US20120226362A1

Movatterモバイル変換

Info

Publication number: US20120226362A1
Application number: US13/358,821
Authority: US
Inventors: Hans A. Mische
Original assignee: Individual
Current assignee: Individual
Priority date: 1999-12-09
Filing date: 2012-01-26
Publication date: 2012-09-06
Also published as: US9351772B2; US20080125805A1

Abstract

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.

Description

CROSS-REFERENCE TO RELATED APPLICATION(S)

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 INVENTION

The 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.

BACKGROUND

The 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.FIG. 14 shows the paranasal sinuses. Paranasal sinuses are air-filled spaces, communicating with the nasal cavity, within the bones of the skull and face. The paranasal sinuses are joined to the nasal cavity via small orifices called ostia. These become blocked relatively easily by allergic inflammation, or by swelling in the nasal lining which occurs with a cold. If this happens, normal drainage of mucus within the sinuses is disrupted, and sinusitis may occur. Humans possess a number of paranasal sinuses, divided into subgroups that are named according to the bones within which the sinuses lie:

- 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 (FIG. 1). This can usually be repaired at the time of the initial surgery, although in rare cases further complications such as meningitis may ensue.

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.

SUMMARY

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.

BRIEF DESCRIPTION OF THE DRAWINGS

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:

FIG. 1 is a diagram showing the advancement and deployment of a device utilizing a catheter with an expandable element.

FIG. 2 is a diagram showing the advancement and deployment of a self-expanding device.

FIG. 3 is a diagram showing the advancement and deployment of the device, utilizing a catheter with an expandable element, within a compressed bone segment.

FIG. 4 shows a variety of acceptable device structures and designs.

FIGS. 5A & B depict a device that can be expanded or contracted by relative movement of the ends of the structure.

FIG. 6 shows a device that can be expanded or contracted by relative movement of the ends of the structure.

FIG. 7 shows a device that can be expanded or contracted by relative movement of the ends of the structure.

FIGS. 8A & 8B show the placement of a coil device.

FIGS. 9A & 9B show the placement of a braided device.

FIG. 10 shows the screws or nails used in conjunction with an implanted device.

FIG. 11 shows a device used in conjunction with external supporting elements.

FIGS. 12A & 12B shows an implanted device connected to an electrical generator.

FIG. 13 shows an expansion device using a rubber grommet.

FIG. 14. is a diagram of a patients head showing the major sinus cavities.

FIG. 15 is a diagram of the head showing a device located in the frontal sinus cavity and other locations.

FIGS. 16A,16B,16C depicts a sequence of device placement in the sinus cavity.

FIGS. 17A & 17B shows a sinus before and after a device placement.

FIGS. 18A,18B, and18C show a covered expandable device in various states of expansion.

FIGS. 19A & 19B shows views of a device tubular element with cutting elements on its external surface.

FIGS. 20A & 20B are schematic diagrams of the device correcting and supporting a deviated septum.

FIGS. 21A & 21B are schematic diagrams of bilateral devices correcting and supporting a deviated septum.

FIGS. 22A & 22B are schematic diagrams of a device correcting a perforated septum.

FIGS. 23A & 23B are schematic diagrams of the device sealing a fistula connecting2 sinus cavities.

FIGS. 24A & 24B are schematic diagrams of showing steps in a procedure for placing a device in the sinus cavity by advancing through the tooth and tooth socket.

FIGS. 25A & 25B are diagrams that show the device treating a unilateral cleft palate.

FIGS. 26A & 26B are diagrams that show the device treating a bilateral cleft palate

FIG. 27 shows a device with a 1-way valve.

FIG. 28 shows a device with filter media within the interior.

FIG. 29 shows a device with a one-way valve.

DETAILED DESCRIPTION

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.

