WO2011148241A2

WO2011148241A2 - Safely disposable cannula device

Info

Publication number: WO2011148241A2
Application number: PCT/IB2011/001097
Authority: WO
Inventors: Samarth Malhotra
Original assignee: Samarth Malhotra
Priority date: 2010-05-24
Filing date: 2011-05-23
Publication date: 2011-12-01
Also published as: WO2011148241A3

Abstract

A safety module (600) for a needle (622) in a disposable cannula device, the safety module comprising two arms (602a, 602b), inclide to each other and defining a cavity between one end of each of the two arms, the cavity slidably resting against an outer surface of the needle disposed between the two arms thereby defining a first contact surface (616) between the two arms and the needle: a connecting member (604) joining the other two ends of the arms, the connecting member having a circular through hole (606) such that the center of the through hole and the first contact surface (616) define an axis (620) along which the needle moves while passing through the hole; two flange components (608a, 608b) extending from the two ends of the arms from the first contact surface (616); two module locking components (610a, 610b) extending from the two flange components.

Description

SAFELY DISPOSABLE CANNULA DEVICE

FIELD OF INVENTION

[0001] The present invention generally relates to medical devices, and, more particularly, to disposable medical devices for introducing fluids into a patient's body, and/or for taking fluid out of the patient's body.

BACKGROUND OF INVENTION

[0002] Typically, it is well-known and common practice by medical practitioners to inject fluids and drugs directly into the blood stream of patients. Also, during surgical operations, it is frequently necessary to administer whole blood transfusions and parenteral fluids. Historically, introduction of such fluids into the cardiovascular system of a patient has required the making of a venipuncture using a hollow rigid needle having a proximal attachment site for fluid connecting the needle to a source of intravenous fluid or the like. This method of administering fluids created some persisting problems in the art. Primarily, the rigidity of the needle within the vein requires that the needle, usually on the arm, be maintained, for reasons of safety, in a fixed position at the general site of the venipuncture throughout the duration of fluid administration or transfusion, which may consume considerable time. Secondly, where it has been necessary to periodically draw blood samples and/or successively administer intravenous fluids, the patients may be required to experience a venipuncture each time which results in a highly traumatic experience.

[0003] Subsequently, it had been the practice to insert a flexible catheter tube into a vein and leave the catheter tube in such a position for purposes such as periodically administering fluids, transfusions and medication, collecting of blood samples, etc. In this way, the trauma, extravasation, infiltration, etc., of repeated venipunctures are avoided and the danger and discomfort of leaving a rigid needle in the body for a prolonged period are overcome. To place the distal end of such a flexible catheter tube within a body cavity, such as a vascular cavity, a cannulated or hollow needle was used to make the venipuncture. Thereafter, the catheter tube, telescopically carried on the outer circumference of the needle, was fed overtop of the needle into the vein following the venipuncture. The needle

CONFIRMATION COPY may thereafter be completely removed from the catheter tube and disposed of. For removal of the needle, it has been the practice to use a syringe hub-mounted needle or a retractable stylet needle assembly including a leading needle, a flexible wire rigidly secured to the trailing end of the needle, and a handle joined to the trailing end of the wire. Thus, the needle may be retracted from the catheter tube by means of the syringe or the retraction handle. However, according to practice, a catheter unit with a syringe needle or a retractable stylet needle must have an inserter clamp device which was structurally separate from and slideably engageable with the catheter tube for purposes of locking the needle at venipuncture and/or subsequent catheter placement. The inserter clamp device used, however, was relatively expensive to fabricate and had to meet exacting dimensional specifications.

[0004] In view of the above, it was a significant contribution to the catheter art and a conventional intravenous catheter placement unit was introduced, which had a built-in inserter serving to facilitate controlled aseptic insertion and precise body placement of the catheter, in which inserter was easily fabricated and was an integral part of the catheter. The intravenous catheter apparatus generally included an intravenous catheter tube, a manually guidable circumferentially deformable elastomeric bore-defining tubular inserter integral with and in axial alignment with the catheter tube for use with a patient. The intravenous catheter further included a needle concentric within the catheter tube and the inserter and extending through at least part of the bore of the inserter to beyond the distal end of the catheter tube. The inserter may or may not include opposed laterally extending wings adapted to be manually compressed together from an at-rest position to a needle control position, the bore of the inserter being sufficiently large to permit retraction of the needle from the catheter tube and the inserter when the inserter was at rest, and when the inserter wings were compressed to the needle control position sufficiently constricted to enable the inserter to grip the needle firmly to permit inserter-forced injection of the distal end of the needle into the body of a patient. [0005] Generally, an intravenous (IV) catheter is an instrument for introducing certain fluids such as but not restricted to saline or dextrose solution or medicaments directly into a bloodstream of a patient. Typically, a needle is first introduced into the skin of the patient at the desired location such as, for example, but not limited to the back of the patient's hand or to a vessel on the inside of the arm. The needle is employed to pierce the skin of the patient to enter the blood vessel and guides the catheter into the vein. Once insertion is complete, the needle is removed and only the catheter remains in the blood vessel. After removing the needle, a fluid handling device such as an Infusion set may be attached to the proximal end of the catheter hub. Fluid then flows directly from the fluid handling device through the catheter into the bloodstream of the patient.

