US20010044607A1 - Safety needle apparatus and method - Google Patents
Safety needle apparatus and method Download PDFInfo
- Publication number
- US20010044607A1 US20010044607A1 US09/730,370 US73037000A US2001044607A1 US 20010044607 A1 US20010044607 A1 US 20010044607A1 US 73037000 A US73037000 A US 73037000A US 2001044607 A1 US2001044607 A1 US 2001044607A1
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- United States
- Prior art keywords
- needle
- housing
- catheter
- plunger
- cap
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
- A61M25/0612—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders
- A61M25/0631—Devices for protecting the needle; Devices to help insertion of the needle, e.g. wings or holders having means for fully covering the needle after its withdrawal, e.g. needle being withdrawn inside the handle or a cover being advanced over the needle
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
- A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
- A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
- A61M5/321—Means for protection against accidental injuries by used needles
- A61M5/322—Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston
Definitions
- This invention relates to safety needles of the type used to puncture the skin of patients. More particularly, this invention relates to intravenous catheters that protect the needle both before use and upon withdrawal from a patient.
- Safety needles and catheters are old in the art.
- safety catheters are disclosed in: (1) U.S. Pat. No. 4,834,718 (“the '718 patent”) issued on May 30, 1989, to Michael McDonald; and (2) U.S. Pat. No. 4,944,725 (“the '725 patent”), issued on Jul. 31, 1990, to Michael McDonald. Mr. McDonald is one of the inventors of the present invention in this application.
- the catheter in the '718 patent was the first catheter to provide convenient, reliable, economical, and automatic sheathing of the needle upon withdrawal of the needle from the patient.
- the '725 patent discloses improvements to Mr. McDonald's first patented structure in the '718 patent.
- the applicants hereby incorporate by reference the complete disclosures of the '718 and '725 patents.
- Needles such those shown in the '718 patent and '725 patent do sheath the needle upon withdrawal from the patient. This provides the great advantage of automatic sheathing and protection against needle sticks upon withdrawal, but it leaves the operator without the comfort of having taken any action on his or her own to cover the needle.
- Existing paramedics, nurses, and doctors in the field are often accustomed to the prior art devices that do not automatically sheath the needle upon withdrawal from the patient. These types of operators are often most comfortable with capping of the needle whether it is necessary or not.
- the prior safety catheters of the '718 and '725 patents, and other safety catheters in the prior art did not provide any such additional capping feature, probably because it appears to be unnecessary. It is often necessary, in fact, however, since such a cap can put certain types of operators at ease and reduce their reluctance to use a safety needle such as that shown in the '718 and '725 patents.
- the prior McDonald safety catheters of the '718 and '725 patents incorporated needle hub design that had a reduced and thin neck (shown as number 36 in FIG. 1 of the '718 patent).
- This neck is easy for the operator to grasp and hold in place with one hand while simultaneously, with the other hand, pulling back on the outer housing and thus automatically sheathing the needle within the needle housing.
- the reduced diameter neck is relatively weak, however, and may be subject to breakage when in use out in the field.
- the prior McDonald safety catheter employed a cylindrical outer housing with a smooth, transparent plastic surface. The operator grasps and pushes and pulls on the this smooth surface when using the device out in the field.
- this cylindrical transparent design is particularly effective and reliable for a number of reasons, the operator's fingers can slip on the smooth surface, particularly when wet, and risk puncturing the patient incorrectly or at least not as accurately as desired.
- An incorrectly positioned needle puncture which misses the vein or goes through it, can be painful and cause bleeding.
- a further object is to provide a needle that also protects against accidental sticks upon opening of the needle package, removal of the needle from the package, and pre-use manipulation of the needle and catheter.
- Another object is to provide a catheter and needle that also provides recapping structure to allow the operator to place an otherwise separate cap over the needle after its withdrawal from the patient.
- Yet another object is to provide a single cap structure that provides both pre-use capping and post-withdrawal capping of the needle.
- a still further object of the invention is to provide a catheter and needle housing that is less subject to slipping in the hands of a user while still being predominantly transparent and generally cylindrical for easy use and grasping.
- Another object is to provide a safety catheter that is stronger, and less subject to accidental breakage in use, than prior catheters and needles.
- An additional object is to provide a safety catheter that meets the prior objects while providing a safety catheter that is convenient, easy and economical to manufacture, assemble, and ship, slim yet sturdy, and easy to use and dispose of properly and safely.
- an improved safety needle preferably a catheter needle
- the inner needle housing includes a catheter mounting end opposite the junction of the needle housing and the outer housing.
- a removable cap which is preferably frusto-conical, has one end mountable about the catheter mounting end and another end mountable on the outer housing.
- the cap can be mounted on the inner needle housing to protect against needle sticks during shipping of the inner needle housing and assembly of the catheter on the needle and the inner housing within the outer housing.
- the cap can then be reversed and mounted on the outer housing to protect against needle sticks during packaging, shipment, and pre-insertion manipulation of the catheter.
- the cap can be remounted on the outer housing to provide protection against accidental sticks after use of the needle and during disposal.
- the outer housing may include a plunger penetrating the outer housing on the side of the outer housing opposite the needle.
