Patent Application
20220338871
The present invention relates to a method and apparatus for holding a surgical suture.
Medical procedures have advanced to the point where doctors routinely conduct complex surgeries on patients for a variety of reasons. In some cases, the surgeries involve removal of cancerous or otherwise diseased tissues. In other cases, the surgery is meant to minimize the injury done during an accident. And in still other procedures surgeons are able to improve a person's appearance by various plastic surgery techniques. Regardless of the purpose of the surgery, virtually all require some suturing of the skin and/or other tissues of the patient.
Depending on the type of surgery and the types of tissues involved, a surgeon may elect to use a variety of different suture needles. Common surgical needles include ⅝ circle, ½ circle, 3/8 circle, 1/4 circle, J-shape, compound curve, 1/2 curved and straight. Each of these needles may also have a point type such as a taper point, blunt taper point, cutting edge, reverse cutting edge, taper cut and micro-point spatula. In the course of a surgery, a surgeon may elect any combination of needle shapes and points depending on the types of tissue which need to be closed and the types of incisions which were formed.
Additionally, there are numerous different suturing threads, including polypropylene monofilament, polyester, polyester braided, nylon monofilament, silk, silk braided, and many others. These materials come in different sizes and are often color coded to allow the surgeon to verify what material he or she is working with. When combined with the different needle shapes and needle points, there are literally hundreds of potential combinations which may be used.
Because of the harm which has been caused from needles left in patients during surgeries, many states and virtually all hospitals require that every surgical needle/suture be maintained in the operating field and accounted for before the patient is closed up at the end of the surgery.
The suture tray 12a-12j usually includes a needle 16e-16j and a length of suture thread 20e-20j of the desired material and thickness needed for the surgery. The needle is usually held in place by a needle holder 18e-18j which is commonly formed from two plastic posts with the needle press-fit between the posts.
A portion of the thread 20e-20j is usually covered by a label 22e-22j made of paper or the like which is attached to the top of the suture tray 12e-12j. The labels 22e-22j have printed thereon information about the type of needle and the type/size of the suture material. The labels 22e-22j also typically cover at least part of the needle to protect the needle from getting damaged or catching on things, while leaving an opening 23e-23j through which the needle 16e-16j and the suture material 20e-20j can be withdrawn.
When a particular needle/suture thread is needed, the surgical technician in the operating room is responsible to grasp the desired needle with hemostats/forceps and hand it to the surgeon. When the surgeon is finished making the needed sutures, the needle is returned to the surgical technician who is responsible for securing the needle so that it can be used again as needed, and so that the surgical technician can readily identify which needle/suture combination is which.
Surgical technicians are often also required to hold retractors and other instruments to assist the surgeon. Thus, the surgical technician may be required to secure the needle with one hand, while the other hand is being used to assist the surgeon with other tools. When a surgery is complex, the surgical technician may be dealing with ten or more different needle/suture combinations, as well as other surgical tools. Thus, it is easy to lose track of exactly which needle/suture combinations is in which location.
In an attempt to control the needles, many surgical technicians have resorted to using a foam block or sponge 30 into which the suture needles are secured when not in use. To further prevent the wrong needle/suture combination being given to the surgeon, some surgical technicians write on the sponge with a marker during surgery to indicate which needle/suture combination is which. It will be appreciated that to the naked eye, it is difficult to distinguish between a size 4 silk suture and a size 6 silk suture. While the size 6 silk suture may hold an incision closed, a size 3 or 4 may be more likely to break, thereby creating potential issues after the surgery. While writing the numbers helps identify which suture is which, it is also distracting during the surgery and if the surgical technician's attention is drawn away by the surgeon, it is easy to confuse the different needle/suture combinations or to place one in the wrong place.
While a surgical technician can write a code for the various needle/suture thread combinations which are likely to be used in advance, doing so requires the surgical technician to constantly determine which needles are disposed on the sponge, which packets have not yet been opened, and which needles are in use. This can be particularly confusing if a suture breaks when the needle is pulled from the suture tray 12. If, for example, a 4 silk ½ circle needle is pulled out and the suture breaks, the surgical technician may dispose the needle in the sponge at the number indicated. He or she must then get another 4 silk ½ circle package and open it for use. While the surgeon uses the needle, the location on the sponge for the 4 silk ½ circle is already filled—potentially leading to confusion. When there are unfilled numbers on the sponge, the technician must determine if the needle is missing or has yet to be used.
