JP5140744B2 - Medical skin applicator device - Google Patents

Description

(background)
1. TECHNICAL FIELD The present disclosure relates generally to medical skin applicators, and more particularly to a skin applicator device adapted to uniformly and consistently dispense sterile fluid to a patient's skin surface.

2. Description of Related Technical Fields Many medical procedures provide the application of pharmaceuticals, sterilizing fluids, preservatives, gels, reagents or other materials to body parts such as skin for preparation, treatment, etc. including. Such medicaments, sterilizing fluids, and reagents are typically transferred to the skin via an applicator. Conventional liquid applicators incorporate a glass ampoule or plastic blown bottle for storing liquid and a mechanism for folding an ampoule for discharging stored liquid. The released liquid comes into contact with a cotton swab, foam pad or tip for application to the skin.

  However, many problems are encountered with this type of applicator. Folding glass ampoules creates debris in the applicator that can pose risks to the patient. Attempts to overcome these possible risks include devices that employ screens or foam to contain glass fragments. However, there is still the possibility of introducing these debris into the fluid pathway, which imposes unacceptable and unnecessary risks on the patient.

  Another drawback of the devices mentioned above is the permeation of certain gases through the bottle seal and bottle plastic. Ethylene oxide (EO) travels through most plastics (thickness 0.04 inches or less) at the thickness used for blow molded containers, and certain sterilized products, most notably chlorohexidine gluconate (CHG) ) Form a toxic by-product. Manufacturers have devised methods to eliminate permeation, such as by packaging in glass ampoules or by using a plastic with gas barrier properties such as polyethylene terephthalate (PET). PET greatly reduces permeation when a sufficient cross section is provided in the package; however, current devices employ blown containers in combination with conventional caps. Thus, these caps are the weakest part of these systems and are often due to caps that loosen due to inconsistent seals (PET / foil) or due to pressure applied during the EO sterilization process. Leak.

  The current devices mentioned above employ either glass or blow molded plastic containers with a thickness of 0.030 inches or less. This minimum thickness allows for significant permeation of EO through the container wall during sterilization. Furthermore, current devices that use blow molded containers during manufacture are picked at the opening or cut by a spindle and knife device. The result is a sharp and irregular top surface in the container, which is a problem when a seal is applied to the non-uniform surface and an irregular seal is formed.

  Furthermore, current container designs utilize a single welded inner seal as a means for sealing bottle contents. The size of the bottle cap and the force tightened on the bottle is therefore important for maintaining the force necessary to mechanically reinforce the foil over time. This cap looseness is a common failure, and often the bottle contents, especially when the system is pressurized or required to remain stored for a long time before use. Cause leakage.

Finally, current devices struggle to control the contained fluid due to their design.
Ampoule applicators rely on low density fluids less than 200 centipoise due to the small orifice associated with the ampoule after folding. Higher viscosity fluids do not flow easily from standard ampoule designs when inverted. These lower viscosity fluids, however, require metering in the applicator, especially when smaller (less than 4 square inches) sponges are used. Inevitably, these lower viscosity fluids, once dispensed to the patient's skin, result in a loss of fluid control, which is ignited due to the associated storage of alcohol in the surgical drape. Imposing unnecessary risks.

  An alternative embodiment attempts to address this problem by the addition of gel components in a preservative that results in a 100-fold (2,000 centipoise) increase in viscosity. These devices cannot move this fluid to the sponge dispensing means.

  Thus, it can flow easily under gravity (400-700 centipoise), thereby combining with absorbent members, for example sponge designs with sufficient fluid capacity such that there is little or no storage of preservative fluids It would be highly desirable to overcome this disadvantage of fluid control and viscosity associated with preservative-containing devices that eliminates the need for compression of the handling elements.

  Thus, including a fluid container having a penetrable surface that is engageable with the piercing member to facilitate fluid communication with the dispensing member of the skin applicator, thereby allowing preparation and treatment of the patient's skin surface. It may be desirable to overcome the disadvantages and disadvantages of the prior art associated with medical skin applicators. It would be desirable if the skin applicator could be placed in a transposed orientation during use. Such skin applicators can also accommodate multiple combinations of sterilants and applicator head designs. The skin applicator and its components can be highly desirable if they are efficiently manufactured and assembled.

(Summary)
According to a preferred embodiment of the present disclosure, a medical skin applicator device has a fluid chamber for storing a medicament and a penetrable wall that allows access to the fluid chamber and then the release of the medicament. A fluid chamber and an applicator coupled to the fluid housing. The applicator includes an applicator surface for applying the medicament to a patient. The applicator is adapted to penetrate a penetrable wall of the fluid housing in achieving a predetermined coupled relationship between the fluid housing and the applicator, thereby dispensing the medicament from the fluid chamber. And a penetrating member applied to the patient at the applicator surface. The fluid housing is adapted to move relative to the applicator from a first transition position to a second actuated position, causing penetration of the penetrating member with the penetrable wall, and its predetermined Establish a linked relationship.

  The fluid housing may include an end cap attached adjacent to the through wall. The end cap may preferably define an open inlet upon movement of the fluid housing to the actuated second position, the penetrating member passing through a penetrable wall of the fluid housing, and Allows to penetrate. The end cap may include at least one retaining member attached along its outer surface. The at least one retaining member is received in a locking recess associated with the applicator upon movement of the fluid housing to the second actuated position to hold the fluid housing in the second actuated position. To do. The at least one retaining member includes a locking tab that is received in a corresponding channel in the dispenser. The locking tab is adapted to traverse the channel during movement of the fluid housing to the second actuated position for receipt within the locking recess of the fluid housing. Additional means for holding the fluid housing in the second actuated position are envisioned.

  The applicator can include at least two penetrating members. The first penetrating member is dimensioned and positioned to penetrate the penetrable wall at a first position, allowing the medicament to exit the fluid chamber. The second penetrating member is dimensioned and positioned to penetrate the penetrable wall at a second position spaced from the first position, and allows air to enter the fluid chamber. to enable. In an alternative, the at least two penetrating members are adapted to divide the penetrable wall into a plurality of wall portions. The at least two penetrating members may be arranged in a spaced relationship coaxially about the axis. Four penetrating members are provided to divide the penetrable wall into quadrant portions. In a further alternative, the penetrating members are arranged in an annular array, for example, a plurality of penetrating members forming a substantially annular opening in the penetrable wall.

  In one preferred embodiment, at least one of the fluid housing and the applicator includes an internal member. The inner member is positioned to engage a wall portion defined within the penetrable wall opening and causes the wall portion to move during movement of the fluid housing to the second actuated position. replace. This internal member is an internal wall in the fluid housing. The inner wall extends generally longitudinally and is positioned to rotate the wall portion of the penetrable wall during movement of the fluid housing to the second actuated position. Preferably, an internal wall is included in the applicator. The inner wall extends generally longitudinally and within the annular array and is positioned to cooperate with the inner wall of the fluid housing to rotate the penetrable wall.

  The applicator includes an applicator frame and an absorbent member attached to the lower surface of the applicator frame. The replicator includes a relatively enlarged section and a relatively narrow probe that depends from the enlarged section. The probe section includes opposing generally concave surfaces extending to the leading surface, the leading surface interconnecting with the concave surface. This leading surface is preferably generally arcuate. The enlarged section includes opposing generally convex surfaces extending from a subsequent surface that interconnects the convex surfaces. Alternatively, the applicator defines a complex curve shape in the plane. The composite curve configuration includes a pair of opposing generally convex surfaces and a pair of opposing generally concave surfaces that extend continuously from the convex surface to the leading surface.

  The fluid housing is preferably adapted for longitudinal movement to move from the first transition position to the second actuated position. The fluid housing may also be adapted for rotational movement relative to the applicator to open the fluid housing, allowing its movement toward the second actuated position. One of the fluid housing and the applicator may include a locking tab, and the other of the fluid housing and the applicator includes a locking recess for cooperating with the locking tab, and the fluid housing and the applicator are connected to the second Selectively lock in the actuated position.

  An outer housing may be provided for at least partially housing the fluid housing. The outer housing can be attached to the applicator. The fluid housing is adapted for longitudinal movement within the outer housing. A manually engageable member is coupled to the fluid housing and extends beyond the outer housing. This manually engageable member is depressible and causes longitudinal movement of the fluid housing to the second actuated position. The manually engageable member may include a locking member that is received in a corresponding locking recess in the outer housing and releasably holds the fluid housing in the first transition position. The lock member of the manually engageable member may include a bendable tab. The bendable tab is movable from the locking recess and releases the manually engageable member and allows the fluid housing to move to the second position. Means are also provided for securing the fluid housing in the second position. In one arrangement, the outer housing includes a locking recess adapted to receive the bendable tab to secure the fluid housing in the second position.

  In another preferred embodiment, the manually engageable member includes a locking tab removably attached thereto. The locking tab selectively secures the fluid housing in a first transition position and allows the manually engageable member to be advanced to move the fluid housing to the second actuated position. Allow.

  In another preferred embodiment, the applicator frame of the applicator includes a conduit for passage of the medicament from the fluid chamber to the absorbent member. The applicator frame includes a plurality of channels in communication with the conduit on its lower surface. The channels are dimensioned to carry fluid along the lower surface and to the absorbent member. The applicator frame may include a plurality of arcuate channels defined in its lower surface and communicating within the conduit to convey fluid to the absorbent member. At least two of these arcuate channels are in a substantially concentric arrangement. Alternatively, the channels of the applicator frame are in a crossing relationship. These channels can define a generally grid pattern on the lower surface of the applicator frame. As a further alternative, the applicator frame includes first and second substantially in its lower surfaces and in communication with a conduit for conveying fluid to the absorbent member. Includes straight channels.

