CN100571796C - Resettable safety shield for medical needles - Google Patents

Abstract

The invention provides a kind of medical needle protective cover, this medical needle protective cover comprises needle stand (104), and this needle stand (104) comprises the outer needle guard (103) from its extension.Interior pin (106) is according to being provided with respect to the mode that outer needle guard (103) slides.At least one protective cover (101) can extend to extended position with the distal portion sealing cover with pin (101) in above-mentioned from reclaiming the position.Above-mentioned protective cover (101) comprises link (105), this link (105) is arranged at the inside of protective cover (101) and determines connection surface (122), and this connection surface (122) forms the hole (138) that constitutes according to the mode of admitting interior pin (106) slidably.Above-mentioned link (105) comprises the link surface (107) that resets, and aliging with the surface that resets (108) engaging in this link surface (107) that resets, thereby allows reusing of needle protection device.

Description

Resettable safety shield for medical needles

technical field

The present invention relates generally to safety shields for medical needles, and more particularly, the present invention relates to safety shields for protecting the tips of medical needles.

Background technique

The problems associated with accidental needle sticks are well known in the art of blood sampling using medical needles, percutaneous drug injections, and other medical procedures. Due to the current susceptibility to presentation of AIDS, hepatitis and other serious blood-borne pathogens, the problem of needle sticking is of significant concern.

The procedure for removing a needle from a patient typically requires a professional to apply pressure with one hand to the wound from which the needle is to be withdrawn, while simultaneously removing the needle device with the other hand. It is also common practice for attending professionals to prioritize patient care over needle management. In the absence of a safety shield for typical needle devices, the aforementioned priority patient care requires either a conveniently accessible sharps container, or another device for safe disposal without detaching from the patient. Adequate patient care while adhering to safety procedures is often a combination of the patient's physical condition and mental state, for example, in burn centers and psychiatric wards, where it is difficult for professionals to properly dispose of used equipment while caring for the patient. needles.

Common knowledge, as well as history, regarding needle concerns and disposal issues has given rise to many devices for preventing accidental needle sticks. Problems with current safety devices include difficulty in use and relatively high cost due to their complexity and number of parts.

Other known devices employ spring actuated, telescoping, rotating, etc. sheaths. However, these devices have the disadvantage that they do not actuate, or are difficult to actuate. Disadvantages of this device also include its relatively high manufacturing costs due to the complexity and number of parts. Therefore, these types of existing devices are likely to be unable to adequately and reliably shield medical needle devices from the presentation of hazards.

Therefore, there is a need to provide a more satisfactory solution for needle safety devices by overcoming the above-mentioned shortcomings and disadvantages of the prior art. Therefore, there is a need to provide a more adequate and reliable medical needle guard, which employs a safety shield that can slide along the medical needle to prevent the hazardous presentation of the needle tip. It would be desirable to provide a safety shield that can be reset to safely allow re-use of certain needle devices. Such a needle shield device should be easily and reliably movable to cover the needle tip of the needle cannula.

Contents of the invention

Accordingly, the present invention addresses the need for a medical needle shield device that effectively and cost-effectively protects the tips of medical needles after use. The present invention overcomes the associated disadvantages and disadvantages of the prior art. More specifically, the device and method of the present invention constitute a significant advance in the field of safety needle devices.

In a specific embodiment, in accordance with the principles of the present invention, a medical needle shield assembly is provided. The medical needle shielding device comprises a shield extendable from a retracted position to an extended position to cover the distal end of the needle; a connecting member is disposed inside the shield and defines a connecting surface formed according to the above-mentioned an aperture configured to slidably receive the needle between a retracted position and an extended position; said connecting member including at least one tension generating member configured to slidably engage said needle between a retracted position and an extended position, thereby said at least one tension-generating member engages said needle to generate tension on the needle; said tension causes the connecting member to rotate relative to the longitudinal axis of the needle, as described hereinafter, so that said connecting surface engages said needle to prevent protruding from said shield The sliding of the above-mentioned needle in position; the above-mentioned connecting member also includes a retainer extending therefrom, and the above-mentioned retaining member is engageable with the above-mentioned needle to prevent rotation of the connecting member.

In another specific embodiment, a medical needle shield device includes a hub having an outer hub extending distally therefrom; the inner needle being slidably disposed relative to the outer hub. At least one shield is extendable from a retracted position to an extended position to cover the top of the needle; said shield comprises a connecting member disposed inside the shield and defining a connecting surface defining a hole which is closed by and configured to slidably receive said inner needle between said retracted position and an extended position.

The connecting member includes at least one tension generating member which engages the inner needle to generate a pulling force on the inner needle during slidable reception of the inner needle. said pulling force causes said connecting member to rotate relative to the longitudinal axis of the inner needle so that said connecting surface engages said inner needle to prevent said inner needle from slidably moving in the extended position of said shield; said connecting member further includes a A needle connection surface such that said needle connection surface engages said inner needle to prevent rotation of the connection member. A retainer extends transversely from the above-mentioned connecting member for releasable engagement with the hub.

Between a non-connected orientation and a connected orientation, the connecting member is rotatable relative to the longitudinal axis of the inner needle; in the non-connected orientation, the inner needle is slidable relative to the connecting member; in the connected orientation, the connecting surface engages the inner needle The needle prevents the inner needle from slidably moving in the extended position of the at least one shield; the connection member may include one or more arcuate arms extending outwardly to the needle connection surface.

The above-mentioned inner needle can be connected with a handle for manipulating it; the above-mentioned needle seat can form a needle-seat slot configured to receive the above-mentioned holder; the above-mentioned needle seat can be detachably mounted on at least one shell of a protective cover. The above-mentioned medical needle shield device may also include a plurality of shields.

Said at least one tension generating member may define a cavity substantially aligned with said aperture; said cavity may be configured to slidably receive said needle for generating tension on said needle; said connecting member may comprise a substantially planar orifice plate, said The orifice plate includes a connecting surface forming the above-mentioned hole; the at least one tension generating member may include a pair of arms extending from the orifice plate; the arms may have curved ends spaced apart from the orifice plate; the arms may include a bendable member .

The above-mentioned protective cover may include a housing forming at least one blocking member extending from its inner surface; the at least one blocking member is engageable with the connecting member to drive the connecting member to a connecting orientation; The at least one blocking member engages, the at least one blocking member causing the connecting member to rotate into a connected orientation.

The connection part may comprise a reset surface extending transversely from said connection part. Said hub may also include a reset surface aligned in such a manner as to contact a connector reset surface of said actuated connector when said shield housing is concentrically engaged with said hub; said reset surface causes said connector to The reset surface bends together with the needle engaging surface to a position above the inner needle surface, driving the connecting member to move from the connecting orientation to the sliding orientation; at the same time, due to the contact between the reset surface and the connecting member reset surface, the above-mentioned hub holder is held Actuating to a position to re-engage the hub and retain the hub on the needle shield; in one illustrative embodiment, the reset surface is the facing surface of the distal end of the hub holder.

The above-mentioned medical needle shield device may also be supported in a relatively rotatable manner by at least one bearing.

In another embodiment, the medical needle shield device includes a shield extendable from a retracted position to an extended position to cover the distal end of the outer needle sheath; A probe guide is formed, and the probe guide is configured to receive the probe; the probe is configured to be slidable relative to the outer needle cover.

