Patent Application
20240366365
Valvular heart disease such as aortic stenosis (AS) is becoming more common as populations age in many countries. Surgical valve replacement with either a mechanical or a biological valve is currently the gold standard of care for patients with severe valvular heart disease. Sewed-in, stented bioprosthetic valves are the most commonly implanted devices, especially in elderly patients. They typically consist of a plastic and/or metal frame that is coated with fabric or tissue and that supports leaflets made of xenograft soft tissue. At the base of the valve, a sewing ring covered in fine fabric is attached.
Pledget-armed sutures are commonly used to secure an artificial heart valve to a native valve annulus in either an intra-or supra-annular position. In one popular attachment procedure, sutures each having a thread with needles on both ends and a pledget intermediate the needles are used. Both needles of a suture are passed through a native valve annulus and then passed through the sewing ring of the artificial valve. After all of the sutures are placed in this manner, the loose ends of the sutures are tightened to firmly seat their pledgets against the native valve annulus and then tied.
Unfortunately, the above-described attachment procedure and similar procedures can lead to problems. As a suture is tightened to seat its corresponding pledget, the pledget is pulled behind the artificial valve where it can't be seen by the surgeon, so the seating process is partially blind. Surgeons also have difficulty in distinguishing the many loose ends of the sutures from one another because the sutures are closely spaced. Surgeons therefore often have difficulty in determining which suture ends belong to which pledget. These issues often lead to either overtightening or undertightening of sutures. Overtightening occurs when a surgeon continues to pull on the loose ends of a suture to seat its corresponding pledget when the pledget has actually already been seated. This happens because the surgeon may be looking at the wrong pledget when the correct pledget has already been seated and is therefore no longer visible. In this case, the surgeon may continue pulling on the already tightened suture, causing the seated pledget and thread to pull through or otherwise damage the native annulus. Undertightening occurs when a surgeon stops pulling on the loose ends of a suture when the surgeon believes it has been properly seated when its pledget is in fact still loose and not properly seated. This happens because the surgeon may believe a pledget is out of view and seated but is looking for the wrong pledget when the correct pledget is still loose and not securely seated. Both suture overtightening and undertightening can jeopardize a valve replacement procedure and lead to significant surgical and post-surgical problems.
The present invention solves the above-described problems and provides a distinct advance in the art of heart valve replacement surgery. More particularly, the present invention provides a surgical heart valve replacement method that uses improved sutures that reduce the propensity for surgeons to overtighten and/or undertighten the sutures when securing an artificial heart valve to a native valve annulus.
The surgical method of the present invention overcomes the above-described problems by using at least first and second distinct sets of sutures. Each suture from the first set of sutures includes a thread with two ends, a first needle secured to the first end of the thread, a second needle attached to the second end of the thread, and a pledget. Importantly, the thread and pledget from each suture in the first set of sutures have a first distinguishing feature. In other words, the thread and pledget of each suture are matched in some way.
Each suture from the second set of sutures also includes a thread with two ends, a first needle secured to the first end of the thread, a second needle attached to the second end of the thread, and a pledget. As with the first set of sutures, the thread and pledget from each suture in the second set of sutures have a second distinguishing feature.
In one embodiment, the first and second distinguishing features are colors, such that the primary difference between the first and second sets of sutures is that their threads and pledgets have different colors. For example, the threads and pledgets of the sutures in the first set of sutures may be white, and the threads and pledgets of the sutures in the second set of sutures may be blue.
A cardiac surgeon may use the above-described sutures to attach an artificial heart valve to a native valve annulus as follows. After a patient's heart is exposed and a defective native heart valve is removed, the artificial heart valve is positioned near the native valve annulus. To attach the artificial heart valve to the native valve annulus, a suture from the first set of sutures is attached to the native valve annulus by passing both needles of the suture through the native valve annulus. The needles are then passed through the sewing ring of the artificial valve. A suture from the second set of sutures is then attached to the native valve annulus adjacent to the prior suture in the same manner by passing both needles of the suture through the native valve annulus and then through the sewing ring of the artificial valve. These steps are repeated with alternating sutures from the first and second sets of sutures such that adjacently positioned sutures are from different sets of sutures. After all of the sutures are placed, the loose ends of the sutures are tightened to firmly seat their pledgets against the native valve annulus and then tied.
Advantageously, the alternating sutures from the first and second sets of the sutures allow the cardiac surgeon to more easily distinguish the sutures and determine which suture ends belong to which pledgets. For example, if the surgeon tightens the ends of a blue suture thread, the surgeon knows to look for and monitor the seating of a blue pledget and not the two adjacent white pledgets. Similarly, if the surgeon tightens the ends of a white suture thread, the surgeon knows to look for and monitor the seating of a white pledget and not the two adjacent blue pledgets. This not only prevents the above-described overtightening and undertightening problems but also allows surgeons to proceed more quickly by spending less time trying to match suture threads with their pledgets.
Other embodiments of the sutures may have distinguishing features other than color. For example, the first set of sutures may have threads and pledgets with a first distinguishing pattern such as stripes, and the second set of sutures may have threads and pledgets with a second distinguishing pattern such as dots. In yet another embodiment, the threads and pledgets of the first set of sutures may have a pattern such as stripes or dots, and the threads and pledgets of the second set of sutures may have a solid color with no pattern. Thus, the present invention is intended to encompass sets of sutures which are distinct from one another such that the first set of sutures can be easily distinguished from the second set of sutures.
This summary is provided to introduce a selection of concepts in a simplified form that are further described in the detailed description below. This summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used to limit the scope of the claimed subject matter. Other aspects and advantages of the present invention will be apparent from the following detailed description of the embodiments and the accompanying drawing figures.
Embodiments of the present invention are described in detail below with reference to the attached drawing figures, wherein:
The drawing figures do not limit the present invention to the specific embodiments disclosed and described herein. The drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the invention.
The present invention provides a surgical method and improved sutures that are used in the surgical method. The surgical method and sutures may be used for aortic valve replacement, mitral valve replacement, or any other surgery in which a medical device is attached to a patient. The surgical method and sutures reduce the propensity for surgeons to overtighten and/or undertighten the sutures when securing an artificial heart valve to a native valve annulus or when performing other surgeries.
Embodiments of the present invention include at least two distinct sets of sutures, with each set of sutures including any number of sutures needed by a surgeon for a heart valve replacement surgery or other surgery.
An exemplary first set of sutures 10 is shown in
The thread 14 of each suture 12 is a conventional surgical thread and may be made of synthetic materials and may be any length and diameter. The needles 16A, B of each suture 12 are conventional surgical needles and may be any shape and size commonly used for cardiac surgeries. In some embodiments, each suture may only include one needle. The pledget 18 of each suture 12 is a relatively thin and small pad which includes two openings through which the thread 14 is positioned. The pledget is roughly midway along the length of the thread. Importantly, the thread 14 and pledget 18 of each suture 12 in the first set of pledgets 10 are matched with a common first distinguishing feature. In one embodiment, the first distinguishing feature is a color. For example, the threads and pledgets of the first set of pledgets may be all white.
A second set of sutures 20 is shown in
Importantly, the thread 24 and pledget 28 of each suture 22 in the second set of pledgets 20 are matched with some distinguishing feature. In one embodiment, the threads and pledgets of the second set of pledgets are all blue. Thus, in this embodiment, the only significant difference between the first and second sets of sutures is color. Specifically, the thread and pledget of each suture in the first set of sutures has the same first color, such as white, and the thread and pledget of each suture in the second set of sutures has the same second color, such as blue.
