Patent Application
20110034802
The present invention relates generally to medical devices. More particularly the present invention relates to systems, methods, and apparatus for imaging an implantable device and methods for manufacturing.
Catheterization and interventional procedures, such as stenting or placement of a lumen filter, generally are performed by inserting a hollow needle through a patient's skin and tissue into the vascular system. A guide wire may be advanced through the needle and into the patient's blood vessel accessed by the needle. The needle is then removed, enabling an introducer sheath to be advanced over the guide wire into the vessel, e.g., in conjunction with or subsequent to a dilator.
A catheter or other device may then be advanced through a lumen of the introducer sheath and over the guide wire into a position for performing a medical procedure (for example, inserting a stent or lumen filter into a body lumen). Thus, the introducer sheath may facilitate introducing various devices into the vessel, while minimizing trauma to the vessel wall and/or minimizing blood loss during a procedure. Because implantable devices are typically implanted in a patient, it may be desirable to image the implantable device during and/or after implantation.
Accordingly, systems, methods, and apparatus for imaging an implantable device and methods for manufacturing may also be useful.
A method for imaging an implantable device is described. The method may include positioning an implantable device within a patient. The implantable device may include a first outer surface and a plurality of ultrasonically visible portions formed into the first outer surface. At least one of the plurality of ultrasonically visible portions may have a first size dimension. At least two of the plurality of ultrasonically visible portions may be separated by a first spacing dimension. Ultrasonic energy may be transmitted toward the implantable device. The returning ultrasonic energy may be analyzed to determine a first characteristic of the implantable device.
In some embodiments, analyzing the returning ultrasonic energy to determine a first characteristic of the implantable device includes determining the relative position of the implantable device within the patient. In further embodiments, determining the relative position of the implantable device within the patient includes determining the relative position of the implantable device within the patient during positioning of the implantable device within the patient.
An attempt may be made, in some embodiments, to deploy the implantable device within the patient. In further embodiments, determining the relative position of the implantable device within the patient includes determining the relative position of the implantable device within the patient prior to deployment of the implantable device within the patient.
In some embodiments, it may be determined whether the implantable device was deployed. In further embodiments, if the implantable device did not deploy, the relative position of the implantable device within the delivery apparatus may be determined.
The first characteristic may include the orientation of the implantable device, the location of the implantable device within the patient, the state of the implantable device within the patient, or other characteristics, or combinations thereof. In further embodiments, the state of the implantable device within the patient includes whether the implantable device is in a deployed state.
In some embodiments, the first outer surface may be a part of an ultrasonically visible marker operatively associated with the implantable device. The first outer surface, in further embodiments, may be integral to the implantable device. In still further embodiments, the plurality of ultrasonically visible portions may cover the first outer surface of the implantable device. The implantable device, in some embodiments, may be a vascular filter, a closure element, a valve frame, a stent, other implantable devices, or combinations thereof.
In another embodiment, a method for manufacturing an implantable device is described. The method includes selecting a first size dimension for a plurality of ultrasonically visible portions. A first spacing dimension may be selected for the plurality of ultrasonically visible portions. The first spacing dimension may be used to determine the spacing between at least two of the plurality of ultrasonically visible portions. An implantable device may be formed having a first outer surface. The plurality of ultrasonically visible portions may be formed into the first outer surface using the selected first size dimension and the selected first spacing dimension.
In some embodiments, forming a plurality of ultrasonically visible portions into the first outer surface may be performed by plastically deforming at least a portion of the first outer surface. In further embodiments, forming a plurality of ultrasonically visible portions into the first outer surface may be performed by removing at least a portion of the first outer surface. Forming a plurality of ultrasonically visible portions into the first outer surface, in still further embodiments, may be performed using a shot peening process, a shot blasting process, a laser texturing process, a textured die, an extrusion die, other forming processes, or combinations thereof.
The first size dimension, in some embodiments, may be selected to create an approximate surface area of one of the plurality of ultrasonically visible portions. The approximate surface area of one of the plurality of ultrasonically visible portions, in further embodiments, may be predetermined to facilitate ultrasonic visibility.
In some embodiments, the ultrasonically visible portions may have at least one surface that is non-parallel to a portion of the first outer surface proximate the ultrasonically visible portions. In further embodiments, the first size dimension may be selected to create an approximate depth of one of the plurality of ultrasonically visible portions. The approximate depth of one of the plurality of ultrasonically visible portions may be predetermined, in still further embodiments, to facilitate ultrasonic visibility. In yet further embodiments, the first outer surface may be a part of an ultrasonically visible marker operatively associated with the implantable device.
