System for reconstituting pastes and methods of using same

• US 20010037091A1
• Filed: 02/26/2001
• Published: 11/01/2001
• Est. Priority Date: 12/29/1999
• Status: Abandoned Application

• Current Assignee: Regeneration Technologies Incorporated (Surgalign Holdings, Inc.)
• Original Assignee: Regeneration Technologies Incorporated (Surgalign Holdings, Inc.)
• Inventors: Walpole, Marlo, Wironen, John F.
• Application Number:
  US09/792,894
• Publication Number:
  US 20010037091A1
• Time in Patent Office: Days
• US Class Current: 604/236
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8825 characterised by syringe details A61B17/8822, A61B17/8827 take precedence
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61F 2/4601 for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
• CPC Class Codes: A61F 2/4644 Preparation of bone graft, bone plugs or bone dowels, e.g. grinding or milling bone material bone material A61F2/28; disintegrating or milling devices B02C
• CPC Class Codes: A61F 2002/2817 Bone stimulation by chemical reactions or by osteogenic or biological products for enhancing ossification, e.g. by bone morphogenetic or morphogenic proteins [BMP] or by transforming growth factors [TGF]
• CPC Class Codes: A61F 2002/2835 Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/4685 by means of vacuum
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2041 having removable plugs
• CPC Class Codes: A61J 1/2058 having multiple connecting ports
• CPC Class Codes: A61J 1/2062 with directional valves
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: B01F 2101/20 Mixing of ingredients for bone cement
• CPC Class Codes: B01F 31/441 performing a rectilinear reciprocating movement
• CPC Class Codes: B01F 33/5011 portable during use, e.g. hand-held
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• CPC Class Codes: B01F 35/3202 Hand driven
• CPC Class Codes: B01F 35/712 : for feeding fluids
• CPC Class Codes: B01F 35/7163 : the containers being connected in a mouth-to-mouth, end-to-end disposition, i.e. the openings are juxtaposed before contacting the contents
• CPC Class Codes: B01F 35/7174 : using pistons, plungers or syringes
• CPC Class Codes: B01F 35/754251 : reciprocating in the mixing receptacle
• CPC Class Codes: B01F 35/7547 : using valves, gates, orifices or openings

Abstract

Disclosed herein is an efficient and cost-effective system for reconstituting bone pastes comprising a first syringe containing a reconstitution fluid and second syringe containing paste components, wherein said first and second syringes are communicatingly interconnectable. Also disclosed are novel methods for producing and storing bone pastes. Alternatively, a mixing syringe is disclosed, which is useful for reconstituting a paste, inter alia, comprising a flexible midportion, whereby repeated compression of the flexible midportion results in mixing the contents of the syringe.

Claims

1. A mixing syringe comprising:

a barrel comprising a first end, a second end and a midsection; and

a plunger adapted for insertion into said barrel at said second end;

wherein midsection comprises a flexible portion such that said flexible portion is compressible by hand, and wherein contents of said syringe are mixed upon compression of said midsection.

2. The mixing syringe of

claim 1

wherein said midsection comprises a rigid portion proximate to said second end, wherein said rigid portion is more rigid than said flexible portion.

3. The mixing syringe of

claim 2

, wherein said rigid portion is made of polypropylene.

4. The mixing syringe of

claim 1

, wherein said flexible portion is made of polyethylene, silicone, laminate plastic, polyurethane, Krayton, or rubber latex.

5. The mixing syringe of

claim 1

, wherein said first end comprises an opening for receiving a fluid.

6. The mixing syringe of

claim 5

, wherein said first end comprises a connector rigidly attached thereon, or integral thereto, that is configured for engaging a fluid delivery device.

7. The mixing syringe of

claim 6

, wherein said connector is a luer-lok type connector, a septum, a one-way valve, a multiple-way valve, threaded neck, or smooth neck.

8. The mixing syringe of

claim 1

, wherein said plunger comprises a tapered end or a flat end.

9. The mixing syringe of

claim 1

, wherein said barrel comprises a flange to facilitate manipulation of the mixing syringe.

10. A method of mixing two or more substances comprising the steps of:

disposing said two or more substances into the mixing syringe of

claim 1

; and

squeezing said midsection of said mixing syringe.

11. The method of

claim 10

, wherein said disposing step comprises disposing at least one paste component into said mixing syringe;

storing said paste component in said mixing syringe for at least 24 hours; and

subsequent to said storing step, disposing an amount of reconstitution fluid into said mixing syringe.

12. The method of

claim 10

further comprising the step of extruding said two or more substances out of said mixing syringe at said first end.

13. The method of

claim 12

further comprising removing a portion of said first end of said barrel of said mixing syringe.

14. The method of

claim 10

, wherein said two or more substances comprise a paste component and a reconstitution fluid.

15. The method of

claim 14

further comprising introducing said reconstitution fluid through said first end of said mixing syringe.

16. The method of

claim 10

wherein said squeezing is carried out by hand or by a mechanical device.

19. A method of repairing a bone defect, injury or deformation comprising the steps of:

disposing at least one paste component in the mixing syringe of

claim 1

;

storing said at least one paste component in said mixing syringe for at least 24 hours;

subsequent to said storing step, disposing an amount of reconstitution fluid into said mixing syringe;

squeezing said flexible portion of said mixing syringe such that said at least one paste component and reconstitution fluid are mixed to form a mixture; and

extruding said mixture to a site of need.

20. The method of

claim 19

, wherein extruding comprises removing a portion of said first end of said barrel of said mixing syringe.

17. An article of manufacture comprising a mixing syringe that comprises:

a barrel comprising a first end, a second end and a midsection; and

a plunger adapted for insertion into said barrel at said second end;

wherein a portion of said midsection is flexible such that contents of said syringe are mixed upon compression of said midsection; and

at least one biomedical substance disposed in said mixing syringe.

18. The article of manufacture of

claim 17

, wherein said at least one biomedical substance comprises a paste component.