Additionally, at the end of the surgery, every suture needle must be accounted for. If one is missing, the surgical technician must figure out which one is missing and why. While knowing exactly which needle/suture combination is missing may help indicate places to look, this is only possible if one knows exactly which one is missing. Thus, there is a need for an improved method and apparatus for securing surgical needles.
The complication and stress for a surgical technician can be multiplied when there are multiple surgeons or other medical professionals suturing at the same time. For example, surgeon 1 may need a certain needle/suture combination at the same time surgeon 2 needs a different needle/suture combination. If they both get returned at approximately the same time, it is easy to confuse the two and place them in the wrong positions.
The following summary of the present invention is not intended to describe each illustrated embodiment or every possible implementation of the invention, but rather to give illustrative examples of application of principles of the invention.
A method and apparatus for holding surgical sutures may include disposing a suture needle holding pad on the suture tray or a cover thereof. The suture needle holding pad may be made from open cell or closed cell foam, styrofoam, rubber, or even a magnet or other material which will receive and hold the needle in place. In a preferred embodiment, the surgical suture holding pad is made from a material which will not damage the tip of the needle when the needle is inserted therein and will allow the needle to be pulled out so that it can be used again. Alternatively, the suture needle holding pad could be made from a magnet which holds the needle without requiring insertion of the needle tip.
In accordance with one aspect of the invention, the suture needle holding pad is disposed on the label which includes the information about the needle and suture so that the surgical technician and the surgeon can readily identify which needle/suture combination is present.
In accordance with another aspect of the invention, the suture needle holding pad is disposed on the cover while the needle holder is disposed in a different location, thereby instantly conveying to the surgical technician and the surgeon that the needle has been used if the needle is secured in the suture needle holding pad rather than in the needle holder.
In accordance with one aspect of the invention, only a single needle/suture combination is used at a time so that every needle/suture combination used in the operating field is attached to the proper tray except the one that is in use, thereby preventing the possibility of needles getting mixed up.
In accordance with another aspect of the invention, a needle/wet suture material is disposed in a fluid tight envelope having a needle holding pad attached thereto, so that once the envelope has been open and the needle used, the needle may be mounted in a needle holding pad disposed on the envelope, preferably near the location of the information regarding the needle.
Various embodiments of the present disclosure are shown and described in reference to the numbered drawings wherein:
It will be appreciated that the drawings are illustrative and not limiting of the scope of the invention which is defined by the appended claims. The embodiments shown accomplish various aspects and objects of the invention. It will be appreciated that it is not possible to clearly show each element and aspect of the present disclosure in a single figure, and as such, multiple figures are presented to separately illustrate the various details of different aspects of the invention in greater clarity. Similarly, not all configurations or embodiments described herein or covered by the appended claims will include all of the aspects of the present disclosure as discussed above.
Various aspects of the invention and accompanying drawings will now be discussed in reference to the numerals provided therein so as to enable one skilled in the art to practice the present invention. The skilled artisan will understand, however, that the methods described below can be practiced without employing these specific details, or that they can be used for purposes other than those described herein. Indeed, they can be modified and can be used in conjunction with products and techniques known to those of skill in the art in light of the present disclosure. The drawings and the descriptions thereof are intended to be exemplary of various aspects of the invention and are not intended to narrow the scope of the appended claims. Furthermore, it will be appreciated that the drawings may show aspects of the invention in isolation and the elements in one figure may be used in conjunction with elements shown in other figures.
Reference in the specification to “one embodiment,” “one configuration,” “an embodiment,” or “a configuration” means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment, etc. The appearances of the phrase “in one embodiment” in various places may not necessarily limit the inclusion of a particular element of the invention to a single embodiment, rather the element may be included in other or all embodiments discussed herein.