- the plunger is slidably mounted in the outer housing to draw a vacuum within the outer housing.
- the plunger may be omitted and the plunger passage blocked with a plug.
- the outer housing may also include a gripping friction surface which preferably results from embossing a trademark or suitable indicia on the outer surface of the outer housing.
- the inner needle housing may also include ribs or columns on the periphery of the needle housing to strengthen it while minimizing material use and providing grasping surfaces on the needle housing.
- FIG. 1 is an exploded isometric view of the major components of the preferred catheter embodiment having a plunger, a separable needle cap, and an embossed trademark/friction surface on the outer housing;
- FIG. 2 is a partial plan view of the catheter needle of FIG. 1 after assembly and showing the plunger in partial cutaway within the housing;
- FIG. 3 is a partial cross-sectional view through section line 3 - 3 of FIG. 2, showing the indicia embossing of the outer wall of the outer housing;
- FIG. 4 is a cross-sectional view of the preferred plunger catheter showing the narrow end of the cap mounted on the inner needle housing to cover the needle during shipment and assembly;
- FIG. 5 is a cross-sectional view of the preferred plunger catheter showing the cap being removed from the inner needle housing after assembly of the inner needle housing within the outer housing of the catheter;
- FIG. 6 is a cross-sectional view of the preferred plunger catheter showing the cap inverted from the orientation of FIG. 5 and mounted on the outer housing to cover the catheter and needle during packaging, shipment, removal from the packaging by the user, and pre-use manipulation of the catheter;
- FIG. 7 is a cross-sectional view of the preferred plunger catheter showing removal of the cap from the outer housing prior to insertion of the needle and catheter into the patient;
- FIG. 8 is a cross-sectional view of the preferred plunger catheter showing the withdrawal of the needle from the patient and automatic sheathing of the needle within the inner needle housing;
- FIG. 9 is a cross-sectional view of the preferred plunger catheter showing the cap mounted once again on the outer housing to further protect the inner housing and needle within the inner housing;
- FIG. 10 is a cross-section view of the preferred catheter without the plunger and with a flash back plug abutting and thus blocking the plunger passage in the back of the outer housing.
- the applicant's preferred plunger safety needle has a plunger rod 12 and plunger 14 , a needle mounting cylinder 16 , a needle 18 , a catheter 20 , an inner needle housing 22 , an outer handle housing 24 , and a cap 26 .
- the plunger rod 12 consists of an “X” shaped plunger beam 28 extending perpendicularly from a planar plunger end cap 30 .
- the plunger beam 28 slidably penetrates the open end 31 of a cylindrical flash back chamber 32 on the interior of the needle mounting cylinder 16 ; and the needle 18 is mounted on the end of the needle mounting cylinder 16 opposite the open end 31 of the flash back chamber 32 .
- the needle mounting cylinder 16 slidably penetrates an open passage 34 in the needle housing 22 .
- the needle housing 22 , the needle mounting cylinder 16 , plunger rod 12 , and plunger 14 are mounted within the generally cylindrical interior wall 36 of the outer handle housing 24 .
- the plunger beam 28 of the plunger rod 12 slidably penetrates and abuts the “X” shaped plunger passage 38 cooperatively provided by the mating upper 40 and lower 42 halves of the handle housing 24 when sonically welded together with the needle housing 22 and the associated structure assembled within the handle housing 24 .
- the plunger rod 12 is thus slidably mounted in the plunger passage 38 to slidably penetrate the cylindrical flash back chamber 32 within the needle mounting cylinder 16 .
- the substantially cylindrical needle housing 22 slidably penetrates a housing passage 44 provided within the interior wall 36 of the handle housing 24 .
- the catheter 20 has a skin penetration tube 46 coaxially extending from an expanded catheter hub 48 .
- the catheter hub 48 mounts on the catheter mount 50 extending from the needle housing 22
- the cap 26 is mountable on the needle housing 22 or the handle housing 24 as explained below.
- the plunger beam 28 has a resilient plunger 14 mounted within and slidably abutting the interior wall 52 of the needle mounting cylinder 16 .
- the plunger cap 30 is drawn away from the handle housing 24 and air cannot enter through the needle 18 (not shown in FIG. 2) into the interior vacuum space 54 within the needle mounting cylinder 16
- the plunger 14 slides within the mounting cylinder 16 in the same direction and simultaneously draws a vacuum in the interior vacuum space 54 . If the needle 18 has penetrated the vein of a patient (not shown) when the vacuum is drawn in the interior vacuum space 54 , blood is urged to flow from the vein, through the needle, and into the vacuum space 54 .
- the outer surface of the handle housing 24 includes trademark indicia 56 .
- the indicia 56 projects from the outer surface of the housing 24 .
- the raised indicia 56 not only can identify the product and convey information about the product 10 but also can provide a surface that is more likely to cause greater friction in the hands of a user and less likely to result in slippage when in use. This is particularly helpful in an emergency, when sweaty palms and other fluids, including blood, etc., may otherwise render the outer surface of the handle housing 24 quite slippery.
- the preferred indicia 56 are cut into the molds for the needle housing 24 so that the indicia 24 are included into the transparent housing 24 automatically when molded. Other surface alteration or scoring may also be utilized.