FIG. 1A is a diagram showing thedevice10, which is mounted to a ballooncatheter delivery device11 within a segment of fracturedbone12. The entire system is advanced through anopening13 in thebone12. Thedevice10 is positioned to span the fracture. At this point, the balloon is inflated causing the device to expand against the inside of the bone. The balloon may be inflated via a syringe or pump14 and apressure gauge15. The balloon may have a pre-determined minimum or maximum diameter. In addition, the balloon can have a complex shape to provide proper placement and conformance of the device based on anatomical requirements and location. One or more inflations may be used to insure proper positioning and results.FIG. 1B shows the expandeddevice10 spanning the fracture and connecting the bone segments. Thedelivery device11 is being withdrawn. If required, the balloon may be reinserted and reinflated for additional device manipulation.

FIG. 2A is a diagram showing a self-expandingdevice20, which is compressed and inserted within acatheter delivery device21, within a segment of fracturedbone22. The entire system is advanced through anopening23 in thebone22. Thedevice20 is positioned to span the fracture.

At this point, thedevice20 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.

FIG. 2B shows the expandeddevice20 spanning the fracture and connecting the bone segments. Thedelivery catheter21 is being withdrawn. In the self-expanding case, the tubular mesh has a predetermined maximum expandable diameter.

FIG. 3A shows adevice30 on aballoon catheter31 being advanced into a crushed area of a bone.

FIG. 3B shows thedevice30 expanded within the crush zone causing the crushed bone to resume its original diameter. The same results can be attained using any of the aforementioned device designs, such as self-expanding or manually expanded, and placement methods. In the case of self-expanding designs, further expansion of the device can be performed using a balloon catheter or another type of expansion device such as those mentioned within this invention or can use solid dilator rods.

FIG. 4 shows a variety of possible device shapes and geometries. Atubular mesh42, amulti-element spline44, acoil46, slottedtube48, and a clam-shell orsleeve49. In the case of slotted tube, other geometric configurations of the slots (i.e.; hexagonal, sinusoidal, circular, meandering, spiraling, and multigeometric patterns) may be utilized alone or in conjunction with a combination thereof. Likewise, variations in the geometry of any of the devices may be altered to achieve desired performance criteria such as radial strength, longitudinal flexibility or stiffness, expansion ease, profile, surface area, mass and volume, and material selection. The elements of the device may be porous, have through holes, or have a covering. In addition, the surface of the device may be textured, rough, and sharp or have cleats or small pins integrated or attached. Each of the various shapes and geometries may find its own specialized use in the treatment of specific type of bone fractures.

FIG. 5 shows two states of a manuallyexpandable device51.FIG. 5A showsdevice51 in a first, reduced configuration, andFIG. 5B showsdevice51 in a second, expanded configuration. The device consists of acoaxial shaft52 andtube53 arrangement. Attached to the distal end of theshaft52 and thetube53 is a braidedmesh tube device51. When theshaft52 andtube53 are moved opposite of the other by manipulating the proximal ends, thedevice51 expands54 or contracts55. As shownFIG. 5A,device51 has a relatively small diameter and height and a relatively long axial body length when in the reduced configuration. As shown inFIG. 5B, device has a grater diameter and height, but a shorter axial body length when in the expanded configuration. In this case, thedevice51 can be made of any structure that expands and contracts such as a coil, splined-elements, etc. The various methods of expanding and contracting these structures are, but not limited to, push-pull, rotation, and balloon manipulation. In this type of device, direct connection to either an electrical generator, laser, or monitoring system can be made. In addition, it be envisioned that a device of similar nature be connected to a mechanical energy source, such as rotational or vibrational sources.

FIG. 6 shows a manually expandeddevice60 with aninternal rod61 andcompression nut mechanism62. One end of the device is fixed to one end of therod63, while theother end64 is allowed to move relative to the rod. As the compression nut is tightened, it forces theend64 of the device to move, thus compressing the device in an axial or linear direction and forcing it to expand. Using a customized tool, the compression nut is tightened and the device expanded until the desired affect is achieved. The nut can have a locking mechanism, such as a lock washer or other means, to maintain position. Alternatively, the nut and rod components can be exchanged for a bolt and nut or a bolt and internally threaded tubular rod. In any event, the expansion is caused by the relative movement of a screw threaded mechanism.