  The applicator frame includes an enlarged opening extending through its lower surface and in communication with the conduit. This opening is for conveying the fluid to the absorbing member. An auxiliary channel can be adjacent to the enlarged opening and in communication with the conduit. This auxiliary channel facilitates the dispensing of the medicament. Preferably, the first and second auxiliary channels are adjacent to the front and rear ends of the applicator frame and are in communication with a conduit for facilitating dispensing of the medicinal fluid. This first and / or second channel may serve as an outlet for the release of air trapped within the absorbent member.

  The absorbent member may include at least one slit defined therein. The at least one slit is substantially open to allow passage of the medicament upon application of pressure to the absorbent member and is substantially closed in the absence of pressure on the absorbent member. And is adapted to substantially prevent the medicament from passing therethrough. Preferably, the absorbing member includes a plurality of spaced slits. Alternatively, the absorbent member includes a recessed channel defined in its lower surface, the channel being adapted to facilitate the passage of the medicament therethrough.

  The penetrable wall may include one of a metal and a polymer member coupled to the fluid housing. Preferably, the penetrable wall includes a foil backing, which is attached to the fluid housing. The foil backing can be attached to the fluid housing and the end cap.

  In one preferred embodiment, the outer housing and the fluid housing are arranged about a first major axis and the applicator is in a direction perpendicular to the applicator surface from the first major axis. Arranged around a second major axis that has been transposed to.

  A dye may be positioned with respect to the fluid housing. The dye contacts the medicament upon release of the medicament from the internal chamber of the fluid housing. The dye may be stored in the fluid housing in an isolated relationship from the medicament, whereby the penetrating member penetrates the penetrable wall upon movement to the second actuated position, Allow release of the medicament and its contact with the dye. The fluid housing includes a second penetrable wall in a distal direction of the first penetrable wall and has a dye stored therebetween, whereby the first of the fluid housing. Upon movement to the two actuated positions, the penetrating member penetrates the first penetrable wall and the second penetrable wall, allowing individual release of the medicament and the dye.

  In another preferred embodiment, a medical skin applicator device defines a longitudinal axis and has a fluid housing having a fluid chamber for storing and selectively releasing a medicament, and coupled to the fluid housing Includes applicator. The applicator includes an applicator surface that is in fluid communication with the fluid chamber to deliver the medication to a patient. The applicator surface defines a form characterized by having a relatively enlarged portion and a relatively narrow portion extending from the enlarged portion. The relatively narrowed portion includes opposing generally concave surfaces that extend to the leading surface, which leads the interconnecting concave surfaces. This leading surface can be generally arcuate. The enlarged section includes opposing generally convex surfaces extending from the trailing surface, the trailing surface interconnecting the convex surfaces. In the alternative, the applicator defines a compound curve configuration in a plane. The composite curve configuration includes a pair of opposing generally convex surfaces and a pair of opposing generally concave surfaces that extend continuously from the convex surface to the leading surface.

A method of using a medical skin applicator device is also disclosed. The method includes providing a fluid housing defining a fluid chamber, and an applicator having an applicator member for dispensing fluid, and operating the applicator with one hand to provide fluid between the chamber and the applicator member. Including a step of promoting communication.
More specifically, the present invention can relate to the following items.
(Item 1)
A medical skin applicator device comprising:
A fluid housing having a fluid chamber for storing a medicament, the fluid housing having penetrable walls, allowing access to the fluid chamber and then the release of the medicament; and coupled to the fluid housing An applicator comprising an applicator surface for applying the medicament to a patient and penetrating a pierceable wall of the fluid housing in achieving a predetermined coupled relationship between the fluid housing and the applicator A medical skin applicator device comprising: an applicator having a penetrating member adapted to be dispensed from the fluid chamber and applied to the patient at the applicator surface.
(Item 2)
The fluid housing is adapted to move relative to the applicator from a first transition position to a second actuated position, causing penetration of the penetrating member with the penetrable wall, and its predetermined Item 2. The medical skin applicator device of item 1, establishing a linked relationship.
(Item 3)
Item 3. The medical skin applicator device of item 2, wherein the fluid housing includes an end cap attached adjacent to the through wall.
(Item 4)
The end cap defines an open inlet upon movement of the fluid housing to the actuated second position, allowing the penetrating member to pass through and penetrate the penetrable wall of the fluid housing. 4. The medical skin applicator device according to item 3, enabling.
(Item 5)
The end cap includes at least one retaining member attached along an outer surface thereof, the at least one retaining member upon movement of the fluid housing to the second actuated position. 5. The medical skin applicator device of item 4, wherein the medical skin applicator device is received in a lock recess associated therewith to hold the fluid housing in the second activated position.
(Item 6)
The at least one retaining member includes a locking tab, the locking tab is received in a corresponding channel in the dispenser, and the fluid into the second activated position for reception in the locking recess of the fluid housing. Item 6. The medical skin applicator device of item 5, adapted to traverse the channel during movement of the housing.
(Item 7)
Item 3. The medical skin applicator device of item 2, comprising means for holding the fluid housing in the second activated position.
(Item 8)
Item 3. The medical skin applicator device of item 2, wherein the applicator includes at least two penetrating members.
(Item 9)
A first penetrating member of the at least two penetrating members is dimensioned and positioned to penetrate the penetrable wall at a first position to allow the medicament to exit the fluid chamber. And the second penetrating member of the at least two penetrating members is dimensioned and positioned to penetrate the penetrable wall at a second position, allowing air to enter the fluid chamber. The medical skin applicator device according to item 8, wherein
(Item 10)
9. The medical skin applicator device of item 8, wherein the at least two penetrating members are adapted to divide the penetrable wall into a plurality of wall portions.
(Item 11)
Item 11. The medical skin applicator device of item 10, comprising four penetrating members adapted to divide the penetrable wall into quadrant portions.
(Item 12)
Item 11. The medical skin applicator device of item 10, wherein the at least two penetrating members are coaxially arranged about the axis and are in a spaced relationship.
(Item 13)
Item 3. The medical skin applicator device of item 2, wherein the penetrating members are arranged in an annular array to form a substantially annular opening in the penetrable wall.
(Item 14)
14. The medical skin applicator device of item 13, comprising a plurality of penetrating members arranged in the annular array.
(Item 15)
At least one of the fluid housing and the applicator includes an inner member, the inner member positioned to engage a wall portion defined within the penetrable wall opening, and the second of the fluid housing. 14. The medical skin applicator device of item 13, wherein the wall portion is replaced during movement of the device to an activated position.
(Item 16)
The inner member is an inner wall within the fluid housing, the inner wall extends generally longitudinally, and the penetrable wall during movement of the fluid housing to the second actuated position. Item 16. The medical skin applicator device of item 15, positioned to rotate the wall portion of the device.
(Item 17)
An internal wall is included in the applicator, the internal wall extends generally longitudinally and within the annular array, and is positioned to cooperate with the internal wall of the fluid housing to rotate the penetrable wall. Item 17. The medical skin applicator device according to Item 16.
(Item 18)
Item 3. The medical skin applicator device of item 2, wherein the applicator includes an applicator frame and an absorbent member attached to a lower surface of the applicator frame.
(Item 19)
19. A medical skin applicator device according to item 18, wherein the applicator includes a relatively enlarged section and a relatively narrow probe depending from the enlarged section.
(Item 20)
20. A medical skin applicator device according to item 19, wherein the prosection includes opposing generally concave surfaces extending to a leading surface, the leading surface interconnecting with the concave surface.
(Item 21)
Item 21. The medical skin applicator device of item 20, wherein the leading surface is generally arcuate.
(Item 22)
20. The medical skin applicator device of item 19, wherein the enlarged section includes opposing generally convex surfaces extending from a trailing surface, the trailing surface interconnecting the convex surfaces.
(Item 23)
The applicator defines a composite curve form in a plane, the composite curve form being a pair of opposing substantially convex surfaces, and a pair of opposing substantially concave shapes extending continuously from the convex surface to the leading surface. Item 19. The medical skin applicator device of item 18, comprising the surface of:
(Item 24)
Item 3. The medical skin applicator device of item 2, wherein the fluid housing is adapted for longitudinal movement such that the fluid housing moves from the first transition position to the second actuated position.
(Item 25)
25. The medical device of item 24, wherein the fluid housing is adapted for rotational movement relative to the applicator to open the fluid housing and allows its movement toward the second actuated position. Skin applicator device.
(Item 26)
One of the fluid housing and the applicator includes a locking tab, and the other of the fluid housing and the applicator includes a locking recess for cooperating with the locking tab, and the fluid housing and the applicator are second actuated. 25. The medical skin applicator device of item 24, which selectively locks in place.
(Item 27)
25. The medical skin applicator device of item 24, further comprising an outer housing for at least partially containing the fluid housing, wherein the outer housing is attachable to the applicator.
(Item 28)
28. The medical skin applicator device of item 27, wherein the fluid housing is adapted for longitudinal movement within the outer housing.
(Item 29)
A manually engageable member coupled to the fluid housing and extending beyond the outer housing, wherein the manually engageable member is depressible and the second actuated member of the fluid housing 29. The medical skin applicator device of item 28, causing a longitudinal movement to a position.
(Item 30)
The manually engageable member includes a locking member, the locking member being received in a corresponding locking recess in the outer housing, releasably holding the fluid housing in the first transition position; 29. A medical skin applicator device according to 29.
(Item 31)
The lock member of the manually engageable member includes a bendable tab, the bendable tab being movable from the lock recess to release the manually engageable member and the fluid 31. The medical skin applicator device of item 30, which allows movement of the housing to its second position.
(Item 32)
32. The medical skin applicator device of item 31, comprising means for securing the fluid housing in the second position.
(Item 33)
Item 33. The medical skin applicator device of item 32, wherein the outer housing includes a locking recess adapted to receive the bendable tab to secure the fluid housing in the second position.
(Item 34)
Item 17. The medical skin applicator device of item 16, wherein the applicator frame includes a conduit for passage of the medicament from the fluid chamber to the absorbent member.
(Item 35)
35. The item 34, wherein the applicator frame includes a plurality of channels in communication with the conduit on its lower surface, the channels for conveying fluid along the lower surface and to the absorbent member. Medical skin applicator device.
(Item 36)
36. The medical skin applicator device of item 35, wherein the applicator frame includes a plurality of arcuate channels defined in its lower surface and communicating within the conduit to convey fluid to the absorbent member.
(Item 37)
40. The medical skin applicator device of item 36, wherein at least two of the arcuate channels are in a substantially concentric arrangement.
(Item 38)
36. The medical skin applicator device of item 35, wherein the channels of the applicator frame are in an intersecting relationship.
(Item 39)
39. The medical skin applicator device of item 38, wherein the channel defines a generally lattice pattern on the lower surface of the applicator frame.
(Item 40)
First and second substantially straight channels in the lower surface of the applicator frame and in communication with a conduit for conveying fluid to the absorbent member. 40. The medical skin applicator device of item 38, comprising:
(Item 41)
37. The medical skin applicator device of item 36, wherein the applicator frame includes a plurality of arcuate channels in its lower surface and in communication with the linear channels.
(Item 42)
35. The item 34, wherein the applicator frame includes an enlarged opening extending through its lower surface and in communication with the conduit, the opening being for conveying fluid to the absorbent member. Medical skin applicator device.
(Item 43)
43. The medical skin applicator device of item 42, wherein the applicator frame includes an auxiliary channel adjacent to the enlarged opening and in communication with the conduit, the auxiliary channel facilitating dispensing of the medicament. .
(Item 44)
44. The medical device of item 43, comprising first and second auxiliary channels adjacent to the front and rear ends of the applicator frame and in communication with a conduit for facilitating dispensing of the medicinal fluid. Skin applicator device.
(Item 45)
Item 17. The medical skin applicator device of item 16, wherein the absorbent member includes at least one slit defined therein.
(Item 46)
The at least one slit is substantially open when pressure is applied to the absorbent member to allow passage of the medicament and is substantially closed in the absence of pressure on the absorbent member. 46. The medical skin applicator device of item 45, adapted to substantially prevent the medication from passing therethrough.
(Item 47)
Item 47. The medical skin applicator device of item 46, wherein the absorbent member includes a plurality of spaced slits.
(Item 48)
Item 17. The medical skin applicator device of item 16, wherein the absorbent member includes a recessed channel defined in a lower surface thereof, the channel being adapted to facilitate passage of the medicament therethrough.
(Item 49)
Item 3. The medical skin applicator device of item 2, wherein the penetrable wall comprises one of a metal and a polymer member connected to the fluid housing.
(Item 50)
50. The medical skin applicator device of item 49, wherein the penetrable wall includes a foil backing, and the foil backing is attached to the fluid housing.
(Item 51)
Item 5. The medical skin applicator device of item 4, wherein the penetrable wall includes a foil backing, and the foil backing is attached to the fluid housing.
(Item 52)
52. The medical skin applicator device of item 51, wherein the foil backing is attached to the fluid housing and the end cap.
(Item 53)
A second longitudinal axis wherein the fluid housing is arranged about a first longitudinal axis and the applicator is transposed from the first longitudinal axis in a direction perpendicular to the surface of the applicator; 2. The medical skin applicator device according to item 1, arranged around.
(Item 54)
54. The medical skin applicator device of item 53, wherein the first axis of the fluid housing is substantially parallel to the second axis of the applicator.
(Item 55)
Item 3. The medical skin applicator device of item 2, wherein the fluid housing is compressible.
(Item 56)
Item 3. The medical skin applicator device of item 2, comprising a pigment positioned with respect to the fluid housing, wherein the pigment contacts the medication upon release of the medication from an internal chamber of the fluid housing.
(Item 57)
The dye is stored in the fluid housing in a segregated relationship with the medicament, whereby the penetrating member penetrates the penetrable wall upon movement to the second actuated position, and the medicament 57. A medical skin applicator device according to item 56, which permits release of and a contact with said pigment.
(Item 58)
The fluid housing includes a second penetrable wall distally of the first penetrable wall and has a dye stored therebetween, whereby the first of the fluid housing. The penetrating member through the first penetrable wall and the second penetrable wall upon movement to the two actuated positions, allowing individual release of the medicament and the dye. 58. A medical skin applicator device according to 57.
(Item 59)
The manually engageable member includes a lock tab removably attached thereto, the lock tab selectively securing the fluid housing in a first transition position, and the manually engageable member 30. The medical skin applicator device of item 29, wherein the device is advanced to allow the fluid housing to move to the second actuated position.
(Item 60)
A medical skin applicator device comprising:
A fluid housing defining a longitudinal axis and having a fluid chamber for storing and selectively releasing medication; and an applicator coupled to the fluid housing for delivering the medication to a patient An applicator that includes an applicator surface in fluid communication with the fluid chamber, the applicator surface defining an asymmetric configuration characterized by having a relatively enlarged portion and a relatively narrow portion extending from the enlarged portion A medical skin applicator device.
(Item 61)
41. The medical skin applicator device of item 40, wherein the relatively narrowed portion includes opposing generally concave surfaces extending to the leading surface, the leading surface interconnecting the concave surfaces.
(Item 62)
62. The medical skin applicator device of item 61, wherein the leading surface is generally arcuate.
(Item 63)
61. The medical skin applicator device of item 60, wherein the enlarged section includes opposing generally convex surfaces extending from a trailing surface, the trailing surface interconnecting the convex surfaces.
(Item 64)
The applicator defines a complex curve configuration in a plane, the compound curve configuration is a pair of opposing generally convex surfaces, and a pair of opposing generally concave shapes extending continuously from the convex surface to the leading surface. 61. The medical skin applicator device of item 60, comprising the surface of
(Item 65)
A method of using a medical skin applicator device comprising:
Providing an applicator having a fluid housing defining a fluid chamber and an applicator member for dispensing the fluid; and actuating the applicator with one hand to facilitate fluid communication between the chamber and the applicator member Comprising the steps of:

The objects and features of the disclosure are particularly set forth in the appended claims. The present disclosure, together with further objects and advantages, both in terms of its construction and mode of operation, may be best understood by reference to the following description, taken in conjunction with the accompanying drawings presented below.
FIG. 1 is a perspective view of a medical skin applicator according to the principles of the present disclosure showing a fluid container assembly and an applicator head assembly. FIG. 2 is an exploded perspective view of the skin applicator device of FIG. FIG. 3 is a side view of the skin applicator showing the fluid container assembly in a first transition position. FIG. 4 is a side cross-sectional view of the skin applicator device. FIG. 5 is an enlarged perspective view showing the end cap attached to the fluid housing of the fluid container assembly. FIG. 6 is an enlarged side view showing the locking tab of the end cap mounted in the axial channel of the applicator head assembly. FIG. 7 is a perspective view showing attachment of an end cap in the applicator frame of the applicator head assembly. FIG. 8 is an enlarged perspective view of a cross section showing the relationship between the end cap of the applicator head assembly and the penetrating member. FIG. 9 is a plan view showing the lower surface of the applicator frame of the applicator head assembly. FIG. 10 is a plan view showing the form of the applicator member of the applicator head assembly. FIG. 11 is a side view similar to the view of FIG. 3 showing the fluid container assembly in a second actuated position. FIG. 12 is a view similar to that of FIG. 6 showing the locking tab of the end cap secured within the locking recess of the applicator head assembly when the fluid container assembly is in the second actuated position. FIG. 13 is a view similar to the view of FIG. 8 showing the penetrating member through the end cap when the fluid container assembly is in the second actuated position. FIG. 14 is a perspective view of the fluid container assembly showing the drainage aperture formed in the backing in the end cap when in the second actuated position. FIG. 15 is a perspective view of another embodiment of a skin applicator device of the present disclosure. 16 is an exploded perspective view of the skin applicator device of FIG. FIG. 17 is a side view of the skin applicator device of FIG. 15 showing the fluid housing assembly in its first transition position. FIG. 18 is a cross-sectional side view of the skin applicator device in the first transition position. FIG. 19 is a perspective view of the end cap. FIG. 20 is a plan view of the bottom of the applicator frame of the applicator head assembly. FIG. 21 is a side view similar to the view of FIG. 17 showing the fluid housing assembly in its second actuated position. FIG. 22 is a side view of another alternative embodiment of the skin applicator device of the present disclosure. 23 is an exploded view of the skin applicator device of FIG. FIG. 24 is a side view of the skin applicator device in the second actuated position. FIG. 25 is a side view of another alternative embodiment of the skin applicator device of the present disclosure showing the fluid housing in a first transition position. FIG. 26 is an exploded perspective view of the skin applicator device of FIG. FIG. 27 is a side view showing rotation of the fluid housing to release the fluid housing from the first transition position. FIG. 28 is a side view of the skin applicator device showing the fluid housing in a second actuated position. FIG. 29 is a perspective view of another alternative embodiment of the skin applicator device of the present disclosure. 30 is a side view of the skin applicator device of FIG. 29 showing the fluid container assembly in a first transition position. FIG. 31 is an exploded perspective view of the skin applicator device of FIG. FIG. 32 is a cross-sectional side view of the proximal end of the skin applicator device showing the relationship of the lock lever and release lever of the outer housing and housing extension. FIG. 33 is a side cross-sectional view of the distal end of the applicator device. FIG. 34 is a side view of the fluid housing and end cap. FIG. 35 is an axial view of the fluid housing and end cap. FIG. 36 is a cross-sectional perspective view of the applicator frame and absorbent member of the applicator head assembly. FIG. 37 is a further perspective view of the applicator frame. FIG. 38 is a further perspective view of the applicator frame. FIG. 39 is a plan view of the bottom of the applicator device. FIG. 40 is a side cross-sectional view similar to the view of FIG. 32 showing the release of the lock lever and the movement of the housing extension and fluid housing to the second actuated position. FIG. 41 is a side cross-sectional view similar to the view of FIG. 33, showing the relationship of the components after movement to the second actuated position. 42 is a perspective view of the fluid housing and backing after movement to the second actuated position. FIG. 43 is an enlarged perspective view of the penetrated backing. FIG. 44 is a side view of another alternative embodiment of the skin applicator device of the present disclosure. FIG. 45 is a side cross-sectional view showing the fluid housing in the first transition position. FIG. 46 is a side cross-sectional view showing the fluid housing in a second actuated position. FIG. 47 is a perspective view of another alternative embodiment of a skin applicator device of the present disclosure. FIG. 48 is a side cross-sectional view of the skin applicator device of FIG. FIG. 49 is a partial side cross-sectional view of another embodiment of a skin applicator device of the present disclosure. 50 is an exploded perspective view of the skin applicator device of FIG. 49. FIG. 51 is a partial cross-sectional perspective view of another embodiment of a skin applicator device of the present disclosure. FIG. FIG. 52 is a perspective view of an alternative embodiment of a skin applicator device of the present disclosure, wherein the applicator frame has a circular array of penetrating members. 53 is a side cross-sectional view of the skin applicator device of FIG. 52 in its first transition position. FIG. 54 is a side cross-sectional view of the skin applicator device in the second actuated position. FIG. 55 is a side view of another alternative embodiment of the skin applicator device of the present disclosure. 56 is an exploded perspective view of the skin applicator device of FIG. 55. FIG. 57 is another plan view of the skin applicator device of FIG. 55. FIG. 58 is a perspective view of the skin applicator device of FIG. 55. FIG.

