The disclosure relates to medical devices with visibility-enhancing features. More specifically, the disclosure relates to the distribution and characteristics of such visibility-enhancing features.
In one broad aspect, embodiments of the present invention include a medical device comprising an elongate member having proximal and distal regions, the distal region comprising: a first echogenic region including a plurality of circumferential first region cuts, each of the first region cuts having a first region cut volume; and a second echogenic region including a plurality of circumferential second region cuts, each of the second region cuts having a second region cut volume greater than said first region cut volume; wherein the second echogenic region is located at a portion of the distal region subject to less bending stress in use, relative to a location of the first echogenic region.
As a feature of the first broad, the elongate member has a circular cross-section and is operable to be inserted through a dilator when in use. The elongate member is configured such that, in use, the second echogenic region is located further distal than the first echogenic region relative to an end of the dilator through which the elongate member is inserted.
As another feature of the first broad aspect, mechanical integrity of the elongate member under stress is substantially equivalent along its length.
As another feature of the first broad aspect, a second region cut density is greater than a first region cut density i.e. the second region has a higher number of cuts per unit of area than the first area.
In another broad aspect, embodiments of the present invention include a medical device comprising an elongate member having proximal and distal regions, the distal region comprising: a first echogenic region including a plurality of circumferential first region cuts, each of the first region cuts having a first region cut volume; and a second echogenic region, distal of the first echogenic region, including a plurality of circumferential second region cuts, each of the second region cuts having a second region cut volume greater than said first region cut volume.
In yet another broad aspect, embodiments of the present invention are for a method of creating a perforation of tissue within a heart, the method comprising: inserting an elongate medical device into a heart of a patient's body; visualizing one or more echogenic markings associated with the medical device to facilitate positioning of the medical device at a target tissue site within the heart; and delivering energy to a distal region of the elongate medical device to create a perforation through the target tissue site.
As a feature of the broad aspect, the target tissue site comprises a septum of a heart.
In order that the invention may be readily understood, embodiments of the invention are illustrated by way of examples in the accompanying drawings, in which:
Imaging systems utilized during the course of medical procedures include X-ray (fluoroscopy), ultrasound and magnetic resonance imaging (MRI). Examples of means to improve imaging include radiopaque markers and coatings in the case of fluoroscopy, magnetic components including magnetic coils for MRI, and surface markings in the case of ultrasound.
Ultrasound techniques include intracardiac echocardiography (ICE) and transesophageal echocardiography (TEE). A partial list of devices that may use ultrasound includes biopsy needles, tissue puncture devices (e.g. transseptal puncture devices), fluid collection devices, lesioning devices, devices requiring vascular access, in vitro fertilization devices, obstetrics and gynecology devices, and devices for tissue removal. To aid in the performance of medical procedures, it is desirable to increase the visibility of medical devices under imaging without compromising overall device efficacy or safety. To increase visibility under ultrasound, it is beneficial to have larger cuts into the surface of a medical device as echogenic performance tends to increase with depth, diameter, and density of surface voids. For example, deeper and wider rings may improve the effective viewing angles and the mount of signal that can be reflected back to an ultrasound sensor. However, as understood by one skilled in the art, cuts in the surface of a long shaft (an elongate member) subject to bending moments, can reduce the local mechanical integrity of the shaft at the location (i.e. region) of the cuts, thereby making the shaft more susceptible to breakage.
The present inventors have discovered a novel and unique means for enhancing visibility under imaging of a medical device which, while reducing mechanical strength locally, avoids compromising the overall device effectiveness or safety. The means include increasing visibility under imaging with a non-uniform distribution of visibility-enhancing features as a function of the local stresses expected during use. Embodiments of the devices provided by said means display increased visibility along the device both in areas of relatively greater mechanical vulnerability and lesser mechanical vulnerability, wherein the visibility is increased to a greater extent in areas of lesser mechanical vulnerability (expected stress) relative to areas of greater mechanical vulnerability (expected stress). Larger, denser, and ultimately more effective echogenic features are located in areas wherein low expected mechanical stress is expected in use. Conversely, in areas where higher stresses are expected in use, smaller features are used. Embodiments of the present invention provide enhanced visibility of medical devices while maintaining the structural integrity of the devices to a greater extent relative to other devices with similar visibility enhancing features.
