Devices and methods for protecting a user from a sharp tip of a medical needle

There are disclosed devices and methods for protecting a user from a sharp tip of a medical needle. In an embodiment, a device includes a central body portion, a medical needle having a sharp tip, a pair of wings in attachment to the central body portion, and a mechanical fastener disposed on at least one of the wings, the mechanical fastener configured to selectively attach the wings together with the medical needle positioned between the wings so as to protect a user from the sharp tip of the medical needle. In another embodiment, a method includes withdrawing a sharp tip of a medical needle from a patient, closing a pair of wings with the medical needle positioned between the wings, and fastening the wings together with the medical needle positioned between the wings so as to protect a user from the sharp tip of the medical needle.

BACKGROUND

Generally, Huber needles, subcutaneous needles, and other types of medical needles with sharp tips are inserted by medical workers for medical procedures into patients. These users typically have to carefully maintain the sharp tip during and after removal of the medical needle from the patient until the medical needle is properly disposed of in a biohazard container. As this sharp tip is contaminated with blood or other fluids from the patient, it is considered a significant hazard.

Due to difficulties with the patient, including both physical and mental issues, the carrier portion with the medical needle often is not handled with the degree of care necessary by the user. In contending with various patient issues, a user may become injured by the sharp tip of the needle.FIG. 1illustrates an example of a device100having a sharp tip102at the end of a medical needle104between a pair of wings106,108. Wings106,108are positioned to allow placement of needle104into a patient, and to assist with removal of needle104from the patient. However, wings106,108provide little, if any, protection to a user from needle104during or after removal from the patient.

Various safety devices have been used as an attempt to ameliorate the danger of the medical needle. However, the currently known safety devices are generally not designed to meet clinical protocols and are difficult to use with other devices. Current devices tend to have a profile which will extend away from a patient's body.

SUMMARY

In an embodiment, there is provided a device for protecting a user from a sharp tip of a medical needle, the device comprising a central body portion in fluid connection with a delivery tube; a medical needle having a first end and a second end in opposition to one another, the first end in fluid connection with the central body portion and the delivery tube, and the second end of the needle extending away from the central body portion to a sharp tip, and a line from the first end to the second end of the medical needle defining a longitudinal axis; a pair of wings having an inner region and an outer region, the inner region of each one of the pair of wings in attachment to the central body portion, the outer region of each one of the pair of wings extending away from the central body portion, the pair of wings disposed in opposition to one another with the medical needle positioned therebetween, and the pair of wings being selectively positionable from a first position to a second position, the first position for placing the medical needle into a patient and delivering a medicinal fluid to a second position, and the second position for removing the medical from the patient; and a mechanical fastener disposed on at least one of the pair of wings, the mechanical fastener configured to selectively attach the pair of wings together with the medical needle positioned therebetween so as to protect a user from the sharp tip of the medical needle.

In another embodiment, there is provided a device for protecting a user from a sharp tip of a medical needle, the device comprising a central body portion in fluid connection with a delivery tube; a medical needle having a first end and a second end in opposition to one another, the first end in fluid connection with the central body portion and the delivery tube, and the second end of the needle extending away from the central body portion to a sharp tip, and a line from the first end to the second end of the medical needle defining a longitudinal axis; and a sleeve slideably disposed in a surrounding configuration to the central body portion, a sliding mechanism formed by the sleeve and the central body portion allowing movement of the sleeve from a first position to a second position, the sleeve in the first position providing the medical needle in a configuration for insertion into a patient and delivery of a medicinal fluid in the patient, and the sleeve in the second position covering the medical needle so as to protect a user from the sharp tip of the medical needle.

