Systems, methods and apparatuses for formation and insertion of tissue prosthesis

• US 9,492,291 B2
• Filed: 03/28/2014
• Issued: 11/15/2016
• Est. Priority Date: 08/15/2005
• Status: Active Grant

• Current Assignee: Kunovus Pty Ltd.
• Original Assignee: Kunovus Pty Ltd.
• Inventors: Diwan, Ashish Dhar, Choi, Johnathon, Milijasevic, Zoran
• Primary Examiner(s): Hammond, Ellen C
• Assistant Examiner(s): Bray, Stuart S
• Application Number:
  US14/229,241
• Publication Number:
  US 20140257417A1
• Time in Patent Office: 963 Days
• Field of Search: 606/93
• US Class Current: 1/1
• 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 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/4684 Trial or dummy prostheses
• CPC Class Codes: A61F 2002/30069 elastomeric
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2002/30586 having two or more inflatable pockets or chambers
• CPC Class Codes: A61F 2002/444 for replacing the nucleus pulposus
• CPC Class Codes: A61F 2002/4635 using minimally invasive surgery
• CPC Class Codes: A61F 2002/4663 for measuring volumes or other three-dimensional shapes
• CPC Class Codes: A61F 2002/4685 by means of vacuum
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

A tissue prosthesis insertion system includes a first assembly comprising a plurality of nested tubes, one of the tubes being a carrier tube which, in use, receives a component of a tissue prosthesis at a distal end of the carrier tube. A magnetic mount is carried at a proximal end of the first assembly. A second assembly is removably attachable to the first assembly. An attachment device is carried at a distal end of the second assembly, the attachment device being responsive to the magnetic mount of the first assembly, the magnetic mount and the attachment device carrying complementary engaging formations to facilitate hermetic sealing between the magnetic mount and the attachment device.

Claims

1. A self-contained closed implant system for the formation of a prosthesis device percutaneously within a nucleus cavity formed in an intervertebral disc at an in situ implant site, comprising:

a single lumen working cannula, said single lumen working cannula configured to be docked against an outer surface area of an annulus surrounding the nucleus cavity, wherein said single lumen working cannula has arranged at about its proximal end a collar assembly to facilitate matingly engaging the single lumen working cannula with said closed insertion assembly;

a closed sizing assembly configured to be partially received within said single lumen working cannula for carrying at a distal end thereof an elastically deformable mock implant member to the in situ implant site to facilitate determining, without fluid evacuation from the closed implant system, a known volume of filler material to substantially fill the volume of the nucleus cavity;

a closed insertion assembly configured to be partially received within said single lumen working cannula in place and stead of said closed sizing assembly for protectively carrying an elastically deformable implant member to the in situ implant site to facilitate its filling with said known volume of filler material;

a closed dispensing assembly configured to be partially received within said single lumen working cannula and removably coupled to said closed insertion assembly without relative rotational motion therebetween to facilitate the filling of the elastically deformable implant member with said known volume of filler material without fluid evacuation from the closed implant system; and

wherein the closed dispensing assembly includes a distal end magnetic mount for removably coupling the closed dispensing assembly to the single lumen working cannula and a proximal end magnetic mount for removably coupling the closed dispensing assembly to the closed sizing assembly to facilitate determining, without fluid evacuation from the closed implant stem the known volume of filler material to substantially fill the volume of the nucleus cavity and for removably coupling the dispensing assembly to the closed insertion assembly in place and stead of the closed sizing assembly to facilitate the filling of the elastically deformable implant member with the known volume of filler material without fluid evacuation from the closed implant system to help reduce tissue trauma to a patient by obviating relative rotational coupling motions.

2. The self-contained closed implant system according to claim 1, wherein said closed sizing assembly includes:

a tube having a single lumen for carrying the mock implant member at a distal end thereof;

a connector coupled at a proximal end of said tube, said connector defining a primary lumen for fluid communication with said tube and a secondary lumen for fluid communication with said tube;

at least one pressure transducer coupled fluid dispenser arrangement including a primary syringe connectable to the primary lumen for fluid communication with said single tube and a secondary syringe connectable to the secondary lumen for fluid communication with said single tube;

a fluid control arrangement disposed at a proximal end area of said single tube operable to place either the primary lumen of the connector in fluid communication with the tube or secondary lumen of the connector in fluid communication with the tube;

wherein said primary syringe is connectable to said connector to be in fluid communication with said primary lumen, said primary syringe having a barrel and a plunger slidably displaceable in the barrel to facilitate the delivery and removal of a non-compressible liquid to the mock implant member;

wherein said secondary syringe is connectable to said connector to be in fluid communication with said secondary lumen, said secondary syringe having another barrel and another plunger slidably displaceable in said another barrel to facilitate the delivery and removal of a compressible liquid to the mock implant member;

