The present application claims priority to International Application Number PCT/US2015/036365 filed on Jun. 18, 2015, which is incorporated herein in its entirety by reference hereto.
The present invention relates generally to echogenic devices and more particularly to an echogenic catheter member that may be used with medical devices that are insertable into a medium such as biological tissue and imageable with sonic imaging equipment.
Ultrasonic imaging in the medical field is widely used for a variety of applications. In addition to imaging physiological structures and tissue such as organs, tumors, vessels, and the like, it is often desirable for a physician or technician to have an image of a medical device which has been inserted into the tissue or passageway of a patient. The types of devices which are surgically sterilized and inserted into patients are many. Typical examples include: needles, catheters and a variety of other medical products such as stents, dilators, pacing leads, introducers, angiography devices, angioplasty devices, pacemakers, in-patient appliances such as pumps and other devices. Various approaches have been used to enhance ultrasonic imaging by modifying the reflective surface characteristics of these devices.
U.S. Pat. No. 5,081,997 to Bosley, Jr. et al, for “Echogenic Devices, Material and Method” discloses a device such as a needle that includes an interface having a shape that is formed with a dimension that is less than a wavelength of the incident sonic beam. According to Bosley, Jr. et al., the shape includes a dimension such as a radius of curvature which is much less than the wavelength of the sonic beam. The interface may include the outside surface a device or article or material. That surface has a plurality of partially spherical discontinuities for producing a scattered component of the image in response to the incident beam. This image is produced regardless of the incident beam angle of which conventional devices depend for producing a reflected or constructive interference image. The scattered component of the image is produced when the radius of the partially spherical discontinuities or a dimension of another geometric shape or surface are much less than the wavelength of the incoming sonic beam.
U.S. Patent Application Publication No. 2004/0249288 A1 to Ichikawa for “Ultrasonic Puncture Needle” discloses a device including an array of doughnut shaped recesses having a center portion remaining as a protrusion. According to U.S. Publication No. 2004/0249288 A1, the recesses are also formed with faces, bottoms and sides being generally flat so to obtain reflection echoes with a great intensity for the incident ultrasonic waves with a shallow incident angle.
While the approaches described in U.S. Pat. No. 5,081,997 and U.S. Publication No. 2004/0249288 A1 have shown promise, improvements have been sought that would result in an echogenic catheter that provides enhanced ultrasonic imaging, in a manner that is inexpensive to manufacture, and simple and reliable to use.
Accordingly, the present disclosure is directed to an echogenic member for a catheter assembly that provides enhanced ultrasonic imaging without compromising the inherent flexibility of the catheter.
Objects and advantages of the invention will be set forth in part in the following description, or may be obvious from the description, or may be learned through practice of the invention.
In one aspect, the present invention is directed to an echogenic over-the-needle (OTN) catheter assembly. The catheter assembly includes a catheter having a proximal end and a distal end that defines a lumen extending from the proximal end to the distal end. Further, the catheter assembly includes a needle configured within the lumen of the catheter. Moreover, the catheter assembly includes an echogenic member configured with the catheter. The echogenic member includes a body defining an exterior surface extending between a first end and a second end. Further, the exterior surface includes a plurality of discontinuities configured to enhance ultrasonic imaging.
In one embodiment, the echogenic member is located in a distal region of the catheter. For example, in certain embodiments, the echogenic member may be located at the distal tip of the catheter. In another embodiment, the distal end of the catheter may include an open distal tip, wherein the needle extends past the open distal tip. Further, in certain embodiments, the echogenic member may surround the needle and/or may be embedded into an interior wall of the catheter. Alternatively, the echogenic member may be configured to surround an exterior surface of the catheter.
In alternative embodiments, the catheter assembly may include a coil configured within the lumen of the catheter, wherein the coil extends from a proximal end to a distal end. In such an embodiment, the echogenic member may be secured to the distal end of the coil. In another embodiment, the echogenic member may be sized to fit within the lumen of the catheter and within the distal end of the coil. In additional embodiments, the echogenic member may be secured to the distal end of the coil and embedded to the interior wall of the catheter. Alternatively, the echogenic member may simply fit within the lumen of the catheter rather than being embedded.