Description of drawings

With reference to the detailed description of the following embodiments, in conjunction with the accompanying drawings, the following and other features and advantages of the present invention will be more fully understood:

Figure 1 is a perspective view of a specific embodiment of a medical needle shield device made in accordance with the principles of the present invention;

Figure 2 is a perspective view of the embodiment shown in Figure 1 in a guarded shape;

Figure 3 is a cutaway perspective view of the shield of the medical needle shield device shown in Figure 1 in a non-attached orientation;

Figure 4 is a cutaway perspective view of the medical needle shield device shown in Figure 2 in the connected orientation;

Figure 5 is a perspective view of a bearing of the needle safety device shown in Figure 1;

6 is a cutaway perspective view of the stylet shield of the needle safety device shown in FIG. 1;

Fig. 7 is the enlarged perspective view of the connecting part of the medical needle shield device shown in Fig. 1;

Figure 8 is a perspective view of the needle shield device shown in Figure 1 with a protective needle cover installed thereon;

Fig. 9 is another enlarged perspective view of the connection part shown in Fig. 7;

10-11 are cross-sectional perspective views of the medical needle safety device of the present invention showing engagement between the reset surface and the connecting member reset surface;

12 is a cutaway perspective view of an embodiment of a medical needle safety device of the present invention suitable for luer locking a needle hub;

Figure 13 is a cross-sectional perspective view of the medical needle safety device shown in Figure 12 in a protective shape;

Figure 14 is an enlarged perspective view of the medical needle safety device of the present invention shown in Figure 12 showing engagement between the reset surface and the connecting member reset surface;

Figure 15 is an enlarged perspective view of the medical needle safety device shown in Figure 12 in a reset shape;

16 is a perspective view of an embodiment of a medical needle shield device suitable for a bone biopsy needle made in accordance with the principles of the present invention;

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 handle assembly shown in Figure 16;

19 is a perspective view of the medical needle shield assembly shown in FIG. 16 with the depth stop assembly partially advanced along the threaded sleeve;

20 is a perspective view of the medical needle shield assembly shown in FIG. 16 with the stylet partially extending from the hub;

Fig. 21 is a cross-sectional view of the medical needle shield device shown in Fig. 20;

Figure 22 is a perspective view of the medical needle shield assembly shown in Figure 16, with the stylet shield fully extending from the hub;

Figure 23A is an enlarged cross-sectional view of the medical needle shield device shown in Figure 22;

23B is an enlarged cross-sectional view of another embodiment of the medical needle shield device shown in FIG. 22;

Figure 24 is a perspective view of the medical needle shield device shown in Figure 16 with the stylet removed for aspiration and the syringe inserted into the hub;

Figure 25 is a perspective view of the medical needle shield assembly shown in Figure 16 with the depth stop assembly removed;

Fig. 26 is a perspective view of the medical needle shield device shown in Fig. 16 in a shield shape;

Figure 27 is an enlarged cross-sectional view of the medical needle shield device shown in Figure 26;

28 is a perspective view of an embodiment of a medical needle shield device suitable for a PICC introducer made in accordance with the principles of the present invention;

Figure 29 is another perspective view of the embodiment of the medical needle shield device shown in Figure 28;

Figure 30 is an enlarged cutaway perspective view of the embodiment shown in Figure 28 in the retracted position;

Figure 31 is a perspective view of the embodiment shown in Figure 28 in a shield shape;

Figure 32 is a cross-sectional perspective view of the embodiment shown in Figure 28 in a shield shape;

Figure 33 is a cross-sectional perspective view of the embodiment of the present invention shown in Figure 28 in a reset shape;

34 is a perspective view of an embodiment of a medical needle shield device suitable for implantable port access made in accordance with the principles of the present invention;

Figure 35 is a perspective view of the embodiment shown in Figure 34 in an unshielded configuration;

Figure 36 is a cross-sectional perspective view of the embodiment shown in Figure 34 in a shield shape;

Figure 37 is a cutaway perspective view of the embodiment shown in Figure 34 in an unshielded shape;

38 is a perspective view of an embodiment of a medical needle shield device suitable for vial access made in accordance with the principles of the present invention;

Figure 39 is a perspective view of the embodiment shown in Figure 38 in an unshielded configuration;

Figure 40 is a cutaway perspective view of the embodiment shown in Figure 39 in a guard shape;

Figure 41 is a sectional perspective view of the embodiment shown in Figure 39 in a reset shape made according to the principles of the present invention;

Fig. 42 is the perspective view of the specific embodiment of the above-mentioned medical protective cover device with reset feature bearing;

Figure 43 is a perspective view of an embodiment of a connection part with a reset part;

44 is a perspective view of another embodiment of the medical needle shield device of the present invention;

Figure 45 is an enlarged sectional view of Figure 44;

Fig. 46 is an enlarged cross-sectional view of Fig. 44 when the reset function is engaged;

47 is a perspective view of another embodiment of the medical needle shield device of the present invention;

48 is a perspective view of another embodiment of the medical needle shield device of the present invention;

Figure 49 is a sectional view of Figure 48;

Figure 50 is a cross-sectional view of Figure 48 with the stylet withdrawn from the outer needle;

Figure 51 is an enlarged view of the stylet handle shown in Figure 48;

52 is a perspective view of another embodiment of the medical needle guard of the present invention;

Fig. 53 is a perspective view of the adjustment function of a specific embodiment of the medical needle shield device of the present invention;

54 is a perspective view of another embodiment of the medical needle shield device of the present invention;

Figure 55 is an enlarged perspective view of the depth stop of the device shown in Figure 54;

Figure 56 is a cross-sectional view of the depth stop shown in Figure 55;

Fig. 57 is an enlarged view of another embodiment of the connecting part of the medical needle shield device of the present invention;

Fig. 58 is an enlarged view of the connecting member shown in Fig. 57 in the connected position;

Figure 59 is an enlarged view of the connection part shown in Figure 57, wherein the reset part is disengaged from the connection part;

Fig. 60 is an enlarged view of the connection part shown in Fig. 57, wherein the reset part is engaged with the connection part;

61 is a perspective view of another embodiment of the medical needle shield device of the present invention;

Figure 62 is a perspective view of the embodiment shown in Figure 61 with the depth stop moved partially down the needle;

Figure 63 is a perspective view of an obturator with an integral funnel-shaped guide and reset function;

Figure 64 is a perspective view of the embodiment shown in Figure 63 during repositionable engagement;

Figure 65 is a cross-sectional view of the embodiment shown in Figure 64;

Figure 66 is an enlarged cross-sectional view of the embodiment shown in Figure 64;

Figure 67 is a perspective view of the embodiment shown in Figure 64, wherein the obturator is inserted through the needle;

Figure 68 is a cross-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 an obturator;

71 is a perspective view of another embodiment of the medical needle shield device of the present invention;

Figure 72 is a sectional view of the safety shield 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 for obturator guidance;

Figure 76 is a perspective view of a funnel placed over a needle;

Figure 77 shows the positioning feature located on the inner diameter of the safety shield for guiding the obturator toward the needle;

Figure 78 shows the obturator inserted into the funnel;

79 is a perspective view of another embodiment of the medical needle shield device of the present invention;

Figure 80 is a cross-sectional view of the embodiment shown in Figure 79;

Figure 81 is an enlarged view of the safety shield of the embodiment shown in Figure 79;

Figure 82 is a cross-sectional view of a safety shield with a needle inserted;

Figure 83 is a perspective view of the safety shield with the obturator inserted;

Figure 84 is an enlarged perspective view of a safety shield with adjustable guides;

Figure 85 is an enlarged perspective view of a safety shield having an adjustable guide with a reset area;

Figure 86 is a guide member integral with the obturator;

Figure 87 is a guide member integrated with a spring-loaded obturator;

Figure 88 is an enlarged view of the guide member shown in Figure 87;

Figure 89 is an obturator handle with resettable features;

Figure 90 is a needle inserted obturator handle with resettable features;

Fig. 91 is another embodiment of the medical needle shield device of the present invention;

Fig. 92 is yet another embodiment of the medical needle shield device of the present invention.

Detailed ways

For infusion of intravenous fluids, drug infusion, fluid collection, guidance of other needles, such as medical needles for biopsy, and more specifically, needle shields employing needle guards that prevent hazardous presentation of the needle tip Devices, including, for example, Accidental Needle Sticks, are discussed for exemplary embodiments of the disclosed medical needle shield devices and methods of operation. However, it is conceivable that the present invention finds a wide variety of needle covers and devices for the infusion of prophylactic drugs, medicaments, therapeutic agents, etc. for subjects such as dural needles, spinal needles, biopsy needles , suction (chlba) needles, potts cournand needles, coaxial needles, Y-sites, etc. It is also contemplated that the present invention may be used to collect bodily fluids and/or tissues employed during procedures including soft tissue biopsies, bone biopsies, phlebotomy, digestion, bowel, urine, veterinary, and the like. It is contemplated that the medical needle shield assembly may be used in other medical needle applications including, but not limited to, fluid infusion, fluid collection, catheters, catheter introducers, guide wire introducers, biopsy needle introducers (introducer), spine and dura mater, biopsy, aphaeresis, dialysis, blood donor, spring-filled (veress) needle, Huber needle, etc.

In the following discussion, the term "proximal" refers to the portion of the structure that is closer to the clinician, and the term "distal" refers to the portion that is further from the clinician. As used herein, the term "subject" refers to a patient receiving an infusion using the medical needle shield device described above or having blood and/or fluid collected from the device. In accordance with the present invention, the term "clinician" refers to a person who controls infusions, performs fluid or tissue collection, loads and removes needle covers from medical needle shield devices, and may include support personnel.

