Surgical tray containing a bone graft substitute resistant to autoclaving and method of using the same

Abstract

A surgical tray includes a set of surgical instruments and a containerized bone graft substitute (BGS) capable of being repeatedly autoclaved. Preferred BGS include calcium phosphate salts. The BGS is preferably provided pre-sterilized from the manufacturer, and may be contained, e.g., in an ampoule, a cartridge for a delivery device, or pre-loaded in a syringe. The BGS container may be wrapped in a protecting pouch.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

The application claims the benefit of U.S. Provisional Application Ser. No. 60/600,514, filed Aug. 11, 2004, which is incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates broadly to surgical apparatus and procedures. More particularly, this invention relates to surgical instrument trays and bone graft substitutes.

2. State of the Art

Bone grafts or bone graft substitutes (BGS) are often used during surgery, mostly, but not limited to orthopedic, maxillofacial and plastic surgery. Generally, a graft is used when a defect or void in a bone results from disease, trauma or surgery or a gap between bone ends remains after the reduction of a fracture. The graft or BGS accelerates the healing process at the site of the defect, void or gap.

The ‘established standard’, called an autograft, uses the patient's own bone. The autograft is osteogenic (provides live precursor cells), osteoinductive (provides bone growth factors) and osteoconductive (provides a scaffold to enable the attachment, distribution and migration of cells). However an autograft requires harvesting bone from a donor site in the patient, usually the iliac crest, which can lead to morbidity, risk of infection and pain in a site separate from the site where the autograft is used. This creates additional risk, inconvenience and time of convalescence for the patient.

Bone graft substitutes eliminate the disadvantages of an autograft. One type of substitute, called allograft, is derived from human donor bone. Allograft is usually osteoinductive and osteoconductive. However, drawbacks of allograft are the somewhat limited supply and high cost. Furthermore, there is inconsistency in composition due to its natural derivation and also some risk of disease transmission.

Other types of substitutes are synthetic and primarily osteoconductive. They are usually calcium sulfate and calcium phosphate salts. Their supply is unlimited, their cost is relatively low, they are consistent in composition and there is no risk of disease transmission.

When performing a surgical procedure, a surgical tray is provided for the surgeon which includes the required instruments for the procedure and oftentimes implantable devices as well. The instruments and implants in the tray are cleaned and sterilized prior to each surgical procedure. Autoclaving is a method commonly used for sterilization of the tray, instruments and implants.

No known surgical tray is provided with bone graft substitute inside the tray at the time just prior to autoclaving. Instead, the bone graft substitute is provided in a separate package, outside of the surgical tray, to be used by the surgeon if and when required.

Bone graft substitutes generally require several hands for preparation and/or application at the time of use. One method is to apply the BGS into the bone void with an instrument such as a curette. However this requires the surgeon to use two hands—one to hold the container and the other to manipulate the curette to remove the BGS and pack it into the void. No hand remains available for manipulation of another instrument or the patient. Another preferred delivery method is via a syringe. However, in many cases, the bulk BGS must be removed from its package and placed within the syringe prior to use which is time consuming during the surgical procedure. Moreover, even standard syringes for use with BGS have difficulty directing the BGS to the desired location which may be around a side of the bone not easily accessible to the surgeon.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a surgical tray which includes a BGS.

It is another object of the invention to provide a surgical tray which includes a pre-sterilized BGS that will not be adversely affected by autoclaving.

It is a further object of the invention to provide a surgical tray which includes a BGS pre-packaged in a delivery device or a container directly insertable into a delivery device.

It is an additional object of the invention to provide a BGS prepackaged in a delivery device which can provide better access to hard to reach bone voids.

In accord with these objects, which will be discussed in detail below, a surgical tray is provided including a set of surgical instruments, implants and a containerized bone graft substitute (BGS). Preferred BGS include calcium salts for their tolerance of autoclaving. The BGS is preferably provided pre-sterilized from the manufacturer, and may be contained, e.g., in an ampoule, a cartridge for a delivery device, or pre-loaded in a syringe, all of which are suitable for autoclaving. When pre-loaded in a syringe, the syringe preferably includes a curved tip which can direct the BGS into a hard to reach location. The containerized BGS may be further provided in a pouch that is suitable for autoclaving.

In accord with the invention, the surgical tray with instruments, implants and BGS is provided to the surgeon. Initially, the instruments and implants may be autoclaved together or separately from the BGS. In the event the instruments and implants were autoclaved separately, the pre-sterilized BGS is then provided in the tray just prior to surgery.

