HK1180930A - Safety scalpel - Google Patents

Description

Safety scalpel

Cross Reference to Related Applications

The present invention claims priority from U.S. provisional patent application No. 61/359,249, "safety scalpel", filed on 6/28/2010, the contents of which are incorporated herein by reference.

Technical Field

The present invention relates to cutting devices and, more particularly, to safety scalpels for health care.

Background

Health care is the second rapidly growing economic sector in the united states, employing over 1200 million employees. Health care workers can face a wide range of hazards during work, including: needle and sharps puncture, back injury, latex hypersensitivity, violence and stress. While these health care workers may be prevented or reduced from exposure to these hazards, the number of health care workers suffering from occupational injuries and diseases is actually increasing. The proportion of occupational injuries to health care workers has continued to increase over the past decade. By contrast, two of the most dangerous industries, the agricultural and construction industries, are now safer than ten years ago.

In health care workers, the annual number of needle sticks and other percutaneous injuries cannot obtain correct data from the authorities; however, such injuries are estimated to occur in the hundreds to eighty thousand cases per year. Approximately half of these injuries have not been reported. Data from the Exposure Prevention Information Network (EPINet) shows that nearly thirty needle injuries occur in each hundred beds per year by each hospital employee on average.

Most reported needle and sharps injuries are mainly caregivers, but laboratory staff, physicians, miscellaneous workers, and other caregivers are also injured. Some of these injuries expose workers to the hazards of blood-borne infectious pathogens that cause infection. Among the more dangerous of these pathogens are Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), and Human Immunodeficiency Virus (HIV). Infection with each of these pathogens can be life threatening, but can be prevented.

Even if serious infectious diseases are not transmitted, emotional impact of needle and sharp pricks can be severe and long lasting. Emotional shock can be particularly severe when these injuries involve the harm of exposure to HIV. In the study reports for twenty health care workers exposed to HIV, eleven showed severe distress, seven were in constant moderate distress, and six were resigned for HIV exposure. Other stress responses requiring counseling are shown in this report. The lack of knowledge of the infection status of the source patient can put the caregiver under stress. Both colleagues and family are subjected to emotional stress, except for the caregivers themselves, who are compromised by exposure.

In designing a comprehensive prevention plan, safety and health issues must be addressed, taking into account all types of work environments and staff involvement and management level efforts. Implementing improved engineering control is a component of this comprehensive program. However, other control strategy elements that must be noted include: modifying dangerous work practices, administrative changes to address needle hazards in the environment (e.g., timely removal of a full sharps disposal bin), safety education and recognition, feedback on safety improvements, and actions taken on ongoing problems.

The needle stick prevention program is an important element in the improved engineering controls often used in many of the most effective solutions to reduce occupational hazards. Such controls include eliminating unnecessary use of needles and employing devices with safety features. Many sources of evidence have identified desirable features for security devices, with more preferred features of security devices including: a needle head is not needed; incorporating a security feature as an integral part of the device; passive operation (i.e., no user activation is required); if it is necessary for the user to activate, it is necessary to have a one-handed safety feature and allow the user's hands to remain behind the sharps; can allow the user to easily determine whether the security feature has been activated; the safety feature that can not be cancelled is provided, and the protection effect is still provided when the safety feature is discarded; the operation is reliable; the use is easy; and, patient care is safe and effective.

While each of these features is desirable, some are difficult to implement, impractical, or unavailable in certain health care situations. For example, needles are always still needed when alternatives to skin penetration are not available. Additionally, security features that require user activation may be better than passive security features in some cases. Each device must consider its own advantages and, ultimately, its ability to reduce workplace injuries.

In particular, regarding the scalpel, the conventional scalpel currently used in the medical care industry includes: a metal handle and a disposable blade that is mounted on the handle prior to use and removed after use. The process of mounting and dismounting the blade is an easy and dangerous procedure that exposes the medical practitioner to potential injury from blood contamination from and on the blade.

There is another risk during operation. When a surgeon needs a particular scalpel, a nurse, physician's assistant, or brushing technician must hold the scalpel in the surgeon with the end of the handle facing the surgeon so that the surgeon can easily hold the scalpel. Thus, the nurse must hold the end of the scalpel having the bare blade. As such, the nurse is often cut by the blade during the delivery of the scalpel. Similarly, when the surgeon returns the scalpel to the nurse, the surgeon hands the blade end to the nurse, who must then be able to grasp the blade without being nicked.

Surgeons who have a feel for the shape and weight of metal handles do not like disposable safety scalpels currently in use because, among many others, plastic handles are too light and feel "different". The plastic handle of the scalpel produces greater flexibility during use than a metal handle scalpel, which is undesirable to the surgeon. In addition, disposable safety scalpels are much more expensive than conventional disposable blades. These two factors limit the use of safety scalpels in the health care industry.

Therefore, there is a great need for a safe and reliable scalpel that overcomes the objections of health care practitioners to existing designs, while providing adequate protection to the medical practitioner holding the scalpel.

