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WO2006014151A1 - Aiguille pénétrante extensible et méthode d’utilisation - Google Patents

Aiguille pénétrante extensible et méthode d’utilisation Download PDF

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Publication number
WO2006014151A1
WO2006014151A1 PCT/US2004/021197 US2004021197W WO2006014151A1 WO 2006014151 A1 WO2006014151 A1 WO 2006014151A1 US 2004021197 W US2004021197 W US 2004021197W WO 2006014151 A1 WO2006014151 A1 WO 2006014151A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
hub
expandable penetrating
shaft
expandable
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.)
Ceased
Application number
PCT/US2004/021197
Other languages
English (en)
Inventor
Victor Katz
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to PCT/US2004/021197 priority Critical patent/WO2006014151A1/fr
Publication of WO2006014151A1 publication Critical patent/WO2006014151A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150053—Details for enhanced collection of blood or interstitial fluid at the sample site, e.g. by applying compression, heat, vibration, ultrasound, suction or vacuum to tissue; for reduction of pain or discomfort; Skin piercing elements, e.g. blades, needles, lancets or canulas, with adjustable piercing speed
    • A61B5/150106—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced
    • A61B5/15016—Means for reducing pain or discomfort applied before puncturing; desensitising the skin at the location where body is to be pierced by accessories for bringing the piercing element into the body, e.g. through rotation of the piercing element
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150236—Pistons, i.e. cylindrical bodies that sit inside the syringe barrel, typically with an air tight seal, and slide in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150206—Construction or design features not otherwise provided for; manufacturing or production; packages; sterilisation of piercing element, piercing device or sampling device
    • A61B5/150244—Rods for actuating or driving the piston, i.e. the cylindrical body that sits inside the syringe barrel, typically with an air tight seal, and slides in the barrel to create a vacuum or to expel blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150389—Hollow piercing elements, e.g. canulas, needles, for piercing the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150381—Design of piercing elements
    • A61B5/150503—Single-ended needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150374—Details of piercing elements or protective means for preventing accidental injuries by such piercing elements
    • A61B5/150534—Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
    • A61B5/150633—Protective sleeves which are axially extensible, e.g. sleeves connected to, or integrated in, the piercing or driving device; pivotable protective sleeves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/153—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
    • A61B5/1535—Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes comprising means for indicating vein or arterial entry
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150801—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming
    • A61B5/150824—Means for facilitating use, e.g. by people with impaired vision; means for indicating when used correctly or incorrectly; means for alarming by visual feedback
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0024—Expandable catheters or sheaths

Definitions

  • the present invention relates to an expandable penetrating needle. More specifically, the present invention relates to a needle having a main body that is shaped essentially like a sharply pointed cone when in an unexpended state, but that opens into a substantially cylindrical shape when expanded.
  • the needle is substantially hollow, such that a second needle or other similar tubing may be passed therethrough. Insertion of a second needle or other tubing into the penetrating needle causes its expansion.
  • the expandable penetrating needle may be used to pierce various materials, such as rubber or plastic. However, the expandable penetrating needle is especially well suited for use in venipuncture procedures, wherein the skin and vein of a patient must be penetrated.
  • a flexible or semi-rigid material typically in order to gain access to the contents of a container to which the flexible material is affixed.
  • materials are commonly formed from a plastic, or more commonly, from a rubber material.
  • rubber stoppers may be used to seal vials or other containers of laboratory chemicals, such as reagents and the like. Access and removal of such chemicals or other materials is typically accomplished by piercing the rubber stopper with a needle, cannula, or other similarly sharp-tipped hollow tool. The desired amount of chemicals may then be drawn into a syringe or other container. Upon removal of the needle or cannula, the hole produced in the stopper thereby is substantially resealed by the expansion of its rubber composition.
  • venipuncture Another common procedure requiring the non-destructive piercing of a flexible material is the insertion of a needle into the tissue of a patient.
  • One such procedure is commonly referred to as venipuncture, and involves passing a needle through a patients skin and into a vein, whereby access to the patients blood supply is accomplished.
  • Venipuncture may be practiced as a portion of a variety of medical procedures. For example, drug introduction and the drawing of a blood sample (phlebotomy) both employ venipuncture.
