Shield for protecting a needle inserted in a patient.

FIELD OF THE INVENTION

[0001] The present invention relates generally to medical equipments and, more particularly, to a shield for protecting a needle inserted in a patient, for example at an infusion site on a patient's limb.

BACKGROUND

[0002] Devices for protecting an infusion site on a patient's limb are known in the art and are useful for covering, protecting and, generally, providing a ready access means to an infusion site on a patient's limb. These protection devices of the prior art generally comprise a base portion, or splint member, that is removably attached to a back or underside portion of a patient's limb, relative to an infusion site on the latter, using conventional medical adhesive tape, or using Velcro straps encompassing the base portion of the device and the concerned limb portion. The protective device is then completed with a cover portion that is removably attached to, or otherwise pivotably attached to, the base portion. The cover portion is suitably shaped and sized to cover the front or upper side of the concerned limb portion, but without actually getting in direct contact with the infusion site thereunder.

[0003] It is to be noted that these protection devices may be particularly useful when the patient is a toddler or a young child who may become agitated by the discomfort or pain generated by the presence of, or be simply frightened at the sight of, an infusion canula applied to one of his or her limbs. [0004] Some examples of the prior art are U.S. Pat. Nos. 7,425,206, to Byrne and Doherty (September 16, 2008), U.S. Pat. Nos. D541.934, to Gomez (May 1 , 2007), U.S. Pat. Nos. 5,682,905, to Grant (November 4, 1997), U.S. Pat. Nos. 5,339,834, to Marcelli (August 23, 1994), and U.S. Pat. Nos. 5,018,534, to Grant (May 28, 1991).

[0005] While these prior art devices generally offer a means for protecting an infusion site on a patient's limb, they also entail one or more of the following disadvantages.

[0006] First, they generally require adhesive tape to prevent the dislodgement of the canula which, eventually, generate pain or discomfort to the patient when the catheter needs to be removed form the infusion site. This problem is particularly felt by young patients generally having a more sensitive skin. Furthermore, the use of adhesive tape generally means relatively costly medical waste to be processed by medical institution;

[0007] Second, they generally provide strict minimal protection for the infusion site, but generally do not provide suitable protective cushioning means between the protection device and the concerned limb portion of the patient. In other words they are not particularly well suited to provide suitable protection to the infusion site and limb portion of the patient when the latter is a toddler or young child who may get inadvertently agitated;

[0008] Finally, they generally represent a complex assembly of numerous parts that are generally expensive to produce. [0009] Against this background, there exists a need for a new and improved shield for protecting a needle inserted in a patient. It is a general object of the present invention to provide a shield for protecting a needle inserted in a patient.

SUMMARY OF THE INVENTION

[0010] In a broad aspect, the invention provides a shield for protecting a needle connected to a tube when the needle is inserted into a body part of a patient, the shield comprising: a main body defining a shell for receiving the body part thereinto, the shell defining an aperture extending therethrough, the aperture being positionable substantially in register with the needle when the body part is received in the shell; and a cover movable between a cover open position and a cover closed position, wherein, in the cover closed position, the cover extends across the aperture, and, in the cover open position, the cover is substantially retracted from the aperture, the cover being releasably fastenable to the shell in the cover closed position; whereby the cover provides selective access to the needle with the shield remaining positioned around the body part.

[0011] Advantageously, the proposed shield separates the action of positioning the shield on the patient from the action of providing access to the needle afterwards. Therefore, access to the needle is facilitated without requiring removal of the shield, which speeds up this access and reduces risks of disturbing the needle when installing the shield, which is a possible cause of pain.

[0012] According to an embodiment of the present invention, the shield generally comprises an integrally-molded main body having a clam shell-like configuration being defined by an integral hinge portion and two opposing side panels extending perpendicularly from and rotatable about the centrally disposed, longitudinal hinge portion.

