# Patent

## Title
Limited-use medical device

## Abstract

A medical device including one or more components positioned to contact contaminants during use of the medical device. The one or more components including one or more limited-use portions transitionable upon use from an initial state, wherein the limited-use portion(s) exhibits a clean appearance, to a used state, wherein the limited-use portion(s) exhibits a contaminated appearance that visually indicates to a user that the at least one component is not further usable.

## Background
CROSS REFERENCE TO RELATED APPLICATION
The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/884,558, filed on Sep. 30, 2013, the entire contents of which are incorporated herein by reference.


BACKGROUND
Technical Field
The present disclosure relates to medical devices. More particularly, the present disclosure is directed to limited-use medical devices and medical devices including limited-use portions.
Background of the Related Art
Certain medical devices (or components thereof) are capable of being used multiple times, and are thus referred to as reusable devices (or reusable components), while other medical devices (or components thereof) are configured for single use, and are thus referred to as disposable devices (or disposable components). Many such reusable and disposable medical devices, and/or the components thereof, are designed for a pre-determined number of uses and/or for a pre-determined usage time. Use of these devices beyond their prescribed usage time or number of uses may result in failure of the device, damage to the device or surrounds, and/or injury to the patient or clinician. On the other hand, given the rising costs of performing medical procedures, clinician's have an incentive to maximize the reuse of medical devices (or components thereof).
SUMMARY
Like reference numerals may refer to similar or identical elements throughout the description of the figures. As shown in the drawings and described throughout the following description, as is traditional when referring to relative positioning on a surgical instrument, the term “proximal” refers to the end of the apparatus that is closer to the user and the term “distal” refers to the end of the apparatus that is farther away from the user. The term “clinician” refers to any medical professional (e.g., doctor, surgeon, nurse, or the like) performing a medical procedure. To the extent consistent, any of the aspects and features described herein may be used in conjunction with any or all of the other aspects and features described herein.
In accordance with an aspect of the present disclosure, a medical device may include at least one component positioned to contact contaminants during use of the medical device, the at least one component including at least one limited-use portion, the limited-use portion transitionable upon use from an initial state, wherein the limited-use portion exhibits a clean appearance, to a used state, wherein the limited-use portion exhibits a contaminated appearance that visually indicates to a user that the at least one component is not further usable.
In accordance with another aspect of the disclosure herein, the at least one component may be a jaw member of a surgical forceps.
In accordance with another aspect of the disclosure herein, the at least one component may be a disposable electrode assembly.
In accordance with another aspect of the disclosure herein, the disposable electrode assembly may be configured to conduct electrosurgical energy to tissue.
In accordance with another aspect of the disclosure herein, the at least one component may be a housing of an endoscopic medical device.
In accordance with another aspect of the disclosure herein, the at least one limited-use portion may be a contamination trap.
In accordance with another aspect of the disclosure herein, the contamination trap may include a plurality of grooves configured to trap bodily fluids and tissue remnants.
In accordance with another aspect of the disclosure herein, the contamination trap may have a window disposed thereon configured to allow a user to view contaminants within the contamination trap.
In accordance with another aspect of the disclosure herein, the contamination trap may include at least one indicator for indicating that the contamination trap is contaminated.
In accordance with another aspect of the disclosure herein, the at least one limited-use portion may be a color change material configured to exhibit a contaminated appearance in the used state.
In accordance with another aspect of the disclosure herein, the color change may be effected via contact of the at least one limited-use portion with at least one of blood, tissue, and fluids.
In accordance with another aspect of the disclosure herein, the color change material may be temperature-sensitive.
In accordance with another aspect of the disclosure herein, a method may include providing a medical device including at least one component, using the medical device to perform a surgical task, wherein, during use of the medical device, the at least one component comes into contact with contaminants, and visually displaying to a user an indication that the at least one component is not further usable after use of the medical device.
In accordance with another aspect of the disclosure herein, upon use of the medical device, at least one limited-use portion of the at least one component may be transitioned from an initial state, wherein the limited-use portion exhibits a clean appearance, to a used state, wherein the limited-use portion exhibits a contaminated appearance that visually indicates to the user that the at least one component is not further usable.
In accordance with another aspect of the disclosure herein, the at least one limited-use portion may be a contamination trap including a plurality of grooves configured to trap of bodily fluids and tissue remnants.
In accordance with another aspect of the disclosure herein, the contamination trap may have a window disposed thereon configured to allow a user to view contaminants within the contamination trap.
In accordance with another aspect of the disclosure herein, the contamination trap may include at least one indicator for indicating that the contamination trap is contaminated.
In accordance with another aspect of the disclosure herein, the at least one limited-use portion may be a color change material configured to exhibit a contaminated appearance in the used state.
In accordance with another aspect of the disclosure herein, the color change may be effected via contact of the at least one limited-use portion with at least one of blood, tissue, and fluids.