  • a hypodermic needle and syringe such as, for example, a hypodermic needle and syringe, a single or multi-sample needle and an evacuated collection tube, and a winged (butterfly) needle that may be connected to an infusion set, a syringe, or an evacuated collection tube.
  • a winged (butterfly) needle that may be connected to an infusion set, a syringe, or an evacuated collection tube.
  • Venipuncture is also practiced when inserting a catheter into a patient's vein. In this case, a needle is used to penetrate the vein and a catheter tube is thereafter inserted into the vein, over the needle, and into the hole in the vein made by the needle.
  • Needles come in various shapes and sizes, depending largely on their intended use.
  • needles may be single-ended, such as for use with a syringe, or double-ended, such as for use with an evacuated collection tube.
  • Needles generally consist of a shaft that is inserted into the patient, and a hub for attachment to a syringe, collection tube, or other device.
  • the penetrating end of the needle is typically beveled, with the leading edge of the bevel forming the point of the needle.
  • Double-ended needles typically have a bevel and point at both ends. The point is typically made as sharp as possible to provide for penetration of a patient's skin and vein (and the rubber stopper of a collection tube in the case of double-ended needles).
  • Needles are also generally hollow to allow for the delivery of fluids or to allow for the withdrawal of an amount of a patient's blood.
  • the passageway that runs through the length of the needle is commonly referred to as the lumen.
  • the diameter of the lumen determines the gauge, or size, of the needle.
  • needles may also be used to pierce other flexible materials, as described above.
  • the use of such needles is not without problems, however - whether they are used to pierce flexible materials, such as plastic and rubber, or in venipuncture procedures.
  • the lumen In order to properly withdraw or inject fluids through a needle, the lumen must be of adequate diameter. Adequate lumen diameter is based, at least somewhat, on the type and viscosity of the material to be passed through the needle.
  • a needle will encounter at least some resistance during piercing of a patient's skin, a rubber stopper, or another material to be penetrated. As such, the needle must have sufficient strength and rigidity to prevent it from bending or breaking during insertion.
  • the needle In addition to the diameter of the lumen, the needle must also have a wall thickness sufficient to impart the necessary rigidity thereto. This wall thickness contributes to the overall diameter of the needle, which diameter must pass through the material to be penetrated.
  • a needle of greater diameter will create a larger opening in the material it penetrates. Therefore, it is typically desired, particularly in venipuncture, to use the smallest needle possible.
  • the use of a smaller needle will encounter less resistance from a patient's skin and vein (or another material to be penetrated), thereby generally producing less pain and resulting in less bleeding.
  • the minimum diameter of a needle used in venipuncture is limited. For example, when dispensing intravenous drugs, the needle must be able to adequately pass the material into the patients vein. In a catheter procedure, the needle must be large enough to create a hole of sufficient size to accept the catheter. And, in phlebotomy, a lumen of too small a diameter can cause damage to red blood cells, leading to an unusable blood sample.
  • the bevel common to typical needles is intended to make insertion (penetration) of the needle easier.
  • the bevel allows the diameter of the needle to be inserted incrementally - as opposed to the instantaneous insertion of the needle's diameter that would occur with a blunt (squared off) tip.
  • the use of a bevel also has drawbacks, however. For example, it is known to be somewhat difficult to produce a bevel on needles, especially those of small diameter (gauge), while simultaneously maintaining a sharp point and a clean lumen opening. Also, while the bevel allows for incremental insertion of the needle diameter, it also requires that a greater length of needle be inserted before materials may be withdrawn or injected therethrough.
  • the bevel also imparts a larger surface area to the cutting portion of the needle.
  • the expandable penetrating needle of the present invention overcomes the aforementioned shortcomings of typical, known needles.
  • typical needles which require that the full diameter of the needle cut through the material to be penetrated (such as the skin and vein of a patient)
  • the expandable penetrating needle of the present invention is designed to produce a smaller initial entryway.
  • penetration of a subject material by the expandable penetrating needle of the present invention is less invasive than penetration by typical needles.
  • the expandable penetrating needle of the present invention is preferably designed to have a substantially conical shape when in an unexpanded state. More specifically, the expandable penetrating needle has a shaft that is formed into a segmented cone having a sharp point.