wherein said fluid control arrangement is operable in a priming step to occlude, the fluid communication path between said primary lumen and the tube and to open the fluid communication path between said secondary lumen and the tube to facilitate inflating said mock implant member with compressible liquid dispensed from said secondary syringe and compressible liquid contained within the closed delivery system; and

wherein said fluid control arrangement is operable in another priming step to occlude the fluid communication path between said secondary lumen and the tube and open the communication path between said primary lumen and the tube to facilitate placing said primary syringe in fluid communication with said tube for inflating the mock implant member with non-compressible liquid dispensed from said primary syringe, said primary syringe containing a sufficient volume of the non-compressible liquid to inflate said mock implant member to a fully expanded state conforming to the shape of the nucleus cavity to provide an indication of said known volume of filler material to substantially fill the volume of the nucleus cavity.

3. The self-contained closed implant system according to claim 2, wherein the non-compressible fluid dispensed from said primary syringe is heavier that the compressible fluid dispensed from said secondary syringe;

wherein said heavier non-compressible fluid sinks to a distal end portion of the mock implant member; and

wherein the compressible fluid contained within the closed implant system collects at about a distal end of the tube.

4. The self-contained closed implant system according to claim 3, wherein said mock implant member, in its fully collapsed primed state, points upwardly since the buoyancy of the compressible fluid within the closed sizing assembly causes the compressible fluid therein to disperse toward a distal portion of said mock implant member in close proximity to the single lumen of said tube;

and

wherein said mock implant member, in its fully inflated state, points downwardly during said priming step to facilitate an accurate measurement of the nucleus cavity.

5. The self-contained closed implant system according to claim 4, wherein withdrawal displacement of said another plunger within said another barrel is prevented in the closed sizing assembly from extending beyond a zeroing position when said mock implant member is in said fully collapsed state and is extendable in an opposite displacement until a sudden increase in pressure resulting from the mock implant member becoming fully inflated with a sufficient volume of non-compressible liquid so the mock implant member substantially conforms to the shape of the nucleus cavity.

6. The self-contained closed implant system according to claim 5, wherein said sudden increase in pressure causes a transducer coupled to the plunger of said primary syringe to emit an enunciation.

7. The self-contained closed implant system according to claim 6, wherein said enunciation is an audible enunciation indicative of an end point in filling the mock implant member with the non-compressible fluid.

8. The self-contained closed implant system according to claim 6, wherein said enunciation is a visible enunciation indicative of n end point in filling the mock implant member with the non-compressible fluid.

9. The self-contained closed implant system according to claim 1, wherein said closed dispensing assembly includes:

a connector in fluid communication with the elastically deformable implant member;

a withdrawing device in fluid communication with said connector for increasing the volume of the closed implant system to facilitate collapsing the elastically deformable implant member and removing substantially all fluids therefrom so said elastically deformable implant member may be filed with said know volume of filler material without fluid evacuation from the closed implant system; and

a dispensing device in fluid communication with said connector for dispensing to collapsed elastically deformable implant member said known volume of filler material without fluid evacuation from the closed implant system.

10. The self-contained closed implant system according to claim 9, wherein said closed dispensing assembly further includes a sensing arrangement for providing an indication that the elastically deformable implant member has been inflated with a sufficient volume of filler material corresponding to said known volume of filler material;

wherein upon said sensing arrangement providing said indication, said dispensing assembly may be immediately removed from the working cannula without waiting for the filler material in the elastically deformable implant member to cure.

11. The self-contained closed implant system according to claim 10, wherein said dispensing assembly still further includes an occluding arrangement for occluding access to the inflated elastically deformable implant member concurrently with the immediate removal of said dispensing assembly.

12. The self-contained closed implant system according to claim 1, said collar assembly including:

a cannula collar secured at a proximal end of said single lumen working, cannula;

said cannula collar having a set of recesses to help facilitate the removal of a protective sheath surrounding the implant member once it is placed within nucleus cavity;

a push-off collar removably secured to a proximal end of said cannula collar to help facilitate separating the implant member from the closed implant system;

a connector collar removably secured to a proximal end of said push-off collar for coupling said closed insertion assembly to said closed dispensing assembly without relative rotational motion therebetween to facilitate the filling of the implant member with said known volume of filler material without fluid evacuation from the closed implant system; and

wherein said single lumen working cannula is configured with a pair of oppositely disposed longitudinally extending slits dimensioned for slidably receiving therein a set of tabs extending outwardly from said protective sheath, said tabs being dimensioned to be received within the set of recesses disposed in said cannula collar to further help facilitate the removal of the protective sheath from the implant member once the implant member is placed within the nucleus cavity.

