WO2020093021A1

WO2020093021A1 - Cutting guide system for use with orthopedic saws and drills

Info

Publication number: WO2020093021A1
Application number: PCT/US2019/059552
Authority: WO
Inventors: Theodore R. Kucklick
Original assignee: Cannuflow, Inc.
Priority date: 2018-11-01
Filing date: 2019-11-01
Publication date: 2020-05-07

Abstract

Cutting guide system for use with orthopedic saws and drills for preventing thermal necrosis of bone or tissue.

Description

CUTTING GUIDE SYSTEM FOR USE WITH ORTHOPEDIC SAWS AND DRILLS

Field of the Inventions

[0001] The inventions described below relate to the field of surgical procedures and more specifically, to surgical procedures that create a heat, or a heated byproduct that causes a deleterious effect on tissue or bone.

Background of the Inventions

[0002] In nearly every surgical specialty there are heat- producing devices that can cause collateral tissue damage. These devices may include but are not limited to bipolar and monopolar radiofrequency cutting and ablation wands, surgical saws and drills that generate frictional heating, lasers, ultrasound cutting devices and thermal cautery devices.

Tissues such as cartilage, nerve, brain, and cancerous bone are especially sensitive to heat, and thermal spread into these tissues can cause irreversible damage. In neurosurgery it is well known that brain tissue is especially heat

sensitive and conducts heat very readily, causing thermal damage to spread deeply into tissues. Heating of bone during sawing and drilling can lead to osteonecrosis and failure of fixation screws and loosening of joint implants. Surgical cutting guides for orthopedic surgery are known in the art. These guides are used in knee, hip, spine, and other

procedures where a precise cut is needed.

[0003] Currently, room temperature saline is used to irrigate these heat intensive surgical sites. However, there is no ready source of temperature controlled sterile pre cooled fluid in the operating room. Previous cumbersome attempts to produce chilled sterile saline involve ice baths or cooling saline in a bowl delivered with a bulb syringe. [0004] There exists a need for a convenient source of pre cooled sterile saline to cool tissues at risk of thermal damage, and the ability to connect a variety of cooling accessories to this cooled saline source, that deliver cooling to the surgical site in a precise and controlled manner. The system must also be versatile to deliver coolant saline to any surgical site whether arthroscopic, endoscopic, laparoscopic, or an open procedure such as a knee or hip replacement.

Summary

[0005] The devices, systems and methods described below provide for cooling a surgical cutting or drilling tool for preventing thermal necrosis of bone or tissue. When cutting or drilling, the foot pedal of the insulated fluid chilling assembly is pressed and the pump is activated, delivering a mist or stream of temperature controlled cooled sterile fluid on demand to the cutting tool and or the surgical site to prevent overheating. Alternatively, the fluid spray may be operable when the surgical tool is turned on, such as by a finger switch on the drill or saw to activate the flow of saline .

[0006] Various other devices, such as surgical cutting guides, may be operably connected to the outflow of the insulated fluid chilling assembly. These devices utilize circulating cooled fluid operably connected to the insulated fluid chilling assembly outflow. The circulated cooled fluid may be open or closed loop. For example, surgical cutting guides are provided with interior fluid channels to cool the guide while the surgical saw resects bone.

[0007] Putting water on a drill or saw is well known in the art. However, what is described below is a system and method of having a supply of sterile fluid at a specific temperature, whether to cool an RF wand, a saw blade or a drill. The system is like "Instacold" for the operating room, where cold fluid is pumped to a surgical site on demand.

[0008] The devices and methods described below provide for a system for identifying a device with either a printed bar code or QR code label, or for a camera and processor system to be able to recognize the product through the use of machine vision. This is especially suited to a system that can identify product, perform presets, and transmit inventory data with low-cost hardware.

Brief Description of the Drawings

[0009] Figure la illustrates the insulated fluid chilling assembly.

[0010] Figure lb illustrates the spray/mist/stream device assembly removably attached to a surgical saw.

[0011] Figure lc illustrates the spray/mist/stream device assembly removably attached to a surgical drill.

[0012] Figure Id illustrates the spray/mist/stream device assembly with suction and LED lights.

[0013] Figure le illustrates an irrigation/suction/light pen.

[0014] Figure 2a illustrates a cutting guide with internal cooling channels.

[0015] Figure 2b illustrates a cutting guide with internal cooling channels.

[0016] Figure 2c illustrates a cooled single drill guide.

[0017] Figure 2d illustrates a bipolar RF or ultrasound cutting and sealing device with built in cooling channels.

[0018] Figure 2e illustrates a cooling loop. [0019] Figure 2f illustrates a dual drill guide with internal cooling channels for spine and orthopedic surgery.

