Static mixer

• US 6,079,868 A
• Filed: 03/02/1998
• Issued: 06/27/2000
• Est. Priority Date: 12/18/1997
• Status: Expired due to Term

• Current Assignee: Disc Dynamics, Inc.
• Original Assignee: Advanced Bio Surfaces, Inc.
• Inventors: Rydell, Mark A.
• Primary Examiner(s): SOOHOO, TONY GLEN
• Application Number:
  US09/033,261
• Time in Patent Office: 848 Days
• Field of Search: 366/154.1, 366/158.5, 366/162.1, 366/162.3, 366/176.1, 366/176.3, 366/174.1, 366/177.1, 366/181.5, 366/182.2, 366/189, 366/190, 366/192, 366/339 , 366/336, 222/136, 222/137, 222/142, 222/145.5, 222/145.6, 222/325, 604/416, 604/61, 604/62
• US Class Current: 366/189
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/8822 characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 17/8833 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
• CPC Class Codes: A61B 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61F 2/30756 Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/38 for elbows or knees
• CPC Class Codes: A61F 2/4081 Glenoid components, e.g. cups
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/441 made of inflatable pockets or chambers filled with fluid, e.g. with hydrogel
• CPC Class Codes: A61F 2/442 Intervertebral or spinal discs, e.g. resilient non-disc-shaped intervertebral inflatable pockets A61F2/441; non-disc-shaped intervertebral fusion implants A61F2/4455
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4618 of cartilage
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30957 using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4233 for metatarso-phalangeal joints, i.e. MTP joints
• CPC Class Codes: A61F 2002/4627 : with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4628 : with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/465 : using heating means
• CPC Class Codes: A61F 2210/0085 : hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61L 2430/38 : for reconstruction of the spine, vertebrae or intervertebral discs
• CPC Class Codes: A61L 27/18 : obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/041 : obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: B01F 2101/2305 : Mixers of the two-component package type, i.e. where at least two components are separately stored, and are mixed in the moment of application
• CPC Class Codes: B01F 25/43141 : composed of consecutive sections of helical formed elements
• CPC Class Codes: B01F 25/433 : Mixing tubes wherein the shape of the tube influences the mixing, e.g. mixing tubes with varying cross-section or provided with inwardly extending profiles
• CPC Class Codes: B01F 33/5011 : portable during use, e.g. hand-held
• CPC Class Codes: B01F 33/50114 : of the hand-held gun type
• CPC Class Codes: B01F 35/181 : Preventing generation of dust or dirt; Sieves; Filters B01F35/145, B01F35/43 take precedence
• CPC Class Codes: B01F 35/189 : Venting, degassing or ventilating of gases, fumes or toxic vapours during mixing
• CPC Class Codes: C08G 18/10 : Prepolymer processes involving reaction of isocyanates or isothiocyanates with compounds having active hydrogen in a first reaction step
• CPC Class Codes: C08G 18/3206 : aliphatic
• CPC Class Codes: C08G 18/4854 : Polyethers containing oxyalkylene groups having four carbon atoms in the alkylene group
• CPC Class Codes: C08G 18/69 : Polymers of conjugated dienes hydrogenated polymers of conjugated dienes C08G18/6208
• CPC Class Codes: C08L 23/00 : Compositions of homopolymers or copolymers of unsaturated aliphatic hydrocarbons having only one carbon-to-carbon double bond; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: C08L 83/04 : Polysiloxanes

Abstract

A device for mixing and delivering a curable biomaterial using minimally invasive techniques. The device provides a mixing path that is configured to contribute a longitudinal distance dimension to the device that is considerably less than the length of the mixing path itself. In so doing, the device can provide improved ergonomic control and single-handed operation in the course of mixing biomaterial components, in order to initiate cure, and delivering the mixed biomaterial through a delivery conduit and to a tissue site in vivo. Optional features of the device include the ability to warm the biomaterial components, to position or retract a protective sheath covering the delivery conduit, and the ability to divert or shunt an initial volume of mixed biomaterial.

Claims

1. A device for mixing and delivering a curable biomaterial, the device comprising:

(a) an attachment site for a biomaterial source, the source comprising a plurality of biomaterial components adapted to be mixed in order to initiate cure,

(b) a body portion comprising

i) a handle for gripping and actuating the device, and

ii) a biomaterial mixing path having inlet and exit ends, the inlet end of the mixing path adapted to be placed in fluid communication with the biomaterial component source, the mixing path being adapted to combine and mix the components within a time suitable to permit the mixed components to traverse the mixing path in a flowable fashion, and within an longitudinal distance adapted to provide controllable, ergonomic operation in the course of minimally invasive surgery, and

(c) a delivery unit comprising a deliver conduit having an inlet end in fluid communication with the exit end of the mixing path, and an exit end adapted to deliver the mixed biomaterial to a tissue site,

wherein the device is adapted for single-handed operation, and the mixing path provides a longitudinal length dimension to the device that is on the order of one-tenth, or less, the overall length of the mixing path, and

further comprising a mechanism for controllably shunting an initial portion of mixed biomaterial.

2. A device according to claim 1 wherein the mechanism comprises a plunger and a cylinder assembly disposed in fluid communication between the outlet end of the mixing path and the inlet end of the delivery conduit adapted to permit a predetermined volume of biomaterial to enter the cylinder, and raise the plunger in a manner that redirects the flow of biomaterial to the conduit upon shunting a predetermined volume of biomaterial.