[0006] While removing the needle from the cannula, the health care worker must always place the exposed needle tip at a nearby location and simultaneously addressing the task required to accomplish the infusion of fluids. Procedures for removing a needle from a patient commonly require the health care worker to use one hand to place pressure at the site of puncture from where the needle is being withdrawn, while removing the needle device with the other hand. It is also a common practice for an attending doctor or paramedic to give higher priority to care for the site of puncture and either lock it or connect it to the infusion set such as an IV Set than is given to disposal of a needle. It is at this juncture that the exposed needle tip creates a danger of occurrence of an accidental needle prick which leaves the health care worker vulnerable to the transmission of various, dangerous blood-borne pathogens such as human immune virus (HIV), hepatitis and other serious blood-borne pathogen exposures. Providing adequate care while following safety procedures is often compounded by the patient's physical condition and mental state, such as in burn units and in the psychiatric wards. Under such conditions, it is difficult to properly dispose of the used needle while caring for a patient.

[0007] It is well known that existence of infectious diseases such as Acquired Immune deficiency Syndrome (AIDS) and hepatitis has highlighted a worldwide danger to which a medical personnel may be exposed while treating patients by means of catheter devices and syringes whereby a sharp needle point is used to pierce the skin of the patient. In recent scenario, several medical personnel have been infected by a physical contact with or an accidental puncture by an infected needle.

[0008] With widespread awareness associated with needle care and disposal problems and an aim to safeguard medical personnel against inadvertent needle injury, numerous solutions have been developed whereby protective mechanisms incorporated within a catheter or syringe prevents physical contact with the needle after use and hence against the inadvertent needle stick.

[0009] Typically, most of the solutions developed are complicated and include a withdrawal of the needle within a needle hub once the needle has been utilized. Such complications result in an expensive product as well as multiple manufacturing difficulties involved in the development of the product that provides adequate anti-needle stick protection.

[0010] The risk of a contaminated needle injury is not just isolated to the health care worker inserting the intravenous catheter. Careless disposal of used needles may put other health care workers at risk as well. Even others outside the health care profession, for example those involved in the clean-up and final disposal of the medical waste, are at risk of an accidental needle prick from a carelessly discarded needle.

[0011] Gradually, the danger to health care workers and others outside the health care profession from accidental needle sticks has yielded the development of catheters with safety mechanisms in which the occurrence of such accidental needle sticks is prevented. U.S. Pat. No. 6,544,239 titled "Releasable locking needle assembly with optional release accessory therefore" issued to Kinsey discloses a needle assembly including a needle member and a blunting member. The needle member contains a needle cannula having a puncture tip and a needle passageway there through. The blunting member contains a blunting probe having a blunt end. The assembly may be combined with an accessory device (such as a catheter hub, guide wire, etc.) to produce an apparatus that is lockable in a blunted configuration and that can be released by the associated accessory, or may be configured to be released by manual manipulation. However, the overall design of the invention is bulky. Moreover, special training would be required to be given to the technician who will be handling the device.

[0012] Another example of a catheter having a safety mechanism is disclosed in U.S. Pat. No. 6,117,108 titled "Spring clip safety IV catheter" issued to Woehr et al. The IV catheter is described in the invention includes a resilient needle guard which protects the needle tip upon removal of the needle from the catheter hub. The needle guard includes an arm that includes an opening through which a needle passes causing axial movement of the arm. This axial movement forces the arm into a groove or behind a rib located on the inside of the catheter hub, capturing the needle guard in the catheter hub. However, a potential issue with this design develops when the needle guard is not properly seated into the catheter hub. If the distal end of the needle guard arm is not in alignment with the groove in the catheter hub, excessive forces are placed on the needle causing a high drag force as the clinician removes the needle. Moreover, as the needle guard arm is not properly seated in t groove, it may prematurely release from the catheter hub upon the removal of the needle leaving the needle tip exposed.

[0013] U.S. Pat. No. 6918891 titled "Safety device" issued to Becton Dickinson Co discloses a safety needle assembly having a hub and a needle cannula that projects distally from the hub. A shield is made on the needle cannula which may move from a proximal position adjacent the hub and a distal position for shielding the tip of the needle cannula. A fin projects from the hub to facilitate digital manipulation of the needle assembly. A proximal arm is hinged to the hub and a distal arm is hinged to both the proximal arm and the shield. The proximal arm is releasably engaged with the fin when the shield is in the proximal position. However, the design of the cannula is very complex.

[0014] In addition to the above, WO/1989/002757 titled "a self-blunting needle assembly and device including the same" discloses a self-blunting needle assembly filed by bio-plexus. The assembly includes a hollow needle, having a needle mouth and a needle shank terminating in a puncture tip, has is made within it a blunting member including an elongate probe which slidably fits within the bore of the needle shank. The probe terminates in a distal tip which is initially positioned short of the puncture tip of the needle so as not to interfere with injection of the needle either into a patient or into a connecting device. After injection, the blunting member is advanced to an extended position in which its distal tip protrudes beyond the puncture tip. However, the design of the self- blunting needle assembly is bulky. Moreover, the manufacturing cost of this design is expensive.