Detailed Description of the Inventions

[0020] Figure la illustrates the insulated fluid chilling assembly 1. The fluid bag holder 2 is provided with a display 3 and a touchscreen 4 for control. A saline fluid bag (not shown) is inserted into the fluid bag holder. The fluid bag holder is insulated to keep the fluid at the optimal

temperature. A peristaltic fluid pump 5 pumps fluid from the fluid bag through a fluid outflow tube 6 for dispensing the fluid to the surgical instrument. The pump is controlled by a foot pedal 7. A sensor 8 for sensing RF is connected to an RF ablation device or foot pedal (or both) for sensing when the RF tool is activated.

[0021] The surgical instruments shown are outfitted with a removably attachable spray/mist/stream device assembly 9 comprising a tube 10 with a fitting 11 at the proximal end of the tube 10 and a spray/mist/stream device 12 at the distal end of the tube 10. The fitting 11 is operably connected to the chilling assembly fluid outflow tube 6. The

spray/mist/stream device assembly 9 provides a means for cooling the surgical device, such as a saw, drill, burr or the like. The spray/mist/stream device assembly 9 is shown removably attachable to a surgical saw 13 (Figure lb) and surgical drill 14 (Figure lc). The spray/mist/stream device assembly 9 may also be releasably attached to a mounting structure (i.e., it may be readily attached and detached by hand, without the use of tools, during a surgical procedure) with a friction fit or detent arrangement between the

spray/mist/stream device assembly 9 and a channel on the mounting structure.

[0022] As shown in Figures Id and le, the spray/mist/stream device assembly 9 can alternatively provide a suction device 17 operably connected to the distal end of the tube 10 to provide for suction capabilities. LED lights 18 powered from the insulated fluid chilling assembly or batteries may also be provided. Figure Id illustrates a spray accessory with suction and lighting. Figure le illustrates an

irrigation/suction/light pen. These cooling accessories may also have a suction lumen and means to remove surgical smoke from the work site, and this may be connected to a vent or smoke filtering device.

[0023] The insulated fluid chilling assembly system and method for cooling a surgical cutting or drilling tool is described for preventing thermal necrosis of bone from the drill and saw friction. When cutting or drilling, the surgeon presses the foot pedal to activate the pump, delivering a spray, mist or stream of temperature controlled cooled sterile fluid to the cutting tool and surgical site to prevent

undesirable heating. Alternatively there may be a finger switch on the drill or saw for the surgeon to activate the flow of saline. Alternatively, the fluid spray may be

operable when the drill or saw is turned on. The system provides a supply of sterile fluid at a specific temperature, whether to cool a saw blade or a drill or other heat-producing surgical instrument.

[0024] The insulated fluid chilling assembly 1 may have a camera or scanner 20 to read a QR bar code 21 on a surgical device, as shown in Figure Id. The bar code and reader operate to recognize the device, identify the product, activate presets, wirelessly transmit serial number, inventory data tracking, billing and also to spot counterfeit products and manage inventory.

[0025] The insulated fluid chilling assembly with camera or scanner for QR tag reader operates as follows. In use, the operator scans the tab 21 with QR code on the surgical device using the camera/scanner 20. The system identifies the device. The system wirelessly transmits the device model number and serial number to a cloud ledger or locally stored inventory. The system activates the insulated fluid chilling assembly temperature and flow presets from a lookup table based on the device identity. The system provides the

capability of blocking a user from using the system if it detects reused or unauthorized devices.

[0026] Alternatively, the camera system can look at the device (without a bar code or QR code) and use machine vision and recognition software (like facial recognition) to identify the product, either by its general shape, by color, or by way of distinctive landmarks molded into the device (similar to Braille dots). No RFID or bar code would required in this embodiment. There can be a molded part on the device like a pinch clamp with identifying features that the machine vision can recognize to identify the product.

[0027] Various other devices may be operably connected to the outflow of the insulated fluid chilling assembly 1. These devices utilize circulating cooled fluid operably connected to the insulated fluid chilling assembly outflow. The circulated cooled fluid may be open or closed loop.

[0028] Figure 2a illustrates a cooled cutting guide 30 to protect tissue from thermal spread when cutting with an energy-based cutting device (such as a Bovie®) . The cutting guide 30 is cooled with circulating cooled fluid operably connected through a handle 31 providing fluid inflow 32 and outflow 33 from fitting 11 operably connected to the insulated fluid chilling assembly fluid outflow tube 6. The cutting guide as shown has a U-shape, or fork like shape with a hollow core to accommodate the circulating cooled fluid. Figure 2a shows the cooling fork-shaped device with cooling fluid circulating through hollow tines and channels in the device. The cooling fork legs set adjacent to the thermal cutter to keep adjacent tissue cool and thermally protected.

