1. Field of the Invention
This application claims priority to U.S. Provisional Application Ser. No. 61/360,380 filed Jun. 30, 2010, and is incorporated in its entirety by reference.
The disclosed device herein relates generally to sterile suturing products employed by medical professionals for suturing lacerations and incisions and internal tissue on humans and animals. More specifically, the disclosed device and method relate to a device employed with a sterile suturing kit employed in surgical procedures which dispenses the suturing material in a straightened condition rather than the coiled condition such material dispenses from conventional circular storage containers.
2. Prior Art
Modern medicine for animals and humans frequently requires that the patient undergo surgical procedures during treatment for illness or other infirmities which requires incisions internally and externally. Additionally, it is common for patients who have injured themselves to require suturing of lacerations and other injuries. As a consequence, the need to suture lacerations and the like from both injuries and surgical procedures, is a day-to-day requirement in most hospitals, surgical centers and with other medical treatment providers.
As a convenience to the surgeon or medical professional performing the surgery, and as necessitated by the strict sterility requirements to avoid patient infection, both the needle and the suture material must at all times remain sterile prior to use. Further, in order to save time and to avoid the need for the surgeon or medical professional to engage the suture material with the suturing needle, conventionally, such needles and suture material are provided with the suture material operatively engaged with the proximate end of the needle to be employed by the surgeon.
As a consequence of the strict sterility requirements, as well as the conventional provision of needles which are preengaged with suture material, the packaging in which a suture-needle combination is provided by manufacturers has become a key component in the safe and efficient execution of the surgical suturing procedure.
Due to the nature of their use, in a crowded surgical room where the user generally wears latex gloves, suture packaging works best if it is compact, maintains the sterility of the suturing contents, and allows for easy removal of long strands of suture material which is already engaged with the needle to be employed. Such packaging and suture and needle combinations are taught in prior art such as U.S. Pat. Nos. 5,129,511; 5,220,769; 5,284,240; 5,341,922 and 5,439,102 which are included herein by reference thereto.
As disclosed in the prior art, and in what has become a conventional manner of packaging and supply for the medical industry, the sterile packaging provides the suture material in a determined length for the surgeon. The length of the suture strand, for convenience, is much longer than the length of the packaging. In order to provide these long suture lengths, it requires that the suture material be wound within or upon a packaging structure in a circular fashion, either upon a suture holder, or a device adapted to maintain the suture material wound prior to opening and use of the suture material and needle within the package.
In current use of such suturing packs, the user or an assistant will open the package housing the sterile suturing material which is pre-engaged with the needle, and remove it. Once the needle-suture combination is removed from the packaging to be employed by the surgeon or medical professional, a vexing problem arises for the surgeon. The suture material, which is frequently monofilament thread engaged to the needle, will maintain a memory of the shape of the holder upon which it has been wound and stored. This memory effect happens with other types of suturing thread be it wound, spunbond, or monofilament.
This curled trailing strand of suturing material engaged to the rear of a needle results in the user holding the needle with the suture material trailing from the proximate end of the needle and deformed by a multitude of curls and twists having been imparted to it from being wound on a holder and stored in the package. The tighter the wind during storage and the longer the suture material has been held wound on a holder, the more such curls and bends are memorized into the suture strand when deployed and hanging from the needle.
While the suture material is perfectly useable in this state, the mess of bunched up suturing thread or monofilament is a distracting nuisance to a surgeon or medical professional who must use it. The act of suturing a wound or laceration or surgical incision is a delicate process which requires years of practice to master. Many different types of suturing techniques and knots are employed by surgeons in closing a wound or incision depending upon the desired outcome of the healed patient. This suturing may occur on the outside of the body, or it can occur in layers below the skin, or in the tight confines of the mouth.
During this process, the surgeon is delicately trying to guide the needle end into and out of a patient's wound using their fingers or forceps. Concurrently, the surgeon is trying to maintain an even line, even tension, and position a determined number of stitches over a given length.
