The present disclosure relates to an intubation device and, more particularly, relates to an intubation device having a novel flexural capability.
This section provides background information related to the present disclosure which is not necessarily prior art. This section also provides a general summary of the disclosure, and is not a comprehensive disclosure of its full scope or all of its features.
Over twenty million intubations occur in the United States each year. Endotracheal intubation is a procedure where a tube is placed through the mouth and into the trachea to create an artificial circuit for breathing. In the emergency setting, this life-saving procedure is most often performed by health care personnel with the least amount of experience and in the most difficult of circumstances. Failure rates in emergency intubations when conducted by emergency medical personnel range from 10-50%, incurring high human and healthcare costs, not limited to brain damage and death. There are 180,000 deaths per year in the pre-hospital emergency setting alone from misplaced endotracheal tubes and many more when including misplaced tubes in the hospital setting. The cost of failed or difficult intubation can be very high as reflected in a private settlement in excess of $15 million in 2002.
Over half of emergency intubations are performed by first-responders in the pre-hospital setting. The majority of first-responders are in their middle twenties, have minimal training and an average of only three years of experience. First responders are mandated to perform only five intubations to be certified, yet studies have shown that 15 to 20 intubations are necessary to attain basic skill proficiency. Once in the field, 67% of paramedics will only perform one or two intubations per year. The training standard for paramedics is also significantly less than the minimum requirement of 200 intubations for emergency medicine clinicians or over 400 for anesthesiologists.
The intubation device of the present teachings enables less experienced practitioners to be as successful as highly trained anesthesiologists because the device enables enhanced control of the distal tip of the intubation device for placing the tube within the trachea of the patient.
The intubation device of the present teachings is a medical device that is designed to improve the efficacy and safety of emergency intubations, especially in the hands of less-skilled practitioners. The intubation device can comprise a main body portion defining a first longitudinal axis, a distal tip portion coupled to the main body portion and defining a second longitudinal axis, and a deflection system having a single drive member extending within at least the distal tip portion and coupled thereto. The deflection system is operable to exert a tensile force upon the distal tip portion to articulate the distal tip portion relative to the main body portion between a resting position and a positive incline position and a negative incline position. In some embodiments, the intubation device can comprise a plurality of notches formed along the distal tip portion and can be actuated in response to movement of a slider member.
Further areas of applicability will become apparent from the description provided herein. The description and specific examples in this summary are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.
The drawings described herein are for illustrative purposes only of selected embodiments and not all possible implementations, and are not intended to limit the scope of the present disclosure.
Corresponding reference numerals indicate corresponding parts throughout the several views of the drawings.
Example embodiments will now be described more fully with reference to the accompanying drawings. Example embodiments are provided so that this disclosure will be thorough, and will fully convey the scope to those who are skilled in the art. Numerous specific details are set forth such as examples of specific components, devices, and methods, to provide a thorough understanding of embodiments of the present disclosure. It will be apparent to those skilled in the art that specific details need not be employed, that example embodiments may be embodied in many different forms and that neither should be construed to limit the scope of the disclosure.
The terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms “a”, “an” and “the” may be intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms “comprises,” “comprising,” “including,” and “having,” are inclusive and therefore specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order discussed or illustrated, unless specifically identified as an order of performance. It is also to be understood that additional or alternative steps may be employed.
When an element or layer is referred to as being “on”, “engaged to”, “connected to” or “coupled to” another element or layer, it may be directly on, engaged, connected or coupled to the other element or layer, or intervening elements or layers may be present. In contrast, when an element is referred to as being “directly on,” “directly engaged to”, “directly connected to” or “directly coupled to” another element or layer, there may be no intervening elements or layers present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.). As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items.
Spatially relative terms, such as “inner,” “outer,” “beneath”, “below”, “lower”, “above”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. Spatially relative terms may be intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” the other elements or features. Thus, the example term “below” can encompass both an orientation of above and below. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
According to the principles of the present teachings, an intubation device is provided having advantageous construction and method of use. More particularly, the intubation device of the present teachings provides enhanced flexural movement of the distal tip portion thereof and is capable of both positive and negative flexural movement (relative to a longitudinal reference axis of the main body) generally about a single axis transverse to the longitudinal axis of the main body. This flexural movement can be controlled using a user-actuated input that is conveniently and efficiently coupled with a deflection mechanism for actuating the distal tip portion. In some embodiments, this deflection mechanism can comprise a single drive cable for the positive and negative flexural movement. The intubation device is sized to be slid within an endotracheal tube during intubation. Those skilled in the art will recognize additional advantages of the intubation device of the present teachings in light of the discussion herein.
With reference to the several figures, an intubation device 10 according to the principles of the present teachings is illustrated. In some embodiments, as illustrated in
Main body portion 12 and distal tip portion 14 can define a generally constant cross-sectional shape and size. However, it should be appreciated that alternative cross-sectional shapes and/or varying cross-sectional dimensions are anticipated by the present disclosure. Such variations in cross-sectional shape and/or size can enhance articulation in some embodiments.