FIG. 7 shows another manually expandeddevice70 with aninternal rod71 andcompression element72. One end of the device is fixed to one end of therod73, while theother end74 is allowed to move relative to the rod. As the compression element is pushed forward, it forces theend74 of the device to move, thus compressing the device and forcing it to expand. The compression element is advanced and the device expanded until the desired affect is achieved. The element can maintain its position utilizing mechanical friction or a detent mechanism. Other means of maintaining position are possible. The internal rod of the manually expanded devices may be flexile or rigid. The expanding elements of the manually expanded devices may utilize geometries such as those discussed inFIG. 4

FIGS. 8A & 8B show the use of a coil device. Thecoil device81 is advanced to the fracture in a stretched state with a diameter less than its natural, unstretched diameter. When it is released from thedelivery device82, the coil device expands to a state of greater diameter. As it expands to agreater diameter83 it naturally shortens in length. This simultaneously draws the fracture together and fixates the fracture.

FIGS. 9A & 9B show the use of a braid device. Thebraid device91 is advanced to the fracture in a stretched state with a diameter less than its natural, unstretched diameter. When it is released from thedelivery device92, thebraid device93 expands to a state of greater diameter. As it expands to a greater diameter it naturally shortens in length. This simultaneously draws the fracture together and fixates the fracture. The devices inFIG. 8 andFIG. 9 can utilize other geometries that function similarly with similar results. In addition, shape memory materials that exhibit similar change of length and diameter may be used in the construction of devices inFIG. 8 andFIG. 9.

FIG. 10 shows thedevice100 invention including the use ofexternal screws101 that join the device through the bone. This provides an extra measure of securement and strength.

FIG. 11 showsexternal plates10 incorporated with this combination ofexternal screws111 anddevice112. There maybe fractures that require the additional stabilization that this combination provides.

FIG. 12A shows an implanteddevice120 connected to anelectrical generator121 in order to expedite bone growth. The external screws inFIG. 10 can serve the dual purpose of adding securement and acting aselectrodes122.

FIG. 12B shows adevice123 similar to that inFIG. 5 that is connected to anelectrical generator124. In this scenario, the device can be used is in a temporary or permanent fashion. It may be desirable to remove the device after the bone has healed.

FIG. 13 shows aexpansion device130 that uses a rubber sleeve orgrommet131 that when compressed axially132, expands radially133.

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.

FIG. 14 shows three of the four major nasal sinus cavities:

- 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.

FIG. 15 shows anexpandable device150 similar to the device positioned within thefrontal sinus151.FIG. 15 is taken from the incorporated references by Mische (i.e. U.S. Pat. No. 6,375,666 filed Dec. 9, 1999 entitled “Methods and Devices for the Treatment of Neurological Disorders”) and identified asFIG. 2 in these references for treating neurologic disorders and physiologic disorders. However, one skilled in the art can appreciate the obviousness and inventiveness provided by the figure in depicting the ability of the expandable device for maintaining patency of the sinus cavity, specifically the frontal sinus cavity.

FIG. 16A,FIG. 16B andFIG. 16C shows a sequence of the placement of the device within the sinus. These figures are similar to theFIGS. 3A and 3B which show a bone structure being dilated and are in the pending U.S. patent application Ser. No. 09/733,775 filed on Dec. 8, 2000 entitled “Methods and Devices for Treatment of Bone Fractures”, of which this application claims the benefit of. U.S. patent application Ser. No. 09/733,775 discusses treating the sinuses and nose with the device and associated technology.

