# US 12,178,488 B2 · Kyphoplasty system and method

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- Number: US 12,178,488 B2
- Document ID: US12178488B2
- Status: Granted
- Kind: B2
- Application number: 18/425,560
- Filed: 2024-01-29
- Published: 2024-05-23
- Granted: 2024-12-31
- Earliest claimed: 2019-07-15
- Assignees: Osteon Medical LLC
- Applicants: Osteon Medical LLC
- Inventors: Nathan William Murdoch; Cody L. Evans
- Web page: https://patentgrep.com/patent/US12178488B2

## CPC

- A61B 17/8855: {inflatable, e.g. kyphoplasty balloons}
- A61B 10/025: {for taking bone, bone marrow or cartilage samples}
- A61B 17/3415: {for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters (A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06)}
- A61B 17/3472: {for bones, e.g. intraosseus injections}
- A61B 17/8822: {characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum}
- A61G 13/121: {Head or neck}
- A61M 39/10: Tube connectors or tube couplings
- G09B 23/285: {for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas}
- G09B 23/30: Anatomical models {(G09B23/281 - G09B23/288 take precedence)}
- A61B 17/8811: {characterised by the introducer tip, i.e. the part inserted into or onto the bone}
- A61B 17/8816: {characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections}
- A61B 17/8819: {characterised by the introducer proximal part, e.g. cannula handle, or by parts which are inserted inside each other, e.g. stylet and cannula (A61B17/8825 takes precedence)}
- A61B 90/361: {Image-producing devices, e.g. surgical cameras}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61G: TRANSPORT, PERSONAL CONVEYANCES OR ACCOMMODATION SPECIALLY ADAPTED FOR PATIENTS OR DISABLED PERSONS (appliances for aiding patients or disabled persons to walk A61H3/00); OPERATING TABLES OR CHAIRS; CHAIRS FOR DENTISTRY; FUNERAL DEVICES (embalming corpses A01N1/00)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- G09B: EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS (devices for psychotechnics or for testing reaction times A61B5/16; games, sports, amusements A63; projectors, projector screens G03B)

## Abstract

A kyphoplasty system includes various instruments which can be selectively used in a surgical theater (e.g., during a surgical operation on a patient) or a surgical training environment. The kyphoplasty system can include one or more of a kyphoplasty apparatus, a prone table mat, a connector system, a bone introducer needle, and a biopsy device. The kyphoplasty system may also include a training system for use in the training environment.

## Claims

### Claim 1

A kyphoplasty method comprising:
implanting within a vertebral body a coaxial balloon implant having an inflatable kyphoplasty balloon coaxially mounted to a central implant shaft such that the inflatable kyphoplasty balloon simultaneously engages with a balloon inflation medium along an interior of the inflatable kyphoplasty balloon and with a bone filler material along an exterior of the inflatable kyphoplasty balloon, wherein:
the central implant shaft includes a proximal end, a distal end, a balloon inflation port along a circumferential shaft surface, a central conduit that extends from the proximal end to a bone filler output port at the distal end, and a detachment coupler at the proximal end configured to releasably mount with a removable delivery instrument; and
the inflatable kyphoplasty balloon is coaxially mounted to an exterior of the central implant shaft at a fixed position so that that inflatable kyphoplasty balloon is distal of the detachment coupler and is proximal of the bone filler output port, wherein the central implant shaft extends entirely through the inflatable kyphoplasty balloon; and
after the inflatable kyphoplasty balloon simultaneously engages with the balloon inflation medium along the interior of the inflatable kyphoplasty balloon and with the bone filler material along the exterior of the inflatable kyphoplasty balloon, disconnecting the removable delivery instrument from the central implant shaft of the coaxial balloon implant.

### Claim 2 (depends on 1)

The method of claim 1, wherein proximal and distal ends of inflatable kyphoplasty balloon are mounted to the central implant shaft at proximal and distal circumferential wall portions having a same outer diameter.

### Claim 3 (depends on 1)

The method of claim 1, wherein the inflatable kyphoplasty balloon is sized to maintain a selected height of the vertebral body while a balloon wall of the inflatable kyphoplasty balloon simultaneously engages the balloon inflation medium along the interior and the bone filler material along the exterior.

### Claim 4 (depends on 1)

The method of claim 1, wherein the balloon inflation port of the central implant shaft is a first radially facing port for balloon inflation, and the central implant shaft further comprises a second radially facing port for balloon inflation positioned along an outer circumferential surface of the central implant shaft and located opposite from the first radially facing port for balloon inflation.

### Claim 5 (depends on 1)

The method of claim 1, further comprising a balloon port valve positioned at the balloon inflation port and configured to selectively open and close the balloon inflation port and prevent a backflow of the balloon inflation medium through the balloon inflation port.

### Claim 6 (depends on 1)

The method of claim 1, further comprising a first valve disposed in the central implant shaft to prevent a backflow of the balloon inflation medium.

