CA2151548A1 - Improved balloon catheter for internal fixation of bone fractures - Google Patents
Improved balloon catheter for internal fixation of bone fracturesInfo
- Publication number
- CA2151548A1 CA2151548A1 CA002151548A CA2151548A CA2151548A1 CA 2151548 A1 CA2151548 A1 CA 2151548A1 CA 002151548 A CA002151548 A CA 002151548A CA 2151548 A CA2151548 A CA 2151548A CA 2151548 A1 CA2151548 A1 CA 2151548A1
- Authority
- CA
- Canada
- Prior art keywords
- balloon
- bone
- catheter
- tubing
- balloon catheter
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7216—Intramedullary pins, nails or other devices for bone lengthening or compression
- A61B17/7225—Intramedullary pins, nails or other devices for bone lengthening or compression for bone compression
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
- A61B17/7275—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with expanding cylindrical parts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/72—Intramedullary pins, nails or other devices
- A61B17/7233—Intramedullary pins, nails or other devices with special means of locking the nail to the bone
- A61B17/7258—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone
- A61B17/7266—Intramedullary pins, nails or other devices with special means of locking the nail to the bone with laterally expanding parts, e.g. for gripping the bone with fingers moving radially outwardly
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00535—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
- A61B2017/00557—Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated inflatable
Abstract
The present invention is directed toward a method and apparatus for performing an internal fixation of fractures of tubular bones using a balloon catheter fixation device which is guided and transported through the medullary canal and fracture site of the bone by a plurality of guide wires mounted in said balloon catheter fixation device. A bone cement is applied to the fracture site and the balloon catheter is inflated inside the bone and tightened by applying pressure on the catheter outside of the bone by tightening the catheter tube and holding the same in place in an inflated condition to apply a compression force across the fracture site enhancing the stability of the fractured bone and promoting osseous healing.
Description
~ACKGROUND OF T~E INVENTION
1. Field of the Invention The present invelltion is ~enerally directed toward an apparatus for the internal fixation of fractures of tubular bones by compress~on.
1. Field of the Invention The present invelltion is ~enerally directed toward an apparatus for the internal fixation of fractures of tubular bones by compress~on.
2. Brief Description of the Backs~round Currently, fractured tubular bones are transfixed surgically by eitller metal plates and screws or in~L~ dlll 1 ary metal rods.
It is known that with internal fixation of fractures with plate and screw devices it is desirable to apply a compressive force across the fracture site. Bone is a viscoelastic material and support of the structure and transmission of load is the mechanical function of bone. Bone is strongest in compression and weakest in tension. When a compressive force is applied across a fracture site it allows the fractured segments of bone to be placed in close proximity and the compressive force stimulates the bone in healing. If compression is applied at the fracture s~te, the intimate contact of the bone fragments restores the structural stability of the bone and allows the direct transfer of force from fragment to fragment rather than only through the implant. A
compressive force applied directly at the fracture site hastens the healing of bone by encouraging the formation of new osteons which brid~e the fracture line promoting a primary type of bone healing.
~ 21~ 8 Some bone fracture ref~l 1,, t procedures involve insertion of a wire into the medullary canal which is then guided through the bone segments ~ of ten in conjunction with a partially inserted nail for leverage.
When the segments are aligned, the nail i8 fully inserted and the wire is withdrawn.
Metal inl~ ry devices, which function as internal splints, have been used for many years to align fractures of tubular bones These devices may take the form nails, United States Patent Number 5,034,013; tubular members, United States Pal;ent Number 4,467,794; or a multiple pin device, Ullited States Patent Number 4,457,301. A steerable intramedullary fracture reduction device having an elongate~l shaft with a steerable tip pivotally mounted to the distal end of the shaft is shown by United States Patent Numl~er 5,002,543. In this patent, a tip actuating apparatus near the proximal end of the shaft enables the operator to steer the tip and the shaft into successive segments of the fractured bone, even when the segments are transversely or rotationally displaced so that the segment can be aligned by the shaft. Metal compression devices which are used for fractures are shown by United States Patent Numbers 4,275,717; 4,227,518;
It is known that with internal fixation of fractures with plate and screw devices it is desirable to apply a compressive force across the fracture site. Bone is a viscoelastic material and support of the structure and transmission of load is the mechanical function of bone. Bone is strongest in compression and weakest in tension. When a compressive force is applied across a fracture site it allows the fractured segments of bone to be placed in close proximity and the compressive force stimulates the bone in healing. If compression is applied at the fracture s~te, the intimate contact of the bone fragments restores the structural stability of the bone and allows the direct transfer of force from fragment to fragment rather than only through the implant. A
compressive force applied directly at the fracture site hastens the healing of bone by encouraging the formation of new osteons which brid~e the fracture line promoting a primary type of bone healing.