(Detailed description of embodiment)
Medical skin applicator device and exemplary embodiments of its use are employed during medical procedures involving the application of sterile fluids, gels or reagents to the skin of the body for preparation, treatment, etc. Will be discussed. The skin applicator device is advantageously configured to facilitate fluid communication of a sterilizing fluid with the skin contact member or dispensing member of the skin applicator device, thereby preparing and preparing the patient's skin surface. Allow treatment. It is envisioned that the skin applicator device may be employed in a range of medical procedures such as, for example, surgery, diagnosis of patient and body conditions and associated procedures. It is further envisioned that the principles relating to the disclosed skin applicator device include the application of various drugs to the body, such as, for example, pharmaceuticals and other fluids.

  In the discussion that follows, the term “proximal” refers to the portion of the structure that is closer to the practitioner, while the term “distal” refers to the portion that is further from the practitioner or user. As used herein, the term “subject” refers to a human patient or other animal. According to the present disclosure, the term “practitioner” or “user” typically refers to a doctor, nurse or other care provider, and may include support personnel.

  The following discussion includes a description of various embodiments of a skin applicator device according to the principles of the present disclosure, followed by a description of the use of the device.

  Reference is now made to the drawings, wherein like components are designated by like reference throughout the several views, and FIGS. 1-3 are combined with the cross-sectional view of FIG. 1 shows a skin applicator device for use. The apparatus 100 includes two main assemblies: a fluid container assembly 102 and an applicator head assembly 104 coupled to the fluid container assembly 102. In general, the fluid container assembly 102 is adapted for movement relative to the applicator head assembly 104 from a first transition position to a second actuated position to separate medication or fluid for application to a patient. Give. The fluid container assembly 102 includes a fluid housing 106 that defines a housing axis “X” and an end cap 108 that is removably attachable to the fluid housing 106. The fluid housing 106 defines an internal chamber 106a (FIG. 4) that is filled with medication, cleaning solution, and the like. Such medicaments include antiseptic solutions in liquid or gel form, sterile solutions and the like. One suitable sterilizing fluid is a sterilized liquid manufactured by Applied, Branford CT and made under the trade name Excel-AP. This liquid contains, among other suitable ingredients, 7.5% w / w available iodine, 64.5% w / w isopropanol, and 25.3% USP sterile water.

  The fluid housing 106 further defines a handle section 110, a cylindrical section 110 and a nipple section 114. The handle section 110 has a lower surface decorated with scallops to facilitate gripping engagement by the user, particularly with one hand of the user. The cylindrical section 112 includes an outer peripheral rib 116 that is defined at the connection between the cylindrical section 112 and the handle section 110. The peripheral edge 116 serves as a stop to properly position the fluid container assembly 102 relative to the applicator head assembly 104 during operation of the device 100. The nipple section 114 takes in an external screw 118.

  The fluid housing 106, in particular the handle section 110, can be made from a suitable flexible material, allowing the handle section 110 to be compressed to expel fluid. In one preferred embodiment, the fluid housing 106 is fabricated from a suitable polymer material, such as polypropylene, and is manufactured via conventional injection molding techniques. Other elastomeric materials are also envisioned.

  The fluid housing 106 also includes a penetrable wall or surface coupled to the distal end surface of the nipple section 114, for example in the form of a seal or backing 120. The backing 120 can be malleable or can be a polymeric material and is attached to the fluid housing 106 after the housing 106 has been filled with a pharmaceutical fluid. In one preferred embodiment, the backing 120 is a foil backing that is inductively sealed to the nipple 114 of the fluid housing 106. In the alternative, the backing 120 can be secured within the end cap 108 and fits the seal nipple 114 when the end cap 108 is attached to the fluid housing 106. The backing 120 may also be a double ply with one ply attached to the end cap 108 and the other ply attached to the nipple 114. In the alternative, the backing 120 may be a spin welded plastic cap having a thin wall that is connected to the nipple 114, such as by spin welding. Plastic caps may be required with preservative solutions containing alcohol. The plastic cap may have a selected notched geometry that provides a fracture point for the sharp point of the penetrating member, reducing the required puncture holes. In operation of the device 100, the backing 120 is punctured to allow the release of medication or liquid from the fluid housing 106.

  4-5 together with FIG. 2, the end cap 108 of the fluid container assembly 102 will be discussed. The end cap 108 is generally cylindrical in shape and defines an outer wall 122 and an annular flange 124 disposed at the distal end of the outer wall in a relationship transverse to the housing axis “X”. Outer sidewall 122 is disposed in a diametrically opposed relationship and incorporates a pair of guide ribs 126 extending along axis “X” of fluid housing 106. The guide ribs 126 orient the cap 108 in a predetermined rotational position relative to the applicator head assembly 104 and / or prevent the end cap 108 from rotating within the applicator head assembly 104 during assembly. The outer wall 122 of the end cap 108 further possesses a pair of locking tabs 128 disposed in a diametrically opposed relationship displaced from the guide rib 126 by approximately 90 °. The locking tabs 128 are each in the form of a baseball plate having a leading v-shaped head with an angled lateral surface 130, and a lateral surface 132 extends continuously from the v-shaped head. Lock tab 128 secures fluid container assembly 102 in the second actuated position.

  The annular flange 124 of the end cap 108 defines a central opening 132 that allows access to the backing 120 attached to the fluid housing 106. The annular flange 124 has a peripheral rib 134 disposed around the periphery of the flange 124. The peripheral rib 134 extends a predetermined distance along the housing axis “X” and cooperates with a corresponding structure in the applicator head assembly 104 to provide a fluid tight seal within the device 100 when the device 100 is actuated. Form. End cap 108 further defines internal threads 136. The internal screw 136 cooperates with the external screw 118 of the fluid housing 106 to attach the end cap 108 to the fluid housing 106.

  2-4 and enlarged views of FIGS. 6-7, the applicator head assembly 104 includes an applicator frame 138 and an applicator 140 attached to the applicator frame 138 (in the form of an absorbent member). . Applicator frame 138 captures housing support collar 142 at its proximal end and cap support collar 144 disposed distally of housing support collar 142. The housing support collar 142 defines an internal cavity having a diameter that approximates the diameter of the cylindrical section 112 of the fluid housing 106 and receives the cylindrical section 112 during assembly. Similarly, the cap support collar 144 defines an inner diameter or dimension that corresponds to the diameter of the end cap 108. As depicted in FIGS. 6-7, the cap support collar 144 includes at least one, preferably a pair of diametrically opposed axial channels 146 that extend completely through its outer wall, and each axial direction. Further included are longitudinal relief slots 148 on opposite sides of channel 146. The axial channel 146 is defined by an opposing cam surface 150 that extends in an oblique relationship with respect to the housing axis “X” and terminates in a locking recess 152. The axial channel 146 receives the locking tab 128 of the end cap 108 and allows the locking tab 128 to traverse the channel 146 during operation of the device 10. The functionality of the axial channel 146 and the longitudinal slot 148 will be discussed in more detail later herein.