- the cap 26 is frusto-conical and thus has a larger somewhat cylindrical end 58 opposite a narrower somewhat cylindrical end 60 .
- the cap is made out of resilient material, and its narrower end 60 is mountable on the narrowed cap mounting hub 62 on the needle housing 22 .
- the cap mounting hub 62 is intermediate the wider needle mounting housing central body 64 and the narrower raised column guard hub 66 .
- the cap 26 When mounted on the hub 62 , the cap 26 thus provides a protective shield around the needle 18 extending from the needle housing 22 when the needle mounting cylinder 16 is placed within the needle housing 22 as shown in FIG. 1.
- the partial needle assembly 99 (consisting of the needle housing 22 , needle mounting cylinder 16 , needle 18 , and cap 26 ) can be shipped or moved from one assembling or manufacturing area to another with significantly reduced risk of any accidental needle stick to an assemblers, handlers, etc.
- the cap 26 is readily removed by an operator.
- the partial needle assembly 99 can then be further assembled into the handle housing 24 as shown in FIG. 1.
- the catheter mount 50 has a cylindrical mounting body 71 with diametrically opposed catheter hub engaging arms 72 , 74 extending radially outwardly from the mounting body 71 .
- the catheter hub 48 has a radially extending detent or undercut 76 penetrating the cylindrical interior wall 78 of the catheter hub 48 .
- the catheter hub 48 mounts on the catheter mount 50 and is retained in place on the mount 50 by the radially extending arms 72 , 74 , which penetrate the radially extending undercut 76 in the catheter hub 48 .
- the catheter hub 48 is made of resilient material and is held in place by the arms 72 , 74 until the operator forces the catheter 20 off of the mount 50 until it is fully separated from the needle housing 22 .
- the larger end 58 of the cap 26 has an internal radial rib or lip 68 .
- the handle housing 24 has a mating radial detent 70 on the needle end 61 of the handle housing 24 opposite the plunger end cap 30 (not shown in FIG. 6).
- the larger end 58 of the cap 26 is mounted on the needle end 61 so that the cap's internal rib 68 abuts the radial detent 70 in the housing 24 .
- the protective cap 26 is mounted on the handle housing 24 to extend from the housing 24 and surround the needle 18 and catheter 20 .
- the protective cap 26 once again provides a protective sheath around the needle 18 and catheter 20 to minimize accidental needle sticks during (i) further packaging, shipment, and handling of the packaging, (ii) opening of the packaging, and (iii) pre-use manipulation of the catheter 10 prior to actual use to puncture the skin of a patient.
- the cap 26 may be pulled off of the handle housing 24 (not shown). The operator may now insert the needle 18 and catheter 20 into the patient as described in the '718 and '725 patents.
- the raised column guard hub 66 which is exposed upon removal of the cap 26 , provides significant strength with minimum material between the cap mounting hub 62 and catheter mounting hub 50 on the needle housing 22 .
- the operator can readily grasp this area 66 of the needle housing to hold the housing 22 when withdrawing the needle 18 from the patient (not shown).
- the handle housing (not shown in FIG. 5) can be drawn away from the patient with one hand while grasping the guard hub 66 and holding it in place as (i) the needle 18 is drawn out of the patient, (ii) the mounting hub 50 separates from the catheter hub 48 as shown in FIG. 7, (iii) the needle 18 slides out of the catheter 20 as also shown in FIG. 7, and (iv) the needle 18 is drawn into the needle housing 22 as shown in FIG. 8. This operation is described in greater detail in the '718 and '725 patents.
- the operator can, as shown in FIG. 9, slide the large end 58 of the cap 26 over the needle housing 22 to yet again engage the radial detent 70 and secure the cap 26 on the handle housing 24 .
- the same cap 26 thus provides yet another level of protection against subsequent needle sticks.
- This cap-remounting procedure also provides the clinician, particularly one who is accustomed to manual capping of needles after use, with a greater level of comfort and security in using the safety needle 10 . It also reduces the likelihood that the cap 26 will be left behind on the street or any other accident or trauma location.
- the cap 26 , indicia 56 , (FIG. 1) on the housing 24 , mounting hub 50 , and catheter hub 48 described above may also be used on a safety needle not having a plunger at all.
- This type of catheter is preferably for use with patients having sufficient blood pressure.
- This non-plunger needle 100 has a resilient plug 102 mounted within the mounting cylinder 16 to extend therefrom and abut the generally planar interior end 104 of the needle housing 24 . The plug 102 thus abuts the “X” shaped plunger passage 38 and prevents the flow of blood from the flash back chamber 32 through the plunger passage 38 .
- the protective cap 26 , plunger rod 12 and catheter hub 48 are preferably made from polypropylene.
- the plug 102 is made from rubber, and the handle housing 24 and needle mount 16 are made from high impact polystyrene.
- the needle is made of steel.
- the catheter 20 is made from radiopaque Teflon, and the needle housing 22 is made from ploycarbonate.