[0015] A few examples of prior art patents incorporating the use of a needle guard to shield the introducer needle after use include Purdy, et al., U.S. Pat. Nos. 5,207,528; Rossetti, 5,201,713; Lemieux, 4,952,207; Dembrowski, 4,978,344; and Moorehead, 4,177,809. Each of these prior art patent discloses the use of a shield to cover the introducer needle after contact with potentially contaminated bodily fluids.

[0016] Some of these systems generally fail to address the problem of blood flowback just after needle withdrawal. Once the needle is withdrawn, the catheter hub is open to low pressure venous blood flow until the infusion set is connected. A health risk is presented by this blood flowback. Another existing device, the INTIMA IV CATHETER, manufactured by Becton Dickinson and Company has attempted to address this concern by placing a rubber seal at the proximal end of the catheter hub which reseals after needle withdrawal. However, this system does not address the problem of needle sticks. Other solutions either and expensive or complex to implement. Further improvements are thus needed.

[0017] In addition to the above, cost-benefit requirements dictate the need of a desirable shielding system, which is disposable along with the needle. Furthermore, the system must be quick and easy to use as to present as little imposition as possible to the administration and function of the catheter. Previous available solutions include moving parts, which may malfunction or stick as well as telescoping sheaths requiring deployment from the flash chamber, are less desirable in this regard and may drive up the manufacturing cost for a disposable unit. The further requirements for sealing the system against fluid leakage and backflow may also make such designs to be complex. [0018] Accordingly, there exists a well-felt need for a device providing a safely disposable cannula that is not expensive, simple and convenient to use, and prevents health workers from being infected by accidental needle sticks.

SUMMARY OF INVENTION

[0019] It is an object of the disclosed invention to provide for an improved safely disposable cannula device.

[0020] It is another object of the disclosed invention to provide for a safely disposable cannula device that is easy to manufacture and easy to use.

[0021] It is yet another object of the disclosed invention to provide a safety module for a needle in a disposable cannula device.

[0022] Embodiments of a safety module for a needle in a disposable cannula device are disclosed. Accordingly, the safety module includes two arms inclined to each other and defining a cavity between one end of each of the two arms. The cavity slidably rests against an outer surface of the needle disposed between the two arms thereby defining a first contact surface between the two arms and the needle. The safety module further includes a connecting member joining the other two ends of the arms, the connecting member having a circular through hole such that the center of the through hole and the first contact surface define an axis along which the needle moves while passing through the hole.

[0023] The safety module also includes two flange components extending from the two ends of the arms from the first contact surface and two module locking components extending from the two flange components configured to securely engage the safety module to the disposable cannula device. The safety module further includes a lance fixed at one of the arms, having a semi-cylindrical cavity resting against the needle defining a second contact surface. The lance can be configured to securely engage in a slot on the other arm. The safety module also includes a base component attached to the two arms and the connecting member in such a manner that a first tension acts at the first contact surface between the two arms and the needle and a second tension acts at the second contact surface between the lance and the needle. [0024] Due to the first tension, the ends of the arms at the first contact surface come in contact with each other when the needle retracts away from the first contact surface towards the through hole. Further, due to the second tension, the lance engages in the slot whenever the needle retracts away from the second contact surface towards the through hole.

[0025] While the invention is described herein by way of example using several embodiments and illustrative drawings, those skilled in the art will recognize that the invention is not limited to the embodiments of drawing or drawings described. It should be understood that the drawings and detailed description thereto are not intended to limit the invention to the particular form disclosed, but on the contrary, the invention is to cover all modification, equivalents, and alternatives falling within the spirit and scope of the present invention. The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description. As used throughout this application, the word "may" is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words "include," "including," and "includes" mean including, but not limited to.

[0026] Additional features of the invention will be set forth in the description that follows, and in part will be obvious from the description, or may be learned by the practice of the invention. The features and advantages of the invention may be realized and obtained by means of the system and combinations particularly pointed out in the appended claims. These and other features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF DRAWINGS

[0027] These and other features, benefits and advantages of the present invention will become apparent by reference to the following text figures, with like reference numbers referring to like structures across the views, wherein:

[0028] Figs. 100a to lOOg illustrate various aspects of safely disposable cannula device according to an embodiment of the present invention. [0029] Figs. 200a to 200h illustrate various aspects of safely disposable cannula device according to another embodiment of the present invention.

[0030] Figs. 300a to 3 OOf illustrate various aspects of safely disposable cannula device according to one of the implementation of the present invention.

[0031] Figs. 400a to 400f illustrate various aspects of safely disposable cannula device according to an embodiment according to an example embodiment of the present invention.

[0032] Figs. 500a to 500f illustrate various aspects of safely disposable cannula device according to an embodiment according to another example embodiment of the present invention.

[0033] Figs. 600a to 600f illustrate various aspects of safety module for a needle in disposable cannula device according to an example embodiment of the present invention.

DETAILED DESCRIPTION OF DRAWINGS

[0034] Safety against needle sticks has been a concern for quite some time now and various attempts have been made to safeguard medical practitioners against health hazards arising out of use of cannula devices. Existing designs of safely disposable cannula devices are either complex or expensive to implement.

