Tension isolating adjustable adapter for external fixation and methods of production and use thereof

Patent metadata

Field	Value
Publication number	US-11806050-B2
Application number	US-202017027018-A
Country	US
Kind code	B2
Filing date	Sep 21, 2020
Priority date	Sep 21, 2020
Publication date	Nov 7, 2023
Grant date	Nov 7, 2023

Abstract

Tension isolating adjustable adapters are disclosed, along with kits and systems containing same, as well as methods of production and use thereof. The tension isolating adjustable adapters include a percutaneous device holder that can be releasably connected to a percutaneous device via a locking element, and a tensioning member that engages the percutaneous device holder. The tensioning member has at least one tension pad that is shaped and configured to be disposed about the percutaneous device insertion site in the patient's skin, and the engagement of the tensioning member(s) to the percutaneous device holder allows for adjustment of the tension pad(s).

First claim

What is claimed is:

1. A tension isolating adjustable adapter for use with a percutaneous device, the adapter comprising:
a percutaneous device holder, the percutaneous device holder having a recess sized and shaped to receive a portion of a percutaneous device, the percutaneous device holder further comprising a first groove and a second groove;
a tensioning member releasably coupled to the percutaneous device holder, the tensioning member having at least one guide rail and at least one tension pad coupled to the guide rail, the at least one guide rail being releasably inserted into the second groove of the percutaneous device holder, wherein the at least one tension pad is shaped and configured to be disposed about an insertion site of the percutaneous device, and wherein the at least one guide rail engages the second groove of the percutaneous device holder in a manner that allows for adjustment of the at least one tension pad; and
a locking element coupled to the first groove of the percutaneous device holder, wherein the locking element is shaped and configured to secure the percutaneous device holder to the percutaneous device.

2. The tension isolating adjustable adapter of claim 1 , wherein the at least one tension pad of the tensioning member is designed to contact the patient's skin with a sufficient amount of pressure so as to maintain the skin disposed between the at least one tension pad and the percutaneous device insertion site in a substantially taut orientation and thereby distribute any force exerted by the percutaneous device around the area of skin disposed between the percutaneous device insertion site and the at least one tension pad.

3. The tension isolating adjustable adapter of claim 1 , wherein the at least one guide rail comprises a first guide rail and a second guide rail, and wherein the at least one tension pad comprises a first tension pad and a second tension pad, wherein the first tension pad is coupled to the first guide rail and the second tension pad is coupled to the second guide rail, and wherein the first and second guide rails are spaced apart from one another in a parallel relationship, the first and second guide rails being releasably inserted into opposite sides of the second groove of the percutaneous device holder, wherein the first and second tension pads are shaped and configured to be disposed about the percutaneous device's insertion site in the patient's skin, wherein each of the first and second guide rails engages the second groove of the percutaneous device holder and allows for adjustment of the first and second tension pads.

4. The tension isolating adjustable adapter of claim 3 , wherein the first and second tension pads are designed to contact the patient's skin with a sufficient amount of pressure so as to maintain the skin disposed between the first and second tension pads in a substantially taut orientation and thereby distribute any force exerted by the percutaneous device around the area of skin disposed between the first and second tension pads.

5. The tension isolating adjustable adapter of claim 1 , wherein the locking element engages the at least one guide rail of the tensioning member and secures the tensioning member in position with respect to the percutaneous device holder.

6. The tension isolating adjustable adapter of claim 1 , wherein the at least one tension pad is adjustable to a shape of the patient's skin surface.

7. The tension isolating adjustable adapter of claim 1 , wherein the at least one tension pad is substantially anatomically-shaped.

8. The tension isolating adjustable adapter of claim 1 , wherein the at least one tension pad is adjustable to an insertion angle of the percutaneous device.

9. The tension isolating adjustable adapter of claim 1 , wherein the tension isolating adjustable adapter is releasably securable to the percutaneous device.

10. The tension isolating adjustable adapter of claim 1 , wherein the first and second grooves of the percutaneous device holder are each formed on an outer surface of the percutaneous device holder.

11. The tension isolating adjustable adapter of claim 1 , wherein at least one of:
the locking element slidably engages the first groove of the percutaneous device holder; or
the at least one guide rail of the tensioning member slidably engages the second groove of the percutaneous device holder.

12. A kit, comprising:
the tension isolating adjustable adapter of claim 1 ; and
at least one percutaneous device.

13. The kit of claim 12 , further comprising at least one of:
(i) at least one segment of elastically deformable membrane, wherein the membrane has a bonding material attached to at least a portion of a surface thereof for connecting the membrane to a patient's skin; or
(ii) an electrical device, comprising:
a housing;
a power source configured to supply electrical power to a conductive percutaneous implant in a circuit including the conductive percutaneous implant and tissue of a patient adjacent to the conductive percutaneous implant;
an electrical sensor configured to generate a signal indicative of at least one electrical parameter of the circuit; and
at least one data processing system having one or more processors configured to receive the signal and analyze the signal to determine at least one of a presence or change of infection of the tissue, and pass a control signal to the power source to vary the electrical power responsive to determining at least one of the presence or change of infection of the tissue.

14. A system, comprising:
the tension isolating adjustable adapter of claim 1 ; and
at least one percutaneous device.

15. A method, comprising the steps of:
(A) connecting a tension isolating adjustable adapter to a portion of a percutaneous device, inserting a portion of the percutaneous device through a skin of a patient, and fixating the inserted portion of the percutaneous device within a body of the patient, whereby the portion of the percutaneous device to which the tension isolating adjustable adapter is connected extends above the patient's skin, and wherein the tension isolating adjustable adapter comprises:
a percutaneous device holder having a recess in which a portion of the percutaneous device is received, and wherein the percutaneous device holder further comprises a first groove and a second groove;
a tensioning member releasably coupled to the percutaneous device holder, the tensioning member having at least one guide rail and at least one tension pad coupled to the guide rail, the at least one guide rail being releasably inserted into the second groove of the percutaneous device holder, wherein the at least one tension pad is disposed about an insertion site of the percutaneous device, and wherein the at least one guide rail engages the second groove of the percutaneous device holder in a manner that allows for adjustment of the at least one tension pad; and
a locking element coupled to the first groove of the percutaneous device holder, wherein the locking element secures the percutaneous device holder to the percutaneous device;

(B) adjusting the tension isolating adjustable adapter along the length of the percutaneous device until the at least one tension pad of the tension isolating adjustable adapter contacts the skin of the patient; and
(C) adjusting the at least one tension pad until the at least one tension pad contacts the patient's skin with a sufficient amount of pressure so as to maintain the skin disposed between the insertion site of the percutaneous device and the at least one tension pad in a substantially taut orientation and ther

Assignees

• Depuy Synthes Products Inc

Inventors

• Zastrozna Anna
• Amis James
• Wahl Michael

Classifications

• A61B17/66 Primary

  {Alignment}, compression or distraction mechanisms · CPC title

• A61B5/053

  Measuring electrical impedance or conductance of a portion of the body · CPC title

• A61B5/4851

  Prosthesis assessment or monitoring · CPC title

• A61B17/64

  Devices extending alongside the bones to be positioned · CPC title

• A61B17/8869

  Tensioning devices · CPC title