Some embodiments of the invention incorporate one or more discrete surface irregularities, such as a single cut or groove, or a plurality of cuts or grooves, for imaging under ultrasound. As previously noted, deeper and wider cuts, in general, improve the effective viewing angles and the amount of signal that may be reflected back to an ultrasound sensor. An embodiment of the present invention displaying such features is a medical device comprising an elongate member having proximal and distal regions. The distal region comprises a first echogenic region including a plurality of circumferential first region cuts, each of the first region cuts having a first region cut volume, and a second echogenic region including a plurality of circumferential second region cuts, each of the second region cuts having a second region cut volume greater than said first region cut volume wherein the second echogenic region is located at a portion of the distal region subject to less bending stress in use, relative to a location of the first echogenic region. Such embodiments provide for increased echogenicity by having the surface cuts in the stronger regions of the device, thereby maintaining the overall mechanical integrity of a device. In some embodiments, the second region is distal of the first region; reasons for a distal region being under less bending stress than a relatively proximal region are explained hereinbelow.
The circumferential cuts of the above example are located around 360° of the circumference of the device (or for non-circular alternative embodiments, around substantially 360° of the perimeter of the device), whereby the device is substantially visible from all (radial) directions (that is, at any angle relative to a transducer).
In general, a visibility enhancing feature, in accordance with embodiments of the invention, is positioned in regions of the device located between structural discontinuities (points of weakness e.g. hinges, joints, welds, apertures). In the case of the above described example of a medical device, the circumferential cuts are located between structural weaknesses, rather than in the region of a structural discontinuity.
With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of certain embodiments of the present invention only. Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting.
Medical device 30 of
In a particular embodiment (without a coating of insulation), larger volume cut-out rings 24 have a width W1 of about 0.25±0.05 millimeters (mm) and a depth D1 of about 0.075 mm (with an upper deviation of 0.000 and a lower deviation of 0.025), and smaller volume cut-out rings 22 have a width of about 0.15±0.05 mm and a depth D1 of about 0.04 mm (with an upper deviation of 0.00 and a lower deviation of 0.02 mm). In some particular embodiments the medical device defines a lumen and a basic (nominal) wall thickness of about 0.15 mm. In some embodiments having a wall thickness of about 0.15 mm the depth of the larger volume cut-out rings 24 will be from about 33 to 50 percent of the wall thickness and the smaller volume cut-out rings 22 will be from about 13 to 27 percent of the wall thickness. In the illustrated embodiments, one or more of the individual components of the visibility enhancing feature (the cut rings) are located around 360° of the perimeter or circumference of the medical device. In alternative embodiments, the cut rings do not extend around the entire (i.e. the full 360°) perimeter or circumference. The rings may be produced using tooling of the appropriate size.
The embodiments shown in
Differences in acoustic impedances between two materials may create an interface that will cause a portion of the ultrasonic pulsed beam to be reflected. The greater the acoustic mismatch, the greater will be the intensity of the reflected portion of the beam. Some embodiments of the medical device include a metal shaft, having relatively high acoustic impedance, covered by a coating having an acoustic impedance that facilitates the use of ultrasound for imaging wherein the coating has an acoustic impedance substantially similar to the acoustic impedance of blood (about 1.51 MRayl) and soft tissues (from about 1.30 MRayl for fat to about 1.7 MRayl for muscle). Due to this matching of acoustic impedance between the coating and the surrounding material (blood or soft tissue) when the device is in use in the patient's body, the interface between the coating and the soft tissue (or blood) will reflect a relatively small portion of an ultrasonic pulsed beam. This then allows a large portion of the ultrasonic beam to proceed through to the metal shaft, which has a relatively high acoustic impedance (e.g. Z=45.7 MRayl for stainless steel), whereby a large portion of the ultrasonic beam will be reflected by the metallic surface (or the interface between the coating and the shaft).
An example of such an embodiment may include a coating comprising a polymeric electrical insulation layer with acoustic impedance that substantially matches blood to thereby allow a majority of the ultrasonic wave through the blood-insulation interface in order to reflect off of the metal-insulation interface This acoustic impedance matching helps to provide an improved image relative to the image provided by a coating with an acoustic impedance outside the range of soft tissue and blood. Examples of suitable polymer coatings with suitable acoustic impedances include silicone rubber which may have an acoustic impedance of 1.40 MRayl, and DGEBA (epoxy resin) which may have an acoustic impedance of about 1.48 to about 1.53 MRayl.