An embodiment of an implantable device is described. The implantable device may include a first outer surface that may include a first ultrasonically visible portion having a first size dimension. The implantable device may include a second ultrasonically visible portion having a first size dimension. The second ultrasonically visible portion may be separated from said first ultrasonically visible portion by a spacing dimension.
In some embodiments, the first ultrasonically visible portion and/or the second ultrasonically visible portion may be formed by removing portions of said first surface, by plastically deforming portions of said first surface, by other processes, or combinations thereof. The first size dimension of the first ultrasonically visible portion and/or the first size dimension of the second ultrasonically visible portion, in further embodiments, may be about the same dimension. In still further embodiments, the first ultrasonically visible portion may include a second size dimension. The second size dimension may include a width.
Other aspects and features of the present invention will become apparent from consideration of the following description in conjunction with the accompanying drawings.
In order to describe the manner in which the above-recited and other advantages and features of the invention can be obtained, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. Understanding that these drawings depict only typical embodiments of the invention and are not therefore to be considered to be limiting of its scope, the invention will be described and explained with additional specificity and detail through the use of the accompanying drawings.
It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are generally represented by like reference numerals for illustrative purposes throughout the figures. It also should be noted that the figures are only intended to facilitate the description of embodiments of the present invention.
The embodiments described herein extend generally to methods, systems, and apparatus for imaging an implantable device and methods for manufacturing. It may be desirable for implantable devices to be visible under ultrasonic signals. In addition, the use of ultrasonic imaging devices often allows for noninvasive imaging. Implantable devices are typically implanted under fluoroscopy. However, fluoroscopes are relatively expensive. Thus, it is generally impractical for most rooms in a hospital, clinic, office, or other medical facility to have a fluoroscope. Ultrasonic imaging devices, on the other hand, are often found in many parts of a medical facility. For example, an intensive care unit will typically have an ultrasonic imaging device while generally not having a fluoroscope. Furthermore ultrasonic imaging devices may be desirable in some body locations, such as a heart valve.
In many cases, implantable device are not readily visible in ultrasonic images. To facilitate the imaging of an implantable device, it may be desirable to alter a surface of the implantable device. For example, the surface may be roughened in an organized way. Examples of processes for roughing the surface of the implantable device may include laser texturing, cold drawing with a textured roll, cold extrusion through textured dies, shot peening, shot blasting, fabrication using the powder processing route, other processes, or combinations thereof.
Processes such as shot blasting and/or shot peening may be used with particles of known or unknown sizes and/or shapes. The particle sizes and/or shapes may be determined to increase the visibility of the surface during ultrasonic imaging.
The implantable device 100 may include an outer surface 102 that may include a first ultrasonically visible portion 104a and/or a second ultrasonically visible portion 104b. The first and/or second ultrasonically visible portions 104a, 104b may be concave with respect to the rest of the outer surface 102. For example, the first and/or second ultrasonically visible portions 104a, 104b may have a generally polygonal shape. Alternatively, the first and/or second ultrasonically visible portions 104a, 104b may have other shapes. For example, the first and/or second ultrasonically visible portions 104a, 104b may be part of a pyramid, cone, sphere, other shape, may have a generally random geometric pattern, or combinations thereof.
In the present embodiment, the first and/or second ultrasonically visible portions 104a, 104b may be formed by removing material from the outer surface 102 of the implantable device 100. In other embodiments, the first and/or second ultrasonically visible portions 104a, 104b may be formed by plastically deforming the outer surface 102 of the implantable device 100.
The first and/or second ultrasonically visible portions 104a, 104b may include at least one size dimension 106a′, 106a″, 106b′, 106b″, 106c′, 106c″. Size dimensions may include a depth, a maximum depth, an average depth, a width, an angle, a length, a radius, a diameter, a diagonal length, a surface area, and/or other size dimensions.
In the embodiment of
The depth may range from about 1 μm to about 100 μm. The width may range from about 1 μm to about 100 μm. The length (not shown) may range from about 1 μm to about 100 μm.