[0013] In some embodiments of the invention, the two opposing side panels define each a respective body section have a suitable cushioning thickness, and are suitably shaped and sized such that they respectively form a paired upper and lower arcuate-shaped half shields that, when the device is in a body closed configuration, cooperatively form a hollow substantially tubular element. The hollow tubular element has a substantially elongated shape of oval cross-section and is provided with a lateral opening that can integrally cover the wrist and palm portion of a patient's hand, excluding the distal end portions of the fingers and thumb. A plurality, but typically two, stretchable attachment strips, in combination with suitable anchors, allow to hold the two opposing side panels in a body closed configuration around a patient's hand.

[0014] A suitably sized aperture is provided, typically in a substantially central position in the upper side panel, to allow a ready access to an infusion site on a top portion of a patient's hand. The aperture is provided with an openable cover that is joined along a first longitudinal side edge of the aperture and is releasably fastenable through suitable attachment elements to the opposite, longitudinal side edge thereof. The openable cover is typically made of a flexible and transparent planar material which allows a visual inspection of the infusion site when in a body closed configuration over the aperture.

[0015] The stretchable attachment element, in cooperative relation with relatively small gaps provided along the edges of the transparent cover, provide suitably resilient retaining means of the catheter tubing and canula applied to the infusion site. [0016] The main body of the shield is, in some embodiments of the invention, made of a semi-rigid material such as Santoprene®, which is a low density, elastomeric thermoplastic rubber that can be formed into substantially any desired shape and size using a conventional injection molding process. Injection molded elements made of medical grade Santoprene®, such as the Santoprene® Product Ref. No. 28155ME2, generally have a substantially smooth, non-porous surface finish and are compatible with manual or automated sterilization processes commonly used in the medical field. However, in alternative embodiments of the invention, the main body is made out of a relatively inexpensive and disposable material, such a a cotton fabric.

[0017] In other embodiments of the present invention, the shell is configured and sized for receiving a body part selected from the group consisting of: at least a portion of a hand, at least a portion of a wrist, at least a portion of a limb, at least a portion of and ankle and at least a portion of a foot.

[0018] Some advantages present in at least some embodiments of the invention are to provide a shield for protecting a needle, for example at an infusion site, which does not require the use of adhesive tape to prevent the dislodgement of the canula and, thus, does not induce pain or discomfort that normally accompany the removal of such adhesive tape after use.

[0019] Also, in some embodiments of the invention, all-around smooth edges and non-porous surface finish renders the device readily compatible with manual or automated sterilization processes commonly used in the medical field and, thus, does not generate medical waste material since the device remains integrally reusable. [0020] Furthermore, in some embodiments of the invention, use of a relatively thick material in a 3-dimensional design that integrally covers the concerned limb portion of a patient having an infusion site inherently provides a protective cushioning means between the protection device and the patient's limb, a particularly appreciated aspect when the patient is a toddler or a young child who can get suddenly agitated without warning.

[0021] Finally, the proposed shield can be relatively simple and economical to produce.

[0022] In another broad aspect, the invention provides a shield for protecting a needle connected to a tube when the needle is inserted into a body part of a patient, the shield comprising: a main body defining a shell for receiving the body part thereinto, the main body including a first body section and a second body section, the first and second body sections being hinged to each other and movable between a body open configuration and a body closed configuration, wherein, in the body open configuration, the shield is removable from the body part, and, in the body closed configuration, the shield is securable around the body part, the first body section defining an aperture extending therethrough, the aperture being positionable substantially in register with the needle when the body part is received in the shell and the needle is inserted into the body part; a cover movable between a cover closed position and a cover open position, wherein, in the cover closed position, the cover extends across the aperture, and, in the cover open position, the cover is substantially retracted from the aperture, the cover being releasably fastenable to the shell in the cover closed position, the cover and the first body section together defining a gap therebetween allowing insertion of the tube therethrough and through the aperture when the cover is in the cover closed position; and a restraining element mounted to the shell for receiving the tube and substantially immobilizing at least a section of the tube relative to the shell.

[0023] The restraining element stabilizes the tube and therefore reduces the discomfort that could be experienced by the patient if the tube moved freely.

[0024] In some embodiments of the invention, the restraining element includes a pair of attachment strips each extending from the first body section, and a pair of anchors extending from the second body section, each of the attachment strips being removably attachable to a respective one of the anchors for selectively and reversibly locking the first and second body sections to each other in the body closed position, the tube being insertable between the first body section and each of the attachment strips when the attachment strips lock the first and second body sections to each other in said body closed position. Advantageously, the same component is usable for both closing and locking the first and second body sections to each other and for stabilizing the tube.