Echogenic markings (rings, dimples, notches, etc.) in a medical device may reduce the mechanical integrity of the device (i.e. the ability of the device to withstand forces and stresses without permanently deforming or breaking), with markings produced by removing a larger amount of material causing larger reductions in mechanical integrity. Considering the embodiment of
Referring to
The medical device of
The above example, using the formula M(x)=F·(L−x), represents a simplification, as not all forces are accounted for and the in-use position of the medical device (relative to the dilator) may vary. A different in-use position may require an analysis based on a different device position, a different length L, and a different force F magnitude or direction. Considering the different possibilities of normal use, a device may be designed by one skilled in the art to account for the maximum extension and force expected in normal use.
Making reference to
wherein x is a point along a supported elongate member 26 (a shaft) of medical device 30, σ is bending stress, F is a downward/lateral force, I1 is the distance from the end of the elongate member to x, and Do(x) is the outer diameter of elongate member 26 at position x. Elongate member 26 is supported at support end SE. In this formula, the bending stress is proportional to the inverse of outer diameter Do (x) to the third power. The above formula does not take into account all of the design features a medical device may have, and does not include all the forces that may act on a medical device. It may be simplified to express the approximation σ≈K/Do(x)3 wherein K is a constant.
In the example of
In order to represent the distribution of visibility enhancing features (which may also be referred to as the individual components of a visibility enhancing feature) along the device, a parameter referred to as an “echogenic feature scale” may be defined. The echogenic feature scale refers to the distribution, size and configuration of the cuts, grooves or other features along the device, which will typically be non-uniform and which is governed by and optimized in view of the stress expected at a given position (approximated by σ≈K/Do(x)3) as well as the increase in visibility provided by the particular feature.
For example, in the case of a cut or groove, both the increase in visibility as well as the decrease in mechanical integrity, are proportional to the volume of the cut/groove. Therefore, if a given location along the device is expected to experience lower stresses, then less mechanical integrity is required and the cuts/grooves may be made deeper and/or wider than at other locations along the device in order to increase the visibility at that location. The same device may also include locations where greater stresses are expected, in which case the cuts/grooves at those locations may be made shallower and/or narrower relative to the cuts/grooves mentioned previously in order to avoid substantially reducing the mechanical integrity of the device at those locations. In this case, the “echogenic feature scale” may refer to the depth and/or width of the individual cuts/grooves, such that the echogenic feature scale may be described to be non-uniform along the device. In alternate embodiments, the echogenic feature scale may refer to any other feature or characteristic of the visibility enhancing feature or the individual components of the visibility enhancing feature, including but not limited to size (depth, width, etc.), shape and density (number of visibility enhancing feature(s) within a given area).
The second step is to further analyze possible in-use configurations using formulas known to a person having ordinary skill in the art. Examples are the formulas previously disclosed in this description.
The third step is to modify region(s) of a test device not having the weakest point to increase visibility (e.g. echogenicity) as a function of the mechanical strength of the region(s) taking into account that the visibility features of concern reduce mechanical integrity. In other words, an echogenic feature may be added at a location of the medical device having greater mechanical integrity relative to other portions of the device.
The fourth step is mechanical testing of the test device to determine mechanical integrity of the modified test device.
The next step depends on the results of the previous mechanical testing. For example, if any other region is weaker than the “weak point region” (the region or portion of the device with the weakest point), then that region is modified to have greater structural strength. If a region is stronger than required, the design may be modified for that region to have greater visibility.
In the last step, if the parameters of the regions are found to be acceptable in the mechanical testing, the design process may be stopped, temporarily or permanently. A person having ordinary skill in the art would understand that further testing of the medical device for visibility under imaging may be required.
In alternative embodiments, cuts or markings in the surface of a medical device may comprise, for example, dimples, notches (triangular in cross-section) or non-rounded grooves. The markings may be identical throughout region(s) of a device to facilitate manufacturing simplicity. Alternatively, the markings may vary in a specific region or throughout a device. For example, in an embodiment having cut away rings, the size of the rings could increase with each successive ring.
In some embodiments, as described hereinabove, the cuts or markings circumscribe the device substantially completely. In alternative embodiments, the cuts or markings are not formed around the entire circumference (or perimeter, for non-circular device cross-sections).
In general, an aspect of some embodiments of the invention is that larger volumes of cuts are made in areas of relatively lower expected mechanical stress; including wider cuts or markings, deeper cuts, and/or increased densities of cuts (more cuts per area).
