Search

EP-4740871-A2 - A TIBIAL SUPRAPATELLAR ENTRY PORTAL SYSTEM

EP4740871A2EP 4740871 A2EP4740871 A2EP 4740871A2EP-4740871-A2

Abstract

A tibial suprapatellar entry portal system (1) comprising a sleeve (2), an anchor pin (200), and a trocar (40).

Inventors

  • DALY, CHARLES
  • KIELY, GERARD
  • O'CALLAGHAN, SEAN
  • GOUGH, Richie

Assignees

  • OrthoXel DAC

Dates

Publication Date
20260513
Application Date
20210526

Claims (12)

  1. A tibial suprapatellar and retrograde entry portal system (1) comprising a sleeve (2) having a substantially elliptical outline, an anchor pin (200) and a trocar (40), wherein the sleeve (2) comprises a sheath (2a) and a sleeve handle (20); the sheath (2a) having a proximal end (5) with an entry port (6) and a distal end (4) having an exit port (77) separated by a longitudinal body (3) having an outer surface (3a), an inner surface (3b), and an internal shaft (3c), and at least two circular cannulations (7a,8a) extending from the proximal end (5) to the distal end (4) between the outer surface (3b) and inner surface (3a) of the longitudinal body (3) providing at least two anchor points, wherein the sheath (2a) is rigid and wherein the proximal end (5) further comprises a third anchor point (11) comprising an aperture suitable to accommodate the anchor pin (200) or an entry wire; and wherein the third anchor point (11) is offset at about 0° to 20° relative to the horizontal axis of the internal shaft (3c) and about 5° to 15° relative to the vertical axis of the internal shaft (3c), allowing securement to the femur during tibia suprapatellar use and tibia retrograde entry.
  2. The tibial suprapatellar and retrograde entry portal system (1) according to Claim 1, wherein the proximal end (5) further comprises portals (7,8) configured to access the circular cannulations (7a,8a) and a securing means (9) configured to engage with the trocar (40).
  3. The tibial suprapatellar and retrograde entry portal system (1) according to any one of Claims 1 to 2, wherein the circular cannulations (7a,8a) are either parallel to the longitudinal axis of the body (3), are convergent from the proximal end (5) to the distal end (4), or are divergent from proximal end (5) to the distal end (4).
  4. The tibial suprapatellar and retrograde entry portal system (1) according to any one of the preceding claims, wherein the body (3) further comprises a channel (50) running parallel with and in communication with the circular cannulation (7a) or circular cannulation (8a).
  5. The tibial suprapatellar and retrograde entry portal system (1) according to any one of the preceding claims, wherein the anchor pin (200) has a threaded portion at a distal end, and a proximal end having a larger diameter than the distal end, creating a stop configured to engage with the proximal end (5) of the sheath (2a).
  6. The tibial suprapatellar and retrograde entry portal system (1) according to any one of the preceding claims, wherein the trocar (40) comprises an insertion guide (42) at a proximal end thereof and a tip (43) at a distal end thereof, separated by a longitudinal body (41).
  7. The tibial suprapatellar and retrograde entry portal system (1) according to Claim 6, wherein the insertion guide (42) comprises at least one entry point guide (44) at the proximal end.
  8. The tibial suprapatellar and retrograde entry portal system (1) according to any one of the preceding claims, wherein the sleeve (2) is composed of a durable, yet rigid material selected from polypropylene, polyethylene (PE), polyethylene terephthalate copolymer (PETG), amorphous polyethylene terephthalate (APET), stainless steel and titanium. Preferably, the material is stainless steel, titanium, or a combination thereof.
  9. The tibial suprapatellar and retrograde entry portal system (1) according to any one of the preceding claims wherein the anchor pins are composed of stainless steel or titanium.
  10. The tibial suprapatellar and retrograde entry portal system (1) according to any one of Claims 1 to 9, wherein the anchor pin (200) has a shoulder (202) that, when the anchor pin (200) is inserted into the circular cannulations (7a,8a), creates a mechanical hard stop by contacting the top surface of the portals (7,8) of the proximal end (5) of the sheath (2a) and securing the distal end of the sheath (2a) rigidly against the tibia or the femur.
  11. The tibial suprapatellar and retrograde entry portal system (1) according to Claim 10, wherein the anchor pin (200) has a distal diameter that is accommodated within the circular cannulations (7a,7b) and a larger proximal diameter that butts against trocar (40).
  12. The tibial suprapatellar and retrograde entry portal system (1) according Claim 11, wherein the distal diameter of the anchor pin (200) is fully threaded or partially threaded.