BRIEF DESCRIPTION OF THE DRAWINGS
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings, wherein:
FIG. 1 is a perspective view of a medical device provided in accordance with the present disclosure;
FIG. 2 is a perspective view of an end effector assembly provided in accordance with the present disclosure and configured for use with the medical device of FIG. 1;
FIG. 3A is a perspective view of another a medical device provided in accordance with the present disclosure, shown in an unused condition;
FIG. 3B is a perspective view of the medical device of FIG. 3A, shown in a used condition;
FIG. 4A is a perspective view of an end effector assembly provided in accordance with the present disclosure and configured for use with the medical device of FIG. 1, shown in an unused condition;
FIG. 4B is an perspective view of the end effector assembly of FIG. 4A, shown in a used condition;
FIG. 5A is an enlarged, side view of a limited-use portion provided in accordance with the present disclosure and configured for incorporation into any of the medical devices or end effector assemblies of FIGS. 1-4B;
FIG. 5B is an enlarged, cross-sectional view of the limited-use portion of FIG. 5A;
FIG. 6 is an enlarged, side view of another limited-use portion provided in accordance with the present disclosure and configured for incorporation into any of the medical devices or end effector assemblies of FIGS. 1-4B;
FIG. 7 is an enlarged, side view of another limited-use portion provided in accordance with the present disclosure and configured for incorporation into any of the medical devices or end effector assemblies of FIGS. 1-4B; and
FIG. 8 is a perspective, exploded view of another medical device provided in accordance with the present disclosure.