  As best depicted in FIG. 7, the cap support collar 144 further defines an internal longitudinal groove 154. Inner groove 154 receives axial guide rib 126 of end cap 108, which traverses this inner groove 154 during operation of device 108. Internal grooves 154 and axial guide ribs rotatably fix fluid container assembly 102 within applicator head assembly 104. The cap support collar 144 further defines an annular groove 156 in a cavity within the support collar 144. The annular groove 156 is arranged in opposing relation to the peripheral rib 134 of the end cap 108 and receives the peripheral rib 134 during operation of the device 100. The annular groove 156 and the peripheral rib 134 form a seal within the internal cavity of the cap support collar 144 with appropriate dimensions during operation of the device and substantially allow fluid movement back toward the fluid housing 106. Minimize to

  Referring now to FIG. 8, the applicator frame 138 further defines a pair of piercing members or spikes 158 disposed within the cap support collar 144. The piercing member 158 defines a sharp tip that penetrates the backing 120 during operation of the device 100. The piercing members 158 are preferably spaced as shown. Although two piercing members 158 are shown, more or fewer piercing members 158 may be provided and still achieve the objectives of the present disclosure.

  8-9, the applicator frame 138 further includes a throat 160 and an applicator support plate 162 extending from the throat 160. The throat 160 defines an internal bore 160b through which medication or fluid released from the fluid housing 106 flows to the applicator member 140. The applicator support plate 162 supports the applicator member 140. The support plate 162 includes a central aperture 164 in communication with the inner bore 160a of the throat 160 and first and second channels 166, 168 disposed on the lower surface of the support plate. The central aperture 164 is dimensioned to allow a relatively large volume of medication or fluid to be dispensed therefrom and communicated through the first and second channels 166, 168. The first channel 166 extends generally in the longitudinal direction and the second channel 168 extends in a transverse relationship to the first channel 166. The first channel 166 defines an enlarged width relative to the second channel 168, and a sufficient volume of medical fluid is in communication with the outermost portion, ie, the leading and trailing ends of the applicator frame 138. Is acceptable. Applicator frame 138 may further define a plurality of radial or arcuate grooves 170 that are generally arranged in the concentric relationship shown. An arcuate groove 170 is in fluid communication with the first and second channels 166, 168. The arcuate groove 170 dispenses medication to substantially the entire surface of the support plate 160 for delivery to the applicator member 140. In this regard, the medicament is uniform in the applicator member 140 through a fluid manifold defined in a support plate 162 that includes first and second channels 166, 168, arcuate grooves 170 and a central aperture 164. This results in a uniform application to the patient.

  The applicator member 140 is attached to the support plate 162. Applicator member 140 preferably includes an absorbent member in the form of an open cell reticulated urethane foam 75 +/− 10 pores / inch (ppi). The applicator member 140 is bonded to the support plate 160 by an adhesive, welding, or the like. Applicator member 140 is configured for delivery of medication dispensed from fluid container assembly 102. The capacity of the absorbent member of the applicator member 140 is balanced with the entire contents of the fluid container, thereby acting as a fluid reservoir during application to the patient's skin. This ability is used to control fluid release and to minimize the accumulation of preservatives on the patient's skin.

As best depicted in FIG. 10, when viewed in a plane, the applicator member 140 defines a generally tear drop or dolphin nose form. In particular, support plate 160 and applicator member 140 define an enlarged section 172 and an elongated neck or plow section 174 depending from the enlarged section 172. Enlarged section 172 is envisioned to facilitate the application of pharmaceutical fluid to a relatively large body region. The elongated neck section 174 is dimensioned to be positioned in a narrow remote area, such as a patient's finger, toe, eye area, etc., or an area where only a relatively small amount of fluid is needed. The elongate section 172 includes opposing generally convex surfaces 176 that are interconnected by an arcuate trailing surface 178. In one preferred embodiment, the enlarged section 172 defines a partial ellipse having a maximum width “w” of about 2 inches to about 4 inches. The elongated neck or pro-section 174 defines an opposing concave surface 180 that extends continuously from the convex surface 176 of the enlarged section 172, which leads the arcuate surface 182 that interconnects the concave surface 180. To. The arcuate form of the concave surface 180 facilitates operation of the device 100 around the patient's fingers, toes, and the like. In particular, the curvature of the concave surface 180 substantially matches the curvature of the various parts of the anatomical structure, whereby the applicator member 140 is rolled and rotated with respect to the anatomical body part. It can be given to the body with the service 180 of FIG. The probe section 174 defines a minimum width “w ₂ ” of about 0.5 inches to about 1.5 inches. The absorbent applicator member 140 defines a length “l” that ranges from about 3 inches to about 6 inches.

  The operation of the device 100 will now be discussed. In use, the practitioner grasps applicator 100 with one hand by anchoring his or her last three fingers to the underside of fluid housing 106. The thumb is then placed across the top of the applicator frame 138 and the frame 138 is gripped. The index finger is anchored to the applicator frame 138 and then both the thumb and index finger are pulled simultaneously toward the anchored finger to create a predetermined connection force between the fluid container assembly 102 and the applicator housing assembly 104. . The fluid housing assembly 102 is therefore moved relative to the applicator head assembly 104 to its second actuated position, as depicted by arrow “z” in FIG. This range of longitudinal movement can be limited by the engagement of the peripheral stops or ribs 116 with the collar 142 supported by the housing.

  Referring now to FIG. 12, during axial movement of the fluid housing 106, the locking tab 132 of the end cap 108 traverses the axial channel 146 of the applicator frame 138. As noted, the longitudinal relief slot 148 adjacent to the axial channel 146 provides cam motion with the side surface 130 at which the cam surface 150 (which defines the axial channel) forms the angle of the locking tab 128. The locking tab 128 is received in the locking recess 152 by allowing it to bend outwardly through engaging engagement. As will be appreciated, the cam surface 150 provides a certain degree of resistance to movement of the locking tab 128 through the axial channel 146. This resistance provides the practitioner with a tactile indication of the status of the device 100, thereby minimizing the possibility of inadvertent activation of the device 100. With the locking tab 128 received in the locking recess 152, the fluid container assembly 102 is held in the second actuated position as shown in FIGS. Simultaneously with relative advancement of the fluid housing assembly 102, the piercing member 158 of the applicator head assembly 104 penetrates the backing 120 as depicted in FIG. In the second actuated position, the peripheral ribs 134 are received in the recesses 156 (see FIG. 7), forming a substantially fluid tight seal in this position, and thereby the fluid housing 106. Minimize fluid returning toward

The piercing member 158 can be adapted to completely cover the backing 120. Alternatively, the piercing member 158 is arranged to drill two holes in the backing 120 as depicted in FIG. These two openings O ₁ , O ₂ created by this action create a fluid channel, one in the throat of the applicator frame 136 under pressure generated by the practitioner by moderate compression of the fluid housing 106. It is a preservative solution that spills. The second opening O ₂ facilitates the exit of fluid by allowing air to enter the fluid housing 106, thereby balancing its interior, preventing vapor lock of the container contents, and Provides more consistent release of fluid. The assembly position is defined as the second or “actuated” position.

  Fluid contained within the fluid housing 106 is allowed to flow to the applicator frame 138 immediately after the lining 120 is broken. Moderate compression of the fluid housing 106 allows a portion of the contents therein to be excreted, while releasing the compression allows air to replace the contents of the fluid housing 106. . Allowing air ingress thus increases the speed of fluid flow. In this manner, fluid is metered or pumped, and a few pumps will drain about 60 ml of the entire contents from the fluid housing 106.

  With reference to FIGS. 8-9, fluid travels to applicator support plate 162 and is dispensed through central device 164 and first and second channels 166, 168 and arcuate channel 170. Gentle compression of the fluid housing 106 can push the preservative downward, for example, into the pores of the absorbent member. The arrangement of the applicator plate 162 allows transfer of the entire container contents into the absorbent member 142 in 2-3 seconds, i.e., almost instantaneous fluid filling and equilibration, thereby increasing the asymmetric profile of the sponge. Allows uniform wetting.

  In use, the multi-contour absorbent member 140 conforms to substantially all body contours or topologies of the patient. For example, a plow-shaped nose facilitates the preparation of eyes, ears, fingers, toes, or other compartmental topologies. In addition, the contoured or section matches the radial surface of the subject's arm or leg. The extended footprint length L of the applicator 70 (ie, the longer sponge interface) is about 4 times the coverage when compared to the prior art in a single stroke by using side-to-side motion. Enable. This translates to an increase of about 400% in productivity over the prior art with a flatter profile, which saves preparation time and effort, especially during turnover involving multiple surgeries.

  As noted above, the applicator device 100 of the present disclosure includes key features and advantages not found in the prior art. One-handed braking mechanism and one-handed active improve ease and productivity--no snap ring to handle or necessary pre-braking mechanism, and no other parts that need to be removed before use . Instead, a single snap braking mechanism is employed. The minimum number of parts reduces complexity and manufacturing costs. Further, the fluid housing 106 allows for faster wetting and the built-in fluid manifold in the applicator frame 138 provides uniform wetting and balanced filling of any sponge regardless of fluid viscosity. Enable. Larger sponges result in inverted use of the applicator, faster preparation and controlled fluid release. The contoured versatile sponge can match any patient topology, and the incorporated sponge stick / proe provides the dexterity of conventional sponge sticks along with applicator speed.