13. The self-contained closed implant system according to claim 1, wherein said closed insertion assembly includes:

a single lumen carrier tube for carrying at a distal end thereof the elastically deformable implant member;

a protective sheath extending over the elastically deformable implant member for protecting it while being carried and placed within the nucleus cavity by said single lumen carrier tube;

a stiffening rod dimensioned to be slidably received within said single lumen carrier tube and having a sufficient length extending between a distance beyond the distal end of the single lumen carrier tube to be received within the interior of the elastically deformable implant member and another distance beyond a proximal end of said single lumen working cannula to facilitate collapsing the elastically deformable implant member onto a distal end of said stiffening rod; and

a push off tube to facilitate the removal of the elastically deformable implant member from said single lumen carrier tube once filled with said known volume of filler material, said push off tube dimensioned to be slidably received within said single lumen working cannula and for slidably receiving therein said single lumen carrier tube;

said push off tube having arranged about its distal end the protective sheath, said sheath extending beyond a distal end of the elastically deformable implant member during its placement within the nucleus cavity;

said push off tube having disposed at about its proximal end a bayonet fitted collar dimensioned to be received within said cannula collar to facilitate locking engagement between the single lumen working cannula and the closed insertion assembly; and

the proximal end magnetic mount being coupled to a tube connector in fluid communication with said carrier tube to facilitate coupling said closed insertion system to said closed dispensing system without relative rotational motion therebetween for filling of the elastically deformable implant member with said known volume of filler material without fluid evacuation from the closed implant system.

14. An apparatus for use with a working cannula, said cannula being configured to be fixedly docked percutaneously to an in situ implant site, the apparatus comprising:

a closed dispensing assembly which includes a distal end magnetic mount for removably coupling said closed dispensing assembly to a working cannula and a proximal end magnetic mount for removably coupling said closed dispensing assembly to a closed suing assembly during an implant site size determination procedure and for removably coupling said closed dispensing assembly to a closed insertion assembly in place and stead of said closed sizing assembly during an implant placement and filling procedure;

said closed sizing assembly is configured to be partially received within the working cannula for carrying at a distal end thereof an elastically deformable mock implant member to an in situ implant site to facilitate determining, without fluid evacuation from a closed implant system, a known volume of filler material to substantially fill a prosthesis implant to be formed at the implant site;

wherein the closed insertion assembly is configured to be partially received within said working cannula in place and stead of the closed sizing assembly for protectively carrying an elastically deformable implant member to the in situ implant site to facilitate its filling with the known volume of filler material;

wherein the closed dispensing assembly is configured to be partially received within the working cannula and removably coupled to the closed insertion assembly to facilitate the filling of the elastically deformable implant member with the known volume of filler material without fluid evacuation from the closed implant system;

wherein said distal end magnetic mount facilitates connecting and disconnecting said dispensing assembly from said working cannula without relative rotational motion therebetween to help reduce tissue trauma to the patient; and

wherein said proximal end magnetic mount facilitates connecting and disconnecting said dispensing assembly from said closed sizing assembly without relative rotational motion therebetween to further help reduce tissue trauma to the patient and to further facilitate connecting and disconnecting said dispensing assembly from said insertion assembly without relative rotational motion therebetween to still further help reduce tissue trauma to the patient.

15. A self-contained closed implant system for the formation of a prosthesis device percutaneously at an in situ implant site, comprising:

a single lumen working cannula, said single lumen working cannula configured to be docked against an outer surface area of the in situ implant site for the implanting of a prosthesis device percutaneously at an in situ implant site;

a closed sizing assembly configured to be partially received within the single lumen working cannula, said closed sizing assembly for carrying at a distal end thereof an elastically deformable mock implant member to the in situ implant site to facilitate determining, without fluid evacuation from the closed implant system, a known volume of filler material to substantially fill the volume of an implant receiving cavity;

a closed insertion assembly configured to be partially received within said single lumen working cannula in place and stead of said closed sizing assembly for protectively carrying an elastically deformable implant member to the in situ implant site to facilitate its filling with said known volume of filler material;

a closed dispensing assembly configured to be partially received within said single lumen working cannula and removably coupled to said closed insertion assembly without relative rotational motion therebetween to facilitate the filling of the elastically deformable implant member with said known volume of filler material without fluid evacuation from the closed implant system; and

wherein the closed dispensing assembly includes a distal end magnetic mount for removably coupling the closed dispensing assembly to the single lumen working cannula and a proximal end magnetic mount for removably coupling the closed dispensing assembly to the closed sizing assembly to facilitate determining, without fluid evacuation from the closed implant system, the known volume of filler material to substantially fill the volume of the implant receiving cavity and for removably coupling the dispensing assembly to the closed insertion assembly in place and stead of the closed sizing assembly to facilitate the filling of the elastically deformable implant member with the known volume of filler material without fluid evacuation from the closed implant system to help reduce tissue trauma to a patient by obviating relative rotational coupling motions.