US20030125746A1 - Vertebroplasty system - Google Patents
Vertebroplasty system Download PDFInfo
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- US20030125746A1 US20030125746A1 US10/035,670 US3567001A US2003125746A1 US 20030125746 A1 US20030125746 A1 US 20030125746A1 US 3567001 A US3567001 A US 3567001A US 2003125746 A1 US2003125746 A1 US 2003125746A1
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- cannula
- needle
- handle
- bone
- surgical kit
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8819—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
- A61B17/3421—Cannulas
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3472—Trocars; Puncturing needles for bones, e.g. intraosseus injections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00261—Discectomy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/0046—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable
- A61B2017/00469—Surgical instruments, devices or methods, e.g. tourniquets with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
- A61B2017/22014—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
- A61B2017/22015—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire with details of the transmission member
Abstract
Description
- This invention relates to the orthopedic field of vertebroplasty and to the apparatus and process for injecting biological material into the cancellous portion of bones for treatment and support.
- Vertebroplasty was introduced to the medical arts as a percutaneous technique for repairing spinal compression fractures by injecting bone cement into the vertebral body. However, the technique quickly expanded to osteoporotic individuals that had been treated with narcotics and immobilization. The bone cement is used to shore up the collapsing vertebrae for support which relieves the pain associated with undue pressure on the nerves.
- Radiologists and surgeons are involved in the procedure since the process is monitored by fluoroscopy and has the potential for leakage of the cement into the local blood stream. Some of the critical parameters of the procedure involve the mixing of the cement to an appropriate viscosity, ensuring that the cement is radio-dense for viewing, properly placing the injector inside the cancellous portion of a vertebra, and rigorously controlling injection pressure and quantity. See “Vertebroplasty: Dangerous Learning Curve,”START-UP, June 2001.
- U.S. Pat. No. 6,273,916 to Murphy describes vertebroplasty, generally, as performed on a prepped and draped prone patient who has been injected with a local anaesthetic. A skin incision is made over the selected vertebrae and a needle is inserted in a posterior approach to engage the vertebral body. A suitable cement is prepared using a contrast medium, such as barium powder, mixed with methylmethacrylate powder, and a monomer liquid. The cement (PMMA) becomes unworkable within 4 to 11 minutes from mixing.
- Cement is injected into the vertebrae, while visualized by lateral and anterior-posterior X-ray projection fluoroscopy imaging. The injection is halted if the cement starts to extend into unwanted locations, such as the disc space or towards the posterior quarter of the vertebral body where the risk of epidural venous filling and spinal cord compression is greatest. If no unwanted migration is detected, the injection continues until the vertebrae is adequately filled. The amount of cement injected may vary considerably, e.g. from 4 to 36 cc.
- Reiley et al, U.S. Pat. No. 6,048,346, teach a posterior-lateral approach for accessing the interior of the vertebrae for injecting bone cement or treatment substances or a combination of both. The bone cement is injected using a caulking gun-like device with a ram rod in the barrel.
- Goldenberg et al, U.S. Pat. No. 5,634,473, and Goldenberg, U.S. Pat. No. 5,843,001, both teach a removable handle for biopsy needles used for bone biopsy.
- What is needed in the art is a simple apparatus having several components operated by the same handle to perform biopsy and inject high viscosity cement or other biological material or a combination of both in precisely measured quantities.
- Accordingly, it is an objective of the instant invention to teach a kit for biopsy and injection of biological materials having a guide needle, cannulas, several different cannula tips, a plunger, a clearing tool, a connector and a universal tool.
- It is a further objective of the instant invention to teach a kit for biopsy and injection of biological materials which is sized to deliver a precise amount of biological material.
- It is another objective to teach a kit with several interchangeable tips to be fitted on the leading end of the cannula for different penetrations of the bone.
- It is yet another objective of the instant invention to teach a procedure for delivery of a biological material at high viscosity and low pressure.
- It is a still further objective of the invention to teach a kit for orthopedic use to perform bone biopsy and to deliver a biological material to the cancellous portion of bone.
- Other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention. The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.
- FIG. 1 is a perspective of the docking needle and a cannula removably telescoped together;
- FIG. 2 is a cross section of the telescoped docking needle and cannula taken along line A-A of FIG. 1;
- FIG. 3 is a longitudinal cross section of a cannula and a plunger;
- FIG. 4 is a perspective of the cannula and clearing tool assembly;
- FIG. 5 is a longitudinal cross section of the cannula and clearing tool taken along line B-B of FIG. 4;
- FIG. 6 is a perspective of the biopsy instrument;
- FIG. 7 is a side view of the hex Luer-type fitting;
- FIG. 8 is a top plan view of the handle with the docking needle engaged;
- FIG. 9 is a perspective of the handle with the needle and plunger engaged;
- FIG. 10 is a perspective of the handle with the docking needle engaged;
- FIG. 11 is a perspective of a modification of the delivery cannula tip;
- FIG. 12 is a perspective of another modification of the delivery cannula tip; and
- FIG. 13 is a perspective of another modification of the delivery cannula tip.
- The orthopedic system of this invention is in the form of a kit which includes a
docking needle 10 with an elongated shaft 11, shown in FIGS. 1 and 2, having aninsertion point 12 for penetration through the cutaneous layer of a patient. Thepoint 12 passes through the skin, muscle and the hard shell of a bone into the softer cancellous bone material. Thepoint 12 forms a tapered end portion with the base of the taper 13 smoothly merging into the shaft 11. - The needle is of a size and material to withstand the compression required for insertion without deformation. The needle may be made of stainless steel, other metals, or suitable polymers. Normally, the insertion is performed manually by axial pressure at the trailing
end 14 of the needle to include striking the needle with a surgical hammer. The tool or handle 50, shown in FIGS. 8, 9, and 10 is designed to fit on thetrailing end 14 of the needle for translating the manual axial pressure to theneedle 10. - Preferably, in vertebroplasty, the
needle 10 is inserted on a posterior-lateral tract, using X-ray fluoroscopy, to dock in a vertebrae anteriorly of the lateral process. Other approaches may be chosen by the surgeon. Regardless, of the orthopedic surgical procedure involved, the docked needle serves as a guide for the subsequent insertion of the cannulas of the system. Of course, in some applications, the needle and cannula may be inserted simultaneously. - In operation, a cannula is telescoped over the
docking needle 10 to provide a pathway for removal or delivery of material from the bone. The surgeon removes the handle 50 from the trailing end of the docking needle and connects the handle with the trailing end of the cannula. The leading end of the cannula is then placed over the trailing end of the needle. Axial pressure is applied to the cannula to slide the cannula along the needle to the desired location. Using fluoroscopy, the surgeon telescopes the cannula over the docking needle until the leading end of cannula and the leading end of the docking needle are flush or superimposed within the bone site thereby designating proper placement of the delivery cannula. - FIGS. 1 and 2 show a
delivery cannula 15 telescoped over the docking needle. The leadingend 16 of the cannula may be tapered to form a smooth transition from the needle point to thecannula shaft 17. In one embodiment, the delivery cannula is included in a kit without an attached leading end. The leadingend 16 is selected and placed on the shaft to provide a range of choices to the surgeon. The trailingend 18 of the cannula has aconnector 80 either removably affixed by internal threads 82, in the nature of a Leur-type fitting, or permanently connected to the shaft. Theconnector 80 has external planar surfaces 81 which provide a gripping surface for manipulating the cannula. In one embodiment, the connector has a hex-nut outer surface to prevent rotation within handle 50 although other configurations are a matter of choice. Theconnector 80 has a reduceddiameter portion 83 between ashoulder 84 and aflange 85 to prevent longitudinal movement within the handle 50. - Once the cannula is telescoped over the needle to the desired location within the bone, the handle is removed from the trailing end of the cannula and re-attached to the trailing end of the needle which extends beyond the trailing end of the cannula. Axial force is then applied in the opposite direction to remove the needle from the bone and the cannula. After the needle has been removed, the cannula bore19 is open for either removing material for biopsy or for dispensing a biological material for treatment.
- FIG. 6 shows a
biopsy cannula 20 with a leadingend having serrations 21. Of course, the leadingend 16 of thedelivery cannula 15 may be modified to enhance the ability to cut through bone, also, as shown in FIGS. 11-13. Once thebiopsy cannula 20 has been manipulated either rotationally or longitudinally or both by the handle 50 engaged with theconnector 80, the handle is used to withdraw the cannula from the patient's body. Aclearing tool 22, shown in FIGS. 4 and 5, is inserted into thebore 23. Theclearing tool 22 is advanced through the bore to push the tissue sample from the cannula. - If a biopsy is not required or after removal of the biopsy cannula, a
delivery cannula 15 is telescoped over the docking needle, as described above. The delivery cannula is provided with aconnector 80 at its trailing end. The longitudinal dimension of the connector is such that it fits within arecess 61 in the handle 50. - The tool or handle50, illustrated in FIGS. 8, 9 and 10, is made from surgical stainless steel or other magnetizable or non-magnetizable metals, or, preferably, molded from a high impact polymer, such as polyethylene, polypropylene, NYLON or similar compositions capable of withstanding repeated sterilizations. The handle is flexible and, preferably, resilient. The handle has a top surface 51, a bottom surface 52 and side walls defining a periphery 53. A
slit 54 extends through the side walls from the periphery toward the center portion 60. The slit has opposingjaws jaws bore - Another slit57 extends through the side walls from the periphery toward the center portion. Slit 57 has opposing
jaws jaws connector 80. - By applying pressure on the opposing pairs of jaws of each slit, the jaws may approach with each other. When pressure is released, the respective pairs of jaws resiliently move away from each other. As illustrated, the slits are arranged to oppose each other.
- A blind bore62 is formed in the periphery of the handle for the purpose of engaging the trailing end of the docking needle. The shaft of the blind bore 62 is shaped to cooperate with the trailing end of the needle to provide rotation of the needle upon rotation of the handle. The surgeon manually grips the handle and applies longitudinal and/or rotational force through the handle to the needle to penetrate the soft tissue and bone of the patient. The handle may also provide a striking plate for receiving blows from a surgical hammer for driving the needle into the bone. Once the needle is properly docked in the bone, the handle is removed from the needle.
- Blind bore65 is of suitable size to accommodate the trailing end of the cannula fitted with a
connector 80. As shown in FIG. 8, the blind bore 65 has a larger diameter terminating with a shoulder 66 which will engage and stop theconnector 80. Asmaller diameter portion 67 of the bore continues above the shoulder to allow the trailing end of the docking needle to extend beyond the trailing end of theconnector 80. Because the cannula is somewhat larger than the docking needle, the tip of the cannula may be sharpened to cut through the bone. A surgical hammer may be used to drive the delivery cannula, at least, through the hard outer shell of the bone. Once the cannula is located in the cancellous portion of the bone, the cannula may be removed from theblind bore 65. - The cannula with an attached
connector 80 may then placed in the slit 57, of the handle, with theconnector 80 inrecess 61. Theconnector 80 is engaged with thejaws end 14 of the telescoped docking needle emerges from the trailing end of the cannula. When the trailing end of theneedle 14 is level with the top surface 51 of the handle, the leadingend 16 of the cannula is flush with the end of the needle. The top surface 51 of the handle and the trailingend 14 of the needle serve as a visual and tactile gauge, in the surgeon's hand, for properly placing the leading end of the cannula in the bone. - The handle50 is then removed from the cannula and the jaws of
slit 54 are pivoted to place thebores bores jaws - In FIGS. 11, 12, and13, alternate
removable tips 16A, 16B and 16C are shown. The kit may be supplied with several interchangeable tips to provide the surgeon with flexibility in dealing with anomalies of the bones or individual preference. Also, if a larger diameter delivery cannula is needed for the proper amount of biological substance, a relatively smaller tip can be used to penetrate the bone. In FIG. 11, thedelivery cannula 15 has a removable tip 91 with a necked down portion 92 and a smallerleading end portion 93 that penetrates the hard outer shell of the bone. - FIG. 12 shows another
tip 16B that is tapered to aleading end 94 withserrations 95 which may be necessary to cut through the dense bone. - FIG. 13 illustrates another tip16C which has a tapered leading end and a
closed point 98. The tapered tip hasscrew threads 96 for auguring into bone. Thedelivery port 97 is on the lateral aspect of the leading end. - Other
replaceable tips 16 may have other shapes or a variety of cannulas may be furnished with permanent tips. - The delivery cannula is now positioned to transmit the biological material to the bone. In general, the biological substance may be either structural or a treating agent or a combination of both.
- For example, the material may be selected from such groups of substances as BMP, bone morphogenic proteins, DBM, demineralized bone matrix, BOTOX and other viral vectors, any bone marrow aspirate, platelet rich plasma, composite ceramic hydroxyapatite, tricalcium phosphate, glass resin mixtures, resorbable highly purified polylacttides/polylactides-coglycolides and others. The treating agent may include hormonal, antibiotic, anti-cancer, or growth factor substances, among others. In vertebroplasty, polymethylmethacrylate (PMMA) is the customary bone cement though other compounds may be used.
- Regardless of the chemical make-up of the biological substance, this system preferably uses a high viscosity biological material delivered through the cannula at a low pressure. To accomplish this objective, after the delivery cannula is properly placed in the bone, it is filled with a biological material having a viscosity allowing it to flow into the cannula. The viscosity of some of the materials continues to increase within the cannula to reach a consistency acceptable to the surgeon. Other materials may be ready for use, when loaded in the cannula.
- When the material is sufficiently stiff, the surgeon inserts a
plunger 24 into thecannula 15 to express the biological substance into the cancellous portion of the bone. Theplunger 24 is fitted with aconnector 80 and manipulated by handle 50. As shown in FIG. 3, both theplunger 24 and thecannula 15 are telescoped together and the plunger is sized to substantially co-terminate with the leading end of the delivery cannula when both theconnectors 80 are in contact. The diameter of the plunger is slightly less than the diameter of the cannula to provide a vent for the system. The viscosity of the biological material will be such that the entire amount of the material will be expressed from the cannula. In this instance, the amount of biological material delivered is precisely measured to be the corresponding volume of the delivery cannula, for example, 4 cc. - Of course, the amount of biological material may be adjusted to a particular patient. This is accomplished through the continued fluoroscopic observance of the procedure. If more material is necessary in a particular procedure, the syringe used to load the delivery cannula may be utilized to pre-load the bone cavity before the plunger is inserted into the delivery cannula.
- When the appropriate amount of biological material has been injected into the bone, the handle50 is used to rotate and withdraw the
plunger 24. Once the biological substance has begun to solidify, the handle is placed on the delivery cannula and twisted to rotate the cannula thereby separating the cannula from the substance. The cannula is subsequently withdrawn from the bone. - It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement of parts herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and drawings.
Claims (19)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
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US10/035,670 US6582439B1 (en) | 2001-12-28 | 2001-12-28 | Vertebroplasty system |
US10/190,044 US6780191B2 (en) | 2001-12-28 | 2002-07-05 | Cannula system |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
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US10/035,670 US6582439B1 (en) | 2001-12-28 | 2001-12-28 | Vertebroplasty system |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
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US10/190,044 Continuation-In-Part US6780191B2 (en) | 2001-12-28 | 2002-07-05 | Cannula system |
Publications (2)
Publication Number | Publication Date |
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US6582439B1 US6582439B1 (en) | 2003-06-24 |
US20030125746A1 true US20030125746A1 (en) | 2003-07-03 |
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Application Number | Title | Priority Date | Filing Date |
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US10/035,670 Expired - Fee Related US6582439B1 (en) | 2001-12-28 | 2001-12-28 | Vertebroplasty system |
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US (1) | US6582439B1 (en) |
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US8092464B2 (en) * | 2005-04-30 | 2012-01-10 | Warsaw Orthopedic, Inc. | Syringe devices and methods useful for delivering osteogenic material |
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