DETAILED DESCRIPTION
Particular embodiments of the present disclosure are described hereinbelow with reference to the accompanying drawings; however, the disclosed embodiments are merely examples of the disclosure and may be embodied in various forms. Well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present disclosure in virtually any appropriately detailed structure.
Referring now to FIG. 1, a forceps 10 for use in connection with endoscopic surgical procedures is shown, although forceps 10 may also be configured for use in connection with traditional open surgical procedures. Alternatively, the present disclosure may be embodied in any other suitable medical devices such as, but not limited to scissors, staplers, probes, syringes, and any other electrical, mechanical, or electromechanical medical devices.
Continuing with reference to FIG. 1, forceps 10 defines a longitudinal axis “A-A” and includes a housing 20, a handle assembly 30, a rotating assembly 70, a trigger assembly 80 and an end effector assembly 100. End effector assembly 100 includes first and second jaw members 110, 120, respectively, configured to pivot relative to one another between a spaced-apart position and an approximated position for grasping tissue therebetween. Forceps 10 further includes a shaft 12 having a distal end 14 configured to mechanically engage end effector assembly 100 and a proximal end 16 that mechanically engages housing 20. Forceps 10 also includes a cable 310 that connects forceps 10 to a generator (not shown) or other suitable power source, although forceps 10 may alternatively be configured as a battery powered instrument. Cable 310 includes wires extending therethrough and into housing 20 to ultimately connect the source of energy (not shown) to tissue-contacting surfaces 216, 226 (FIG. 2) of jaw members 110, 120, respectively, to conduct energy therebetween and through tissue grasped between jaw members 110, 120 to treat tissue. As disclosed above, the medical device is described herein as an electrosurgical forceps 10, however, the medical device may also be a mechanical forceps or other medical device or a device with electrical or moving parts.
With continued reference to FIG. 1, handle assembly 30 includes a fixed handle 50 and a moveable handle 40. Fixed handle 50 is integrally associated with housing 20 and handle 40 is moveable relative to fixed handle 50. Rotating assembly 70 is rotatable in either direction about a longitudinal axis “A-A” to rotate end effector assembly 100 about longitudinal axis “A-A.” The housing 20 houses the internal working components of the forceps 10.
Referring FIG. 2, end effector assembly 100 is shown attached at a distal end 14 of shaft 12 and includes a pair of opposing jaw members 110 and 120. Each of the first and second jaw members 110, 120 includes a fixed jaw frame 112, 122, respectively, and a replaceable component 210, 220, respectively, selectively engagable with the respective jaw frame 112, 122 to form the fully assembled jaw members 110, 120, respectively. However, jaw members 110, 120 of end effector assembly 100 may also be configured as integral components, e.g., wherein components 210, 220 are fixedly engaged or otherwise integrated with jaw frames 112, 122 of jaw members 110, 120, respectively.
End effector assembly 100 is designed as a unilateral assembly, i.e., where jaw member 120 is fixed relative to shaft 12 and jaw member 110 is moveable relative to both shaft 12 and fixed jaw member 120. However, end effector assembly 100 may alternatively be configured as a bilateral assembly, i.e., where both jaw member 110 and jaw member 120 are moveable relative to one another and with respect to shaft 12.
Each jaw member 110, 120 defines an electrically conductive tissue-contacting surface 216, 226 configured to connect to the energy source (not shown), e.g., via the wires of cable 310 (FIG. 1), for conducting energy therebetween and through tissue grasped between jaw members 110, 120 to treat tissue. In some embodiments, a knife assembly (not shown) is disposed within shaft 12 and a knife channel (not shown) is defined within one or both of jaw members 110, 120, respectively, to permit reciprocation of a knife blade (not shown) therethrough for mechanically cutting tissue grasped between jaw members 110, 120. In such an embodiment, trigger 82 of trigger assembly 80 (see FIG. 1) is operable to advance the knife blade (not shown) between a retracted position, wherein the knife blade (not shown) is disposed within shaft 12, and an extended position, wherein the knife blade (not shown) extends between jaw members 110, 120 to cut tissue grasped therebetween. End effector assembly 100 may also be adapted for electrical cutting via an electrical cutting insert 190 connected to the source of energy (not shown), e.g., via the wires of cable 310 (FIG. 1), thus obviating the need for a knife assembly (not shown). Further, end effector assembly 100 may be adapted for both mechanical cutting and electrical cutting, thus allowing a user to select a mode of operation best suited for the particular surgical procedure to be performed.
Referring again to FIG. 1, moveable handle 40 of handle assembly 30 is ultimately connected to a drive assembly (not explicitly shown) that, together, mechanically cooperate to impart movement of jaw members 110 and 120 between a spaced-apart position and an approximated position to grasp tissue between tissue-contacting surfaces 216 and 226 of jaw members 110, 120, respectively. As shown in FIG. 1, moveable handle 40 is initially spaced-apart from fixed handle 50 and, correspondingly, jaw members 110, 120 are disposed in the spaced-apart position. Moveable handle 40 is compressible from this initial position to a compressed position corresponding to the approximated position of jaw members 110, 120.