Furthermore, the described features, structures, or characteristics of embodiments of the present disclosure may be combined in any suitable manner in one or more embodiments. In the following description, numerous specific details may be provided, such as examples of products or manufacturing techniques that may be used, to provide a thorough understanding of embodiments of the invention. One skilled in the relevant art will recognize, however, that embodiments discussed in the disclosure may be practiced without one or more of the specific details, or with other methods, components, materials, and so forth. In other instances, well-known structures, materials, or operations may not be shown or described in detail to avoid obscuring aspects of the invention.
Before the present invention is disclosed and described in detail, it should be understood that the present invention is not limited to any particular structures, process steps, or materials discussed or disclosed herein, but is extended to include equivalents thereof as would be recognized by those of ordinary skill in the relevant art. More specifically, the invention is defined by the terms set forth in the claims. It should also be understood that terminology contained herein is used for the purpose of describing particular aspects of the invention only and is not intended to limit the invention to the aspects or embodiments shown unless expressly indicated as such. Likewise, the discussion of any particular aspect of the invention is not to be understood as a requirement that such aspect is required to be present apart from an express inclusion of that aspect in the claims.
It should also be noted that, as used in this specification and the appended claims, singular forms such as “a,” “an,” and “the” may include the plural unless the context clearly dictates otherwise. Thus, for example, reference to “a bracket” may include an embodiment having one or more of such brackets, and reference to “the target plate” may include reference to one or more of such target plates.
As used herein, the term “substantially” refers to the complete or nearly complete extent or degree of an action, characteristic, property, state, structure, item, or result to function as indicated. For example, an object that is “substantially” enclosed would mean that the object is either completely enclosed or nearly completely enclosed. The exact allowable degree of deviation from absolute completeness may in some cases depend on the specific context, such that enclosing nearly all the length of a lumen would be substantially enclosed, even if the distal end of the structure enclosing the lumen had a slit or channel formed along a portion thereof. The use of “substantially” is equally applicable when used in a negative connotation to refer to the complete or near complete lack of an action, characteristic, property, state, structure, item, or result. For example, structure which is “substantially free of” a bottom would either completely lack a bottom or so nearly completely lack a bottom that the effect would be effectively the same as if it completely lacked a bottom.
As used herein, the term “generally” refers to something that has characteristics of a quality without necessarily being exactly that quality. For example, a structure said to be generally vertical would be at least as vertical as horizontal, i.e., would extend 45 degrees or greater from horizontal. Likewise, something said to be generally circular may be rounded like an oval but need not have a consistent diameter in every direction.
As used herein, the term “about” is used to provide flexibility to a numerical range endpoint by providing that a given value may be “a little above” or “a little below” the endpoint while still accomplishing the function associated with the range.
As used herein, a plurality of items, structural elements, compositional elements, and/or materials may be presented in a common list for convenience. However, these lists should be construed as though each member of the list is individually identified as a separate and unique member.
Concentrations, amounts, proportions, and other numerical data may be expressed or presented herein in a range format. It is to be understood that such a range format is used merely for convenience and brevity and thus should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also to include all the individual numerical values or sub-ranges encompassed within that range as if each numerical value and sub-range is explicitly recited. As an illustration, a numerical range of “about 1 to about 5” should be interpreted to include not only the explicitly recited values of about 1 to about 5, but also include individual values and sub-ranges within the indicated range. Thus, included in this numerical range are individual values such as 2, 3, and 4 and sub-ranges such as from 1-3, from 2-4, and from 3-5, etc., as well as 1, 2, 3, 4, and 5, individually. This same principle applies to ranges reciting only one numerical value as a minimum or a maximum. Furthermore, such an interpretation should apply regardless of the breadth of the range or the characteristics being described.
Turning now to
The suture tray may include an upper cover 70, typically formed by paper, cardboard or mylar coated material, which protects most of the suture material and the tip of the needle. The cover 70 may have information associated with the needle and/or the suture thread disposed thereon, such as the type of needle and the size and material of the suture material. Thus, the suture thread is shown in dashed line. The needle 16 is often held in the needle holder 18 on the bottom of the suture tray 62 so that the sharp end of the needle is covered by the upper cover 70 and is thus shown partially dashed. Other brand suture trays can be configured differently. The upper cover 70 may include an opening 23, through which the surgical technician or the physician can access the needle to remove it from the needle holder 18 and pull the suture material out through the opening.
