METHOD AND DEVICES FOR THE TREATMENT OF BONE FRACTURES
A system for treating bone fractures includes a tubular implant and a means for compressing the tubular implant. The tubular implant is configured to expand from a reduced configuration to an expanded configuration. The expanded configuration has a greater diameter than the reduced configuration. The means for compressing the tubular implant causes the tubular implant to expand from the reduced configuration to the expanded configuration thereby fixating a bone fracture.
The present application is a continuation of U.S. patent application Ser. No. 12/011,115, filed Dec. 23, 2008, which is a continuation-in-part of U.S. patent application Ser. No. 09/733,775, filed Dec. 8, 2000, now U.S. Pat. No. 8,007,498, and claims the benefit of the following U.S. Provisional applications: U.S. Provisional Application Ser. No. 60/169,778, filed Dec. 9, 1999; U.S. Provisional Application Ser. No. 60/181,651, filed Feb. 10, 2000; U.S. Provisional Application Ser. No. 60/191,664, filed Mar. 23, 2000; and U.S. Provisional Application Ser. No. 60/849,246, filed Oct. 3, 2006; U.S. Provisional Application Ser. No. 60/982,931, filed on Oct. 26, 2007, which are all hereby incorporated by reference as if they were set forth in their entirety.
FIELD OF THE INVENTIONThe present invention relates generally to medical devices and methods, and more particularly to minimally invasive, catheter based devices, systems and methods for treating bone fractures.
BACKGROUNDThe current methods of treating bone fractures ranges from simple setting of the bone and constraining motion via a cast or wrap to using pins, screws, rods and cement to fixate fracture site. With the use of casts, the bone is not stabilized and misalignment may occur after placing the cast. This may require the cast to be removed and the bone reset. This is a very uncomfortable and painful procedure for the victim and can ultimately result in permanent misalignment of the healed bone. The treatment modalities requiring a surgical procedure are painful and are associated with a high rate of complications. Post-procedural infections are one of the major complications associated with these surgical procedures. Many of these infections result in necrosis of bone and tissue and require additional surgical interventions and therapy.
The nose, nose structures and its associated nasal sinuses suffer many afflictions that manifest into painful and uncomfortable situations for the owner of the nose. Some of these inflictions include sinusitis, deviated septums, allergies, broken noses, and infections. Sinusitis is infection or inflammation of the mucous membranes that line the inside of the nose and sinuses. Sinuses are hollow spaces, or cavities, located around your eyes, cheeks, and nose.
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- the maxillary sinuses (MF), also called the maxillary antra and the largest of the paranasal sinuses, are under the eyes, in the maxillary bones (cheek bones).
- the frontal sinuses (FS), over the eyes, in the frontal bone, which forms the hard part of the forehead.
- the ethmoid sinuses (ES), which are formed from several discrete air cells within the ethmoid bone between the nose and the eyes.
- the sphenoid sinuses, in the sphenoid bone at the center of the skull base under the pituitary gland.
The paranasal sinuses are not the only sinuses within the skull: the mastoid cells in the mastoid bone around the middle ear are also a type of sinus.
When a mucous membrane becomes inflamed, it swells, blocking the drainage of fluid from the sinuses into the nose and throat, which causes pressure and pain in the sinuses. Bacteria and fungus are more likely to grow in sinuses that are unable to drain properly. Bacterial or fungal infections in the sinuses often cause more inflammation and pain, and they are more likely to last longer, worsen with time, and become chronic. While colds usually trigger this process, any factor that causes the mucous membrane to become inflamed may lead to sinusitis. Many people with nasal allergies (allergic rhinitis), are likely to have recurring or long-term (chronic) sinus infections. Nasal polyps and structural problems in the nose such as a deviated septum, and other conditions can also block the nasal passages, increasing the risk of developing sinusitis.
Sinuses can become blocked during a viral infection such as a cold, and sinus inflammation and infection can develop as a result. One key distinction between a cold and sinusitis is that cold symptoms, including a stuffy nose, begin to improve within 5 to 7 days. Sinusitis symptoms last longer and get worse after 7 days. There are two types of sinusitis: acute (sudden) and chronic (long-term). Acute (sudden) sinusitis is usually caused by a viral infection and often develops rapidly. It usually lasts for 4 weeks or less, and the symptoms often begin to clear up within a week without any treatment. Acute sinusitis caused by a bacterial infection is less likely to clear up on its own and may lead to chronic sinusitis or to complications in which the infection spreads beyond the sinuses. Nasal discharge that contains pus and worsens after 5 days or persists for more than 10 days is usually a strong sign of acute sinusitis caused by a bacterial infection. With chronic sinusitis, the sufferers always have a low level of sinusitis symptoms. Chronic sinusitis can lead to permanent changes in the mucous membranes that line the sinuses and may make you more prone to sinus infections. The main symptoms of sinusitis are a runny or stuffy nose and facial pain and pressure. A yellow or greenish discharge from the nose or down the back of the throat (postnasal discharge). The location of pain and tenderness depends on which sinus is affected. The location of pain and tenderness may depend on which sinus is affected; Pain over the cheeks and upper teeth is often caused by maxillary sinus inflammation; Pain in the forehead, above the eyebrow, may be caused by frontal sinus inflammation; Pain behind the eyes, on top of the head, or in both temples may be caused by sphenoid sinus inflammation; Pain around or behind the eyes is caused by ethmoid sinus inflammation.
Other common symptoms of sinusitis may include, headache, bad breath, runny or stuffy nose, cough that produces mucus, fever, tooth pain, reduced sense of taste or smell, post-nasal drainage or drip. Sinusitis often improves on its own, but it may need to be treated with antibiotics or other medications, depending on the severity and duration of symptoms. With chronic sinusitis, a longer course of medications is often needed. Surgery may be required if the sufferers have taken antibiotics and other medications for an extended period of time but still have symptoms, or when complications (such as the spread of infection beyond the sinuses) are likely. Fungal infections, which account for a significant number of chronic sinusitis cases, do not respond to antibiotic treatment. They may require treatment with antifungal medications, corticosteroids, or surgery. Chronic sinusitis may last 3 to 8 weeks or longer and usually requires 3 to 4 weeks of antibiotic treatment. Symptoms may persist or return despite adequate antibiotic treatment. A different antibiotic may be needed to treat the infection. Referral to an ear, nose, and throat (ENT) specialist (also called an otolaryngologist) may be necessary if symptoms of sinusitis do not go away despite long-term antibiotic treatment.
Medications are used and sometimes combined to treat sinusitis. Antibiotics kill bacteria. A few examples of antibiotics used are amoxicillin (Amoxil, Larotid, Trimox), cefaclor (Ceclor), and telithromycin (Ketek). Decongestants reduce the swelling of the mucous membranes in the nose. Some examples may include oxymetazoline hydrochloride (Afrin) and phenylephrine hydrochloride (Neo-Synephrine, Sinex Decongestant Nasal Spray). Analgesics, such as aspirin, acetaminophen or ibuprofen, are used to relieve pain. Corticosteroids, such as beclomethasone dipropionate (Beconase, Vancenase) or prednisone (Deltasone, Prednicen-M), reduce inflammation in the nasal passages and may be given as an inhaled nasal spray. Mucolytics, such as guaifenesin (Robitussin), are used to thin the mucus
Current Sinus Treatment Options Include the Following:
Functional endoscopic sinus surgery (FESS): FESS involves the insertion of the endoscope, a very thin fiber-optic tube, into the nose for a direct visual examination of the openings into the sinuses. With state of the art micro-telescopes and instruments, abnormal and obstructive tissues are then removed. In the majority of cases, the surgical procedure is performed entirely through the nostrils, leaving no external scars. There is little swelling and only mild discomfort. The advantage of the procedure is that the surgery is less extensive, there is often less removal of normal tissues, and can frequently be performed on an outpatient basis. After the operation, the patient will sometimes have nasal packing. Ten days after the procedure, nasal irrigation may be recommended to prevent crusting.
Image guided surgery: The sinuses are physically close to the brain, the eye, and major arteries, always areas of concern when a fiber optic tube is inserted into the sinus region. The growing use of a new technology, image guided endoscopic surgery, is alleviating that concern. This type of surgery may be recommended for severe forms of chronic sinusitis, in cases when previous sinus surgery has altered anatomical landmarks, or where a patient's sinus anatomy is very unusual, making typical surgery difficult.
Image guidance is a near-three-dimensional mapping system that combines computed tomography (CT) scans and real-time information about the exact position of surgical instruments using infrared signals. In this way, surgeons can navigate their surgical instruments through complex sinus passages and provide surgical relief more precisely.
Another option is the Caldwell-Luc operation, which relieves chronic sinusitis by improving the drainage of the maxillary sinus, one of the cavities beneath the eye. The maxillary sinus is entered through the upper jaw above one of the second molar teeth. A “window” is created to connect the maxillary sinus with the nose, thus improving drainage. The operation is named after American physician George Caldwell and French laryngologist Henry Luc and is most often performed when a malignancy is present in the sinus cavity.
Other imaging technologies can be used as well. For example magnetic resonance imaging or forms or x-ray and fluoroscopy.
Surgery on the nasal septum, turbinates, and sinuses is recommended only after it has been determined that medical management has been unsuccessful. While these procedures are generally very successful, patients must be aware of certain risks before electing to proceed. These risks include, but are not necessarily limited to, the following:
Postoperative bleeding: Aspirin, ibuprofen and certain non-prescription supplements (vitamin E, garlic, etc.) can increase the propensity to bleed, so patients should consult with their physicians before using these agents before or after surgery. Intranasal packing is utilized by many sinus surgeons to help avoid this complication but occasionally postoperative bleeding is encountered despite all precautions.
Anesthesia complications: Adverse reactions to local or general anesthesia may occur, including cardiac and pulmonary complications. Fortunately, these risks are quite rare in this era of modern anesthesia.
Intracranial complications: The base of the skull forms the roof of the ethmoid and sphenoid sinuses. If this layer is violated, a leak of cerebrospinal fluid (the fluid that bathes the brain and spinal cord) may occur (
Intraorbital complications: The orbit is situated immediately adjacent to several of the paranasal sinuses but is separated by a layer of bone. Because of this close proximity, in rare cases bleeding may occur into the orbit requiring repair at the time of the initial surgery. Visual loss and blindness have been reported but are extremely rare.
Smell: The sense of smell usually improves, although it may occasionally worsen, depending on the extent of infection, allergy or polyps.
Voice changes: One of the functions of the sinuses is to affect resonance, so vocal professionals should be aware of potential changes in their voice after sinus surgery. Infection: The most common reason to undergo sinus surgery is a chronic infection that does not resolve with medications. The patient with sinusitis is therefore at risk of developing certain other infections in this area (abscesses, meningitis, etc.) regardless of whether they manage the sinusitis with or without surgery.
Nasal obstruction: Much of the nasal septum is made of cartilage, which has “memory”—the propensity to move back to its original position. Despite certain measures performed by the surgeon at the time of septoplasty this may still occur and require a secondary procedure. Small scar bands may also occur in the nose and require removal by the surgeon at postoperative visits.
Numbness: A transient numbness of the front upper teeth, lip or nose may occur after surgery but is usually self-limiting.
While surgery may entail these complications, it is also crucial to remember that the failure to intervene may also place the patient at risk for certain complications. When left untreated, the infection may rarely spread to adjacent structures such as the eye or brain and lead to abscesses in these areas, meningitis, visual loss, or even death.
As aforementioned background, there are a number of treatments for sinusitis and other nasal sinus maladies. However, there is a need for more effective methods and devices for the treatment of these ailments.
SUMMARYA system for treating bone fractures includes a tubular implant and a means for compressing the tubular implant. The tubular implant is configured to expand from a reduced configuration to an expanded configuration. The expanded configuration has a greater diameter than the reduced configuration. The means for compressing the tubular implant causes the tubular implant to expand from the reduced configuration to the expanded configuration thereby fixating a bone fracture.
A method for treating bone fractures includes placing a tubular implant in a reduced configuration at a treatment site and compressing the tubular implant thereby causing the tubular implant to expand from the reduced configuration to an expanded configuration. The expanded configuration has a greater diameter than the reduced configuration. The method further includes fixating a bone fracture at the treatment site with the expanded tubular implant.
Throughout the several views of the drawings several illustrative embodiments of the invention are disclosed. It should be understood that various modifications of the embodiments might be made without departing from the scope of the invention.
Throughout the views identical reference numerals depict equivalent structure wherein:
The invention discussed here provides for a unique and novel means of treating a variety of bone fractures with minimally invasive techniques and low complication rates. In addition, as further discussed, this invention also provides for methods and devices for the treatment of nasal sinus disorders and maladies. A number of therapies are available for treating nasal sinus disorders such as sinusitis, deviated septums, allergies, and infections. Drugs, surgery, and devices are used commonly to attempt to treat or alleviate these afflictions. This invention uses devices, device-based systems and delivery systems to provide improved acute and long-term therapies
In contrast to the prior art, the present invention proposes treatment of bone fractures using minimally invasive techniques, methods, equipment and devices to position and deliver an expandable fracture fixating device into the medullary cavity (marrow conduit). The device is preferably an expandable structure that “bridges” the fracture site and fixates the site upon expansion. In addition to fixation, the device also joins the fractured bone such as in the case of a compound fracture. Referring to the device as a bridge device, the bridge device is substantially hollow and has low surface area and mass, the majority of bone marrow volume can be preserved. The ability to preserve a large quantity of the bone marrow cavity is beneficial for healing, bone health and maintaining the body's natural ability to generate red blood cells. In addition, the stress applied to the bone by the expanded or expanding the bridge device facilitates rapid bone growth and strength. The operable level of stress applied to the bone will vary from low levels to high levels dependent on the type, size and location of bone to be treated. It is also envisioned that the bridge device can be used to expand and support bones that are crushed or compressed. The bridge device can be delivered by a variety of expansion devices, can be self expanding to due to inherent spring forces within the bridge structure, or can be expansively actuated utilizing elements and mechanisms within the bridge structure. These various devices and alternative embodiments will be detailed further.
Although standard medical equipment may be used to facilitate the procedure, it may be necessary to design unique, specialized tools in order for this invention to be properly utilized. These devices may include tissue separators, retractors, drills, introducers, coring tools, and others.
The invention is disclosed in the context of treating bone fractures but other organs and anatomical tissues are contemplated as well. For example, the invention may be used to treat spinal stenosis, individual vertebrae, and support or fixate segments of the spinal column. Likewise, a broken nose, sinus cavity or collapsed lung can be supported using this invention. Pelvic fractures in females could also benefit from placing this device within the vaginal cavity in order to support and fixate the pelvis or pubic bone. Additionally, the invention may also be used in the treatment of sleep apnea and its associated complications.
Therefore, the present invention proposes treatment bone fractures, and various sinus and nasal ailments using minimally invasive techniques, methods, equipment and devices to position and deliver therapeutic devices within the bones, sinus cavities, and nasal cavities. These inventions will be summarized in greater detail in the following discussion and disclosures.
Throughout the description the term device refers to an expandable device that is used to fixate or repair bone fractures. The device may be made of metals such as stainless steel, tantalum, titanium, Nitinol or Elgiloy and it may form an electrode for electrical stimulation. One or more electrodes may be associated with it. The device may incorporate fiber optics for imaging, sensing, or the transmission of energy to heat, ablate, or illuminate. The device may also be made from a plastic or other non-metallic material. The device may also incorporate a covering of polymer or other materials. The device may also be a composition of different materials. The device may be smooth or have cutting or abrasive surfaces. The device can be self-expanding or use a device such as a balloon catheter to mechanically expand or further expand it. In addition, other means of expanding the device may be utilized such as any mechanical means of expansion, or thermal, vibrational, electrical, hydraulic, pneumatic actuation. Mechanical means might employ a system consisting of a rubber grommet that expands when it is compressed axially. Another mechanical means of expansion may use a tubular array of elements such as splines, wires or braided wire that expand radially outward when compressed at each end. Another mechanical means could employ wedges in a tubular or cylindrical type of array that collectively force the device to expand when they are moved relative to each other. The device delivery system may also employ fiber optic technology in order to endoscopically diagnose, control placement and review procedural outcome. Likewise, a number of other technologies such as pressure monitoring, stress monitoring, volume monitoring, etc. can be employed to benefit the outcome of the procedure.