Abstract
Disclosed is a safety catheter that automatically sheaths the needle upon withdrawal of the needle from a patient. The catheter can include a plunger for drawing a vacuum to draw blood or alternatively may delete the plunger and use nearly identical components with the addition of a blocking plug. The catheter also includes a cap/re-cap device that provides additional sheathing of the needle during assembly, shipping, and use of the needle. It also includes raised indicia that serves as a trademark as well as a friction gripping surface. The catheter includes improved catheter hub mounting structure as well as strengthened ribbed areas for grasping during use of the catheter.
Description
- This is a continuation of application Ser. No. 09/477,213, filed Jan. 4, 2000, now U.S. Pat. No. 6,156,015, which is a continuation of application Ser. No. 09/102,467, filed Jun. 22, 1998, now U.S. Pat. No. 6,010,487, which is a continuation of application Ser. No. 08/823,830, filed Mar. 25, 1997, now U.S. Pat. No. 5,769,827, which is a continuation of application Ser. No. 08/296,329, filed Aug. 25, 1994 now abandoned. Each application identified above is incorporated here by reference in its entirety.
- NOT APPLICABLE
- This invention relates to safety needles of the type used to puncture the skin of patients. More particularly, this invention relates to intravenous catheters that protect the needle both before use and upon withdrawal from a patient.
- Safety needles and catheters are old in the art. For example, safety catheters are disclosed in: (1) U.S. Pat. No. 4,834,718 (“the '718 patent”) issued on May 30, 1989, to Michael McDonald; and (2) U.S. Pat. No. 4,944,725 (“the '725 patent”), issued on Jul. 31, 1990, to Michael McDonald. Mr. McDonald is one of the inventors of the present invention in this application.
- The catheter in the '718 patent was the first catheter to provide convenient, reliable, economical, and automatic sheathing of the needle upon withdrawal of the needle from the patient. The '725 patent discloses improvements to Mr. McDonald's first patented structure in the '718 patent. The applicants hereby incorporate by reference the complete disclosures of the '718 and '725 patents.
- The structures shown in the '718 and '725 patents were significant advances in the art. They included “flash back” chambers to determine, by relatively small sliding movement of an outer housing away from the catheter, whether the vein had been punctured sufficiently so that blood would flow through the catheter and needle into the flash back chamber where the blood could be seen at the back of the housing.
- These prior structures, however, were not as effective in drawing blood into the flash back chamber when used on trauma patients with very low blood pressure. For these types of patients, the blood pressure of the patient can be too low to force blood through the catheter and needle into the flash back chamber in the housing. These prior art devices did not provide any way to draw a substantial vacuum in the housing in order to draw blood from the trauma patient into the flash back chamber when the needle and associated catheter penetrate the vein of the patient.
- Other safety needles in the art have employed plungers penetrating the back of the needle housing to draw a vacuum in the housing. None of these prior art structures, however, have provided such a vacuum plunger for the McDonald safety needles shown in the '718 and '725 patents.
- Another problem with the prior art safety catheters and needles is the lack of capping structure for complete capping of the entire needle and catheter during assembly, shipping, and pre-use handling. Thus, the prior art catheters and needles such as shown in the '718 and '725 patents provided an exposed needle during needle assembly and shipping. The needles are also exposed when removed from their packaging and prior to actual alignment for injection into the patient. This brings about risk of inadvertent needle sticks to manufacturers and needle operators, and subsequent inappropriate use of the same needles on patients. Accidental needle sticks can have dire consequences and have long been recognized as a great problem in the industry and, indeed, in society in general.
- Needles such those shown in the '718 patent and '725 patent do sheath the needle upon withdrawal from the patient. This provides the great advantage of automatic sheathing and protection against needle sticks upon withdrawal, but it leaves the operator without the comfort of having taken any action on his or her own to cover the needle. Existing paramedics, nurses, and doctors in the field are often accustomed to the prior art devices that do not automatically sheath the needle upon withdrawal from the patient. These types of operators are often most comfortable with capping of the needle whether it is necessary or not. The prior safety catheters of the '718 and '725 patents, and other safety catheters in the prior art, did not provide any such additional capping feature, probably because it appears to be unnecessary. It is often necessary, in fact, however, since such a cap can put certain types of operators at ease and reduce their reluctance to use a safety needle such as that shown in the '718 and '725 patents.
- The prior McDonald safety catheters of the '718 and '725 patents incorporated needle hub design that had a reduced and thin neck (shown as
number 36 in FIG. 1 of the '718 patent). This neck is easy for the operator to grasp and hold in place with one hand while simultaneously, with the other hand, pulling back on the outer housing and thus automatically sheathing the needle within the needle housing. The reduced diameter neck is relatively weak, however, and may be subject to breakage when in use out in the field. - Finally, the prior McDonald safety catheter employed a cylindrical outer housing with a smooth, transparent plastic surface. The operator grasps and pushes and pulls on the this smooth surface when using the device out in the field. Although this cylindrical transparent design is particularly effective and reliable for a number of reasons, the operator's fingers can slip on the smooth surface, particularly when wet, and risk puncturing the patient incorrectly or at least not as accurately as desired. An incorrectly positioned needle puncture, which misses the vein or goes through it, can be painful and cause bleeding.
- It is therefore an object of the present invention to develop a safety catheter and needle that develops a vacuum to draw blood into the flash back chamber when the needle is used on trauma patients having low blood pressure.