The following discussion includes a description of the medical needle shield device followed by a description of the method of operation of the medical needle shield device of the present invention. Specific reference is made to the following embodiments of the present invention, which are provided by the accompanying drawings.

Turning to the drawings, in these figures, like numerals refer to like parts throughout the several views. Referring first to Figures 1-11, an example of a medical needle shield device constructed in accordance with the principles of the present invention is shown. The medical needle shield device includes a shield 101 that is extendable from a retracted position (Fig. 1, 3) to an extended position (Fig. The distal end 115 of 106 is enveloped. The needle assembly described above includes a hollow outer needle 103 . The stylet 106 is slidably and concentrically disposed relative to the outer needle 103 for use with the outer needle 103 during medical needle applications, as will be discussed later. A stylet handle 113 is connected to the stylet 106 to facilitate its manipulation. Other needle assemblies are also contemplated, including, for example, needle guards, guidewires/introducers, and the like.

The connection part 105 is disposed inside the protective cover 101 and defines the connection surface 122 . The connection surface 122 forms a bore configured to slidably receive the stylet 106 in the retracted position and the extended position, and the connection member 105 includes a tension generating member, such as a friction member 126 extending therefrom. The connection member 105 includes a stylet connection surface 123 engageable with the stylet 106 to prevent rotation into the connected position of the connection member 105 .

The friction member 126 is configured to slidably engage the stylet 106 between the retracted position and the extended position such that the friction member 126 engages the stylet 106 to apply a pulling force to the stylet 106 . It is contemplated that one or more friction members 126 may be used.

A pulling force corresponding to one of the blocking members 116 and/or 117 moves the connecting member 105 into the connected position ( FIG. 4 ). The force generated by the blocking elements 116 and/or 117 acts in the opposite direction to the pulling force. The resulting force couple moves the connecting member 105 into the connected position.

When the above-mentioned stylet 106 is disengaged from the stylet connection surface 123, the connection member 105 and the holder 114 move to the connection position. At the stylet connection surface 123 , rotation of the connection member 105 is no longer impeded by engagement with the stylet 106 . Then, the connection part 105 and the holder 114 are tilted to the connection position. Rotation of the connection member 105 frictionally engages the connection surface 122 with the stylet 106, preventing movement thereof.

The blocking members 116 and/or 117 move the connecting member 105 into the connected position when a force acting on the shield 101 causes a relative movement in any direction along the longitudinal axis x. This keeps the stylet 106 inside the shield 101 from presenting the hazard of the distal portion 115 . It is contemplated that the stylet attachment surface 123 may include ribs, protrusions, cavities, etc. for engaging the stylet 106 , or a portion of the stylet attachment surface 123 to engage the stylet 106 .

Depending on the particular medical application and/or the preference of the clinician, the components of the medical needle shield device may be made of medically suitable materials such as polymers or metals such as stainless steel. Consider semi-rigid and rigid polymers, as well as elastomeric materials such as molded medical-grade polypropylene. However, those of ordinary skill in the art will appreciate that other materials and fabrication methods suitable for assembly and fabrication may also be suitable in accordance with the present invention.

In the exemplary embodiment, shield 101 includes bearing 102 that houses connection member 105 . Bearing 102 may be integrally formed, or assembled from multiple segments, which may be substantially transparent, opaque, etc.

In the retracted position, the shield 101 is positioned adjacent to the hub 104 of the outer needle 103 . It is conceivable that the outer needle 103 can also be made of a flexible polymeric material, and the components of the medical needle device can be used in conjunction with other needle applications, such as catheters, PICC introducer needles, and the like.

The connection part 105 may be integrally formed and it includes the orifice plate 118 , the friction part 126 , the tip sensing part 119 , the stylet connection surface 123 , the connection part reset surface 107 and the retainer 114 . It is contemplated that the connection member 105 may include one or more friction members 126 and that the retainer 114 may extend from the bearing 102 . Orifice plate 118 may have a rectangular, generally planar configuration with sufficient stiffness to apply a force for coupling stylet 106, as will be described later. It is contemplated that the orifice plate 118 may have a curved surface, be corrugated, and the like. It is also contemplated that the orifice plate 118 may comprise various durometers as desired for a particular application.

The embodiment of the resettable passive safety device shown in Figures 1-11 has a hollow needle 103, a solid stylet 106, a rotating housing with a stylet shield 125 and a thrust hole 133, with a thrust collar 132 of the bearing 102 and the connection part 105 with it. The thrust hole 133 and the thrust ring 132 are configured to allow the stylet shield 125 to rotate relative to the bearing 102 .

After actuating the passive safety device, the resettable function of the above-mentioned device is used. Initially, safety shield 101 and needle 103 are positioned over stylet 106 (FIG. 1). During medical procedures, the stylet 106 is automatically protected by the safety shield 101 as it is withdrawn from the needle (FIG. 2).

The safety shield 101 is advanced to approach the position where the distal end of the stylet 115 is in front of the drive connection member 105 (FIG. 3). In this position, the hub retainer 114 retains the proximal end of the hub 104 to the safety shield 101 through the interaction of the hub slot 124 and the connecting member 105 in the sliding orientation. It is contemplated that hub slot 124 may be formed from other shapes that form a cavity.

In FIG. 4 , the safety shield 101 is further positioned towards the distal end of the stylet 115 in a position where the safety shield 101 is driven. The connecting part 105 is moved to the connecting position, and the needle holder 114 of the connecting part 105 is disengaged from the needle holder 104 .

FIG. 2 shows the safety shield 101 actuated and locked. In this structure, the outer needle 103 is removed, the distal end portion 115 of the stylet is located inside the shell at a distance to prevent human body contact, and the connecting member 105 is in the connecting orientation.

Friction member 126 may be integrally formed with connection member 105 and extend from mating aperture plate 118 so as to align with aperture 138 and engage stylet 106 . This engagement creates a frictional pull on the stylet 106 . The frictional pull corresponding to one of the blocking members 116 and/or 117 moves the connecting member 105 together with the stylet 106 , creating a rotational force and tilting the orifice plate 118 . This rotational force and tilt rotate the connecting member 105 . It is contemplated that a single friction member could be used. It is also contemplated that friction member 126 may have a soft portion that may have varying flexibility to meet the specific requirements of the needle application.

As accomplished by the movement of the stylet 106 , the tilting force acts as a lever, or moment, of the end sensing member 119 , which is resisted, thereby preventing rotation of the connection member 105 . By engaging the stylet attachment surface 123 with the stylet 106 when the attachment member 105 is in the non-attached or sliding orientation (FIG. 3), the aforementioned tilting forces are resisted.

The end sensing member 119 extends away from the aperture plate 118 . The end sensing member 119 may be oriented perpendicularly relative to the plane defined by the orifice plate 118 . This vertical orientation enables tilting of the orifice plate 118 so that the attachment member 105 is disposed in either an attached or a non-attached orientation. It is contemplated that the end sensing member 119 can be oriented relative to the aperture plate 118 in a variety of ways and can flexibly extend therefrom.

The stylet attachment surface 123 resists a tilting force directed towards the end sensing member 119 of the stylet 106 . The aforementioned tilting force is generated by the friction member 126 cooperating with one of the blocking members 116 and/or 117 and tilts the orifice plate 118 . However, due to the engagement of the stylet attachment surface 123 with the stylet 106, tilting in the non-attached or slipped orientation is prevented. The stylet 106 is continuously slidably engaged with the stylet attachment surface 123 as the stylet 106 is retracted proximally and the shield 101 is extended distally.

When the stylet 106 is disengaged from the above-mentioned stylet connection surface 123 , as shown in FIG. 4 , a pulling force is generated between the friction member 126 and the stylet 106 . As already discussed, the orifice plate 118 is moved into the connected position in response to the pulling force of the blocking member 116 .

Rotation of the orifice plate 118 frictionally engages the connecting member 122 with the stylet 106, preventing it from moving. When reinforcement is acted on the shield 101 in any direction along the longitudinal axis x, the blocking members 116, 117 move the orifice plate 118 into the connected position. This keeps the stylet 106 inside the shield 101 from presenting the hazard of the distal portion 115 .

An aperture 138 is formed in the aperture plate 118 to slidably engage the stylet 106 during movement of the shield 101 between the retracted position and the extended position. Aperture 138 includes attachment surfaces 122 formed on opposite sides of aperture 138 that engage stylet 106 to prevent movement thereof in the extended position of shield 101 . It is contemplated that engagement to prevent movement of the stylet 106 may include penetration, friction, interference, and the like. It is contemplated that apertures 138 may include various geometric shapes, such as radial, polygonal, and the like. It is also contemplated that the apertures 138 may be within the interior of the aperture plate 118 , forming an open cavity, eg, in a “U” shape, opening toward one or more edges of the aperture plate 118 .