  • the shaft may be perforated, scored, or possess weakened sections, for example, that divide the cone into a plurality of substantially triangular sections.
  • the base of the conical shaft may be attached to a variety of hubs or other similar attachment structures.
  • the expandable penetrating needle when employed in the medical field, may be designed for attachment to a hypodermic syringe, an evacuated collection tube holder, a butterfly infusion system, or a catheter insertion apparatus.
  • a catheter insertion apparatus A multitude of other configurations are also possible.
  • the segmented design of the expandable penetrating needle shaft allows it to expand upon insertion of another device.
  • a section of tubing such as a second needle or catheter may be inserted into the hub of the expandable penetrating needle. As the second needle or section of tubing is moved toward the tip of the expandable penetrating needle, the individual segments of the conical shaft are forced to separate and expand.
  • the expandable penetrating needle of the present invention can be used to permit the substantially less invasive insertion of a device of considerably greater diameter than the entryway initially created by the needle. Because the expandable penetrating needle produces an enlarged entryway by gradual expansion, as opposed to cutting, penetration of a material can be achieved with less destructive effect on the penetrated material and, in the case of venipuncture, with less pain experienced by the patient.
  • an expandable penetrating needle of the present invention may have a plurality of uses, and may be connected to a variety of other devices.
  • a better understanding of the expandable penetrating needle of the present invention can be gained by reference to the following detailed description of certain exemplary embodiments thereof.
  • Figure 1a is an enlarged view illustrating a known type of needle, commonly referred to as a hypodermic needle;
  • Figure 1b is an enlarged view illustrating a similar, known needle, and its use in a catheter assembly
  • Figure 2a depicts a venipuncture procedure, wherein a typical hypodermic needle has been inserted into a normal vein of a patient
  • Figure 2b depicts a venipuncture procedure, wherein a typical hypodermic needle has been inserted into a small, or collapsed vein of a patient;
  • Figure 3a is an enlarged view, in partial cross-section, showing one embodiment of an expandable penetrating needle of the present invention in an unexpanded state;
  • Figure 3b shows the expandable penetrating needle of Figure 3a in an expanded state
  • Figure 4a is an enlarged view showing another embodiment of an expandable penetrating needle of the present invention in an unexpanded state;
  • Figure 4b shows the expandable penetrating needle of Figure 4a in an expanded state;
  • Figure 5a is an enlarged cross-sectional view of the expandable penetrating needle of Figure 4a
  • Figure 5b is an enlarged cross-sectional view, showing a second needle partially inserted into the expandable penetrating needle of Figure 5a;
  • Figure 5c is an enlarged, partial cut-away view, showing the needle assembly of Figure 5b with substantially full insertion of the second needle into the expandable penetrating needle;
  • Figure 6a depicts a venipuncture procedure, wherein an expandable penetrating needle of the present invention has been inserted into a small, or collapsed vein of a patient, to facilitate the subsequent insertion of a typical hypodermic needle;
  • Figure 6b shows the arrangement of Figure 6a, with the hypodermic needle fully inserted through the expandable penetrating needle and into the patient's vein.
  • the expandable penetrating needle of the present invention is designed to be used in a variety of applications, including those in which typical needles are currently employed.
  • a typical hypodermic needle 5 can be observed by reference to Figure 1a.
  • the hypodermic needle 5 can be seen to have a shaft 10 that is attached at a first end to a hub 15.
  • the hub 15 is provided to attach or connect the needle 5 to another device, such as a syringe or evacuated collection tube holder, for example.
  • the second end of the shaft 10 is provided with a bevel 20 that forms a point 25 at the tip of the needle 5.
  • the bevel 20 acts as a cutting edge to allow the shaft 10 of the needle 5 to pass through a material to be penetrated.
  • the hollow interior of the needle is generally referred to as the lumen 30.
  • the diameter of the lumen 30 determines the gauge, or size, of the needle.
  • Other types of needles also exist. For example, double-ended needles, with each end having a bevel, are produced for use with evacuated collection tubes/holders. Such devices are commonly used during phlebotomy.
  • Other needles may be used to provide an entryway, or pilot hole, for the insertion of another device.
