CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63/245,441 , filed September 17, 2021 , entitled SURGICAL SUTURE REMOVAL DEVICE, the entirety of which is incorporated herein by reference.

FIELD OF THE INVENTION

[0002] The present invention relates to a surgical suture removal device, and more particularly to a surgical suture removal device which more efficiently and safely cuts the sutures for removal of the suture remnants by tweezers without leaving any suture remnants under the patient’s skin.

BACKGROUND OF THE INVENTION

[0003] There are several disadvantages associated with currently available suture removal instruments and methods. Disposable suture removal kits are often used, which come with low grade disposable scissors and tweezers. The tweezers are used to lift the sutures so that they can be cut with the scissors and then pulled-out of the skin. These kits provide the advantage of a single use disposable unit and work reasonably well to remove coarse sutures; however, they are not at all well suited for removal of fine sutures. The tips of the disposable scissors are too large and bulky to easily slide under fine sutures without exerting undue pressure on the skin. Attempting to use these types of kits to remove fine sutures is time consuming and frustrating for the healthcare provider, and often quite painful or even traumatic for the patient.

[0004] In addition, there is a significant failure rate associated with the use of these kits. Using the tweezer to lift the knot of the suture obscures the provider’s view. It is not rare for the knot of the suture on the surface of the skin to be cut off, leaving the loop of the suture under the skin, where it may result in a foreign body reaction. High quality, fine-tipped scissors and tweezers make suture removal easier, but they are very expensive and must be cleaned and sterilized after every use. These instruments must also be intermittently replaced. Even when using high quality suture removal instruments, the tweezers can obstruct the provider’s view so there is still a risk of cutting the knot off and leaving a loop of the suture in the skin. It should be noted that although this problem is more common with finer sutures it can also arise with coarse sutures.

[0005] There is a group of instruments designed for cutting surgical stitches that are slightly modified surgical scalpels. However, during use these devices continue to have exposed cutting surfaces which may injure the patient or medical personnel.

[0006] Thus, there is a need for a suture removal device which efficiently and safely cuts the sutures for removal. The present invention addresses these, and other, needs.

SUMMARY OF THE INVENTION

[0007] It is, therefore, an aspect of the present invention to provide a surgical suture removal device that addresses the need for a safer, more efficient and cost- effective alternative to currently available instruments for suture removal. In addition to increased efficiency resulting in decreased time required for suture removal, this device makes the process of suture removal much more comfortable, thereby minimizing pain for the patient, such as when removing very fine sutures used in facial surgery.

[0008] In accordance with a first aspect of the present invention, an arcuate member is bent to an acute angle whereby the tip or terminus of the member can easily slide under the sutures. With the added control gained, the sutures can more easily be cut and removed, increasing the overall efficiency of the process and decreasing discomfort to the patient. A fine tapered but blunt point facilitates positioning the head of the device under the suture and greatly reduces the risk of member injuring the provider or patient.

[0009] A cutting edge is provided on the inner surface of the member. The addition of a slowly increasing height to the cutting edge on the inside surface greatly reduces the need to pull the suture up and away from the skin. The cutting edge slides against the underside of the suture, and with only minimal tension the suture is cut. This results in a significant decrease in “tugging” and the associated pain. This improvement makes the process significantly more comfortable for the patient. [0010] In a further aspect, when removing sutures with scissors there is a risk of cutting on both sides of the knot and removing only the knot which leaves a retained loop of suture material in the skin to cause subsequent complications and irritation. An embodiment of the device of the present invention ensures the suture is cut at only one point, thereby significantly reducing the risk of leaving suture material in the skin to cause complications.

[0011] In accordance with another aspect of the present invention, the suture removal device may be provided in sealed sterile packaging similar to that used for disposable syringe needles. The provider may then open the sterile packaging, utilize the device and then dispose of the device in a sharps container. In an alternative aspect, a reusable version of the device (with a replaceable cutting edge) would require cleaning and sterilization after each use.

