SAFELY DISPOSABLE LV. CANNULA DEVICE
FIELD OF INVENTION
[001] Embodiments of the present invention generally relate 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 THE INVENTION
[002] 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 needed 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 repeated venipunctures are generally highly traumatic. [003] 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 of time 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 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.
[004] 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, and 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.
[005] 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. [006] 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.
[007] 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.
[008] 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. '
[009] Typically, most of the solutions developed are complicated and include a withdrawal of the needle within a housing 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 the 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.
[0014J 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. 5,215,528; 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] However, what these systems generally fail to address is 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. One prior 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. 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. Lathering the needle circumference to alter the circumference over particular segments requires precise tooling and hence substantially added cost. The further requirements for sealing the system against fluid leakage and backflow may also show such designs to be problematic.
[0018] Accordingly, there exists a need in the art for a device providing a safely disposable cannula that is not expensive, simple and convenient to use, and prevents the health worker from being infected by the accidental needle stick.
SUMMARY OF THE INVENTION
[0019] In one aspect of the present invention, a safely disposable medical device for introducing fluids into or onto a patient's body includes a needle 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 indented sections. The device further includes a housing configured for enclosing at least a portion of the needle, an elongated member for enclosing at least a front portion of the needle, and a needle locking compartment coupled to the housing. The needle locking compartment includes a stopper pin operatively configured to rest on the needle and a lock spring positioned around the stopper pin on an inside of the needle locking compartment. The one or more indented sections of the needle facilitate holding of the stopper pin of the needle locking compartment thereby forming a locking mechanism with the one or more indented section of the needle when the needle is retracted from the elongated member.
[0020] In one embodiment of the present invention, the elongated member is a catheter. The locking mechanism between the stopper pin of the needle locking compartment and the one or more indented sections on the outer surface of the needle is formed by a movement of the stopper pin in a downward direction. The movement is caused by the lock spring of the needle locking compartment. The movement results in locking of the stopper pin inside the one or more indented sections of the needle when the needle is retracted from the elongated member. The locking mechanism forms an enclosure of the tip of the needle inside the housing to form an assembly. The assembly is withdrawn from the device by pulling one or more jaws of the housing from a winged body of the device. The spring is composed of a metallic or plastic material.
[0021] In another aspect of the present invention, a safely disposable medical device for introducing fluids into or onto a patient's body includes a needle 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 indented sections. The device further includes an elongated member for enclosing at least a front portion of the needle, and a needle point cover component including a first extended safety portion, a second extended safety portion and a base portion. The first extended safety portion and the second extended safety portion extend from the base portion. The device further includes a housing attached to the elongated member, and the housing includes an internal opening extending therethrough. The housing member encloses the needle point cover component and at least a portion of the needle.
[0022] In one embodiment of the present invention, the first extended safety portion and/or the second extended safety portion of the needle point cover component include one or more protrusions on inner periphery. The one or more indented sections of the needle facilitate holding of the one or more protrusions of the first extended safety portion of the needle point cover component forming a locking mechanism with the one or more indented sections of the needle when the needle is retracted from the elongated member. The second extended safety portion of the needle point cover component is attached to a locking vertical member, and the locking vertical member includes a slot on a top surface to facilitate holding of the needle in position and a projection on a bottom surface to facilitate fastening of the needle point cover component to the housing. The housing may or may not include a pair of generally planar wings extending from opposing sides of the housing. The base portion of the needle point cover component includes an orifice to provide positioning of the needle therethrough and a first pair of short projections mounted at distal end of the needle point cover component on opposite sides of outer periphery. The housing includes a second pair of short projections mounted at distal end on opposite sides of outer periphery. The second pair of short projections of the housing is configured to securely position the first pair of short projections of the base portion of the needle point cover component.
[0023] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] So that the manner in which the above recited features of the present invention can be understood in detail, a more particular description of the invention, briefly summarized above, may be had by reference to embodiments, some of which are illustrated in the appended drawings. It is to be noted, however, that the appended drawings illustrate only typical embodiments of this invention and are therefore not to be considered limiting of its scope, for the invention may admit to other equally effective embodiments. [0025] 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:
[0026] Figs. Ia, Ib, and Ic illustrate various aspects of a safely disposable cannula device, according to an embodiment of the present invention;
[0027] Figs. 2a, 2b, 2c, 2d, and 2e illustrate various aspects of a safely disposable cannula device, according to another embodiment of the present invention; and
[0028] Figs. 3a, 3b, and 3c illustrate various aspects of a safely disposable cannula device, according to yet another embodiment of the present invention.
