Vertebral Access System and Methods

• US 20090194446A1
• Filed: 03/19/2009
• Published: 08/06/2009
• Est. Priority Date: 09/12/2006
• Status: Active Grant

• Current Assignee: Teleflex Life Sciences II LLC
• Original Assignee: Vidacare LLC (Teleflex Incorporated)
• Inventors: Eisbrenner, Eric W., Miller, Larry J.
• Granted Patent: US 8,944,069 B2
• Time in Patent Office: Days
• US Class Current: 206/438
• CPC Class Codes: A61B 10/025 for taking bone, bone marrow or cartilage samples
• CPC Class Codes: A61B 17/3472 for bones, e.g. intraosseus injections
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0258 Marrow samples
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00734 battery operated
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2050/0065 Peelable cover
• CPC Class Codes: A61B 2050/3008 having multiple compartments
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2562/247 Hygienic covers, i.e. for covering the sensor or apparatus during use
• CPC Class Codes: A61B 46/00 Surgical drapes
• CPC Class Codes: A61B 46/10 specially adapted for instruments, e.g. microscopes
• CPC Class Codes: A61B 46/23 with means to retain or hold surgical implements
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/3001 for sharps
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: A61B 90/40 Apparatus fixed or close to patients specially adapted for providing an aseptic surgical environment
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Medical devices, medical procedure trays, kits and related methods are provided for use to perform medical procedures that require access to the interior of a bone. The devices, trays and methods allow multiple use of non-sterile medical devices with sterile medical devices for performing medical procedures requiring sterile conditions. A coupler assembly, capable of releasably attaching to a non-sterile medical device at one end and releasably attaching to one or more sterile medical devices at another end, and further comprising a containment bag which allows maintaining sterility of a non-sterile medical device which may be used in conjunction with sterile medical devices and procedures. The devices, trays, kits and methods enable the performance of multiple medical procedures with a single insertion into bone. For example, a vertebral procedure such as a vertebroplasty may be performed along with biopsy and/or bone marrow aspiration procedures, thereby reducing patient trauma and costs.

Claims

1. An intraosseous (IO) medical procedures tray comprising:

at least one IO device comprising at least one set of IO needles;

the IO needle set comprising at least one IO needle operable to penetrate a bone and at least one IO needle operable to deliver a therapeutic agent to the bone;

a coupler assembly comprising a first end operable to releasably engage one or more IO devices and a second end operable to releasably engage a powered driver;

the coupler further comprising a sterile containment bag operable to enclose the powered driver;

slots and holders for each component; and

a removable sterile cover over the IO medical procedures tray to maintain sterility of the components.

2. An intraosseous (IO) medical procedures tray of claim 1, wherein the IO needle set further comprises at least one IO needle operable to obtain a medical sample from the bone.

3. An intraosseous (IO) medical procedures tray of claim 1 or claim 2, further comprising other components for placement in the tray from the group consisting of a containers for sharps, a container for collecting a medical sample, an ejector funnel, and one or more smaller trays comprising one or more components of the tray.

4. An intraosseous (IO) medical procedures tray of claim 1 or claim 2, further comprising selecting IO devices for placement in the tray from the group consisting of an IO needle operable to penetrate any bone, a vertebral needle set, a biopsy needle set, an aspiration needle set, a vertebral needle operable to penetrate a vertebral bone, a biopsy needle, an aspiration needle, a trocar operable to inject a therapeutic agent into a bone, an ejector rod operable to inject a therapeutic agent into a bone, an ejector operable to remove a biopsy sample from a bone, a rod operable to remove a biopsy sample from a vertebral bone, a rod operable to be slidably inserted into a vertebral needle that is operable to penetrate a vertebral bone, an IO needle operable to inject bone cement into a bone and combinations thereof.

5. A method for performing one or more IO medical procedures using a medical procedures tray comprising:

unwrapping a sterile removable cover on the medical procedures tray;

attaching a non-sterile powered driver to one end of a coupler assembly disposed in the medical procedures tray;

extending a sterile containment bag attached proximate the one end of the coupler assembly over the non-sterile power driver;

securing the non-sterile power driver in the sterile containment bag;

engaging a second end of the coupler assembly with a first IO needle operable to penetrate a bone;

activating the powered driver to insert a first end of the first IO needle into a selected target site on the bone;

detaching the powered driver and coupler assembly leaving the first IO needle inserted into the bone;

slidably disposing a second IO needle of the IO device into the first IO needle inserted into the bone, wherein the second IO needle is operable deliver at least one therapeutic agent and comprises at least one therapeutic agent;

delivering the therapeutic agent from the second IO needle into the bone;

detaching the second IO needle from the first IO needle;

reattaching the powered driver and coupler assembly to the first IO needle; and

activating the powered driver to withdraw the first IO needle from the bone.

6. A method of claim 5, further comprising visualization of at least portions of the medical procedure using imaging technology.

7. A method of claim 5, further comprising:

slidably inserting a third IO needle into the first IO needle, wherein the third IO needle is operable to obtain a bone sample for diagnostic analysis;

contacting the interior of the bone with the third IO needle thereby collecting a bone sample into a lumen of the third IO needle; and

slidably withdrawing the third IO needle comprising the collected bone sample from the first needle.

8. A method of claim 7, further comprising selecting the third IO needle from a group consisting of a biopsy needle and an aspiration needle.

9. A method of manufacture and assembly of an IO medical procedure tray comprising at least one IO device operable to be used with a powered driver and operable to penetrate a bone and deliver a therapeutic agent to the bone comprising:

forming a big tray with a plurality of slots and holders disposed within the big tray;

forming each slot and holder with a respective configuration and dimensions operable to allow placing one or more smaller trays or one or more respective IO device or other component associated with the medical procedure therein;

forming a first small tray with a plurality of slots and holders disposed within the first small tray;

forming each slot and holder with a respective configuration and dimensions operable to allow placing at least a first respective IO device or other component associated with the medical procedure therein;

forming a second small tray with a plurality of slots and holders disposed within the second tray;

placing a coupler assembly into a respective holder in the second small tray wherein a first end of the coupler assembly is placed into the respective holder and a second end of the coupler assembly is looking up from the medical procedure tray whereby the medical procedure tray provides support for the coupler assembly to allow one end of a powered driver to be inserted into the second end of the coupler assembly and to remove the coupler assembly from the tray;

optionally forming a third small tray with a plurality of slots and holders disposed within the third small tray;

forming each slot and holder with a respective configuration and dimensions operable to allow placing at least a second respective IO device or other component associated with the medical procedure therein;

placing the first small tray, the second small tray and optionally the third small tray adjoining one another in the big tray; and

placing a removable cover over the big tray to contain all the small trays and their components.

10. A method of claim 9, further comprising sterilizing the tray and its components.

11. A method of claim 9, further comprising selecting IO devices and other components for placement in the tray from the group consisting of an IO needle operable to penetrate any bone, a vertebral needle set, a biopsy needle set, an aspiration needle set, a vertebral needle operable to penetrate a vertebral bone, a biopsy needle, an aspiration needle, a trocar operable to inject a therapeutic agent into a bone, an ejector rod operable to inject a therapeutic agent into a bone, an ejector operable to remove a biopsy sample from a bone, a rod operable to remove a biopsy sample from a vertebral bone, a rod operable to be slidably inserted into a vertebral needle that is operable to penetrate a vertebral bone, an IO needle operable to inject bone cement into a bone, a funnel operable to assist with inserting one end of the injector into a first end of the biopsy needle to remove the biopsy sample through the lumen and out of a second end of the biopsy needle and a container operable to collect a biopsy sample, containers for sharps, one or more smaller trays comprising one or more components of the tray and combinations thereof.

12. The method of claim 9, wherein placing the first intraosseous device in the first small tray further comprises:

placing a vertebral needle set comprising a cannula operable to penetrate a vertebral bone and a trocar or a stylet operable to deliver a therapeutic agent into a vertebral body; and

placing at least one ejector funnel and at least one sharps protector in respective holders.

13. The method of claim 9, wherein placing the second intraosseous device in the third small tray further comprises:

placing a biopsy needle set and a biopsy specimen ejector rod in respective slots; and

placing an ejector funnel and a sharps protector in respective holders.

14. The method of claim 9, wherein placing the second intraosseous device in the third small tray further comprises:

placing an aspiration needle set in respective slots; and

placing an ejector funnel and a sharps protector in respective holders.

15. A vertebral medical procedures tray comprising slots and holders for each component, the components comprising:

at least one vertebral IO device comprising at least one vertebral IO needle set;

the vertebral IO needle set comprising at least one vertebral IO needle operable to penetrate a vertebral bone and at least one IO needle operable to deliver a therapeutic agent to the vertebral bone or a vertebral body;

a coupler assembly comprising a first end operable to releasably engage one or more vertebral IO devices and a second end operable to releasably engage a non-sterile powered driver;

the coupler further comprising a sterile containment bag operable to enclose the non-sterile powered driver; and

a removable cover over the vertebral IO medical procedures tray to maintain sterility of the components.

16. A vertebral medical procedures tray of claim 15, wherein the at least one IO needle operable to deliver a therapeutic agent to the vertebral bone or a vertebral body is an IO needle operable to deliver bone cement into the vertebral bone or the vertebral body.

17. A vertebral medical procedures tray of claim 15, further comprising a vertebral biopsy needle set comprising at least one biopsy needle operable to obtain a medical sample from a vertebral body.

18. A vertebral medical procedures tray of claim 15, further comprising a vertebral aspiration needle set comprising at least one aspiration needle operable to obtain a medical sample from a vertebral body.

19. A vertebral medical procedures tray of claim 15, further comprising selecting vertebral IO devices or other components for placement in the tray from the group consisting of a containers for sharps, a container for collecting a medical sample, an ejector funnel, and one or more smaller trays comprising one or more components of the tray, a vertebral needle set, a biopsy needle set, an aspiration needle set, a vertebral needle operable to penetrate a vertebral bone, a biopsy needle, an aspiration needle, a trocar operable to inject a therapeutic agent into a vertebral bone, an ejector rod operable to inject a therapeutic agent into a vertebral bone, an ejector operable to remove a biopsy sample from a vertebral bone, a rod operable to remove a biopsy sample from a vertebral bone, a rod operable to be slidably inserted into a vertebral needle that is operable to penetrate a vertebral bone, an IO needle operable to inject bone cement into a vertebral body and combinations thereof.

20. A method for performing a vertebral medical procedure using a vertebral procedures tray of claim 15 comprising:

opening the sterile cover of the vertebral procedures tray;

attaching a non-sterile powered driver to the second end of the coupler assembly;

extending the sterile containment bag of the coupler assembly over the non-sterile power driver;

securing the non-sterile power driver into the sterile containment bag by a securing means;

engaging the second end of the coupler assembly with a first vertebral IO needle of the vertebral IO device wherein the first vertebral IO needle is operable to penetrate a vertebral bone;

activating the powered driver to insert a first end of the first vertebral IO needle into a selected target site on the vertebral bone;

detaching the powered driver and coupler assembly leaving the first vertebral IO needle inserted into the vertebral bone;

slidably disposing a second vertebral IO needle of the vertebral IO device into the lumen of the first vertebral IO needle inserted into the vertebral bone, wherein the second vertebral IO needle is operable deliver at least one therapeutic agent and comprises at least one therapeutic agent;

delivering the at least one therapeutic agent from the second vertebral IO needle into the vertebral bone;

slidably detaching the second vertebral IO needle from the first vertebral IO needle;

reattaching the powered driver and coupler assembly to the first vertebral needle; and

activating the powered driver to withdraw the first vertebral IO needle from the vertebral bone.

21. A method of claim 20, further comprising visualization of the vertebral procedure using imaging technology.

22. A method of claim 20, further comprising:

slidably inserting a third vertebral IO needle into the first vertebral IO needle, wherein the third vertebral IO needle is operable to obtain a sample from the vertebral bone for diagnostic analysis;

contacting the interior of the vertebral bone with the third vertebral IO needle thereby disposing a bone sample into the lumen of the third vertebral IO needle;

slidably withdrawing the third vertebral IO needle comprising the collected vertebral sample.

23. A method of claim 20, wherein the therapeutic agent may be selected from a group consisting of a bone cement, a surgical cements, a bone morphogenetic factor, a cartilage-derived morphogenetic factor, an osteogenic factor, a differentiating factor, an anti-resorption agent, a hormone, a growth hormone, a nucleic acid construct, or a pharmaceutical.

24. A coupler assembly operable to releasably attach a plurality of IO devices and releasably attach a non-sterile powered driver comprising:

a coupler housing;

a first end operable to releasably attach a plurality of intraosseous devices;

a second end operable to releasably attach the non-sterile powered driver;

a sterile containment bag proximate the second end comprising an opening operable to insert and enclose the non-sterile powered driver to prevent contamination of the IO devices by the non-sterile powered driver;

a torturous path proximate the second end and proximate the sterile containment bag, wherein the torturous path prevents contamination of the coupler housing following attachment with the non-sterile driver at the second end; and

a spinner operable to be rotated for insertion and securing of an IO device at the first end of the coupler assembly.

25. The coupler assembly of claim 24, wherein the sterile containment bag further comprises:

a flexible stay engaged with portions of the opening;

a first end and a second end of the flexible stay releasably engaged with respective holders in a medical tray to retain the containment bag in an open position to allow inserting the powered driver therein;

a flap operable to wrap around the flexible stay to enclose the opening; and

a means to secure the flap and the inserted powered driver in the containment bag.

26. The coupler assembly of claim 24, wherein the containment bag is attached proximate the second end using an attachment means.

27. The coupler assembly of claim 26, wherein the attachment means is hot glue.