Description

Field of the Invention The invention relates to a tibial suprapatellar entry portal system. In particular, the invention relates to a tibial suprapatellar entry portal system that includes a guide sleeve and a handle for suprapatellar surgery. Background to the Invention Fractures of the tibia can be difficult and awkward to treat as the patient's knee is typically flexed at about 90° so the surgeon can access to the top of the tibia and insert an intramedullary nail, for example, in particular to treat proximal or segmental fractures where fracture reduction is difficult or hampered by the flexion of the knee and the resulting forces applied by the patella on the proximal portion of the fractured tibia. While infrapatellar insertion of the intramedullary nail into the tibia had been the preferred option since the 1940s, the required hyperflexion of the leg produced unintended problems. Firstly, obtaining a starting point location in the proximal end of the tibia using fluoroscopy needed significant tilting of the C-arm. This was often limited by the bottom of the operating table and often caused issues with locating an adequate starting point. Secondly, the pull of the quadriceps as well as the posteriorly directed nail caused flexion in the proximal segment, which could cause procurvatum deformity. Many techniques have been developed over time to combat these problems and in 1996 a new technique described a semi-extended position with the knee at approximately 15° to 20° flexion as a potential solution to the problem. This allowed lateral mobilisation of the patellar permitting easy access to a starting point, with maintained relaxed extensor mechanism. Building on this many surgeons proposed techniques that would complement this approach and in 2010 a described technique using the leg in the previous described position but creating the incision suprapatellar and passing the tools needed to create an opening in the proximal tibia behind the patella and through the patellofemoral joint. This created easier access to the proximal tibia without having the leg muscles tensed and also allowed for easier imaging using the C-arm as it did not need to be tilted as much. A way to protect the patella from damage during the obtaining of access to the proximal tibia starting point and the use of opening reaming through the patellofemoral joint gave rise to the need of a protection sleeve instrument, to protect the patella. US 9566078 describes a sleeve comprising an elastic material which has a longitudinal axis and comprises a first end, a second end, an inner surface, a flexible outer surface and at least two grooves that extend at the inner surface from the first end to the second end, and wherein the grooves are adapted to accommodate elongated fixation elements. The elongated fixation elements may, for example, be realized as wires (e.g., so-called K-wires), nails or pins. EP 2797521 describes a system for inserting and securing, through a suprapatellar region of a leg, a nail into a medullary canal of a bone, the system comprising a flexible sleeve configured to flex so as to change a shape of the first axis from a first configuration to a second configuration and further comprises a retaining member configured to support at least a portion of the flexible sleeve in the leg, wherein the retaining member is configured to position the flexible sleeve through the suprapatellar region of the leg such that the flexible sleeve leading end is aligned with a proximal end of the bone. The problems with the guide sleeves described above and currently being used is that they are difficult to assemble due to multiple components, difficulty in separating the sleeve from the internal member, a complicated mechanism for removing the internal guide/trocar and can only anchor in one direction. It is an object of the present invention to overcome at least some of the above-mentioned problems. Summary of the Invention The inventors have developed a tibial nail that also includes a stainless-steel instrument for a suprapatellar entry surgical approach. The tibial suprapatellar and retrograde entry portal system is a substantially elliptical single piece that can be anchored in position to help retain the system during the nail implantation procedure and to facilitate ease of use. The design of the system also aids with speeding up the procedure. The anchoring technique used by the suprapatellar entry portal system of the claimed invention allows for tailoring of the insertion system fixation by the surgeon. In practice, this means that the surgeons can anchor the insertion system to either the tibia, femur or both. Clinically, the claimed invention provides a protective sleeve to allow reamers, guidewires and entry wires pass through, to open the end of the medullary canal, and ream the intramedullary canal shaft. The reason for anchoring using up to three anchor pins (a first anchor pin, a second anchor pin, and a third anchor pi