With reference generally to FIGS. 3A-8, various embodiments of medical devices, or components thereof, are shown including one or more limited-use portions. Generally, these limited-use portions are configured to alert the user that the device (or component thereof) is not to be used further or cannot be used further. The alert scheme may be a visual alert, a tactile alert, and audio alert, any other suitable alert scheme, or any combination thereof. For example, these limited-use portions may be configured for a single use such that, after performing a medical procedure, the medical devices incorporating such limited-use portions are noticeably contaminated or appear contaminated such that the user is alerted to perceived issues of reuse. Further, although the limited-use portions are described below as being incorporated into different components and/or features of particular example medical devices to inhibit reuse of these medical devices, it is contemplated that the limited-used portions be incorporated, attached, or otherwise coupled to any suitable component(s) of any suitable medical device for similar purposes.
As shown in FIGS. 3A and 3B, a forceps 300 similar to forceps 10 (FIG. 1) is shown including one or more limited-use portions 303. Limited-use portions 303 may be incorporated into outer or externally-disposed components or features of forceps 300. Incorporating limited-use portions 303 into the outer or externally-disposed components of forceps 300 is advantageous in that the externally-visible limited-use portions 303 provide the user with a clear visual indication that forceps 300 is contaminated (or appears contaminated) and should not be used. As discussed in more detail below, limited-use portions 303 may include any suitable contamination trap or indicator such as, but not limited to, blood (or other contamination) traps, blood (or other bodily or surgical fluid) sensitive materials, absorptive materials, etc.
With continued reference to FIGS. 3A and 3B, as mentioned above, forceps 300 is similar to forceps 10 (FIG. 1) and, thus, will not be described in detail herein for purposes of brevity. Limited-use portion 303 may be incorporated into, e.g., formed integrally with, disposed within, or otherwise attached or coupled to, housing 320, shaft 312, fixed handle 350, and/or any other suitable externally-disposed component of medical device 300.
In one embodiment, e.g., prior to use when forceps 300 is in a first state, as shown in FIG. 3A, limited-use portions 303 exhibit an initial appearance in which limited-use portions 303 substantially blend into the surrounding components of forceps 300 or otherwise appear as innocuous portions of forceps 300. As shown in FIG. 3B, after a prescribed use of forceps 300 wherein limited-use portions 303 come into contact with blood, contaminants, fluids, etc., one or more of the limited-use portions 303 are transitioned to a second state to exhibit a used appearance in which the limited-use portions 303 exhibit actual or perceived contamination, e.g., such that the limited-use portions 303 are visibly changed in color, state, appearance, configuration, and/or content, thereby indicating that forceps 300 should no longer be used.
While the above embodiment describes limited-use portion 303 being disposed on an outer surface of the medical device 300, it should be understood that limited-use portions 303 may also or alternatively be disposed on an interior portion of any suitable medical device that is exposed to contamination during use. For example, a compartment trap or oubliette may be formed on the inside of forceps 300 to trap blood or similar bodily fluids. Other embodiments of limited-use portions as described herein may also be employed internally. Particular embodiments of limited-use portions 303 configured to provide the appearance of contamination after use are described in detail below.
Referring to FIGS. 4A and 4B, an end effector assembly 400 similar to end effector assembly 100 (FIG. 1) and configured for use with forceps 10 (FIG. 1) is shown. As end effector assembly 400 is similar to end effector assembly 100 (FIG. 1), end effector 400 will not be described in detail herein for purposes of brevity. End effector assembly 400 may include one or more limited-use portions 403. Limited-use portions 403, which are included, integrated, or disposed within portions or components of end effector assembly 400, e.g., of either or both of jaw members 410, 420 or portions thereof, are configured such that, once used beyond a prescribed limit (such as, but not limited to, a set amount of uses and/or an amount of time being activated for use), the limited-use portions 403, and hence the end effector assembly 400, appear contaminated beyond a point of safe use, thus inhibiting or cautioning a user from further using end effector assembly 400. A dimension and/or configuration of limited use portions 403 may be modified to define the prescribed limit. Similarly, as described above with respect to forceps 300 (FIGS. 3A-3B), limited-use portions 403 are configured to transition from an first state (FIG. 4A) to a second state (FIG. 4B) after use, e.g., after contact with blood, contaminants, fluids, etc., such that the user is visually alerted to the fact that end effector assembly 400 should no longer be used.
Various embodiments of limited-use portions which may be incorporated into medical devices or components thereof, e.g., as limited-use portions 303, 403 (FIGS. 3A-3B and 4A-4B, respectively), are shown and described below with reference to FIGS. 5A-7. Other suitable configurations are also contemplated. In each of these embodiments, the limited-use portions are configured to trap contaminants, display trapped contaminants or provide an appearance of trapped contaminants, and/or transition to a different state upon contact with blood, tissue, tissue remnants, fluids, and/or any other contaminants or surgical materials encountered during typical use of a surgical device.