  • needles are typically used to create an entryway into a patient's vein for the insertion of a catheter.
  • a portion of such an assembly 35 is depicted in Figure 1 b. As can be seen from this portion of the catheter assembly 35, a penetrating needle 40 is located interior to a section of hollow catheter tubing 50.
  • the catheter tubing may reside inside the lumen 45 of the needle, although such an arrangement is generally less common.
  • the needle 40 is first inserted through a patient's skin and into a vein. Once the needle is secured, the catheter tubing 50 is passed over the needle 40, and inserted into the vein through the hole therein made by the needle.
  • the catheter tubing 50 is generally of considerably larger diameter than the needle 40, the leading end of the catheter tubing may be beveled or otherwise designed to facilitate its entry into the vein.
  • the catheter tubing 50 is inserted, provision is generally made for removal of the needle 40.
  • hypodermic needle 5 is shown attached to a syringe 55.
  • the hypodermic needle 5 has been inserted into the arm 60 of a patient, whereby the needle has penetrated both the skin 65 and a vein 70 of the patient.
  • the needle 5 and syringe 55 are shown to be oriented at a slight angle with respect to horizontal (and the patient's arm),
  • an entryway is created through the tissue of the patient's arm by the needle 5, the angle of entry and beveled cutting edge 20 of which can increase the size of the entryway beyond that of the needle diameter.
  • the needle 5 has been inserted into a substantially normal vein 70 (i.e., the vein is of normal size and is not collapsed).
  • the hypodermic needle 5 and syringe 55 of Figure 2a are again shown inserted into the arm 75 of a patient in Figure 2b. Again, the needle 5 and syringe 55 are shown to be oriented at a slight angle with respect to horizontal, and the needle has penetrated through the patient's skin 80 and into a vein 85. However, in this example the vein 85 is shown to be collapsed, such as may occur from, for example, repeated injection (needle penetration) of the same site. A similar problem may occur when performing venipuncture on a patient with small veins, such as a child or an elderly person. In either case, the vein generally has a significantly reduced diameter.
  • the needle 5 may be exceedingly difficult, if not impossible, to insert the needle 5 into the vein without at least the tip 25 of the needle also penetrating partially or fully through both walls thereof. Further, insertion of the needle 5 to a point wherein less than the whole of the lumen 30 resides within the vein can cause blood loss and an incomplete blood draw or injection.
  • the expandable penetrating needle of the present invention minimizes or eliminates many of the disadvantages associated with the use of typical needles.
  • One embodiment of an expandable penetrating needle 100 of the present invention can be observed in Figure 3a. While the embodiment of the expandable penetrating needle shown in Figure 3a, as well as the other exemplary embodiments depicted in the remaining drawing figures will be described specifically with respect to their use in venipuncture, it should be realized that such needles could also be used in a variety of other areas, such as has been briefly discussed above.
  • the expandable penetrating needle 100 of Figure 3a is shown in an unexpanded condition.
  • the expandable penetrating needle 100 can be seen to have a shaft 105 of substantially conical shape.
  • the distal end 110 of the shaft is formed into a sharp point (tip) 115 when the needle 100 is in an unexpanded state, while the proximal end (base) 120 of the shaft is attached to a hub 125.
  • the base 125 of the needle shaft 105 could form the hub 125.
  • the hub 125 has a forward portion 130 that is attached to the base 120 of the needle shaft 105, and an open, receiving end 135 opposite thereof.
  • the hub 125 is merely provided to be grasped by a user of the expandable penetrating needle 100 and to receive a section of tubing 160, such as catheter or intravenous tubing, that will eventually be passed through the needle.
  • the hub 125 be of a specific shape or size.
  • the expandable penetrating needle 100 will be used for phlebotomy, it is preferred that at least the forward portion 130 of the hub 125 be transparent, or otherwise allow a user of the needle to view a flow of blood from the patient's vein. In this manner, the phlebotomist is able to determine with certainty that the expandable penetrating needle 100 has been adequately inserted into the vein.
  • the shaft 105 of the expandable penetrating needle 100 may also be modified to facilitate this process.
  • the shaft 105 of the expandable penetrating needle 100 is shown to be divided into a plurality of segments 140, 145, 150.