Then during the surgical procedure if the surgeon requires use of a BGS, the BGS is conveniently located within easy reach of the surgeon. In addition, if the BGS is already provided in a syringe or cartridge and does not have to be placed within the syringe, the preparation time for using the BGS is greatly reduced.

If the BGS was not required during the procedure, it is left within the tray. The instruments are cleaned and the tray as whole (instruments, implants and containerized BGS) is autoclaved in preparation for a subsequent surgical procedure in which the BGS may be required. The autoclave-resistant BGS can withstand multiple cycles of autoclaving and is conveniently available when needed.

Additional objects and advantages of the invention will become apparent to those skilled in the art upon reference to the detailed description taken in conjunction with the provided figures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of a surgical tray including a pre-sterilized bone graft substitute containerized according to a first embodiment of the invention.

FIG. 2 is a schematic view of a surgical tray including a pre-sterilized bone graft substitute containerized according to a second embodiment of the invention.

FIG. 3 is a schematic view of a surgical tray including a pre-sterilized bone graft substitute containerized according to a third embodiment of the invention.

FIG. 4 is a schematic view of a surgical tray including a pre-sterilized bone graft substitute containerized according to a fourth embodiment of the invention.

DETAILED DESCRIPTION

Referring now to FIG. 1, a surgical tray 10, in this exemplary case for orthopedic surgery, is shown. The tray includes non-disposable instruments such as a drill guide 16, drill bits 18a, 18b, a driver 20, and rongeur 22. The tray may include multiple implants, including fixation plates 12a, 12b and 12c and screws and pegs 14. According to the invention, the tray also includes a container, e.g., a glass ampoule 24, containing a bulk quantity of a bone graft substitute (BGS) 26. The ampoule preferably includes a groove 28 which facilitates snapping a tip cleanly off the ampoule for access to and removal of the BGS by a curette 30. The curette 30 can then be used to apply the BGS to a bone void requiring the BGS.

Initially, the implants 12a-c and 14 and instruments 16, 18a-b, 20, 22 and 30 can be sterilized separately from the containerized BGS 26. This is because the BGS 26 is generally received from the manufacturer in a sterilized state and does not require the same initial sterilization as the implants and instruments. However, it is certainly possible and even practical to place the BGS 26 into the tray 10 prior to implant and instrument sterilization and to sterilize the tray with the containerized BGS already inside it in order to reduce the number of steps required once the surgery is initiated.

Turning to FIG. 2, the containerized BGS 126 (and any containerized BGS discussed herein) may be provided inside an autoclave resistant pouch 132 within the tray 110. When using the pouch 132, the BGS is double-packaged, providing two-layers of sterilization.

Referring now to FIG. 3, the BGS 226 is provided in a cartridge 224 for a delivery device 234. The cartridge 224 includes a movable seal 236 at one end, and a removable or breakable opposite end 238 through which the BGS 226 can be dispensed. The cartridge 224 is preferably substantially constant in diameter between the seal 236 and breaking point 228. The delivery device 234 includes a chamber 240 to receive the cartridge and a plunger 242 which can be forced against the seal 236 to cause the seal to function as a piston and dispense the BGS from the cartridge. The constant diameter of the cartridge 224 provides desirable flow of the BGS 226 from the cartridge when under pressure of the plunger 242. The delivery device can be designed to provide mechanical advantage between a force applied by the user and the pressure exerted on the BGS to expel the BGS from the cartridge.

Turning now to FIG. 4, the BGS 326 is pre-loaded in a syringe 350. The syringe 350 has a nozzle 352 with a curved portion 354 preferably having a 1-5 cm radius of curvature, optionally a straight portion 356 after the curved portion 354 of the nozzle of 0-1 cm in length, and an outlet 360 of 2-5 mm in diameter. A break-off tip or removable cap is provided at the outlet. The shape of the nozzle 352 permits delivery of the BGS to hard to reach places. The syringe 350 has a delivery capacity of 1-5 cc, and most preferably 2-2.5 cc. By providing a pre-filled syringe, the surgeon can, after breaking off tip or removing cap, quickly apply the BGS to the bone void with one hand. No filling of a delivery device or two-handed application is required.