Referring to FIGS. 5A and 5B, an embodiment of a limited-use portion 500 including a contamination trap 503 is shown. Limited-use portion 500 includes contamination trap 503 that has grooves 505 for trapping tissue remnants, blood, and other bodily fluids encountered during surgery. The grooves 505 are suitably designed to make sterilization and cleaning exceedingly difficult and provide a clear visual indication of how contaminated the limited-use portion 500 has become after use, e.g., after a surgical procedure. The grooves 505 are simplified representations and do not indicate the only groove configuration disclosed herein. For example, grooves 505 may be misaligned, non-straight, curved, asymmetric, angled towards each other, a patterned feature, and/or walls that are specifically configured to make cleaning difficult.
Referring to FIG. 6, another limited-use portion 600 including a contamination trap 603 having a window 605 covering at least a portion of the contamination trap 603 is shown. Contamination trap 603 extends beyond window 605 on at least one side thereof to allow the passage of fluid and/or solid contaminants into trap 603 while inhibiting at least some fluid and/or solid contaminants from leaving contamination trap 603 once disposed therein. Window 605 allows the user to see into contamination trap 603, while sufficiently obscuring access to contamination trap 603 for cleaning or removal of contaminants. A window similar to window 605 may also be disposed about contamination trap 503 (FIGS. 5A-5B), for similar purposes.
Referring to FIG. 7, another limited-use portion 700 including a contamination trap 703 is shown. Contamination trap 703 includes a sponge-like or otherwise absorptive material configured to soak in contaminants. The sponge-like contamination trap 703 exhibits at least some of the contaminants absorbed therein while also being difficult to clean after contamination from a surgical procedure, thus visually alerting a user to the fact that the device incorporating limited-use portion 700 should no longer be used.
Referring to FIG. 8, another embodiment of a forceps 800 is shown having a removable electrode assembly 801 with a limited-use portion including a contamination trap 803 disposed thereon. Contamination trap 803 may be configured similar to any of the contamination traps described above. As shown in FIG. 8, the limited-use portion 803 is disposed on an upper portion of electrode 809 of electrode assembly 801 such that the limited-use portion 803 is at least partially sandwiched between jaw member 805 and electrode 809 when the disposable electrode assembly 801 is attached to the forceps 800. In such an embodiment, the contamination trap 803 becomes contaminated during use and forces the user to remove electrode assembly 801 from forceps 800 to attempt to clean contamination trap 803. As contamination trap 803 inhibits cleaning, the user would ultimately be inclined to discard electrode assembly 801 and provide a new electrode for use with forceps 800. Additionally or alternatively, electrode assembly 801 may be configured to break upon removal from the forceps 800, in which case, removing electrode assembly 801 in an attempt to clean contamination trap 803 will break electrode assembly 801 and substantially prohibit reuse of the electrode assembly 801.
As also shown in FIG. 8, a limited-use portion including a heat sensitive material, such as a plastic or polymer, which changes state (e.g., color) to indicate that the device has been used may also be provided. For example, flex joint 811, or electrode substrate 813 may include the heat sensitive material such that changes the appearance of flex joint 811 or substrate 813. Upon changing color, the flex joint 811 or substrate 813 may exhibit an appearance of contamination, e.g., flex joint 811 or substrate 813 or a portion thereof may turn the color of blood or exhibit a contaminant-like pattern. Other portions of the forceps 800 may also include similar features. Likewise, any of the other medical devices described herein or any other suitable medical device may include such features.
The limited-use portions of any or all of the above-described embodiments may also include a sterilization sensitive ink that reveals a message upon an attempt to sterilize the limited-use portion, or after use. For example, flex joint 811 may include a message such as “Do Not Use” that appears after a re-sterilization or use. Any suitable message may be written or engraved with sterilization cycle sensitive materials. Also, a blood-sensitive ink, bodily fluid-sensitive ink, tissue-sensitive ink, etc., may be used to discolor or re-pattern the limited-use portion to make the device appear to be contaminated inhibiting further use.
It should be understood that the foregoing description is only illustrative of the present disclosure. Various alternatives and modifications can be devised by those skilled in the art without departing from the disclosure. Accordingly, the present disclosure is intended to embrace all such alternatives, modifications and variances. The embodiments described with reference to the attached figures are presented only to demonstrate certain examples of the disclosure. Other elements, steps, methods and techniques that are insubstantially different from those described above and/or in the appended claims are also intended to be within the scope of the disclosure.