The device may be implanted for chronic use or for acute use. In acute use, the device is used for temporary stabilization and fixation of bone fractures. After a period of time, the device is withdrawn.
Biodegradable materials that degrade or dissolve over time may be used to form the device. Various coatings may be applied to the device including, but not limited to, thrombo-resistant materials, electrically conductive, non-conductive, thermo-luminescent, heparin, radioactive, or biocompatible coatings. Materials such as calcium, minerals, or irritants can be applied to the device in order to expedite bone growth. Drugs, chemicals, and biologics such as morphine, dopamine, aspirin, genetic materials, antibiotics and growth factors can be applied to the device in order to facilitate treatment. Other types of additives can be applied as required for specific treatments.
Electrically conductive devices with electrode elements may be used with companion pulse generators to deliver stimulation energy to the bone to expedite bone growth. This electrical therapy may be used alone or in combination with other therapies to treat the affected site. Electrical therapies may be supplied from implantable devices or they may be coupled directly to external generators. Coupling between the device and external generators can be achieved using technologies such as inductive or microwave coupling as examples. The device may also be designed of geometries or materials that absorb radioactive energies for the treatment of bone cancer, as an example.
In the preferred embodiment, access is gained to a location on the bone that the device will pass through. A surgical incision is made through tissue to expose the entry site at the bone. The size and scope of the incision is dependent on the need for each case, Preferably, a small hole is drilled through the bone into the medullary cavity (marrow conduit). Larger holes or removal of a portion of the bone may be required dependent on the need for each case. In the example of a fractured femur, an access location might be the either the greater trochanter or the patellar surface. In the case of a fractured humerus, the access might be made at the greater tubercle or the capitulum.
The device, on its delivery system, is then passed through the marrow cavity and positioned across the fracture. When the right position is attained (potentially guided by CAT scan, MRI, x-ray, or fluoroscopic imaging), the fracture can be manipulated to an optimum configuration if needed, and the device is expanded or released for expansion. The delivery system is then removed after expansion. If necessary, the access hole in the bone can be plugged with retained bone chips from the drilling procedure, fibrin or other acceptable materials. Any surgical incision is closed with standard techniques.
It may be necessary to remove some bone marrow to facilitate placement of the device. After placement of the device, the marrow can be reinserted into the bone and within the device. Another alternative treatment may be to replace the marrow with a polymeric substance that hardens after placement within the device and bone portions. This would enhance the immediate fixation strength. The polymeric substance can be biodegradable or otherwise metabolized by the body. In addition, the polymeric substance may incorporate drugs, antibiotics other clinically relevant substances and materials. The polymeric substance can also form a foam or cellular structure to allow for marrow formation. Other embodiments of the invention can include the use of external screws that join the device through the bone. This provides and extra measure of securement and strength.
At this point, the device 20 is released from the catheter and self-expands against the inside of the bone. The release mechanism can be simply pushing the device out of a catheter lumen or retracting a retaining sleeve. The device self-expands due to the spring forces inherent in its materials and design. Likewise, the device can be made of a shape-memory material such as Nitinol so that when subjected to body temperature the structure expands. With shape memory materials, the shape of the expanded device can be predetermined. Additionally, the device can be retrieved, repositioned, or removed by using temperature-based shape-memory characteristics.
It should be apparent that various modifications might be made to the devices and methods by one of ordinary skill in the art, without departing from the scope or spirit of the invention.
These devices and methods which have been discussed in the preceding detailed description are also suitable for treating afflictions of various cavities and orifices such as the nasal sinus cavity. The afflictions include, but are not limited to, deviated septums, broken nose, damaged sinus structures, bloody nose, sinusitis, perforated septums, sinus fistula, cleft palates and sinus cancer.
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- the maxillary sinuses (MF), also called the maxillary antra and the largest of the paranasal sinuses, are under the eyes, in the maxillary bones (cheek bones).
- the frontal sinuses (FS), over the eyes, in the frontal bone, which forms the hard part of the forehead.
- the ethmoid sinuses (ES), which are formed from several discrete air cells within the ethmoid bone between the nose and the eyes.
- the sphenoid sinuses, in the sphenoid bone at the center of the skull base under the pituitary gland.