In yet another embodiment, there is provided device for protecting a user from a sharp tip of a medical needle, the device comprising a central body portion in fluid connection with a delivery tube; a medical needle having a first end and a second end in opposition to one another, the first end in fluid connection with the central body portion and the delivery tube, and the second end of the needle extending away from the central body portion to a sharp tip, and a line from the first end to the second end of the medical needle defining a longitudinal axis; and a frame member having a polygonal structure extending from the central body portion, the polygonal structure having a first hinged portion, a second hinged portion, a third hinged portion, and a fourth hinged portion, the first hinged portion positioned at the central body portion, the second hinged portion positioned in opposition to the first hinged portion, the third hinged portion and the fourth hinged portion positioned, in opposition to one another, between the first hinged portion and the second hinged portion, the polygonal structure forming an opening at the second hinged portion sized for passage of the medical needle, the polygonal structure selectively positionable from a first position to a second position, the first position configured with the first hinged portion and the second hinged portion in an open configuration, and the third hinged portion and the fourth hinged portion in a closed configuration, with the medical needle extended through the opening for placement into a patient and delivery of a medicinal fluid, and the second position configured with the first hinged portion and the second hinged portion in a closed configuration, and the third hinged portion and the fourth hinged portion in an open configuration, with the polygonal structure surrounding the medical needle so as to protect a user from the sharp tip of the medical needle.

In still another embodiment, there is provided a method of protecting a user from a sharp tip of a medical needle, the method comprising withdrawing a sharp tip of a medical needle from a patient; closing a pair of wings with the medical needle positioned therebetween; and fastening the pair of wings together with the medical needle positioned therebetween so as to protect a user from the sharp tip of the medical needle.

In another embodiment, there is provided a method of protecting a user from a sharp tip of a medical needle, the method comprising withdrawing a sharp tip of a medical needle from a patient; and sliding a sleeve slideably disposed in a surrounding configuration to a central body portion from a first position providing the medical needle in a configuration for insertion into the patient and delivery of a medicinal fluid in the patient to a second position covering the medical needle so as to protect a user from the sharp tip of the medical needle.

In yet another embodiment, there is provided a method of protecting a user from a sharp tip of a medical needle, the method comprising withdrawing a sharp tip of a medical needle from a patient through an opening formed in a polygonal structure of frame member; and articulating hinges of the polygonal structure to close the frame member surrounding the medical needle so as to protect a user from the sharp tip of the medical needle.

It is to be understood that the scope of the invention is to be determined by the scope of the claims as issued. Nothing in this Summary or the Background is to be construed as requiring a feature set forth herein or that a given embodiment address issues identified in the Background. In this regard, there are other aspects and features of varying embodiments. The will become apparent as the Specification proceeds.

DETAILED DESCRIPTION

Referring toFIGS. 2-15, there are provided devices for protecting a user from a sharp tip of a medical needle. These safety devices provide protection to eliminate needle stick injuries when using needles associated with subcutaneous fluid administration as well as access to implanted ports.

Subcutaneous sets needles and sets are used to infuse a pharmaceutical product into the subcutaneous tissue. During the insertion and removal, the needle is exposed to users and may cause needle-stick injuries. In addition to subcutaneous needle, Huber needle sets (otherwise known as non-coring needles) are used to infuse a pharmaceutical product into a previously implanted port (which is typically made from titanium). The port has a septum space defined between the titanium port body and an elastic membrane that covers it. Huber needles are inserted through the skin into the port.

Conventional Huber devices can pose difficulty when removing from the patient. A clinician may need to apply a significant amount of force to remove the device. During this process, the needle may free suddenly, as a result of the force applied, and increase the risk of accidental needle stick injury from the exposed needle.

The safety devices described herein include, but are not limited to, subcutaneous needles and Huber needles. The safety devices improve user safety during removal of the needle from the patient. The safety devices described herein may also be applied to other devices that have needles.

A device200, which is shown inFIG. 2, may include a central body portion202in fluid connection with a delivery tube204. A medical needle206has a first end208and a second end210in opposition to one another. First end208is in fluid connection with central body portion202and delivery tube204. Second end210of needle206may extend away from central body portion202to a sharp tip212. A line from first end208to second end210of medical needle defines a longitudinal axis214.

