Custom radiographically designed cutting guides and instruments for use in total ankle replacement surgery

• US 20100262150A1
• Filed: 04/02/2010
• Published: 10/14/2010
• Est. Priority Date: 04/13/2009
• Status: Active Grant

• Current Assignee: George John Lian
• Original Assignee: George John Lian
• Inventors: Lian, George John
• Granted Patent: US 8,337,503 B2
• Time in Patent Office: Days
• US Class Current: 606/87
• CPC Class Codes: A61B 17/15 Guides therefor arrangements for guiding straight saw blades in general B23D51/025
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1682 for the foot or ankle
• CPC Class Codes: A61B 17/1775 for the foot or ankle
• CPC Class Codes: A61B 2017/568 produced with shape and dimensions specific for an individual patient
• CPC Class Codes: A61B 2034/108 Computer aided selection or customisation of medical implants or cutting guides
• CPC Class Codes: A61F 2/4202 for ankles
• CPC Class Codes: A61F 2/4606 of wrists or ankles; of hands, e.g. fingers; of feet, e.g. toes
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/4205 Tibial components
• CPC Class Codes: A61F 2002/4207 Talar components

Abstract

A system comprised of custom radiographically designed tibial and talar cutting guides, a tibial reaming guide and bit, and instrumentalities for use in total ankle replacement surgery and a computer-based system and method for making the custom radiographically designed tibial and talar cutting guides.

Claims

1. A custom radiographically designed cutting guide system for use in total ankle replacement surgery, said system comprising:

a tibial cutting guide having a first posterior surface portion with a topography that is a preoperatively defined negative of an anterior topography of a distal portion of a tibia of a patient to fit said first posterior surface portion of said tibial cutting guide to the distal portion of the tibia in one unique position;

said tibial cutting guide having a second posterior surface portion anteriorly recessed from said first posterior surface portion at a preoperatively defined distance from a central longitudinal axis of the tibia for defining a tibial reaming guide locator notch anteriorly recessed from said first posterior surface portion; and

said tibial cutting guide having at least one slit to guide a cutting instrument to make at least one cut in the distal portion of the tibia of the patient with said tibial cutting guide in said one unique position wherein at least the one cut is in a boundary of a segment of the distal portion of the tibia to resect during total ankle replacement surgery.

2. The system of claim 1 further comprising a talar cutting guide comprised of a dome member and a neck member, said dome member having an inferior surface portion with a topography that is a preoperatively defined negative of a topography of at least a portion of a dome surface of a dome of a talus of the patient to fit said inferior surface portion of said dome member to at least the portion of the dome surface of the dome of the talus in one unique position, and said neck member having a posterior surface portion with a topography that is a preoperatively defined negative of a topography of at least a portion of a dorsum surface of a talar neck of the talus to fit said posterior surface portion of said neck member to at least the portion of the dorsum surface of the talar neck of the talus in one unique position.

3. The system of claim 2 wherein said dome member is comprised of an open ended channel disposed through said dome member at a preoperatively defined location and at a preoperatively defined angle relative to a superior surface of said dome member to allow passage of a drilling instrument to drill a blind bore into the talus at the preoperatively defined angle relative to the superior surface of said dome member.

4. The system of claim 3 wherein said neck member is comprised of a preoperatively sized and located talus cutting slit disposed through said neck member to guide a passage of a cutting instrument to resect a top segment of the talus during the total ankle replacement surgery wherein the resected segment of the distal portion of the tibia and the resected top segment of the talus form a space between the tibia and the talus defined as a tibial-talar space.

5. The system of claim 4 further comprising a tibial reaming guide circumscribing a cannulated reaming bit, said tibial reaming guide having a first portion received within said tibial reaming guide locator notch of said tibial cutting guide and having a second portion received within said tibial-talar space to locate said removable reaming bit relative to the central longitudinal axis of the tibia by said tibial cutting guide being fit to the distal portion of the tibia in said one unique position.

6. The system of claim 5 further comprising an alignment guide comprising a generally arcuate body having a medial section transitioning to a superior end supporting a locating member and to an inferior end supporting a sleeve attachment wherein said locating member is at least partially received within an alignment guide locator notch of said tibial cutting guide for locating said sleeve attachment just off of a sole of a foot of the patient while aligning said sleeve attachment relative to the central longitudinal axis of the tibia by said tibial cutting guide being fit to the distal portion of the tibia in said one unique position.

7. The system of claim 6 wherein said sleeve attachment includes an open ended bore sized to closely receive at least two removable, alternate inner sleeve guides comprised of an inner sleeve wire guide having a open ended interior bore extending therethrough and an inner sleeve drill and driver bit guide having a open ended interior bore extending therethrough.

8. The system of claim 7 wherein a wire is passed through said open ended interior bore of said inner sleeve wire guide closely received within said sleeve attachment to guide drilling of the wire up through a bottom of a calcaneus and the talus, through a central hole in said cannulated reaming bit circumscribed by said tibial reaming guide, and into the distal portion of the tibia for a predetermined distance along the central longitudinal axis of the tibia.

9. The system of claim 8 wherein a cannulated drill bit is passed through said open ended interior bore of said inner sleeve drill and driver bit guide closely received within said sleeve attachment to guide driving of the cannulated drill bit over the wire and up through the bottom of the calcaneus and the talus and up to said central hole in said cannulated reaming bit for forming a drill bore extending from the bottom of the calcaneus to and in open communication with said central hole in said cannulated reaming bit.