[0035] Figs. 100a, 100b, 100c, 100c, lOOd, lOOe, lOOf, and lOOg illustrate various aspects of a safely disposable cannula device 100, according to an embodiment of the present invention. The safely disposable cannula device 100 for introducing fluids into or onto a patient's body includes a needle 111. The needle 111 comprising a needle front, a needle rear and an outer surface. The needle front includes a tip and the outer surface of the needle 1 11 includes a portion contoured to provide at least one indented section. In an embodiment, the indented section corresponds to a slot 124 or a dent 125 on the outer surface of the needle 1 1 1.

[0036] The safely disposable medical device 100 includes an elongated member 1 10 for enclosing at least a portion of the needle 111. In an implementation, the elongated member 110 corresponds to a catheter. The at least one indented section (e.g. 124) of the needle 111 facilitates a backflow of body fluid within the elongated member 110. [0037] The safely disposable medical device 100 includes a safety compartment 108 that house one or more safety components. The safety compartment 108 includes a locking pin 109 operatively configured to rest on the needle 111 and a drive element 1 14 positioned around the locking pin 109 inside of the safety compartment 108. In an implementation, the locking pin 109 can be constructed using a plastic material. In one of the configurations, the drive element 1 14 corresponds to a spring. The spring can be made up of a material selected from a group comprising a metallic material, a plastic material, and the like. The safety compartment 108 includes a needle locking component 113 coupled to the locking pin 109 by means of the drive element 114.

[0038] The at least one indented section (e.g. 124) of the needle 1 1 1 facilitates holding of the locking pin 109 thereby forming a locking mechanism with the at least one indented section of the needle 111 when the needle retracts from the elongated member 110.

[0039] In an embodiment, the locking mechanism between the locking pin 109 and the at least one indented section 124 is formed by actuating means of the locking pin 109 in a downward direction when the needle 1 11 is retracted from the elongated member 1 10.

[0040] In an embodiment, the locking mechanism between the locking pin 109 of the safety compartment 108 and the at least one indented section 124 is formed by the drive element in safety compartment 108. The locking mechanism results in a mechanical fitment of the locking pin 109 inside the at least one indented section

124 when the needle retracts from the elongated member 1 10 after use.

[0041] It may be noted here that the at least one indented section provides an opening for backflow of blood. At the same time, the at least one indented section acts as a slot for the locking pin 109 to engage the needle 111 in a mechanical fitment. In yet another embodiment, the locking mechanism forms an enclosure of at least a portion of the needle 111 to form an assembly. The device 100 further includes a needle hub 107, coupled to the safety compartment 108, configured for enclosing at least a portion of the needle 111. Particularly, the front portion including the tip of the needle 111 is enclosed inside the needle hub 107 thereby preventing any needle prick injuries in the inactivated position.

[0042] The safety compartment 108 may further include a protrusion on the inner surface that comes in contact with the needle 111. Such protrusions can engage with an indented section, for example, a slot on the outer surface of the needle 1 1 1. It may be noted herein that the outer surface of the needle 1 11 may have two slots such as 124, one of which engages the locking pin and the other engages with the protrusions. In case of only one slot 124 and a dent 125 (as shown in fig. lOOd) the safety compartment has no protrusions but has a fixed inner diameter. Due to the presence of a dent on the outer surface of the needle 11 1, there is a non-uniformity of the needle's diameter. This non-uniformity restricts the movement of the needle 111 backwards once the dent 125 has crossed a certain point on the inner surface of the safety compartment 108.

[0043] In an implementation, the indented sections (e.g. 124 and 125) of the needle 111 facilitate a mechanical fitment of the locking pin 109 of the safety compartment 108 thereby defining a locking mechanism. During an inactivated position, the locking pin 109 rests against the outer surface of the needle 1 1 1 due to the restoration force of the drive element 1 14. Since the locking pin 109 is made up of a plastic material, the locking pin 109 does not scrap the metal needle 111 during a retraction. During the retraction of the needle 11 1 (after use) from the elongated member 110, the outer surface of the needle 111 moves inwards and the indented section 124 comes below the locking pin 109. The locking pin 109 moves into the indented section 124. In an implementation, this may be accompanied by a mechanical fitment between yet another slot on the outer surface of the needle 1 11 and the protrusions of the safety compartment 108. The locking mechanism renders the needle 111 disposed safely in the safety compartment 108 and this position may be referred to as the "activated position".

[0044] Such a safety arrangement locks the needle 1 11 securely and prevents a translational motion along the cylindrical axis of the needle 111 and rotational motion about the cylindrical axis respectively. [0045] The safely disposable cannula device 100 further includes a thread stopper 101. At least a portion of the needle hub 107 is covered by a hub cover 102 coupled to the thread stopper 101 and a needle hub cover 103. Further, the device 100 may also include a wing body 104 and a port cap 105. The needle 111 can be covered by a needle cover 106 that also encloses at least a portion of the elongated member 1 10. The needle hub 107 extends over the needle 1 1 1 and encloses the catheter below the needle cover by means of a cap 112.