The figures show a device 160 and method for delivery of an expandable device 166. This device 160 comprises a flexible catheter 162 having a balloon 164 thereon. Initially, as shown in
Assisting in this phenomena would be a device such as that shown in
Although the device can be delivered via the nasal passage, as illustrated in
Radioactive substances can also be incorporated into the device and/or device coating so as to treat ailments such as aggressive infections or cancer. Obviously, other medicates or therapeutic substances can be incorporated as required. The coating can also absorb therapeutic or diagnostic substances when mist, fluids, sprays, vapors or fumes are inhaled. This allows for localized treatment of sinus ailments. The coating 182 may also be a material that is biodegradable or bioabsorable at a rate that is prescriptive.
Such as in
Similarly,
In this scenario, when implanted into the nasal or sinus passage, the valve prevents inhaled air to pass but allows exhaled air to pass. The orientation of the device will determine air flow in and out of the nasal and sinus passages. This can help control contaminated air form entering the sinuses, or to balance the pressure across the cavities.
The treatment of these diseases is illustrative and is not meant to be limiting. With the foregoing detailed description of the present invention, it has been shown how the objects of the invention have been attained in a preferred manner. Modifications and equivalents of disclosed concepts such as those which might readily occur to one skilled in the art are intended to be included in the scope of the claims which are appended hereto.
While the invention has been described with reference to an exemplary embodiment(s), it will be understood by those skilled in the art that various changes may be made and equivalents may be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiment(s) disclosed, but that the invention will include all embodiments falling within the scope of the appended claims.
Claims
1. A system for treating bone fractures, the system comprising;
- a tubular implant configured to expand from a reduced configuration to an expanded configuration, the expanded configuration having a greater diameter than the reduced configuration; and
- a means for compressing the tubular implant whereby compression of the tubular implant causes the tubular implant to expand from the reduced configuration to the expanded configuration thereby fixating a bone fracture.
2. The system of claim 1, wherein the expanded configuration of the tubular implant has a shorter axial length than the reduced configuration of the tubular implant.
3. The system of claim 1, wherein the expanded configuration of the tubular implant has a greater height than the reduced configuration of the tubular implant.
4. The system of claim 1, wherein the means for compressing the tubular implant is a means for compressing the tubular implant in an axial direction.
5. The system of claim 1, wherein the means for compressing the tubular implant is a means for compressing the tubular implant in a linear direction.
6. The system of claim 1, further comprising:
- a delivery device for placing the tubular implant at a treatment site, wherein the delivery device includes the means for compressing the tubular implant.
7. The system of claim 1, wherein the means for compressing the tubular implant includes a screw mechanism.
8. The system of claim 1, wherein the means for compressing the tubular implant includes an axial rod.
9. The system of claim 1, wherein the tubular implant includes a hardenable substance.
10. The system of claim 1, wherein the tubular implant includes multiple splines.
11. The system of claim 1, wherein the tubular implant includes is a coil.
12. A method for treating bone fractures, the method comprising:
- placing a tubular implant in a reduced configuration at a treatment site;
- compressing the tubular implant thereby causing the tubular implant to expand from the reduced configuration to an expanded configuration, wherein the expanded configuration has a greater diameter than the reduced configuration; and
- fixating a bone fracture at the treatment site with the expanded tubular implant.
13. The method of claim 12, wherein the expanded configuration of the tubular implant has a shorter axial length than the reduced configuration of the tubular implant.
14. The method of claim 12, wherein the expanded configuration of the tubular implant has a greater height than the reduced configuration of the tubular implant.
15. The method of claim 12, wherein compression is axial compression.
16. The method of claim 12, wherein compression is linear compression.
17. The method of claim 12,
- removing a device that caused compression of the tubular implant from the treatment site.
18. The method of claim 17, wherein the device is a delivery device for the tubular implant.
19. The method of claim 12, further comprising:
- inserting bone marrow into the tubular implant.
20. The method of claim 12, wherein compressing the tubular implant includes moving a first end of the tubular implant closer to a second end of the tubular implant.
Type: Application
Filed: Jan 26, 2012
Publication Date: Sep 6, 2012
Inventor: Hans A. Mische (Grey Eagle, MN)
Application Number: 13/358,821