface layer comprises one or more granules of a microporous biomaterial, the granules forming a surface macrotopography that includes a plurality of peaks and valleys, each peak having a height of between about 100 micrometers and about 2000 micrometers, and wherein each granule comprises a plurality of interconnecting pores having a mean pore diameter of between about 5 and 100 micrometers, and any two adjacent pores are connected by a throat, a mean throat diameter of the throats being between 5 and 50 micrometers, and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured.
A method for forming a microporous biomaterial with macrotopographic features:
- (a) arranging macro-porogens to form the template for a dissolvable mold surface with macrotopographic mold features, wherein the macro-porogens have a mean macro-porogen diameter that is between about 100 and about 2000 micrometers;
- (b) removing the macro-porogens from the mold surface of (a) by chemical dissolution;
- (c) filling the macrotopographic mold features with micro-porogens such that points of contact and interstitial spaces between adjacent micro-porogens are formed, wherein the micro-porogens have a mean micro-porogen diameter that is between about 5 micrometers and about 100 micrometers;
- (d) fusing the micro-porogens together and to the surface of the mold at the points of contact;
- (e) introducing a liquid biocompatible polymer precursor into the interstitial space between the micro-porogens;
- (f) solidifying the biocompatible polymer precursor;
- and
- (g) removing the micro-porogens and the dissolvable mold surface.
A method for reducing the foreign body response comprising:
- implanting an implantable device comprising:
- a device body;
- and a microporous biomaterial or an implantable device, wherein the microporous biomaterial has macrotopographic surface features and a plurality of pores, and wherein substantially all the pores are each interconnected to at least 2 other pores, a mean diameter of the pores is between about 5 and about 100 micrometers, and any two adjacent pores are connected by a throat, a mean throat diameter of the throats being between about 5 micrometers and about 50 micrometers, and wherein the macrotopography is defined by a plurality of peaks and valleys wherein each peak is porous and has a height of between about 100 micrometers and about 2000 micrometers, and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured;
- and
- wherein the implantable device comprises a device body;
- and a textured surface layer overlying the device body, wherein the textured surface layer comprises one or more granules of a microporous biomaterial, the granules forming a surface macrotopography that includes a plurality of peaks and valleys, each peak having a height of between about 100 micrometers and about 2000 micrometers, and wherein each granule comprises a plurality of interconnecting pores having a mean pore diameter of between about 5 and 100 micrometers, and any two adjacent pores are connected by a throat, a mean throat diameter of the throats being between 5 and 50 micrometers, and at least two adjacent peaks define a valley, the valley having a floor from which the heights of the adjacent peaks are measured.
Dependencies are inferred from the claim text.