The figures show adevice160 and method for delivery of anexpandable device166. Thisdevice160 comprises aflexible catheter162 having aballoon164 thereon. Initially, as shown inFIG. 16A, theballoon164 is deflated and thedevice166 is radially compressed to a collapsed configuration, around the deflatedballoon164. Thecatheter162 with theballoon164 deflated and thecollapsed device166 mounted thereon is advanced into a passageway such as a nostril, nasal cavity, meatus, ostium, interior of a sinus, etc. that is to be expanded or dilated by device. Thereafter, theballoon164 is inflated causing thedevice166 to expand to a size that frictionally engages the surrounding tissue so as to hold thedevice166 in place, as shown inFIG. 16B. In some instances the procedure will be performed for the purpose of enlarging a passageway (e.g., an ostium, meatus, etc.) and thedevice166 will be expanded to a diameter that is sufficiently large to cause the desired enlargement of the passageway and the device will then perform a scaffolding function, maintaining the passageway in such enlarged condition. After thedevice166 has been fully expanded and implanted, theballoon164 may be deflated and thecatheter162 removed as shown inFIG. 16C. In some applications, the device may contain a diagnostic or therapeutic substance as defined herein and such substance may elute from thedevice166 into the surrounding tissue to bring about a desired diagnostic or therapeutic effect. In some cases, thedevice166 may be permanently implanted. In other cases thedevice166 may be temporarily implanted. In cases where thedevice166 is temporarily implanted, it may be removed in a second procedure conducted to retrieve thedevice166 or thedevice166 may be made of bioabsorbable or biodegradable material such that it degrades or is absorbed within a desired period of time after implantation. In some cases, such as when the device is to be placed within the ostium of a paranasal sinus, the device and/or the balloon may be specifically shaped to facilitate and/or cause thedevice166 to form and seat in a desired position and to prevent unwanted slippage of thedevice166. For example, thedevice166 and/orballoon164 may have an annular groove formed about the middle thereof or may be hourglass or venturi shaped, to facilitate seating of thedevice166 within an ostium or orifice without longitudinal slippage of thedevice166. In some cases it may be desirable to leave a tether or suture attached to thedevice166 to allow for simple removal of thedevice166. In some cases the procedure may be intended to mechanically remodel or enlarge a sinus location. In this case, the dilating force of the delivery device (e.g. balloon, grommet, expansion tool, etc) is strong enough to cause bone or cartilage to yield, deform or break.

Assisting in this phenomena would be a device such as that shown inFIG. 19A andFIG. 19B where physical features on the exterior of the device facilitates cutting or breaking of the sinus structure. This will be further elaborated in the upcoming description ofFIGS. 19A and 19B.

FIG. 17A shows a constrictedsinus passageway170. The constriction could be the result of sinusitis-related inflammation, trauma, lesion, polyp, tumor, or other condition.FIG. 17B shows a tubular device that has been placed at the constriction and thus resulting in an increase of the passageway opening. A device of similar designs and method of placement may be used in the nasopharynx to maintain patency for fluid drainage as well as to treat sleep apnea. In sleep apnea, many times the nasopharynx will be occluded or collapse during the sleep cycle. When it collapses, a natural respiratory pressure release via the nasal passage is blocked and a vacuum is formed in the back of the mouth and the throat. This phenomenon exacerbates the soft palate prolapse into the throat and causes sleep apnea. Using a device within the nasopharynx will ensure air passage through the nose, and prevent nasopharynx collapse and avoid the vacuum formed when this happen. The soft palate can be attached to the device residing in the nasopharynx in order to maintain the position and shape of the soft palate. This will prevent the soft palate from prolapsing into the throat and blocking breathing. The attachment means can be sutures, clips, staples, pins, screws, nails, or other means of attachment.

Although the device can be delivered via the nasal passage, as illustrated inFIGS. 1 and 2, access to the sinus cavity can be gained through an access hole made in the bone structures of the face. Such bone structure can be the maxilla, uncinate process of ethmoid bone, or more specifically the canine fossa. One option for accessing the sinus cavity is to dissect the tissue above the top gum line, exposing the bone structure. A hole can then be made in the bone structure by drill, punch, probe, scalpel, cannula as examples. With the hole into the sinus cavity created, the device can then be advanced to the sinus cavity treatment site. Another option is to drive an introducer cannula simultaneously through the gum tissue and the bone structure. The cannula can have an inner coaxial element with a sharp tip that extends past the tip of the cannula. This arrangement aids in driving the cannula through the tissue and bone structure, as well as preventing the cannula from getting clogged with tissue and bone. The inner coaxial element is then removed allowing for passage of devices (i.e. device and delivery system) through the cannula and into the sinus cavity.