- It is yet another object of the present invention to develop such a safety catheter and needle that provides protection against accidental needle sticks during needle and catheter assembly and shipping.
- A further object is to provide a needle that also protects against accidental sticks upon opening of the needle package, removal of the needle from the package, and pre-use manipulation of the needle and catheter.
- Another object is to provide a catheter and needle that also provides recapping structure to allow the operator to place an otherwise separate cap over the needle after its withdrawal from the patient.
- Yet another object is to provide a single cap structure that provides both pre-use capping and post-withdrawal capping of the needle.
- A still further object of the invention is to provide a catheter and needle housing that is less subject to slipping in the hands of a user while still being predominantly transparent and generally cylindrical for easy use and grasping.
- Another object is to provide a safety catheter that is stronger, and less subject to accidental breakage in use, than prior catheters and needles.
- An additional object is to provide a safety catheter that meets the prior objects while providing a safety catheter that is convenient, easy and economical to manufacture, assemble, and ship, slim yet sturdy, and easy to use and dispose of properly and safely.
- There are other objects that will become apparent as the specification proceeds.
- The foregoing objects and advantages are attained by our invention of an improved safety needle, preferably a catheter needle, that has an outer housing and an inner needle housing slidably mounted in the outer housing. The inner needle housing includes a catheter mounting end opposite the junction of the needle housing and the outer housing. Preferably, a removable cap, which is preferably frusto-conical, has one end mountable about the catheter mounting end and another end mountable on the outer housing. The cap can be mounted on the inner needle housing to protect against needle sticks during shipping of the inner needle housing and assembly of the catheter on the needle and the inner housing within the outer housing. The cap can then be reversed and mounted on the outer housing to protect against needle sticks during packaging, shipment, and pre-insertion manipulation of the catheter. Preferably, after withdrawal of the needle, the cap can be remounted on the outer housing to provide protection against accidental sticks after use of the needle and during disposal.
- The outer housing may include a plunger penetrating the outer housing on the side of the outer housing opposite the needle. The plunger is slidably mounted in the outer housing to draw a vacuum within the outer housing. Alternatively, the plunger may be omitted and the plunger passage blocked with a plug.
- The outer housing may also include a gripping friction surface which preferably results from embossing a trademark or suitable indicia on the outer surface of the outer housing. The inner needle housing may also include ribs or columns on the periphery of the needle housing to strengthen it while minimizing material use and providing grasping surfaces on the needle housing.
- The preferred embodiments of the applicants' invention are depicted in the following drawings in which:
- FIG. 1 is an exploded isometric view of the major components of the preferred catheter embodiment having a plunger, a separable needle cap, and an embossed trademark/friction surface on the outer housing;
- FIG. 2 is a partial plan view of the catheter needle of FIG. 1 after assembly and showing the plunger in partial cutaway within the housing;
- FIG. 3 is a partial cross-sectional view through section line3-3 of FIG. 2, showing the indicia embossing of the outer wall of the outer housing;
- FIG. 4 is a cross-sectional view of the preferred plunger catheter showing the narrow end of the cap mounted on the inner needle housing to cover the needle during shipment and assembly;
- FIG. 5 is a cross-sectional view of the preferred plunger catheter showing the cap being removed from the inner needle housing after assembly of the inner needle housing within the outer housing of the catheter;
- FIG. 6 is a cross-sectional view of the preferred plunger catheter showing the cap inverted from the orientation of FIG. 5 and mounted on the outer housing to cover the catheter and needle during packaging, shipment, removal from the packaging by the user, and pre-use manipulation of the catheter;
- FIG. 7 is a cross-sectional view of the preferred plunger catheter showing removal of the cap from the outer housing prior to insertion of the needle and catheter into the patient;
- FIG. 8 is a cross-sectional view of the preferred plunger catheter showing the withdrawal of the needle from the patient and automatic sheathing of the needle within the inner needle housing;
- FIG. 9 is a cross-sectional view of the preferred plunger catheter showing the cap mounted once again on the outer housing to further protect the inner housing and needle within the inner housing; and
- FIG. 10 is a cross-section view of the preferred catheter without the plunger and with a flash back plug abutting and thus blocking the plunger passage in the back of the outer housing.
- This description of the preferred embodiment utilizes spacial orienting terms such as “back” and “outer.” It is to be understood that these terms are used for convenience of description and not themselves limiting or requiring a particular location in space.