For example, in certain embodiments, the coil and the echogenic member may each include a hollow cross-section such that, when arranged together, form a lumen between the proximal end of the catheter to an open distal tip of the catheter. Alternatively, the echogenic member may include a solid cross-section. In such an embodiment, the catheter may include one or more infusion holes configured through the wall of the catheter and a closed distal tip. Thus, the infusion holes allow a medication flowing through the lumen of the catheter (and a lumen created by the coil) to exit therethrough.
In further embodiments, the echogenic catheter assembly may further include a plurality of echogenic members configured with the exterior surface of the catheter and spaced along a longitudinal length of the catheter. More specifically, the spacing of the plurality of echogenic members does not compromise the flexibility of the catheter.
In additional embodiments, the discontinuities of the echogenic member may include any suitable discontinuities (e.g. dimples, recesses, or similar) having any suitable size and/or shape arranged in any suitable pattern so as to provide enhanced ultrasonic imagine. For example, in certain embodiments, the discontinuities may include at least one or more of the following: indentations, grooves, notches, recesses, threads, protrusions, or similar. More specifically, in particular embodiments, the indentations may include flat bottoms and flat sides. In further embodiments, the indentations may include a first spherical indentation and a second spherical indentation contained within the first indentation to enhance ultrasonic imaging. In addition, the pattern of the discontinuities may be organized or random.
In yet another embodiment, the catheter assembly may also include a filler material configured between the echogenic member and an interior wall of the catheter. Thus, the filler material is configured to fill in any voids between an outer surface of the echogenic member (e.g. created by the discontinuities) and the interior wall of the catheter so as to enhance ultrasonic imaging of the echogenic member. More specifically, in certain embodiments, the filler material may have a density of about 0.9 g/cm3 to about 1.1 g/cm3, which is similar to the density of fat and/or muscle tissue, as well as the density of the catheter material.
In still additional embodiments, the echogenic member may be constructed of any suitable material. For example, in specific embodiments, the echogenic member may be constructed of a metal or metal alloy. More particularly, the metal or metal alloy may include at least one of or a combination of the following: aluminum, titanium, copper, tin, nickel, zinc, magnesium, stainless steel, or similar.
In another aspect, the present disclosure is directed to an echogenic catheter assembly. The catheter assembly includes a catheter, an echogenic member, and a filler material. The catheter has a proximal end and a distal end and defines a lumen extending from said proximal end to the distal end. The echogenic member is configured with the distal end of the catheter and includes a body defining an exterior surface extending between a first end and a second end. Further, the exterior surface includes a plurality of discontinuities (e.g. threads). The catheter assembly also includes a filler material configured between the discontinuities of the echogenic member and an interior wall of the catheter so as to enhance ultrasonic imaging of the echogenic member. In one embodiment, the catheter may have a closed distal tip. Alternatively, the catheter may have an open distal tip such that the echogenic member may be used as a plug at the distal tip.
In yet another aspect, the present disclosure is directed to an echogenic member assembly for use with an over-the-needle (OTN) catheter assembly. The echogenic member assembly includes at least one echogenic member. The echogenic member includes a cylindrical body having a first end and a second end defining a longitudinal length therebetween. The cylindrical body defines an exterior surface extending from the first end to the second end. Further, the exterior surface includes a plurality of discontinuities. The discontinuities are arranged in a predetermined pattern so as to enhance ultrasonic imaging. In addition, the longitudinal length of the echogenic member is less than a total length of a catheter of the OTN catheter assembly. As such, the echogenic member provides enhanced ultrasonic imaging to the OTN catheter assembly without compromising the inherent flexibility of the catheter.
In one embodiment, the echogenic member assembly may include a plurality of echogenic members. As such, the plurality of echogenic members can be spaced apart along the total length of the catheter to provide enhanced ultrasonic imaging without compromising the inherent flexibility of the catheter.