~ 21~ 8 Some bone fracture ref~l 1,, t procedures involve insertion of a wire into the medullary canal which is then guided through the bone segments ~ of ten in conjunction with a partially inserted nail for leverage.
When the segments are aligned, the nail i8 fully inserted and the wire is withdrawn.
Metal inl~ ry devices, which function as internal splints, have been used for many years to align fractures of tubular bones These devices may take the form nails, United States Patent Number 5,034,013; tubular members, United States Pal;ent Number 4,467,794; or a multiple pin device, Ullited States Patent Number 4,457,301. A steerable intramedullary fracture reduction device having an elongate~l shaft with a steerable tip pivotally mounted to the distal end of the shaft is shown by United States Patent Numl~er 5,002,543. In this patent, a tip actuating apparatus near the proximal end of the shaft enables the operator to steer the tip and the shaft into successive segments of the fractured bone, even when the segments are transversely or rotationally displaced so that the segment can be aligned by the shaft. Metal compression devices which are used for fractures are shown by United States Patent Numbers 4,275,717; 4,227,518;
3,779,239 and 3,760,802. The aforenoted metal compression devices are generally directed towards a threaded rod which is inserted within, the medullary canal of a fractured tubular bone. ~he rod is provided with a distal end having an expandable spreadable sheath or fingers ,~ 2151548 which expand upon rotation of the rod. The proximal end of the rod is located outside oi the bone and is provided with a nut which holds the rod in place inside the bone thereby causing the fractured bone portions to be held together. United States Patent Number 4,946,459 shows an in~ 1..1 l ary device for fixing and extending separated portions of a long bone witllin the body of a patient. The device has a tubular sleeve which is nailed to one end of the bone and an adJustment assembly with a moveable member whlch bears against an end of the nail. The moveable member can be moved from outside the patient to adJust the separation between the portions of the fractured bone.
The aforementioned prlor art devices have metal fingers or sleeves which engage the walls of the medullary canal of the bone with deleterious effects.
The use of such prior art inl,l ?~ l ary devices involves the reaming of the medullary cavity which has the effect of destroying the inner lining of blood vessels.
Furthermore the ends of long bones in children are also the growth center of the bones. Drilling or gouging through the ends causes damage and may stop or deform f urther growth .
Other prior art deviccs currently use dynamic compression plates and screw devices to apply compression across the fracture site. However, for insertion of this type of device, it is necessary to make a large surgical incision over the outer cortex of the bone directly at the fracture site. Placing this type of fixation device ~ 21')1~48 entails the disturbance of the soft tissues overlying the fracture site, disturbance of the fracture hematoma, and stripping the periosteium ~f bone which ,, _ ~ ces the blood supply to the bone at the fracture site.
A flexible bladder device has been described by United States Patent Number 4,313,434 to align fractures irl~l ?~ rly, However, this bladder device is designed to be placed directly at the fracture site to provide fixation. The bladder device was not designed for compression at the fracture slte and when inflated at the fracturo site actually promotes separation of the fracture fragments and has the opposite effect of the present balloon catheter compressiorl device.
There is no known illl,L~ lary device currently available that applies a compressive force at the fracture site in addition to aligning the fraoture.