  Referring now to FIGS. 15-18, another preferred embodiment of the present disclosure is shown. Skin applicator device 200 includes a fluid container assembly 202 and an applicator head assembly 204 attached to a fluid housing assembly 202. The fluid container assembly 202 includes a fluid housing 206 and a collar 208 that extends continuously from the fluid housing 206. The fluid housing 206 is preferably in the form of a dome and may incorporate an accordion-like configuration, allowing the housing 206 to be compressed to discharge the fluid contained therein. The fluid housing 206 can have a variety of forms, such as, for example, cylindrical, rectangular, elliptical, polygonal, etc., depending on the requirements of a particular application. The fluid housing 206 may be formed from either an elastomeric material or a material as defined above. The fluid container assembly 202 further includes an end cap 212 that attaches to the backing 210 and the collar 208 of the fluid housing 206. The backing 210 is preferably in the form of a foil seal and can be adhered to the collar 208 and / or can be within the end cap 212.

  As best depicted in FIG. 19, the end cap 212 is unthreaded and can be secured to the collar 208 with adhesive, welding, cement, or the like. End cap 212 includes a pair of diametrically opposed locking tabs 214 and axial ribs 216 on its outer surface, preferably about 180 ° apart. Lock tabs and axial ribs 216 function in a manner similar to the lock tabs and axial ribs of FIGS.

  With reference to FIGS. 16-18, applicator head assembly 204 includes an applicator frame 218 having a throat 220 and an applicator support plate 222 coupled to the throat 220. The throat 220 defines an internal opening 224 that allows the passage of medication to the support plate 222 and has a proximal flange 226 that is preferably dimensioned to be grasped by the practitioner's fingers. A pair of axial channels 228 with corresponding longitudinal relief slots 230 extend within the wall of the throat 220. The axial channel 228 receives the locking tab 214 and allows it to traverse the channel 228 during instrument operation. The throat 220 has a penetrating spike or member 230 that extends upwardly from an applicator support plate 222 having an opening 224 therein. Although the spike 230 is shown as a single conical shaped element, the spike 230 can take the form of any shape or multiple.

  With reference to FIGS. 18 and 20, applicator support plate 222 includes a plurality of apertures 232 that communicate with an opening 224 in the interior of throat 220 and are centrally located within the center of applicator plate 222. On its lower surface, the applicator support plate 222 is in a substantially transverse relationship with each other and is centered along the major and minor axes “y”, “z” of the support plate 222. Of straight channels 230, 232. Applicator support plate 222 further includes a grid-type array having a plurality of narrow intersecting channels 234 on its lower surface and intersecting linear channels 230, 232.

  In use, the fluid container assembly 202 is moved from the first transition position of FIG. 17 to the second actuated position of FIG. Preferably, the practitioner grasps the flange 226 of the applicator frame 218 with the index and middle fingers and positions his palm relative to the upper surface of the fluid housing 206. During this movement, the locking tab 214 traverses the axial channel 228 and is secured within the locking recess 228a of the axial channel 228 in a manner similar to that described hereinabove. At the same time, the penetrating member 230 punctures the backing 210 and allows the fluid contained within the fluid housing 206 to be removed. The fluid then communicates through the throat 220 and the opening 224 inside the aperture 232. The fluid medicament then communicates through the straight channels 230, 232 provided on the lower surface of the applicator frame 218 and further through the grid type array 234. This arrangement substantially saturates the entire absorbent member 236 with the medicament. The device 200 is then utilized to apply medication to the patient's skin. The fluid housing 206 can be compressed to facilitate the discharge of fluid medication, or the medication can be supplied by gravity by transposing the fluid housing 206.

  With reference now to FIGS. 22-24, an alternative embodiment of the present disclosure is shown. This embodiment is substantially similar to the embodiment of FIG. However, according to this embodiment, the skin applicator device 300 has a pair of diametrically opposed ribs 304 disposed on the outer surface of the cylindrical section 306. The locking rib 304 is generally linear in shape and possesses an enlarged arcuate rib section 304a at its distal end. Applicator frame 306 has a locking channel 310 that approximately corresponds in shape and position to locking rib 304 of fluid housing 302. Specifically, the lock channel 310 is substantially straight and includes first and second arcuate channel sections 310a, 310b. In the first transition position of the fluid housing 302 shown in FIG. 22, each enlarged arcuate rib section 304a of the lock rib 304 is in the first arcuate section 310a of the lock channel 310 and the channel section 310a. Of the fluid housing 302 is removably attached to the first transition position. When it is determined to activate the device 300, the practitioner advances the fluid housing 302 relative to the applicator frame 306. During this movement, the locking rib 304 traverses the locking channel 310 so that the surface defining the locking channel 310 is deflected outward, the passage of the enlarged rib section 304a, and the second arcuate channel section. Allow its acceptance in a snap-fit relationship with that in 310b. In this position, the locking rib 304 is secured within the locking channel 310, thereby securing the fluid housing 302 in the second actuated position of FIG. In all other respects, the device 300 is similar in function to the device 100 of FIG.

  Figures 25-28 illustrate another preferred embodiment of the present disclosure. The skin applicator device 400 is substantially similar to the device 200 described in combination with the embodiment of FIG. However, according to this embodiment, the fluid housing 402 includes at least one or a pair of diametrically opposed locking tabs 404 on the distal collar 406. In this embodiment, the device 200 does not have an end cap; however, it is envisioned that the device 200 may have an end cap with the locking tab 404 described above. Lock tab 404 is received in a corresponding generally z-shaped slot 408 defined in throat 410 of applicator frame 412. The z-shaped slot 408 is characterized by having a first vertical section 414, a horizontal section 416 and a second vertical section 418 extending from the horizontal section 416. The vertical sections 414, 418 include lock recesses 420, 422. A longitudinal relief slot 424 is disposed adjacent each vertical section 414, 418 of the z-shaped slot 408. The relief slot 424 allows outward deflection of the wall surfaces defining the vertical sections 414, 418 and allows the locking tab 404 to be received within the locking recesses 420, 422. In use, the collar 406 of the fluid housing 402 is positioned in the vertical section 414 of the z-shaped slot 408 and is positioned in the throat 410 of the applicator frame 412 with the locking tab 404 received in the locking recess 420. In this position, the fluid housing 402 is retained in the applicator frame 412 and releasably secured to the first transition position by cooperation of the tab 404 with the wall surface defining the locking recess 420. When it is determined to operate the device 400, the practitioner rotates the fluid housing 402 in the direction of the directional arrow “a” relative to the applicator frame 412 as shown in FIG. The locking tab 404 is pushed out of the locking recess 420 so that the relief slot 424 allows the surface defining the locking recess 420 to deflect outward. The force required to displace the locking tab 404 from the locking recess 420 provides the practitioner with a tactile indication of movement toward the second actuated position of the fluid housing 402. The locking tab 404 traverses the horizontal section 416 of the z-shaped slot 408 to a position that aligns with the second vertical section 418 shown in FIG. The practitioner then applies a distal force to the fluid housing 402 and advances the fluid housing 402 relative to the applicator frame 412 to the position depicted in FIG. During this movement, the locking tab 404 traverses the second vertical section 418 of the shape slot 408 and is received in the locking recess 422. As will be appreciated, during this movement, the wall surface defining the vertical section 418 is deflected outward by the provision of the longitudinal relief slot 424 so that the locking tab 404 is received within the locking recess 422. Allow. The lock well 422 thus holds the lock tab 404, thereby holding the fluid housing 402 in its second activated position and dispensing medication to the absorbent member 426.

  29-31, another alternative embodiment of the skin applicator device of the present disclosure is shown. Skin applicator device 500 includes a fluid container assembly 502 and an applicator head assembly 504 coupled to the fluid container assembly 502. The fluid container assembly 502 includes a fluid housing 506, an end cap 508 coupled to the housing 506, and a backing 510. The fluid housing 506 includes at least one cylindrical locking protrusion, or alternatively, a pair of locking protrusions 512 extending radially outward relative to the housing axis “x”, and the distal of the locking protrusions 512. It includes a peripheral rib 514 in the lateral direction. The fluid housing 506 further includes an external screw 516 at its distal end and a plurality of radially spaced wings 518 extending outwardly from the wall of the fluid housing 506 proximal to the screw 516. The backing 510 is preferably a foil backing and can be secured to the fluid housing 506 by any of the means described above. The end cap 508 includes an internal screw 520 that cooperates with the external screw 516 of the fluid housing 506 to secure the end cap 508 on the fluid housing 506 (FIG. 33). The end cap 508 further includes teeth 519 that are angled at the mouth of the end cap (FIGS. 31 and 35). In a fixed position, the radially spaced wings 518 on the outer surface of the fluid housing 506 engage or mesh with the angled teeth 519 of the end cap 508 so that the end cap 508 moves away from the fluid housing 506. Preventing inadvertent removal (FIG. 35). The end cap 508 further defines a distal collar section 508c having a reduced diameter—its function is discussed in more detail herein below.

  Referring again to FIGS. 30-32, the fluid container assembly 502 further includes a housing extension 522 that is coupled to the fluid housing 506. In one preferred method of attachment, the housing extension 522 includes a pair of cylindrical openings 524 through its walls for receipt in a snap-fit relationship with that of the locking projection 512 of the fluid housing 506. Other means for connecting the housing extension 522 to the fluid housing 506 are also envisioned. The fluid housing 506 further includes a lock lever 526 on its outer wall. Lock lever 526 is adapted to removably retain fluid housing 506 in the first inoperative position. Lock lever 526 defines lock shelf 528 and is adapted to deflect radially inward along its integral hinge, releasing lock shelf 528 as discussed. The housing extension 522 further defines a manually engageable button 530 at its proximal end. Button 530 defines a reduced diameter relative to the remainder of housing extension 522 and has a rail 532 extending axially along its outer surface. Rail 532 ensures a single alignment position and facilitates assembly.