A pair of wings216,218have an inner region220and an outer region222. Inner region220of each one of the pair of wings216,218may be provided in attachment to central body portion202. Outer region222of each one of the pair of wings216,218may extend away from central body portion202. The pair of wings216,218disposed in opposition to one another with the medical needle positioned therebetween, and the pair of wings216,218being selectively positionable from a first position to a second position. The first position may be generally configured for placing medical needle206into a patient and delivering a medicinal fluid. The second position may be configured for removing the medical needle206from the patient.

A mechanical fastener224may be disposed on at least one of pair of wings216,218. Mechanical fastener224may be configured to selectively attach the pair of wings216,218together with medical needle206positioned in between wings216,216. This attachment of the wings216,218protects a user from sharp tip212of medical needle206. In one embodiment, fastener224may include portions224A and224B.

Optionally, central body portion202may include a handle. For example,FIG. 11illustrates a handle1126extending from central body portion202.

Referring toFIG. 2, mechanical fastener224may include one of wings216,218with an orifice224A and a pin224B extending from other one of wings216,218. Orifice224A and pin224B may be configured to engage with one another to selectively attach the pair of wings216,218together with medical needle218positioned between wings216,216. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

Orifice224A has a diameter226. Pin224B also has a diameter228. In one embodiment, diameter226of orifice224A is shorter than the diameter228of pin224B. Looking atFIG. 3, there is shown a device300having mechanical fastener324. In one embodiment, mechanical fastener may include portions324A and324B. For example, an orifice324A is provided with a major axis330and a minor axis332. A pin324B is provided with a diameter328. Major axis330of orifice324A is longer than diameter328of pin324B. Minor axis324B of orifice324B is shorter than diameter328of pin324B.

In an embodiment, a device400(FIG. 4) with mechanical fastener424may include a male portion424A and a female portion424B. For example, mechanical fastener may be configured as a snap button424Male portion424A of snap button424may be mounted to one of wings216,218. Female portion424B of snap button424B may be mounted to the other one of the wings216,218. Male portion424A and female portion424B of snap button424are configured to engage with one another to selectively attach the pair of wings216,218together with the medical needle206positioned between wings216,218. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

Referring now toFIG. 5, and in an embodiment, a device500may include mechanical fastener524with female portions524A and a male portions524B. For example, one of the wings216,218forms a plurality of orifices524A and the other one of the wings216,218has a plurality of pins524B. The plurality of pins524B and the plurality of orifices524A may be configured to engage with one another to selectively attach the pair of wings216,218together with medical needle206positioned between wings216,218. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

A device900, which is shown inFIG. 9, may include a mechanical fastener924with a first portion934in attachment to one of the wings216,218, and a second portion936in attachment to the other one of the wings216,218. First portion934and second portion936may be configured to engage with one another to selectively attach the pair of wings216,218together with medical needle206positioned between wings214,216. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

In an embodiment, a device1000(FIG. 10) may include a mechanical fastener1024with one or both of the wings216,218forming a recessed portion1038adjacent a perimeter1040. Mechanical fastener1024may also include a lip1042extending from at least a portion of perimeter1040of one or both of the wings216,218. Recessed portion1038and lip1042may be configured to engage with one another to selectively attach the pair of wings216,218together with medical needle206positioned between wings216,218. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

In one embodiment, the pair of wings216,218may include rigid material. In another embodiment, the pair of wings216,218may include semi-rigid material. The pair of wings216,218of device1000may be provided in various shapes including, but not limited to, circular shapes and rectangular shapes.

Device1000may be provided with a groove1044in at least one of the wings216,218. Groove1044may be sized for housing medical needle206after the pair of wings216,218are attached to one another. This attachment of the wings216,218protects a user from sharp tip212of medical needle206. In one embodiment, groove1044may be formed in a single one of the wings216,218. In another embodiment, groove may be formed in both of the wings216,218.

A device1100(FIG. 11) provides an exemplary embodiment of handle1126extending from central body portion202. One or more of the embodiments disclosed herein may include a handle extending away from central body portion202in opposition to medical needle206and in a direction from second end210to first end208of medical needle206.

Looking atFIG. 12, and in an embodiment, mechanical fastener1200may include a hook-and-loop fastening system1224disposed on the pair of wings216,218. Hook-and-loop fastening system1124may be configured to engage with one another to selectively attach the pair of wings216,218together with medical needle206positioned between wings216,218. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

Hook-and-loop fastening system1224may include a hook material1224A disposed on one of the wings216,218. A loop material1224B may be disposed on the other one of the wings216,218. Hook material1224A and loop material1224B may be configured to engage with one another to selectively attach the pair of wings216,218together with medical needle206positioned between wings216,218. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

Referring toFIG. 13, and in one embodiment, device1300may provide hook-and-loop fastening system1224with hook material1224A having a low profile together with loop material1224B having a low profile.

Referring back toFIG. 12, hook-and-loop fastening system1224may also include hook material1224A and loop material1224B on each of the pair of wings216,218. Hook material1224A and loop material1224B may be disposed for engagement with one another on opposed wings216,218. This configuration of hook material1224A and loop material1224B provides a dual locking configuration.

In an embodiment, hook-and-loop fastening system1224may include hook material1224A on one of the wings216,218, loop material1224B on the other one of the pair of wings216,218, and adhesive material1246within one or both of hook material1224A and loop material1224B. Adhesive material1246in hook material1224A and loop material1224B may be disposed for engagement with one another to attach the pair of wings216,218together with medical needle206positioned between wings216,218. This attachment of the wings216,218protects a user from sharp tip212of medical needle206.

In various embodiments, wings216,218may be configured with various materials and in various shapes. For example, wings216,218of device1200may include rigid material. Wings216,218of device1200may include semi-rigid material. Wings216,218of device1200may include soft material. Wings216,218of device1200may include gel material. Wings216,218of device1200may include cloth. Wings216,218of device1200may include non-woven cloth. In addition, the pair of wings216,218may include a combination of a rigid material, a semi-rigid material, a soft material, a gel material, a cloth material, and a non-woven cloth material. Wings216,218of device1200may have one or more shapes, including, for example, a circular shape, a rectangular shape.

In an embodiment, adhesive material1246may be dynamically activated. Dynamic bonding agents may include a two component glue-primer and glue each applied to one of the two surfaces to be bonded in which neither component is active until contact with one another. In an alternative example, a “bubble” full of instant glue, which may have a response time of under three seconds, may be configured to burst upon pressing wings216,218together.

Adhesive material1246may be incorporated in a gel carrier. A gel carrier is a good way to house a bubble of the instant glue above. Gel or silicone are a very comfortable materials for patients and can overlay hypo-allergenic double-sided adhesive tapes. This may facilitate attachment of the device to the patient's skin.

Referring now toFIG. 14, and in an embodiment, a device1400is provided to protect a user from sharp tip of medical needle. Device1400may include a central body portion1402in fluid connection with a delivery tube1404.

A medical needle1406may be provided with a first end1408and a second end1410in opposition to one another. First end1408may be in fluid connection with central body portion1402and delivery tube1404. Second end1410of needle1406may extending away from central body portion1402to a sharp tip1412. A line from first end1408to second end1410of medical needle1406defines a longitudinal axis1414.

A sleeve1416may be slideably disposed in a surrounding configuration to central body portion1402. A sliding mechanism1418(e.g., grooves1418) may formed by sleeve1416and central body portion1402to allow movement of sleeve1416from a first position to a second position.

In the first position, sleeve1416may provide medical needle1416in a configuration for insertion into a patient and delivery of a medicinal fluid in the patient (i.e., needle1406is substantially perpendicular to delivery tube1404.) In the second position, sleeve1416may cover medical needle1406so as to protect a user from sharp tip1412of medical needle1406(i.e., needle1406is substantially parallel to delivery tube1404.)