[0025] Other objects, advantages and features of the present invention will become more apparent upon reading of the following non-restrictive description of preferred embodiments thereof, given by way of example only with reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] FIGURE 1 , in a top plan view, illustrates a shield in accordance with an embodiment of the present invention, here shown covering the wrist and palm portion of the hand of a patient on top of which is applied an infusion canula; [0027] FIGURE 2, in a fragmented, top plan elevation view, illustrates the shield shown in FIG. 1 , here shown in a body open configuration;

[0028] FIGURE 3, in a fragmented, top plan view, illustrates a top body portion of the shield of FIG. 1 ;

[0029] FIGURE 4, in a transversal, cross-sectional view taken along section line IV-IV of FIG. 1 , illustrates a stretchable attachment strip of the shield of FIG. 1 shown detached with the shield in a slightly open configuration;

[0030] FIGURE 5, in a transversal, cross-sectional view taken along section line V-V of FIG. 1 , illustrates a cover part of the shield shown in FIG. 1 , the cover being here shown detached and partially open;

[0031] FIGURE 6, in a perspective view, illustrates a shield in accordance with an alternative embodiment of the present invention, the shield being adapted to cover a substantially rectilinear portion of a patient's limb, such as a portion of a forearm (as shown);

[0032] FIGURE 7, in a perspective view, illustrates a shield in accordance with another alternative embodiment of the present invention, the shield being adapted to cover the ankle and portion of a foot of a patient; and

[0033] FIGURE 8 , in a fragmented, perspective view, illustrates a shield in accordance with yet another alternative embodiment of the present invention, the shield being adapted to cover a portion of the forearm and bent elbow of a patient, here shown in a semi-open configuration. DETAILED DESCRIPTION

[0034] FIGS. 1 and 2 show various aspects of an embodiment of a shield 10 according to the present invention. The shield 10 generally comprises a typically integrally-molded or integrally manufactured main body 12 having a clam shell-like configuration being defined by an integral hinge portion 14 and two opposing side panels, or first and second body sections 16 and 18 respectively, extending perpendicularly from and rotatable about hinge portion 14. In this configuration, the first and second body sections 16 and 18 extend integrally from each other.

[0035] Main body 12 is made, for example of a semi-rigid material such as Santoprene®, which is a low density, elastomeric thermoplastic rubber that can be formed into substantially any desired shape and size using a conventional injection molding process. Injection molded elements made of medical grade Santoprene®, such as the Santoprene® Product Ref. No. 28155ME2, generally have a substantially smooth, non-porous surface finish and are compatible with manual or automated sterilization processes commonly used in the medical field. However, in alternative embodiments of the invention, the main body is made out of a relatively inexpensive and disposable material, such as a cotton fabric.

[0036] FIG. 2 shows first and second body sections 16 and 18 represented by substantially similar and rectangular shaped panel elements generally defined by a pair of adjacent inner side edges 20 and 22, proximal end edges 24 and 26, distal end edges 28 and 30, and corresponding pairs of longitudinal outer side edges 32 and 34 respectively. Outer side edges 32 and 34 are in turn defined by a plurality of corresponding side edge portions 36 and 38, 40 and 42, 44 and 46 respectively. The first and second body sections 16 and 18 are hinged to each other substantially adjacent the inner side edges 20 and 22. [0037] The first and second body sections 16 and 18 are movable between a body open configuration and a body closed configuration. In the body open configuration, the shield 10 is removable from the body part, such as hand 130, and, in the body closed configuration, the shield 10 is securable around the body part.