[0046] Figs. 200a_f 200b, 200c, 200d, 200e, 200f, 200g, and 200h illustrate various aspects of a safely disposable cannula device 200, according to another embodiment of the present invention. The safely disposable medical device 200 for introducing fluids into or onto a patient's body includes a needle 207 having a needle front, a needle rear, and an outer surface. The needle front includes a tip and the outer surface includes a portion contoured to provide one or more indentations 214.

[0047] The device further includes a thread stopper 201 and a hub cover 202 followed by a needle hub 203 attached to an elongated member 208. The needle hub 203 includes an internal opening extending there through. The device also includes a safety cover 211 that houses safety components 210 attached with the safety cover 211 and wing body 204. The needle hub 203 encloses the safety cover 211 and the safety components 210 and at least a portion of the needle 207.

[0048] In one embodiment of the present invention, the safety components 210 include one or more protrusions on the inner periphery. One or more slots 214 on the outer surface of the needle 207 facilitate holding of the one or more protrusions thereby forming a locking mechanism when the needle 207 is retracted from the elongated member 208 after use. The locking arrangement with the safety cover 211, the locking of safety components 210 to wing body 204 (also attached to a port cap 205) and the engagement of the one or more slots 214 and the one or more protrusions (not shown) act simultaneously to engage the needle 207 in a secure position when the needle 207 is retracted. The device 200 further include a cap 209, which is an extension of the safety component 210, encloses at least a portion of the needle 207 and the elongated member 208. The device 200 includes a needle cover 206 configured to enclose the needle 207 and the elongated member 208 respectively. The safety component 210 has two body cover locking components 212 and 213 that engage in a mechanical fitment with the needle hub 203.

[0049] In operation, while in an inactivated position, the safety components 210 rests against the outer surface of the needle 207. When the needle 207 is retracted after use, the safety components 210 meet each other thereby closing the opening through which the needle 207 retracted. Further, the protrusions on the inner periphery of the safety components 210 engage the needle 207 due to the one or more slots 214 on the outer surface of the needle 207. This is referred to as an activated position and renders the needle 207 safely disposed.

[0050] Figs. 300a, 300b, 300c, 300d, 300e, and 300f illustrate various aspects of a safely disposable cannula device 300, according to yet another embodiment of the present invention. In one embodiment, the device 300 includes a needle cover 305, a needle 310 enclosed completely inside a elongated member 320 (e.g. a catheter), a wing body 340, a cap 330 enclosed inside the wing body 340 and a needle hub 350 including at least one jaw 380 at one end.

[0051] In operation, after use of device 300, the needle 310 is retracted from the catheter 320 by gliding the needle hub 350 on a housing 360. At least one protrusion 370 is made inside the housing 360 and forms a fastening mechanism with the at least one jaw 380 of the needle hub 350 as illustrated in fig. 300d.

[0052] As the fastening mechanism is formed between the at least one protrusion 370 made inside the housing 360 and the at least one jaw 380 of the needle hub 350, a tip of the needle 310 is enclosed inside the cap 330. Consequently, the needle 310 inside the housing 360 is withdrawn from the wing body 340 by retracting the needle hub 350. Subsequently, the needle 310 within housing 360 as illustrated in fig. 300f has its tip 390 inside the needle cover 305 and may be disposed of easily without any trouble.

[0053] Figs. 400a, 400b, 400c, 400d, 400e, and 400f illustrate various aspects of a safely disposable cannula device 400, according to yet another implementation of the present invention. In one embodiment, the device 400 includes a needle cover 405, a needle 411 enclosed completely inside a catheter 410, and a hub body 401. The device may also include a port cap 403 and a wing body 404. The needle 411 is disposed inside the catheter 410 through the hub component 408.

[0054] The hub body 401 encloses the body of the device 400 up to the wing body 404. The device 400 further includes a stopper 402 locked by a stopper locking 418 in the hub body 401. The safety mechanism in the device includes a first spring 413 in an elongated state fixed at the stopper 402 at one end and at a lock 406 at the other end. The lock 406 is mounted onto the hub component 408 by a second spring 412. Further, the lock 406 rests at the hub body at 422 in an inactive position (when the device 400 is being used and the needle 411 has not yet retracted). The lock 406 stops at the needle hub at 420 as shown in fig. 400c.

[0055] The hub body 401 also encloses hub component 408 that further encloses a filter 407 fixed by means of a filter fitting. The hub component 408 can includes a needle guide and a needle bonding or fixing 416. The first spring 413 is fastened to the lock 406 that can be pressed to move about a lock guide in hub component 408.

[0056] Fig. 400a illustrates an inactivated position of the device 400 whereas 400d, 400e, and 400f illustrate the aspects of the device 400 in activated position, i.e. when the needle has been retracted. In operation, when the needle 41 1 needs to be retracted, a user simply presses the lock 406 on the upper surface of the hub component 408. The pressing of the lock 406 due to the restoration force of the second spring 412 releases the elongated first spring 413 from the hub component 408. The first spring 413 which is attached to the needle 41 1 at one-end moves towards the stopper 402 thereby retracting the needle 41 1 due to the restoration force of the first spring 413. The retracted needle 411 now is securely positioned inside the hub body 401 and can be safely disposed.