### Claim 7 (depends on 1)

The method of claim 1, wherein said disconnecting the removable delivery instrument from the central implant shaft of the coaxial balloon implant comprises threadably disengaging from the detachment coupler at the proximal end of the central implant shaft.

### Claim 8 (depends on 7)

The method of claim 7, further comprising, after said disconnecting the removable delivery instrument from the central implant shaft of the coaxial balloon implant, withdrawing the removable delivery instrument away from the vertebral body while the inflatable kyphoplasty balloon remains within the vertebral body and simultaneously engaged with the balloon inflation medium along the interior of the inflatable kyphoplasty balloon and with the bone filler material along the exterior of the inflatable kyphoplasty balloon.

### Claim 9 (depends on 1)

The method of claim 1, wherein the removable delivery instrument includes an elongate shaft having a distal end configured to threadably engage with detachment coupler at the proximal end of the central implant shaft.

### Claim 10 (depends on 9)

The method of claim 9, further comprising:
injecting the balloon inflation medium through the elongate shaft of the removable delivery instrument and into the balloon inflation port of the central implant shaft of the coaxial balloon implant so as to inflate the inflatable kyphoplasty balloon to maintain a selected height of the vertebral body; and
after said injecting the balloon inflation medium through the elongate shaft of the removable delivery instrument, injecting the bone filler material through the elongate shaft of the removable delivery instrument and distally from the distal end of central implant shaft of the coaxial balloon implant.

### Claim 11

A kyphoplasty method comprising:
inserting into a vertebral body an kyphoplasty implant including an implant shaft body extending entirely through, and coaxial with, an implant balloon device that is fixedly mounted to an exterior circumferential surface of the implant shaft body, wherein the implant shaft body has a proximal end, a distal end, a proximal detachment coupler, a central access conduit extending to a distal facing access port, and a radially facing port for balloon inflation positioned along an outer circumferential surface of the implant shaft body, wherein the implant balloon device is coaxially mounted to the implant shaft body so that the proximal detachment coupler of the implant shaft body is positioned proximally of the implant balloon device and the distal facing access port of the implant shaft body is positioned distally of the implant balloon device;
delivering a balloon inflation medium through the radially facing port positioned along the outer circumferential surface of the implant shaft body so that the implant balloon device of the kyphoplasty implant is adjusted to an inflated configuration;
after the implant balloon device of the kyphoplasty implant is adjusted to the inflated configuration, delivering a bone cement into the vertebral body and distally from the distal end of the implant shaft body so that a balloon wall of the implant balloon device simultaneously engages the balloon inflation medium along an interior surface of the balloon wall and the bone cement along an exterior surface of the balloon wall.

### Claim 12 (depends on 11)

The method of claim 11, wherein the implant shaft body further comprises a one-way valve located at the radially facing port for balloon inflation so that the balloon inflation medium is deliverable through the radially facing port into the implant balloon device while the one-way valve hinders deflation of the implant balloon device.

### Claim 13 (depends on 12)

The method of claim 12, wherein the central access conduit extends from the proximal detachment coupler to the distal facing access port for delivery of the bone cement distally from the distal end implant shaft body.

### Claim 14 (depends on 11)

The method of claim 11, wherein during said inserting the kyphoplasty implant into the vertebral body, the proximal detachment coupler of the implant shaft body is threadably engaged with a removable delivery shaft.

### Claim 15 (depends on 14)

The method of claim 14, wherein the removable delivery shaft comprises a central conduit that is axially aligned with both the central access conduit and the distal facing access port of the implant shaft body when the removable delivery shaft is threadably engaged with the proximal detachment coupler of the implant shaft body.

### Claim 16 (depends on 14)

The method of claim 14, further comprising disconnecting the removable delivery shaft from the proximal detachment coupler of the implant shaft body of the kyphoplasty implant while the balloon wall of the implant balloon device of the kyphoplasty implant remains simultaneously engaged with the balloon inflation medium along the interior surface of the balloon wall and the bone cement along the exterior surface of the balloon wall.

### Claim 17 (depends on 11)

The method of claim 11, wherein the implant balloon device is sized to maintain a selected height of the vertebral body while the balloon wall of the implant balloon device simultaneously engages the balloon inflation medium along the interior surface of the balloon wall and the bone cement along the exterior surface of the balloon wall.

### Claim 18 (depends on 11)

The method of claim 11, the implant shaft body includes a balloon port valve positioned at the radially facing port and configured to prevent a backflow of the balloon inflation medium through the radially facing port.

### Claim 19 (depends on 11)

The method of claim 11, wherein the radially facing port for balloon inflation is a first radially facing port for balloon inflation, and the implant shaft body further comprises a second radially facing port for balloon inflation positioned along the outer circumferential surface of the implant shaft body and located opposite from the first radially facing port for balloon inflation.

### Claim 20 (depends on 11)

The method of claim 11, wherein proximal and distal ends of implant balloon device engage circumferential wall portions of the implant shaft body having a same outer diameter.