Disclosure of Invention

Briefly, embodiments of the present invention are directed to a safety scalpel. This safety scalpel is a significant improvement over conventional scalpels in that the scalpel of the present invention is formed by combining a handle having a thickness, length, weight, balance, shape and feel similar to conventional metal handles preferred by most surgeons, with a cartridge assembly that can be easily inserted into and removed from the scalpel handle. The handle can be reused and is made of metal. The cartridge assembly may be made of a disposable material and is therefore preferably detachable from the handle. The cartridge assembly includes: a guard, a slider with a blade, and a button for moving the blade between engaged and disengaged positions. For example, the blade extends from the housing during use, and the blade can be completely disposed within the housing when the scalpel is not in use.

In a preferred embodiment, the safety scalpel may comprise: a handle and a cartridge assembly, the handle having a first end and a second end, the cartridge assembly comprising: a shield fitted into the second end of the grip, a slider disposed within the shield, and a blade fitted over the slider.

The second end of the handle is generally flat and narrower than the first end of the handle. Generally, the shroud may be elongated, have a rectangular cross-section, and be substantially hollow. The second end of the grip may be inserted into the shroud and secured therein to define a pocket. A locking snap incorporated into the shroud engages a hole defined in one of the handles to lock the cartridge to the handles.

In some embodiments, when the cartridge assembly is fully assembled, the blade contained within it cannot be extended unless the blade is placed on the handle. This prevents inadvertent extension of the blade and reduces injury.

In some embodiments, such safety scalpels are configured to be telescopic. For example, this general/intuitive action is similar to using conventional carton cutting apparatus. In contrast to some conventional scalpels, the user must slide the guard rearwardly to expose the blade and inconveniently slide the guard further forwardly to consciously cover the blade; the safety scalpel of the present invention is adapted to be extended or retracted by pushing the button down and then sliding the button along the shield to change its position.

Other features of embodiments of the present invention and advantages offered thereby will be described in detail with respect to particular embodiments thereof as illustrated in the accompanying drawings in which like reference numerals refer to like elements throughout.

Drawings

Fig. 1 is an exploded view of a safety scalpel according to an exemplary embodiment of the present invention.

Fig. 2 is a front perspective view of a handle and cartridge assembly of a safety scalpel according to an exemplary embodiment of the present invention.

Fig. 3 is a rear perspective view of the handle and cartridge assembly of the safety scalpel in accordance with an exemplary embodiment of the present invention.

Fig. 4 is a front perspective view of a safety scalpel with a blade in a retracted position in accordance with an exemplary embodiment of the present invention.

Fig. 5 is a front perspective view of a safety scalpel with a blade in an extended position in accordance with an exemplary embodiment of the present invention.

Fig. 6 is a rear perspective view of the blade in a retracted position in the integrated safety scalpel of the exemplary embodiment of the present invention.

Fig. 7A is a front view of the handle of the safety scalpel in accordance with an exemplary embodiment of the present invention.

Fig. 7B is a rear view of the handle of the safety scalpel in accordance with an exemplary embodiment of the present invention.

Fig. 7C is a side view of the handle of the safety scalpel in accordance with an exemplary embodiment of the present invention.

Fig. 8A is a front perspective view of a cartridge assembly of a safety scalpel according to an exemplary embodiment of the present invention.

Fig. 8B is a front perspective view of a cartridge assembly of the safety scalpel with the blade exposed according to an exemplary embodiment of the present invention.

Fig. 9 is a rear perspective view of a cartridge assembly of the safety scalpel according to an exemplary embodiment of the present invention.

Fig. 10A is a front perspective view of a shield of a cartridge assembly of a safety scalpel according to an exemplary embodiment of the present invention.

Fig. 10B is a rear perspective view of a shield of a cartridge assembly of the safety scalpel according to an exemplary embodiment of the present invention.

Fig. 10C is an end perspective view of a shield of a cartridge assembly of the safety scalpel according to an exemplary embodiment of the present invention.

Figure 10D is an end view of the hollow cavity of the shield of the cartridge assembly of the safety scalpel according to an exemplary embodiment of the present invention.

Fig. 11A is a top perspective view of a slider of a cartridge assembly of a safety scalpel according to an exemplary embodiment of the present invention.

Fig. 11B is a bottom perspective view of the slider of the cartridge assembly of the safety scalpel according to an exemplary embodiment of the present invention.

Fig. 12 is a perspective view of a blade of a cartridge assembly of a safety scalpel according to an exemplary embodiment of the present invention.

Fig. 13A is a top perspective view of a button of a cartridge assembly of the safety scalpel according to an exemplary embodiment of the present invention.

Fig. 13B is a bottom perspective view of a button of the cartridge assembly of the safety scalpel according to an exemplary embodiment of the present invention.

Fig. 14A is a top perspective view of a slider of a cartridge assembly of a safety scalpel with a blade in accordance with an exemplary embodiment of the present invention.

Fig. 14B is a bottom perspective view of the slider of the cartridge assembly of the safety scalpel with blade in accordance with an exemplary embodiment of the present invention.

FIG. 15A is a perspective view of a cartridge assembly according to an exemplary embodiment of the invention.