In one embodiment, needle safety devices may be provided non-DEHP tubing1500(FIG. 15) or polypropylene lined tubing1600(FIG. 16) with a layer1602of polypropylene surrounding an inner lumen1604. Most needle safety devices may be built with a non-DEHP tubing. Polypropylene is a means to minimize chemical interaction (i.e., between the drug and the plastic, thus, minimizing the bleaching effect). Devices may be provided with two tubing material options to minimize chemical interchange with drug. One of these options may include non-DEHP tubing. Another option is polyethylene lined tubing, which provides the least interaction with infused drug.

Referring toFIGS. 17-18, and in an embodiment, a device1700is provided for protecting a user from a sharp tip of a medical needle. Device1700includes a central body portion1702in fluid connection with a delivery tube1704. A medical needle1706has a first end1708and a second end1710in opposition to one another. First end1708may be in fluid connection with central body portion1702and delivery tube1704. Second end1710of needle1706extends away from central body portion1702to a sharp tip1712. A line from first end1708to second end1710of medical needle1706defines a longitudinal axis1714.

Device1700includes a frame member1716forming a polygonal structure1718extending from central body portion1702. Polygonal structure1718has a first hinged portion1720A, a second hinged portion1720B, a third hinged portion1720C, and a fourth hinged portion1720D. First hinged portion1720A and second hinged portion1720C may be positioned at central body portion1720. First hinged portion1720A and second hinged portion1720B may be positioned in opposition to one another. Third hinged portion1720C and fourth hinged portion1720D may be positioned in opposition to one another and extend from first hinged portion1720A and second hinged portion1720B. Polygonal structure1718may form an opening1722at second hinged portion1720B sized for passage of medical needle1706.

Polygonal structure1718may be selectively positionable from a first position to a second position. First position1718may be configured with each of first hinged portion1720A and second hinged portion1720B in a closed configuration, and third hinged portion1720C and fourth hinged portion1720D in a closed configuration. For insertion into patient,1720A and1720B are typically in an open position, which allows wings1730to serve as the handle and device to insert the needle while third hinged portion1720C and fourth hinged portion1720D are in the closed position with layer1726laying flat against mechanical fasteners1724In this configuration, medical needle1706is extended through opening1722for placement into a patient and delivery of a medicinal fluid. After insertion, mechanical fastener portions1732are laid over base portion1728(mechanical fastener portions1732and base portion1728may have hook-and-loop fastener portions on both sides) to secure the overall device in place. Prior to removal, fastener portions1732are removed from base portion1728, then the clinician's hand (left or right depending on preference) is placed over layer1726but not over any other layer and first hinged portion1720A and second hinged portion1720B are moved to an open position to allow for the needle to be pulled out thus bringing third hinged portion1720C and fourth hinged portion1720D to a closed position. Second position may be configured with first hinged portion1720A and second hinged portion1720B in an open configuration, and third hinged portion1720C and fourth hinged portion1720D in an open configuration. In this configuration, medical needle1706is withdrawn through opening1722and polygonal structure1718is closed around medical needle1706. This surrounding configuration of polygonal structure1718around medical needle1706protects a user from sharp tip1712.

In an embodiment, one or more mechanical fasteners1724may be disposed on frame1716. Mechanical fastener1724may be configured to selectively attach opposed areas of portions1720C and1720D to one another with medical needle1706positioned between opposed ones of portion1720A and1720B, and portion1720C and1720D. This surrounding configuration of polygonal structure1718around medical needle1706protects a user from sharp tip1712.

In one embodiment, one or more mechanical fasteners1724may include a hook-and-loop fastening system. The hook-and-loop fastening system may include a hook material having a low profile as well as a loop material having a low profile. In an embodiment, the hook-and-loop fastening system may include a hook material and a loop material on each of the regions1724between third hinged portion1720C and fourth hinged portion1720D. The hook material and the loop material may be disposed to engage with one another so as to provide a dual locking configuration.