  • the shaft is divided into three segments 140, 145, 150, but a fewer or greater number of segments are also possible.
  • the segments 140, 145, 150 may be produced by cutting or scoring the shaft, for example. If the expandable penetrating needle 100 is of molded construction, it is also anticipated that the segments 140, 145, 150 may be produced by providing minute areas of weakened (thinner) material therebetween.
  • the cuts, score lines, or other means of segmenting the shaft 105 may run through the tip 115 or, alternatively, may stop slightly short of the tip to help ensure that the segments are maintained in a tightly abutting relationship while the expandable penetrating needle 100 is in an unexpanded state.
  • the tubing 160 may be partially inserted into the hub 125 of the expandable penetrating needle 100 prior to insertion of the expandable penetrating needle into a patient.
  • the expandable penetrating needle 100 and tubing 160 may be provided as a pre-assembled kit, or the components may be supplied separately and assembled prior to use.
  • the fit of the outer diameter of the tubing 160 and the inner diameter of the hub 125 or the base 120 of the needle shaft 105 provides a substantial seal and also prevents inadvertent movement of the tubing toward the tip 115 of the expandable penetrating needle 100.
  • Other means of tubing retention may also be employed.
  • a threaded collar (not shown) may be provided at the open end 135 of the hub 125 to engage a like-threaded portion (not shown) of tubing.
  • rotation of the collar in a first direction controllably and incrementally forces the tubing into the needle, while rotation of the collar in an opposite direction withdraws the tubing from the needle.
  • the threaded portion of the tubing may be integral thereto or, alternatively, may be applied to the tubing, such as in the form of an adhesively attachable section.
  • the tubing 160 may be pushed through the needle shaft 105.
  • the expandable penetrating needle 100 may be held in place by the user during this operation but, preferably, the needle is secured to the patient, such as with tape or the like.
  • the segments 140, 145, 150 are forced to progressively separate, causing the outside diameter of the needle shaft 105 to gradually increase, and thereby slowly stretching the initial entryway produced in the vein by the needle tip 115.
  • the needle shaft 105 becomes substantially cylindrical in shape, with its inner diameter typically, but not essentially, similar in dimension to the outside diameter of the tubing 160.
  • a mark or similar indicator may be provided on the tubing 160 to alert the user when the distal end thereof has reached the distal end 110 of the needle shaft 105.
  • the user has the option of retracting the expandable penetrating needle 100 from the patient. For example, if the tubing 160 will be used only for a short-term procedure, the user may simply leave the expandable penetrating needle 100 in its inserted position, whereafter it may be withdrawn from the patient along with the tubing. However, if the tubing 160 will be used for a long-term procedure, the user may wish to remove the expandable penetrating needle 100 from the patient and allow only the tubing to remain in the vein.
  • the expanded inner diameter of the needle shaft 105 allows the expandable penetrating needle 100 to be retracted from the patient and moved to a position along the tubing 160 that is safely removed from the patient and/or contact by the user or others.
  • the retracted expandable penetrating needle 100 may be affixed to the tubing 160 by a number of means, such as, for example, a piece of tape.
  • the hub 125 of the expandable penetrating needle 100 may also have an optional retention mechanism 165, such as the spring-loaded hook shown attached thereto.
  • the hook 165 is designed to mate with a corresponding connector 170 that is affixed to the tubing 160 at a location away from the patient.
  • the connector 170 may come pre-installed to the tubing 160, or may be installed to the tubing by the user prior to installation of the expandable penetrating needle.
  • the connector 170 is designed to be moveable along the length of the tubing 160, but to also firmly resist inadvertent movement. Such may be accomplished, for example, by carefully controlling the fit of the connector inner diameter to the outer diameter of the tubing 160, or by forming at least the inner diameter of the connector 170 from a material that firmly but releasably grips the tubing.
  • Such constructions are known and need not be discussed in detail herein.
  • FIG. 4a and 4b An alternate embodiment of an expandable penetrating needle 200 of the present invention in an unexpanded and expanded state is shown in Figures 4a and 4b, respectively.
  • This embodiment of the expandable penetrating needle 200 is similar in design to the embodiment 100 shown in Figures 3a-3b.