Figure 15B is a perspective view of the cartridge assembly of the exemplary embodiment of the present invention prior to insertion of the handle into the cartridge assembly to form a safety scalpel.

Detailed Description

Although some preferred embodiments of the present invention are described in detail herein, it is to be understood that other embodiments are also contemplated. Thus, the scope of the present invention should not be limited to the details of the construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or of being carried out in various ways. In addition, in describing the preferred embodiments, specific terminology is employed to make the description more clear.

It must be expressly noted that, as used in the specification and the appended claims, the singular forms "a," "an," and "the" (the articles a, an, the) also include plural referents unless the context clearly dictates otherwise.

In addition, in describing the preferred embodiments, certain terminology is employed to make the description more clear. Each term is to be interpreted in its broadest sense as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.

Ranges described herein are from "about" or "approximately" one particular value, and/or to "about" or "approximately" another particular value. When such a range is expressed, another embodiment includes from the "one particular value" and/or "to the other particular value.

The terms "comprises," "comprising," or "including," or the like, mean that at least the recited compound, element, particle, or method step is present in the composition, article, or method, but does not preclude the presence of other compounds, materials, particles, or method steps, if they serve the same function as recited herein.

It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between the already described method steps. Similarly, it will also be understood that reference to one or more components in a device or system does not preclude the presence of additional components or intervening components between the described components.

Referring now in detail to the drawings in which like reference numerals refer to like parts, fig. 1 shows an exploded view of an exemplary embodiment of a safety scalpel 100. The safety scalpel 100 can have a longitudinal axis 201 and includes a handle 200 and a cartridge assembly 300. The cartridge assembly 300, which in many embodiments is disposable, can be removably mounted on the handle 200. Preferably, the cartridge assembly 300 is mounted on the handle 200 by sliding the cartridge assembly 300 substantially parallel to the longitudinal axis 201. The handle 200 can have a wall or stop surface to limit the distance the cartridge assembly 300 can slide on the handle 200.

As shown, and particularly in fig. 1 and 8A, the cartridge assembly 300 includes: the shroud 400, slider 500, blade 600, and actuating member 700; the guard 400 may also be referred to as a blade guard, or housing; the slider 500 may also be referred to as a blade holder; the actuating member 700 may also be referred to as a button.

Fig. 2 shows a front perspective view of the handle 200 and cartridge assembly 300 prior to assembly of the safety scalpel 100.

Fig. 3 shows a rear perspective view of the handle 200 and cartridge assembly 300 prior to assembly of the safety scalpel 100.

Fig. 4 to 6 show the safety scalpel 100 in a state after assembly. Fig. 4 is a front perspective view of the safety scalpel 100 with the blade in a retracted position within the guard 400. Fig. 5 is a front perspective view of the safety scalpel 100 with the blade 600 in an extended position outside the guard 400. Fig. 6 is a rear perspective view of the safety scalpel 100 with the blade 600 in a retracted position.

As shown in fig. 1 and fig. 7A to 7C, the handle 200 of the safety scalpel 100 includes: a first end 202 and a second end 204. The handle 200 generally includes three portions: a grip portion 210, a locking portion 220, and an engaging portion 230. The grip portion 210 extends from the first end 202 to the lock portion 220. The engaging portion 230 extends from the second end 204 to the locking portion 220.

The grip portion 210 of the handle 200 may include indicia. It is desirable for the user of the safety scalpel 100 to measure or calculate the length while in use. Indicia, such as graduations 212, may be printed or etched on at least one side of the grip portion 210 of the handle 200. In many embodiments, the scale 212 may be in inches, centimeters, millimeters, or the like.

The locking portion 220 of the handle 200 can engage an end of the cartridge assembly 300. As will be described later, the locking portion 220 engages an end of the shield 400 and is engaged with the shield 400 to reduce, if not eliminate, wobble of the cartridge assembly 300 relative to the handle 200.

The engagement portion 230 of the handle 200 is adapted to be received within a hollow pocket of the cartridge assembly 300. The engaging portion 230 includes: along the ramp 232 on each opposing side of the latch 230, the defined cut-out 234, the keyway 236 configured to receive a portion of the slider 500, the anti-wobble detent or tab 238, and an aperture 240; with the apertures 240 configured to receive tabs 410 from the shield 400 to lock the cartridge assembly 300 to the handle 200. The tab 238 and the slider 500 engage with each other to prevent the blade 600 from wobbling in the first direction when the safety scalpel 100 is operated in the operating position; as shown in fig. 11B, the keyway 236 of the handle 200 and the projecting member 502 of the slider 500 cooperate to prevent wobble in the second direction.

Figure 8A is a front perspective view of the cartridge assembly 300 with the blade 600 in a retracted position. Figure 8B is a front perspective view of the cartridge assembly 300 with the blade 600 in an extended position. As shown in fig. 8A and 8B, the cartridge assembly 300 has: the guard or blade guard 400, the slider or blade support 500, the blade 600, and the button 700 or actuation member 700, with the slider or blade support 500 slidably mounted within the pocket 402 of the guard or blade guard 400. Figure 9 is a rear perspective view of the cartridge assembly 300.