In certain embodiments, the echogenic member(s) may be configured to surround a portion of a needle of the OTN catheter assembly. In such an embodiment, the echogenic member(s) may be embedded within an interior wall of the catheter assembly or may simply provide an interference fit with the interior wall of the catheter. Alternatively, the echogenic member(s) may be configured to surround a portion of the catheter of the OTN catheter assembly. In such an embodiment, the catheter may be heated and stretched such that the echogenic member(s) can be easily inserted around the outer diameter of the catheter. Thus, once the catheter cools, the echogenic member(s) remain secure.
In further embodiments, the echogenic member(s) may be configured to fit within a lumen of the catheter and may include a solid cross-section or a hollow cross-section. In addition, it should be understood that the echogenic member(s) of the echogenic member assembly may further include any of the additional features described herein.
These and other features, aspects and advantages of the present invention will become better understood with reference to the following description and appended claims. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the description, serve to explain the principles of the invention.
A full and enabling disclosure of the present invention, including the best mode thereof, directed to one of ordinary skill in the art, is set forth in the specification, which makes reference to the appended figures, in which:
Reference will now be made in detail to one or more embodiments of the invention, examples of the invention, examples of which are illustrated in the drawings. Each example and embodiment is provided by way of explanation of the invention, and is not meant as a limitation of the invention. For example, features illustrated or described as part of one embodiment may be used with another embodiment to yield still a further embodiment. It is intended that the invention include these and other modifications and variations as coming within the scope and spirit of the invention.
The positional terms “proximal” and “distal” are used herein to orient the various components relative to each other and to the patient. “Distal” refers to the direction that is closest to the wound site (e.g., the distal end of the connector is the end oriented towards a catheter insertion site), and “proximal” refers to the opposite direction (e.g., the proximal end of the catheter is inserted into the distal end of the connector).
Generally, the present disclosure is directed to an echogenic member for use with an over-the-needle (OTN) catheter. The echogenic member includes a cylindrical body having a first end and a second end defining a longitudinal length therebetween. Each cylindrical body defines an exterior surface having a plurality of discontinuities arranged in a predetermined pattern so as to enhance ultrasonic imaging. In addition, the longitudinal length of the echogenic member is less than a total length of a catheter of the OTN catheter assembly so as to maintain the inherent flexibility of the catheter.
Referring now to the drawings,
In addition, the echogenic catheter assembly 10 may also include a heat application assembly 50 configured to apply heat to the catheter 14. For example, as shown in
Referring now to
It should be understood that certain embodiments of the catheter assembly 10 may include one echogenic member 30, for example, located in the distal region 18 of the catheter 14 as shown in
In additional embodiments, the discontinuities 40 of the echogenic member(s) 30 may include any suitable discontinuities having any suitable size and/or shape arranged in any suitable pattern so as to provide enhanced ultrasonic imagine. For example, in certain embodiments, the discontinuities 40 may include at least one or more of the following: indentations, grooves, notches, recesses, threads, protrusions, or similar. In addition, as mentioned the pattern of the discontinuities 40 may be organized or random. More particularly, as shown in generally in
In further embodiments, the discontinuities 40 of the echogenic member(s) may be manufactured using any suitable means. For example, in certain embodiments, the discontinuities 40 may be manufactured using laser etching, spatter techniques (i.e. displacement of metal and/or other phenomena), cutting, machining, or similar. In still additional embodiments, the echogenic member 30 may be constructed of any suitable echogenic material. For example, in specific embodiments, the echogenic member 30 may be constructed of a metal or metal alloy. More particularly, the metal or metal alloy may include at least one of or a combination of the following: aluminum, titanium, copper, tin, nickel, zinc, magnesium, stainless steel, or similar.