  • the expandable penetrating needle 200 can be seen to have a segmented shaft 205 of substantially conical shape with a distal end 210 thereof formed into a sharp point (tip) 215.
  • the proximal end (base) 220 of the shaft 205 is attached to a specialized hub 225.
  • the hub 225 has a forward portion 230 that is attached to the base 220 of the needle shaft 205, and an open, receiving end 235 opposite thereof.
  • the hub 225 is specifically designed to mate with the hub of another needle, such as, for example, a hypodermic needle, or a double- ended needle.
  • another needle such as, for example, a hypodermic needle, or a double- ended needle.
  • the expandable penetrating needle 200 can be used in conjunction with another needle during venipuncture to more easily penetrate a patient's skin and vein.
  • a hypodermic needle attached to a syringe or a double-ended needle attached to an evacuated collection tube/holder, for example, may thereafter be inserted through the expandable penetrating needle 200.
  • the expandable penetrating needle 200 depicted in Figures 4a-4b can be seen in cross-section in Figures 5a-5c.
  • the base 220 of the needle shaft 205 may be somewhat elongated to help in guiding the device, in this case the needle, that will be passed therethrough.
  • the needle shaft 205 and hub 225 are of two-piece construction.
  • the base 220 of the needle shaft 205 is shown to reside within a forward portion 230 of the hub 225.
  • the forward portion 230 of the hub 225 could reside within the base 220 of the needle shaft 205.
  • the expandable penetrating needle 200 could be of one piece construction, wherein the base 220 of the needle shaft 205 and the forward portion 230 of the hub 225 could have substantially the same inside diameter.
  • the shaft 205 of the expandable penetrating needle 200 is divided into three segments 240, 245, 250.
  • the shaft 205 could also be divided into a fewer or greater number of segments.
  • the segments 240, 245, 250 may be produced by cutting or scoring the shaft, for example. If the expandable penetrating needle 200 is of molded construction, it is also anticipated that the segments 240, 245, 250 may be produced by providing minute areas of weakened (thinner) material therebetween.
  • the cuts, score lines, or other means of segmenting the shaft 205 may run through the tip 215 or, alternatively, may stop slightly short of the tip to help ensure that the segments 240, 245, 250 are maintained in a tightly abutting relationship while the expandable penetrating needle 200 is in an unexpanded state.
  • the hub 225 may contain a seal 260.
  • the seal 260 is provided primarily for use in phlebotomy applicatipns, to help prevent any of the initial flow of blood that occurs after insertion of the tip 215 of the expandable penetrating needle 200 into a patient's vein from exiting the open end 235 of the hub 225.
  • the design of the seal 260 may depend on the type of second needle 265 to be passed through the expandable penetrating needle 200. For example, if a blunt-ended second needle is to be used, the seal may be substantially a grommet, wherein a predefined (but substantially sealed) passageway is located therethrough. If the second needle has a beveled end, it may be possible to employ a solid seal 260, wherein the second needle simply punctures the seal upon its insertion into the expandable penetrating needle 200.
  • the second needle 265 when the second needle 265 is initially inserted into the expandable penetrating needle 200, it may be guided by the inside diameter of the hub 225, or in this particular case, the inside diameter of the base 220 of the needle shaft 205.
  • the length of the guiding section may vary. It is also possible that the outside diameter of the second needle 265 may be smaller than the inside diameter of the hub 225 or base 220 of the needle shaft 205, in which case the second needle may not make contact with the expandable penetrating needle 200 until the second needle reaches the conical (tapered) portion of the needle shaft 205.
  • the shaft 205 thereof is caused to expand by a separation of the segments 240, 245, 250.
  • the expandable penetrating needle 200 is shown in an expanded state in Figure 5c.
  • this particular embodiment of the expandable penetrating needle 200 is designed to mate with, or engage, a hub 270 of the second needle 265. Further, in this particular embodiment, full insertion of the second needle 265 (as shown) into the expandable penetrating needle 200 is indicated by full insertion of the hub 270 of the second needle 265 into the hub 225 of the expandable penetrating needle 200. In this case, when the second hub 270 is fully inserted into the expandable penetrating needle hub 225, the tip 275 of the second needle 265 is substantially aligned with the distal end 210 of the expandable penetrating needle shaft 205.