With continued reference to
With reference to
In some embodiments, as illustrated in
With reference to
A first end (proximal) of drive member 22 can be fixedly coupled to slider member 24 for movement therewith and an opposing end (distal) can be fixedly coupled to at least a portion of distal tip portion 14. More particularly, in some embodiments, drive member 22 can be fixedly coupled within an aperture 44 formed in at least one of central region 20 and/or exterior surface portion 28 of slider member 24 using a press fit connection, interference fit connection, fastener, bonding agent (e.g. epoxy) or other conventional retaining system. Drive member 22 can then extend through one or a plurality of apertures 46 formed through main body portion 12 (
In some embodiments, the one or a plurality of apertures 46 in main body portion 12 and/or the plurality of apertures 48 in distal tip portion 14 can be offset above axis B-B of main body portion 12 and axis C-C of distal tip portion 14, respectively, to provide enhance mechanical advantage in exerting the tensile or compressive forces upon distal tip portion 14. By way of non-limiting example, in some embodiments apertures 46 and 48 can be about 1.5 mm in diameter and located about 1.35 mm above axis B-B.
In some embodiments, drive member 22 is a wire or spring steel member that is capable of exerting both tensile force to articulate or flex distal tip portion 14 into the positive incline position and a compressive force to articulate or flex distal tip portion 14 into the negative incline position. Although it should be appreciated that the shape, contour, materials selected, and overall design of distal tip portion 14 will affect the design of the drive member 22, it has been found that the following wire can be used. Specifically, drive member 22 can be a 1080 carbon steel, spring temper wire having a diameter of about 0.015″ (commonly called “music wire”). Alternative materials can also be used, including 1) spring temper stainless steel wires including type 304, 316, PTFE-coated type 304, 2) spring temper carbon steels including 1065, 1075 (and 1080, as indicated above), 3) alloy 510 phosphor bronze, and 4) shape-memory alloy such as Nitinol (Nickel titanium).
In operation, aft movement of slider member 24 (e.g. in a direction such that aft end 40 of slider 24 approaches and possibly contacts aft edge 42 of slider channel 26) causes slider member 24 to apply a tensile force to drive member 22 thereby articulating distal tip portion 14 into the positive incline position. Similarly, fore movement of slider member 24 (e.g. in a direction such that fore end 36 of slider member 24 approaches and possibly contacts fore edge 38 of slider channel 26) cause slider member 24 to apply a compressive force to drive member 22 thereby articulating distal tip portion 14 into the negative incline position. As described herein, it should be understood that through actuation of slider member 24 between the fore edge 38 and aft edge 42 of slider channel 26, distal tip portion 14 can be positioned at any location or at any inclination between the positive incline position and the negative incline position.
With particular reference to
In some embodiments, notches 60 can be sized, spaced, and/or otherwise shaped to encourage a particular or beneficial flexural behavior. As illustrated in
In some embodiments, intubation device 10 can be made of a flexible polymeric or metallic material. More particularly, intubation device 10 and, in particular, distal tip portion 14 can be made of a material having a Shore durometer of about 86 and, in some embodiments, distal tip portion 14 can have different materials used between ribs (e.g. within notches 60) having a Shore durometer of about 40. In some embodiments, materials can be chosen for distal tip portion 14 having a different and perhaps more flexible elastic modulus than main body portion 12. Moreover, in some embodiments, distal tip portion 14 can have a different material having a more flexible elastic modulus (or a less flexible elastic modulus, if desired) used between ribs (e.g. within notches 60) as opposed to adjacent areas (e.g. ribs). The outer diameter of intubation device 10 can be in the range of about 1 mm to about 12 mm, or more particularly about 5 mm. The length of intubation device 10 can be in the range of about 20 cm to 60 cm, with distal tip portion 14 being about 1 mm to about 60 mm, or more particularly about 34.5 mm. In some embodiments, distal tip portion 14 can be made of a material different than main body portion 12. In some embodiments, distal tip portion 14 can be made of a flexible polymer or a jointed rigid material.
It should be appreciated that alternatives to the present embodiments are possible. For example, in some embodiments, as mentioned herein, the shape of notches 60 can be varied to achieve different flexural control and behavior (see
The foregoing description of the embodiments has been provided for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosure. Individual elements or features of a particular embodiment are generally not limited to that particular embodiment, but, where applicable, are interchangeable and can be used in a selected embodiment, even if not specifically shown or described. The same may also be varied in many ways. Such variations are not to be regarded as a departure from the disclosure, and all such modifications are intended to be included within the scope of the disclosure.
This application claims the benefit of U.S. Provisional Application No. 61/482,267, filed on May 4, 2011. The entire disclosure of the above application is incorporated herein by reference.
This invention was made with government support under FD-R-003787 awarded by the Food and Drug Administration. The government has certain rights in the invention.
Filing Document | Filing Date | Country | Kind | 371c Date |
---|---|---|---|---|
PCT/US2012/036290 | 5/3/2012 | WO | 00 | 1/16/2014 |
Publishing Document | Publishing Date | Country | Kind |
---|---|---|---|
WO2012/151381 | 11/8/2012 | WO | A |
Number | Name | Date | Kind |
---|---|---|---|
2498692 | Mains | Feb 1950 | A |
3060972 | Sheldon | Oct 1962 | A |
3314431 | Smith, Jr. | Apr 1967 | A |
3557780 | Sato | Jan 1971 | A |
3572325 | Bazell | Mar 1971 | A |
3669098 | Takahashi | Jun 1972 | A |
3802440 | Salem | Apr 1974 | A |
4840172 | Augustine | Jun 1989 | A |
5095888 | Hawley | Mar 1992 | A |
5259377 | Schroeder | Nov 1993 | A |
5306245 | Heaven | Apr 1994 | A |
5318008 | Bullard | Jun 1994 | A |
5392791 | Nyman | Feb 1995 | A |
5441483 | Avitall | Aug 1995 | A |
5445161 | Huang | Aug 1995 | A |
5607386 | Flam | Mar 1997 | A |
5791338 | Merchant | Aug 1998 | A |
5842194 | Arbuckle | Nov 1998 | A |
5842973 | Bullard | Dec 1998 | A |
5885248 | Denton | Mar 1999 | A |
6164277 | Merideth | Dec 2000 | A |
6251069 | Mentzelopoulos et al. | Jun 2001 | B1 |
6266442 | Laumeyer et al. | Jul 2001 | B1 |
6321749 | Toti et al. | Nov 2001 | B1 |
6501857 | Gotsman et al. | Dec 2002 | B1 |
6587601 | Hsu et al. | Jul 2003 | B1 |
6647139 | Kunii et al. | Nov 2003 | B1 |
6678545 | Bucholz | Jan 2004 | B2 |
6728635 | Hamada et al. | Apr 2004 | B2 |
6746422 | Noriega et al. | Jun 2004 | B1 |
6757557 | Bladen et al. | Jun 2004 | B1 |
6776765 | Soukup | Aug 2004 | B2 |
6875169 | Berci et al. | Apr 2005 | B2 |
7031496 | Shimano et al. | Apr 2006 | B2 |
7044909 | Berci et al. | May 2006 | B2 |
7072704 | Bucholz | Jul 2006 | B2 |
7089928 | Besharim et al. | Aug 2006 | B2 |
7137981 | Long | Nov 2006 | B2 |
7174202 | Bladen et al. | Feb 2007 | B2 |
7221797 | Koshizen et al. | May 2007 | B2 |
D580549 | Schwartz et al. | Nov 2008 | S |
D603958 | Schwartz et al. | Nov 2009 | S |
D605758 | Schwartz et al. | Dec 2009 | S |
7658708 | Schwartz et al. | Feb 2010 | B2 |
7747319 | Freeman | Jun 2010 | B2 |
7774054 | Myklebust | Aug 2010 | B2 |
7892186 | Soukup | Feb 2011 | B2 |
7925339 | Wik | Apr 2011 | B2 |
8095336 | Goncalves et al. | Jan 2012 | B2 |
8684953 | Cabiri | Apr 2014 | B2 |
8746239 | Yoshida | Jun 2014 | B2 |
9138566 | Cabiri | Sep 2015 | B2 |
20050075661 | Levine et al. | Apr 2005 | A1 |
20090044799 | Qiu | Feb 2009 | A1 |
20090125001 | Anderson et al. | May 2009 | A1 |
20100108060 | Pecherer et al. | May 2010 | A1 |
20100224187 | Dalton | Sep 2010 | A1 |
20110137127 | Schwartz et al. | Jun 2011 | A1 |
20110144514 | Booker | Jun 2011 | A1 |
20110178419 | Wood et al. | Jul 2011 | A1 |
20110196204 | Setty | Aug 2011 | A1 |
20110201882 | Schwartz et al. | Aug 2011 | A1 |
20110263935 | Qiu | Oct 2011 | A1 |
20110265795 | Tagawa et al. | Nov 2011 | A1 |
20130255671 | Furman | Oct 2013 | A1 |
20150246201 | Kirn | Sep 2015 | A1 |
Number | Date | Country |
---|---|---|
08-047536 | Feb 1996 | JP |
WO-2007138569 | Dec 2007 | WO |
WO-2010065566 | Jun 2010 | WO |
Entry |
---|
Supplementary European Search Report in Corresponding European Patent Application No. EP 12 779 414.7, dated Oct. 31, 2014. |
International Search Report and Written Opinion (both in English) for PCT/US2012/036290, mailed Nov. 28, 2012; ISA/KR. |
Number | Date | Country | |
---|---|---|---|
20140123976 A1 | May 2014 | US |
Number | Date | Country | |
---|---|---|---|
61482267 | May 2011 | US |