  Skin applicator device 500 further includes an outer housing 534. Outer housing 534 is secured to applicator head assembly 504 and is sized to receive fluid housing 506 and housing extension 522. The outer housing 534 defines a contoured configuration having a plurality of spaced ribs 536 on its outer surface to facilitate engagement by the practitioner. Outer housing 534 receives at its proximal end a central aperture 538 that receives a manually engageable button 530 of housing extension 522 and a rail 532 for receiving a rail 532 of housing extension 522. The key opening 540 is defined (FIG. 31). In this regard, the housing extension 522 is adapted to move in a generally longitudinal direction relative to the outer housing 534, but is rotatably fixed relative to the outer housing 534.

  The outer housing 534 further defines an opening 542 in its outer wall to at least partially receive the lock lever 526 of the housing extension 522 (FIG. 31). Opening 542 defines a distal locking surface 544 that is engaged by lock shelf 528 of locking lever 526 of housing extension 522 when in the first transition position of fluid housing 506 (FIG. 32). The outer housing 534 takes in a release lever 546 that extends to the lock lever 526 of the housing extension 522 in a superimposed relationship within the opening 542 of the outer housing 534. Release lever 546 pivots radially inward about its integral hinge and causes a corresponding pivoting movement of lock lever 526 to release lock shelf 528 from engagement with its lock surface 544. To do. In this orientation, housing extension 522 and fluid housing 506 are moved longitudinally to the second actuated position.

  Referring now to FIGS. 33 and 36-38, the applicator head assembly 504 will be discussed. Applicator head assembly 504 includes an applicator frame 548 and an absorbent applicator member 550 attached to the applicator frame 548. Applicator frame 548 includes a throat 552 and a fluid housing 506 that define an internal bore for receipt of end cap 508. The throat 552 has at least one opening 552a (FIG. 31) in its outer wall to accommodate a corresponding locking projection 554 of the outer housing 534 to secure the applicator frame 548 to the outer housing 534. And attach.

  As best depicted in FIGS. 33, 36-37, inside the throat 552 is an internal collar 556 attached to the lateral wall 557, and a plurality of penetrating members 558 extend from the internal collar 556. . The penetrating members 558 are preferably four in number and arranged along intersecting planes that define four quadrants when the penetrating members 558 puncture the backing 510. More or fewer through members 558 are also envisioned. Specifically, each penetrating member 558 extends to a point 560, and each of the points 560 of these penetrating members 558 is disposed about a central axis “c” in an adjacently spaced relationship as shown.

  36-38, the applicator frame 548 includes first and second channels 562, 564 disposed around the periphery of the inner collar 556 adjacent to the upper and lower regions of the throat. Further stipulate. First and second channels or manifolds 562, 564 facilitate passage of medication or fluid directly to the leading and trailing ends of applicator member 550, respectively. The first channel 562 is substantially semicircular in cross section and extends from a passage 562 a adjacent the periphery of the inner collar 556 to the upper or forward end of the applicator frame 548. The second channel 564 extends from an arcuate or crescent shaped opening 564 a in the lateral wall 557 and communicates with the lower or rear end of the applicator frame 548. Applicator frame 548 further defines a central enlarged orifice 566 extending to the lower surface of applicator frame 548. The orifice 566 is sized to fluidly communicate with the first and second channels 562, 564 and expel a substantial volume of fluid on the central region of the absorbent member 550.

  Referring now to FIGS. 36 and 39, the absorbent member 550 is similar in shape to the absorbent member discussed hereinabove and is preferably in the form of an absorbent sponge, foam, etc. . Absorbing member 550 is attached to the lower surface of applicator frame 548 by conventional means. Absorbing member 550 includes a plurality of spaced slits 568 extending along the central axis of absorbing member 550 through the thickness of absorbing member 550 completely. The slit 568 functions as a zero closure valve, i.e., the slit 568 is adapted to remain closed in the absence of pressure on the absorbent member 550, but when pressure is applied to the absorbent member 550, Allows fluid to flow through it.

  In use, the practitioner grasps the device 500 with one hand, preferably around the outer housing 534. Thereafter, to operate the device 500, the practitioner engages the release lever 546 of the outer housing 534 and engages the release lever 546 in the radially inward direction “i” as depicted in FIG. Press down. The release lever 546 pivots about its integral hinge and engages the lock lever 526 of the housing extension 522, causing a corresponding inward movement of the lock lever 526. When the lock lever 526 pivots inward, the lock shelf 528 of the lock lever 526 is released from its engagement with the lock surface of the outer housing 534. In this position, the housing extension 522 and fluid housing 506 are free and move in the longitudinal direction.

  Referring now to FIG. 40, the practitioner then advances button 530 with the heel of his hand at the proximal end of housing extension 522 or with the practitioner's thumb instead. The required actuation force (approximately 8-12 pounds) can be placed on the thumb, if desired, with the housing extension 522 and fluid housing 506 distal to the outer housing 534 and applicator head assembly 504. Proceed in the direction. With particular reference now to FIGS. 42-43, the distal direction of the fluid housing 506 allows the backing 510 to be penetrated by four penetrating members 558, which is the four-quarter portion of the backing 510. It is penetrated by 510a-d. The stroke involved causes the foil to peel onto the side wall of the puncture cylinder, thereby providing the overall diameter of the fluid flow. Upon breaking of the backing 510, the medication in the fluid housing 506 passes through the inner bore of the inner collar 556 for dispensing the first and second channels 562, 564 in the enlarged orifice 556 of the applicator frame 548. It is ejected almost immediately inside. The enlarged orifice 566 is substantially dimensioned so that the adhesive force associated with the medication is overcome by the mass of the fluid. This makes it possible to “drop” in seconds by gravity. That is, compression of the fluid housing is not necessary. Further, the first channel 562 directs fluid to the elongated neck section of the applicator member and the second channel 564 directs fluid to the rear region. In this way, a uniform layer of fluid is dispensed to the absorbent member 550. In addition, the first and / or second channels 562, 564 establish an equilibrium within the applicator frame 548 by allowing air to pass through the interior of the applicator frame 548, thus providing sufficient To ensure a smooth flow. Preferably, either or both of the first and second channels 562, 564 return the air through the channels 562, 564 for ventilation to the atmosphere during compression of the absorbent member 550, It provides outlets that are replaced to pass through the individual openings or passages 562a, 564a and into the applicator frame 548. FIG. 33 shows the manner in which the first channel 562 extends through the passage 562 a around the collar 556 and communicates with the interior of the applicator frame 548. The assembly tolerances associated with the components of apparatus 500 are sufficient to allow air to be exhausted. Further, in the activated position, the distal collar 508c of the end cap 508 seals and seals around the outer surface of the inner collar 556 to prevent leakage toward the proximal end of the applicator frame (see FIG. 41). ) This arrangement can also serve as a friction fit or interference fit that holds the fluid housing in the second actuated position. A predetermined volume of medication may pass back through the passage 562a or opening 564a in the lateral wall 557 during compression of the absorbent member 550 and accommodate a fluid volumetric replenishment. The fluid housing 506 may be held in the second activated position by engagement of the lock shield 528 of the lock lever 526 with the corresponding position lock aperture 570 in the outer wall of the outer housing 534 (see, eg, FIG. 40). See

  As noted above, the applicator device of the present disclosure includes key features and advantages not found in the prior art. While the prior art requires the use of both hands and high force actuation, the present disclosure provides light actuation pressure similar to operating with one hand and activating the click pen. This results in less hand fatigue and does not require "slap". To prevent false launches, no snap ring or high actuation force is required, and no parts need to be removed before use. Instead, a single step, squeeze-release shipping lock prevents unintended actuation, and a minimum number of parts reduces complexity and manufacturing costs. Further, prior art applicator handles are smooth, straight, and angled at 45 °, providing limited comfort and control. In contrast, the ergonomic handle of the present disclosure ridges for comfort and traction even when wet. The constricted contour and rounded end of the handle accommodate any size handle, and a reduced handle angle of between 30 and 40, and preferably 35 °, allows greater access and control. Although the prior art includes a restriction conduit or mesh to delay fluid transfer, the wide mouth bottle of the present disclosure allows the preservative mass to overcome surface tension and even drain the absorbent member quickly. To. The discharge of the bottle contents is also accelerated by a double piercing means that creates an air inlet above the fluid layer in the fluid housing. Prior art sponges are symmetrically shaped to compensate for the lack of manifolds. In contrast, the “c-channel” manifold of the present disclosure uniformly wets the opposing ends of the asymmetric sponge. Prior art devices do not work well when displaced due to small sponge volume and slow fluid transfer, but the present disclosure provides for displaced use and faster preparation. This is because the large sponge acts as a reservoir for fluid that is rapidly transferred. The prior art includes rectangular sponges and has poor performance for contoured topologies. However, the contoured multi-use sponge matches any patient topology, and the incorporated sponge neck region provides the dexterity of a conventional sponge stick along with the applicator speed. This sponge has a thickness T that is twice that of the prior art, which acclimates the patient to less risk of injury, and the longer sponge length L allows for faster preparation.

  The components of the medical skin applicator device are made from materials suitable for medical applications, such as, for example, stainless steel, polymers or metals, depending on the specific application and / or practitioner's choice Can be done. Semi-rigid and rigid polymers and elastic materials such as molded medical grade polypropylene are contemplated for fabrication. However, those skilled in the art will appreciate that other materials and fabrication suitable for assembly and manufacture may also be suitable according to the present disclosure.