Other embodiments of the of the first and second sets of sutures 10, 20 may have distinguishing features other than color. For example, the first set of sutures may have threads and pledgets with a common pattern such as stripes that serve as their first distinguishing feature, and the second set of sutures may have threads and pledgets with another pattern such as dots that serve as their second distinguishing feature. In yet another embodiment, the threads and pledgets of the first set of sutures pledgets may have a pattern such as stripes or dots, and the threads and pledgets of the second set of sutures may have a solid color with no pattern. Thus, the present invention is intended to encompass any two sets of sutures which are distinct from one another such that sutures from the first set of sutures can be easily distinguished from sutures from the second set of sutures. In yet other embodiments, more than two distinct sets of sutures may be used. For example, three sets of distinct sutures may be used, wherein the threads and pledgets in the first set of sutures may be white; the threads and pledgets in the second set of sutures may be blue; and the threads and pledgets in the third set of sutures may be orange. This further spaces like-colored threads and pledgets so a surgeon can even better distinguish the sutures.
As depicted in
The flow chart of
First, as depicted in block 602, a cardiac patient is prepped for surgery. Then as depicted in block 604, the patient's chest cavity is exposed. A defective native heart valve is then removed as depicted in block 606 to expose a native valve annulus 32, and the artificial heart valve 30 is positioned near the native valve annulus as depicted in block 608 and as shown in
To attach the artificial heart valve 30 to the native valve annulus 32, a suture 12 from the first set of sutures 10 is attached to the native valve annulus 32 as depicted in block 610 and
Advantageously, the alternating sutures allow the cardiac surgeon to more easily distinguish the sutures and determine which suture ends belong to which pledgets. Specifically, for the blue and white sutures in the embodiment described above, if the surgeon tightens the ends of a blue suture thread, the surgeon knows to look for and monitor the seating of a blue pledget and not the two adjacent white pledgets. Similarly, if the surgeon tightens the ends of a white suture thread, the surgeon knows to look for and monitor the seating of a white pledget and not the two adjacent blue pledgets. This not only prevents the above-described overtightening and undertightening problems but also allows surgeons to proceed more quickly by spending less time trying to match suture threads with their pledgets.
In this description, references to “one embodiment,” “an embodiment,” or “embodiments” mean that the feature or features being referred to are included in at least one embodiment of the technology. Separate references to “one embodiment,” “an embodiment,” or “embodiments” in this description do not necessarily refer to the same embodiment and are also not mutually exclusive unless so stated and/or except as will be readily apparent to those skilled in the art from the description. For example, a feature, structure, act, etc. described in one embodiment may also be included in other embodiments but is not necessarily included. Thus, the current technology can include a variety of combinations and/or integrations of the embodiments described herein.
Although the present application sets forth a detailed description of numerous different embodiments, the legal scope of the description is defined by the words of the claims set forth at the end of this patent and equivalents. The detailed description is to be construed as exemplary only and does not describe every possible embodiment since describing every possible embodiment would be impractical. Numerous alternative embodiments may be implemented, using either current technology or technology developed after the filing date of this patent, which would still fall within the scope of the claims.
Throughout this specification, plural instances may implement components, operations, or structures described as a single instance. Although individual operations of one or more methods are illustrated and described as separate operations, one or more of the individual operations may be performed concurrently, and nothing requires that the operations be performed in the order illustrated. Structures and functionality presented as separate components in example configurations may be implemented as a combined structure or component. Similarly, structures and functionality presented as a single component may be implemented as separate components. These and other variations, modifications, additions, and improvements fall within the scope of the subject matter herein.
As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having” or any other variation thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.
The patent claims at the end of this patent application are not intended to be construed under 35 U.S.C. § 112(f) unless traditional means-plus-function language is expressly recited, such as “means for” or “step for” language being explicitly recited in the claim(s).
Although the invention has been described with reference to the embodiments illustrated in the attached drawing figures, it is noted that equivalents may be employed and substitutions made herein without departing from the scope of the invention as recited in the claims.
Having thus described various embodiments of the invention, what is claimed as new and desired to be protected by Letters Patent includes the following:
