ES2395331T3 - Resettable safety sleeve for medical needles - Google Patents

Abstract

A medical needle sheath apparatus comprising: a needle cap having an outer needle cannula extending therefrom to an extremodistal, an inner needle arranged for sliding movement with the outer needle cannula; and at least one sheath that is extensible from a retracted position to an extended position to include a distal end of the inner needle, the sheath includes a joining member disposed inside the sheath and defining joining surfaces that form an opening configured for sliding reception of the inner needle between the retracted position and the extended position, characterized in that the connecting member includes at least one drag induction member so that the at least one drag induction member engages the inner needle during the sliding reception of the inner needle to create a drag force with the inner needle, facilitating the drag force facilitates the rotation of the connecting member with respect to a longitudinal axis of the inner needle so that the joining surfaces are coupled to the inner needle, to prevent Sliding movement of the inner needle in the extended position of the sheath, the member In addition, a connecting pin includes a needle communication surface that extends from it in such a way that the needle communication surface can be coupled with the inner needle to prevent rotation of the connecting member, a retainer for removable engagement with the needle bushing, and the connecting member that includes a readjustment surface of the selectively aligned joint member with a bushing readjustment surface.

Description

Resettable safety sleeve for medical needles

Background

1.- Technical field

The present disclosure relates, in general, to the safety covers for medical needles and, more particularly, to safety covers that protect a needle tip of a medical needle.

2.- Description of the related technique

Problems associated with accidental needle sticks are well known in the art of blood sampling, percutaneous medication injection and other medical procedures that involve the use of medical needles. Special attention has been given to the problems of needle sticks due to contemporary sensitivity due to exposure to AIDS, hepatitis and other exposures to blood borne pathogens.

Procedures for removing a needle from a patient usually require a practitioner to use one hand to press on the wound site if the needle is being removed, while the needle device is removed with the other hand. It is also common practice for a practitioner to give greater priority to the cure of the patient than to the removal of a needle. In the case of typical needle devices without safety covers, such priority requires either the convenience of a sharps container available at your fingertips or other means for safe disposal without leaving the patient aside. Providing adequate care while following safety procedures is often aggravated by the physical condition and mental state of the patient, such as in burn units and psychiatric units. Under such conditions it is difficult to properly dispose of a used needle while a patient is healing.

Document US 2003/100868 A1 discloses a medical needle sheath apparatus according to the preamble of claim 1. Generalized knowledge and history associated with needle protection problems and their disposal have resulted in numerous devices to prevent accidental needle sticks. The problems of the usual safety devices include a difficulty of use and a high cost due to its complexity and its number of pieces.

Other known devices employ sleeves that are spring activated, telescopic, rotating, etc. These devices, however, may have the disadvantage of failing or being complicated for activation. Additional drawbacks of current devices include a high manufacturing cost due to the complexity and number of parts. Thus, devices of the prior art type may not adequately and reliably protect medical needle devices to prevent risk exposures.

Consequently, there remains a need to provide a more satisfactory solution of needle safety devices that solve the disadvantages and disadvantages of the prior art. Therefore, it would be desirable to provide a more suitable and reliable medical needle sheath apparatus that employs a safety sheath that can slide slidably along a medical needle to prevent a risky exposure to a needle tip. It would be advantageous to provide such a safety case that is capable of being reset to allow the reuse of a certain needle apparatus. Such a needle case apparatus should be able to move easily and reliably to protect a needle tip of a needle cannula.

Summary

Consequently, the present disclosure addresses a need for a medical needle sheath apparatus that effectively and economically protects a tip of a medical needle after use. The present disclosure resolves the related disadvantages and disadvantages experienced in the art. More specifically, the apparatus and method of the present invention constitute an important advance in the technique of needle safety devices.

In a particular embodiment, a medical needle sheath apparatus is provided according to the principles of the present disclosure. The medical needle sheath apparatus includes a sheath that is extensible from a retracted position to an extended position to include a distal end of a needle. A joint member is disposed within the sheath and defines joint surfaces that form an opening configured to slidably receive the needle between the retracted position and the extended position. The connecting member includes at least one drag induction element that is configured to slide slidingly with the needle between the retracted position and the extended position such that at least one drag induction element couples the needle to create a force of Drag with the needle. The drag force facilitates the rotation, as will be mentioned hereinafter, of the joint member with respect to a longitudinal axis of the needle such that the joint surfaces engage with the needle to prevent the sliding movement of the needle in the extended position of the cover. The joint member further includes a retainer that extends therefrom so that the retainer can be coupled with the needle to prevent rotation of the binding member.

In another particular embodiment, a medical needle sheath apparatus includes a needle cap having an outer needle cannula extending therefrom to a distal end. An inner needle is arranged for sliding movement with the outer needle cannula. At least one sheath is extensible from a retracted position to an extended position to include a distal end of the inner needle. The sheath includes a joint member disposed inside the sheath and defines joint surfaces that form an opening configured for the sliding reception of the inner needle between the retracted position and the extended position.

The connecting member includes at least one drag induction member so that the member engages the inner needle during sliding reception of the inner needle to create a drag force with the inner needle. The drag force facilitates the rotation of the connecting member relative to a longitudinal axis of the inner needle so that the joining surfaces are coupled to the inner needle to prevent the sliding movement of the inner needle in the extended position of the sheath. The joint member further includes a needle communication surface extending therefrom such that the needle communication surface can be coupled with the inner needle to prevent rotation of the joint member. A retainer extends transversely from the connecting member to removably engage with the needle bushing.

The joint member may be rotated, relative to a longitudinal axis of the inner needle, between a non-union orientation through which the inner needle can slide relative to the joint member and a joint orientation through which the joint surfaces are couple with the needle to prevent the sliding movement of the inner needle in the extended position of the at least one sheath. The connecting member may include one or more outwardly arcuate arms extending towards the needle communication surface.

The inner needle can be fixed to a handle for handling. The needle bushing can define a bushing groove configured to receive the retainer. The needle bushing can be removably mounted with a housing of the at least one sheath. The medical needle sheath apparatus may also include a plurality of covers.

The at least one drag induction member may define a cavity that is substantially aligned with the opening. The cavity is configured to slidably receive the needle to create the drag force with the needle. The joining member may include a substantially flat opening plate that includes the joining surfaces that form the opening. The at least one drag induction member may include a pair of arms extending from the opening plate. The arms may have curved end portions separated from the opening plate. The arms may include deviable members.

The sheath may include a housing that defines at least one locking member that extends from an inner surface thereof. The at least one locking member can be coupled with the connecting member to push the connecting member in a joining orientation. The opening plate can be displaced axially for engagement with the at least one locking member that causes the rotation of the joint member in a joint orientation.

A joint member may include a readjustment surface that extends transversely from the joint member. The needle bushing may also include a resetting surface aligned to come into contact with the reactive joint member resetting surface when the sheath housing is concentrically matched with the needle bushing. The readjustment surface deflects the readjustment surface of the joint member together with the needle engagement surface to a position above the inner needle surface and pushes the joint member from the joint orientation to the sliding orientation. Concurrently, due to the contact between the readjustment surface and the readjustment surface of the connecting member, the bushing retainer is pushed into a position that reattaches the needle bushing and retains the needle bushing in the needle sleeve. In an illustrative embodiment, the readjustment surface is the distal front surface of the bushing retainer.

The medical needle sheath apparatus can also be supported for relative rotational movement by at least one bearing.

In an alternative embodiment, the medical needle sheath apparatus includes a sheath that is extensible from a retracted position to an extended position to include a distal end of the outer needle cannula. The sheath defines a probe guide at a distal end thereof that is configured to receive a probe. The probe is configured to move slidably with the outer needle cannula.