Regardless of which containerized form of BGS is provided in the surgical tray, such BGS must be able to withstand repeated cycles of autoclave sterilization. Preferred BGS for use in the invention include calcium salts, and most preferably include calcium sulfate, beta-tricalcium phosphate and hydroxyapatite. In addition, a mixture of two or more of calcium phosphate and/or calcium sulfate and/or hydroxyapatite can be used.

If the BGS can withstand repeated sterilization cycles, but only a limited number of such cycles, it may be preferable to include a counter 370 (FIG. 4) in association with the BGS which records the number of times the tray or BGS has been autoclaved. Such counters may be mechanical or electronic devices. Suitable temperature cycle counters are known in the art and described in U.S. Pat. No. 5,452,335, which is hereby incorporated by reference in its entirety.

There have been described and illustrated herein several embodiments of an orthopedic surgical tray. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular delivery devices have been disclosed, it will be appreciated that other delivery devices could be used as well. In addition, while particular types of autoclavable BGS have been disclosed, it will be understood that other BGS that can tolerate autoclaving without serious adverse affect (i.e., material breakdown and/or failure to function as a BGS) can be used. Furthermore, BGS, for purposes herein, is intended to also mean an osseous bone paste which includes a bone graft substitute material as described above provided in an autoclave resistant carrier or excipient. Also, while a surgical tray for an orthopedic surgical procedure is shown, trays for other procedures during which BGS is used may likewise be provided with the BGS. By way of example, surgical trays for maxillofacial surgery, neurosurgery, cosmetic surgery, etc. may be provided with the pre-sterilized and autoclave-resistant BGS. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.

Claims

1. An surgical tray, comprising:

a) a tray;

b) a plurality of surgical instruments in said tray; and

c) a containerized, pre-sterilized bone graft substitute (BGS) in said tray.

2. A surgical tray according to claim 1, wherein:

said BGS is capable of being autoclaved without serious adverse effect to the BGS.

3. A surgical tray according to claim 1, wherein:

said BGS is a calcium salt or a mixture of two or more calcium salts

4. A surgical tray according to claim 1, wherein:

said BGS is beta-tricalcium phosphate.

5. A surgical tray according to claim 1, wherein:

said BGS is hydroxyapatite.

6. A surgical tray according to claim 1, wherein:

said BGS is a mixture of beta-tricalcium phosphate and hydroxyapatite.

7. A surgical tray according to claim 1, wherein:

said containerized BGS includes a BGS in an ampoule.

8. A surgical tray according to claim 1, wherein:

said containerized BGS includes a BGS in a cartridge for a delivery device.

9. A surgical tray according to claim 1, wherein:

said containerized BGS includes a BGS preloaded in a syringe.

10. A surgical tray according to claim 9, wherein:

said syringe has a curved tip.

11. A surgical tray according to claim 1, further comprising:

a plurality of orthopedic implantable devices in said tray.

12. An orthopedic surgical tray according to claim 11, wherein:

said orthopedic implantable devices include at least one fracture fixation plate and a plurality of at least one of screws and pegs.

13. An orthopedic surgical tray according to claim 1, further comprising:

a heat cycle counter in association with at least one of said containerized BGS.

14. An orthopedic surgical tray according to claim 1, further comprising:

a pouch in which said containerized pre-sterilized BGS is provided.

15. A method of providing a surgical tray, comprising:

a) providing a tray;

b) providing surgical instruments in the tray; and

c) providing a containerized pre-sterilized bone graft substitute (BGS) in the tray.

16. A method according to claim 15, further comprising:

providing a plurality of orthopedic implantable devices in the tray.

17. A method according to claim 15, further comprising:

using the tray in a surgical procedure during which at least one of the surgical instrument is used, and the BGS is not used; and subsequently

sterilizing the tray and the surgical instruments with the containerized BGS inside the tray.

18. A method according to claim 15, wherein:

said BGS includes a calcium salt.

19. A method according to claim 15, wherein:

said BGS is selected from the group of calcium sulfate, beta-tricalcium phosphate, hydroxyapatite, and a mixture thereof.

20. A method according to claim 15, wherein:

said providing a containerized BGS includes providing the BGS in a cartridge which can be inserted into a delivery device.

21. A method according to claim 15, wherein:

said providing a containerized BGS includes providing the BGS pre-loaded in a syringe.

22. A method according to claim 15, wherein:

said providing a containerized BGS includes providing the BGS pre-loaded in a syringe having a curved tip.