[0038] Furthermore, first and second body sections 16 and 18 are suitably shaped and sized such that, when main body 12 is in a body closed configuration, as best exemplified in FIGS. 1 and 5, they respectively form a paired upper and lower arcuate-shaped half shields that cooperatively and integrally cover the wrist and palm portions 132 and 134 of a patient's hand 130, excluding the distal end portions of the fingers 138 and thumb 136. In other words, when main body 12 is in the body closed configuration, first and second body sections 16 and 18 cooperatively form a hollow substantially tubular element having a substantially elongated shape of substantially oval transversal cross-section, as shown in FIGS. 4 and 5, and defining an inner open space 140 therein that is generally conforming to the shape of the palm and wrist portions 134 and 132of a patient's hand 130.

[0039] Corresponding outer side edge portions 40 and 42 cooperatively define a thumb aperture 41 through which may outwardly extend the thumb 136 when main body 12 is closed around a hand 130, as illustrated in FIG. 1. Outer side edge portion 40 of first body section 16 defines a lightly inwardly extending arcuate recess, while corresponding outer side edge portion 42 of second body section 18 defines an outwardly extending, trapezoidal-shaped tab portion 52. Tab portion 52 provides a support means for the underside of the base of the thumb 136 for increased rest and comfort of the patient. [0040] Thus, when main body 12 is closed around the hand 130 of a patient, as illustrated in FIG. 1 , integrally formed hinge portion 14 substantially extends parallelly adjacent the outer side edge portion of the hand 130 and wrist 132, while the oppositely disposed longitudinal side edges 32 and 34 are joined together substantially along the inner side edge of the hand 130 of the patient.

[0041] Typically, the inner dimensions of the hollow tubular element represented by main body 12, when in the body closed configuration, is comfortably slightly oversized relative to the shape and size of the patient's hand 130. Thus, the shield 10 of the present invention may be offered in a plurality of differently sized formats that are suitable to comfortably cover, for examples, the average size wrist and palm portions 132 and 134 of the hand 130 of a toddler, a young child, a teenager, an adult female, an adult male (for example in small, medium and large formats).

[0042] As best illustrated in FIGS. 4 and 5, in some embodiments of the invention, integrally formed hinge portion 14 is generally represented by a substantially linear, longitudinal decreased thickness portion along the adjacent inner side edges 20 and 22 of the first and second body sections 16 and 18 respectively. Hinge portion 14 may be advantageously shaped in a slightly outwardly protruding V-configuration, as shown in a cross-section view in FIGS. 4 and 5, for increased ease of the relative articulation of the first and second body sections 16 and 18 about the hinge portion 14, as well as for an increased mechanical longevity of the latter.

[0043] FIG. 4 shows a plurality of oppositely disposed and compatibly shaped longitudinal flanges 54 that are integrally formed and extending distally along the corresponding longitudinal side edges portions 36, 38, 44 and 46 of the first and second body sections 16 and 18 respectively. Thus, side edge portions 36 and 44 of first body section 16 correspondingly engage with substantially same size and oppositely configured side edge portions 38 and 46 respectively of second body section 18 (better seen in FIG. 2) to form a seemingly continuous wall portions when the shield 10 is in the body closed configuration.

[0044] Referring to FIG 1 , the main body 12 includes one or more attachments 60, 62 for securing the first and second body sections 16 and 18 to each other in the body closed configuration. Also, the attachments 60 and 62, in some embodiments of the invention, act as restraining elements for substantially immobilizing the tube 120 with respect to the main body 12. For example, a plurality, but typically two, releasable attachments 60 and 62 are provided for releasably holding first and second body sections 16 and 18 in the body closed configuration. As seen for example in FIG. 4, each attachment 60 and 62 includes an attachment strip 64, typically stretchable, extending from one of the first and second body sections 16 and 18, shown in the drawings as extending from the first body section 16. The attachment strips 64 are provided with a hooking element 66 for cooperatively engaging with an anchor 68 provided on the other one of the first and second body sections 16 and 18 and securing the first and second body sections 16 and 18 to each other in the body closed configuration.