Mechanical fastener1724may include an adhesive material disposed on one or more of portion1720C and1720D. The adhesive material may be configured to engage with another area of portions1720C and1720D of polygonal structure1718to selectively attach opposed portions1720C and1720D of polygonal structure1718to one another with medical needle1706positioned between opposed portions1720A,1720B,1720C, and1720D. This surrounding configuration of polygonal structure1718around medical needle1706protects a user from sharp tip1712.

In an embodiment, the adhesive material may be dynamically activated. The adhesive material may optionally be incorporated in a gel carrier. In various embodiments, mechanical fastener1724may include peelable coverings containing adhesive.

Opposed portions1720A,1720B,1720C, and1720D of polygonal structure1718may be shaped in a variety of shapes, which include, but are not limited to a circular shape, a rectangular shape, and an elliptical shape. Opposed portions1720A and1724B as well as1720C and1720D of polygonal structure1718may include rigid material, semi-rigid material, soft material, gel material, cloth, non-woven cloth, or a combination of these materials.

In an embodiment, an adhesive layer1726may extend from central body portion1702.

Handle1730may extend away from central body portion1702in opposition to medical needle1706and in a direction from first end1708to second end1710of medical needle1706. Handle1730, or any of the handles described hereinabove, facilitates the manipulation of the device during removal. Handle1730may be shaped as a tab, a loop, with flaps or wings, or as a detachable clip. Handle1730may include rigid material, semi-rigid material, soft material, gel material, cloth, non-woven cloth, or a combination of these materials. Handle1730allows the user to remove device1700by providing a grab portion to be pulled upwardly. Handle1730may include a mechanical fastener1732(for example, hook-and-loop material1732) that mates with base portion1728. In an embodiment, a mechanical fastener1732may extend from base1728. Handle1730and mechanical fastener1732may be used to maintain device1700in a relatively flat configuration, and are generally not attached to a patient. Mechanical fastener1732may be configured to removeably attach to a patient.

Various methods of protecting a user from a sharp tip of a medical needle are provided by the present invention. In one exemplary embodiment, a method of protecting a user from a sharp tip of a medical needle includes withdrawing a sharp tip of a medical needle from a patient. The method further includes closing a pair of wings with the medical needle positioned between the wings. The method also includes fastening the pair of wings together with the medical needle positioned between the wings. This protects a user from the sharp tip of the medical needle.

In another exemplary embodiment, a method of protecting a user from a sharp tip of a medical needle includes withdrawing a sharp tip of a medical needle from a patient. The method also includes sliding a sleeve slideably disposed in a surrounding configuration to a central body portion from a first position providing the medical needle in a configuration for insertion into the patient and delivery of a medicinal fluid in the patient to a second position covering the medical needle. This protects a user from the sharp tip of the medical needle.

In an embodiment, a method of protecting a user from a sharp tip of a medical needle includes withdrawing a sharp tip of a medical needle from a patient through an opening formed in a polygonal structure of frame member. The method further includes articulating hinges of the polygonal structure to close the frame member surrounding the medical needle. This protects a user from the sharp tip of the medical needle.

Most of the safety devices may be configured with a low profile and small foot print. A small foot-print is particularly useful when the implanted port is a dual port that can only be accessed by two needle sets with a small footprint. Selected materials and a low profile provide enhanced patient comfort, ease of manipulation, ease of fixation, and reduced number of separate pieces to be used when the device is put on the patient.

A misaligned orifice may be provided in device1700by providing a non-concentric needle axis through orifice1722. Needle1706is forced to fit through orifice1722during assembly of the device. Once the needle is pulled through orifice1722, its axis will force it to its natural position and, thus, it will not be in alignment with orifice1722. In one embodiment, the orifice through which the needle goes through on a lower wing can be purposely misaligned (e.g., about twice as much as the needle diameter) so that when the needle is pulled and the double wings take a diamond shape that gradually flattens; the needle will shift out of alignment with the hole.

In an embodiment, a hook-and-loop material1734may be positioned on the lower side of wings1730and the upper part of frame member1716. When the needle is in the patient and the device is flat against the skin, hook-and-loop material1732secures the device in its flat position. The loop is the simplest of the three options to be able to pull up the entire polygonal structure. Removal may also be accomplished by pulling on a tab or wings1730.

In an embodiment, there may be a shroud1900positioned between hinged portions1720A-1720D. Shroud1900may extend from a low-profile annular ring1900A (FIG. 19) to an extended cylinder1900C (FIG. 21) so as to cover sharp tip1712of needle1706when pulled back into a retracted position. As needle1706is being removed from a patient, for example, shroud1900will from a more elongated cylinder1900B (FIG. 20) between hinged portions1720A-1720D until shroud1900is deployed to cover sharp tip1712as extended cylinder1900C. In other words, the operation of the movement of the operator pulling handle1730upwardly opens the bellows of shroud1900as frame1716opens to a greater height. This can be used instead of, or in addition to, other protection devices.

A needle trap2200may be provided at the end of shroud1900or other needle protection devices. Needle trap2200has a rounded tip2202that has a diameter slightly larger than the diameter of needle1706. Flaps2204are positioned to abut needle1706prior to entrapment within shroud1900or another needle protection device. Flaps2204are resilient and biased to move toward one another, for example, to a flat position when needle1706is removed. Flaps2204may be positioned relative to one another such that one overlaps the other preventing needle1706from going back through needle trap2200.

The material of flaps2204can be a number of semi-rigid plastics, which may include, for example, PVC and polypropylene, or metal. If plastic is used, the both body and flaps2204can be manufactured by injection molding techniques in a single process. The thickness and angle of flaps2240and may be configured to allow bending closer to the inner wall, so that the needle may be positioned through the end of the needle trap2200during assembly time. After needle1706is withdrawn into shroud1900, the inwardly angled flaps2204prevents needle1706from going through again.

In another embodiment, and referring toFIGS. 26-29, a flat spring trap2600has a low-profile configuration with a loaded position and an activated position to retain needle1706subsequent to use. Flat spring trap2600may be used in place of needle trap2200with shroud1900, or trap2600may be used with other needle protection devices. For example, a tempered flat wire forming a flat spring2602may be bonded at a point2604to a surface of trap2600. Away from bonded point2604, a cover2606may be in connection with spring2602. Cover2606may have a height substantially equal to spring2602. Alternatively, cover2606may have a different height than spring2602. An orifice2608is positioned through trap2600with a size to accommodate needle1706. During assembly of a needle protection device, spring2602and cover2608are shifted away from orifice2608so that needle1706is threaded through orifice2608. When needle1706is withdrawn through orifice2608, spring2602moves cover2606to a position near orifice2608so as to prevent needle1706from again going through orifice2608.FIG. 26illustrates needle1706configured through trap2600in a loaded, ready to use position.FIG. 27illustrates cover2606in an activated position with needle1706withdrawn from trap2600. Trap2600is advantageous with a low-profile, an almost flat configuration. For example, spring2602may have a thickness of 1/32 of an inch. In an embodiment, spring2602may be made out of stainless steel. In another embodiment, spring2602may be stamped or otherwise configured from a plastic material. In an embodiment, spring2602may be completely flat to have a total height in the same amount as the thickness of the wire or other material forming the spring.