FIGS. 18A,18B, and18C show adevice180 with anexterior coating182 in various views.FIG. 18A shows theentire device180 device in a pre-expanded state.FIG. 18B shows a section of thedevice180 in a pre-expanded state and itsexterior coating182 intact.

FIG. 18C shows a section of the device in the post-expanded state. The exterior coating can be made of a fabric material that aids in compressing the lining of the sinus in order to expedite hemostasis of a bloody nose. The device can include coatings such as drugs, minerals, gauze, fabric, lubricants or other materials that assist in causing hemostasis. A tubular form would allow air passage through the device and maintain patient comfort; however other forms can are anticipated. As mentioned in the parent case, U.S. patent application Ser. No. 09/733,775 filed on Dec. 8, 2000 entitled “Methods and Devices for Treatment of Bone Fractures”, the device can also be connected to an RF generator to assist in healing, as well as creating coagulation and hemostasis. In addition, the device and/or the coating can be loaded with therapeutic substances such as antibiotics like used are amoxicillin (Amoxil, Larotid, Trimox), cefaclor (Ceclor), and telithromycin (Ketek). Or 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, can be added to relieve pain. Corticosteroids, such as beclomethasone dipropionate (Beconase, Vancenase) or prednisone (Deltasone, Prednicen-M), to reduce inflammation in the nasal passages and may be given as an inhaled nasal spray that is absorbed by the device and/or device coating. Mucolytics, such as guaifenesin (Robitussin), can be used to thin the mucus. These medications can be added or incorporated into the Sinus device in order to provide acute or sustained localized complementary treatments that persist over a time that is equivalent to that of oral medications. In a tubular form of the Sinus device, air flow through the device allows for patient comfort and, thus, improved treatment compliance and treatment success is anticipated. Inhaled antibiotics are a fairly new treatment choice for chronic sinusitis. Initial studies show that because inhaled antibiotics make direct contact with the mucous membranes, they may be effective when other treatments have failed. The Sinus device may have materials which absorb these inhaled antibiotics or other medications which are introduced through the nose. When absorbed by the Sinus device, the localized and sustained direct affects that persist for a prescribed period of time. The absorbent materials can consist of, but not limited to, fibrous, expanded PTFE, chemicals, compounds, gels, foams, liquids, and porous materials.

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. Thecoating182 may also be a material that is biodegradable or bioabsorable at a rate that is prescriptive.

FIGS. 19A and 19B are views of adevice190 that has four cuttingelements192 on the exterior surface. The number and orientation of the cuttingelements192 can be varied. For example, the cutting elements can spiral around the device surface or be interrupted in a predetermined pattern. The cuttingelements192 provide the ability to cut into tenacious tissue or bone structure. In this embodiment, dilation of the tissue is eased and scar formation and be predetermined. In addition, the cutting elements embed into the biologic tissues resulting in increased fixation of the device.

FIG. 20A shows a deviatedseptum200 that is occluding thenasal passage202.FIG. 20B shows an implantedtubular device204 that has pushed the deviatedseptum200 back into proper alignment. The tubular device allows for air passage through its interior lumen. The device may also be used to force apposition of polyps or other occlusive anatomy against the walls of the passageways and out of the passageways to allow for proper air flow and fluid flows.