[0045] As shown in FIG. 1 , a first stretchable attachment strip 64 may have its base portion 70 integrally formed, or otherwise glued, thermally welded of sewn, typically to a surface portion of first body section 16 proximal the junction between proximal end edge 24 and hinge portion 14. Likewise, second stretchable attachment strip 64 may have its base portion 70 integrally formed, or otherwise glued, thermally welded of sewn, typically to a surface portion of first body section 16 proximal the junction between distal edge 28 and hinge portion 14. [0046] The hooking element 66 may take the form of a square-shaped ring made of, for examples, a rust-proof metal or a suitably rigid plastic material. Hooking element 66 is adapted to be pivotably engaged through a transversal hole provided through the distal free end of the attachment strips 64. Thus, by pulling on the attachment strips 64 attached to first body section 16, the square-shaped rings may be engaged about the appropriately shaped anchors 68 attached to the second body section 18 and, thus, hold both first and second body sections 16 and 18 in the body closed configuration. Anchors 68 will be described in more details hereinbelow.

[0047] In alternate embodiments of the invention (not shown in the drawings), the hooking element takes the form of a substantially rectangular through hole provided proximal the distal end of the stretchable attachment strip 64, with an extra pulling tab portion at the distal end thereof to ease its manipulation. The through hole is adapted to be engaged about anchor 68.

[0048] A pair of corresponding anchors 68 are disposed at substantially diametrically opposite positions relative to the pair of base portions 70 of the stretchable attachment strips 64, as best illustrated in a cross-sectional view in FIG. 4. Anchors 68 are suitably configured with a protruding lip portion 82 extending distally relative to outer side edge 34 of second body section 18, for engaging with hooking elements 66 at the distal end of the stretchable attachment strips 64, as best illustrated in FIGS. 3 and 4.

[0049] Likewise the attachment strips 64, the anchors 68 may be integrally formed or otherwise glued or thermally welded to the outer surface of second body section 18. [0050] It is to be understood that the positions of the base portions 70 of the stretchable attachment strips 64, relative to the position of their corresponding anchors 68, may be mutually interchanged or reversed. In other words, the base portions 70 may be integrally formed with the second body section 18 and, inversely, the anchors 68 may be integrally formed with first body section 16.

[0051] A substantially rectangular-shaped aperture 90 of suitable dimension is provided, for example, through first body section 16 for allowing a ready access to the infusion site. The aperture 90 is positionable substantially in register with the needle 124 when the body part is received in the shell, and is typically centrally positioned in one of the first and second body sections 16 and 18.

[0052] Referring to FIG. 5, a substantially rectangular, openable cover 92, typically made of a flexible and slightly stretchable planar material, is generally defined by a first proximal side edge 94 integrally formed, or otherwise glued or thermally welded to a first side edge 96 of aperture 90, and a free distal side edge 98, or free end. The cover 92 is therefore hinged to the main body 12 substantially adjacent to the aperture 90. The cover 92 is movable between a cover open position and a cover closed position. In the cover closed position, the cover 92 extends across the aperture 90, and, in the cover open position, the cover 92 is substantially retracted from the aperture 90. The cover 92 provides selective access to the needle 124 with the shield 10 remaining positioned around the body part.

[0053] Cover 92 is typically transparent or translucent in order to allow a visual inspection of the infusion site even though the cover 92 is in the body closed configuration. [0054] Cover 92 is releasably fastenable to the shell of the main body 12 in the cover closed position and is provided, to that effect, with a pair of integrally formed attachment tabs 100 perpendicularly extending from its free distal side edge 98. Likewise the stretchable attachment strips 64 of first body section 16, the attachment tabs 100 are slightly stretchable and are provided with hooking elements 104 adapted to be engaged about corresponding anchors 102 suitably disposed along side edge 106 of aperture 90.

[0055] As seen for example in FIG. 2, the cover 92 is relatively shorter than the longitudinal dimension of aperture 90, which provides open gaps 97 near the proximal and distal edges 110 and 112 of the aperture, and through one of which may loosely be passed through the tubing 120 of at least one catheter 122 without applying pressure on the latter or creating distortion in the cover 92. The open gaps 97 thus created further provide natural ventilation means to aerate the infusion site. It is to be noted that the cover 92 may further be provided with perforations, or even be made of, in part or in whole, a flexible screen material, to allow additional ventilation of the site.

[0056] Cover 92 may be relatively wider than the lateral dimension of aperture 90 such that its free distal side edge 98 slightly overlaps the shell adjacent the side edge 106 of aperture 90 in order to provide added mechanical support to the cover 92 when the latter is in the closed position, as shown in FIGS. 1 and 3.