[0057] Figs. 500a, 500b, 500c, 500d, 500e, and 500f illustrate various aspects of a safely disposable cannula device 500, according to yet another implementation of the present invention. In one embodiment, the device 500 includes a needle cover 505, a needle 511 enclosed, at least in part, inside a catheter 510, and a hub body 501. The device 500 may also includes a port cap 503 and a wing body 504. The needle 51 1 is disposed through the needle hub 508 inside the catheter 510.

[0058] The safety mechanism in the device includes a first spring 513 in a compressed state, fixed at the needle hub 508 at one end and the body cover 502 at the other end. A lock 506 is mounted onto the needle hub 508 by a second spring 512. Further, the lock 506 rests at the hub body at 524 in an inactive position (when the device is being used and the needle 511 has not been retracted). The lock 506 stops at the needle hub at 522 as shown in fig. 500c.

[0059] The hub body 501 also encloses needle hub 508 and fits into the body cover 502 by means of body cover locking 519. The needle hub 508 further encloses a filter 507. The filter 507 is fixed by means of filter fitting. The needle hub 508 includes a needle guide and a needle bonding or fixing. The second spring 512 is fastened to the lock 506. The lock 506 can be pressed to move the lock 506 about a lock guide in hub body 501.

[0060] Fig. 500d, 500e, and 500f illustrate the aspects of the device 500 in activated position, i.e. when the needle has been retracted. In operation, when the needle 511 needs to be retracted, a user simply presses the lock 506 on the upper surface of the hub body 501. The pressing of the lock 506 due to the restoration force of the second spring 512 releases the first spring 513 from needle hub 508.

[0061] The first spring 513 which is attached to the needle 511 at one end moves towards the hub body 501 thereby retracting the needle 511 due to the restoration force. The retracted needle 51 1 is securely positioned inside the hub body 501 and can be disposed off safely.

[0062] According to various embodiments of the present invention, the devices 100, 200, 300, 400, and 500 enable a fast, reliable and secure method for disposing a used needle, in comparison to the conventional IV Cannula that find great use in both ordinary cases and especially in case of emergency accidents where the patient may have lost substantial amount of blood. Moreover, as the needle once withdrawn is permanently locked, there is no chance of reuse of the needle. [0063] Figs. 600a, 600b, 600c, 600d, 600e, and 600f illustrate various aspects of a safety module 600 for a needle in a disposable cannula device, according to an implementation of the present invention. FIG. 600-1 illustrates the safety module 600 without a needle. FIG. 600-2 and FIG. 600-3 illustrate the safety module 600 in an inactivated position and an activated position respectively. For the purposes of the ongoing description, an inactivated position of the safety module 600 corresponds to a state when the needle of the disposable cannula device is in use. On the other hand, an activated position of the safety module 600 corresponds to a state when the needle has retracted from an elongated member or a catheter of the disposable cannula device.

[0064] The safety module 600 can be constructed from a material selected from a group comprising of: stainless steel, plastic, and metal. It may be appreciated by those skilled in the art that any suitable material can be used for the construction of the safety module 600 as per industry standards. However, the selection of material is based at least in part on the magnitude of force (tension) exerted by the arms 602a and 602b and the lance 612 on the needle 622. In yet another embodiment, the safety module 600 can be a separable component of the disposable cannula device. In a still further embodiment, the separable component can be, for example, a safety enclosure or compartment built into the disposable cannula device.

[0065] It may be appreciated that the embodiments disclosed with references to Figs. 100, 200, 300, 400, and 500 may be implemented either alone or in combination, with each other and with the safety module 600 as per the ongoing description.

[0066] In one embodiment, the safety module 600 includes two arms (602a and 602b) inclined to each other and defining a cavity between one end of each of the two arms. The cavity slidably rests against an outer surface of the needle 622 disposed between the two arms thereby defining a first contact surface 616 between the two arms (602a, 602b) and the needle 622 during an inactivated position. [0067] The safety module 600 further includes a connecting member 604 that joins the other two ends of the arms 602a and 602b. The connecting member 604 has a circular through hole 606 such that the center of the through hole 606 and the first contact surface 616 define an axis 620 along which the needle 622 is disposed and can engage in a translational motion during the retraction of the needle.

[0068] In an embodiment, the diameter of the needle 622 near the tip is made greater than the diameter of the circular through hole 606. In various embodiments, the diameter can be increased by means of a dent or an indentation on the outer surface of the needle 622. In operation such a difference in the diameters would not allow the needle 622 to move back from the safe position after retraction (as shown in FIG. 600c) to an unsafe position (as shown in FIG. 600b).

[0069] The safety module 606 also includes two flange components 608a and 608b extending from the two ends of the arms 602a and 602b at the first contact surface 616. The two flange components 608a and 608b extend away from each other to define a 'V-shaped' curvature.

[0070] The safety module 600 further includes two module locking components 610a and 610b extending from the two flange components 608a and 608b. The two module locking components 610a and 610b securely engage the safety module 600 to the disposable cannula device.

[0071] The safety module 600 further includes a base component 611 attached to the two arms and the connecting member 604 in such a manner that a first tension acts at the first contact surface 616 between the two arms (602a, 602b) and the needle 622 and a second tension acts at the second contact surface 618 between the lance 612 and the needle 622. Due to the first tension, the ends of the arms (602a, 602b) at the first contact surface 616 come in contact with each other when the needle 622 retracts away from the first contact surface 616 towards the through hole 606. In an embodiment, the base component (611) is made up of a plastic material. In yet another embodiment, the connecting member 604 is insert-molded into the base component 61 1. [0072] The safety module 600 further includes a lance 612 fixed at one of the arms (for example 602a) and has a semi-cylindrical cavity resting against the needle 622. The cavity and the needle 622 define a second contact surface 618. The lance 612 can be configured to securely engage in a slot 614 on the other clip arm (for example 602b) whenever the needle 622 retracts away from the second contact surface 618 towards the through hole 606. Due to the second tension the lance 612 engages in the slot 614 whenever the needle 622 retracts away from the second contact surface 618 towards the through hole 606.

[0073] The inclined arms 602a and 602b, the lance 612 and the slot 614, and the difference in diameters of the needle 622 and the through hole 606, there is a threefold safety from needle prick injuries. For example, the first safety mechanism becomes operative when the needle 622 has retracted away from the first contact surface 616 towards the through hole 606 but has not yet crossed the second contact surface 618 during the retraction. This is because the two arms 602a and 602b come in direct contact with each other thereby not allowing the needle 622 move to an unsafe position (as illustrated in FIG. 600b).

[0074] In a successive progression the second safety mechanism becomes operative when the needle 622 retracts further towards the through hole 606 and away from the second contact surface 618. This is because the lance 612 engages into the slot 614 thereby preventing the movement of the needle 622 beyond the second contact surface 618. Finally, the third safety mechanism becomes operative when the needle 622 has retracted further to an extent where the dent or indentation on the needle 622 has moved out of the through hole during retraction. This is because the difference in diameters of the needle 622 and the through hole 606 prevents the needle 622 from moving back towards the second contact surface 618 once the indentation or dent on the needle 622 has moved beyond the through hole 606.

[0075] Fig. 600d illustrates a cross sectional view of the first contact surface from the top when the two arms (602a, 602b) meet each other in an activated position. Fig. 600e illustrates the side view of the safety module 600 in an activated position (without the needle). [0076] Fig. 600f illustrates the placement of the safety module 600 in a safely disposable cannula device according to an embodiment. The safety module can be manufactured as a part of the cannula device or can be a separated module that can be assembled into the cannula device.

[0077] As may be obvious, the various embodiments of the present invention may be further modified in numerous fashions to ensure a safe disposable of the needle.

[0078] In the foregoing specification, specific embodiments of the present invention have been described. However, one of ordinary skill in the art will appreciate that various modifications and changes can be made without departing from the spirit and scope of the present invention as set forth in the various embodiments discussed above. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present invention. The benefits, advantages, solutions to problems, and any element(s) that may cause any benefit, advantage, or solution to occur or become more pronounced are not to be construed as a critical, required, or essential features or elements as described herein.

[0079] Even though particular combinations of features are recited in the claims and/or disclosed in the specification, these combinations are not intended to limit the invention. In fact, many of these features may be combined in ways not specifically recited in the claims and/or disclosed in the specification.

[0080] No element, act, or instruction used in the present application should be construed as critical or essential to the invention unless explicitly described as such. Further, the phrase "based on" is intended to mean, "based, at least in part, on" unless explicitly stated otherwise.

[0081] While certain present preferred embodiments of the invention and certain present preferred methods of practicing the same have been illustrated and described herein, it is to be distinctly understood that the invention is not limited thereto but may be otherwise variously embodied and practiced within the scope of the following claims.

Claims

We Claim :

1. A safety module (600) for a needle (622) in a disposable cannula device, the safety module (600) comprising:

two arms (602a, 602b) inclined to each other and defining a cavity between one end of each of the two arms, the cavity slidably resting against an outer surface of the needle (622) disposed between the two arms thereby defining a first contact surface (616) between the two arms (602a, 602b) and the needle (622);

a connecting member (604) joining the other two ends of the arms, the connecting member (604) having a circular through hole (606) such that the center of the through hole and the first contact surface (616) define an axis (620) along which the needle (622) moves while passing through the hole (606);

two flange components (608a, 608b) extending from the two ends of the arms from the first contact surface (616);

two module locking components (610a, 610b) extending from the two flange components (608a, 608b) configured to securely engage the safety module (600) to the disposable cannula device;

a lance (612) fixed at one of the arms, having a semi-cylindrical cavity resting against the needle (622) defining a second contact surface (618), the lance (612) configured to securely engage in a slot (614) on the other arm; and a base component (61 1) attached to the two arms and the connecting member (604) in such a manner that a first tension acts at the first contact surface (616) between the two arms and the needle and a second tension acts at the second contact surface (618) between the lance (612) and the needle

(622),

wherein due to the first tension, the ends of the arms (602a, and 602b) at the first contact surface (616) come in contact with each other when the needle (622) retracts away from the first contact surface (616) towards the through hole (606), and wherein due to the second tension the lance (612) engages in the slot (614) whenever the needle (622) retracts away from the second contact surface (618) towards the through hole (606).

2. The safety module (600) as recited in claim 1, wherein the safety module (600) is constructed from a material selected from a group comprising of: stainless steel, plastic, and metal.

3; The safety module as (600) recited in claim 1, wherein the safety module (600) is insert-molded to a component of the disposable cannula device.

4. The safety module (600) as recited in claim 1, wherein diameter of the needle (622) is greater than the diameter of the through hole (606) near the tip of the needle (622).

5. The safety module (600) as recited in claim 4, wherein the diameter of needle (622) is increased by means of a dent and/or indentations.

6. The safety module (600) as recited in claim 1, wherein the base component (611) is made up of a plastic material.

7. The safety module (600) as recited in claim 6, wherein the connecting member (604) is insert molded into the base component (611).

8. A safely disposable cannula device (100) comprising:

a needle (111) comprising a needle front, a needle rear and an outer surface, the needle front comprising a tip and the outer surface comprising a portion contoured to provide at least one indented section (124);

an elongated member (110) for enclosing at least a portion of the needle (111);

a safety compartment (108) comprising a locking pin (109) operatively configured to rest on the needle (111) and a drive element (114) positioned around the locking pin (109) inside of the safety compartment (108),

wherein the at least one indented section (124) of the needle facilitates holding of the locking pin (109) thereby forming a locking mechanism with the at least one indented section (124) of the needle (111) when the needle is retracted from the elongated member (1 10).

9. The safely disposable cannula device (100) according to claim 8, wherein the locking mechanism between the locking pin (109) and the at least one indented section (124) is formed by actuating means of the locking pin (109) in a downward direction when the needle (11 1) is retracted from the elongated member (110).

10. The safely disposable cannula device (100) according to claim 8, wherein the locking pin (109) is made up of a plastic material.

1 1. The safely disposable cannula device (100) according to claim 8, wherein the locking mechanism between locking pin (109) of the safety compartment (108) and the at least one indented section (124, 125) on the outer surface of the needle (111) is formed by a drive element (114) in safety compartment

(108) resulting in a mechanical fitment of the locking pin (109) inside the at least one indented section (124) when the needle is retracted from the elongated member (110).

12. The safely disposable cannula device (100) according to claim 8, wherein the locking mechanism forms an enclosure of at least the portion of the needle

(111) to form an assembly.

13. The safely disposable cannula device (100) according to claim 8, wherein the elongated member (110) corresponds to a catheter.

14. The safely disposable cannula device (100) according to claim 8, wherein the at least one indented section (124) of the needle (1 11) facilitates a backflow of body fluid within the catheter.

15. The safely disposable cannula device (100) according to claim 8, wherein the drive element (114) corresponds to a spring.

16. The safely disposable cannula device (100) according to claim 15, wherein the compression spring is made up of a material selected from a group comprising a metallic material, a plastic material, and the like.

17. The safely disposable cannula device (100) according to claim 8, wherein the at least one indented section corresponds to a slot (124) on the outer surface of the needle (111).

18. The safely disposable cannula device (100) according to claim 8, wherein the at least one indented section corresponds to a dent (125) on the outer surface of the needle (1 1 1).

19. A safely disposable cannula device (300) comprising:

a needle (310) comprising a needle front, a needle rear and an outer surface, the needle front comprising a tip;

an elongated member (320) for enclosing at least a front portion of the needle (310);

a needle cover (305) enclosing at least a portion of the elongated member (320);

a needle hub (350) coupled to the needle (310), the needle hub comprising at least one jaw (380); and

a housing (360) slidably coupled to the needle hub (350), the housing comprising at least one protrusion (370), wherein the jaw (380) of the needle hub (350) engages with the protrusion (370) in the housing (360) to form a fastening mechanism when the needle (310) retracts from the elongated member (320).

20. A safely disposable cannula device (400) comprising:

a needle (411) comprising a needle front, a needle rear and an outer surface, the needle front comprising a tip;

an elongated member (410) for enclosing at least a front portion of the needle (411);

a needle hub coupled to the needle (411);

a housing slidably coupled to the needle hub, the housing comprising a first spring (413) in an elongated state, one end of the first spring (413) being fixed to a stopper (402) in the housing and the other end of the first spring (413) being fixed to the needle hub; and

a lock (406) configured to hold, at a contact point (420), the first spring (413) in an elongated state, the lock attached to a housing by means of a second spring (412), wherein pressing of the lock (406) against a restoration force of the second spring (412) releases the elongated first spring (413) thereby retracting the needle (41 1) from the elongated member (410) under the restoration force of the first spring (413).

21. A safely disposable cannula device (500) comprising:

a needle (51 1) comprising a needle front, a needle rear and an outer surface, the needle front comprising a tip;

an elongated member (510) for enclosing at least a front portion of the needle (51 1 );

a needle hub (508) coupled to the needle (51 1);

a first spring (513) fixed to the needle hub (508) at one end and fixed to a housing (502) at the other end, the first spring disposed in a compressed state; and

a lock (506) configured to hold, at a contact point (522), the needle hub (508) thereby maintaining the compressed state of the first spring (513), the lock (506) attached to the housing by means of a second spring (512), wherein pressing of the lock (506) against a restoration force of the second spring (512) releases the compressed first spring (513) thereby retracting the needle (51 1) from the elongated member (510) under the restoration force of the first spring (513).