  • the tip 275 of the second needle 265 may reside slightly within the expandable penetrating needle shaft 205, or protrude slightly therefrom. However, it is preferred that the tip 275 the second needle 265 not be allowed to protrude too far from the distal end 210 of the expandable penetrating needle shaft 205, as it may penetrate through the bottom wall of the vein. In other embodiments, the hub 270 of the second needle 265 may not be inserted into the hub 225 of the expandable penetrating needle 200. For example, the distal end of the hub 270 of the second needle 265 may simply abut the open end 235 of the expandable penetrating needle 200.
  • the hubs 225, 270 may not make contact due to, for example, the length of the second needle 265.
  • the second needle 265 be marked to indicate the point of insertion wherein the tip 275 thereof will exit the open distal end 210 of the expandable penetrating needle shaft 205.
  • At least the forward portion 230 of the hub 225 be transparent, or otherwise allow a user of the expandable penetrating needle 200 to view a flow of blood from the patient's vein. In this manner, the phlebotomist is able to determine with certainty that the expandable penetrating needle 200 has been adequately inserted into the vein.
  • the shaft 205 of the expandable penetrating needle 200 has also been modified to facilitate this process.
  • the expandable penetrating needle arcuate sections of the needle shaft segments 240, 245, 250 have been removed along the abutting edges 255 (i.e., along the score lines, cut lines, etc., that separate the segments) thereof.
  • small elliptical-shaped apertures 280 are formed through the needle shaft 205 to allow a small amount of blood to flow into the interior of the expandable penetrating needle 200 while it is still in an unexpanded state.
  • the apertures 280 are located toward the tip 215 of the needle shaft 205 so that the initial blood flow may be established with only a minimal insertion of the needle tip into the patient's vein.
  • FIG. 4a-4b and 5a-5c The expandable penetrating needle 200 of Figures 4a-4b and 5a-5c is shown in Figures 6a-6b during its use in a venipuncture procedure.
  • the expandable penetrating needle 200 is used in conjunction with the hypodermic needle 5 and syringe 55 of Figures 2a-2b, although it should be realized that the expandable penetrating needle could be configured to work with virtually any venipuncture device.
  • the hypodermic needle 5 and syringe 55 may be used, for example, to introduce an intravenous drug to the patient, or to obtain a blood sample.
  • the expandable penetrating needle 200 has been inserted into the arm 285 of a patient, whereby the shaft 205 of the expandable penetrating needle has penetrated the patient's skin 290 and the tip 215 of the expandable penetrating needle has penetrated a vein 295 of the patient.
  • the vein 295 is shown to be collapsed or of small size in order to demonstrate how an expandable penetrating needle of the present invention can facilitate entry thereto more easily than a typical needle.
  • the expandable penetrating needle 200 is oriented at a slight angle with respect to horizontal (and the patient's arm).
  • the conical shape of the expandable penetrating needle 200 may also allow an entry angle (not shown) into the patient's arm that is more vertical.
  • the tip 215 of the expandable penetrating needle 200 creates an initial entryway into the vein 295 of the patient.
  • this initial entryway is of much smaller diameter than would be created by the cutting action of a typical beveled needle.
  • apertures 280 or other similar features in the needle shaft 205 allow an initial blood flow to be established, thereby indicating to the user thereof that proper entry of the expandable penetrating needle 200 into the vein 295 has been made.
  • the hypodermic needle 5 can be inserted therethrough. Progressive insertion of the hypodermic needle 5 into the expandable penetrating needle 200 causes a gradual expansion of the expandable penetrating needle shaft 205, as well as a gentle expansion of the initial entryway created in the vein 295. As can be seen in Figure 6b, once the hypodermic needle 5 is substantially fully inserted into the expandable penetrating needle 200, the expandable penetrating needle shaft 205 becomes substantially fully open (expanded). Thus, the initial entryway in the vein 295 is stretched sufficiently to allow insertion of the larger diameter hypodermic needle 5, without forcing the hypodermic needle into the vein or requiring any additional cutting thereof. As can be seen in Figure 6b, the expanding action of the needle shaft 205 acts to open up the previously collapsed section of the vein 295, thereby permitting access by the hypodermic needle 5 without fully penetrating or otherwise causing additional damage to the vein.
  • the expandable penetrating needle may be provided with a self-blunting feature.
  • extension of the tubing 160 past the distal end 110 of the needle shaft 105 effectively blunts the end of the expandable penetrating needle 100.
  • the expandable penetrating needle 100 may be moved along the tubing 160 in a direction away from the patient after insertion of the tubing, or may otherwise be removed from the patient along with the tubing, accidental needle sticks can be prevented.
  • a blunt-ended needle may be substituted for the beveled second needle 265 shown. Consequently, insertion of a blunt-ended second needle to a point wherein its blunt end extends slightly beyond the end 210 of the shaft 205 of the expandable penetrating needle 200, acts as a safety device (guard) to prevent accidental needle sticks from the sharp points 215 thereof.
  • the expandable penetrating needle of the present invention may be a part of a self-blunting apparatus. While certain exemplary embodiments of the present invention are described in detail above, it should be realized that a pluarality of modifications are possible within the scope of the invention.
  • the expandable penetrating needle of the present invention can be configured to connect to substantially any venipuncture device available.
  • the expandable penetrating needle may be manufactured from virtually any material that provides the necessary strength and allows for the segmentation thereof. A multitude of different connectors, guards, etc., may be provided for storing and/or covering the expandable penetrating needle after its initial use.
  • the expandable penetrating needle of the present invention is not limited to use in venipuncture procedures, or to medical procedures in general but, rather, may be employed anywhere a needle would typically be used to pierce or penetrate a material. Therefore, the present invention is not to be considered limited by the above disclosure of exemplary embodiments, and modifications are possible without departing from the spirit of the invention as evidenced by the following claims:

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  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
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  • Manufacturing & Machinery (AREA)
  • Pain & Pain Management (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L’invention a pour objet une aiguille pénétrante extensible (200) de forme essentiellement conique lorsque non expansée. L’aiguille pénétrante extensible(200) comporte une tige (205) dont une première extrémité sera de préférence pointue (215) tandis que l’autre extrémité servira de base (220) pour raccordement à un embout pratiquement creux (225). La tige de l’aiguille est composée de plusieurs segments(240, 245, 250). Un dispositif supplémentaire peut être introduit dans la tige de l’aiguille via l’embout creux. Le passage du dispositif supplémentaire (265, 270) à travers la tige de l’aiguille provoque la séparation progressive des divers segments et donc l’expansion graduelle d’une voie d’accès initiale par insertion de la pointe de l’aiguille dans le matériau que l’on cherche à pénétrer. Cette aiguille pénétrante extensible peut être utilisée à des fins médicales ou non médicales.
PCT/US2004/021197 2004-07-01 2004-07-01 Aiguille pénétrante extensible et méthode d’utilisation Ceased WO2006014151A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2004/021197 WO2006014151A1 (fr) 2004-07-01 2004-07-01 Aiguille pénétrante extensible et méthode d’utilisation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2004/021197 WO2006014151A1 (fr) 2004-07-01 2004-07-01 Aiguille pénétrante extensible et méthode d’utilisation

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WO2006014151A1 true WO2006014151A1 (fr) 2006-02-09

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015063497A1 (fr) * 2013-10-31 2015-05-07 Davies Dr Iain Trocart et canule

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5263937A (en) * 1993-02-11 1993-11-23 Shipp John I Trocar with profile to reduce insertion force
US6030364A (en) * 1997-10-03 2000-02-29 Boston Scientific Corporation Apparatus and method for percutaneous placement of gastro-intestinal tubes
US6436119B1 (en) * 1999-09-30 2002-08-20 Raymedica, Inc. Adjustable surgical dilator

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5263937A (en) * 1993-02-11 1993-11-23 Shipp John I Trocar with profile to reduce insertion force
US6030364A (en) * 1997-10-03 2000-02-29 Boston Scientific Corporation Apparatus and method for percutaneous placement of gastro-intestinal tubes
US6436119B1 (en) * 1999-09-30 2002-08-20 Raymedica, Inc. Adjustable surgical dilator

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015063497A1 (fr) * 2013-10-31 2015-05-07 Davies Dr Iain Trocart et canule

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