As shown in fig. 1-6, 8A, 8B, 9, 10A-10D, and 11, the shield 400 of the cartridge assembly 300 may be elongated and have a substantially rectangular cross-section. Referring to fig. 10A, the shroud 400 may be substantially hollow defining a cavity 402 and adapted to slide over the second end 204 and substantially cover the engaging portion 230 of the handle 200. The slider 500 may be disposed within the pocket 402 defined by the shroud 400. In some embodiments, the slider 500 may slide along rails 415 disposed within the pocket 402 of the shroud 400.

The shroud 400 extends from a first end 404 to a second end 406, and the first end 404 is adapted to engage the latch 220 of the handle 200. In an exemplary embodiment, the first end 404 is a handle engaging end and the second end 406 is a blade engaging end.

To prevent the cartridge assembly 300 from slipping off the handle 200 and/or moving relative to the handle 200 during use, the cartridge assembly 300 can be locked in the correct position relative to the handle 200 once the cartridge assembly 300 is installed on the engagement portion 230 of the handle 200. The shield 400 of the cartridge assembly 300 can include a locking snap 410 that can be positioned on a second side of the shield 400. The locking snap or tab 410 engages the aperture 240 on the engagement portion 230 of the handle 200 to prevent the cartridge assembly 300 from sliding off the handle 200 after the cartridge assembly 300 is attached to the handle 200. In other words, the hole 240 may receive the locking snap 410.

Unlike many prior art solutions, which may cause the cartridge assembly 300 to inadvertently fall off the handle 200, the safety scalpel 100 of the present invention prevents the cartridge assembly 300 from inadvertently falling off. In many embodiments, the cartridge assembly 300 can be disposable. When the cartridge assembly 300 is to be discarded, the worker removes the cartridge assembly 300 from the handle 200. To remove the cartridge assembly 300, the caregiver may need to use forceps, pliers, or other similar devices. The protruding end of this device can pull the locking snap 410 of the shield 400 out of the hole 240 of the grip 200. Conventional designs enable the cartridge assembly 300 to be detached from the handle 200, but with dangerous consequences, including the possibility of inadvertent detachment during use of the scalpel. Such a safety scalpel 100 prevents the cartridge assembly 300 from inadvertently disengaging the handle 200 because it requires a positive force to pull the locking snap 410 out of the aperture 240.

Referring again to the shield 400, the shield 400 may have a slit 420 extending longitudinally along the first side. The slot 420 extends from a slider release end 422 proximate the first end 404 of the shield 400 to a slider engagement end 424 proximate the second end 406. The slider 500 may additionally be provided with a button 700, as described elsewhere herein. The button 700 can be moved along the slot 420 from a first end (slider release end 422) to a second end (slider engagement end 424) and back. The button 700 may be mounted to the slider 500 by a handle 702. A head 704 of the button 700 may be disposed outside the shroud 400 while the slider 500 remains within the shroud 400.

At least one side of the shield 400 may include a grip 430. The grip 430 may include u-shaped cutouts defined along the side surfaces of the shield 400. As shown, the grip 430 may be disposed on at least one side/surface.

Further, a position indicator or protruding member 440 may extend from at least one side of the shroud 400. When using the safety scalpel 100, the position indicator 440 provides immediate visual and tactile indication of the position of the scalpel 100 by mimicking the transitional step between the handle and the blade on a conventional scalpel to provide a detent or to provide a tactile feel that prevents slippage. This helps determine how long the blade 600 is to cut on a surface, or where the blade is sensed as a whole, and can provide mechanical leverage to prevent slippage during use. For example, the position indicator 440 provides an immediate indication of the distance the surgeon has incised into the patient's epidermis or tissue.

The slider 500 shown generally in fig. 1 and 11A-11B can slidably engage the handle 200 and the shield 400. As the slider 500 slides relative to the shield 400 and the handle 200, the slider 500 and the blade 600 may extend from within the shield 400 and retract into the shield 400. A user, such as a surgeon or health care professional, can extend the blade 600 from the shield 400 by moving the button 700 from the slider release end 422 to the slider engagement end 424. The user retracts the blade 600 into the guard 400 by moving the button 700 from the slider engaging end 424 back to the slider disengaging end 422.

The safety scalpel 100 can be stored with the blade 600 in the retracted position within the guard 400. In this position, the blade 600 is fully seated within the guard 400, wherein the tip 602 or sharp cutting edge 604 of the blade 600 is not exposed.

Holding the scalpel 100 with the blade 600 in the retracted position is safer because inadvertent cuts are avoided. The process of the nurse or brush technician transferring the scalpel 100 to the surgeon becomes safer, particularly because the edge of the blade 600 is not exposed and cannot cut the surgeon or nurse.

For added security, the slider 500 can be keyed within the shield 400 such that the blade 600 is prevented from protruding from within the housing 300 when the cartridge assembly 300 is not mounted to the handle 200.