[0057] Thus, when the shield 10 is in the body closed configuration around a patient's hand 130, and the cover 92 is closed over the aperture 90, the cover 92 leaves sufficient underlying free space between the latter and the surface of the hand 130 for a standard size canula 124 properly inserted through the skin region defining the infusion site.

[0058] It is to be noted that aperture 90, with correspondingly shaped openable cover 92 may have any other suitable shape such as, for examples, a substantially rounded or oval shape. Furthermore, it is to be noted that openable cover 92, with its associated stretchable attachment tabs 100 and anchors 102, may as well be configured to be openable from the opposite side of auxiliary aperture 90.

[0059] It is important to note that in some embodiments of the invention, the shield 10 of the present invention has substantially only soft corners and shallow grooves along its various edges and hinge portions to allow, for example, medical personnel to thoroughly clean and disinfect the shield 10 to medical standards using a conventional cleaning method such as applying a liquid or vaporized disinfectant and wiping with a clean cloth, or using an automatic or semi-automatic sterilizing process.

[0060] Furthermore, the protruding lip portions 82 of the anchors 68 and 102 are suitably rigid, yet flexible enough to be slightly bent outwardly relative to the outer surface of the shield 10 in order to allow a thorough cleaning of the latters, here again, using a conventional cleaning method such as applying a liquid or vaporized disinfectant and wiping with a clean cloth.

[0061] In a manner readily apparent to one skilled in the art of applying and securing an intravenous, or I. V., catheter 122 to a body part, a patient's hand 130, for example, is comfortably positioned, palm 134 first, into the inner surface of second body section 18 of an open shield 10. First body section 16 is then closed over the hand 130 and the stretchable attachment strips 64 fastened to their corresponding anchors 68 in order to hold first and second body sections 16 and 18 in the body closed configuration around the hand 130.

[0062] By slightly stretching the attachment strips 64, the distal end of an elongated tubing 120 of a catheter 122 may be progressively inserted between the attachment strips 64 and the outer surface of first body section 16 such that, finally, at least two suitable portions of the tubing 120 are resiliently held in place therebetween, as illustrated in FIG. 1. With the cover 92 open, the distal end of the canula 124 may then be properly inserted under the skin of the patient's hand 130. The cover 92 may then be closed over the infusion site in order to protect the latter while still allowing a visual inspection of the site.

[0063] To remove the catheter 122 and shield 10 from the patient's hand 130, cover 92 is first opened, the canula 124 removed, followed with detaching the attachment strips 64, which concurrently allow the release of the elongated tubing 120 of the catheter 122 and the opening of the shield 10, thus freeing the hand 130 of the patient.

[0064] FIG. 6 shows an alternate embodiment 160 of the shield of the present invention that is adapted to cover at least a substantially rectilinear portion of a patient's limb, such as, for example, a portion of a forearm 162 (as shown), a portion of a lower leg, or the likes. The general configuration of the present embodiment 160 is substantially similar to the first embodiment 10 described above, except that the hollow tubular element has an essentially rounded transversal cross-section, and that there is no lateral aperture provided.

[006S] FIG. 7 shows another alternate embodiment 163 of the shield that is adapted to cover at least a portion of the ankle and at least a portion of a foot of a patient. The general configuration of the present embodiment 163 is a hollow tubular element having a substantially L-shaped, longitudinal cross-section. Furthermore, the configuration of the aperture 164 and cover 166 are shared between first and second body sections 168 and 169 of the device.

[0066] FIG. 8 shows yet another alternate embodiment 142 of the shield that is adapted to cover a portion of the forearm and bent elbow of a patient, here shown in a semi-open configuration. The alternate embodiment 142 is essentially similar to the alternate embodiment 160 shown in FIG. 6, except that corresponding extension portion 144 of first and second body sections 146 and 148 are provided for circumscribing a lower back portion of a bent elbow.

[0067] Although the present invention has been described hereinabove by way of preferred embodiments thereof, it can be modified, without departing from the spirit and nature of the subject invention as defined in the appended claims.