- Referring now to FIG. 1, the applicant's preferred plunger safety needle, generally10, has a
plunger rod 12 andplunger 14, aneedle mounting cylinder 16, aneedle 18, acatheter 20, aninner needle housing 22, anouter handle housing 24, and acap 26. Theplunger rod 12 consists of an “X” shapedplunger beam 28 extending perpendicularly from a planarplunger end cap 30. Theplunger beam 28 slidably penetrates theopen end 31 of a cylindrical flash backchamber 32 on the interior of theneedle mounting cylinder 16; and theneedle 18 is mounted on the end of theneedle mounting cylinder 16 opposite theopen end 31 of the flash backchamber 32. - The
needle mounting cylinder 16 slidably penetrates anopen passage 34 in theneedle housing 22. In turn, theneedle housing 22, theneedle mounting cylinder 16,plunger rod 12, andplunger 14 are mounted within the generally cylindricalinterior wall 36 of theouter handle housing 24. Theplunger beam 28 of theplunger rod 12 slidably penetrates and abuts the “X” shapedplunger passage 38 cooperatively provided by the mating upper 40 and lower 42 halves of thehandle housing 24 when sonically welded together with theneedle housing 22 and the associated structure assembled within thehandle housing 24. - The
plunger rod 12 is thus slidably mounted in theplunger passage 38 to slidably penetrate the cylindrical flash backchamber 32 within theneedle mounting cylinder 16. In turn, the substantiallycylindrical needle housing 22 slidably penetrates ahousing passage 44 provided within theinterior wall 36 of thehandle housing 24. - The
catheter 20 has askin penetration tube 46 coaxially extending from an expandedcatheter hub 48. Thecatheter hub 48 mounts on thecatheter mount 50 extending from theneedle housing 22, and thecap 26 is mountable on theneedle housing 22 or thehandle housing 24 as explained below. - Referring now to FIG. 2, the
plunger beam 28 has aresilient plunger 14 mounted within and slidably abutting theinterior wall 52 of theneedle mounting cylinder 16. Thus, when theplunger cap 30 is drawn away from thehandle housing 24 and air cannot enter through the needle 18 (not shown in FIG. 2) into theinterior vacuum space 54 within theneedle mounting cylinder 16, theplunger 14 slides within the mountingcylinder 16 in the same direction and simultaneously draws a vacuum in theinterior vacuum space 54. If theneedle 18 has penetrated the vein of a patient (not shown) when the vacuum is drawn in theinterior vacuum space 54, blood is urged to flow from the vein, through the needle, and into thevacuum space 54. - The outer surface of the
handle housing 24 includestrademark indicia 56. With reference to FIG. 3, theindicia 56 projects from the outer surface of thehousing 24. The raisedindicia 56 not only can identify the product and convey information about theproduct 10 but also can provide a surface that is more likely to cause greater friction in the hands of a user and less likely to result in slippage when in use. This is particularly helpful in an emergency, when sweaty palms and other fluids, including blood, etc., may otherwise render the outer surface of thehandle housing 24 quite slippery. Thepreferred indicia 56 are cut into the molds for theneedle housing 24 so that theindicia 24 are included into thetransparent housing 24 automatically when molded. Other surface alteration or scoring may also be utilized. - Referring now to FIG. 4, the
cap 26 is frusto-conical and thus has a larger somewhatcylindrical end 58 opposite a narrower somewhatcylindrical end 60. The cap is made out of resilient material, and itsnarrower end 60 is mountable on the narrowedcap mounting hub 62 on theneedle housing 22. Thecap mounting hub 62 is intermediate the wider needle mounting housingcentral body 64 and the narrower raisedcolumn guard hub 66. When mounted on thehub 62, thecap 26 thus provides a protective shield around theneedle 18 extending from theneedle housing 22 when theneedle mounting cylinder 16 is placed within theneedle housing 22 as shown in FIG. 1. In this manner, the partial needle assembly 99 (consisting of theneedle housing 22,needle mounting cylinder 16,needle 18, and cap 26) can be shipped or moved from one assembling or manufacturing area to another with significantly reduced risk of any accidental needle stick to an assemblers, handlers, etc. - With reference now to FIG. 5, the
cap 26 is readily removed by an operator. Thepartial needle assembly 99 can then be further assembled into thehandle housing 24 as shown in FIG. 1. - With the
cap 26 removed, the next manufacturer can install thecatheter 20 by sliding it over theneedle 18 so that thecatheter hub 48 mounts on thecatheter mount 50. Thecatheter mount 50 has a cylindrical mounting body 71 with diametrically opposed catheterhub engaging arms 72, 74 extending radially outwardly from the mounting body 71. Thecatheter hub 48 has a radially extending detent or undercut 76 penetrating the cylindricalinterior wall 78 of thecatheter hub 48. - Referring now to FIG. 6, the
catheter hub 48 mounts on thecatheter mount 50 and is retained in place on themount 50 by theradially extending arms 72, 74, which penetrate the radially extending undercut 76 in thecatheter hub 48. Thecatheter hub 48 is made of resilient material and is held in place by thearms 72, 74 until the operator forces thecatheter 20 off of themount 50 until it is fully separated from theneedle housing 22. - Still referring to FIG. 6, the
