Supracondylar bullet sleeve

Patent metadata

Field	Value
Publication number	US-2020397450-A1
Application number	US-201916447292-A
Country	US
Kind code	A1
Filing date	Jun 20, 2019
Priority date	Jun 20, 2019
Publication date	Dec 24, 2020
Grant date	—

Abstract

The invention is directed to a surgical device which is externally used as aiming device that permits accurate placement of surgical wire to mend a supracondylar fracture. The device of the invention decreases operative time, risks of the re-dislocation through continuous manipulation, radiology exposure for both the patient and operation room staff, and to decreases anesthesia duration. It is also directed to surgical use of the device for repair of a supracondylar fracture and to methods for making it.

First claim

1 . A surgical device comprising:
a handle suitable for a surgeon to steer the surgical device on skin and having a longitudinal groove suitable for visual alignment of surgical wires introduced into the device, and a functional unit comprising holes A and B, and optionally C, which is suitable to hold and guide surgical wires; wherein the handle is about 50 to 100 mm long and has an average diameter of about 6-10 mm and wherein the handle is connected at its lower end to one side of the functional unit at an angle ranging from about 30-60 degrees; and wherein the functional unit has an anterior and a posterior side and has an average cross-sectional diameter ranging from about 15-30 mm, a vertical thickness between said anterior and posterior sides ranging from about 10-20 mm, and wherein the functional unit comprises holes A and B and optionally, C, which penetrate the anterior and posterior sides of the functional unit, wherein each of holes A and B, or A, B and C is about 1.6 to 2.5 mm in diameter, wherein holes A and B, and holes B and C, when C is present, are about 4-6 mm fixed distance from one another; and wherein a top of each of said holes A and B, and optionally C, is linearly aligned with each other along the anterior surface of the functional unit and with the longitudinal groove of the handle.

2 . The surgical device of claim 1 , wherein the handle has a substantially circular or oval cross-section, the functional unit has a substantially circular, elliptical, or oval cross-section, and the functional unit comprises holes A and B, or holes A, B and C, which have substantially round or oval cross-sections.

3 . The surgical device of claim 1 , wherein the handle has a substantially circular, elliptical, or oval cross-section and is about 54-74 mm long and wherein the handle is connected at its lower end to the functional unit at an angle ranging from about 40-50 degrees,
wherein the functional unit has a substantially circular, elliptical, or oval cross section and has an average diameter of about 20-24 mm and a vertical thickness ranging from about 13-17 mm, wherein the functional unit comprises holes A and B, or holes A, B and C, said holes having substantially round, elliptical, or oval cross sections about 1.8-2.0 in diameter, wherein the vertical alignment of holes A and B or holes A and C as measured by the alignment of the holes through the body of the functional unit diverge by about 3-20 degrees [.

4 . The surgical device of claim 1 , wherein the handle has a substantially circular, elliptical, or oval cross-section and is about 64 mm long and wherein the handle is connected at its lower end to the functional unit at an angle ranging from about 45 degrees.
wherein the functional unit has a substantially circular, elliptical, or oval cross section and has an average diameter of about 22 mm and a vertical thickness ranging from about 15 mm, wherein the functional unit comprises holes A and B, or holes A, B and C, said holes having substantially round, elliptical, or oval cross sections about 1.7, 1.9 or 2.1 mm in diameter, wherein the vertical alignment of holes A and B or Holes A and C diverge by about 3-20 degrees, and wherein holes A and B, or holes A, B and C are about 5 mm fixed distance from one another.

5 . The surgical device of claim 1 , wherein both holes B and C are present and the vertical alignment of holes A and B and holes A and C diverge at the same angle between 3 and 20 degrees.

6 . The surgical device of claim 1 , wherein both holes B and C are present and the vertical alignment of holes A and B and holes A and C diverge at different angles.

7 . A method for treating a supracondylar fracture comprising:
reducing the fracture, steering the device of claim 1 to a location on the skin of a subject proximal to the reduced fracture, introducing K-wire or other surgical wire into hole A and hole B and, optionally, into hole C, through the skin, and into one or more bones or bone fragments of the subject.

8 . The method of claim 7 , wherein the subject has a Type IIA or Type IIB supracondylar fracture.

9 . The method of claim 7 , wherein the subject has a Type IIIA or Type IIIB supracondylar fracture.

10 . The method of claim 7 , wherein said subject has a Type IV supracondylar fracture.

11 . The method of claim 7 , wherein the subject is less than 5 years old.

12 . The method of claim 7 , wherein the subject is at least 5 years old and no more than 9 years old.

13 . The method of claim 7 , wherein the subject is more than 9 years old.

14 . The method of claim 7 , wherein the subject has or is at risk of vascular insufficiency due to the supracondylar fracture.

15 . The method of claim 7 , wherein the subject has or is at risk of neurological deficit due to the supracondylar fracture.

16 . The method of claim 7 , wherein the subject has or is at risk of forearm compartment syndrome associated with the supracondylar fracture.

17 . The method of claim 7 , wherein the subject has or is at risk of malunion associated with the supracondylar fracture.

18 . A kit comprising at least one of the surgical device of claim 1 , surgical wire, packing materials, and instructions for use for treatment of a supracondylar fracture or a kit comprising two or more of the surgical devices of claim 1 , wherein the vertical alignment holes A and B and holes A and C holes B and C of each surgical device are aligned at different angles between 3 and 20 degrees. [same comment]

19 . A method for making the surgical device of claim 1 comprising:
3D printing the surgical device,
drilling or otherwise forming holes A, B and C when holes A, B and C are not produced by the 3D printing, and
equipping an inset around holes B and C with radio-opaque washer-like metal markers or other radio-opaque markers.

20 . The method of claim 19 , further comprising:
imaging a supracondylar fracture thereby producing imaging data describing the supracondylar fracture, designing the surgical device including selecting the size of the handle and functional unit and the vertical alignment of holes B, and C, when present, from the imaging data thereby custom designing the surgical device, 3D printing the custom-designed surgical device, and, incorporating comprises a radio-opaque washer-like metal marker in or around holes B and/or C.

Assignees

• Univ Imam Abdulrahman Bin Faisal

Inventors

• Al Shammari Sulaiman Mohammed

Classifications

• A61B17/90

  Guides therefor · CPC title

• A61B2017/0042

  with special provisions for gripping · CPC title

• A61B17/1739 Primary

  specially adapted for particular parts of the body · CPC title

• A61B17/72

  Intramedullary devices, e.g. pins or nails · CPC title

• A61B17/8897

  Guide wires or guide pins · CPC title