[0029] The cooled cutting guide is used when thermal spread is to be avoided, when using an energy-based cutting device. This is useful in neurosurgery when working around brain tissue which transmits heat readily and where there is a high risk of thermal damage or on any area of flat tissue where a long cut is made and thermal injury is to be avoided. The cooling guide also acts as a cutting guide to assist the surgeon. The guide may also have measurement marks to measure the length of the incision as well.

[0030] Figure 2a illustrates a cutting guide 30 to protect tissue from thermal spread when cutting with an energy-based cutting device 34 (for example, a Bovie®) . The cutting guide has a first guide portion 35 and a second guide portion 36.

The first guide portion has a first guide surface 37 opposing a second guide surface 38 of the second guide portion. The first guide surface and second guide surface define a guide slot 39 between the first guide portion and second guide portion. The guide slot is configured to accept an energy- based cutting device. A first fluid flow channel 40 runs through the first guide portion and is in fluid communication with the reservoir of cooling fluid (fluid outflow tube 6 connected to fitting 11). An optional second fluid flow channel runs through the second guide portion and is in fluid communication with the reservoir of cooling fluid. A handle 31 is operably attached to the cutting guide 30.

[0031] In use, the surgeon places the cutting guide on the tissue of the patient with the guide slot oriented along a desired cutting plane. The surgeon operates the cutting device through the guide slot to contact the operable tissue. While operating the cutting device, cooling fluid is forced from the reservoir through the handle 31 and into the first fluid flow channel to cool the first guide portion, and alternatively through the second fluid channel as well. The cutting guide also acts as a ruler cutting guide to assist the surgeon. The guide may also have measurement marks to measure the length of the incision as well.

[0032] Figure 2b illustrates a cutting guide 41 with internal cooling channels for total joint surgery or

osteotomies to prevent thermal necrosis of bone. These guides are used in knee, hip, spine, and other procedures where a precise cut is needed. The cutting guide is provided with interior fluid channels to cool the guide while the surgical saw resects bone. Fluid inflow outflow is provided through the fitting 11 operably connected to the insulated fluid chilling assembly fluid outflow tube 6 as previously discussed.

[0033] Figure 2b illustrates a cutting guide for use in orthopedic knee surgery. The cutting guide is configured for attachment to a bone 42 of a patient via a mounting bracket 53. The cutting guide has a first guide portion 43 and a second guide portion 44. The first guide portion has a first guide surface 45 opposing a second guide surface 46 of the second guide portion. The first guide surface and second guide surface define a guide slot 47 between the first guide portion and second guide portion. The guide slot is

configured to accept a saw blade 48 of an orthopedic bone saw 49. A first fluid flow channel 50 runs through the first guide portion and is in fluid communication with the reservoir of cooling fluid (fluid outflow tube 6 connected to fitting 1 1 ) . An optional second fluid flow channel runs through the second guide portion and is in fluid communication with the reservoir of cooling fluid (fluid outflow tube 6 connected to fitting 1 1 ) . An outflow channel 51 is provided.

[0034] In use, the surgeon fixes the cutting guide to the bone of the patient with the guide slot oriented relative to the bone such that a saw blade of an orthopedic saw passing through the guide slot is oriented along a desired cutting plane. The surgeon operates the orthopedic saw by passing the saw blade through the guide slot to contact and cut the bone. While operating the orthopedic saw, cooling fluid is forced from the reservoir through the first fluid flow channel to cool the first guide portion, and alternatively through the second fluid channel as well.

[0035] Joint replacement surgery requires large saw cuts with powered tools to remove bone. These large cuts expose bone marrow to frictional heating and can coagulate bone marrow blood, and can kill stem cells, osteoblasts and

osteocytes, which causes bone necrosis, and can cause the joint implant to fail from the bone not growing into and integrating with the joint implant, as well as bone

infections. The cooled cutting guide keeps the saw blade cooled as well as the adjacent bone by means of internal cooling channels and thermal conduction. Frictional heat is removed from the work site and bone is protected from

temperature rise. Similar to the cutting guide, a cap with cooling channels may also be placed on a joint implant after it is cemented in place to draw away heat from the exothermic reaction of bone cement.

[0036] Figure 2c illustrates a cooled single drill guide 52 for orthopedic and spine surgery. The drill guides are provided with a fluid jacket for circulation of chilled fluid to keep the drill cooled. The fluid jacket is a hollow core tube or concentric tubes. Alternatively, the guide can have internal cooling channels. Bone drilling for implants like pedicle screws for spine surgery and for screw plates for trauma repair are at risk for the drill heating up the bone in the drill hole, overheating the bone marrow which can lead to bone necrosis and loosening of the bone screws. This can lead to invasive and costly revision surgery and bone infections. The internal cooling channels in the drill guide keep the drill cooled, and prevents overheating (>45C) of the drill hole tunnel. Figure 2f (described below) is a dual guide.