FIG. 21A shows a deviatedseptum210 that is occluding thenasal passage212. Afirst device214 is placed into thenasal passage212 and pushes the deviated septum back into proper alignment. Asecond device216 is placed into the adjacentnasal passage218. Alternating the sequence can be done in order to get the best outcome. The device can be delivered on a balloon-delivery device and then expanded. Alternatively, the device can be a self-expanding design that is positioned in place, allowed to expand, and forces the deviated septum to change alignment. If necessary, the self-expanding device can be further expanded by an expansion element (e.g. balloon, grommet, wedge, tapered mandrel, etc). In this type of treatment, it may be beneficial to utilize one or more devices that are made of magnets or magnetic materials. Both devices may have magnet properties that result on the adjacent devices in each nasal passage to be magnetically coupled and maintain there position as well as exert force on the deviated septum keeping it in proper alignment. Alternatively, one device could be composed of magnet materials while the other would be made of magnetic materials that are attracted to the adjacent magnet device. If preferred, the devices may be joined through the septum by sutures, clips, staples, tacks, nails or other means. In all variations, the material can be partially or entirely made of materials that biodegrade and/or are bioabsorable.

FIG. 22A shows a septum with a perforation.FIG. 22B shows a device in one nasal passage. The device is covering the perforation, thus isolating one nasal passage from the other. The device may have a coating or covering on the external surface. This coating or covering can be a tissue or fabric,

Such as inFIG. 21B, bilateral devices can be used if so needed. Likewise, the device may be made of magnet or magnetic materials, and can be joined through the septum if so desired.

FIG. 23A shows afistula230 from one sinus passage into another. This can be treated with thedevice232 in one or more variations as discussed inFIGS. 21A through 22B. The same type of device can be used to seal a fistula between the sinus and brain cavities.

FIGS. 24A and 24B show devices in the sequence of treating a sinus passageway by gaining access through thetooth242 and tooth socket. Alternatively, the sinus can be access through the roof of the mouth by gaining access through ahole244 in the bone structure of the oral cavity. A device similar to aguidewire246 is advanced through the tooth and across the sinus location to be treated. Adelivery device247 is then advanced to the sinus treatment location and thedevice248 is deployed. Thedelivery device247 is then retracted. The hole in the tooth can be closed with standard dental materials. Another entry point into the sinuses could be the tear ducts. In fact, these device technology can be use to support the tear duct in order to maintain proper drainage of tear fluids. As well, the device can be placed across the ear drum in order to release pressure and fluid build up. In this case, the device would again be placed in a low profile fashion through and placed across the ear drum and expanded. It would then be left in place to allow drainage through the lumen. It could then be removed as in the previously mentioned methods. The benefit of this over a standard drain plug is that expanding slowing to a larger diameter may be safer and allow for a less traumatic affect to the ear drum.

FIG. 25A shows aunilateral cleft palate250. Thenasal passage252 and theoral cavity254 are now in direct communication via afistula256 that is formed by thecleft palate250. Thefistula256 is sealed by placing atubular device258 into the nasal passage. A covering on the device, similar to that discussed inFIG. 18A would provide a barrier to fluids and air from being transferred to or from the nasal passage into the oral cavity. The axial through-lumen259 of the device allows for proper air exchange through the nose. After placement of the device, the hard and/or soft palate can be attached to the device if desired. The attachment means can be sutures, clips, staples, tacks, nails or other means. In all variations, the material can be partially or entirely made of materials that biodegrade and/or are bioabsorable. In addition, materials can be introduced into the space between the device and the oral cavity in order to fill the void. An example would be a collagen matrix or a paste that is injected into that space.

FIG. 27 shows a longitudinal cross-section view of a device with a one-way valve272. In this case, the valve design is a classic duck-bill form. It can be made of a soft material (e.g. silicone, polyurethane) so that it can contract and expand with the device during processing and delivery. The soft material of the valve allows for devices such as a guidewire to pass through it to enable delivery.

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.

FIG. 28 shows a longitudinal cross-section view of a device containingfilter media282. When the device is implanted into a nasal or sinus passage, thefilter282 prevents contaminants form entering the sinuses. The filter can also be used to balance the pressure in the cavities. The filter media can be soft and pliable enough to allow for the passage of devices as well as allows the device structure to expand or contact as needed.

FIG. 29 shows a longitudinal cross-section view of a device with a one-way valve, similar to that inFIG. 27, placed in between the oral cavity and the maxillary sinus. The valve is oriented to allow for drainage into the oral cavity but prevent air or fluids form entering the sinus.

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.