DETAILED DESCRIPTION QF THE INVENTION
[0029] Figs. Ia, Ib, and Ic illustrate various aspects of a safely disposable cannula device 100, according to an embodiment of the present invention. The safely disposable medical device 100 for introducing fluids into or onto a patient's body includes a needle 115 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 indented sections 130. Particularly, one indented section 130 is utilized in the present invention. The device further includes a housing 150 configured for enclosing at least a portion of the needle 115, an elongated member 110 for enclosing at least a portion of the needle 115, and a releasable needle locking compartment 137 coupled to the housing 150. The needle locking compartment 137 includes a stopper pin 140 operatively configured to rest on the needle 115 and a drive element 135 positioned around the stopper pin 140 on an inside of the needle locking compartment 137. Particularly, the indented section 130 of the needle 1 15 facilitate holding of the stopper pin 140 of the needle locking compartment 137 thereby forming a locking mechanism with the indented section 130 of the needle 115 when the needle is retracted from the elongated member 110.
[0030] In one embodiment of the present invention, the elongated member 110 is a catheter. Particularly, the indented section 130 of the needle 115 facilitate flash back within the catheter 110.
[0031] In one embodiment of the present invention, the locking mechanism between the stopper pin 140 of the needle locking compartment 137 and the indented section 130 on the outer surface of the needle 115 is formed by a driving means of the drive element 135 of the needle locking compartment 137 resulting in locking of the stopper pin 140 of the needle locking compartment 137 inside the indented section 130 of the needle 115 when the needle 115 is retracted from the elongated member 110.
[0032] In one embodiment of the present invention, the drive element 135 is a spring.
[0033] In one embodiment of the present invention, the spring 135 is composed of a metallic material, a plastic material and the like.
[0034] In another embodiment of the present invention, the locking mechanism between the stopper pin 140 of the needle locking compartment 137 and the indented section 130 on the outer surface of the needle 115 is formed by actuating means of the stopper pin 140 in a downward direction when the needle 115 is retracted from the elongated member 110. Particularly, the actuating means provides a movement of the stopper pin 140 in a downward direction. However, any actuating means available in the art may be utilized in the present invention.
[0035] In one embodiment of the present invention, the locking mechanism forms an enclosure of at least the portion of the needle 115 inside the housing 150 to form an assembly. Particularly, the front portion including the tip of the needle 115 is enclosed inside the housing 150 to form the assembly.
[0036] In one embodiment of the present invention, the assembly is withdrawn from the device by pulling one or more jaws 125 of the housing 150 from a winged body 145 of the device. However, the device may or may not have a winged body 145.
[0037] Figs. 2a, 2b, 2c, 2d, and 2e 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 215 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 indented sections 205. The device further includes an elongated member 210 for enclosing at least a front portion of the needle 215, and a releasable needle point cover component 220. Particularly, the needle point cover component 220 includes a first extended safety portion 225, a second extended safety portion 230 and a base portion 235. The first extended safety portion 225 and the second extended safety portion 230 extends from the base portion 235. The device further includes a housing 213 attached to the elongated member 210. Particularly, the housing 213 includes an internal opening extending therethrough. The housing encloses the needle point cover component 220 and at least a portion of the needle 215.
[0038] In one embodiment of the present invention, the first extended safety portion 225 and/or the second extended safety portion 230 of the needle point cover component 220 include one or more protrusions 227 on inner periphery.
[0039] In one embodiment of the present invention, the indented section 205 of the needle 215 facilitate holding of the one or more protrusions 227 of the first extended safety portion 225 of the needle point cover component 220 forming a locking mechanism 229 with the indented section 205 of the needle 215 when the needle 215 is retracted from the elongated member 210.
[0040] In one embodiment of the present invention, the second extended safety portion 230 of the needle point cover component 220 is attached to a locking vertical member 240. The locking vertical member 240 includes a slot 250 on a top surface to facilitate holding of the needle 215 in position and a projection 255 on a bottom surface to facilitate fastening of the needle point cover component 220 to the housing 213.