In the embodiment shown in
As described above, the third size dimension 106c′, 106c″ of the first and/or second ultrasonically visible portions 104a, 104b, in the present embodiment, may include an angle between the outer surface 102 and an inner surface 108′, 108″ of the first and/or second ultrasonically visible portions 104a, 104b. In embodiments, where the angle may be approximately more or less than one hundred and eighty degrees (180), the implantable device 100 may deflect ultrasonic signals (i.e. waves) making the implantable device 100 visible to an ultrasonic imaging device. Other size dimensions may facilitate visibility of the implantable device 100 to an ultrasonic imaging device. For example, the depth, width, length, and/or other size dimensions of an ultrasonically viewable portion may facilitate visibility.
The first and second ultrasonically visible portions 104a, 104b may be separated by a spacing dimension 110. The spacing dimension 110 may be selected to facilitate the ultrasonic visibility of the implantable device 100. For example, ultrasonically visible portions may be separated by a spacing dimension 110 ranging from about 1 μm to about 100 μm.
The implantable device 200 may include an outer surface 202. The outer surface 202 may include a first ultrasonically visible portion 204a, a second ultrasonically visible portion 204b, and/or a third ultrasonically visible portion 204c. The first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may be concave with respect to the rest of the outer surface 202. For example, the first ultrasonically visible portion 204a may have a generally elliptical shape.
The first, second, and/or third ultrasonically visible portions 204a, 204b, 204c, in the present embodiment, may all have approximately the same shape. In other embodiments, the first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may all have different shapes or may have some shapes that are different and some that are approximately the same. The first, second, and/or third ultrasonically visible portions 204a, 204b, 204c, in the present embodiment, have an approximately spherical shape. In other embodiments, the first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may have other shapes and/or a combination of shapes.
In the present embodiment, first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may be formed by removing material from the outer surface 202 of the implantable device 200. In other embodiments, the first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may be formed by plastically deforming the outer surface 202 of the implantable device 200. In further embodiments, the first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may be formed by a combination of removing material from or plastically deforming the outer surface 202 of the implantable device 200.
The first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may include at least one size dimension 206a′, 206a″, 206a′″. In the present embodiment, the first size dimension 206a′, 206a″, 206a′″ may include a radius. The radius may range from about 1 μm to about 100 μm.
In the embodiment shown in
As described above, first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may have an elliptical shape. The first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may include an inner surface 208′, 208″, 208′″ that may be generally non-parallel with the outer surface 202. Non-parallel inner surfaces may deflect ultrasonic signals (i.e. waves) making the implantable device 200 visible to an ultrasonic imaging device. Other inner surfaces may facilitate visibility of the implantable device 200 to an ultrasonic imaging device. In addition, an inner surface that is parallel to the outer surface 202 may deflect ultrasonic signals (i.e. waves) to make the implantable device 200 visible to an ultrasonic imaging device. For example, the inner surfaces 110′, 110″ shown in
The first, second, and/or third ultrasonically visible portions 204a, 204b, 204c may be separated by a spacing dimension 210′, 210″. The spacing dimensions 210′, 210″ may be selected to facilitate the ultrasonic visibility of the implantable device 200. For example, ultrasonically visible portions may be separated by a spacing dimension ranging from about 1 μm to about 100 μm.
In the embodiment shown in
The implantable device 300 may include an outer surface 302. The outer surface 302 may include a first ultrasonically visible portion 304a, a second ultrasonically visible portion 304b, and/or a third ultrasonically visible portion 304c. The first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may include at least one inner surface 308′, 308″, 308′″. In the present embodiment, the first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may be generally concave with respect to the rest of the outer surface 302. For example, portions of the inner surface 308″ of the second ultrasonically visible portion 304b may be convex with respect to the outer surface 302, however, the second ultrasonically visible portion 304b may, nonetheless, be generally concave as a majority of the inner surface 308″ of the second ultrasonically visible portion 304b is also concave. In other embodiments, the first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may be generally convex with respect to the rest of the outer surface 302. This may be accomplished by, for example, heating portions of the outer surface 302 to expand the first, second, and/or third ultrasonically visible portions 304a, 304b, 304c beyond the outer surface 302.