Some alternative embodiments include cuts with substantially sharp angles. As is understood by a person having ordinary skill in the art, a cut with sharp angles (i.e. sharp corners) is more susceptible to mechanical failure than a cut with rounded corners. The top illustration of
In alternative embodiments of the medical device, the echogenic feature comprises a textured surface, for example, a surface formed by grit blasting. In such embodiments, the echogenic feature scale may refer to, for example, the roughness of the surface, such that varying the echogenic feature scale along the device would involve varying the roughness of the texture at different locations along the device.
Embodiments of medical devices having echogenic features as described hereinabove include devices with features formed by removing material (e.g.
If, in the design of a medical device, strong, homogenous material is removed to make space for a less strong but more visible material, the overall mechanical integrity at that location may be compromised. In one example, some of a device's metallic elongate member (a shaft) may be replaced, at locations of greater mechanical integrity (i.e. where the expected in-use stresses are lower), with an impregnated polymer that is structurally weaker than the metal, while the device size (e.g. outer diameter) is kept substantially constant. In a specific example, a device is modified to have about 50% of a metal sidewall, over a selected region, replaced by a polymer that contains bubbles or other echogenic features, without substantially changing the outer diameter of the device. In such and similar embodiments, the echogenic feature scale may refer to the amount of stronger material removed from the device.
An example of such an alternative embodiment is found in the
A partial list of materials and items that a polymer may contain to improve echogenicity includes, but is not limited to:
1) Sonically reflective particles wherein the sonically reflective material is selected from the group consisting of metal oxide powders, hollow glass microspheres and various forms of carbon particles;
2) Metal particles (tungsten, palladium, gold, silver, iron oxide, etc.);
3) Trapped bubbles; and
4) A braid, a strand or a strip of non-metal and biocompatible echogenic material.
The embodiment of
In general, a non-uniform characteristic (distribution, size, configuration, etc.) of a feature enhancing visibility under imaging may be a function of local stresses. Specifically, denser patterns of visibility enhancing features and/or larger visibility enhancing features may be located in areas of expected (relatively) low mechanical stress.
Embodiments of the present invention avoid adding excess visibility enhancing features that reduce mechanical integrity at locations already having greater mechanical vulnerability, either due to their location along the device or due to other features existing at those locations which reduce mechanical integrity. Features that reduce the mechanical integrity (i.e. increase mechanical vulnerability) of a device may be referred to as mechanical discontinuities. A partial list of such features includes, but is not limited to, joints, apertures (including side-ports or lateral apertures), handles, proximal supports, hinges, and welds, material deformed by crimping, locations subject to heat during manufacture or use, and other features interrupting device structural continuity.
One specific embodiment is for a method of using a medical device as disclosed herein, for example as illustrated in
In one such embodiment, an intended user introduces a guidewire into a femoral vein, typically the right femoral vein, and advances it towards the heart. A guiding sheath, for example a sheath as described in U.S. patent application Ser. No. 10/666,288 (filed on Sep. 19, 2003), incorporated herein by reference, is then introduced into the femoral vein over the guidewire, and advanced towards the heart. The distal ends of the guidewire and sheath are then positioned in the superior vena cava. These steps may be performed with the aid of an imaging system appropriate for radiopaque marker 66 and an ultrasound imaging system appropriate for echogenic cut-out rings 22 and 24. When the sheath is in position, a dilator, for example the TorFlex™ Transseptal Dilator of Baylis Medical Company Inc. (Montreal, Canada), or the dilator as described in U.S. patent application Ser. No. 11/727,302 (filed on Mar. 26, 2007), incorporated herein by reference, is introduced into the sheath and over the guidewire, and advanced through the sheath into the superior vena cava. Alternatively, the dilator may be fully inserted into the sheath prior to entering the body, and both may be advanced simultaneously towards the heart. When the guidewire, sheath, and dilator have been positioned in the superior vena cava, the guidewire is removed from the body, and an electrosurgical device, for example medical device 30 (a radiofrequency perforation apparatus), is then introduced into the lumen of the dilator, and advanced toward the heart. The sheath, dilator and medical device 30 are retracted slightly, such that they enter the right atrium of the heart.