[0041] In one embodiment of the present invention, the housing 213 includes a pair of generally planar wings 245 extending from opposing sides of the housing 213. However, the housing may not include the planar wings 245 in one or more embodiments of the present invention.
[0042] In one embodiment of the present invention, the base portion 235 of the needle point cover component 220 includes an orifice 232 to provide positioning of the needle 215 therethrough and a first pair of short projections 275 mounted at distal end of the needle point cover component 220 on opposite sides of outer periphery.
[0043] In one embodiment of the present invention, dimensions of an upper projection and a lower projection of the first pair of short projections 275 are different.
[0044] In another embodiment of the present invention, dimensions of an upper projection and a lower projection of the first pair of short projections 275 are similar.
[0045] In one embodiment of the present invention, the housing 213 includes a second pair of short projections 270 mounted at distal end on opposite sides of outer periphery.
[0046] In one embodiment of the present invention, the second pair of short projections 270 of the housing 213 is configured to securely position the first pair of short projections 275 of the base portion 235 of the needle point cover component 220 in assembled position.
[0047] Figs. 3a, 3b, and 3c illustrate various aspects of a safely disposable cannula device 300, according to yet another embodiment of the present invention. The safely disposable medical device 300 for introducing fluids into or onto a patient's body includes a needle 315 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 indented sections 305. The device further includes an elongated member 310 for enclosing at least a front portion of the needle 315, and a releasable needle point cover component 320. Particularly, the needle point cover component 320 includes a first extended safety portion 325, a second extended safety portion 330 and a base portion 335. The first extended safety portion 325 and the second extended safety portion 330 extends from the base portion 335. The device further includes a housing 313 attached to the elongated member 310. Particularly, the housing 313 includes an internal opening extending therethrough. The housing encloses the needle point cover component 320 and at least a portion of the needle 315.
[0048] In one embodiment of the present invention, the first extended safety portion 325 and/ or the second extended safety portion 330 of the needle point cover component 320 include one or more protrusions 327 on inner periphery.
[0049] In one embodiment of the present invention, the first extended safety portion 325 of the needle point cover component 320 further includes a first projection 355 on outer periphery of proximal end. The second extended safety portion 330 of the needle point cover component 320 further includes a second projection 355 on outer periphery of proximal end. Particularly, the first projection 355 and the second projection 355 facilitate fastening of the needle point cover component 320 with at least two recesses 327 formed inside the housing 313.
[0050] In one embodiment of the present invention, the indented section 305 of the needle 315 facilitate holding of the one or more protrusions 327 of the first extended safety portion 325 of the needle point cover component 320 forming a locking mechanism with the indented section 305 of the needle 315 when the needle 315 is retracted from the elongated member 310.
[0051] In one embodiment of the present invention, the housing 313 includes a pair of generally planar wings 345 extending from opposing sides of the housing 313. However, the housing may not include the planar wings 345 in one or more embodiments of the present invention.
[0052] In one embodiment of the present invention, the base portion 335 of the needle point cover component 320 includes an orifice 332 to provide positioning of the needle 315 therethrough and a first pair of short projections 375 mounted at distal end of the needle point cover component 320 on opposite sides of outer periphery.
[0053] In one embodiment of the present invention, dimensions of an upper projection and a lower projection of the first pair of short projections 375 are different.
[0054] In another embodiment of the present invention, dimensions of an upper projection and a lower projection of the first pair of short projections 375 are similar.
[0055] In one embodiment of the present invention, the device further includes a needle hub 385. The needle hub 385 includes a third pair of short projections 380 mounted at proximal end on opposite sides of outer periphery. Particularly, the third pair of short projections 380 of the needle hub 385 is configured to securely position the first pair of short projections 375 of the base portion 235 of the needle point cover component 320 in assembled position.
[0056] According to various embodiments of the present invention, the device 100, 200 enables a fast, reliable and secure method for disposing a used needle, thereby providing the added necessary advantage of a flash back within the catheter which is much easier than in a conventional IV Cannula and of 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.
[0057] Those of ordinary skill in the art will appreciate that various embodiments of the present invention are based on the principle that the tip of the needle is covered and locked inside a plastic body while retracting it from the catheter after the vein puncture by the means of a spring activated pin and the cut out indentation on the needle. 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.
[0058] 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.