It should be understood that the echogenic member 30 described herein may be located at any suitable location of the catheter assembly 10 so as to provide enhanced ultrasonic imaging. For example, as shown in
Further, as shown particularly in the embodiments of
Referring now to
Referring now to
In addition, as shown particularly in
Referring now to
Thus, as shown generally in
This written description uses examples to disclose the invention, including the best mode, and also to enable any person skilled in the art to practice the invention, including making and using any devices or systems and performing any incorporated methods. The patentable scope of the invention is defined by the claims, and may include other examples that occur to those skilled in the art. Such other examples are intended to be within the scope of the claims if they include structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal languages of the claims.
Filing Document | Filing Date | Country | Kind |
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PCT/US2015/036365 | 6/18/2015 | WO | 00 |
Publishing Document | Publishing Date | Country | Kind |
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WO2016/204760 | 12/22/2016 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
4697595 | Breyer et al. | Oct 1987 | A |
4969890 | Sugita et al. | Nov 1990 | A |
5081997 | Bosley, Jr. et al. | Jan 1992 | A |
5759154 | Hoyns | Jun 1998 | A |
6179809 | Khairkhahan | Jan 2001 | B1 |
6306094 | Joseph | Oct 2001 | B1 |
6860856 | Ward | Mar 2005 | B2 |
7438711 | Deniega et al. | Oct 2008 | B2 |
7465291 | Massengale | Dec 2008 | B2 |
7527609 | Deniega et al. | May 2009 | B2 |
7569045 | Denieoa et al. | Aug 2009 | B2 |
8328771 | Massengale | Dec 2012 | B2 |
8611993 | Vitullo et al. | Dec 2013 | B2 |
8652098 | Haslinger | Feb 2014 | B2 |
8796908 | Okuba | Aug 2014 | B2 |
9802025 | Khalaj | Oct 2017 | B2 |
20020142119 | Seward et al. | Oct 2002 | A1 |
20040077948 | Violante et al. | Apr 2004 | A1 |
20040116896 | Massengale | Jun 2004 | A1 |
20040193109 | Prestidge et al. | Sep 2004 | A1 |
20040249288 | Ichikawa | Dec 2004 | A1 |
20070167739 | Salo | Jul 2007 | A1 |
20080058702 | Arndt et al. | Mar 2008 | A1 |
20090131910 | Webler | May 2009 | A1 |
20110172542 | Racz | Jul 2011 | A1 |
20120059308 | Hsu et al. | Mar 2012 | A1 |
20120095404 | Massengale et al. | Apr 2012 | A1 |
20120126663 | Jenninger et al. | May 2012 | A1 |
20130223702 | Holsing et al. | Aug 2013 | A1 |
20140024928 | Boctor et al. | Jan 2014 | A1 |
20140142509 | Bonutti et al. | May 2014 | A1 |
20140316327 | Rajendran et al. | Oct 2014 | A1 |
20140378841 | Coats et al. | Dec 2014 | A1 |
20150038378 | Cheng et al. | Feb 2015 | A1 |
Number | Date | Country |
---|---|---|
2 343 098 | Jul 2011 | EP |
2 540 336 | Jan 2013 | EP |
2001293091 | Oct 2001 | JP |
2010279546 | Dec 2010 | JP |
WO 9951294 | Oct 1999 | WO |
WO 0004287 | Jul 2000 | WO |
WO 2009091514 | Jul 2009 | WO |
WO 2014174305 | Oct 2014 | WO |
Entry |
---|
Stephen M. Klein, M.D., et al., “Piezoelectric Vibrating Needle and Catheter for Enhancing Ultrasound-Guided Peripheral Nerve Blocks”, Technical Communication from the International Anesthesia Research Society, vol. 105, No. 6, Dec. 2007, 3 pages. |
Co-pending U.S. Appl. No. 15/735,719, filed Dec. 12, 2017. |
Co-pending U.S. Appl. No. 15/743,900, filed Jan. 11, 2018. |
International Search Report for PCT/US2015/036365, dated Nov. 3, 2016, 3 pages. |
Number | Date | Country | |
---|---|---|---|
20180177980 A1 | Jun 2018 | US |