The inclination of the orifice plate 118 with respect to the longitudinal axis x facilitates sliding and connection through the connection surface 122 of the stylet 106 inside the shield 101 to prevent the hazardous presentation of the distal portion 115 . For example, as shown in FIG. 3 , orifice plate 118 is oriented at an angle of about 90° relative to longitudinal axis x such that orifice plate 118 is positioned substantially perpendicular to stylet 106 . In this unattached or slid orientation, the stylet 106 is free to slide inside the bore 138 . As stylet 106 is retracted and shield 101 is extended, stylet 106 continues to engage stylet attachment surface 123 and orifice plate 118 maintains an orientation perpendicular to longitudinal axis x.

Referring to FIG. 4 , the shield 101 is manipulated so that the friction member 126 cooperating with the blocking member 116 rotates the connection member 105 relative to the longitudinal axis x. Orifice plate 118 is rotated out of vertical alignment with stylet 106 such that orifice plate 118 is oriented at an angle of less than 90° relative to longitudinal axis x.

When the orifice plate 118 is rotated, the connection member 105 approaches the connection orientation. The connection orientation includes the state of engagement of the connection surface 122 with the stylet 106 due to the connection orientation of the orifice plate 118 . This engagement, in cooperation with the friction member 126 and the blocking members 116, 117, creates a coupling friction force on the stylet 106, thereby preventing movement of the stylet 106 relative to the shield 101 in the distal and proximal directions, and Retaining the distal portion 115 inside the shield 101 prevents its dangerous presentation.

The blocking members 116 , 117 are arranged so as not to interfere with the stylet 106 . The blocking members 116, 117 form surfaces that facilitate positioning of the orifice plate 118 in the connection orientation.

For example, as shown in FIG. 3, the shield 101 is in the retracted position and the stylet 106 is fully extended. The connecting member 105 and the aperture plate 118 are in an attached or sliding orientation such that the aperture plate 118 is substantially perpendicular to the longitudinal axis x. The blocking members 116, 117 are engageable with the aperture plate 118 to maintain the aperture plate 118 in a vertical orientation. The blocking members 116 , 117 may also maintain this orientation during extension of the stylet 106 , or may not engage the stylet 106 .

When the stylet 106 is retracted and the protective cover 101 is stretched out, as shown in FIG. 4 , the friction member 126 exerts a pulling force on the connecting member 105 through engagement with the stylet 106, and cooperates with the blocking member 116 to make the orifice 118 rotate counterclockwise. Orientation rotates to the connected position. The blocking members 116, 117 engage the orifice plate 118 for rotation from the vertical position to the connection position whereby the connection surface 122 engages the stylet 106, as previously described. The above-described shape prevents movement of the stylet 106 .

The connection member 105 is connected to the stylet 106 by the frictional force generated between the connection surface 122 and the stylet 106 . This frictional engagement prevents axial movement of the stylet 106 relative to the bearing 102 when the shroud 101 is in the extended position. This shape advantageously prevents the presentation of the stylet 106 hazard. It is contemplated that connecting member 122 may include sharp edges to increase frictional engagement. It is also conceivable that one or more other factors, such as the shape and size of the hole 138, the shape and size of the stylet 106, the thickness of the orifice plate 118, the relative The dimensions of the centerline contact points of 116, 117 with the stylet 106, and the coefficient of friction between the bore 138 and the stylet 106, create and change the coupling friction described above. It is contemplated that the friction member 126 may be formed such that a change in the tension of the orifice plate 118 may be varied by a change in the geometry of the friction member 126, e.g., wedge-shaped and grooved, to engage The stylet 106, may also be modified by the selective application of friction modifying materials, or coatings, such as oils, jelly, grease, or friction modifying coatings.

It is contemplated that the apertures in the aperture plate 118 may generate tension through engagement with the stylet 106 to rotate the connection member 105 in a similar manner to that already discussed. It is also contemplated that a material, such as jelly, grease, etc., could be employed to create a frictional pull on the stylet 106 to cause the connecting member 105 to rotate.

Needle 103 is mounted on needle hub 104 , which is removably mounted with shield 101 by releasable engagement with retainer 114 . As required by a particular medical needle application, hub 104 incorporates various uses of the medical needle shield assembly of the present invention. Shield 101 and needle hub 104 slidably support needle 103 and stylet 106 therefor. The handle 113 realizes its manipulation.

The hub 104 includes a hub slot 124 for receiving and engaging the connecting member 105 . The hub 104 includes a finger grip 160 for moving the hub 104 away from the shield 101 in the direction of the longitudinal axis x. This shape facilitates release of hub 104 and needle 103 from shield 101 and use of hub 104 and needle 103 during application of the medical needle. It is contemplated that fingertip 160 may be otherwise configured and sized depending on the needle application.

Flange 162 of hub 104 is supported concentrically on control surface 110 disposed around the inner surface of bearing 102 . Control surface 110 engages outer surface 164 of flange 162 for detachable support thereof. Outer surface 164 may engage control surface 110 in a frictional, frictional, etc. condition suitable to maintain releasable positioning relative to bearing 102 . It is contemplated that the control surface 110 may engage other portions of the hub 104 .

The bearing 102 includes a hub stop surface 112 that positions the hub 104 relative to the bearing 102 . The hub stop surface 112 prevents proximal movement of the hub 104 during installation of the bearing 102 and installation against the bearing 102 . Hub stop surface 112 advantageously controls the degree of insertion relative to bearing 102 as required by a particular medical needle application. One or more hub stop surfaces 112 may be employed. It is contemplated that the hub stop surface 112 includes a spring, spring clip, or the like to couple with the hub 104 .

Retainer 114 may extend laterally from a distal end of stylet connection surface 123 . The retainer 114 extends a length sufficient to just receive inside the hub slot 124 of the hub 104 . Corresponding to the non-connecting or sliding orientation of the connecting part 105 , the holder 114 engages with the needle hub 104 in the needle hub groove 124 to mount the bearing 102 of the shield 101 in a detachable manner.

When the stylet 106 is retracted in the proximal direction and the shield 101 is extended in the distal direction, the retainer 114 rotates in a counterclockwise direction ( FIG. 4 ) relative to the longitudinal axis x due to the tilting force generated by the friction member 126 . The retainer 114 is disengaged from the hub slot 124 to disengage the hub 104 from the bearing 102 . The clinician can manipulate the finger grip 160 to manipulate the needle hub 104 away from the shield 101 . It is contemplated that the retainer 114 may be oriented in a variety of ways relative to the connection member 105 or the stylet connection surface 123 . It is also conceivable that hub slot 124 can be variously sized to extend around the circumference of hub 104 . Hub slot 124 may include tabs or the like to be retained by retainer 114 .

In order to re-enter and exit the stylet distal portion 115 for use with a resettable passive safety device, the stylet shield 125 is concentrically aligned with the proximal end of the needle hub 104 in a manner similar to the pre-actuated state of the device. Cooperate. When this happens, the above-mentioned connection member reset surface 107 comes into contact with the reset surface 108 . This effect is illustrated in the embodiment shown in FIG. 10 .

When the stylet 106 is moved forward in the direction from the proximal end to the distal end, the above-mentioned resetting surface 108 bends the connection part resetting surface 107 together with the end sensing part 119 to a position above the surface of the stylet 106, and The connecting member 105 is actuated to move from the connecting orientation to the sliding orientation. With the connecting member 105 in the sliding orientation, the aforementioned stylet 106 is free to advance into the needle 103 .

Simultaneously, the hub holder 114 is driven into the hub groove 124 due to the contact between the reset surface 108 and the connecting part reset surface 107 . Thus, through the interaction with the hub groove 124, the hub holder 114 of the above-mentioned connecting member 105 holds the hub 104 on the safety shield 101 again ( FIG. 11 ).

In reset, safety shield 101 and needle 103 are positioned over stylet 106 as shown in FIG. 1 . During medical procedures, the safety shield 101 automatically shields the stylet 106 when it is withdrawn from the needle again.

12-15 show the resettable safety shield of the present invention applied to a needle with a luer fitting 121 and a luer cone 109 . In this embodiment, the reset surface 108 is disposed at a part away from the needle hub 104 . The return surface spring 111 applies a force to bias the return surface 108 in the proximal direction. The return surface spring 111 may be fabricated from any number of known suitable resilient materials including metals, plastics, resilient materials and the like.

In this embodiment, when the reset surface 108 is in the luer fitting 121, the above-mentioned reset surface spring 111 ensures that the reset surface 108 is in the correct position in the needle hub, so that there is an alignment and engagement between the reset surface 108 and the connecting part reset surface 107 . The above-mentioned spring 111 may be formed of elastic materials, such as rubber, urethane and the like. When a male luer cone, such as a luer lock or luer slide, is inserted into hub 104, return surface spring 111 is compressed, causing reset surface 108 to move, thereby bringing the male luer cone into contact with luer cone 109. The entire length range fits. It is contemplated that the reset surface 108 may also be disposed around the luer fitting 121, as shown in FIG. 23B. The embodiment shown in FIG. 23B also presents another embodiment of the reset surface 107 extending from the connection member 105 and engaging the retaining surface 141 .

In order to re-enter and exit the stylet distal portion 115 for use with a resettable passive safety device, the stylet shield 125 is concentrically aligned with the proximal end of the needle hub 104 in a manner similar to the pre-actuated state of the device. Cooperate. When this happens, the above-mentioned connection member reset surface 107 comes into contact with the reset surface 108 . This effect is illustrated in the embodiment shown in FIG. 14 .

When the stylet 106 is moved forward in the direction from the proximal end to the distal end, the above-mentioned reset surface 108 bends the connection part reset surface 107 together with the end sensing part 119 to the upper position of the surface of the stylet 106, and drives The connecting member 105 is displaced from the connecting orientation to the sliding orientation. In the sliding orientation of the connecting part 105, the above-mentioned stylet 106 is free to enter into the needle 103.

Simultaneously, the hub holder 114 is driven into the hub groove 124 due to the contact between the reset surface 108 and the connecting part reset surface 107 . In this way, the hub holder 114 of the connecting part 105 again retains the hub 104 on the safety shield 101 by interacting with the hub slot 124 ( FIG. 15 ).

In reset, safety shield 101 and needle 103 are positioned over stylet 106 . During medical procedures, the safety shield 101 automatically shields the stylet 106 when it is withdrawn from the needle again. The safety shield 101 may include snaps that cooperate with the hub (not shown) to facilitate engagement.

16 to 27 show the resettable safety shield of the present invention, which is applied to the bone biopsy needle 101 . In this embodiment, the luer cone 109 is used in the manner previously discussed with respect to Figures 12-15. The bone biopsy needle 101 may also include an adjustable depth stop assembly 140 for setting a desired insertion depth of the needle 103 . A locking nut 142 locks the depth stop assembly 140 in a desired position. Tabs 144 engage corresponding slots 156 (shown in FIG. 25 ) to secure depth stop assembly 140 when locking nut 142 is engaged.

As shown in FIG. 17 , a needle guard 137 may be disposed on the depth stop assembly 140 . Corresponding threads 148 and 150 respectively provided on the depth stop assembly 140 and the sleeve 151 are used to screwably move the depth stop assembly 140 . Needle shield 137 operates in a similar manner to shield 101 discussed with respect to FIGS. 1-11, which will be discussed in more detail below.

The medical needle shield for stylet 106 includes an attachment member 105, in a manner similar to that discussed with respect to FIGS. Extends from the retracted position to the extended position, thereby enveloping the distal end of the stylet 106 of the needle assembly. The stylet 106 is slidably disposed concentrically with respect to the needle 103 of the needle assembly for use with the latter during bone biopsy needle application. A stylet handle 113 is connected to the stylet 106 .

In operation, a clinician (not shown) operates the handle 113 so that the shield 101 is in the retracted position (Figs. 16, 18, 19) and the connecting member 105 is in the non-connecting or sliding position. The handle 113 may include a tab 152 for temporary securing of the hub 104 . Hub 104 includes an opening (not shown) so that handle 113 can be disengaged from the temporary fixation when tab 152 is rotated to align tab 152 with the opening. The stylet 106 protrudes relative to the shield 101 so that a needle hub 104 is disposed around the needle 103, the needle hub 104 having the bearing 102 mounted in a detachable manner. Treatment with the medical needle shield with stylet 106 and needle 103 is performed by the clinician until completion.

A stylet handle 113 is detachably attached to the hub 104 . Referring to FIG. 22 , the stylet 106 is withdrawn proximally, so that the shield 101 is extended to the extended position, and the connecting member 105 is disposed in the connected position. In the extended position, hub 104 is disengaged from stylet shield 125 . This retains the stylet 106 within the stylet shield 125 to avoid hazardous presentation of the distal end of the stylet 106 .

To re-access the stylet distal portion 115 to use the resettable passive safety device, the stylet shield 125 is concentrically engaged with the proximal end of the hub 104 in a manner similar to the pre-actuation of the device. When this happens, the above-mentioned connection member reset surface 107 comes into contact with the reset surface 108 . This effect is illustrated in the embodiment shown in Figure 23A.

When the stylet 106 is moved forward from the proximal end to the distal end, the reset surface 108 bends the connection member reset surface 107 together with the end sensing member 119 to a position above the surface of the stylet 106, and The connecting member 105 is actuated to move from the connecting orientation to the sliding orientation. With the aforementioned connecting member 105 in the sliding orientation, the stylet 106 is free to advance into the needle 103 .

Simultaneously, the hub holder 114 enters into the hub groove 124 due to the contact between the reset surface 108 and the connecting member reset surface 107 . In this way, the needle hub holder 114 of the connection part 105 can hold the needle hub 104 on the safety shield 101 again by interacting with the needle hub groove 124 .

During the reset described above, the stylet shield 125 and needle 103 are positioned over the stylet 106 as shown in FIG. 16 . During the medical procedure, the stylet 106 is automatically protected by the stylet shield 125 when the stylet 106 is withdrawn from the needle again.

Figure 24 shows the syringe inserted into the hub 104 for aspiration with the stylet 106 removed.

Figure 25 shows the resettable safety guard assembly 101 with the depth stop assembly 140 removed and the needle guard 137 in the retracted position. 26-27 show the needle shield 137 in a shielded shape. The connection part 105' is disposed in the needle shield 137 and defines a connection surface (not shown in the figure). The connecting surface forms an aperture configured to slidably receive the hollow needle 103 between a retracted position and an extended position. The connection member 105' includes a tension generating member, such as a friction member 126' extending therefrom. The connection member 105' includes a needle connection surface 123' that is engageable with the hollow needle 103 to prevent rotation of the connection member 105'.

The friction member 126' is configured to be slidable to engage the hollow needle 103 between a retracted position and an extended position such that the friction member 126' engages the hollow needle 103 so that the hollow needle 103 generates a pulling force. It is contemplated that one or more friction members 126' may be employed.

A pulling force corresponding to one of the blocking members 116' and/or 117' moves the connecting member 105' into the connected position (Fig. 27). The force generated by the blocking members 116' and/or 117' acts in a direction opposite to this pulling force. This creates a force couple that moves the connecting member 105' into the connected position.

The funnel 146 in the needle shield 137 acts as an obturator guide to facilitate insertion of an obturator or the like. The depth stop 140 can be slidably removed while the safety shield 137 remains in the proximal position. This allows the clinician to use the entire length of the needle 103 . As shown, the depth stop 140 is removed prior to actuating the safety shield 137 . Alternatively, the safety shield 137 may be connected to, or formed as part of, the depth stop 140 .

Figures 28-29 illustrate the repositioned shield device of the present invention for use with a PICC introducer or similar catheter and needle introducer. In this embodiment, the hollow needle 103 is a polymer and the stylet (or inner needle) 106 is a sharp hollow bore cannula. The handle 113 of the PICC introducer includes a capping plug 135 and a flash chamber 136 in communication with the inner needle 106 . The luer fitting 121 communicates with the flash chamber 136 and allows for cooperation with other medical devices.

The medical needle shield device includes a shield 101 which, similar to that already discussed, is extendable from a retracted position (FIG. 28) to an extended position (FIGS. 31-32), whereby the distal end of the hollow needle 103 of the needle assembly Cover up. The hollow needle 103 is slidably disposed concentrically relative to the needle hub 104 (FIG. 28) of the needle assembly for use therewith during PICC needle application. Hub 104 may be modular or non-modular. Hub 104 is preferably constructed of a polymeric material. It is conceivable that the medical needle of the present invention may be provided with a protective needle sheath component for further protection during transportation and use of the medical needle.

The handle 113 is connected to the inner needle 106 . Handle 113 may include a flash chamber 139 in communication with inner needle 106 . The luer fitting 121 communicates with the flash chamber 139, which is connected to various medical devices either through a luer slide or a luer lock accessory.

The connection part 105 is similar to the discussion of FIGS. 1-11 , and is disposed inside the protective cover 101 . The shield 101 includes a bearing 102 of a housing connection part 105 .

The hollow needle 103 is attached to the needle holder 104 . The hub 104 is mounted with the shield 101 in a detachable manner by detachable engagement with the holder 114 of the connection part 105 . Hub 104 includes a hub slot 124 for receiving and engaging connection member 105 . The above structure facilitates detachment of the hub 104 from the shield 101 and use of the hub 104 during the application of the medical needle.

The flanges of hub 104 are supported concentrically on control surfaces of stylet shield 125, as will be discussed later. The control surface engages the flange for detachable support. The retainer 114 extends to be received inside the hub slot 124 of the hub 104 . Corresponding to the non-connecting or sliding orientation of the connecting part 105 , the retainer 114 is disposed inside the needle seat groove 124 for detachably installing the protective cover 101 . When the inner needle 106 is retracted and the shield 101 is extended, the holder 114 rotates counterclockwise to disengage from the hub slot 124 , thereby disengaging the hub 104 from the stylet guard 125 .

The stylet guard 125 is provided so as to rotate and cover the distal end of the inner needle 106 . The handle 113 is attached to the stylet guard 125 , and the stylet guard 125 is rotated relative to the guard 101 and the inner needle 106 at the extended position of the guard 101 . Similar to the previous discussion, relative rotation of the stylet guard 125 is accomplished by bearings and shafts formed at bearing holes in the stylet guard 125 . In the connected position, the bearing shape provides support for the rotation of the stylet guard 125 relative to the guard 101 and inner needle 106 .

The inner needle 106 is retracted proximally, so that the protective cover 101 is extended to the extended position, and the connecting member 105 is disposed at the connected position. The needle hub 104 is disengaged from the protective cover 101, and the protective cover 101 covers the distal end of the needle 103 in the extended position. This keeps the hollow needle 103 inside the shield 101 , avoiding the presentation of a hazard by the distal end of the needle 103 .

In operation, hub 104 is disengaged from shield 101 and stylet shield 125 covers the distal end of inner needle 106 in the extended position, as previously described. This keeps the inner needle 106 inside the shield 101 to avoid dangerous presentation of its distal end.

To re-enter and exit the inner needle 106 to use the resettable passive safety device, the stylet shield 125 at the center of rotation is concentrically engaged with the proximal end of the needle hub 104 in a manner similar to the pre-actuated state of the device . When this happens, the connecting part reset surface 107 on the end sensing part 119 comes into contact with the reset surface 108 . This effect is illustrated in the embodiment shown in FIGS. 30 and 33 .

When advancing the inner needle 106 in the direction from the proximal end to the distal end, the reset surface 108 rotates the connecting member reset surface 107 together with the end sensing member 119 to a position above the surface of the inner needle 106 and drives the connecting member 105 from connection orientation to sliding orientation. When the connecting part 105 is in the sliding orientation, the inner needle 106 is free to enter the interior of the hollow needle 103 .

Simultaneously, the hub holder 114 enters into the hub groove 124 due to the contact between the reset surface 108 and the connecting member reset surface 107 . In this way, the needle hub holder 114 of the connection part 105 can hold the needle hub 104 on the safety shield 101 again by interacting with the needle hub groove 124 .

In reset, the safety shield 101 and hollow needle 103 are positioned over the stylet 106 as shown in FIG. 28 . During medical procedures, the inner needle 106 is automatically protected by the safety shield 101 when the inner needle 106 is withdrawn from the needle again.

Figures 34-37 illustrate the repositionable protective safety shield device of the present invention for use with an interface access device or an implanted pump. It is contemplated herein that the interface access device may be implanted in or placed outside the patient. The operation and structure of this embodiment may be in accordance with various embodiments described herein, for example, the embodiments shown in FIGS. 1-11 . 34-37 show the implant interface 127 and the skin layer 129 with the implant interface access body 130. The interface access body includes a reset surface 108 . In this embodiment, the stylet 106 is shielded by a safety shield 101 prior to use. The reset surface 108 and the connecting member reset surface 107 reset the safety device to allow the stylet 106 to pass through the skin layer 129 and into the implant interface 127 as previously described. Upon removal of the stylet 106 from the implant interface access body 130, the safety shield device is reactivated.

Referring to Figures 38-41, the resettable safety cover device of the present invention is shown in the figures, which is used for the medicine bottle in and out body. The operation and structure of this embodiment may be in accordance with various embodiments described herein, for example, the embodiments shown in FIGS. 1-11 . 38 to 41 show a medicine bottle 131 and a corresponding medicine bottle inlet and outlet body 134 . Prior to use, the stylet 106 is shielded by the safety shield 101 . The reset surface 108 engages the connection member reset surface 107 to allow the stylet 106 to enter the vial 131 . Upon removal of the stylet 106 from the vial access body 134, the safety shield device is reactivated.

Referring to Fig. 42 to Fig. 46, another embodiment of the medical needle shield device with resettable features is shown in the figures according to the principle of the present invention.

The reset part 201 may form part of, but is not limited to, the following parts: the needle hub/handle 203, the inner shell 202, the outer shell 204, the connecting part 205, or the reset part 201 may be a separate part, the separate A component interacts with any of the components described above. The reset part 201 may comprise a reset surface 206 for interacting with the connection part 207 . When the reset member 201 is activated, the reset surface 206 interacts with the connection member 207 to leave the connection on the stylet 208 in an unlocked state. If the reset member 201 forms part of the connection member 207 , the reset surface 206 may extend from the connection member 207 and may be directly connected so that actuation of the reset member 201 unlocks the connection of the connection member 205 with the stylet 208 .

The aforementioned reset member 201 is preferably inactive, which means that the device cannot be reset by accident. In addition, it is preferable to design the reset member 201 in such a way that special effort must be expended to drive the reset member 201 and the reset device. Therefore, reset component 201 is preferably capable of switching between active and inactive states. This can be accomplished in a number of ways including, but not limited to, hinges, cantilever beams, bi-stable mechanisms, springs, etc.

In order to actuate the reset part 201 a special effort must be expended which would require the reset part 201 to come into contact with the reset geometry 209 which is already in position to reset the device. As shown in FIGS. 3-5 , the reset geometry body 209 can be disposed on the hub/handle 210 . The reset geometry 209 may include a luer piece on the hub/handle, a separate piece with the reset geometry, and a geometry on the disc. However, reset geometry 209 is not limited to geometry on any means for interacting with reset member 201 to reset safety shield 212 .

In addition, it is preferable to include a holding member 211 . In many instances, it is desirable to have a safety shield 212 that remains in place until the safety shield 212 is connected to the stylet 208 in some manner. In the embodiment shown in FIGS. 44-46 , the shield 212 is retained on the hub/handle 210 . In this configuration, the safety shield 212 is maintained until the stylet 208 is removed when the safety shield 212 detects that the end of the stylet 208 is connected to the stylet 208 . This embodiment presents a retaining member 211 that acts as a detent mechanism that allows the safety shield 212 to be retained on the hub/handle 210 . The retaining component 211 may also include a buckle, a lock, a hook, a friction member, etc., but is not limited thereto.

Referring to FIGS. 47-51 , in some procedures it is necessary to retain the stylet handle 221 on the main device handle 222 . Previous retention components included detents and bayonet stylet holders. These methods can create sudden forces upon removal that can cause the device to dislodge by mistake, or cause further pain to the patient. These retention methods may also be impractical due to the high forces of the rotational movement that occur during handling.

The embodiment shown in FIGS. 47-51 shows a holder with a snap mechanism 223 . This allows for a secure hold on the main device handle 222 . The snap members 225 are securely seated against rotational and axial movement. The buckle mechanism 223 may also have a button/lever 226, or other similar buckle mechanism 223, to disengage the buckle 225. This allows for no sudden force and easy one-handed release when removing.

Referring to Figures 52-60, in some procedures it may be desirable to employ a depth stop 231 . The depth stop 231 often has an adjustment feature 232 . As shown in FIG. 53, the adjustment feature 232 may include threads 234, but is not limited thereto. In this case, the safety shield 233 may include an adjustment feature 232 such as threads 234 to advance the depth stop 231 . The safety shield 233 may also include a depth indicator 235 to indicate the depth of the depth stop 231 . The above-mentioned safety shield 233 may also include a holder 236 for the depth stop 231 . The above-mentioned holder 236 may include a pawl, a hook, a friction member, etc., but is not limited thereto. The depth stop 231 may also be the mechanism that drives the safety shield 233 .

FIG. 54 shows another embodiment showing a safety shield 233 with a depth stop 231 having an adjustment feature 232 . The adjustment function 232 mentioned above can be similar to the aforementioned ones. The depth stop 231 may include a retainer 236 similar to that previously described. The above-mentioned holder 236 can also realize the function of the safety shield pawl. One embodiment also includes a lock nut 237 that can be used to interface with the depth stop 231 and the threads 234 (see FIG. 52 ).

Referring to Figures 57 and 58, for certain procedures it may be necessary to introduce a device 240, such as a guide wire, catheter, etc., through a needle 238. In these cases, it is preferable to also actuate the safety shield 233 to protect the sharp portion 239 while the above-mentioned device 240 remains in the needle 238 . One embodiment includes a double-ended sensing member 241 . This type of tip sensing feature allows the full functionality of the device with device 240 to be achieved through needle 238 . The double-ended sensing part 241 is positioned in a sliding manner along the needle 238, thereby preventing connection of the connecting part 242. The dual-ended sensing member 241 can also be positioned in such a way that it slides on the outer edge of the needle 238 . In this position, the double-end sensing part 241 continuously detects the end of the needle 238 . However, the dual-ended sensing member 241 may extend around any device 240 disposed in the needle 238 when the connecting member 242 passes through and reaches its connected state.

Another application of the double-end sensing component 241 is for reset applications. In some resetting occasions, the above-mentioned end sensing part is located under the needle 238 . Doing so will make it impossible to reset the unit. The double-ended sensing member 241 can be forced around the needle 238 by the resetting member 243 while simultaneously resetting it. The double-ended sensing member 241 is soft enough to extend around the needle 238 when repositioning occurs, but stiff enough not to slide around the needle during normal use. This will require a balance of forces. The double ended sensing member 241 can also be driven on the needle cone.

61-62 illustrate a bone biopsy device, often referred to as a Type I bone biopsy device, with a depth stop 253 . Typical Type I bone biopsy devices require the use of depth stops 253 . They often have an adjustment feature 252 that includes, but is not limited to, threads. However, there is a disposition to employ the full needle length 255 of the present device. In this case, the depth stop 253 is removed, thereby exposing the longer needle. This creates problems since the user is required to disassemble the product for certain disposals. The illustrated embodiment allows the full needle length 255 of the needle to be initially exposed. The desired depth stop 253 may be positioned behind the initially exposed full needle length 255 . This allows the user to dispose of the full needle length 255 without disassembly or assembly steps. For other disposals, there is no technical change either. The depth stop 253 is also used in an increasing field of adjustable use. In this case, it is also advantageous for the safety device. Since there is no disassembly or assembly required, there is little chance of a user inadvertently actuating the safety device while removing the depth stop 253 to allow the full needle length 255 to pass in and out.

Referring to Figures 63-78, another embodiment of the present invention with a reset feature is shown. As shown in FIGS. 63 to 70 , an obturator 361 with a reset geometry 362 interacts with a reset member 363 . The obturator 361 may include a handle 370 . The handle 370 may include a cavity 365 that protects the needle 366 during resetting. The obturator 361 may also include a funnel 364 that guides the obturator 361 through a safety shield 369 to the inner diameter of the needle 366 . The funnel 364 may include a locating surface 367 on the housing to facilitate guidance. The funnel 364 slides along the obturator 361 so that the funnel 364 allows the obturator 361 to pass through the funnel 364 . The funnel 364 may be a separate piece. The obturator 361 may also include a blocking member 368 positioned in a manner to prevent resetting. This blocking part 368 is also movable, allowing the resetting geometry 362 to interact with the resetting part 363 in the absence of the blocking part 368 . Mechanisms for moving the blocking member 368 include, but are not limited to, levers, hinges, buttons, locks, snaps, detents, and the like.

In the present exemplary embodiment, the obturator 361 is designed such that after the obturator 361 has passed through the needle 366 and the sample has been expelled, the blocking element 368 prevents the interaction of the restoring geometry 362 with the restoring element 363 . Then, the blocking part 368 is moved to a position where the regeometry 362 interacts with the reset part 363 . The reset geometry 362 interacts with the reset part 363 so that the connecting part 360 is released from the locking position. This allows the safety shield 369 to be ready for reuse. It is also contemplated that the reset geometry 362 may be located at other locations on the obturator 361 including, but not limited to, opposite ends of the obturator 361 .

As shown in FIGS. 71-74 , the safety shield 389 includes a reset surface 387 that is manually actuatable to interact with the reset member 383 . The resurface 387 can be directly connected to the reset member 383 . The reset component 383 also includes, without limitation, a portion of the following components: needle hub/handle, inner housing, outer housing, connecting member and/or obturator. Alternatively, reset component 383 may be a separate piece that interacts with any of the components described above. The aforementioned reset surface 387 can be connected or interacted with a reset geometry 382 for interacting with a reset member 383 to disengage the connecting member 380 from the locked position. The reset interface 387 may include springs, hinges, levers, buttons, switches, sliders, and the like. Reset interface 387 may also include paired interfaces. This is the best way to ensure proper finger placement. Paired interfaces can be staggered to allow dedicated effort to reset the safety shield.

The resetting surface 387 described above may require another orifice 388 so that unlocking of the connection with the originally locked connection member 380 safely allows the safety shield 389 to be removed from the contaminated needle tip. The other orifice 388 may be formed such that actuation of the reset interface 387 positions the connection surface 386 within the safety shield 389 for connection when the safety shield 389 is driven distally. This way can prevent the accidental removal of the safety shield 389 from the contaminated needle tip while resetting.

Funnel 392 guides obturator 391 to the inner diameter of needle 396 as shown in FIGS. 75-78 . The funnel 392 can be configured such that it allows a locking or friction fit with the locking pin 396 . The funnel 392 can also be constructed so that it includes a positioning feature 393 on the safety shield 399 for guiding the obturator 391 to the inner diameter of the needle 396 . The locating feature 393 on the safety shield 399 can also be configured to achieve the desired fit to maintain position. Such mating interfaces include, but are not limited to, snap fits, friction fits, detents, and the like. Preferably, the funnel 362 with or without a safety shield 399 is selected so that the clinician may choose to use the funnel 392 with a safety shield 399 protecting the tip from contamination to guide the obturator 391 toward the needle 396 inside diameter. It also allows general use without safety devices.

Referring to Figures 79-92, in some applications it may be desirable to have the obturator funnel through the needle assembly. Preferably also guide means are provided in the safety shield which may require the safety shield to be actuated before the funnel is employed. In addition, it is preferable to reset the connecting member, which protects the contaminated tip (eg, medical needle, stylet, etc.).

In one embodiment, a guide member 402 is provided which is integral with the safety shield 401 . The guide member 402 comprises a geometrically shaped interface that allows guiding of a penetrating needle device, such as the obturator 403 or the like. The guide member 402 is configured such that the penetrating needle device 403 does not interfere with the locking mechanism 404 in the safety shield 401 . Other embodiments include geometrical bodies which continuously allow guiding of the guide part 402 but which also provide a reset area 406 for the safety shield 401 .

81-82 show a guide member 412 having a flexible member 415 that allows the guide member 412 to change in size. This allows guiding of the penetrating needle device 413 . The flexible member 415 also allows for a larger opening of the reformed area 416 . The reset region 416 is the region that allows the reset geometry 417, or other geometry that interacts with the reset geometry 417, to be positioned so that it interacts with the reset component 418 to disengage the connection of the locking mechanism 414 . This allows the safety shield 411 to be ready for reuse.

As shown in FIGS. 83-85 , another embodiment includes a guide member 422 having an adjustable member 425 that can be positioned by a positioning member 429 . The adjustable member 425 may be rigid or flexible. The positioning member 429 may include a sleeve, button, lever, collar, or other member for interacting with the adjustable member 425, but is not limited thereto. The above-mentioned adjustable member 425 is formed such that the positioning member 429 interacts with the adjustable member 425 to position the adjustable member 425 to guide the penetrating needle device 423 . The adjustable member 425 can be formed such that a more snug guide member 422 can be obtained that would otherwise fit around the needle 420 . Positioning member 429 may include gripping surface 424 . The clamping surface 424 may be formed such that, upon the next actuation of the safety shield 421, the positioning member 429 positions the flexible member 425 upon actuation. The detent member 429 may also be formed such that the detent member 429 is repositionable in a position where the adjustable member 425 provides the reset region 426 .