[0012] Additional aspects, advantages and novel features of the present invention will be set forth in part in the description which follows, and will in part become apparent to those in the practice of the invention, when considered with the attached figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] The accompanying drawings form a part of this specification and are to be read in conjunction therewith, wherein like reference numerals are employed to indicate like parts in the various views, and wherein:

[0014] FIG. 1 shows a side view of an exemplary embodiment of a surgical suture removal device in accordance with an aspect of the present invention;

[0015] FIG. 2 shows a front perspective view of the surgical suture removal device shown in FIG. 1 ;

[0016] FIG. 3 shows a back perspective view of the surgical suture removal device shown in FIG. 1 ;

[0017] FIG. 4 shows an exploded view of the surgical suture removal device shown in FIG. 3;

[0018] FIG. 5 shows a side view of an alternative exemplary embodiment of a surgical suture removal device in accordance with an aspect of the present invention; [0019] FIG. 6A, FIG. 6B and FIG. 6C show expanded views of alternative embodiments of the terminus of the exemplary alternative surgical suture removal device shown in FIG. 5;

[0020] FIG. 7 shows a perspective view of a further alternative exemplary embodiment of a surgical suture removal device in accordance with an aspect of the present invention;

[0021] FIG. 8 shows a side view of the further alternative exemplary embodiment of a surgical suture removal device shown in FIG. 7 showing the placement and mounting of the cutting blade therein in phantom; and

[0022] FIG. 9 shows an exemplary use of an embodiment of a surgical suture removal device in accordance with the present invention during removal of sutures from a patient’s hand.

DETAILED DESCRIPTION

[0023] Turning now to the figures, and with initial reference to FIG. 1 , an exemplary embodiment of a surgical suture removal device is generally designated by reference numeral 10. Device 10 comprises a generally arcuate member 12 having a first arm 14 having a first terminal end 16a and a second end 16b. Arcuate member 12 further includes a second arm 18 having a first end 20a and a second end 20b. Arcuate member 12 also includes a curved portion 22 that joins second end 16b of first arm 14 and first end 20a of second arm 18. In one exemplary embodiment, as seen in FIG. 1 , device 10 may be formed in a generally U-shaped configuration. For example, a longitudinal axis 29 of base portion 21 of second arm 18 may be disposed parallel to or at a slight acute angle relative to a longitudinal axis 25 of first arm 14.

[0024] First end, or head, 16a may include a blunt flattened terminus or tip 24. As shown in FIG. 1 , first end 16a is tapered at terminus 24 and then becomes broader and more rounded as first end 16a extends to form the remainder of first arm 14. In accordance with an aspect of the present invention and as shown most clearly in FIGS. 2 and 3, terminus 24 may also have a rounded profile and may be blunted or rounded over so as to remove any sharp edges thereon. Terminus 24 may lie on an x-z plane that is perpendicular to a plane x-y defined by first arm 14 and second arm 18. Terminus 24 is thus adapted to allow first arm 14 to slide under the sutures, thereby minimizing pain and discomfort to the patient while also reducing the risk of injury to the provider and/or patient as described more fully below with reference to FIG. 9.

[0025] As seen in FIGS. 1 and 3, device 10 further includes a blade 26 disposed on, and extending from, inner surface 28 of first arm 14. Inner surface 28 is facing the second arm 18 of device 10. In one aspect of the present invention, blade 26 is coplanar with the plane x-y (FIG. 2) defined by first arm 14 and second arm 18, and is positioned a spaced distance 30 from the tip of terminus 24. In another aspect of the present invention, the plane defined by blade 26 may be disposed at an angle relative to plane x-y. A cutting edge 26c of blade 26 may also be tapered such that a short end 26a is proximate terminus 24 while the tall end 26b is located proximate curved portion 22. In other words, cutting edge 26c of blade 26 may be disposed at an acute angle A relative to longitudinal axis 25 of first arm 14. It should be understood that angle A may be, but is not limited to, about 5 degrees to about 45 degrees, and more specifically about 10 degrees to about 15 degrees. Blade 26 may be fixedly secured to first arm 14 or may be replaceably mounted onto first arm, such as through sliding engagement with a groove 32 defined along inner surface 28.

[0026] With additional reference to FIG. 4, second end 20b of second arm 18 is configured to be disposed within, or otherwise coupled to, a handle 34. In one aspect of the invention, such as shown in FIGS. 3 and 4, handle 34 may be selectively removable from second arm 18. By way of example and without limitation thereto, handle 34 may include a bore 36 proportioned to receive send arm 18 therein. A fastener, such as for example, a set screw 38 may then be threaded into threaded bore 40 to secure handle 34 to second arm 18 so that an end of screw 38 presses against an outer surface of second arm 18.

[0027] As further shown in FIG. 4, second arm 18 may be of longer length than first arm 14. While shown and described as being set screw fastened, alternative, nonlimiting fasteners may include second arm engaging bore 36 through a clip or snap fit, such as that used with replaceable razor blade cartridges, or through a friction fit, or second arm 18 may include a male thread configured to be matingly received within a female threaded bore 36. In a further aspect, handle 34 may include any suitable grasping construction, and in one embodiment, may be a syringe attached to second arm 18.