[0037] Figure 2d illustrates a bipolar RF or ultrasound cutting and sealing device 60 enabled with cooling fluid to prevent thermal spread. Ultrasound, RF and thermal devices for sealing blood vessels and other structures are popular in surgery. The concern with these devices is thermal spread to the tissue not being sealed. In this embodiment the jaws of the device have built in cooling channels. In another embodiment the distal tip of the instrument shaft has a spray nozzle for spring cooling fluid or chilled gas on to the surgical work site to prevent thermal spread from the energy sealing device.

[0038] Figure 2e illustrates a cooling loop 70 to keep an area of tissue inside the loop and adjacent tissue cooled for neurosurgery to prevent thermal spread. The cooling loop is used where it is important to prevent thermal damage to a section of tissue, such as brain. This may also be used when resecting bone or soft tissue and adjacent nerves need to be protected from thermal spread. The cooling loop keeps the heat from the energy device (RF/Ultrasound/laser/etc . ) confined to the immediate work area and prevents the heat from propagating into the surrounding tissue and damaging heat sensitive structures. As described in Figure 2a, the cooling loop is cooled with circulating cooled fluid operably

connected through a handle 18 providing fluid inflow and outflow from the fitting 11 operable connect to the insulated fluid chilling assembly fluid outflow tube 6. The cooling loop has a hollow core to accommodate the circulating cooled fluid .

[0039] Figure 2f illustrates a dual drill guide 80 for spine and orthopedic surgery. The internal cooling channels (previously described) keep the drill cooled to prevent thermal necrosis. The dual drill guide is used in spinal surgery when placing implants like pedicle screws. The internal cooling channels in the drill guide keep the drill cooled and conducts heat away from the work area. This helps to prevent heating of the bone drill hole which can result in loosening of the screw implant, infections, and costly and invasive revision surgery. The cooled drill guide also prevents thermal spread to adjacent heat sensitive nerve tissue .

[0040] While the preferred embodiments of the devices and methods have been described in reference to the environment in which they were developed, they are merely illustrative of the principles of the inventions. For example, while cooling has been described, the insulated fluid chilling assembly 1 provides the ability to maintain the temperature of the saline at any desired temperature. Heated saline could be desirable in some applications. The elements of the various embodiments may be incorporated into each of the other species to obtain the benefits of those elements in combination with such other species, and the various beneficial features may be employed in embodiments alone or in combination with each other. Other embodiments and configurations may be devised without

departing from the spirit of the inventions and the scope of the appended claims.

Claims

I claim:

1. A cutting guide system for use in orthopedic surgery, said system comprising: a cutting guide configured for attachment to a bone of a patient, said cutting guide comprising a first guide portion and a second guide portion, said first guide portion having a first guide surface opposing a second guide surface of the second guide surface, said first guide surface and second guide surface defining a guide slot between the first guide portion and second guide portion configured to accept a saw blade of an orthopedic bone saw; a reservoir of cooling fluid; and a first fluid flow channel running through the first

guide portion, in fluid communication with the reservoir of cooling fluid.

2. The system of claim 1, further comprising: a second fluid flow channel running through the second guide portion, in fluid communication with the reservoir of cooling fluid.

3. A cutting guide system for use with an energy-based tool for tissue surgery, said system comprising: a cutting guide, said cutting guide comprising a first guide portion and a second guide portion, said first guide portion having a first guide surface opposing a second guide surface of the second guide surface, said first guide surface and second guide surface defining a guide slot between the first guide portion and second guide portion configured to accept an energy-based surgical tool; a reservoir of cooling fluid; and a first fluid flow channel running through the first

guide portion, in fluid communication with the reservoir of cooling fluid.

4. The system of claim 3, further comprising: a second fluid flow channel running through the second guide portion, in fluid communication with the reservoir of cooling fluid.

5. The system of claim 3 further comprising: a handle operably connected to the cutting guide and the reservoir of cooling fluid.

6. The cutting guide of claim 3 wherein the first guide portion further comprises measurement markings.

7. A system for use with a surgical saw, said system

comprising : a sprayer assembly comprising a tube, said tube having a proximal end and a distal end, said sprayer assembly having a fitting disposed at the proximal end of the tube and a sprayer disposed at the distal end of the tube ; a surgical saw characterized by an outer surface and a distal end, further comprising a saw blade disposed at the distal end of the saw; said sprayer assembly releasably attachable to the outer surface of the saw; an insulated fluid chilling assembly, said fluid chilling assembly comprising a reservoir of cooling fluid in fluid communication with the sprayer assembly tube, and a pump operably connected to the reservoir and sprayer assembly tube; wherein the pump is operable to force fluid from the

reservoir through the sprayer assembly tube and out of the sprayer onto the saw blade.