As shown in Figures 86-88, another embodiment is shown in which a guide member 432 is integrally provided with an obturator 431 . The guide element 432 can be designed such that it remains connected to the obturator 431 . The guide element 432 can also be designed in such a way that it can slide along the shutter 431 . In this embodiment, a guide member 432 with a spring 433 is shown (see FIGS. 87 to 88 ). The spring 433 may include springs, folded plastics, telescoping structures, wires, wires, etc., but is not limited thereto. It is formed such that the natural rest position of the aforementioned guide member 432 is at the end of the obturator 431 . This allows guiding of the obturator 431 . The guide member 432 is configured such that when the needle 430 is moved toward the obturator, the guide member 432 sends the needle toward the center. This guidance takes place almost without resistance. When the needle 430 contacts the center of the guide member 432, a locking surface 434 is formed which is formed such that the needle 430 tends to lock on the guide member 432, eg, a luer cone. After the needle 430 is locked on the guide member 432 , the continuous movement tends to slide the guide member 432 along the obturator 431 . Thereafter, the obturator 431 is guided into the needle 430 and the sample is extruded.

As shown in FIGS. 89-90 , the obturator handle 445 may be formed such that the reset geometry 447 is integrally formed on the obturator handle 445 . The obturator handle 445 may also include a locking surface 444 formed such that the needle 440 tends to lock on the obturator handle 445 .

Other embodiments include modifications of the tip sensing member 452 (see FIG. 91). The tip sensing member 452 includes a needle attachment surface 451 that rides over the needle 450 and provides a force against attachment. When the geometry of the needle 450 changes (eg, needle tip, needle grindstone, needle cone, etc.), the tip sensing component 452 detects the change of the needle 450 and no longer prevents the connection. Ways to alter the geometry of the needle 450 include, but are not limited to, beveled surfaces, grooved surfaces, protrusions, any surface for amplifying the tip sense signal. FIG. 91 shows the sloped surface 454 . The sloped surface 454 is formed such that a change in the geometry of the slightly smaller needle 450 causes the sloped surface 454 to switch sharply. It is caused by the geometry created by the inclined surface 454 .

FIG. 92 shows another embodiment which has a separate pin connection surface 461 . The separate needle connection surface 461 applies a frictional force to the needle 460 . This force is used with the needle connection member 462 to resist connection. For the geometry change of the needle 460, a frictional force can be created against the connection on the needle 460, which prevents the applied frictional force (eg, needle cone, needle whetstone, tip of the needle, etc.).

The present invention may be implemented in other specific forms without departing from the essence or essential technical characteristics of the present invention. Accordingly, this embodiment should be considered in all respects as illustrative and not restrictive, the scope of the invention being given by the appended claims rather than by the foregoing discussion, and the invention is to include equivalents of the claims all changes within the meaning and scope of the proposal.

Claims (27)

1. medical needle protective cover, it comprises:

Needle stand, this needle stand have the outer needle guard that extends to distal portion from it, interior pin according to mutually externally needle guard slidably mode be provided with;

At least one protective cover, this protective cover can extend to extended position from reclaiming the position, so that the distal portion big envelope of pin in will being somebody's turn to do;

Above-mentioned protective cover comprises link, and this link is arranged at the inside of above-mentioned protective cover and limit connects the surface, this connections surface go up formation according between above-mentioned recovery position and extended position, admit slidably above-mentioned in the hole that constitutes of the mode of pin;

Above-mentioned link comprises at least one pulling force production part, thereby admit slidably above-mentioned in pin during, at least one pulling force production part engages so that pin in this is produced pulling force with above-mentioned interior pin, this pulling force makes a link internally inclination and the rotation of pin mutually with protective cover, engages with above-mentioned interior pin to prevent the slip of above-mentioned interior pin at the extended position of above-mentioned protective cover thereby connect the surface;

Above-mentioned link also comprises the pin connection surface from its extension, can engage to prevent the rotation of link with above-mentioned interior pin thereby above-mentioned pin connects the surface;

Be used for realizing the keeper that to be disengaged with needle stand;

Above-mentioned link also comprises the surface that can reset with the link of the surface in alignment that resets.

2. medical needle protective cover according to claim 1 is characterized in that at least one pulling force production part forms the chamber, aligns with above-mentioned hole substantially in this chamber, and this chamber constitutes so that pin in above-mentioned is produced pulling force according to the mode of admitting above-mentioned interior pin slidably.

3. medical needle protective cover according to claim 1 is characterized in that above-mentioned link comprises planar substantially orifice plate, and this orifice plate comprises the connection surface that forms above-mentioned hole.

4. medical needle protective cover according to claim 3 is characterized in that above-mentioned at least one pulling force production part comprises the paired arm that extends from above-mentioned orifice plate.

5. medical needle protective cover according to claim 4 is characterized in that above-mentioned paired arm comprises flexible parts.

6. medical needle protective cover according to claim 1, it is characterized in that between disconnected orientation and connection orientation, the internally axle inclination and the rotation of pin mutually of above-mentioned link, according to this disconnected orientation, pin link slip relatively in above-mentioned, according to above-mentioned connection orientation, above-mentioned connection surface engages with above-mentioned interior pin to prevent the slip of pin in the extended position of at least one protective cover above-mentioned.

7. medical needle protective cover according to claim 1, it is characterized in that above-mentioned protective cover comprises shell, this shell limits at least one stop member that extends from its surface, and this at least one stop member can engage with above-mentioned link to order about above-mentioned link and shift to connection orientation.

8. medical needle protective cover according to claim 3, it is characterized in that above-mentioned protective cover comprises shell, this shell limits at least one stop member that extends from its surface, above-mentioned orifice plate can move vertically to engage with above-mentioned at least one stop member, and this at least one stop member makes above-mentioned link rotate to connection orientation.

9. medical needle protective cover according to claim 1 is characterized in that above-mentioned at least one protective cover supports to realize relative rotary motion by at least one bearing.

10. medical needle protective cover according to claim 1 is characterized in that above-mentioned interior pin is connected with the handle that it is handled.

11. medical needle protective cover according to claim 1 is characterized in that above-mentioned needle stand installs the shell of above-mentioned at least one protective cover removably.

12. medical needle protective cover according to claim 1 is characterized in that above-mentioned needle stand limits the needle stand groove, this needle stand groove constitutes according to the mode of the keeper of admitting above-mentioned link.

13. medical needle protective cover according to claim 1 is characterized in that above-mentioned link comprises the arched arm that at least one is outwards outstanding, this arm extends to pin and connects the surface.

14. medical needle protective cover according to claim 1 is characterized in that it also comprises a plurality of protective covers.

15. medical needle protective cover according to claim 1 is characterized in that above-mentioned link reset table face comprises the distal surface of facing of above-mentioned keeper.

16. medical needle protective cover according to claim 1, it is characterized in that the above-mentioned surface that resets constitutes in the following manner, this mode is: make above-mentioned link reset surface curvature so that above-mentioned link above-mentioned relatively in the vertical axis tilt and the rotation of pin, thereby above-mentioned connection surface with above-mentioned in pin throw off.

17. medical needle protective cover according to claim 1 is characterized in that above-mentioned medical needle is applicable to biopsy of bone.

18. medical needle protective cover according to claim 1 is characterized in that the above-mentioned surface that resets separates with above-mentioned needle stand and orders about by spring shifting to the above-mentioned link surface that resets.

19. medical needle protective cover according to claim 18 is characterized in that it also comprises the guiding convex cone that forms by above-mentioned needle stand.

20. medical needle protective cover according to claim 1 is characterized in that it also comprises protection needle sleeve parts.

21. medical needle protective cover according to claim 1 is characterized in that in the distal portion of above-mentioned protective cover the probe guide being set, it constitutes according to the mode of admitting occluder, above-mentioned occluder according to by above-mentioned needle guard slidably mode form.

22. medical needle protective cover according to claim 1 is characterized in that it also comprises holding member.

23. medical needle protective cover according to claim 1 is characterized in that it also comprises and is used for guiding parts that the transfixion pin device is led.

24. medical needle protective cover according to claim 1 is characterized in that it also comprises and is used for funnel-shaped piece that occluder is led.

25. medical needle protective cover according to claim 1 is characterized in that it also comprises the ratchet that is arranged between above-mentioned needle stand and the above-mentioned protective cover.

26. medical needle protective cover according to claim 1 is characterized in that above-mentioned protective cover also comprises flexible funnel-shaped piece.

27. medical needle protective cover according to claim 1 is characterized in that above-mentioned protective cover also comprises degree of depth retainer.

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