Disposable interspinous implant insertion instrument

Patent metadata

Field	Value
Publication number	US-12290287-B2
Application number	US-202318311048-A
Country	US
Kind code	B2
Filing date	May 2, 2023
Priority date	Apr 8, 2022
Publication date	May 6, 2025
Grant date	May 6, 2025

Abstract

A disposable insertion instrument for inserting an implant includes a handle assembly, a drive assembly, and a plunger assembly. The drive assembly comprises an inner shaft and a spring received within an outer sleeve. A locking pin and drive lobes on the inner shaft cooperate to reversibly lock the drive assembly in a retracted position. A medical implant may be attached to the instrument via an adapter located at a distal end of the drive assembly. Following use for insertion of the medical implant into a patient, the disposable insertion instrument may be discarded.

First claim

What is claimed is:

1. An insertion instrument for inserting an implant, the insertion instrument comprising:
a handle assembly comprising:
a handle knob comprising a distally located circumferentially extending groove;
an elongated main body extending distally away from the handle knob; and
a lumen extending from a proximal end of the handle knob to a distal end of the elongated main body,
wherein the distal end of the elongated main body is adapted for engaging with an implant;

a plunger assembly slidably received within the lumen of the handle assembly, the plunger assembly comprising a plunger knob and a plunger shaft, wherein a distal end of the plunger shaft is configured to engage the implant; and
a spring-loaded drive assembly comprising:
an outer sleeve comprising at least one recessed region;
an inner shaft comprising:
an inner shaft knob comprising at least one retaining pin opening aligned with the distally located circumferentially extending groove;
an inner shaft main body;
at least one drive lobe comprising a raised region on an exterior circumference of the inner shaft main body;

at least one retaining pin,
wherein the at least one retaining pin is insertable into the at least one retaining pin opening and is further received by the distally located circumferentially extending groove, operatively coupling the inner shaft to the handle knob; and
a locking pin,
wherein the spring-loaded drive assembly comprises a first extended position and second retracted position, wherein the locking pin is located proximally of the at least one drive lobe in the second retracted position, and wherein the locking pin is located adjacent to the at least one drive lobe in the first extended position, and
wherein the at least one drive lobe is received within the at least one recessed region in the second retracted position.

2. The insertion instrument of claim 1 , wherein the at least one drive lobe comprises at least two drive lobes, the locking pin is fixedly mounted to the outer sleeve, and the locking pin is located between the at least two drive lobes in the first extended position.

3. The insertion instrument of claim 1 , wherein the outer sleeve is configured to be rotated and moved proximally with respect to the inner shaft to move the spring-loaded drive assembly from the first extended position to the second retracted position.

4. The insertion instrument of claim 1 , wherein the distal end of the plunger shaft comprises external threading configured to engage an implant plunger of the implant, and wherein the distal end of the elongated main body comprises a hexagonal extension configured to engage a proximal bore of the implant.

5. The insertion instrument of claim 1 , wherein the inner shaft main body comprises an inner lumen therethrough, and the elongated main body is received within the inner lumen of the inner shaft main body.

6. The insertion instrument of claim 1 , wherein the inner shaft comprises two retaining pin openings, the spring-loaded drive assembly comprises two retaining pins, and the two retaining pins are retained on opposing sides of the distally located circumferentially extending groove via the two retaining pin openings.

7. The insertion instrument of claim 6 , wherein the inner shaft of the spring-loaded drive assembly is configured to rotate around a center point of the distally located circumferentially extending groove.

8. The insertion instrument of claim 1 , wherein the at least one drive lobe comprises a first set of drive lobes and a second set of drive lobes spaced equidistantly apart on an exterior surface of the inner shaft main body, wherein each of the first set of drive lobes and the second set of drive lobes comprises two drive lobes.

9. The insertion instrument of claim 8 , wherein the outer sleeve comprises a first recessed region and a second recessed region, wherein the first recessed region receives the first set of drive lobes, and the second recessed region receives the second set of drive lobes.

10. The insertion instrument of claim 1 , wherein the spring-loaded drive assembly further comprises a spring located at the distal end of the inner shaft main body, wherein the spring-loaded drive assembly is in the first extended position when the spring is relaxed, and the spring-loaded drive assembly is in the second retracted position when the spring is compressed.

11. The insertion instrument of claim 10 , wherein the outer sleeve further comprises a retention point, and wherein a first end of the spring engages with the distal end of the inner shaft main body and a second end of the spring engages with the retention point.

12. A medical implant insertion system comprising:
a handle assembly comprising:
a handle knob comprising at least one retaining pin opening;
an elongated main body extending distally away from the handle knob;
a main body lumen extending from a proximal end of the handle knob to a distal end of the elongated main body,
wherein the distal end of the elongated main body is adapted for engaging with an implant;

a plunger assembly slidably received within the main body lumen of the handle assembly, the plunger assembly comprising a plunger knob and a plunger shaft, wherein a distal end of the plunger shaft is configured to engage the implant; and
a spring-loaded drive assembly comprising:
an outer sleeve comprising at least one recessed region;
an inner shaft comprising:
an inner shaft knob comprising a proximally located circumferentially extending groove aligned with the at least one retaining pin opening;
an inner shaft main body;
at least one drive lobe on the inner shaft main body, said at least one drive lobe being received within the at least one recessed region;

at least one retaining pin,
wherein the at least one retaining pin is insertable into the at least one retaining pin opening and is further received by the proximally located circumferentially extending groove, operatively coupling the inner shaft to the handle knob; and
a locking pin,
wherein the spring-loaded drive assembly comprises a first extended position and second retracted position, wherein the locking pin is located proximally of the at least one drive lobe in the second retracted position, and wherein the locking pin is located adjacent to the at least one drive lobe in the first extended position, and
wherein at least one drive lobe is received within the at least one recessed region in the second retracted position; and

an implant adapter comprising a proximal end and a distal end,
wherein the proximal end of the implant adapter comprises at least one flexible leg reversibly attached to a distal end of the outer sleeve of the spring-loaded drive assembly, and wherein the distal end of the implant adapter is configured to engage the implant.

13. The medical implant insertion system of claim 12 , wherein the implant adapter comprise four flexible legs and the distal end of the outer sleeve comprises four adapter grooves for receiving the four flexible legs.

14. The medical implant insertion system of claim 13 , wherein the implant adapter further comprises a plurality of grooves in a hex configuration for engaging with a hexagonal nut of the implant.

15. A method of inserting a medical implant using an insertion instrument, the method comprising:
providing the insertion instrument comprising:
a handle assembly comprising:
a handle knob comprising a distally located circumferentially extending groove;
an elongated main body extending distally away from the handle knob;
a main body lumen extending from a proximal end o

Assignees

• Spinal Simplicity Llc

Inventors

• Slover Jeff
• Frock Adam
• Moseley Todd
• Lee Jeffrey David
• Aragonez Christian
• Rogers Adam
• Frock Melissa

Classifications

• A61F2/4611

  of spinal prostheses · CPC title

• A61B17/7074

  Tools specially adapted for spinal fixation operations other than for bone removal or filler handling (A61B17/7062, A61B17/808, A61B17/8858 take precedence; for spinal image producing devices A61B90/36, A61B34/20; markers A61B90/39) · CPC title

• A61F2002/30471

  connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type · CPC title

• A61F2002/4627

  with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument · CPC title

• A61F2002/30579

  with mechanically expandable devices, e.g. fixation devices · CPC title