SUMMARY OF T~IE INVENTION
An improved meth~d and apparatus for treatment of fractures of tubular bones relies on the principle of compressive force to align fractures of tubular bones and to promote and hasten the healing of such fractures. The intramedullary balloon of the balloon catheter is desi~ned to be guided and transported through the medullary canal of the bone and placed either proximal or distal to the fracture site. The ballc~on when inflated with sterile saline solution is held securely in place in the medullary oanal of the bone acting as an intramedullary anchor for 21515~8 the balloon catheter. It i8 the elastic L/~ l,y of the eatheter that when tightened against the rigid immobile force of the anehoring balloon allows the fraetured segments of the bone to align and eome in ' intimate eontact. With further tightening of the catheter a .;,, es~iive force is applied aercss the fracture æite.
It is an ob~ect of the invention to provide a fracture eompression deviee whieh minlmizes dama~e to the interior blood vessels and periosteium of the bone and allows the guide wire to be removed.
It is another ob~eet of the invention to provide a fraeture eompression device which utilizes a bioabsorbable bone cement in combination with the compressive force to set the fraeture site.
It is another ob ~ ect of the invention to provide a fracture compression device which utilizes a quick hardening biomaterial such as Norian Sl?~S in combination with the _ essive force to 3et the fracture site.
In the accompanying drawings, there is shown an illustrative embodiment of the invention from which these and other ob~ectives, novel features and advantages will be readily apparent.
BRIEF DESCRIPTION OF T~E DRAWINGS
Figure 1 is a eross seetional sehematie of the invention showing insertion of the inventive balloon catheter deviee into the bone;
2151~i98 Figure 2 is a cross sQctional schematic of the inventlon showing fixation ~f the balloon catheter in the medullary canal of the bone and compressive tightening of the fractured portions of the bone with the sensing and fluid tr~n~ e1t n elements shown in block diagram;
Figure 3 is a cross section of the inflated balloon with a fluted outer.wall; and Figure 4 i8 a cross section schematic of the fixation post with ~alloon catheter extending 2 therethrough .
DETAILED DESCRIPTION OF T~E INVENTION
A preferred embodiment and best mode of the invention is shown in Figur~3s l an~ 2. The inl l, ?~ l ary balloon compression device 10 is used to treat fractures of tubular bones by applying illl.L. ~ l ary compression at the f racture site .
When a tubular bone 40 is fractured at a fracture site 41, the catheter device lO can be inserted into the medullary canal 42 of the bone through a small incision either proximal or distal to the site of the fracture via a catheter introducer. A small aperture 44 is made in the outer cortex of the bone portion 46 with an introducing bone drill and drill bit or bone awl to access the medullary canal of the bone. Once the aperture 44 is created in the bone, the balloon catheter device 10 with lead wire 12 and double guide wires 13 and 15 or additional guide wires if such are needed is inserted into ~ 21~ 48 the medullar cavity of the bone by a catheter introducer 60. The balloon compression device lO is preferably constructed o a plastic e~ctruded material such as polyethylene, teflon, kevlar or other durable material is then guided by the guide wires 13 and 15 past the fracture site 41 into the other porltion 48 of the fractured bone.
The balloon catheter device 10 is formed with a plurality of lumens ll along its lerlgth for guide wire insertion.
~ocation of the lumens 11 are shown in phantom in Figure 2. The guide wires may be removable = from the balloon catheter or permanently incorporated in the catheter. The balloon 16 of the catheter device is inflated to its maximum diameter via the elastic catheter tube 14 with sterile saline solution by means of a syringe 18, associated feed tube 20 and a balloon pressure gauge monitor 22 as shown by respective block diagrams. It is envisioned that the shape of the balloon 16 can be modified in various forms, including smooth, fluted as shown in Figure 3 or ridged outer walls for promoting endosteal blood supply at the site of the balloon insertion. The inflated balloon 16 is held securely in place by the positive pressure applied to the intramedullary walls o~ th~ bone. Once the balloon 16 i8 anchored in place past the fracture site 41, the attached catheter tube 14 can be tightened.
If desired a bone-mineral ~ substitute, bone cement or bioabsorbable bone cement can be applied to the fractured bone ends prior to application of the 21~15~8 compression force. One suitable bone-mineral substitute is a calcium phosphate compound with a sodium phosphate solution. Monocalcium phosphate, monohydrate, triacalcium phosphate and calcium carborlate are dry mixed and a sodium phosphate solution is added to form a paste which is malleable and hardens in about 10 minutes. After implantation the paste harclens and turns into carbonated apatite .