3. A device for mixing and delivering a curable biomaterial, the device comprising:

(a) an attachment site for a biomaterial source, the source comprising a plurality of biomaterial components adapted to be mixed in order to initiate cure,

(b) a body portion comprising

i) a handle for gripping and actuating the device, and

ii) a biomaterial mixing path having inlet and exit ends, the inlet end of the mixing path adapted to be placed in fluid communication with the biomaterial component source, the mixing path being adapted to combine and mix the components within a time suitable to permit the mixed components to traverse the mixing path in a flowable fashion, and within an longitudinal distance adapted to provide controllable, ergonomic operation in the course of minimally invasive surgery, and

(c) a delivery unit comprising a deliver conduit having an inlet end in fluid communication with the exit end of the mixing path, and an exit end adapted to deliver the mixed biomaterial to a tissue site,

wherein the device is adapted for single-handed operation, and the mixing path provides a longitudinal length dimension to the device that is on the order of one-tenth, or less, the overall length of the mixing path, and

further comprising a retractable sheath covering the delivery conduit and an operable control associated with the handle portion.

4. A device for mixing and delivering a curable biomaterial, the device comprising:

(a) an attachment site for a biomaterial source, the source comprising a plurality of biomaterial components adapted to be mixed in order to initiate cure,

(b) a body portion comprising

i) a handle for gripping and actuating the device, and

ii) a biomaterial mixing path having inlet and exit ends, the inlet end of the mixing path adapted to be placed in fluid communication with the biomaterial component source, the mixing path being adapted to combine and mix the components within a time suitable to permit the mixed components to traverse the mixing path in a flowable fashion, and within an longitudinal distance adapted to provide controllable, ergonomic operation in the course of minimally invasive surgery, and

(c) a delivery unit comprising a delivery conduit having an inlet end in fluid communication with the exit end of the mixing path, and an exit end adapted to deliver the mixed biomaterial to a tissue site,

wherein the device is adapted for single-handed operation, and the device further comprises a mechanism for controllably shunting an initial portion of mixed biomaterial.

5. A device according to claim 4 wherein the mechanism comprises a plunger and cylinder assembly disposed in fluid communication between the outlet end of the mixing path and the inlet end of the delivery conduit and adapted to permit a predetermined volume of biomaterial to enter the cylinder, and raise the plunger in a manner that redirects the flow of biomaterial to the conduit upon shunting a predetermined volume of biomaterial.

6. A device according to claim 5 wherein the mixing path provides a longitudinal length dimension to the device that is on the order of one-tenth, or less, the overall length of the mixing path, the mixing path contains between about 30 and about 40 elements within a mixing flow path of between about 20 cm and about 30 cm, and the biomaterial source comprises a two part polyurethane system provided in the form of a syringe cartridge pack.

7. A device according to claim 4 further comprising a retractable sheath covering the delivery conduit and an operable control associated with the handle portion.

8. A device according to claim 4 wherein the mixing path contains between about 10 and about 100 elements within a mixing flow path of between about 10 cm and about 50 cm, the mixing flow path contributing between about 1 cm and about 5 cm to the longitudinal dimension of the device.

9. A device according to claim 8 wherein the mixing path contains between about 30 and about 40 elements within a mixing flow path of between about 20 cm and about 30 cm.

10. A device according to claim 4 wherein the biomaterial source comprises a two part polyurethane system.

11. A device according to claim 10 wherein the components are adapted to be mixed at a ratio of 1 to 1 by volume.

12. A device according to claim 4 wherein the biomaterial source is provided in the form of a syringe cartridge pack.

13. A device according to claim 12 wherein the biomaterial comprises a polyurethane.

14. A device for mixing and delivering a curable biomaterial, the device comprising:

(a) an attachment site for a biomaterial source, the source comprising a plurality of biomaterial components adapted to be mixed in order to initiate cure,

(b) a body portion comprising

i) a handle for gripping and actuating the device, and

ii) a biomaterial mixing path having inlet and exit ends, the inlet end of the mixing path adapted to be placed in fluid communication with the biomaterial component source, the mixing path being adapted to combine and mix the components within a time suitable to permit the mixed components to traverse the mixing path in a flowable fashion, and within an longitudinal distance adapted to provide controllable, ergonomic operation in the course of minimally invasive surgery, and

(c) a delivery unit comprising a delivery conduit having an inlet end in fluid communication with the exit end of the mixing path, and an exit end adapted to deliver the mixed biomaterial to a tissue site,

wherein the device further comprises a retractable sheath covering the delivery conduit and an operable control associated with the handle portion.

15. A device according to claim 14 wherein the mixing path contains between about 10 and about 100 elements within a mixing flow path of between about 10 cm and about 50 cm, the mixing flow path contributing between about 1 cm and about 5 cm to the longitudinal dimension of the device.

16. A device according to claim 14 wherein the mixing path contains between about 30 and about 40 elements within a mixing flow path of between about 20 cm and about 30 cm.

17. A device according to claim 14 wherein the biomaterial source comprises a two part polyurethane system.

18. A device according to claim 17 wherein the components are adapted to be mixed at a ratio of 1 to 1 by volume.

19. A device according to claim 14 wherein the biomaterial source is provided in the form of a syringe cartridge pack.