  Figures 44-46 illustrate alternative embodiments of the present disclosure. According to this embodiment, the skin applicator device 600 incorporates an alternative mechanism for releasably securing the fluid container assembly in the first transition position. In particular, the housing extension 602 includes a pair of outer peripheral portion ribs 604 that are diametrically opposed on the outer surface of the button 606. The ribs 604 exist beyond the outer housing 608 in the first transition position of the fluid housing 610 depicted in FIGS. Outer housing 608 defines a constrained opening 612 at its proximal end that has a dimension or diameter that is smaller than the effective cross-sectional dimension of housing extension 602 across and including partial rib 604. Accordingly, these partial ribs 604 prevent passage of the housing extension 602 through the opening 612 of the outer housing 608. When it is determined that the device 600 is actuated, the practitioner exerts distal pressure on the button 606 of the housing extension 602, which is the partial rib 604, and / or the housing extension 602 and the outer housing. The individual walls of 608 are deflected, deformed, etc., allowing passage of the partial rib 604 through the restricted opening 612, whereby the fluid housing 610 is activated in its second position depicted in FIG. It is possible to move to a different position. It is further envisioned that the housing extension 602 can be secured in the second actuated position by providing an internal locking tab or recess in the outer housing 608. These internal tabs or recesses may be of appropriate dimensions for engaging and receiving the partial tabs 604 in a fixed position. The absorbent member 614 includes a plurality of openings 616 that extend completely through its thickness, as disclosed in FIG. The opening 616 replaces the slit of the previous embodiment.

  Another feature of applicator device 600 and device 500 of FIG. 44 is the arrangement of handle components relative to the applicator head assembly. In particular, the handle components of these devices are displaced with respect to the applicator head assembly, which facilitates operation of the device around the actuation site. In particular, the outer housing 608 and the internal components that form the fluid container assembly are arranged along the handle axis “j” as shown in FIG. Applicator head assembly 620, including applicator frame 622, is coaxially arranged about axis “k”. As will be appreciated, axis “k” is displaced perpendicular to axis “j” by a predetermined distance, but is preferably in a parallel relationship. This offset (offset) allows the practitioner to maintain the most favorable 35 ° relationship with the patient, while allowing further spacing due to this offset, thereby “ Maintaining a “comfort zone”, the practitioner's hand is displaced from the patient, increasing maneuverability around the working site.

  47-48 illustrate another alternative embodiment of the skin applicator device of the present disclosure. According to this embodiment, the skin applicator device 700 is detachably fixed to the transition position via the detachable tag 702. In particular, housing extension 704 attached to fluid housing 706 includes a transverse bore 708 within a manually engageable button 710. The removable tag 702 is positioned within the lateral bore 708 and, when positioned within the bore 708, prevents the advancement of the housing extension 704 and attached fluid housing (not shown), thereby being removable. The fixing device 700 is fixed at the first transition position. The removable tag 702 can be removed from the lateral bore 708 to allow operation of the device and movement of the fluid container assembly to a second activated position. The removable tag 702 can be made from any rigid or flexible material and preferably incorporates a handle 712 to facilitate gripping by the practitioner. The applicator head assembly absorbent member 714 preferably incorporates a longitudinal channel 716 on its lower surface to provide a greater volume of fluid flow. Channel 716 may be coupled with a slot or opening that extends through absorbent member 714.

FIGS. 49-50 illustrate another alternative embodiment of the present disclosure useful for dispensing clear preservatives such as chlorhexidine gluconate / alcohol solutions. Transparent preservatives pose problems for implementers. This is because it is difficult to confirm the area after the grant. Skin applicator device 800 is substantially similar to the skin applicator device discussed in conjunction with FIG. 29, but further includes a dye chamber for introducing a dye or colorant into the medicament or fluid. In particular, the fluid housing 802 has a foil backing 804 coupled thereto as discussed above herein, and a first end cap 806 attached to the housing 802 by screws. The apparatus 800 further includes a second end cap 808 attached to the first end cap 806. In one preferred arrangement, the first end cap 806 includes an external screw 810 and the second end cap 808 includes a corresponding internal screw 812 that engages the external screw 810 and that second The end cap 808 is fixed to the first end cap 806. The second end cap 808 also includes a foil backing 814 that is secured within the end cap. With the second end cap 808 attached to the first end cap 806, a chamber 816 is formed between the individual foil backings 814, 804 of these two components. Dye or colorant 818 is stored in chamber 816. Suitable dyes are Parchem Trading
Ltd .. FD & C Green # 3 dye manufactured by White Plains, NY 10601. During operation of the device, the penetrating member 820 of the applicator frame 822 punctures both backings 814, 804 so that the dye 818 in the chamber 816 mixes with the medication during passage through the applicator frame 822. The dye therefore colors the medicament or preservative to the desired color.

  FIG. 51 shows an alternative embodiment in which the dye tablet 850 is placed in the applicator frame 822. Preferably, this tablet 850 containing pigment is positioned in an internal conduit 854 adjacent to the absorbent member 856. This dye tablet is contacted by the medicament when it is transferred to the absorbent member 856. This dye tablet may contain the dyes discussed in combination with the embodiments of FIGS.

  Figures 52-54 illustrate another alternative embodiment of the present disclosure. Skin applicator device 900 includes an alternative mechanism for cutting the foil backing. This mechanism is preferably in the form of a circular array of penetrating members or spikes 902 extending from the inner collar 904 of the applicator frame 906 shown in perspective view in FIG. This circular array is adapted to form a generally circular opening in a foil backing 908 attached to the fluid housing 910. In further accordance with this embodiment, the fluid housing 910 is provided with an internal dividing wall 912 extending in a generally longitudinal direction. Similarly, the inner collar 904 can be provided with a longitudinal wall 914. Inner walls 912, 914 engage the wall portion of the foil backing 908 cut by the circular array 902 of penetrating members, and the fluid housing from its original lateral position to the second position of FIG. Upon movement of 910, it is provided to rotate to a rotational position that is substantially aligned with the major axis. In this position, the medication can flow in an unrestricted manner through the applicator frame 906 without being interrupted by the cut foil backing 908. Preferably, the inner walls 912, 914 in the fluid housing 910 and the inner collar 904 of the applicator frame 906 have two walls 912 as the foil-lined cut wall portion is moved to the second actuated position. , 914 are displaced in the radial direction to be captured during 914, or misaligned in the major axis direction. In other aspects, this embodiment functions in a manner similar to the previous embodiment of FIG.

  With reference now to FIGS. 55-58, alternative embodiments in accordance with the principles of the present disclosure are disclosed. Skin applicator device 1000 includes a fluid container assembly 1002 that is coupled to an applicator 1004 by a tether wire 1006. More particularly, fluid container assembly 1002 includes a fluid housing 1008, a foil liner 1010, and an end cap 1012 that is screwed to the fluid housing 1008. End cap 1012 includes an internal screw 1014 that engages external screw 1016 of fluid housing 1008 (FIG. 58). Applicator 1004 includes an O-ring connector 1018 to which tether 1006 is coupled. O-ring connector 1018 is positioned on neck 1020 of end cap 1012 and the retainer therein by peripheral ribs 1022 on the exterior of neck 1012. Applicator 1004 incorporates a peripheral array of penetrating members 1024 similar to the array discussed in previous embodiments for puncture backing 1010. Applicator 1004 incorporates a plurality of spaced bulbous applicator tips 1026 with a plurality of spaced openings 1028 for dispensing medication. A circular absorbent sponge 1030 can be mounted on the applicator tip 1026. In use, the applicator 1004 is pivoted onto the assembly 1002 and secured to the fluid container 1002 by receipt of the peripheral rib 1022 with the annular recess 1032 in the applicator 1004. Other means are also envisioned, including interference fits, snap fits, plug-in couplings, and the like. Attachment of applicator 1004 allows the spike to penetrate the backing, thereby actuating device 100.

  It can be understood that various modifications and changes in form and detail may be made to the embodiments of the present disclosure without departing from the spirit and scope of the invention. Therefore, the above description should not be construed as limiting the invention, but merely as exemplifications of preferred embodiments thereof. Those skilled in the art will envision other modifications within the scope and spirit of the invention as defined by the claims appended hereto. Having thus described the invention with details, and particularly with details required by patent law, what is claimed and desired protected is set forth in the appended claims.

Claims (2)

A medical skin applicator device comprising:
  An outer housing defining a longitudinal axis and having an outer wall;
  An applicator coupled to the outer housing, comprising an applicator frame and an applicator member, the applicator frame having an internal penetrating member, the applicator member having a longitudinal axis extending along the length of the applicator member. From the leading end to the trailing end as specified and in plan view:
  Outer leading surface;
  Outer trailing surface;
  An opposing outer surface extending along the longitudinal axis between the leading surface and the trailing surface;
  A fluid housing disposed at least within the outer housing and having a fluid chamber for storing and selectively releasing a medicament, the first transition for accessing the fluid chamber with the inner penetrating member A fluid housing dimensioned for movement from a position to a second actuated position and adapted and dispensed by the applicator member from the fluid chamber to which the medicament is to be applied to a patient; and
  A manually engageable member operably connected to the fluid housing and extending beyond the outer housing, wherein the fluid housing is manually operated to cause longitudinal movement of the fluid housing to the second operating position. A releasable tag that is pushable by operation and releasably attached, wherein the releasable tag selectively secures the fluid housing in the first transition position and is to be manually advanced A medical skin applicator device that defines a manually engageable member that is removable to allow the engageable member to move the fluid housing to the second operating position. The detachable tag is removably receivable within a bore defined in the manually engageable member, and the detachable tag is manually engaged when positioned within the bore. The medical skin applicator device of claim 1, wherein the device is dimensioned to prevent progression of possible members.

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