larger end 58 of thecap 26 has an internal radial rib orlip 68. Thehandle housing 24 has amating radial detent 70 on theneedle end 61 of thehandle housing 24 opposite the plunger end cap 30 (not shown in FIG. 6). Thelarger end 58 of thecap 26 is mounted on theneedle end 61 so that the cap'sinternal rib 68 abuts theradial detent 70 in thehousing 24. In this manner, theprotective cap 26 is mounted on thehandle housing 24 to extend from thehousing 24 and surround theneedle 18 andcatheter 20. Theprotective cap 26 once again provides a protective sheath around theneedle 18 andcatheter 20 to minimize accidental needle sticks during (i) further packaging, shipment, and handling of the packaging, (ii) opening of the packaging, and (iii) pre-use manipulation of thecatheter 10 prior to actual use to puncture the skin of a patient. - Referring now to FIG. 7, when the operator is ready to use the
needle 18 andcatheter 20, thecap 26 may be pulled off of the handle housing 24 (not shown). The operator may now insert theneedle 18 andcatheter 20 into the patient as described in the '718 and '725 patents. - Referring back to FIG. 5, the raised
column guard hub 66, which is exposed upon removal of thecap 26, provides significant strength with minimum material between thecap mounting hub 62 andcatheter mounting hub 50 on theneedle housing 22. The operator can readily grasp thisarea 66 of the needle housing to hold thehousing 22 when withdrawing theneedle 18 from the patient (not shown). In this operation, the handle housing (not shown in FIG. 5) can be drawn away from the patient with one hand while grasping theguard hub 66 and holding it in place as (i) theneedle 18 is drawn out of the patient, (ii) the mountinghub 50 separates from thecatheter hub 48 as shown in FIG. 7, (iii) theneedle 18 slides out of thecatheter 20 as also shown in FIG. 7, and (iv) theneedle 18 is drawn into theneedle housing 22 as shown in FIG. 8. This operation is described in greater detail in the '718 and '725 patents. - Now that the operator has completed use of the
needle 18, the operator can, as shown in FIG. 9, slide thelarge end 58 of thecap 26 over theneedle housing 22 to yet again engage theradial detent 70 and secure thecap 26 on thehandle housing 24. Thesame cap 26 thus provides yet another level of protection against subsequent needle sticks. This cap-remounting procedure also provides the clinician, particularly one who is accustomed to manual capping of needles after use, with a greater level of comfort and security in using thesafety needle 10. It also reduces the likelihood that thecap 26 will be left behind on the street or any other accident or trauma location. - Referring now to FIG. 10, the
cap 26,indicia 56, (FIG. 1) on thehousing 24, mountinghub 50, andcatheter hub 48 described above may also be used on a safety needle not having a plunger at all. This type of catheter is preferably for use with patients having sufficient blood pressure. Thisnon-plunger needle 100 has aresilient plug 102 mounted within the mountingcylinder 16 to extend therefrom and abut the generally planar interior end 104 of theneedle housing 24. Theplug 102 thus abuts the “X” shapedplunger passage 38 and prevents the flow of blood from the flash backchamber 32 through theplunger passage 38. - The
protective cap 26,plunger rod 12 andcatheter hub 48 are preferably made from polypropylene. Theplug 102 is made from rubber, and thehandle housing 24 and needle mount 16 are made from high impact polystyrene. The needle is made of steel. Thecatheter 20 is made from radiopaque Teflon, and theneedle housing 22 is made from ploycarbonate. - It can thus be seen that the applicants have invented a safety catheter and needle that is safer than prior art catheters and needles and yet convenient, economical, and easy to assemble and manufacture. It provides numerous significant advantages over the prior art, and it does so at minimal cost.
- While in the foregoing the applicants have described their preferred embodiments, it is to be understood that the scope of the invention is to be determined by reference to the following claims.
Claims (8)
1. An improved needle apparatus comprising in combination:
a. a first housing having a first end;
b. a needle secured to said first housing, extending beyond said first end, and having a point which can be injected into a patient;
c. a second housing movably captured with respect to said first housing, said second housing having a first end and an opposite end, wherein said first housing and needle are manually movable, with respect to said second housing, between a needle exposing position at which said needle point is outside said second housing, and a needle sheathing position at which said point is withdrawn into said second housing after said needle is fully withdrawn from a patient to prevent an accidental needle stick; and
d. a one-piece removable cap having a first end adapted for engaging said first housing to provide a sheath for said needle, and also having a second end adapted for engaging said second housing to provide a sheath for said needle.
2. The needle apparatus of , wherein said needle has an axially extending internal passage, and said second housing includes a generally cylindrical internal wall defining a chamber communicating with said internal passage.
claim 1
3. The needle apparatus of , further comprising a plunger disposed within said generally cylindrical internal wall and slidably engaging said generally cylindrical internal wall to define a piston.
claim 2
4. The needle apparatus of , further comprising a plunger rod having a first portion secured to said plunger and a second portion accessible to a user for sliding said plunger within said generally cylindrical internal wall.
claim 3
5. The needle apparatus of , further comprising a catheter, wherein said needle is inserted through said catheter when in said needle exposing position and removed from said catheter when in said needle sheathing position.
claim 1
6. The needle apparatus of , wherein the opposite end of said second housing is disposed within at least a portion of said first housing.
claim 1
7. The needle apparatus of , wherein at least one of said first and second housings has an exterior portion accessible for grasping and provided with a grip.