Brief description of the drawings

The foregoing features and other features and advantages of the present invention will be better understood from the following detailed description of the exemplary embodiments, taken in conjunction with the accompanying drawings in which:

FIGURE 1 is a perspective view of a particular embodiment of a medical needle sheath apparatus according to the principles of the present disclosure; FIGURE 2 is a perspective view of the embodiment shown in FIGURE 1 in a protected configuration; FIGURE 3 is a sectioned perspective view of a sheath of the medical needle sheath apparatus shown in FIGURE 1 in an orientation without attachment; FIGURE 4 illustrates the sectioned perspective view of the medical needle sheath apparatus shown in FIGURE 2 in a joint orientation; FIGURE 5 is a perspective view of the bearing of a needle safety apparatus as shown in FIGURE 1; FIGURE 6 is a sectioned perspective view of the stylus cover of a needle safety apparatus as shown in FIGURE 1; FIGURE 7 is an enlarged perspective view of a joint member of the medical needle sheath apparatus shown in FIGURE 1; FIGURE 8 is a perspective view of the needle sheath apparatus as shown in FIGURE 1 having a needle sheath installed therein; FIGURE 9 is an alternative enlarged perspective view of the joint member shown in FIGURE 7; FIGURES 10 and 11 are sectioned perspective views of the medical needle safety apparatus showing coupling between the readjustment surface and the readjustment surface of the joint member according to the present disclosure; FIGURE 12 is a sectioned perspective view of an embodiment of the medical needle safety apparatus according to the present disclosure adapted for use with a needle cap with Luer closure; FIGURE 13 is a sectioned perspective view of the medical needle safety apparatus as shown in FIGURE 12 in a protected configuration; FIGURE 14 is an enlarged perspective view of the medical needle safety apparatus as shown in FIGURE 12 showing coupling between the readjustment surface and the readjustment surface of the joint member according to the present disclosure; FIGURE 15 is an enlarged perspective view of the medical needle safety apparatus as shown in FIGURE 12 in a reset configuration; FIGURE 16 is a perspective view of an embodiment of a medical needle sheath apparatus adapted for use with a bone biopsy needle according to the principles of the present disclosure; FIGURE 17 is an enlarged cross-sectional view of the depth stop assembly shown in FIGURE 16; FIGURE 18 is an enlarged cross-sectional view of the control assembly shown in FIGURE 16; FIGURE 19 is a perspective view of the medical needle sheath apparatus shown in FIGURE 16 with the depth stop assembly partially advanced along the threaded sleeve; FIGURE 20 is a perspective view of the medical needle sheath apparatus shown in FIGURE 16 with the stylet partially extended from the needle cap; FIGURE 21 is a cross-sectional view of the medical needle sleeve apparatus as shown in FIGURE 20; FIGURE 22 is a perspective view of the medical needle sheath apparatus shown in FIGURE 16 with the stylus sheath fully extended from the needle sleeve; FIGURE 23A is an enlarged cross-sectional view of the medical needle sheath apparatus as shown in FIGURE 22; FIGURE 23B is an enlarged cross-sectional view of an alternative embodiment of the medical needle sheath apparatus shown in FIGURE 22. FIGURE 24 is a perspective view of the medical needle sheath apparatus shown in FIGURE 16 with the stylet removed and a syringe inserted into the needle cap confined for aspiration; FIGURE 25 is a perspective view of the medical needle sheath apparatus shown in FIGURE 16 with the depth stop assembly removed; FIGURE 26 is a perspective view of the medical needle sheath apparatus shown in FIGURE 16 in the protected configuration; FIGURE 27 is an enlarged cross-sectional view of the medical needle sheath apparatus shown in FIGURE 26; FIGURE 28 is a perspective view of an embodiment of one of the medical needle sleeve apparatus adapted for use with a PICC introducer according to the principles of the present disclosure; FIGURE 29 is an alternative perspective view of an embodiment of one of the medical needle sheath apparatus illustrated in FIGURE 28; FIGURE 30 is an enlarged sectioned perspective view of the embodiment shown in FIGURE 28 in a retracted position; FIGURE 31 is a perspective view of the embodiment shown in FIGURE 28 in a protected configuration; FIGURE 32 is a sectioned perspective view of the embodiment shown in FIGURE 28 in a protected configuration;

FIGURE 33 is a sectioned perspective view of the embodiment shown in FIGURE 28 in a reset configuration according to the present disclosure; FIGURE 34 is a perspective view of an embodiment of one of the medical needle sheath apparatus adapted for use with an orifice access implanted according to the principles of the present disclosure; FIGURE 35 is a perspective view of the embodiment shown in FIGURE 34 in a unprotected configuration; FIGURE 36 is a sectioned perspective view of the embodiment shown in FIGURE 34 in a protected configuration; FIGURE 37 is a sectioned perspective view of the embodiment shown in FIGURE 34 in a unprotected configuration; FIGURE 38 is a perspective view of an embodiment of a medical needle sheath apparatus adapted for use with a drug vial access according to the principles of the present disclosure; FIGURE 39 is a perspective view of the embodiment shown in FIGURE 38 in a unprotected configuration; FIGURE 40 is a sectioned perspective view of the embodiment shown in FIGURE 39 in a protected configuration; FIGURE 41 is a perspective view of the embodiment shown in FIGURE 39 in a Reset setting according to the principles of this disclosure: FIGURE 42 is a perspective view of a bearing incorporating readjustment elements of a particular embodiment of the medical sheath apparatus; FIGURE 43 is a perspective view of an embodiment of connecting member incorporating a reset element; FIGURE 44 is a perspective view of an alternative embodiment of the needle sheath apparatus medical according to the present disclosure; FIGURE 45 is an enlarged sectional view of FIGURE 44; FIGURE 46 is an enlarged sectional view of FIGURE 44 where the reset element is being coupling FIGURE 47 is a perspective view of an alternative embodiment of the needle sheath apparatus medical according to the present disclosure; FIGURE 48 is a perspective view of an alternative embodiment of the needle sheath apparatus medical according to the present disclosure; FIGURE 49 is a sectional view of FIGURE 48; FIGURE 50 is a sectional view of FIGURE 49 with the stylet being removed from the outer needle; FIGURE 51 is an enlarged view of a stiletto handle shown in FIGURE 48; FIGURE 52 is a perspective view of an alternative embodiment of the needle sheath apparatus medical according to the present disclosure; FIGURE 53 is a perspective view of a reset element of a particular embodiment of the medical needle sleeve apparatus according to the present disclosure; FIGURE 54 is a perspective view of an embodiment of the medical needle sheath apparatus according to the present disclosure; FIGURE 55 is an enlarged perspective view of a depth stop of the apparatus shown in the FIGURE 54; FIGURE 56 is a sectional view of the depth stop shown in FIGURE 55; FIGURE 57 is an enlarged view of a connecting member of an alternative embodiment of the apparatus of medical needle case according to the present disclosure; FIGURE 58 is an enlarged view of the joint member shown in FIGURE 57 and the position of Union; FIGURE 59 is an enlarged view of the joint member shown in FIGURE 57 with a piece of uncoupled readjustment of the binding member; FIGURE 60 is an enlarged view of the connecting member shown in FIGURE 57 with the piece of readjustment that attaches to the connecting member; FIGURE 61 is a perspective view of an embodiment of the medical needle sheath apparatus according to the present disclosure; FIGURE 62 is a perspective view of the embodiment shown in FIGURE 61 having the stopper of partially advanced depth down on the needle; FIGURE 63 is a perspective view of a shutter incorporating an integral funnel guide and a reset element; FIGURE 64 is a perspective view of the embodiment shown in FIGURE 63 during the resettable coupling; FIGURE 65 is a sectional view of the embodiment shown in FIGURE 64; FIGURE 66 is an enlarged sectional view of the embodiment shown in FIGURE 64; FIGURE 67 is a perspective view of the embodiment shown in FIGURE 64 with a shutter inserted through the needle; FIGURE 68 is a sectional view of the embodiment shown in FIGURE 67; FIGURE 69 is an enlarged sectional view of FIGURE 68; FIGURE 70 is a perspective view of a shutter;

FIGURE 71 is a perspective view of an alternative embodiment of the needle sheath apparatus medical according to the present disclosure; FIGURE 72 is a sectional view of the security cover shown in FIGURE 71; FIGURE 73 is an enlarged sectional view of FIGURE 72; FIGURE 74 is an enlarged sectional view of FIGURE 72; FIGURE 75 is a perspective view of a funnel to guide a shutter; FIGURE 76 is a sectional view of a funnel placed on a needle; FIGURE 77 shows location elements on the safety sheath to guide the shutter to the inner diameter of the needle; FIGURE 78 shows a shutter inserted in a funnel; FIGURE 79 is a perspective view of an alternative embodiment of the needle sheath apparatus medical according to the present disclosure; FIGURE 80 is a sectional view of the embodiment shown in FIGURE 79; FIGURE 81 is an enlarged view of the security sheath of the embodiment shown in FIGURE 79; FIGURE 82 is a sectional view of the security sheath having an inserted needle; FIGURE 83 is a perspective view of the security case having an obturator inserted; FIGURE 84 is an enlarged perspective view of the security case having a guide readjustable; FIGURE 85 is an enlarged perspective view of the security case having a guide Resettable with a reset area; FIGURE 86 is a guide member integrated with a shutter; FIGURE 87 is a guide member integrated with a shutter having a spring; FIGURE 88 is an enlarged view of the guide member shown in FIGURE 87; FIGURE 89 is a shutter handle having a resettable element; FIGURE 90 is a shutter handle that has an element inserted in a cage FIGURE 91 is an alternative embodiment of the medical needle sleeve apparatus according to the present divulgation; Y FIGURE 92 is an alternative embodiment of the medical needle sleeve apparatus according to the present divulgation.

Detailed description of exemplary embodiments

Exemplary embodiments of the medical needle sheath apparatus and the disclosed operating procedures are mentioned in terms of medical needles for infusion of intravenous fluids, infusion of medication or fluid collection, guidance of other needles, for example biopsy, and more in particular , in terms of a needle sheath apparatus used with a needle cannula that prevents risk exposure to the needle tip, including, for example, accidental needle sticks. It is considered that the present disclosure, however, finds application in a wide variety of cannula needles and devices for the infusion of preventive medications, medications, therapeutic products, etc. to a subject, such as, for example, epidural needles, spinal needles, biopsy needles, Chiba needles, Potts control needles, coaxial introducer needles, Y sites, etc. It is also considered that the present disclosure can be used for the collection of body fluids and / or tissues, including those used during procedures related to soft tissue biopsy, bone biopsy, phlebotomy, digestive, intestinal, urinary, veterinary, etc. It is contemplated that the medical needle sheath apparatus may be used with other medical needle applications that include, but is not limited to, fluid infusion, fluid collection, catheters, catheter introducers, guide wire introductors, needle introducers biopsy, spinal and epidural, biopsy, apheresis, dialysis, blood donor, Veress needles, Huber needles, etc.

In the discussion that follows, the term "proximal" refers to a portion of a structure that is closer to a practitioner, and the term "distal" refers to a portion that is further away from the practitioner. As used herein, the term "subject" refers to a patient receiving infusions or from whom blood and / or fluid have been removed using the medical needle sheath apparatus. According to the present disclosure, the term "practitioner" refers to an individual who administers an infusion, performs the collection of fluids or tissues, installs or removes a needle cannula from a medical needle sheath apparatus and may include personal support for.

The following discussion includes a description of the medical needle sheath apparatus, followed by a description of the operating procedure of the medical needle sheath apparatus according to the present disclosure. Reference will now be made in detail to the exemplary embodiments of the disclosure, which are illustrated in the attached figures.

Returning now to the figures, in them the same components are designated by equal reference numbers throughout all the various views. With reference initially to FIGURES 1-11, a medical needle sheath apparatus is illustrated, constructed in accordance with the principles of the present disclosure. The medical needle sheath apparatus includes a sheath 101 that is extensible from a retracted position (FIGURES 1, 3) to an extended position (FIGURES 2, 4) to include a distal end 115 of a needle such as, for example, a stiletto 106 of a needle set. The needle assembly includes a hollow outer needle 103. The stylet 106 is slidably and concentrically disposed with the needle 103 for use therewith during a medical needle application, as will be mentioned hereafter. A stylet handle 113 is connected to stylet 106 to facilitate handling thereof. Other needle assemblies are also contemplated, including for example, needle cannulas, guide wire / introducers, etc.

A joint member 105 is disposed within the sheath 101 and defines joint surfaces 122. The joint surfaces 122 form an opening configured to slidably receive the stylet 106 between the retracted position and the extended position. The connecting member 105 includes a drag induction member, such as, for example, friction members 126 extending therefrom. The connecting member 105 has a stylus communication surface 123 that can be coupled with the stylus 106 to prevent rotation in the joining position of the connecting member 105.

The friction members 126 are configured for sliding engagement with the stylet 106 between the retracted position and the extended position such that the friction members 126 are coupled to the stylet 106 to create a force with the stylet 106. It is considered that it can be employ a friction member or a plurality of friction members 126.

The drag force together with one or more locking members 116 and / or 117, causes the connecting member 105 to move to a joining position (FIGURE 4). The force created by the blocking members 116 and / or 117 acts in a direction opposite to the drag force. This causes a torque, which moves the connecting member 105 to the joining position.

As the stylet 106 is released from the coupling with a stylus communication surface 123, the connecting member 105 and a retainer 114 move to the joining position. The rotation of the connecting member 105 is no longer in opposition to the coupling with the stylus 106 to the stylus communication surface 123. Thus, the connecting member 105, with the retainer 114, is inclined in the position of Union. The rotation of the connecting member 105 causes the joining surfaces 122 to frictionally engage the stylet 106 to prevent displacement thereof.

The blocking members 116 and / or 117 cause the connecting member 105 to move to the joining position as the forces imposed on the sheath 101 cause a relative movement thereof either in any direction along the longitudinal axis x. This keeps the stylet 106 inside the sheath 101 to avoid risk exposure to the distal end 115. It is considered that the communication surface of the stylet 123 may include ribs, projections, cavities, etc. For coupling with the stylet 106 or that a portion of the stylus communication surface 123 is coupled to the stylet 106.

The components of the medical needle sheath apparatus may be manufactured from a material suitable for medical applications, such as, for example, polymeric or metallic materials, such as stainless steel, depending on the particular medical application and / or the preference of A practitioner Semi-rigid and rigid polymeric materials are contemplated for manufacturing, as well as resilient materials, such as medical grade molded polypropylene. However, the person skilled in the art will realize that other materials and manufacturing procedures suitable for assembly and manufacturing, according to the present disclosure would also be appropriate.

In an illustrative embodiment, the sheath 101 includes a bearing 102 that houses the joint member 105. The bearing 102 can be monolithically formed or integrally mounted with multiple sections and can be substantially transparent, opaque, etc.

In the retracted position, the sheath 101 is disposed adjacent to a needle bushing 104 of the outer needle 103. It is contemplated that the outer needle 103 may also comprise a flexible polymeric material, and that the components of the medical needle apparatus can be employed with other needle applications, such as, for example, catheters, PICC introducers, etc.

The connecting member 105 can be monolithically formed and includes an opening plate 118, friction members 126, the end sensing member 119, the stylus communication surface 123, the readjustment surface of the connecting member 107 and retainer 114. It is contemplated that joint member 105 may include one

or more friction members 126 and that retainer 114 may extend from bearing 102. The opening plate 118 may have a generally flat rectangular configuration with sufficient rigidity to produce forces to join the stylet 106, as will be mentioned below. It is considered that the opening plate 118 may have an arcuate, undulating surface, etc. It is further considered that the opening plate 118 may have various degrees of stiffness according to the requirements of a particular application.

The embodiment of a resettable passive safety device disclosed in FIGS. 1-11 shows a solid hollow needle stiletto 106, a rotating housing with a stiletto sheath 125 and a thrust hole 133, a bearing 102 with a thrust washer 132, and a connecting member 105. The thrust hole 133 and the thrust washer 132 are configured to allow rotation of the styling sleeve 125 relative to the bearing 102.

The resettable element of this device is used after the passive safety device has been deactivated. Initially, the safety cover 101 and the needle 103 are positioned on the stylet 106 (FIGURE 1).

During the medical procedure, the stylet 106 is automatically protected by the security sheath 101 as the stylet 106 is removed from the needle (FIGURE 2).

The security sheath 101 advances to near the distal end of the stylet 115 in a position prior to activation of the connecting member 105 (FIGURE 3). In this position, the bushing retainer 114 retains the proximity of the needle casing 104 to the security sheath 101 interacting with the bushing groove 124 and the connecting member 105 in the sliding orientation. It is considered that the socket groove 124 can be shaped with other shapes to provide a cavity.

In FIGURE 4, the security sheath 101 is positioned further away towards the distal end of the stylet 115 at the point where the safety sheath 101 is activated. The connecting member 105 has moved in the joining orientation and the bushing retainer 114 of the connecting member 105 has been released from the needle bushing

104.

In FIGURE 2, the activated and locked safety sheath 101 is illustrated. In this configuration, the needle 103 has been removed, the distal stiletto end 115 is inside the housing at a distance that prevents human contact, and the union member 105 is in the orientation of union.

The friction members 126 can be monolithically formed with the connecting member 105 and extend from the opening plate 118 in association therewith for alignment with the opening 138 and coupling with the stylet 106. Such coupling creates a force friction drag with the stylus 106. This frictional drag force together with one of the locking members 116 and / or 117 causes the connecting member 105 to move with the stylet 106, which generates a rotational force and the inclination of the opening plate 118. The rotational force and the inclination force the rotation of the connecting member 105. The use of a single friction member is contemplated, it is also contemplated that the friction members 126 having flexible portions, which can be of varying flexibility according to the particular requirements of a needle application.

Facilitated by the movement of stylet 106, the tilt force causes a leverage or moment of the end sensing member 119, which is in opposition to prevent rotation of the joint member 105. The tilt force is opposed by the coupling of the communication surface 123 with the stylus 106 in an orientation without a sliding joint (FIGURE 3) of the connecting member 105.

The end detection member 119 extends distally from the opening plate 118. The end detection member 119 may be oriented perpendicularly to a plane defined by the opening plate 118. This perpendicular orientation facilitates the inclination of the plate opening 118 for removal in a joint or non-union orientation of the joint member 105. It is considered that the end detection member 119 may have several orientations. With the opening plate 118 and can extend flexibly from it.

The stylus communication surface 123 opposes the tilt force of the end sensing member 119 directed to the stylet 106. The tilt force is generated by the friction members 126 together with one of the blocking members 116 and / or 117 and facilitates the inclination of the opening plate 118. The inclination, however, is avoided in the orientation without joint or sliding due to the coupling of the stylus communication surface 123 with the stylet 106. As the stylet 106 becomes retract proximally and that the sheath 101 extends distally, the stylet 106 continues to slide slidably to the stylus communication surface

123

As the stylet 106 is released from the coupling with the stylus communication surface 123, as shown in FIGURE 4, a drag force is created between the friction members 126 and the stylet 106. The drag force together with the blocking member 116 causes the opening plate 118 to move to the joint position, as mentioned.

The rotation of the opening plate 118 causes the connecting surfaces 122 to frictionally engage the stylet 106 to prevent movement thereof. The locking members 116, 117 cause the opening plate 118 to move to the joint position as the forces are imposed on the sheath 101 in any direction along the longitudinal axis x. This keeps the stylet 106 inside the sheath 101 to avoid risk exposure to the distal end 115.

The opening 138 is formed within the opening plate 118 for the sliding coupling with the stylet 106 during the movement between the retracted position and the extended position of the sheath 101. The opening 138 includes the joining surfaces 122 formed on opposite sides of the opening 138 that is coupled to the stylet 106 to prevent displacement thereof in the extended position of the sheath 101. It is contemplated that the coupling to prevent displacement of the stylet 106 may include penetration, friction, interference, etc. It is considered that the opening 138 may have several geometric configurations, such as radial, polygonal, etc. It is further considered that the opening 138 can define an open cavity within the opening plate 118 such as, for example, "U" shaped and open to one or more edges of the opening plate 118.

The inclination of the opening plate 118 with respect to the longitudinal axis x facilitates the sliding and joining, by the joining surface 122, of the stylet 106 inside the sheath 101 to prevent risk exposure to the distal end 115. For example, as shown in FIGURE 3, the opening plate 118 is oriented at an angle of approximately 90 ° with respect to the longitudinal axis x such that the opening plate 118 is arranged substantially perpendicular to the stiletto 106. In this orientation without joint or sliding, the stylet 106 is free to slide into opening 138. As the stylet 106 retracts and the sheath 101 extends, the stylet 106 continues to engage the stylus communication surface 123 and the aperture plate 118 maintains its orientation perpendicular to the longitudinal axis x.

With reference to FIGURE 4, the sheath 101 is manipulated in such a way that the friction members 126 together with the blocking member 116 cause the connecting member 105 to rotate with respect to the longitudinal axis x. The opening plate 118 rotates in the coupling alignment with the stylus 106 such that the opening plate 118 is oriented at an angle less than 90 degrees from the longitudinal axis x.

As the opening plate 118 rotates, the joint member 105 approaches a joint orientation. The joining orientation includes the coupling of the joining surfaces 122 with the stylet 106 due to the joining orientation of the opening plate 118. This coupling creates frictional joining forces 106, together with the friction members 126 and the members lock 116, 117 to prevent displacement of the stylet 106 with respect to the sheath 101 in both distal and proximal directions, and to maintain the distal end 115 within the sheath 101 to prevent risk exposure to it.

The blocking members 116, 117 are arranged so as not to interfere with the stylet 106. The blocking members 116, 117 define surfaces that facilitate the removal of the opening plate 118 in a joint orientation.

For example, as shown in FIGURE 3, the sheath 101 is in a retracted position and the stylet 106 is fully extended. The connecting member 105 and the opening plate 118 are in a non-union or sliding orientation so that the opening plate 118 is substantially perpendicular to the longitudinal axis x. The locking members 116, 117 can be coupled to the opening plate 118 to keep the opening plate 118 in the perpendicular orientation. The blocking members 116, 117 may also maintain such orientation during the extension of the stylet 106 or may not be coupled to the stylet 106.

As the stylet 106 retracts and the sheath 101 extends, as shown in FIGURE 4, the friction members 126 create a drag force by engaging with the stylet 106 on the joint member 105 and together with the locking member 116 causes the opening plate 118 to rotate in an anti-clockwise direction in the joint position. The locking members 116, 117 are coupled to the opening plate 118 to facilitate rotation thereof from the perpendicular position in the joint position so that the joint surfaces 122 are coupled to the stylet 106, as mentioned. This configuration prevents the displacement of stylet 106.

The joining of the connecting member 105 to the stylet 106 is facilitated by the frictional force generated between the joining surfaces 122 and the stylet 106. This friction coupling prevents axial displacement of the stylet 106 with respect to the bearing 106 when the sheath 101 is in The extended position. This configuration advantageously prevents risk exposure to stylet 106. It is contemplated that the joining surfaces 122 may include sharp edges to increase friction engagement. It is further contemplated that the frictional bonding force can be created and varied by one or more modification factors, such as, for example, the configuration and dimension of the opening 138, the dimension and configuration of the stylet 106, the thickness of the opening plate 118, the dimension from the contact point of the blocking members 116, 117 to the centerline of the stylet 106 and the coefficient of friction between the opening 138 and the stylet 106 depending on the requirements of an application of needle. It is considered that the friction members 126 can be configured to vary the drag force with variation of the inclination of the opening plate 118, this variation in the drag force can be achieved by geometric changes in the shape of the friction members 126, such as wedge shapes or the inclusion of notches to engage the stylet 106, this variation in drag force can also be achieved through the selective application of friction modification materials or coatings such as oils, gels, greases , or coatings that change friction.

It is considered that the opening in the opening plate 118 can create a drag force through the coupling with the stylet 106 to cause rotation of the connecting member 105, similar to that described. It is also considered that materials such as, for example, fatty gels, etc. they can be used to create a drag force by friction with the stylus 106 to cause rotation of the connecting member 105.

The needle bushing 104 is mounted with the needle 103 and removably mounted with the sleeve 101 with removable coupling with the retainer 114. The needle bushing 104 is used with the medical needle sleeve apparatus of the present disclosure for various uses according to the requirements of a particular medical needle application. The sheath 101 and the needle sleeve 104 slidably support the needle 103 and the stylet 106 for use thereof. The handle 113 facilitates the handling thereof.

The needle bushing 104 has a bushing groove 124 for receiving and engaging with the connecting member 105. The needle bushing 104 has a finger guard 160 for pushing the needle bushing 104 in one direction, along the x-axis. , away from the sheath 101. This configuration facilitates the removal and use of the needle sleeve 104 and the needle 103 of the sheath 101 during a medical needle application. It is contemplated that the finger shield 160 may alternatively be configured and sized according to the needle application.

A flange 162 of the needle bushing 104 is concentrically supported by a control surface 110 disposed around an inner surface of the bearing 102. The control surface 110 is coupled to an outer surface 164 of the flange 162 for the removable support thereof. The outer surface 164 can be coupled to the control surface 110 in a friction adjustment, interference, etc. To maintain the removable positioning with the bearing 102. It is contemplated that the control surface 110 can be coupled to other portions of the needle bushing 104.

The bearing 102 includes the bushing stop surfaces 112 that facilitate the positioning of the needle bushing 104 with the bearing 102. The bushing stop surfaces 112 prevent the proximal displacement of the needle bushing 104 during assembly with and with respect to the bearing 102 The bushing stop surfaces 112 advantageously facilitate the control of the degree of insertion with the bearing 102 according to the requirements of a particular medical needle application. A surface of a plurality of bushing stop surfaces 112 may be employed. It is contemplated that bushing stop surfaces 112 may include springs, pliers, etc. To facilitate fixation with needle sleeve 104.

The retainer 114 may extend transversely from a distal end of the stylus communication surface 123. The bushing retainer 114 extends for a length sufficient to be received correspondingly within the bushing groove 124 of the needle bushing 104. In association with a non-contact or sliding orientation of the connecting member 105, the retainer 114 couples the needle bushing 104, in the bushing groove 124, to be removably mounted with the bearing 102 of the sleeve 101.

As the stylet 106 is retracted in a proximal direction and that the sheath 101 is extended in a distal direction, the retainer 114 rotates in an anti-clockwise direction (FIGURE 4) relative to the longitudinal axis x due to the inclination forces generated by the friction members 126. Retainer 114 is disengaged from bushing groove 124 to release needle bushing 104 from bearing 102. A practitioner can manipulate finger guard 160 to manipulate needle bushing 104 distally and away from sheath 101 It is contemplated that the retainer 114 may have various orientations from the connecting member 105 or the stylus communication surface 123. It is further contemplated that the socket groove 124 can be sized in various ways to extend around the circumference of the needle bushing 104. Bushing groove 124 may include tabs, etc., for retention with retainer 114.

To re-access the distal end of the stylet 115 using the resettable passive safety device, the stylet cover 125 is concentrically matched with the proximal end of the needle sleeve 104 in a manner similar to the preactivation state of the device. As this occurs, the joint member reset surface 107 comes into contact with the reset surface 108. This action is illustrated in the embodiment shown in FIGURE 10.

As the stylet 106 advances from a proximal-distal direction, the readjustment surface 108 deflects the readjustment surface of the attachment member 107, together with the end sensing member 119, to a position above the surface of the stylet 106 and pushes the connecting member 105 from the joining orientation to the sliding orientation. With the connecting member 105 in the sliding orientation, the stylet 106 becomes free to advance within the needle 103.

Concurrently, due to the contact between the resetting surface 108 and the resetting surface of the connecting member 107, the bushing retainer 114 is pushed into the bushing groove 124. This causes the bushing retainer 114 of the connecting member 105 retain the needle bushing 104 again in the safety sleeve 101 through the interaction with the bushing groove 124 (FIGURE 11).

When readjusted, the security case 101 and the needle 103 are positioned on the stylet 106, as seen in FIGURE 1. During the medical procedure, the stylet 106 will be automatically protected by the security case 101 as the stylet 106 is removed from the needle again.

FIGURES 12 to 15 illustrate the resettable safety sheath according to the present disclosure as applied to a needle with a Luer 121 adapter and a Luer 109 conical coupling. In this embodiment, the readjustment surface 108 is provided on a separate portion of the bushing. needle 104. A readjustment surface spring 111 exerts a force to deflect the readjustment surface 108 in the proximal direction. The readjustment surface spring 111 may be manufactured from any number of commonly known suitable elastic materials, including metallic, plastic and elastomeric materials, and the like.

In the embodiment in which the readjustment surface 108 is inside the Luer adapter 121, the readjustment surface spring 111 ensures that the readjustment surface 108 is in the correct location in the needle bushing to provide alignment and coupling between the readjustment surface 108 and the readjustment surface of the connecting member 107. The spring 111 may comprise an elastic material such as rubber, urethane, etc. When a conical male Luer coupling or a sliding Luer, is inserted into the needle bushing (104), the readjustment surface spring 111 is compressed and the readjustment surface 108 is displaced to allow the male Luer coupling to mate with all the length of the Luer coupling 109. It is considered that the readjustment surface 108 can also be arranged around the Luer adapter 121, as shown in FIGURE 23B. The embodiment shown in FIGURE 23B also shows an alternative embodiment of the readjustment surfaces 107 that extend from the joint member 105 and that engage the retaining surface 141.

To re-access the distal end of stylet 115 using the resettable passive safety device, the stylet cover 125 is concentrically matched with the proximal end of the needle bushing 104, in a manner similar to the pre-activation state of the device. As this occurs, the joint member reset surface 107 comes into contact with the reset surface 108. This action is illustrated in the embodiment shown in FIGURE 14.

As the stylet 106 advances from a proximal-distal direction, the readjustment surface 108 deflects the readjustment surface of joint member 107, together with the end sensing member 119, to a position above the surface of the stylet 106 and pushes the connecting member 105 from the joining orientation to the sliding orientation. With the connecting member 105 in the sliding orientation, the stylet 106 becomes free to advance within the needle 103.

Concurrently, due to the contact between the resetting surface 108 and the resetting surface of the connecting member 107, the bushing retainer 114 is pushed into the bushing groove 124. This causes the bushing retainer 114 of the connecting member 105 retain the needle bushing 104 again in the security case 101 through the interaction with the bushing groove 124 (FIGURE 15).

When readjusted, the safety case 101 and the needle 103 are positioned on the stylet 106. During the medical procedure, the stylet 106 will be automatically protected by the security case 101 as the stylet 106 is removed from the needle again. . The safety cover 101 may incorporate a pressure reset to the bushing (not shown) to further facilitate coupling.

FIGURES 16-27 illustrate the resettable safety sheath according to the present disclosure as it is applied to a bone biopsy needle 101. In this embodiment, the Luer 109 conical coupling is used in the manner described hereinbefore in relation to FIGURES. 12 to 15. The bone biopsy needle 101 may also include a resettable depth stopper assembly 140 to readjust the desired needle insertion depth 103. A retaining nut 142 blocks the depth stopper assembly 140 in the desired position. . The tabs 144 are coupled to the corresponding slots 156 (shown in FIGURE 25) to fix the depth stop assembly 140 while the retaining nut 142 is engaged.

A needle sheath 137 can be arranged in the depth stop assembly 140 as illustrated in FIGURE

17. The corresponding threads 148 and 150 arranged on the depth stop assembly 140 and the sleeve 151, respectively provide a threadable movement of the depth stop assembly 140. The needle sheath 137 functions similarly to the sheath 101 described in FIGURES 1 to 11, as will be mentioned more in detail hereafter.

The medical stylus sleeve apparatus 106 includes a connecting member 105 which is disposed within a stylus sleeve 125, similar to that described in respect to FIGURES 1 to 11, which is extensible from a retracted position to an extended position to include a distal end of a stylet 106 of a needle assembly. The stylus 106 is slidably and concentrically arranged with a needle 103 of the needle assembly for use during a bone biopsy needle application. A stiletto handle 113 is connected to the stiletto

106.

In operation, the practitioner (not shown) manipulates the handle 113 so that the sheath 101 is in the retracted position (FIGURES 16, 18, 19) and the connecting member 105 is in a contactless or sliding position. The handle 113 may include a tongue 152 for temporary fixation to the sleeve 194. The sleeve 104 includes an opening (not shown) such that the handle 113 can be released from the temporary fixation as the tongue 152 rotates to align the tongue 152 with The opening. The stylus 106 extends with respect to the sheath 101 so that the needle bush 104 is disposed around the needle 103 and the needle bush 104 is removably mounted with the bearing 102. A procedure employing the medical needle sheath apparatus. with the stylet 106 and the needle 103 is carried out by the practitioner until its completion.

The needle bushing 104 is removably mounted with the stylet handle 113. With reference to FIGURE 22, the stylet 106 is retracted proximally so that the sheath 101 extends in the extended position and the joint member 105 is disposed in a joining position Needle sleeve 104 is released from stylet sleeve 125 in the extended position. This keeps the stylet 125 inside the stylet cover 125 to avoid risk exposure to the distal end of the stylet 106.

To re-access the distal end of stylet 115 using the resettable passive safety device, the stylet cover 125 is concentrically matched with the proximal end of the needle sleeve 104, in a manner similar to the preactivation state of the device. As this occurs, the readjustment surface of the attachment member 107 comes into contact with the readjustment surface 108. This action is illustrated in the embodiment shown in FIGURE 23A.

As the stylet 106 advances from a proximal-distal direction, the readjustment surface 108 deflects the readjustment surface of junction member 107, together with the end sensing member 119, to a position above the surface of the stylet 106 and pushes the joint member 105 from the joint orientation to the sliding orientation. With the connecting member 105 in the sliding orientation, the stylet 106 becomes free to advance within the needle 103.

Concurrently, due to the contact between the resetting surface 108 and the resetting surface of the connecting member 107, the bushing retainer 114 is pushed into the bushing groove 124. This causes the bushing retainer 114 of the connecting member 105 retain the needle bushing 104 again in the security sleeve 101 through the interaction with the bushing groove 124.

When readjusted, the safety cover 125 and the needle 103 are positioned on the stylet 106, as seen in FIGURE 16. During the medical procedure, the stylet 106 will be automatically protected by the security cover 125 as the stylet 106 is removed from the needle again.

FIGURE 24 illustrates a syringe inserted into the sleeve 104 for aspiration purposes with the stylus 106 removed.

FIGURE 25 illustrates the resettable safety sheath device 101 with the depth stop assembly 140 removed and the needle sheath 137 in the retracted position. FIGURES 26-27 show needle sleeve 137 in the protected configuration. A joint member 105 is disposed within the needle sheath 137 and defines joint surfaces (not shown). The joining surfaces form an opening configured to slidably receive the hollow needle 103 between the retracted position and the extended position. The connecting member 105 'includes a drag induction member, such as, for example, friction members 126' extending therefrom. The connecting member 105 'has a needle communication surface 123' that can be coupled with the hollow needle 103 to prevent rotation of the connecting member 105 '.

The friction members 126 'are configured for a sliding engagement with the hollow needle 103 between the retracted position and the extended position such that the members 126' are coupled to the hollow needle 103 to create a drag force with the hollow needle 103, It is considered that a member or a plurality of friction members 126 'can be employed.

The drag force together with one of the blocking members 116 ’and / or 117’ causes the connecting member 105 ’to move to a joining position (FIGURE 27). The force created by the blocking members 116 ’and / or 117’ acts in a direction opposite to the drag force. This produces a torque, which displaces the joint member 105 ’to the joint position.

A funnel portion 146 in the needle sleeve 137 acts as an actuator guide to facilitate insertion of a plug or the like. The depth stop 140 can be slidably removed with the safety sleeve 137 which remains in the proximal position. This allows a practitioner to use the entire length of the needle 103. As shown, the depth stop 140 is removed before the activation of the safety sheath 137. Alternatively, the safety sheath 137 can be connected to, or formed as part of the depth stop 140.

FIGURES 28-29 illustrate the resettable safety sheath device according to the present disclosure as applied to a PICC introducer or similar catheter and needle introducers. In this embodiment, the hollow needle 103 is polymeric, and the stylet (or inner needle) 106 is a sharp hollow hole cannula. The handle 113 of the PICC introducer has a quick cap 135 and a quick chamber 136 which is in communication with the inner needle 106. A Luer 121 adapter communicates with the quick chamber 136 and allows the readjustment of other medical devices.

The medical needle sheath apparatus includes a sheath 101, similar to those described, which is extensible from a retracted position (FIGURE 28) to an extended position (FIGURES 31-32) to include a distal end of the hollow needle 103 of a needle set The hollow needle 103 is slidably and concentrically disposed with a sleeve 104 (FIGURE 28) of the needle assembly for use therebetween during a PICC introducer application. The bushing 104 can be divided or not. The bushing 104 is desirably manufactured from a polymeric material. It is contemplated that the medical needles of the present disclosure may incorporate a protective needle sleeve member to facilitate additional protection during transport and use of medical needles.

A handle 113 is connected to the inner needle 106. The handle 113 can have a quick chamber 139 in communication with the inner needle 106. A Luer adapter 121 communicates with the quick chamber 139 which facilitates the connection to various medical devices either by an element Luer fastening slide or Luer lock.

A joint member 105, similar to that described with respect to FIGURES 1-11, is disposed within the sleeve 101. The sleeve 101 includes a bearing 102 that houses the joint member 105.

The needle bushing 104 is mounted with the hollow needle 103. The needle bushing 104 is removably mounted with the sleeve 101 by removable coupling with a retainer 114 of the connecting member 105. The needle bushing 104 has a bushing groove 124 for receiving and engaging with the connecting member 105 from the sleeve 101 during a medical needle application.

A needle cap flange 104 is concentrically supported by a control surface of a stylus sleeve 125, referred to hereafter. The control surface is coupled to the flange for the removable support thereof. Retainer 114 extends for reception within a socket groove 124 of the needle socket

104. In association with a non-union or sliding orientation of the connecting member 105, the retainer 114 is disposed within the socket groove 124 for removable mounting with the sheath 101. As the inner needle 106 is retracted and the sheath 101 extends, retainer 114 rotates in an anti-clockwise direction and is disengaged from bushing groove 124 to release needle bushing 104 from stylet sleeve 125.

A stiletto sheath 125 is arranged to rotate and incorporate the distal end of the inner needle 106. The stiletto sheath 125 is mounted with the handle 113 and rotates freely with respect to the sheath 101 and the inner needle 106 in the extended position of the sheath 101. The relative relationship of the stiletto sheath 125 is facilitated by its support in the bearing openings formed in the stiletto sheath 125 and the shafts, similar to those described above. In a joint position, the bearing configuration supports the rotation of the stylet sleeve 125 relative to the sleeve 101 and the inner needle 106.

The inner needle 106 is retracted proximally such that the sheath 101 is extended in the extended position and the connecting member 105 is disposed in a joining position. Needle bushing 104 is released from sheath 101 and sheath 101 contains distal end 103 in the extended position. This keeps the needle 103 inside the sheath 101 to avoid risk exposure to the distal end of the needle 103.

In operation, the needle sleeve 104 is released from the sheath 101 and a stylus sleeve 125 contains the distal end of the inner needle 106 in the extended position, as described above. This allows the inner needle 106 inside the needle 101 to avoid risk exposure to the distal end thereof.

In order to re-access the inner needle 106 using the resettable passive safety device, the rotating focus stylet cover 125 is matched concentrically with the proximal end of the needle sleeve 104, in a manner similar to the preactivation state of the device. As it occurs, the readjustment surface of junction member 107. On the end detection member 119, it comes into contact with the readjustment surface 108. This action is illustrated in the embodiment shown in FIGURES 30 and 33.

As the needle 106 advances from a proximal-distal direction, the readjustment surface 108 deflects the readjustment surface of the connecting member 107, together with the end sensing member 119, to a position above the surface of the stylet 106 and pushes the connecting member 105 from the joining orientation to the sliding orientation. With the connecting member 105 in the sliding orientation, the stylet 106 becomes free to advance within the needle 103.

Concurrently, due to the contact between the resetting surface 108 and the resetting surface of the connecting member 107, the bushing retainer 114 is pushed into the bushing groove 124. This causes the bushing retainer 114 of the connecting member 105 retain the needle bushing 104 again in the security sleeve 101 through the interaction with the bushing groove 124.

When reset, the security sheath 101 and the needle 103 are positioned on the inner needle 106, as seen in FIGURE 28. During the medical procedure, the inner needle 106 will be automatically protected by the security sheath 101 as it the inner needle 106 is removed from the needle again.

FIGURES 34-37 illustrate the resettable safety sheath device according to the present disclosure as applied to an orifice access device or implanted pump. It is contemplated herein that the orifice access device may be implanted in or outside of a patient. The operation and construction of the present embodiment are in accordance with various embodiments described herein such as for example the embodiments disclosed in FIGURES 1-11. FIGURES 34-37 show an implanted orifice 127 and a skin layer 129 together with an implanted orifice access body 130. The orifice access body contains the readjustment surface 108. In the present embodiment, the stylet 106 is protected by safety case 101 before use. The readjustment surface 108 and the readjustment surface of the connecting member107 readjust the safety device as described above to allow the stylet 106 to pass through the skin layer 129 and into the implanted hole 127. The device The safety cover is reactivated by removing the stylet 106 from the implanted orifice access body 130.

With reference to FIGURES 38-41, a resettable safety sheath device according to the present disclosure is illustrated as applied to a drug vial access. The operation and construction of this embodiment are in accordance with the various embodiments described herein such as for example the embodiments disclosed in FIGURES 1-1. Figures 38-41 show a drug vial 131 together with an access body to the drug vial 134. The stylet 106 is protected by a safety sheath 101 before use. The readjustment surface 108 is coupled to the readjustment surface of the attachment member 107 to allow the stylet 106 to enter the drug vial 131. The safety device is reactivated by removing the stylet 106 from the drug vial access body. 134

With reference to FIGURES 42-46, another embodiment of the medical needle sheathing apparatus having a resettable element, constructed according to the principles of the present disclosure, is illustrated.

The resetting element 201 may be part of, but is not limited to, the following: the bushing / handle 203, the inner housing 202, the outer housing 204, the connecting member 205, or it may be a separate part that interacts with any of the previous pieces. The readjustment element 201 may contain readjustment surfaces 206 that are intended to interact with the joint member 207. When the readjustment element 201 is active, the readjustment surfaces 206 interact with the readjustment member 207 to cause bonding on the Stiletto 208 to unlock. If the resetting element 201 is a part of the connecting member 207, the resetting surfaces 206 can be extended from the connecting member 207 and can be joined directly so that activation of the resetting element unlocks the joint of the connecting member 205 to stiletto 208.

It is desirable that the reset element 201, which means that the device cannot be accidentally reset. It is also desirable to design the reset element 201 in such a way that an intentional effort must be made to activate the reset element 201 and readjust the device. Thus, it may be desirable that the reset element 201 may vary between activation and deactivation states. This can be achieved in many ways that include, but is not limited to, hinges, cantilever rods, flip-flop mechanisms, springs, etc.

To activate the resetting element 201, an intentional effort must be made which may require the resetting element 201 to interact with the resetting geometry 209 that has been brought to a position to reset the device. As illustrated in FIGURES 3-5, the readjustment geometry 209 can be arranged on a bushing / handle 210. This readjustment geometry 209 can include a Luer on a bushing / handle, a separate piece containing a readjustment geometry, and a geometry on a tray. However, the reset geometry 208 is not limited to the geometry on any apparatus intended to interact with the reset element 201 to readjust the safety cover 212.

It may also be desirable to incorporate a retaining element 211. In many cases it is desirable to have the security cover 212 retained in some way until the security cover 212 is attached to the stiletto 208. In the embodiment shown in FIGURES 44-46, the cover 212 is retained in a bushing / handle 210. In the present embodiment, the safety cover is retained until the stylet 208 is removed at which time the security cover 212 detects the end of the stylet and joins the stylet 208. This embodiment illustrates the retaining element 211 as a firing device, which allows the safety sleeve 212 to be retained in the bushing / handle 210. The retaining element 211 may also include, but not be limited to, a snap closure, a latch, a hook, friction, etc.

With reference to FIGURES 47-51, in some procedures it is necessary to retain the stylus handle 221 in the handle of the main device 222. The above retention elements included seals and bayonet-style retention. These procedures can cause abrupt forces after withdrawal, which leads to poor location or additional pain in the patient. These retention procedures may also fail due to high rotational displacement forces experienced during a procedure.

The embodiment shown in FIGURES 47-51 illustrates the retention with a snap closure mechanism 223. This provides a robust retention on the main device handle 222. If automatic closure 225 is safely positioned and resists displacement. of rotation as well as axial displacement. The snap closure mechanism 223 may also have a button / lever 226, or other similar snap closure device, to release the snap lock coupling 225. This does not provide abrupt forces at the omentum of withdrawal and provides a Easy release with one hand.

With reference to FIGURES 52-60, a depth stop 231 may be necessary in certain procedures. The depth stops 231 often have an adjustment element 232. As shown in FIGURE 53, the adjustment element 232 may include, but not be limited to, threads 234. In such cases, the safety cover 233 may contain an adjustment element 232 such as threads 234 for advancing the depth stop 231. The safety cover 233 may also have depth indicators 235 to indicate the depth of the depth stop 231. The safety cover 233 may also include a retainer 236 for the depth stop

231. Retainer 236 may include, but not be limited to, retainers, hooks, friction, etc. The depth stop 231 can also be a means of activating the safety sleeve 233.

Another embodiment is shown in FIGURE 54, which illustrates the security sheath 233 with a depth stop 231 having an adjustment element 232. The adjustment element 232 may be similar to those mentioned above. The depth stop 231 may have a retainer 236 similar to the one mentioned above. The retainer 236 can also function as a safety sleeve retainer. An embodiment also includes a retaining nut 237 that can be used in conjunction with depth stop 231 and thread 234 (see FIGURE 52).

With reference to FIGURES 57 and 58, for some procedures it may be necessary to introduce an apparatus 240, such as a guide wire, a catheter, etc., through a needle 238. In these circumstances it may also be necessary to activate a sheath of security 233 to protect the sharp punch element 239, while the apparatus 240 remains on the needle 238. One embodiment includes a double end detection member 241. This type of end detection member provides full functionality of the device with an apparatus 240 through the needle 238. The double end detection member 241 is positioned to slide along the needle 238, thereby preventing the attachment of the joint member 242. The double end detection member 241 can also be position to slide over the outer edge of the needle 238. In this position, the double end sensing member 241 continues to detect the end of the needle 238. Without e However, as the connecting member 242 passes into its binding state, the double-ended detection member 241 can pass around any apparatus 240 disposed in the needle 238.

Another application of the double-ended detection member 241 is to reset applications. In some cases of readjustment, the end detection member is housed under the needle 238. This may cause the device to be unable to reset. A double end sensing member 241 can be forced around the needle 238 by a reset piece 248 while readjusting. The double end detection member 241 may be flexible enough to surround the needle 238 when the readjustment is being performed, and rigid enough not to slide around the needle 238 during normal use. This may require a balance of forces. A double end sensing member 241 can also be activated on a needle taper.

FIGURES 61-62 illustrate a bone biopsy device, often referred to as a type I bone biopsy device, which has a depth stop 253. They often have adjustment elements 252 that include, but are not limited to, threads. However, there are procedures that make use of the entire needle length 255 of the device. In this case, the depth stop 253 is removed to expose a longer needle. This can create a problem because the user is required to disassemble the product for certain procedures. The illustrated embodiment allows the entire needle length 255 of the needle to be initially exposed. The required depth stop 253 can be arranged behind the initial total exposed length 255. This allows the user to perform a procedure that requires the entire needle length 255 of the needle without disassembly or assembly processes. There is also no change in technique for other procedures. The depth stop 253 remains available for use with a greater adjustable range of use. It is also advantageous for security devices. Due to the fact that assembly or disassembly is not necessary, there is less opportunity for the user to accidentally activate the safety device while removing the depth stop 253 to access the total needle length 255.

With reference to FIGURES 63-78, further embodiments of the present invention are incorporated which incorporate a resettable element. As shown in FIGS. 63-70, a plug 361 having reset geometry 362 interacts with a reset element 363. The plug 361 may have a handle 370. The handle 370 may include a cavity 365 to protect the needle 366 during the readjustment The plug 361 may also include a funnel 364 to guide the plug 361 through the security sheath 369 to the inner diameter of the needle 366. The funnel 364 may include location surfaces 367 on the housing to facilitate guiding. The funnel 364 is sliding along the plug 361 so that the funnel 364 allows the plug 361 to pass through the funnel 364. The funnel 364 can be a separate piece. The shutter 361 may also include a locking element 368 positioned to prevent readjustment. The blocking element 368 can also be mobile so that the absence of the blocking element 368 allows the reset geometry 362 to interact with the reset element 363. The means for moving the blocking element 368 includes, but is not limited to, levers, hinges, buttons, bolts, snap fasteners, seals, etc.

In this embodiment, the shutter 361 is configured such that after the shutter 361 passes through the needle 366 and ejects a sample, the blocking element 368 prevents the readjustment geometry 362 from interacting with the resetting element 363. The member of lock 368 is then moved to a position such that the reset geometry 362 interacts with the reset element so that the joint member 369 is released from a locked position. This allows security case 369 to be ready for reuse. It is also considered that the readjustment geometry 362 can be arranged elsewhere on the plug 361 including, but not limited to, the opposite end of the plug 361.

As shown in FIGURES 71-74, a sheath 389 includes a reset interface 387 that can be manually activated to interact with the reset element 383. The reset interface 387 can be connected directly to the reset element 383. The reset element Reset 383 may also consist of a part of, but not limited to, the following: bush / handle, inner housing, outer housing, connecting member, and / or the plug. Alternatively, the reset element 383 can be a separate part that interacts with any of the previous parts. The reset interface 387 can be connected to or interact with the reset geometry 382 which is intended to interact with the reset element 383 for the purpose of releasing the connecting member 380 from the locked position. The reset interface 387 may contain, but is not limited to, springs, hinges, levers, buttons, switches, slides, etc. The reset interface 387 may also include an interface pairing. This may be desirable to ensure proper finger placement. The interface pairing may be offset to ensure that an intentional effort is made to readjust the security case.

The readjustment interface 387 may require an additional opening plate 388, so that unlocking the joint from the locked original joint member 380 does not cause accidental removal of the safety sheath 389 from the contaminated cutting punch element. The additional opening plate 388 can be configured so that the activation of the reset interface 387 positions the joining surfaces 386 in the security sheath 398 to facilitate bonding when the security sheath 389 is pushed distally. This measure can prevent accidental removal of the safety sheath 389 from a contaminated cutting element while resetting occurs.

As illustrated in FIGS. 75-78, a funnel 392 guides a plug 391 to the inside diameter of a needle 396. The funnel 392 can be configured to provide a locking or friction connection to the needle.

396. The funnel 392 can also be configured so that it incorporates locating elements 393 on the security sheath 399 to guide the shutter 391 to the inner diameter of the needle 396. The locating elements 393 on the security sheath 399 can also be configured as such that a desirable adjustment is carried out to maintain the position, such adjustment interfaces include, but are not limited to, snap closure, friction connection, seals, etc. The option of using the funnel 392 with or without the safety sheath 399 may be desirable so that practitioners can thus choose the funnel 392 with or without the safety sheath that protects the contaminated cutting element to guide a shutter 391 to the diameter inside the needle 396. This also provides its use without safety devices.

With reference to FIGURES 79-92, in certain applications a shutter may be passed through the needle device. It may also be desirable to incorporate this guide member into a safety sheath, which may require activation of the safety sheath before using the funnel. In addition, it may be desirable to readjust a connecting member that protects a contaminated cutting element (eg medical needle, stylet, etc.).

An embodiment illustrates a guide member 402 that is integral with the security sheath 401. The connecting member 402 includes an interface of a particular geometry that provides guidance to a device through a needle, such as a shutter 403, etc. The guide member 402 is configured in such a way that the needle device 403 cannot interfere with the locking mechanism 404 in the security sleeve 401. Other embodiments include a geometry that continues to provide guidance of the guide member 402, but which also provides reset areas 406 for the security case 401.

FIGURES 81-82 show a guide member 412 having flexible members 415 that allow the guide member 412 to change dimensions. This provides guidance of a device through needle 413. Flexible members 415 also provide a larger opening that provides a reset zone 416. The reset zone 416 is in an area that allows reset geometry 417, or other geometry. which interacts with the reset geometry 417 is placed in such a position that it interacts with the reset element 418 to allow the connection from the locking mechanism 414 to be released. This allows security case 411 to be ready for reuse.

As shown in FIGURES 83-85, another embodiment includes a guide member 422 having adjustable members 425 that can be positioned by a positioning member 429. The adjustable members 425 can be rigid or flexible. The positioning member 429 may include, but is not limited to, a shirt, button, lever, collar, or other member intended to interact with the adjustable members 425. The adjustable members 425 are configured such that the positioning member 429 interacts with the adjustable members 425 causing the adjustable members 425 to position themselves to guide a device through a needle 423. The adjustable members 425 can be configured such that a tighter guide member 422 can be obtained, which otherwise can be obtained adjust around the needle 420. The positioning member 429 may contain gripping surfaces 424. The gripping surfaces 424 can be configured such that after the subsequent activation of the safety sleeve 421, the positioning member 429 will position the flexible members 425 when activated. The positioning member 429 can also be configured so that the positioning member 429 can be repositioned and in which the adjustable members 425 provide a reset zone 426.

As seen in FIGS. 86-88, another embodiment is illustrated in which a guide member 432 is integrated with the shutter 431. The guide member 432 can be configured so that it remains fixed to the shutter 431. The guide member 432 can also configured so that it can slide along the shutter 431. This embodiment illustrates the guide member 432 having a spring 433 (see FIGURES 87-88). Spring 433 may include, but is not limited to, a spring, folded plastic, telescopic elements, line, cable, etc. It is configured in such a way that the natural resting position of the guide member 432 is at the end of the plug

431. This provides the guide of the shutter 431. The guide member 432 is configured such that when the needle 430 is brought to the shutter 431, the guide member 432 guides the needle to the center. This guidance is done with little resistance. When the water 430 comes into contact with the center of the guide member 432, there are blocking surfaces 434 configured such that the needle 430 tends to block over the guide member 432, such as a conical Luer coupling. After blocking the needle 430 on the guide member 432, continued displacement tends to cause the guide member 432 to slide along the plug 431. The plug 431 is then guided into the needle 430 and ejects the sample.

As shown in Figs. 89-90, the shutter control 445 can be configured such that the reset geometry 447 is integrated over the shutter handle 445. The shutter handle 445 can also contain locking surfaces 444 configured from such that the needle 440 has to be locked on the shutter handle 445.

5 Other embodiments include modifications to the end detection member 452 (see FIGURE 91). End sensing member 452 includes needle communication surfaces 451 that travel over needle 450 and provide a force to resist bonding. When the geometry of the needle 450 changes (for example, the end of the needle, sharpening of the needle, taper of the needle, etc.), the end detection member 452 detects the change of the needle 450 and the joint already Don't resist anymore. Change the geometry of needle 450 includes,

10 pro is not limited to, angled surfaces, grooved surfaces, corrugations, or any surface intended to amplify end detection. The angled surfaces 454 are shown in FIGURE 91. The angled surfaces 454 are configured such that a slight change in needle geometry 450 causes the angled surfaces 454 to be drastically transformed. This is due to the geometric condition existing from the angled surfaces 454.

Another embodiment is shown in FIGURE 92 that has a separate needle communication surface 461. This needle communication surface 461 applies a frictional force to the needle 460. This force is used in conjunction with the needle communication members 462 to oppose the union. The frictional force that opposes the connection on the needle 460 is available for geometry changes in the needles 460 that prevent friction forces from being applied (for example needle taper, needle sharpening, needle end ,

20 etc.).

Claims (27)

1.-A medical needle case apparatus comprising: a needle cap having an outer needle cannula extending therefrom to a distal end, an inner needle arranged for sliding movement with the outer needle cannula; and at least one sheath that is extensible from a retracted position to an extended position to include a distal end of the inner needle, the sheath includes a joining member disposed inside the sheath and defining joining surfaces that form an opening configured for the sliding reception of the inner needle between the retracted position and the extended position, characterized in that the connecting member includes at least one drag induction member such that the at least one drag induction member engages the needle inside during the sliding reception of the inner needle to create a drag force with the inner needle, facilitating the drag force facilitates the rotation of the connecting member with respect to a longitudinal axis of the inner needle so that the joining surfaces engage to the inner needle, to prevent the sliding movement of the inner needle in the extended position of the f attached, the joint member further includes a needle communication surface extending therefrom such that the needle communication surface can be coupled with the inner needle to prevent rotation of the joint member, a retainer for removable coupling with the needle bushing, and the connecting member which includes a readjustment surface of the selectively aligning member with a bushing readjustment surface. 2. A medical needle sheath apparatus defined in claim 1, wherein the at least one drag induction member defines a cavity that is substantially aligned with the opening, are the cavity configured to slidably receive the inner needle for Create the drag force with the inner needle. 3. A medical needle sheath apparatus defined in claim 1, wherein the joint member includes a substantially flat opening plate that includes the joint surfaces that form the opening. 4. A medical needle sheath apparatus defined in claim 3, wherein the at least one drag induction member includes a pair of arms extending from the opening plate. 5. A medical needle sheath apparatus defined in claim 4, wherein the arm includes a deviable member. 6. A medical needle sheath apparatus defined in claim 1, wherein the connecting member that is rotatable, with respect to a longitudinal axis of the inner axis, between an orientation without union through which the inner needle can slide with respect to the joint member and a joint orientation whereby the joint surfaces are coupled to the inner needle to prevent sliding movement of the inner needle in the extended position of the at least one sheath. 7. A medical needle sheath apparatus defined in claim 1, wherein the sheath includes a housing defining at least one blocking member extending from a surface thereof, the at least one blocking member being able to engage with the joint member to push the joint member in a joint orientation. 8. A medical needle sheath apparatus defined in claim 3, wherein the sheath can include a housing defining at least one locking member extending from a surface thereof, the opening plate being able to move axially to its coupling with the at least one blocking member that causes the rotation of the joint member in a joint orientation. 9. A medical needle sheath apparatus defined in claim 1, wherein the at least one sheath is supported for relative rotational movement by at least one bearing. 10. A medical needle sheath apparatus defined in claim 1, wherein the inner needle is fixed to a handle for handling thereof. 11. A medical needle sheath apparatus defined in claim 1, wherein the needle sleeve can be released releasably with a housing of the at least one sheath. 12. A medical needle sheath apparatus defined in claim 1, wherein the needle sleeve defines a sleeve groove that is configured to receive the retainer of the joint member. 13. A medical needle sheath apparatus defined in claim 1, wherein the connecting member includes at least one outwardly arcuate arm extending towards the needle communication surface. 14. A medical needle sheath apparatus defined in claim 1, further comprising a plurality of covers. 15. A medical needle sheath apparatus defined in claim 1, wherein said readjustment surface of the connecting member comprises the distal front surface of said retainer. 16. A medical needle sheath apparatus defined in claim 1, wherein said readjustment surface is configured to deflect said readjustment surface of binding member to facilitate rotation of the binding member relative to said longitudinal axis so that said joint surface disengages the inner needle. 17. A medical needle sheath apparatus defined in claim 1, wherein said medical needle is adapted for bone biopsy. 18. A medical needle sheath apparatus defined in claim 1, wherein said readjustment surface is separated from said bushing and pushed by a spring towards said readjustment surface of union member. 19. A medical needle sheath apparatus defined in claim 18, further comprising a conical male Luer configured with said bushing. 20. A medical needle sleeve apparatus defined in claim 1, further comprising a needle protective sleeve member. 21. A medical needle sheath apparatus defined in claim 1, wherein the sheath includes a probe guide at a distal end thereof configured to receive a obturator, the obturator being configured to slide slidably with the cannula of needle. 22. A medical needle sheath apparatus defined in claim 1, further comprising a retention element. 23. A medical needle sheath apparatus defined in claim 1, further comprising a guide member for guiding devices through a needle. 24. A medical needle sheath apparatus defined in claim 1, further comprising a funnel to guide a shutter. 25. A medical needle sheath apparatus defined in claim 1, further comprising a retainer disposed between the needle bush and the sheath. 26. A medical needle sheath apparatus defined in claim 1, wherein said sheath comprises a flexible funnel. 27. A medical needle sheath apparatus defined in claim 1, wherein said sheath further comprises a depth stop. FIGURE 18 FIGURE 54 FIGURE 85