The suture needle holding pad 80 may be disposed on the surgical suture tray 62 provided that a label having the needle/suture information is disposed thereon—thus allowing the cover 70 to be torn away as shown in
It will be appreciated that in many surgical environments the number of suture trays 62 will be significantly higher. It is not uncommon to have 10-20 different suture trays in the operating field, and some procedures will have as many as 30 needle/suture combinations on a Mayo tray. The surgical technician is responsible for tracking the location of every one of the needle/suture combinations, as well as helping the surgeon by holding various instruments, etc. during the surgery.
Turning now to
The second step is removing the needle from the suture tray 104. This will typically involve removing the suture thread as well unless the suture thread breaks. The third step is anchoring the needle in the suture needle holding pad 108 when not in use by the physician. At appropriate times during the surgery the surgical technician can verify which needles have been removed but are not on their associated suture needle holding pads and can verify with the surgeon that he or she is using any needle that has been removed but is not on the pad. The method may include additional steps, such as relocating the needle/suture holding structures based on the design of the needle or size or material of the suture. The method may also include relocating the needle/suture holding structure based on whether or not it has been used, and or positioning a needle/suture holding structure to a position where it is more easily reached by the surgeon, or where the surgical technician can easily attach the needle to the needle holding pad.
The method may also include additional steps, such as relocating the suture trays based on whether they have been used, relocating the suture trays based on the needle and/or suture type or size and relocating the tray for the needle being used to make it more accessible.
While the previous embodiments show only a single needle holding pad, it will be appreciated that the multiple needle holding pads could be located on the cover 70, etc. with the different locations providing information to be remembered by the surgical technician. For example, if the surgeon thinks that he or she has used enough of the suture material that there is an insufficient amount left on that needle, or the needle has been damaged by striking bone, has become contaminated, etc., the surgeon may instruct the surgical technician to not reuse that needle. The needle could then be placed on needle holding pad 80a indicating that it is not to be reused, while the needle/suture combinations for reuse are mounted on needle holding pad 80 indicating that they are available for reuse. Because of the packaging material 58, the needle holding pads 80, 80a remain sterile prior to use.
In accordance with one aspect of the present disclosure, a needle holding pad 80 is attached on the outside of the waterproof envelope 90. In use, the packaging 58 is removed and then the envelope 90 is torn or otherwise opened and the needle and suture material removed. The needle 16 and suture material 20 are then used. When finished, the needle 16 can be mounted in the needle holding pad 80 to show that the needle has been used and that it is available for reuse. If a second needle holding pad 80a is included, the holding pads could be color coded to indicate whether the needle is reusable or not.
Specifically, the right-hand side of the Mayo tray may represent a situation where two surgeons are suturing at the same time. The envelope 90 is disposed in the upper corner, consistent with a surgeon who is to the left of the surgical technician, who would be to the left of the Mayo tray 83. The surgical technician thus knows that surgeon 1 to the left is using the needle/suture from envelope 90. On the bottom of the tray in
The various envelops 90-90b and trays 62-62e can be arranged in any arrangement that works for the surgical technician. They can be sorted by needle, by suture material, by which ones have been used, which are open and which are still in the packaging. As shown on tray 62b, they can even be sorted to include those where the needle is no longer useable (signified by the needle being disposed in needle holding pad 80a). Both the surgical technician and the surgeons can look to verify the status of their needle/suture combinations and ensure that all needles are accounted for.
Thus, there is disclosed a method and apparatus for holding suture needles. It will be appreciated that modifications can be made without departing from the scope and spirit of the invention. The appended claims are intended to cover such modifications.
This application claims priority to and incorporates by reference U.S. Provisional Application Ser. No. 63/178,654, filed Apr. 23, 2021 and U.S. patent application Ser. No. 17/334,047, filed May 28, 2021.
| Number | Date | Country | |
|---|---|---|---|
| 63178654 | Apr 2021 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17334047 | May 2021 | US |
| Child | 17726439 | US |