[0028] Additionally or alternatively, all or a portion of surgical suture removal device 10 may be autoclavable/sterilizable for reuse. By way of example, blade 26 may be slidably removed from groove 32 and placed in a sharps container while the remainder (e.g., arcuate member 12 and handle 34) is cleaned, thereby reducing hospital waste. In another example, arcuate member 12 (including blade 26) may be removed from handle 34. Arcuate member 12 and blade 26 may then be placed in a sharps container while handle 34 is cleaned, thereby avoiding unnecessary engagement with the sharp edge 26c of blade 26 and the possibilities for accidents resulting therefrom.

[0029] With reference to FIGS. 5-6C, an alternative embodiment of a surgical suture removal device 100 comprises a generally arcuate member 112 having a first arm 114 and a second arm 118. Arcuate member 112 also includes a curved portion 122 that joins first arm 114 and second arm 118. First arm 114 may further include a terminus or tip 124 and a blade 126 disposed on, and extending from, inner surface 128 of first arm 114 and facing second arm 118 similar to surgical suture removal device 10 described above. Rather than being a two-piece construction, surgical suture removal device 100 may include a handle portion 134 which is integrally formed with second arm 118 of arcuate portion 112 as a one-piece, monolithic structure 102. In one aspect of the invention, surgical suture removal device 100 may be formed via injection molding, with blade 126 secured to second arm 118 through insert molding. Surgical suture removal device 100 may also be configured as a single-use, disposable device intended to be placed within a sharps container when finished.

[0030] As shown in FIG. 5, in a further aspect of the present invention, surgical suture removal device 100 may be constructed such that handle portion 134 is positioned at an angle relative to second arm 118 of arcuate portion 112. Without limitation thereto, the longitudinal axis of handle portion 134 may be oriented at an angle between about 180 degrees to about 120 degrees relative to longitudinal axis 129 of second arm 118. In one embodiment, handle portion 134' may be oriented coplanar with second arm 118 (e.g., the longitudinal axis 135' of handle 134' is parallel to (at a 180 degree angle with respect to) the longitudinal axis 129 of second arm 118). In alternative, non-limiting embodiments, handle portion 134" may be formed such that its longitudinal axis 135" lies at an angle A" relative to longitudinal axis 129 of second arm 118 wherein angle A" is about 165 degrees or handle portion 134"' may be formed such that its longitudinal axis 135"' lies at an angle A'" relative to longitudinal axis 129 of second arm 118 wherein angle A" is about 140 degrees.

[0031] As shown in FIGS. 6A through 6C terminus 124 may be formed to have differing profiles. For instance and without limitation thereto, FIG. 6A shows a straight terminus 124a wherein first arm 114 gently tapers as described above with regard to terminus 24. That is, the longitudinal axis 125a defined by terminus 124 is coaxial with longitudinal axis 127 defined by the outer edge of first arm 114. FIG. 6B shows an upwardly curved terminus 124b such that terminus 124b is directed toward opposing second arm 118. In one aspect of the present invention, the longitudinal axis 125b defined by terminus 124b is disposed at an inward angle Tb between 1 and about 60 degrees relative to longitudinal axis 127 defined by the outer edge of first arm 114. In a further aspect of the present invention, FIG. 6C shows a downwardly curved terminus 124c such that terminus 124c is directed away from opposing second arm 118. Longitudinal axis 125c defined by terminus 124c is disposed at an outward angle T _c between 1 and about 30 degrees relative to longitudinal axis 127 defined by the outer edge of first arm 114. Curved termini 124b, 124c may assist in suture removal depending upon the location of and accessibility to the individual sutures.

[0032] With reference to FIGS. 7 and 8, a further alternative embodiment of a surgical suture removal device 200 may comprise a generally arcuate member 212 having a first arm 214 and a second arm 218, with first arm 214 further including a terminus or tip 224 similar to devices 10, 100 described above. Arcuate member 212 may also include a curved body portion 222 that joins first arm 214 and second arm 218. Curved body portion 222 may define a slot 225 configured to receive a blade 226 therein. Blade 226 is oriented to extend outwardly from inner surface 228 of first arm 214 to face second arm 218 similar to surgical suture removal devices 10, 100 described above. Blade 226 may be secured within slot 225 via a pair of fasteners 227 received within aperture 226a defined within blade 226. Fasteners 227 may be any suitable device, such as but not limited to a screw, bolt or pin.

[0033] Surgical suture removal device 200 may also include a handle portion 234 which is integrally formed with second arm 218 of arcuate portion 212 as a one-piece, monolithic structure 202. Following use, blade 226 may be extracted from first arm 214 (following removal of fasteners 227) and placed in a sharps container while the remainder of surgical suture removal device 200 is sterilized/autoclaved for re-use.

[0034] Turning now to FIG. 9, use surgical suture removal device 10, 100, 200 begins by positioning the tip of terminus 24, 124, 224 under a first suture 42’ of a line of sutures 44. The provider 46 (i.e., a nurse or doctor) then slides rounded terminus 24, 124, 224 along the skin of patient 48 under the line of sutures 44. As a result the underside of the individual sutures 42 becomes exposed to the slowly increasing height of cutting edge 26c, 126c, 226c of blade 26, 126, 226 whereby the individual sutures 42, 42’ are sequentially cut at a single location. After each suture 42, 42’ is cut, the loose suture remnants may then be easily pulled out using tweezers (not shown). It should be further noted that, in the case of imbedded sutures, tweezers may be needed to gently pull the sutures upward away from the skin so that terminus 24, 124, 224 may be safely and comfortably placed under the suture for cutting as described above.

[0035] With reference to FIGS. 2, 3 and 9, it can be seen that curved portion 22, 122, 222 of device 10, 100, 200 may provide at least two distinct advantages. First, the angled design of device 10, 100, 200 provides a functional advantage which facilitates positioning terminus 24, 124, 224 under the sutures 42, 42’ and then allows for device 10, 100, 200 to be gently advanced in a direction 43 parallel to the patient’s skin 48 in a controlled motion. The blunt, broad, rounded end shape of terminus 24, 124, 224 allows first arm 14, 114, 214 to slide under sutures 42, 42' and along the patient's skin 48 without puncturing or gouging the patient, while also preventing blade 26, 126, 226 from cutting the patient.

[0036] Second, by locating the only sharp component (cutting edge 26c, 126c, 226c) of device 10, 100, 200 on inside surface 28, 128, 228 a spaced distance (e.g., space 30, 130, 230) from terminus 24, 124, 224 and within a narrow gap 31 , 131 , 231 formed by curved portion 22, 122, 222 (see FIGS. 1 , 5 and 8), the risk of injury to the patient 48 and provider 46 is minimized. In one exemplary embodiment, gap 31 , 131 , 231 may be, but is not limited to, a distance of about 2mm to about 12mm. To promote safety when using device 10, 100, 200, the magnitude of gap 31 , 131 , 231 may be dimensioned such that a human finger cannot penetrate the gap to such a degree where the finger would engage the sharp edge of the blade and result in cutting of the finger.

[0037] Moreover, as discussed above and as seen in FIGS. 4 and 5, second arm 18, 118 (or integral handle 234, FIG. 8) may extend beyond terminus 24, 124 (224) of first arm 14, 11 (214) which positions a gripping portion of handle 34, 134 (234) a laterally spaced distance away from terminus 24, 124 (224). This spaced distance provides provider 46 with an unobstructed view while also providing leverage to accurately position terminus 24, 124 (224) under each suture 42, 42’. Angled handles 124, 224 may also provide further visual clearance and improved leverage depending upon the location of sutures 42, 42'.

[0038] As can been seen by the above discussion, surgical suture removal device 10, 100, 200 provides numerous economical and efficiency-related advantages over existing instruments, including without limitation increased efficiency of suture removal, decreased time necessary to accomplish the task, and decreased costs due to eliminating the need to purchase and repeatedly sterilize expensive, high-quality medical scissors and tweezers. The device also eliminates the risk of a retained loop of suture material, decreases discomfort to the patient, decreases risk of injury to provider and patient, and decreases risk of transmission of bloodborne pathogens such as Hepatitis B, C, HIV, etc.

[0039] The foregoing description of the preferred embodiment of the invention has been presented for the purpose of illustration and description. It is not intended to be exhaustive nor is it intended to limit the invention to the precise form disclosed. It will be apparent to those skilled in the art that the disclosed embodiments may be modified in light of the above teachings. The embodiments described are chosen to provide an illustration of principles of the invention and its practical application to enable thereby one of ordinary skill in the art to utilize the invention in various embodiments and with various modifications as are suited to the particular use contemplated. Therefore, the foregoing description is to be considered exemplary, rather than limiting, and the true scope of the invention is that described in the following claims.