The catheter tensioning device is provided with a calibrated force measurin(g device such as a strain gauge 50 to measure the compression force. The tightening of the catheter 14 with the fixed balloon 16 in place aligns the fracture and compres~es the proximal and distal portions 46 and 48 of the fractured bone together. After alignment and compression of the fracture with the inl L d--l 1 ary balloon compression catheter, the catheter 14 is secured firmly to the bone 46 at it ' s insertion site 44 with a screw, post or peg type of fixation device 30.
Thus, the balloon compression catheter can be incorporated into existing bone fixa~ion technology such as an intramedullary rod, a fixation screw or plate, hip screw or total ~oint arthroplasty that uses a balloon catheter to enhance fixation to the bone. Preferably, the post 30 is hollow with a head 32 and stem 33 which is exteriorly threaded at 34. The stem 33 defines a throughgoing bore 35 with leads into lumen 31 and opens into an arcuate ball seat 36 which is cut into the lumen wall. The bore 35 is threaded to receive a fixation screw 37 which is used to tighten a crimping ball 38 to crimp the catheter tube 14 within the fixation port. The crimping ball 38 can be instructed of metal or plastic. The catheter tube 14 extending through the lumen 31 of the post is thus clamped or affixed to the bone fixation post. The fixation post 30 and catheter 14 can be respectively released and tightened, if necessary, to apply further compression at the f raoture site .
In operation, th~ fixation post, which may be smooth and possibly threaded, fits into the aperture that was cut in the bone for insertion of the balloon catheter.
~he catheter is inserted through the hollow center of the head 33 and lumen 31 of the shaft portion of the fixation post. After the catheter is gulded past the fracture site in the medullary canal of the bone by guide wires, the balloon portion of the catheter is inflated away from the f racture site and in doing so does not , , I ' ~e the e2LI l ?~ l ary periosteal blood supply or the in~l ?~ flry blood supply at the fracture site. The compression force of the catheter allows the fractured fragments of bone to be aligned in close appositlon promoting healing of the fracture similar to the prior art dynamic compression plate device without making an i nc.l ~ n at the fracture site and without ~ 1 q1 n~ the blood supply at the fracture site. The device does not disturb the fracture hematoma which is essential for healing of the fracture. A tensioning device fits over the -head 33 of the f ixation post . At this stage bone 21~1~48 cement or bone-mineral $ubstitute can be applied. The balloon catheter is then tightened with the tF~ns~n1n~
device. This reduces the fracture distance, spplying compression at the fracture site. After the bone i9 aligned and compressed at the fracturc sita, the crimping ball 38, which lies in a separate tunnel or bore 35 within the shaft of the fixation post is tightened with the threaded set screw 37. When tightened against the tube of the catheter, the crimping ball 38 occludes the central lumen of the catheter tube 14 keeping the balloon 16 inflated thus securing the catheter within the shaft of the f ixation post .
After the fracture is healed, or alternatively in some cases af ter the bone cement has set up, the set screw can be released, the balloon deflated and the catheter and fixation post can be easily removed from the bone. If necessary, additional balloon catheters can be similarly positioned in place for fixation. The balloon compression catheter can be used independently for the inl L ci--l lary compression fixation of tubular bones or can be used as a supplement with bioabsorbable bone cement or to metal intramedullary devices to =apply compression across the fracture site.
The in~l - ' 1 lary balloon compression catheter is designed spec~f1r;~11y to apply a ~ ive force at the fracture site, to align the fractured bone and promote healing of the fracture.
21~1 ~48 Osteogenesis is p~omoted by compression across a fracture site and the in~ l ary baLloon o~ alOn catheter facilitates this in an inl,l -~11ll 1 ary fashion.
In the foregoing description, the invention has been described with reference to a particular preferred embodiment, although it is to be understood that specif ic details shown are merely i:Llustrative, and the invention may be carried out in other ways without departing f rom the true spirlt and scope of the following claims:
The aforementioned prlor art devices have metal fingers or sleeves which engage the walls of the medullary canal of the bone with deleterious effects.