The first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may be separated by a spacing dimension 310′, 310″. The spacing dimensions 310′, 310″ may be selected to facilitate the ultrasonic visibility of the implantable device 300. For example, ultrasonically visible portions may be separated by a spacing dimension 310′, 310″ ranging from about 1 μm to about 100 μm. In the embodiment shown in
The first, second, and/or third ultrasonically visible portions 304a, 304b, 304c, in the present embodiment, may all have varying shapes. In other embodiments, the first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may all have the same shape or may have some shapes that are different and some that are approximately the same. The first, second, and/or third ultrasonically visible portions 304a, 304b, 304c, in the present embodiment, have a generally convex random shape, such as, for example, a shape formed by a shot peening or shot blasting process.
In the present embodiment, the first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may be formed by plastically deforming portions of the outer surface 302 of the implantable device 300. In other embodiments, the first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may be formed by removing material from the outer surface 302 of the implantable device 300. In further embodiments, the first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may be formed by a combination of removing material from or plastically deforming the outer surface 302 of the implantable device 300.
The first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may include at least one size dimension 306a′, 306a″, 306a′″, 306b′, 306b″, 306b′″. Size dimensions may include a depth, a width, an angle, a length, a radius, a diameter, a diagonal length, a surface area, and/or other size dimensions.
In the embodiment of
The size dimensions 306a′, 306a″, 306a′″, 306b′, 306b″, 306b′″ of first, second, and/or third ultrasonically visible portions 304a, 304b, 304c may be different from each other. In other embodiments, the size dimensions may be approximately the same. In further embodiments, some of the size dimensions may be different from each other and some of the size dimensions may be approximately the same.
The implantable device 400 may include an outer surface 402. The outer surface 402 may include a first ultrasonically visible portion 404a, a second ultrasonically visible portion 404b, and/or a third ultrasonically visible portion 404c. The first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may be concave with respect to the rest of the outer surface 402. For example, the first ultrasonically visible portion 404a may have a generally elliptical shape.
The first, second, and/or third ultrasonically visible portions 404a, 404b, 404c, in the present embodiment, may all have approximately the same shape. In other embodiments, the first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may all have different shapes or may have some shapes that are different and some that are approximately the same.
In the present embodiment, first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may be formed by removing material from the outer surface 402 of the implantable device 400. In other embodiments, the first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may be formed by plastically deforming the outer surface 402 of the implantable device 400. In further embodiments, the first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may be formed by a combination of removing material from or plastically deforming the outer surface 402 of the implantable device 400.
The first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may include at least one size dimension 406a′, 406a″, 406a′″. In the present embodiment, the first size dimension 406a′, 406a″, 406a′″ may include an approximate surface area. The surface area may range from about 1 μm to about 100 μm.
In the embodiment shown in
As described above, first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may have an elliptical shape. The first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may include an inner surface 408′, 408″, 408′″ that may be generally non-parallel with the outer surface 402.
The first, second, and/or third ultrasonically visible portions 404a, 404b, 404c may be separated by a spacing dimension 410′, 410″, 410′″. The spacing dimensions 410′, 410″, 410′″ may be selected to facilitate the ultrasonic visibility of the implantable device 400. For example, ultrasonically visible portions may be separated by a spacing dimension 410′, 410″, 410′″ ranging from about 1 μm to about 100 μm. In the embodiment shown in
The outer surface 602 may include more than the extreme outer surface. In some embodiments, the outer surface 602 may include an ablumenal surface of the implantable device 600. In further embodiments, the outer surface 602 may include a side surface of the implantable device 600.
An implantable device may be positioned within a patient, as represented by block 802. Positioning an implantable device within a patient may include positioning the implantable device in a desired location and/or in a desired orientation. For instance, a lumen filter may be positioned in a desired location within a body lumen, such as within the inferior vena cava. In another example, a valve frame may be positioned in a desired location, such as the aortic valve.
Ultrasonic energy may be transmitted toward the implantable device, as represented by block 804. The ultrasonic energy may be transmitted toward the implantable device via an ultrasonic imaging device. A technician may transmit ultrasonic energy into a patient before, during, and/or after positioning the implantable device within the patient.
The returning ultrasonic energy may be analyzed, as represented by block 806. Analyzing the returning ultrasonic energy may include producing an image, for example, on a monitor. In another example, a microprocessor and/or other data processing device may analyze the returning ultrasonic energy. Analyzing the returning ultrasonic energy may further include producing some other indicator, such as sound.
Analyzing the returning ultrasonic energy may include determining a first characteristic of the implantable device. The characteristics of the implantable device may include the relative position of the implantable device within the patient, the orientation of the implantable device within the patient, the location of the implantable device within the patient, the state of the implantable device within the patient (i.e. whether the implantable device is in a deployed state), and/or other characteristics or combinations thereof. Analyzing the returning ultrasonic energy may be performed before, during, and/or after positioning the implantable device within the patient.