claim 1
8. The needle apparatus of , wherein said grip is formed by raised indicia on said exterior portion.
claim 1
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/730,370 US20010044607A1 (en) | 1994-08-25 | 2000-12-05 | Safety needle apparatus and method |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US29632994A | 1994-08-25 | 1994-08-25 | |
US08/823,830 US5769827A (en) | 1994-08-25 | 1997-03-25 | Safety needle apparatus and method |
US09/102,467 US6010487A (en) | 1994-08-25 | 1998-06-22 | Safety needle apparatus and method |
US09/477,213 US6156015A (en) | 1994-08-25 | 2000-01-04 | Safety needle apparatus and method |
US09/730,370 US20010044607A1 (en) | 1994-08-25 | 2000-12-05 | Safety needle apparatus and method |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US09/477,213 Continuation US6156015A (en) | 1994-08-25 | 2000-01-04 | Safety needle apparatus and method |
Publications (1)
Publication Number | Publication Date |
---|---|
US20010044607A1 true US20010044607A1 (en) | 2001-11-22 |
Family
ID=23141571
Family Applications (4)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/823,830 Expired - Fee Related US5769827A (en) | 1994-08-25 | 1997-03-25 | Safety needle apparatus and method |
US09/102,467 Expired - Fee Related US6010487A (en) | 1994-08-25 | 1998-06-22 | Safety needle apparatus and method |
US09/477,213 Expired - Fee Related US6156015A (en) | 1994-08-25 | 2000-01-04 | Safety needle apparatus and method |
US09/730,370 Abandoned US20010044607A1 (en) | 1994-08-25 | 2000-12-05 | Safety needle apparatus and method |
Family Applications Before (3)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US08/823,830 Expired - Fee Related US5769827A (en) | 1994-08-25 | 1997-03-25 | Safety needle apparatus and method |
US09/102,467 Expired - Fee Related US6010487A (en) | 1994-08-25 | 1998-06-22 | Safety needle apparatus and method |
US09/477,213 Expired - Fee Related US6156015A (en) | 1994-08-25 | 2000-01-04 | Safety needle apparatus and method |
Country Status (1)
Country | Link |
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US (4) | US5769827A (en) |
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US20020156427A1 (en) * | 2001-04-24 | 2002-10-24 | Hitoshi Suzuki | Needle protector assemblage, syringe equipped therewith and needle hub |
US20050015058A1 (en) * | 2003-07-17 | 2005-01-20 | Don Millerd | Safety system for a blood collection device |
US20100241029A1 (en) * | 2009-03-20 | 2010-09-23 | Mahurkar Sakharam D | Retractable needle-safety blood sampling device |
US9017288B1 (en) * | 2004-08-11 | 2015-04-28 | Proteckt Catheters, Llc | Catheter with integrated pre-slit cannula diaphragm |
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US6620136B1 (en) | 1999-02-18 | 2003-09-16 | Medsafe Technologies, Llc | Retractable I-V catheter placement device |
EP1165172A1 (en) * | 1999-03-17 | 2002-01-02 | Designodev Limited | A safety assembly for a hypodermic applicator set |
US6117110A (en) * | 1999-03-26 | 2000-09-12 | Radmand; Reza | Catheter needle safety device and method of using same |
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US8403886B2 (en) * | 2005-08-08 | 2013-03-26 | Smiths Medical Asd, Inc. | Needle guard clip with lip |
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US8057431B2 (en) | 2006-12-21 | 2011-11-15 | B. Braun Melsungen Ag | Hinged cap for needle device |
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JP5123306B2 (en) * | 2007-08-02 | 2013-01-23 | テルモ株式会社 | Protector and protector assembly |
US8398597B2 (en) * | 2008-06-17 | 2013-03-19 | Becton, Dickinson And Company | Needle shield and interlock |
US8708969B2 (en) * | 2008-06-30 | 2014-04-29 | Covidien Lp | Safety device actuation system |
US8333737B2 (en) * | 2010-06-03 | 2012-12-18 | Jms North America Corporation | Systems and methods for a medical syringe |
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-
2000
- 2000-01-04 US US09/477,213 patent/US6156015A/en not_active Expired - Fee Related
- 2000-12-05 US US09/730,370 patent/US20010044607A1/en not_active Abandoned
Cited By (7)
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---|---|---|---|---|
US20020156427A1 (en) * | 2001-04-24 | 2002-10-24 | Hitoshi Suzuki | Needle protector assemblage, syringe equipped therewith and needle hub |
US20050015058A1 (en) * | 2003-07-17 | 2005-01-20 | Don Millerd | Safety system for a blood collection device |
US7357783B2 (en) * | 2003-07-17 | 2008-04-15 | Medpro Safety Products, Inc. | Safety system for a blood collection device |
US9017288B1 (en) * | 2004-08-11 | 2015-04-28 | Proteckt Catheters, Llc | Catheter with integrated pre-slit cannula diaphragm |
US20100241029A1 (en) * | 2009-03-20 | 2010-09-23 | Mahurkar Sakharam D | Retractable needle-safety blood sampling device |
US8167820B2 (en) | 2009-03-20 | 2012-05-01 | Mahurkar Sakharam D | Retractable needle-safety blood sampling device |
US8696594B2 (en) | 2009-03-20 | 2014-04-15 | Sakharam D. Mahurkar | Retractable needle-safety blood sampling device |
Also Published As
Publication number | Publication date |
---|---|
US5769827A (en) | 1998-06-23 |
US6156015A (en) | 2000-12-05 |
US6010487A (en) | 2000-01-04 |
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Legal Events
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |