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WO2005060367A2 - Systeme d'apport de substances de forte viscosite avec effraction minimale - Google Patents

Systeme d'apport de substances de forte viscosite avec effraction minimale Download PDF

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Publication number
WO2005060367A2
WO2005060367A2 PCT/US2003/037623 US0337623W WO2005060367A2 WO 2005060367 A2 WO2005060367 A2 WO 2005060367A2 US 0337623 W US0337623 W US 0337623W WO 2005060367 A2 WO2005060367 A2 WO 2005060367A2
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
high viscosity
viscosity material
degrees
opening
Prior art date
Application number
PCT/US2003/037623
Other languages
English (en)
Other versions
WO2005060367A3 (fr
Inventor
John F. Kay
Michael F. Sickler
Original Assignee
Isotis Orthobiologics, Inc.
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 Isotis Orthobiologics, Inc. filed Critical Isotis Orthobiologics, Inc.
Priority to AU2003295908A priority Critical patent/AU2003295908A1/en
Priority to PCT/US2003/037623 priority patent/WO2005060367A2/fr
Publication of WO2005060367A2 publication Critical patent/WO2005060367A2/fr
Publication of WO2005060367A3 publication Critical patent/WO2005060367A3/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/46—Special tools for implanting artificial joints
    • A61F2/4601—Special tools for implanting artificial joints for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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 or setting implements
    • 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
    • A61B17/8833—Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30601—Special structural features of bone or joint prostheses not otherwise provided for telescopic

Definitions

  • Described herein are delivery devices suitable for introduction of high viscosity materials into the body. More specifically, the described delivery systems are particularly suitable for the delivery of high viscosity materials into constricted areas, and as such, are particularly useful in surgical procedures.
  • Tissue regeneration materials may be used to fill bone defects to effect bone grafts. For better and faster recovery, it may be desirable to minimize the size of the surgical incisions required for the delivery of those tissue regeneration materials to the desired site. Since the tissue regeneration materials often have high viscosity, they are difficult to deliver to the surgical site using conventional delivery devices such as syringes. High viscosity materials are difficult to force out of a conventional syringe fitted with a needle. As a practical matter, conventional syringes when used alone (i.e., without a needle) are usually too large or too short for insertion into small surgical incisions.
  • the device described herein is able to deliver a high viscosity material to a constricted area with good control and to reduce the amount of wasted or undeliverable material that would otherwise remain within the delivery device.
  • Described here is a minimally invasive, high viscosity material delivery system suitable for delivering a high viscosity material to a constricted area.
  • An example of such a use or procedure is the delivery of a tissue regeneration material through a small surgical incision and into the graft site, or the like.
  • the system can reduce the amount of material that would otherwise remain within the delivery system.
  • the delivery system due to its design, is easy to manipulate and to control when dispensing high viscosity material.
  • the system design may also be configured to be low cost and perhaps disposable. This is an advantage when prevention of cross-contamination or a desire for avoiding "clean up" are significant design parameters.
  • the described device includes a minimally invasive, high viscosity material delivery system comprising: a.) a cannula associated with a pressure applicator for dispensing a high viscosity material from the cannula, b.) a body member having (i) a first opening that is in fluid communication with the cannula, (ii) a reservoir for receiving the high viscosity material, (iii) a second opening allowing transfer of the high viscosity material into the reservoir, and (iv) a transfer member typically situated in the second opening that transfers or pushes high viscosity material from the reservoir into the cannula via the first opening.
  • the cannula and the body member are connected in a nonlinear angle. Also described is a method of using the minimally invasive high viscosity material delivery system.
  • FIG. 1 is a perspective, exploded view of one variation of the delivery system.
  • This variation of the device may be directly filled with a high viscosity material.
  • FIG. 2 is a perspective, exploded view of another variation of the delivery system. This variation accepts high viscosity material from a removable, interchangeable container.
  • FIG. 3 is a perspective view of the described delivery system having an ergonomic grip.
  • Figures 1-2 show a minimally invasive delivery system 100 for placement of a high viscosity material in the human body.
  • the Figures show a system comprising a cannula 10 that dispenses a high viscosity material 14 (not shown) from an open delivery end or orifice 11 to the selected treatment site in the human body.
  • the end of the cannula 10 opposite the delivery end 11 is associated with a dispenser 12.
  • the dispenser 12 is placed so that it pressures the high viscosity material through and out of the cannula 10.
  • the high viscosity material 14 may be a gel, putty, paste, flowable composition containing particulates, high viscosity liquid (e.g., more viscous than water or the like), a combination thereof, or the like.
  • the cannula 10 may be constructed of a suitable material such as metal, metallic alloys, plastics, glass or the like capable of providing the strength needed to safely introduce the high viscosity material into the treatment site. We have found that stainless steel, polycarbonate, polypropylene, polyethylene, PTFE (Teflon) are quite suitable.
  • the length and width and wall thickness of the cannula 10 may be varied depending, in general, upon the desired application.
  • the length, inner diameter, and outer diameter of the cannula may be chosen to be, respectively, in the range of 5-35 cm, 1 -20 mm, and 2-25 mm; or 7-30 cm, 1 - 15 mm, and 2-20 mm respectively; or 10-25 cm, 1-6 mm, and 2-10 mm.
  • the dispenser 12 is to provide pressure to the high viscosity material 14 in the cannula causing axial movement of the material through the cannula and metered delivery of the material through its delivery end 11.
  • the dispensing pressure may be applied in a variety of ways, e.g., compressed gas (e.g., air, nitrogen or the like); manually, pneumatically, or hydraulically actuated plungers; or the like that is adapted for axial displacement of the high viscosity material 14 within the cannula 10.
  • the dispenser 12 comprises a rod 16 having an optional tip 18 on one end and a knob or cap 20 on the other end.
  • the rod 16, the tip 18, and the cap 20 may be constructed of a suitable material such as metal, metallic alloys, plastics, silicone, or the like.
  • the rod 16 and the cap 20 may be constructed of stainless steel, polycarbonate, aluminum, PVC, ABS, acrylic, or the like and the tip 18 may be constructed of a rubbery Silicone such as sold by Merit Medical Systems, Inc. located in South Jordan, Utah.
  • Rod 16 in this variation, acts like a piston and slides through the interior passageway in cannula 10 displacing the viscous material found there through the distal delivery tip 11 of the cannula 10.
  • the optional tip 18 on the end of rod 16 is simply a wiper and pressure seal and, as such, wipes the interior cannula wall of viscous material and maintains the pressure on the viscous material forward of the rod 16. Note that the cross sectional area of the rod 16 is fairly small to allow significant pressure to be generated at the tip 18 of the rod 16 upon imposition of a much more modest pressure upon knob 20.
  • the delivery system 100 also comprises a body member 22 having a first opening 24 that is in communication with the cannula 10, a reservoir 26 for receiving the high viscosity material 14 and a second opening 28 through which the high viscosity material is placed in the reservoir.
  • the second opening is associated with one or more transfer components (such as the plunger 30 shown in FIG. 1 and the plunger 30 and the associated container 32 shown in FIG. 2) used to move or to transfer the high viscosity material 14 from the body member 22 into the cannula 10 via the first opening 24.
  • the body member 22 and the cannula 10 are connected in a non-linear angle.
  • the body member 22 be constructed of a suitable material such as metal, metallic alloys, plastics, glass, or the like capable of withstanding the substantial pressures generated during use.
  • the body member 22 may be constructed of stainless steel, polycarbonate, polypropylene, polyethylene, PTFE (Telfon), copolymer, or the like.
  • the transfer components 30 be of a variety of designs employing pressure sources such as compressed gas (e.g., air, nitrogen, or the like) or generated with a manually, pneumatically or hydraulically actuated plunger; or the like.
  • the transfer components utilize the pressure to displace the high viscosity material 14 from the body member 22 through the first opening 24 into the cannula 10.
  • the transfer component 30 shown in FIG. 1 comprises a manually actuated plunger that moves axially through the second opening 28 displacing any high viscosity material through the reservoir 26 of the body member 22 thereby causing transfer of that high viscosity material 14 from the reservoir 26 into the cannula 10 via the first opening 24.
  • the rod 16 in most variations of the system, seals the first opening 24 as it presses the high viscosity material 14 from the cannula 10. Withdrawal of the tip of rod 16 is often needed to allow recharging the cannula 10 with additional high viscosity material 14 from the reservoir 26.
  • the reservoir 26 may directly receive (i.e., be filled with) the high viscosity material 14.
  • FIG. 2 shows a reservoir 26 that receives and is removably attachable to an interchangeable, perhaps disposable, container 32, filled with the high viscosity material 14.
  • the container 32 may be attached via threads, lue lock or the like.
  • the container 32 may be of a form such as a cartridge, ampoule, capsule, a syringe or the like.
  • the reservoir 26 is adapted to removably receive an open bore syringe (the interchangeable container 32) filled with the high viscosity material 14 via threads 34.
  • FIGS. 1-2 show the described device to have an angle between the axis of the cannula 10 and axis of the body member 22 to be non-linear.
  • the value of the non-linear angle is chosen (e.g., from 1° to 179° or from 181° to 359°) based upon the desired applications.
  • the non-linear angle may be in the range of 30° to 150° or from 210° to 330°; or from 50° to 130° or from 230° to 310°; or from 70° to 110° or 250° to 290°.
  • a seal 36 may be placed on the opening of body member
  • Such a seal 36 may be removably attached tot he body member 22 and serves to help prevent the high viscosity material located in the cannula 10 from leaking out the cannula' s non-dispensing end 13.
  • the seal 36 may take the form of a break-away hub.
  • the hub or seal 36 may be formed to cooperate with the rod 16 and the tip 18 in such a way that the tip 18 is sheared loose from the rod 16 as the rod 16 slides into the cannula 10 or upon some other designed user activity such as having the rod 16 and the break-away hub 36 connected via threads and applying a desired amount of torque to the rod 16, or the like.
  • the rod 16 takes only one more trip to the end of the cannula 10 delivering viscous material.
  • the sheared tip then remains in the delivery end 11 of the cannula 10 and prevents re-use and consequent reuse related contamination.
  • FIG. 3 provides a perspective view of the delivery system 100 and optional designs for physical handles.
  • An ergonomic grip 38, syringe grip 40, and a split resistance cap 42 are shown.
  • the cannula 10 and the body member 22 also may optionally include markers 44, preferably radiopaque markers, to provide for better visual inspection of the delivery process.
  • the ergonomic grip 38 can be a design that is assembled from two sides, or a pair of shells as shown, affixed together with screws or the like or may be a single piece.
  • To prevent cross-contamination and need for clean up the entire delivery system 100 may be constructed of inexpensive, disposable materials and be disposed of when the reservoir is depleted. Alternatively, the delivery system 100 of the present invention may be cleaned and reused.
  • the delivery device is constructed of materials that are autoclavable. Regardless of whether the delivery system 100 is disposable or autoclavable, it is preferred that each part of the delivery system 100 coming into contact with the high viscosity material 14 be chemically inert to the high viscosity material 14.
  • Conventional fasteners such as snap fits, rivets, machine screws, nut and bolt connectors, machine threaded connectors, snap rings, clamps, toggles, pins, and the like may be used to connect the various components. Friction fitting, welding, or deformation, if suitable may be used as appropriate to connect the various components.
  • materials for making the components of the system may be selected from appropriate, materials such as metals, metallic alloys, fibers, plastics, and the like. Appropriate production methods may include casting, extruding, molding, machining, or the like.
  • the described system may be used to conduct a method a method for delivering high viscosity material comprising: providing the high viscosity material delivery system 100 described above; placing the high viscosity material 14 into the reservoir 26; transferring the high viscosity material 14 from the reservoir 26 into the cannula 10 via the first opening 24; and dispensing the high viscosity material 14 from the cannula 10 by introducing pressure to the cannula 10 from dispenser 12.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Transplantation (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Cette invention se rapporte à un système d'apport de substances de forte viscosité avec effraction minimale, qui comporte une canule associée à un distributeur destiné à distribuer une substance de forte viscosité hors de la canule, un élément de corps comportant une première ouverture en communication avec la canule, un réservoir destiné à recevoir la substance de forte viscosité, et une seconde ouverture associée à l'élément de transfert pour pousser la substance de forte viscosité hors de l'élément de corps jusque dans la canule via la première ouverture. L'élément de transfert est en communication avec la seconde ouverture. La canule et l'élément de corps sont raccordés selon un angle non linéaire. L'invention concerne également un procédé d'utilisation de ce système.
PCT/US2003/037623 2003-11-24 2003-11-24 Systeme d'apport de substances de forte viscosite avec effraction minimale WO2005060367A2 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
AU2003295908A AU2003295908A1 (en) 2003-11-24 2003-11-24 Minimally invasive high viscosity material delivery system
PCT/US2003/037623 WO2005060367A2 (fr) 2003-11-24 2003-11-24 Systeme d'apport de substances de forte viscosite avec effraction minimale

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2003/037623 WO2005060367A2 (fr) 2003-11-24 2003-11-24 Systeme d'apport de substances de forte viscosite avec effraction minimale

Publications (2)

Publication Number Publication Date
WO2005060367A2 true WO2005060367A2 (fr) 2005-07-07
WO2005060367A3 WO2005060367A3 (fr) 2006-07-20

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PCT/US2003/037623 WO2005060367A2 (fr) 2003-11-24 2003-11-24 Systeme d'apport de substances de forte viscosite avec effraction minimale

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AU (1) AU2003295908A1 (fr)
WO (1) WO2005060367A2 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2608748A1 (fr) * 2010-08-27 2013-07-03 Thompson MIS Procédés et systèmes de pose d'un implant intercorporéal et d'une greffe osseuse
US8852282B2 (en) 2010-08-27 2014-10-07 Daniel K. Farley Methods and systems for interbody implant and bone graft delivery
US9480576B2 (en) 2010-08-27 2016-11-01 Thompson Mis Methods and systems for interbody implant and bone graft delivery
EP3284428A1 (fr) * 2016-08-19 2018-02-21 Stryker European Holdings I, LLC Ensemble de chargement de pose de greffe osseuse
US11090438B2 (en) 2017-10-17 2021-08-17 Bobby Nourani Slanted syringe handle
USD960359S1 (en) 2020-06-19 2022-08-09 Bobby Nourani Syringe handle
USD987819S1 (en) 2021-02-18 2023-05-30 Bobby Nourani Syringe holder
USD987818S1 (en) 2019-12-04 2023-05-30 Bobby Nourani Syringe adaptor

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4758234A (en) * 1986-03-20 1988-07-19 Norman Orentreich High viscosity fluid delivery system
US5755362A (en) * 1995-02-27 1998-05-26 Minnesota Mining & Manufacturing Co. Hand-held applicator with force limiting clutch
US6047861A (en) * 1998-04-15 2000-04-11 Vir Engineering, Inc. Two component fluid dispenser
US6126642A (en) * 1998-10-02 2000-10-03 Science Incorporated Patient controlled fluid delivery device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4758234A (en) * 1986-03-20 1988-07-19 Norman Orentreich High viscosity fluid delivery system
US5755362A (en) * 1995-02-27 1998-05-26 Minnesota Mining & Manufacturing Co. Hand-held applicator with force limiting clutch
US6047861A (en) * 1998-04-15 2000-04-11 Vir Engineering, Inc. Two component fluid dispenser
US6126642A (en) * 1998-10-02 2000-10-03 Science Incorporated Patient controlled fluid delivery device

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2608748A1 (fr) * 2010-08-27 2013-07-03 Thompson MIS Procédés et systèmes de pose d'un implant intercorporéal et d'une greffe osseuse
EP2608748A4 (fr) * 2010-08-27 2014-02-19 Thompson Mis Procédés et systèmes de pose d'un implant intercorporéal et d'une greffe osseuse
US8852282B2 (en) 2010-08-27 2014-10-07 Daniel K. Farley Methods and systems for interbody implant and bone graft delivery
US9480576B2 (en) 2010-08-27 2016-11-01 Thompson Mis Methods and systems for interbody implant and bone graft delivery
EP3549542A1 (fr) * 2016-08-19 2019-10-09 Stryker European Holdings I, LLC Ensemble de chargement de pose de greffe osseuse
US10231846B2 (en) 2016-08-19 2019-03-19 Stryker European Holdings I, Llc Bone graft delivery loading assembly
EP3284428A1 (fr) * 2016-08-19 2018-02-21 Stryker European Holdings I, LLC Ensemble de chargement de pose de greffe osseuse
US10857001B2 (en) 2016-08-19 2020-12-08 Stryker European Holdings I, Llc Bone graft delivery loading assembly
US11666456B2 (en) 2016-08-19 2023-06-06 Stryker European Operations Holdings Llc Bone graft delivery loading assembly
US12186206B2 (en) 2016-08-19 2025-01-07 Stryker European Operations Holdings Llc Bone graft delivery loading assembly
US11090438B2 (en) 2017-10-17 2021-08-17 Bobby Nourani Slanted syringe handle
USD987818S1 (en) 2019-12-04 2023-05-30 Bobby Nourani Syringe adaptor
USD960359S1 (en) 2020-06-19 2022-08-09 Bobby Nourani Syringe handle
USD987819S1 (en) 2021-02-18 2023-05-30 Bobby Nourani Syringe holder

Also Published As

Publication number Publication date
WO2005060367A3 (fr) 2006-07-20
AU2003295908A8 (en) 2005-07-14
AU2003295908A1 (en) 2005-07-14

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