In another embodiment, a trap2600A includes a very small diameter spring2602A rather than a flat spring. Small diameter spring2602A may be about 1/16 of an inch in diameter. Small diameter spring trap2602A may be used in place of needle trap2200, or flat spring trap2600, with shroud1900, or with other needle protection devices. For example, a spring2602may be bonded at a point2604A to a portion of trap2600A. Away from bonded point2604A, a cover2606A may be in connection with spring2602A. An orifice2608A is positioned through trap2600with a size to accommodate needle1706. During assembly of a needle protection device, spring2602A and cover2608A are shifted away from orifice2608A so that needle1706is threaded through orifice2608A. When needle1706is withdrawn through orifice2608A, spring2602A moves cover2606A to a position near orifice2608A so as to prevent needle1706from again going through orifice2608A.FIG. 28illustrates needle1706configured through trap2600A in a loaded, ready to use position.FIG. 29illustrates cover2606A in an activated position with needle1706withdrawn from trap2600A. Trap2600A is advantageous with a low-profile, an almost flat configuration. In an embodiment, spring2602A may be a cylindrical minute spring at least as small as 1/16″ in diameter or smaller such that the diameter of the spring wire is approximately 20-30 thousands of an inch.

In another embodiment, a sliding door trap3000includes a door portion3002and a housing portion3004. An exemplary illustration of sliding door trap3000is shown inFIG. 30. One embodiment of door portion3002is illustrated inFIG. 31. A cross-sectional view of sliding door trap3000is shown inFIG. 30. An opening through door portion3002provides an orifice3006for a needle. A spring portion3008(of door portion3002biases against housing portion3004so as to move orifice3006away from the path of the needle when the needle is removed from orifice3006. Door portion3002may include plastic material, metal, or other types of material. In an embodiment, door portion3002has concentric grooves to form biasing spring3008and an off-centered orifice3006. During assembly, orifice3006is forced into a concentric position by reducing the space between the spiral grooves of spring3008to a minimum. When the needle is withdrawn, door portion3002realigns back into a pre-configured natural off-centered position and, thus, the needle cannot go back through to inadvertently stick a user.

In another embodiment, a needle protection device3300includes a needle covering spring3302housed in a recess3303within central body portion202. A needle3304extends from within needle covering spring3302and remains uncovered when needle covering spring3302remains within recess3303. In one embodiment, needle trap2200(described hereinabove) or another end portion of spring3302may engage an abutment3506. To release spring3302after a procedure is completed, abutment3306may be actuated to allow needle trap2200and a portion of spring3304to travel toward the end of the needle. Needle trap2200may operate as described above or the spring may operate in another matter, such as simply covering the end of the needle. One way to release spring3304is to move portions3306A and3306B of abutment3306in connection with wings216,218apart from one another.FIGS. 33 and 34illustrate one embodiment of device3300with abutment3306prior to actuation in a loaded configuration.FIGS. 35 and 36correspond with illustrate device3300after actuation with spring3302actuated to cover needle3304.

Regarding the polygonal designFIG. 17, one variation of such is a multi-axis polygon which is covered all around. Imagine two triangular pyramids with their bases attached such that the needle is not visible from any side and thus there is no possibility for any finger to be placed close to the needle at any time during the withdrawal.

Regarding the patient adhesive on the bottom of the polygonal design, such adhesive provides an added level of safety because the clinician places one hand over this layer with the adhesive still on the patient while the needle is being withdrawn from the patient and thus the needle reaches the inside of the “accordion” while the clinicians hands are busy (one with the lower layer and the other with pulling up the top layer—and thus further reducing the possibility of the needle reaching the clinician).

Most safety devices require complex mechanisms to trap the needle. The devices of the present invention provide simpler, easier to manufacture, and yet modifiable, products that satisfy additional clinical requirements beyond safety. These additional requirements include lower profile, flexibility, customizability, patient comfort, and scalability.

Lower profile is critical for patients that wear these devices during prolonged periods of time. Flexibility of the devices is unique as most other safety devices are made from stiff, mechanically complex plastics. The geometry of these designs can be modified to satisfy specific criteria, including the need to use this device with a “dual implanted port,” which may be limited by larger foot-print of other existing devices, and various clinical preferences. Patient comfort is provided in that softer materials are in contact with patient. The ability to use materials that minimize patient allergenic reactions. As discussed above, lower profile and smaller foot-print reduce patient discomfort. Scalability is achieved in that various design features may be used in conjunction with one another as desired.