## Claims

1. A medical device, comprising:
at least one component configured to contact contaminants during use of the medical device; and
a first limited-use portion associated with the at least one component and configured to transition during use from a first state, wherein the first limited-use portion exhibits a clean appearance, to a second state, wherein the first limited-use portion exhibits a contaminated appearance that visually indicates to a user that the at least one component is not further usable, the first limited-use portion defining a cavity within the at least one component and including a transparent window covering a portion of the cavity to define an opening between the transparent window and an outer surface of the at least one component, the opening configured to allow passage of contaminants therethrough and into the cavity.

2. The medical device of claim 1, wherein the at least one component is a jaw member of a forceps.

3. The medical device of claim 1, wherein the at least one component is a disposable electrode assembly.

4. The medical device of claim 3, wherein the disposable electrode assembly is configured to conduct electrosurgical energy to tissue.

5. The medical device of claim 1, wherein the at least one component is a housing of an endoscopic medical device.

6. The medical device of claim 1, further comprising a second limited-use portion associated with the at least one component.

7. The medical device of claim 6, wherein the second limited-use portion includes a plurality of grooves configured to trap bodily fluids and tissue remnants.

8. The medical device of claim 1, further comprising a second limited-use portion having a color change material associated with the at least one component and configured to transition during use from a first state, wherein the second limited-use portion exhibits a first appearance, to a second state, wherein the second limited-use portion exhibits a second appearance that visually indicates to a user that the at least one component is not further usable.

9. The medical device of claim 8, wherein the color change material is configured to change color upon making contact with at least one of blood, tissue, or fluids.

10. The medical device of claim 8, wherein the color change material is temperature-sensitive such that the color change material changes color in response to a change in temperature.

11. The medical device of claim 1, wherein the transparent window is configured to prevent passage of fluids therethrough.

12. A method, comprising:
providing a medical device including at least one component;
using the medical device to perform a surgical task, wherein, during use of the medical device, a first limited-use portion associated with the at least one component comes into contact with contaminants such that the contaminants are captured within a cavity defined within the at least one component; and
viewing the contaminants captured within the cavity through a transparent window that partially covers the cavity thereby alerting a user that the at least one component is not further usable after use of the medical device,
wherein an opening is defined between the transparent window and an outer surface of the at least one component, and wherein the contaminants move into the cavity via the opening.

13. The method of claim 12, further comprising capturing the contaminants within a plurality of grooves defined in the at least one component, wherein the plurality of grooves is configured to trap bodily fluids and tissue remnants.

14. The method of claim 12, further comprising changing a color of a second limited-use portion associated with the at least one component by contacting the second limited-use portion with the contaminants.

15. The method of claim 12, wherein the transparent window is configured to prevent passage of fluids therethrough.