10. The system of claim 9 wherein a cannulated reamer drive bit is passed through said open ended interior bore of said inner sleeve drill and driver bit guide closely received within said sleeve attachment to guide passing the cannulated reamer drive bit into engagement with said central hole in said cannulated reaming bit and driving said cannulated reamer drive bit over the wire and along a predetermined distance of the central longitudinal axis of the tibia to ream a tibial blind bore into the distal portion of the tibia wherein the tibial blind bore is sized to receive a tibial stem of a preoperatively chosen size of an ankle prosthesis.

11. The system of claim 10 further comprising a first framework having an anterior opening and sized to be received into the tibial-talar space to keep the tibia and talus separated and stabilized to allow modular stem components of the tibial stem of the ankle prostheses to be successively inserted through said anterior opening of said first framework and into the tibial blind bore in the distal portion of the tibia.

12. The system of claim 11 further comprising a second framework having an anterior opening and sized to be received into the tibial-talar space to keep the tibia and talus separated and stabilized to allow an inferior tibial tray to pass through said anterior opening of said second framework and be coupled to a last inserted modular stem component of the tibial stem.

13. A custom radiographically designed cutting guide system for use in total ankle replacement surgery, said system comprising:

a talar cutting guide comprised of a dome member and a neck member;

said dome member having an inferior surface portion with a topography that is a preoperatively defined negative of a topography of at least a portion of a dome surface of a dome of a talus of a patient to fit said inferior surface portion of said dome member to at least the portion of the dome surface of the dome of the talus in one unique position; and

said neck member having a posterior surface portion with a topography that is a preoperatively defined negative of a topography of at least a portion of a dorsum surface of a talar neck of the talus to fit said posterior surface portion of said neck member to at least the portion of the dorsum surface of the talar neck of the talus in one unique position.

14. The system of claim 13 wherein said dome member is comprised of an open ended channel disposed through said dome member at a preoperatively defined location and at a preoperatively defined angle relative to a superior surface of said dome member to allow passage of a drilling instrument to drill a blind bore into the talus at the preoperatively defined angle relative to the superior surface of said dome member.

15. The system of claim 14 wherein said neck member is comprised of a preoperatively sized and located talus cutting slit disposed through said neck member to guide a passage of a cutting instrument to resect a top segment of the talus.

16. A cutting guide system for use in total ankle replacement surgery, said system comprising:

a tibial reaming guide sized to fit in a space formed by a resected segment of a distal portion of a tibia and a resected segment of a dome of a talus, said tibial reaming guide having a opened ended channel;

a cannulated reaming bit removably received within said opened ended channel of said tibial reaming guide; and

said cannulated reaming bit having a bone reaming exterior surface for forming a bore in the tibia when driven wherein said bore is sized to receive an intramedullary stem of a preoperatively chosen ankle prosthesis.

17. The system of claim 16 wherein said tibial reaming guide has a generally pyramidal frustum shaped reamer body comprised of a rectangularly shaped superior face, a rectangularly shaped inferior face, a trapezoidally shaped inner face, a trapezoidally shaped outer face, a trapezoidally shaped posterior face, and a trapezoidally shaped anterior face.

18. The system of claim 17 wherein said opened ended channel of said tibial reaming guide has a central axis substantially perpendicular to said rectangularly shaped superior face and said rectangularly shaped inferior face.

19. The system of claim 18 further comprising means for locating said tibial reaming guide in the space formed by the resected segment of the distal portion of the tibia and the resected segment of the dome of the talus to centrally locate said cannulated reaming bit relative to a central longitudinal axis of the tibia.

20. A computer-based method for making a custom radiographically designed cutting guides for use in total ankle replacement surgery, said method comprising the steps of:

obtaining radiographic data of an ankle of a patient prior to the patient undergoing total ankle replacement surgery;

transforming the radiographic data into a virtual 3-dimensional model of the ankle for obtaining both tibial cutting guide data correlative to a topography of an anterior surface portion of a distal tibia of the ankle and talar cutting guide data correlative to a topography of a dome surface portion and a dorsum surface portion of a talus of the ankle;

controlling a numerical controlled machine system as a function of the tibial cutting guide data for forming a custom radiographically designed tibial cutting guide comprised of a posterior surface having a first posterior surface portion with a topography that is a negative of the anterior surface portion of the distal tibia, a second posterior surface portion anteriorly depressed relative to the first posterior surface portion for defining a posterior notch for receiving and locating a tibial reaming guide circumscribing a reamer bit utilized in reaming a blind bore in the distal tibia along a central longitudinal axis of the distal tibia, and cutting slits bordering the second posterior surface portion for providing guided passage of a saw blade to make a superior cut transversely, a lateral cut, and a medial malleolus cut of the distal tibia; and

controlling the numerical controlled machine system as a function of the talar cutting guide data for forming a custom radiographically designed talar cutting guide comprised of a dome member having an inferior surface which is a negative of the topography of at least a portion of the dome surface portion of the talus, a neck member having a posterior surface which is negative of the topography of at least a portion of the dorsum surface portion of the talus, and a cutting slit in the neck member for providing guided passage of a saw blade to make a dome cut transversely.