The method 900 of this other embodiment may be functionally similar to that of the method 800 previously described above and shown in
An implantable device may be positioned within a patient, as represented by block 902. An attempt to deploy the implantable device may be made, as represented by block 904. Deploying an implantable device may include, for example, transitioning an implantable device from a collapsed to an expanded state (or vice versa), anchoring a lumen filter within a body lumen, engaging the inner surface of a body lumen with the outer surface of a stent, engaging tissue with a tissue engaging portion of an engaging element, and/or other types of deployments.
Ultrasonic energy may be transmitted toward the implantable device, as represented by block 906. The returning ultrasonic energy may be analyzed to determine a first characteristic of the implantable device, as represented by block 908. It may be determined whether the implantable device was deployed, as represented by block 910. Determining whether the implantable device was deployed may include determining whether the implantable device successfully transitioned from a collapsed to an expanded state (or vice versa), whether a lumen filter successfully anchored within a body lumen, whether the outer surface of a stent successfully engaged the inner surface of a body lumen, whether a tissue engaging portion of an engaging element successfully engaged tissue, and/or other indicators of successful deployments.
The method 1000 may include selecting a first size dimension for at least one ultrasonically visible portion, as represented by block 1002. The first size dimension may be similar to the size dimensions described above. For example, the first size dimension may include a depth (i.e. a maximum or average depth), a width, an angle, a length, a radius, a diameter, a diagonal length, a surface area, and/or other size dimensions. Additional size dimensions may also be selected, such as a second dimension. Selecting a size dimension may include selecting a die, roller, shot for a shot peening or shot blasting procedure, and/or other forming device to form the at least one ultrasonically visible portion.
A first spacing dimension for the at least one ultrasonically visible portion may be selected, as represented by block 1004. The first spacing dimension may be similar to the spacing dimensions described above. Selecting a spacing dimension may include selecting a die, roller, shot for a shot peening or shot blasting procedure, and/or other forming device to form the at least one ultrasonically visible portions.
In the present embodiment, both a first size dimension and a first spacing dimension for the at least one ultrasonically visible portion may be selected. In other embodiments, only a first size dimension or a first spacing dimension for the at least one ultrasonically visible portion may be selected.
The first size dimension may be selected to create an approximate surface area, an approximate depth, and/or other dimension of one of the at least one ultrasonically visible portion. The approximate surface area, approximate depth, and/or other dimension of one of the at least one ultrasonically visible portion may be predetermined to facilitate ultrasonic visibility. The first size dimension may be selected to create at least one surface of at least one ultrasonically visible portion that is non-parallel to a portion of the first outer surface proximate the ultrasonically visible portion.
An implantable device may be formed, as represented by block 1006. The implantable device may include a first outer surface, as described above. Forming the implantable device may include forming tissue engaging portions (i.e. in the case of an engaging element implantable device and/or lumen filter implantable device), support members (i.e. in the case of a stent implantable device, lumen filter implantable device, and/or closure element implantable device), and/or other components of the implantable device. The implantable device may be formed from a base material. The base material may be a shape memory material, such as alloys of nickel-titanium, and/or other materials.
Ultrasonically visible portions may be formed into the first outer surface of the implantable device, as represented by block 1008. The ultrasonically visible portions may be formed by removing material from the outer surface of the implantable device, by plastically deforming the outer surface of the implantable device, and/or other forming processes. The ultrasonically visible portions may be formed using a shot peening process, a laser texturing process, a textured die, an extrusion die, and/or other processes.
The ultrasonically visible portions may be formed into the first outer surface of the implantable device using the selected first size dimension, the selected first spacing dimension, and/or other selected dimensions. Additional size, spacing, other dimensions, and/or combinations of the same may be selected and/or used to form the ultrasonically visible portions.
The invention is susceptible to various modifications and alternative means, and specific examples thereof have been shown by way of example in the drawings and are herein described in detail. It should be understood, however, that the invention is not to be limited to the particular devices or methods disclosed, but to the contrary, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the claims.
This application hereby incorporates U.S. Provisional Patent Application No. 61/014,395, filed Dec. 17, 2007, and entitled “Methods for Imaging a Delivery System” by reference in its entirety.