In this embodiment, after inserting the electrosurgical device into a dilator, the user may position the distal end of the dilator against the atrial septum. The electrosurgical device is then positioned using imaging of a marker 66 of functional tip 15 such that electrode 63 (which also functions as a radiopaque marker) is aligned with or protruding slightly from the distal end of the dilator but not retracted inside of the dilator. The dilator and medical device 30 are dragged along the atrial septum and positioned, for example against the fossa ovalis of the atrial septum utilizing medical imaging techniques. Small cut-out rings 22 (proximal of aperture 20) and large cut-out rings 24 (distal of aperture 20), visible under an ultrasound imaging system, may aid in positioning and orientating functional tip 15. A variety of additional steps may be performed, such as measuring one or more properties of the target site, for example an electrogram or ECG (electrocardiogram) tracing and/or a pressure measurement or delivering material to the target site, for example delivering a contrast agent through aperture(s) 20. Such steps may facilitate the localization of the electrode 63 at the desired target site. In addition, tactile feedback provided by medical device 30 (a radiofrequency perforation apparatus) is usable to facilitate positioning of the electrode 63 at the desired target site. The practitioner can visually monitor the position of functional tip 15 as it is advanced upwards into the heart and as it is dragged along the surface of the atrial septum and positioned in the groove of the fossa ovalis using one or more of the radiopaque marker and echogenic rings.
With the electrosurgical device and the dilator positioned at the target site, energy is delivered from the energy source, through medical device 30 (a radiofrequency perforation apparatus), to the target site. For example, if the medical device 30 is used, electrical energy is delivered through the elongate member 26, to the electrode 63, and into the tissue at the target site. In some embodiments, the electrical energy is delivered at a power of at least about 5 W at a voltage of at least about 75 V (peak-to-peak), and functions to vaporize cells in the vicinity of the electrode, thereby creating a void or perforation through the tissue at the target site. Typically, energy is delivered in the radiofrequency range. If the heart was approached via the inferior vena cava, as described hereinabove, the user applies force in the substantially cranial direction to the handle 1 of the electrosurgical device as energy is being delivered. The force is then transmitted from the handle to the distal portion 64 of the medical device 30, such that the distal portion 64 of elongate member 26 advances at least partially through the perforation. In these embodiments, when the distal portion 64 has passed through the target tissue, that is, when it has reached the left atrium, energy delivery is stopped/terminated. In some embodiments, the step of delivering energy occurs over a period of between about 1 s and about 5 s.
Further details regarding fluoroscopic imaging and radiopaque markers may be found in U.S. provisional application 61/653,967, filed May 31, 2012, incorporated herein by reference.
In the method described hereinabove, echogenic features such as those described hereinabove facilitate the localization and/or navigation of the medical device, prior to, during and after the medical procedure. Providing such visibility enhancing features while minimizing the effect on the mechanical integrity of the device, for example by employing a varying echogenic feature scale as described hereinabove, is particularly beneficial in such procedures which may utilize ultrasonic imaging for guidance and localization and which may involve mechanical forces being applied to the device.
Thus, as described herein, the present inventors have discovered and reduced to practice a novel and unique medical device including a means for enhancing visibility under imaging (a visibility enhancing feature) which, while reducing the local mechanical strength, avoids compromising the overall device effectiveness or safety. Embodiments of the device provide increased visibility along the device both in areas of relatively greater mechanical vulnerability and lesser mechanical vulnerability, wherein the visibility is increased to a greater extent in areas of lesser mechanical vulnerability relative to areas of greater mechanical vulnerability. In other words, visibility under imaging is increased by a non-uniform distribution of visibility-enhancing features as a function of the local stresses expected during use.
The embodiments of the invention described above are intended to be exemplary only. The scope of the invention is therefore intended to be limited solely by the scope of the appended claims.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the broad scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention.
This application claims the benefit of the filing date of U.S. Provisional Application Ser. No. 61/681,512, filed Aug. 9, 2012, entitled “Medical devices with visibility-enhancing features,” the entire disclosure of which is hereby incorporated by reference into the present disclosure. This application is also a Continuation-in-part of and claims priority to U.S. patent application Ser. No. 13/468,939, which is a divisional application of, and claims priority from, U.S. application Ser. No. 11/905,447, filed on Oct. 1, 2007, now U.S. Pat. No. 8,192,425, which claims the benefit of: U.S. provisional application No. 60/827,452, filed on Sep. 29, 2006, and U.S. provisional application No. 60/884,285, filed on Jan. 10, 2007, all of which are incorporated by reference herein in their entirety.
Number | Date | Country | |
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61681512 | Aug 2012 | US | |
60827452 | Sep 2006 | US | |
60884285 | Jan 2007 | US |
Number | Date | Country | |
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Parent | 11905447 | Oct 2007 | US |
Child | 13468939 | US |
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Parent | 13468939 | May 2012 | US |
Child | 13962396 | US |