Fig. 1-2, 4-5, and 7A-7C illustrate front perspective views of exemplary embodiments of a scalpel handle 200. The scalpel handle 200 can include: a longitudinal axis 201, a gripping portion 210 for a user to grasp, and a snap-fit portion 230 for receiving the cartridge assembly 300. In an exemplary embodiment, the engaging portion 230 comprises about half of the length of the handle 200, and the holding portion 210 comprises the remaining half. Between the grip portion 210 and the catch portion 230 is a latch 220 sized and shaped to fit within the first end 402 of the shroud 400.

The engagement portion 230 of the handle 200 can be narrower and substantially thinner than the grip portion 210 so that it can fit within the cartridge assembly 300. Preferably, the engagement portion 230 may include a tapered tip 242 to improve insertion of the protective blade housing 300 and assembly of the safety scalpel 100.

A longitudinal groove or keyway 236 may be provided along the catch 230 of the handle 200 to receive the projecting member 502 of the slider 500 after the blade 600 is mounted to the slider 500 by heat staking or the like through the blade detent 504.

The handle 200 may also include a wobble prevention detent 238 positioned within the catch 230 of the handle 200. An anti-wobble detent 238, which in some embodiments is a bump or outwardly projecting member, extends upwardly from the handle 200 and engages the slide 500 when the cartridge assembly 300 is positioned on the handle 200. The anti-wobble pawl 238 can press on the bottom of the slider 500 and make the blade 600 more stable when the blade 600 is extended from the cartridge assembly 300 and used.

To increase the traction of the handle 200 when the handle 200 is in contact with the fingers during use of the safety scalpel 100, the grip portion 210 can include a plurality of grooves on the front and/or rear of the handle 200. These grooves may prevent the safety scalpel 100 from slipping off during use.

As shown, the grip portion 210 of the handle 200 may include indicia 212. These markings 212 may be located on the front surface of the handle 200 as a whole. The indicators 212 may include a plurality of indicia or printing, and the indicia 212 are preferably units of measure, such as, but not limited to, metric units, imperial units, or many other suitable units of measure.

The handle 200 is designed to accept the cartridge assembly 300 and to give the user the tactile feel of a conventional scalpel when in use. Thus, the handle 200 can provide a material, weight, and design that is comfortable for the user. In some embodiments, the handle 200 and the blade 600 may be made of stainless steel, while the guard 400, the slider 500, and the button 700 are made of polycarbonate material.

Fig. 1 to 6 and 8A to 10D illustrate perspective views of the shield 400. The shield 400 may include a longitudinal axis and may be elongated with a substantially rectangular cross-section. The shroud 400 is hollow, defining a cavity 402 having a first opening 407 at a first end 404 and a second opening 409 at a second end 406.

The shroud 400 may include a slot 420 across the front sidewall. The slit 420 may be elongated and substantially parallel to the longitudinal axis 201 of the scalpel 100. The slot 420 may include openings 422 and 424 on its ends, i.e., a slider disengaging end 422 and a slider engaging end 424. Slots 422 and 424 have extensions 425 to maintain the slide in a set position.

The slider 500 may be inserted and stored within the shield 400. The shank 702 of the button 700 may pass through the shank receiving aperture 506 of the slider 500 while the head 704 remains outside of the shroud 400. The shank receiving aperture 506 is wide enough to receive the shank 702 of the button 700. The user may move the slider 500 within the shield 400 by first pushing down (toward the shield 400) and pushing or pulling the button 700 in the desired direction. The slot 420 can prevent the slider 500 from moving in directions other than a direction longitudinally parallel to the length of the shroud 400 by restricting the movement of the handle 702 of the button 700 when the slider 500 is moved. The slot 420 also limits the total distance the slider 500 can move because the handle 702 can only move in the area of the slot 420. In some embodiments, the head 704 of the button 700 may have a plurality of ridges 705 on its surface to provide a better grip for the user when engaging the button 700.

As described above, such a safety scalpel 100 is configured to be able to extend/retract into the blade 600. For example, this general/intuitive action is similar to conventional carton cutting devices. In contrast to some conventional scalpels, in which the user must slide the guard 400 rearwardly to expose the blade 600 and even more inconveniently slide the guard 400 forwardly to consciously cover the blade 600, the scalpel 100 of the present invention is adapted to extend or retract the blade 600 by pushing the button 700 downwardly and then sliding it laterally along the guard 400.

The shield 400 may be attached to the handle 200 of the scalpel 100 by inserting the engaging portion 230 of the handle 200 through the first opening 407 of the shield 400. The shield 400 can slide along the engaging portion 230 until the end of the shield 400 abuts against the wall of the locking portion 220 of the handle 200, and the locking snap 410 engages the hole 240.

The shield 400 may be removed from the handle 200 by pulling the locking snap 410 out of the hole 240. This requires the use of forceps, proboscis forceps, or other similar tools. Once the locking snap 410 has been removed from the aperture 240, the shield 400 is removed, more integrally and to the cartridge assembly 300, by moving the shield 400 away from the grip portion 210 of the handle 200.

The slider catch end 424 can help lock the slider 500 in the extended position. The slider engagement end 424 secures the slider 500 in the extended position and prevents forces generated in the direction of the first end 404 when the scalpel is squeezed against an object from pushing the slider 500 or the blade support 500 back into the blade housing 300. The slider 500 is retracted by squeezing the button 700 to disengage it from the slider engagement end 424 and pulling the button 700 in the direction of the first end 404.

For added security, the slider 500 can be locked within the shield 400 to prevent inadvertent extension of the blade 600 when the cartridge assembly 300 is not yet mounted on the handle 200. As shown in fig. 1, the shroud 400 may include a slide lock aperture 450 located near the first end 404. On the other hand, the slider 500 includes a pair of legs, i.e., at least one front leg 510 and at least one rear leg 520. Rear leg 520 may include a pair of front feet 522 and 524 and a pair of rear feet 526 and 528. The rear legs 526 and 528 may be spring loaded and may be received in the locking apertures 450, and the locking apertures 450 may include one or more holes. As shown, the locking hole 450 may include two separate and distinct holes, each capable of receiving at least one of the rear legs 526 or 528. Because the rear feet 526 and 528 of the guard 500 are locked within the locking apertures of the guard 400, the slider 500, also with the blade 600, cannot move to extend from the guard 400 and, therefore, cannot cut the user once assembled.

As described, the blade 600 does not inadvertently protrude from the shield 400 when the cartridge assembly 300 is fully assembled, the fully assembled cartridge assembly 300 including the blade 600 carried by the slide 500. Referring to fig. 12, the blade 600 has: a blade tip 602, a cutting edge 604, and a slider aperture 606. The protruding member 504 of the slider 500 may be snapped into and thus received in the slider aperture 606 of the blade 600. The slider aperture 606 and the protruding member 504 are keyed to mate with each other. The slider 500 is then positioned within the pocket 402 of the shroud 400. The slider 500 with the blade 600 may be inserted into the second opening 409 on the second end 406 of the shroud 400.

Now, the button 700 may be connected to the slider 500. Referring to fig. 13A and 13B, the button 700 has a head 704 having a first surface 706 and a second surface 707. The head 704 may have a shank 702 extending from a first surface 706. The head 704 may also include a plurality of protuberances 705 on the second surface 707. The shank 702 may be inserted into the shank receiving aperture 506 of the slider 500. In some embodiments, the handle 702 may be heat staked to the slider 500. In such an embodiment, the heat stake hole 455 is disposed on a side of the shroud 400 opposite the slit 420. The heat required is applied through the heat stake hole 455 to bond the shank 702 of the button to the slider 500. The button 700 may slide along the slot 420 such that the slider 500 may be locked near the first end 404 of the shield 400. In this position, the rear legs 520 may be received within the locking apertures 450 of the shroud 400. The slider 500 may be locked within the shield 400 by engaging the rear legs 526 and 528 within the apertures 450 of the shield 400. As a result, unless the slider 500 is placed on the handle 200, the slider 500 cannot move and the blade 600 cannot extend from the guard 400.

When the cartridge assembly 300 is coupled to the handle 200, the slider 500 can be moved between an extended or engaged position where the blade 600 can be used, and a disengaged or secured position where the blade 600 is stored.

As described above, the cartridge assembly 300 may be fixed to the engaging portion 230 of the handle 200. The second end 202 of the handle 200 may be inserted into a first opening 407 located at the first end 406 of the shroud 400. The handle 200 includes a pair of ramps 232 along opposite sides of the engagement portion 230. The projecting member 502 of the slider 500 is sized to nest within the keyway 236 of the snap-fit portion 230. When the cartridge assembly 300 receives the engaging portion 230 of the handle 200, the protruding member 502 engages the key slot 236 and the rear leg 520 slides along the ramp 232. The first end 404 of the shield 400 receives the locking portion 220 of the handle 200 when the cartridge assembly 300 is secured to the handle 200 and the locking snap 410 is engaged with the aperture 240. The latch 220 is insertable into a first opening 407 of a portion of the first end 404 of the shroud 400. For example, the first opening 407 may have chamfered corners to engage with the locking portion 220. When the cartridge assembly 300 slides along the engaging portion 230 of the handle 200, the rear leg 520 of the slider 500 slides along the inclined surface 236. This causes the rear legs 520 to be pulled out of the locking holes 450 of the shield 400. Thus, when the button 700 is depressed, the slider 500 may slide within the guard 400, and the button 700 may slide along the slit 420 of the guard 400, eventually exposing and extending the blade 600.

When the button 700 is depressed, a bottom portion of a portion of the slider 500 can drop into the u-shaped cutout 234 of the catch 230 of the handle 200. The cutout 234 is sized and shaped to receive the necessary portion of the slider 500 to move the slider 500 along the engagement portion 230 of the handle 200.

The second opening 409 near the second end of the guard 400 may be configured to allow the slider 500 to extend the blade 600 in a direction out of the guard 400 when the user moves the button 700 in the direction in which the blade 600 extends.

In some embodiments, the blade 600 may be heat staked to the slider 500. That is, by applying heat energy, the blade 600 may be secured to the slider 500, firmly securing the blade 600 in place.

Fig. 14A and 14B illustrate perspective views of an exemplary embodiment of a slider 500 with a blade 600 attached thereto. Those skilled in the art will appreciate that the blade 600 may be made of a variety of suitable materials, including but not limited to carbon and stainless steel. Generally, the carbon and stainless steel used to make blade 600 are manufactured according to a number of industry standards, including British Standard (BS)2982:1992, International Standards Organization (ISO)7740:1985, and European Standard (EN)27740: 1992. The blade 600 may be sterilized using, for example, gamma radiation.

Fig. 1-6, 8A-9, and 15A-15B illustrate perspective views of an exemplary embodiment of a cartridge assembly 300. As described, the cartridge assembly 300 can include: a guard 400, a slider 500, and a blade 600. The cartridge assembly 300 can be attached to the handle 200 and can be easily removed for disposal and/or replacement. By inserting the second end 204 through the first opening 407, the cartridge assembly 300 can be securely mounted to the engagement portion 230 of the scalpel handle 200. The locking snap 410 can engage the aperture 240 to secure the cartridge assembly 300 to the handle 200 to prevent the cartridge assembly 300 from slipping off the handle 200 during use.

The slider 500 may be disposed within the shroud 300 between the engaging portion 230 of the scalpel handle 200 and the front sidewall of the shroud 300. When the user moves the button 700, the slider 500 may slide over the engaging portion 230.

The slider 500 may be retracted from the locked position by depressing the button 700 and pulling the button 700 toward the second end 406 of the shield 400. The scalpel 100 is designed to be stored and accessed with the slider 500 fully retracted. In this position, the blade 600 is completely covered by the guard 400 and the scalpel 100 is safe to handle because the sharp edge of the blade 600 is not exposed.

When the slider 500 is in the retracted position, the cartridge assembly 300 can be removed from the handle 200. This involves removing the locking snap 410 from the aperture 240.

Figure 15A is a perspective view of the cartridge assembly 300 prior to insertion of the handle 200. In particular, the spring-loaded rear feet 526, 528 are configured to prevent the blade 600 from protruding when the handle 200 is not inserted. In particular, the rear feet 526, 528 are locked within the slide lock apertures 450 proximate the first end 404 of the shroud 400. In this manner, the slider 500 with the blade 600 is locked within the guard 400 to prevent the blade 600 from inadvertently extending from within the guard 400 when the handle 200 is not installed. To unlock the slider, the rear legs 526, 528 may be pulled or lifted out of the apertures 450 by inserting the handle 200, as shown in FIG. 15B. Specifically, by inserting the handle 200, each ramp 232 raises the respective rear foot 526, 528. Once the handle 200 is inserted into the cartridge assembly 300, the locking snap 410 of the shield 400 engages the aperture 240 on the engagement portion of the handle 200 to prevent the cartridge assembly 300 from inadvertently slipping off after assembly to the handle 200. In other words, the hole 240 may receive the locking snap 410. The cartridge assembly 300 can be detached from the handle 200 by both hands and an external tool, for example, by using the external tool to pull the locking snap 410 out of the aperture 240. For example, the locking snap 410 can be pulled out of the aperture 240 by an unlocking tool adapted to unlock the snap lock or the locking snap to remove the cartridge assembly 300 from the handle 200. The unlocking tool may be a tweezers. The advantage of using only an external tool to remove the cartridge assembly 300 is: the cartridge assembly 300 can be prevented from being inadvertently detached from the handle 200 when an improper hand motion occurs while the scalpel 100 is in an operating state or during delivery. By requiring two hands to remove the cartridge assembly 300, i.e., one hand to hold the scalpel 100 and the other hand to use an external tool to pull the locking snap 410 out of the aperture 240, the risk of inadvertent removal of the cartridge assembly 300 is reduced.

Furthermore, in all of the above embodiments, the handle 200, and particularly the gripping surface, such as the gripping portion 210 of the handle 200, may be made of or coated with a non-slip material, such as rubber, to increase the friction between the hand and the gripping surface. For example, the grip portion 210 may be coated with an elastomer material. The handle 200 may be made of a metallic material. The blade guard, blade support and actuation member may be made of plastic, such as, but not limited to, a thermoplastic such as polycarbonate.

From the foregoing, it can be seen that the present invention is capable of providing a variety of cutting devices. The various embodiments of the present invention described above provide a safety scalpel having a handle for holding a cutting portion and a disposable cartridge assembly.

Embodiments of the present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. For example, although the embodiments of the present invention are described with reference to a scalpel used by a surgeon, the scope of the present invention is not limited to the illustrated embodiments.

Although the embodiments have been described in detail with reference to the accompanying drawings, it is to be understood that various changes and modifications may be made therein without departing from the scope of the invention.