It is during this process that the curls and bends of the trailing suture material become a constant nuisance to the medical professional performing the suturing. The curved and curled suture strand is hard to see and can easily become unintentionally entangled in the individual sutures or stitches being delicately placed by the surgeon. In confined spaces such as the mouth, the nuisance of the curled suture strand is multiplied. It is not an infrequent occurrence where the surgeon is required to actually remove stitches or sutures because the curled trailing suture strand has become caught in a prior stitch or wrapped around something it should not, or has become knotted.
As such, there exists an unmet need for a device and method which will allow surgeons and medical professionals to employ wound suture material from kits and eliminate the noted problems therewith. Such a device should easily straighten the suture material engaged with the needle, while concurrently being compact and easily housed within the sterile packaging. Such a device upon removal from the sterile package should be easily employed with the suturing material also housed in the sterile packaging. Such a device should be easily employed by users, all of whom are conventionally gloved in latex or other surgical gloves which impair their finger dexterity. Such a device and method should at all costs, protect the sterility of the packaged needle and suture material to maintain the sterile field in the operating room and protect the patient from infection. Finally, such a device should provide means to straighten the dispensed suture while avoiding breakage of the delicate monofilament.
The disclosed device and method herein provide a remedy to the noted shortcomings of conventional packaged sterile needle and suture kits with wound suturing material housed therein. The device herein described and disclosed provides a straightening component and method for an easily employed means to straighten suture strand trailing from its engagement to the proximal end of a sterile needle.
In use, the device may be employed by itself, mounted to a ring or surgical table. However being small the device may also be easily engaged to the supporting structures of sterile suturing kits so that it may be maintained sterile while housed in sterile packaging with the kit. So housed, it provides for easy employment to straighten curved and curled suturing strands being drawn from the sterile packaging, even with the users wearing surgical gloves. During such use, the device renders the conventional curled suture strand to a substantially straight and curl-less strand ready for suturing. When housed inside the suture kit, the device remains sterile and concurrently protects the sterility of both the needle and the suture material when used, as is required in modern surgical procedures.
The device may be provided in various modes all of which will provide for a straightening of strands of suturing material which has been wound upon a storage component. In particularly preferred modes, the device is configured such that it is attached to the suture and needle holder which is conventionally housed within a wrapper to maintain sterility of the contents.
Upon opening the packaging in a sterile environment the device is easily employed for use. The device positioned on the body of the suture and needle holder employs an elongated soft member having a resilience which allows for a suture or suture-needle combination, to be drawn through it during detachment of the needle and suture material from the housing on which the suture strand was wound up.
The housing on which strands of suture material are wound are conventionally formed of paper, plastic, cardboard, or other material, and feature a planar body and winding guides all of which are housed inside the wrapper. During dismount of the needle and suturing material for use on the patient, the strand of suture material trailing from an attachment to the needle, is drawn through the elongated and preferably pliable body member of the device herein. Pressure from the pliable member itself, or imparted to the pliable member by the user, is communicated to the strand of sliding suture material being drawn through the member. This pressure and the sliding frictional engagement of the strand of suture material through the pliable body, creates a substantially uniform tension which is imparted to the suture strand by the radial pressure on the exterior surface of the strand caused by the member along the suture material being drawn through the member forming the device. This tensioning helps to slightly stretch and realign the material forming the strand of the suture to thereby substantially remove the memorized shape imparted to the strand by winding on the guides of the housing in the container. The entire length of the suture material may be drawn through the elongated member providing a means for straightening and removing any memorized curves or bends. The user is thereby left with a substantially straight strand of suture material hanging from the needle, devoid of coils and twists, all of which remain sterile.
In one mode of the device a force may be exerted about the external circumference of the suture material to impart the tension to the suture material drawn through the member along a pathway formed through the member. This pathway has a diameter substantially equal to or slightly smaller then that of the strand of suture material.
In use in this mode, the suture or needle-suture combination is fed through an aperture communicating with the pathway where the squeezing pressure caused by the smaller diameter of the passage forming the pathway through the pliable or compressible member provides a calculable and determined pressure needed to effectively stretch and straighten out any curves or bends in the suture material. It should be noted that the pressure exerted on the suture is not limited by the equal or smaller passage diameter and the hardness of the material forming the member. By employing a compressible material for the elongated body of the device, such as silicone, additional circumferential pressure may be applied to the strand of suture material by a compression of the member forming the body of the device. This compression force imparts additional pressure against the exterior surface of the suture which may more effectively straighten the suture material of its memorized curves and curls. The compression force may be imparted easily by the gloved fingers and thumb of the user, or using a means for imparting inward bias upon the compressible member such as a spring loaded clip.
In many cases the suture needle employed by the surgeon is curved. As such, the ability to feed the needle through the passageway may be difficult during use in the sterile confines of the operating room by a gloved user. Consequently, the needle, if curved, is best fed through the passage through the compressible member prior to packaging within the sterile wrapper thereby eliminating the need for users to do so.
In another mode of the invention herein, the passage through the elongated member, rather than formed and accessible through apertures in the surface, is instead comprised of an elongated slit along the length of the body of the member. In use, the slit is accessible by a gap communicating to the exterior surface of the member, whereby the needle and/or the suture material may be drawn into the passage formed by the slit.
The slit may taper to a smaller size from the access point to the bottom of the slit forming the passageway through the member. The narrowest part of the slit thereby can be narrower than the diameter of the suture material and impart and determinable pressure to the suture material drawn therethrough. Alternatively, a pinching or compression of the member may also be exerted on the member, to achieve pressure on the suture or increase pressure on the suture material drawn through the compressible member. As with the first mode of the device, employing a defined passage or conduit, drawing the suture through the device having the passageway formed by a slit, will impart the circumferential pressure to the suture material sufficient to cause any and all memorized bends or curves to be straightened.
A particularly preferred mode of the device is as an attached component to existing suture packaging by engagement to housing on which the suture strand is wound. The body of the device is engaged to the card or other structure employed for the winding of the suture material. As noted above, many conventional suture packages wind a predetermined length of a strand of suture material upon a card, or other planar structure having winding guides thereon. The housing or card is placed within a sterile cavity formed by a surrounding package enclosure along with a needle secured to one end. In use, once the package is opened to reveal the sterile cavity, the needled end is grasped and pulled, and pulls along the trailing strand of suture material from the winding guides and the package. It is at this point that the suture material goes into a curved, coiled and twisted state.
It is therefor particularly preferred, to engage the device to the housing or card holding the guides and the wound suture material which is placed inside the sterile cavity of the packaging. The member would of course also be sterile. So positioned within the sterile cavity, the device, in combination with the card or winding component or support, would have the needle pre-threaded through the passageway communicating through the compressible member. In this fashion, once the package is opened to reveal the sterile suture, needle, and device herein, the needle can be grasped and pulled to draw the suture material through the passageway of the member wherein pressure is imparted to the circumference of the suture material. As the needle and suture material are drawn from the package the suture material is concurrently straightened.
Alternatively, the compressible member may be positioned on the card or container or structure on which the strand of suture material is wound and housed inside the sterile cavity of the package. However, a slit may form the passage which allows the user to either draw the suture material through the passageway through the compressible member, or not, if such is not desirable. In either mode, placing the member in engagement on housing for the wound strand of suture such as the card or other component on which the suture material is wound, allows the compressible member to be sterilized and eliminates the need to package the device in a separate sterile package.
As noted, in either mode, where the passageway is formed by a slit, or a conduit, employing compressible material such as silicone for the member body, allows the user to impart more frictional compressive force to the circumferential surface of the suture material drawn therethrough. This can be done by pinching the member between the thumb and a finger, or using an inwardly biased clip engaged to impart force to two sides of the compressible member.
In a third mode of the device herein, which is well adapted for separate employment with packaged suturing kits which do not have the compressible member housed within the packaging, the device may be attached to a clip or other means of engagement of the compressible member to a surgical table or tray. In this mode of the device, a passageway is formed through the compressible member, by either a slit, or conduit. A slit provides an easier engagement for the user, however a conduit may be employed also, or, the member may be provided with no pathway through the compressible body, and the user may push the needle through the compressible body. The strand of suture is drawn through the compressible body thereafter in all modes of formation and employment of the pathway through the compressible body. A compression or means for inward bias of the compressible material of the body may be employed to exert compressive pressure to the compressible body should more pressure on the suture be desired.
In this respect, before explaining at least one object of the invention in detail it is to be understood that the invention is not limited in its application to the details of the construction and to the arrangement of the components set forth in the previous description or illustrated in the drawings. The suture straitening device and method herein is capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.
As such, those skilled in the art will appreciate that the conception, upon which this disclosure is based, may readily be utilized as a basis for the designing of other methods and systems for exerting a compressive force upon the exterior surface of a suture and for carrying out the several purposes of the present invention. It is important, therefore, that the claims be regarded as including such equivalent construction insofar as they do not depart form the spirit and scope of the present invention.
It is an object of the present invention to provide a sterile means to straighten curved, coiled, or twisted sutures which exit from standard suture packaging.
Another object of the invention is to allow for an economically viable hand held device to straighten strands of suture material in a sterile manner.
Yet another object of the invention is to provide a component for employment in combination with conventionally packaged housings, cards and components on which suture material is wound and stored in a sterile package.
An additional object of the invention is to employ a means of straightening strands of suture material in suture-needle combinations for a plurality of needle types.
These together with other objects and advantages which will become subsequently apparent reside in the details of the construction and method as more fully hereinafter described and claimed, reference being had to the accompanying drawings forming a part thereof, wherein like numerals refer to like parts.
a shows a side view of the device described in
b shows a front view of the device of
a shows a side view of the device described in
b shows a front view of the device described in
a depicts a sliced through
a depicts a slice through
Now referring to drawings in
As can be seen in
In
In
The engagement or disengagement of the strand of suture 18 with a body 11 having a slot 14, is shown in
In
All modes of the body 11, either with the slot 14 or with the conduit type of passageway 12, impart a force to the exterior surface of strand of suture material 18 drawn through the passageway 12 running trough the body 11. This can be a set amount of force by forming the passageway 12 to be slightly smaller than the diameter of the strand of suture material 18. Or, as shown in
The problem with conventional wound suture kits is best depicted in
Passage through the passageway 12 of the body 11 subjects the strand of suture material 18 exterior to a compressive force and frictional engagement while drawn through the passageway 12 by a pulling of the user. The force so exerted on the strand of suture material 18, causes a stretching of the strand of suture material 18 which results in a straitening thereof shown in
In
a depicts a sliced through
A second mode of the device 10 formed as a unit adapted to hold a strand of suture material 18 wound on a card like winding component 20 is shown in
The device 10 may also provide a second body 19 substantially inline with the body 11 through which the passageway 12 is formed as shown in
Finally, a stand alone mode of the device 10 is shown in
While all of the fundamental characteristics and features of the invention have been shown and described herein, with reference to particular embodiments thereof, a latitude of modification, various changes and substitutions are intended in the foregoing disclosure and it will be apparent that in some instances, some features of the invention may be employed without a corresponding use of other features without departing from the scope of the invention as set forth. It should also be understood that various substitutions, modifications, and variations may be made by those skilled in the art without departing from the spirit or scope of the invention. Consequently, all such modifications and variations and substitutions are included within the scope of the invention as defined by the following claims.
Number | Date | Country | |
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61360380 | Jun 2010 | US |