Claims (26)

1. A safety scalpel, comprising:

a handle having a first end and a second end, and having a longitudinal axis extending between the first end and the second end, the handle comprising:

a grip portion extending from the first end to a lock portion, the lock portion being located between the first end and the second end; and

the clamping part extends from the second end to the locking part; and

a cartridge assembly removably and slidably mounted to the engagement portion of the handle substantially parallel to the longitudinal axis, the cartridge assembly comprising:

a blade guard having a first end, a second end, and a keying aperture defined proximate the first end, the blade guard defining a substantial pocket, wherein the blade guard is slidably mounted to the second end of the handle such that the blade guard covers the snap-fit portion and the first end of the blade guard snaps over the keying portion;

a blade holder slidably mounted in said pocket of said blade guard, said blade holder having at least one front leg and at least one rear leg, wherein said at least one rear leg has a pair of front legs and a pair of rear legs, and said pair of rear legs are spring loadable and receivable in said keying apertures of said blade guard;

a blade cooperatively assembled with said blade support such that said blade extends from or retracts into said second end of said blade guard when said blade support slides within said pocket of said blade guard; and

an actuation member attached to the blade support, wherein the actuation member is adapted to actuate the blade support to move a portion of the blade between an extended position outside the second end of the blade guard and a retracted position within the second end of the blade guard.

2. A safety scalpel as defined in claim 1 wherein said actuating member includes a handle portion insertable into a handle receiving aperture of said blade mount.

3. The safety scalpel of claim 1, the catch of the handle having a wall to limit the distance the cartridge assembly is slidably mounted on the handle.

4. The safety scalpel of claim 1, the grip portion of the handle comprising indicia.

5. The safety scalpel of claim 1, wherein the latch engages the first end of the blade guard and cooperates with the blade guard to substantially reduce wobble of the cartridge assembly relative to the handle.

6. The safety scalpel of claim 1, wherein the handle includes an anti-wobble pawl extending therefrom to engage the blade holder to substantially reduce wobble of the blade relative to the handle in the extended position.

7. The safety scalpel of claim 1, wherein the cartridge component comprises a locking snap disposed on a side of the blade guard, wherein the locking snap engages an aperture on the engagement portion of the handle to prevent the cartridge component from slipping off after being attached to the handle.

8. The safety scalpel of claim 7, wherein the cartridge assembly is detached from the handle by pulling the locking snap out of the aperture.

9. The safety scalpel of claim 1, wherein at least one side of the blade guard includes a grip portion, wherein the grip portion comprises a plurality of u-shaped cuts defined along a surface of the at least one side of the blade guard.

10. The safety scalpel of claim 1, further comprising a position indicator extending from at least one side of the blade guard, the position indicator providing a visual and tactile indication of the distance a user has cut into a patient's tissue.

11. The safety scalpel of claim 1, wherein the engaging portion of the handle is narrower and substantially thinner than the gripping portion of the handle to accommodate the cartridge assembly.

12. The safety scalpel of claim 1, wherein the handle is made of stainless steel.

13. A safety scalpel as defined in claim 1 wherein said blade is made of carbon, stainless steel or a combination thereof.

14. The safety scalpel of claim 1, wherein the blade guard, the blade support, and the actuation member are made of a polycarbonate material.

15. The safety scalpel of claim 1, wherein the cartridge assembly is disposable.

16. The safety scalpel of claim 1, wherein the handle further comprises a pair of ramps along opposite sides of the engaging portion, wherein the at least one rear leg of the blade support slides along the pair of ramps.

17. A safety scalpel, comprising:

a handle having a first end and a second end, and having a longitudinal axis extending between the first end and the second end; and

a cartridge component removably and slidably mounted along the longitudinal axis on at least a portion of the handle, the cartridge component comprising:

a blade guard having a first end, a second end, and a keying aperture defined proximate the first end, the blade guard defining a substantially hollow pocket, wherein the blade guard is slidably mounted to the second end of the handle;

a blade holder slidably mounted in said pocket of said blade guard, said blade holder having at least one front leg and at least one rear leg, wherein said at least one rear leg has a pair of front legs and a pair of rear legs, and said pair of rear legs are spring loadable and receivable in said keying apertures of said blade guard; and

a blade cooperatively assembled with said blade support such that said blade extends from or retracts into said second end of said blade guard when said blade support slides within said pocket of said blade guard.

18. A safety scalpel as defined in claim 17 wherein said cartridge assembly further includes an actuating member attached to said blade support, wherein said actuating member actuates said blade support to extend and retract said blade.

19. A safety scalpel as defined in claim 18 wherein said actuating member comprises a handle portion insertable into a handle receiving aperture of said blade mount.

20. The safety scalpel of claim 17, wherein the cartridge component comprises a locking snap disposed on a side of the blade guard, wherein the locking snap engages an aperture on the handle to prevent the cartridge component from slipping off after being attached to the handle.

21. The safety scalpel of claim 17, wherein at least one side of the blade guard includes a grip portion, wherein the grip portion includes a plurality of u-shaped cuts defined along a surface of the at least one side of the blade guard.

22. The safety scalpel of claim 17, further comprising a position indicator extending from at least one side of the blade guard, the position indicator providing a visual and tactile indication of the distance a user has cut into a patient's tissue.

23. The safety scalpel of claim 17, wherein the handle is made of stainless steel.

24. A safety scalpel as defined in claim 17 wherein said blade is made of carbon, stainless steel or a combination thereof.

25. The safety scalpel of claim 16, wherein the blade guard, the blade support, and the actuation member are made of a polycarbonate material.

26. The safety scalpel of claim 16, wherein the cartridge assembly is disposable.