The use of such prior art inl,l ?~ l ary devices involves the reaming of the medullary cavity which has the effect of destroying the inner lining of blood vessels.
Furthermore the ends of long bones in children are also the growth center of the bones. Drilling or gouging through the ends causes damage and may stop or deform f urther growth .
Other prior art deviccs currently use dynamic compression plates and screw devices to apply compression across the fracture site. However, for insertion of this type of device, it is necessary to make a large surgical incision over the outer cortex of the bone directly at the fracture site. Placing this type of fixation device ~ 21')1~48 entails the disturbance of the soft tissues overlying the fracture site, disturbance of the fracture hematoma, and stripping the periosteium ~f bone which ,, _ ~ ces the blood supply to the bone at the fracture site.
A flexible bladder device has been described by United States Patent Number 4,313,434 to align fractures irl~l ?~ rly, However, this bladder device is designed to be placed directly at the fracture site to provide fixation. The bladder device was not designed for compression at the fracture slte and when inflated at the fracturo site actually promotes separation of the fracture fragments and has the opposite effect of the present balloon catheter compressiorl device.
There is no known illl,L~ lary device currently available that applies a compressive force at the fracture site in addition to aligning the fraoture.
SUMMARY OF T~IE INVENTION
An improved meth~d and apparatus for treatment of fractures of tubular bones relies on the principle of compressive force to align fractures of tubular bones and to promote and hasten the healing of such fractures. The intramedullary balloon of the balloon catheter is desi~ned to be guided and transported through the medullary canal of the bone and placed either proximal or distal to the fracture site. The ballc~on when inflated with sterile saline solution is held securely in place in the medullary oanal of the bone acting as an intramedullary anchor for 21515~8 the balloon catheter. It i8 the elastic L/~ l,y of the eatheter that when tightened against the rigid immobile force of the anehoring balloon allows the fraetured segments of the bone to align and eome in ' intimate eontact. With further tightening of the catheter a .;,, es~iive force is applied aercss the fracture æite.
It is an ob~ect of the invention to provide a fracture eompression deviee whieh minlmizes dama~e to the interior blood vessels and periosteium of the bone and allows the guide wire to be removed.
It is another ob~eet of the invention to provide a fraeture eompression device which utilizes a bioabsorbable bone cement in combination with the compressive force to set the fraeture site.
It is another ob ~ ect of the invention to provide a fracture compression device which utilizes a quick hardening biomaterial such as Norian Sl?~S in combination with the _ essive force to 3et the fracture site.
In the accompanying drawings, there is shown an illustrative embodiment of the invention from which these and other ob~ectives, novel features and advantages will be readily apparent.
BRIEF DESCRIPTION OF T~E DRAWINGS
Figure 1 is a eross seetional sehematie of the invention showing insertion of the inventive balloon catheter deviee into the bone;
2151~i98 Figure 2 is a cross sQctional schematic of the inventlon showing fixation ~f the balloon catheter in the medullary canal of the bone and compressive tightening of the fractured portions of the bone with the sensing and fluid tr~n~ e1t n elements shown in block diagram;
Figure 3 is a cross section of the inflated balloon with a fluted outer.wall; and Figure 4 i8 a cross section schematic of the fixation post with ~alloon catheter extending 2 therethrough .
DETAILED DESCRIPTION OF T~E INVENTION
A preferred embodiment and best mode of the invention is shown in Figur~3s l an~ 2. The inl l, ?~ l ary balloon compression device 10 is used to treat fractures of tubular bones by applying illl.L. ~ l ary compression at the f racture site .
When a tubular bone 40 is fractured at a fracture site 41, the catheter device lO can be inserted into the medullary canal 42 of the bone through a small incision either proximal or distal to the site of the fracture via a catheter introducer. A small aperture 44 is made in the outer cortex of the bone portion 46 with an introducing bone drill and drill bit or bone awl to access the medullary canal of the bone. Once the aperture 44 is created in the bone, the balloon catheter device 10 with lead wire 12 and double guide wires 13 and 15 or additional guide wires if such are needed is inserted into ~ 21~ 48 the medullar cavity of the bone by a catheter introducer 60. The balloon compression device lO is preferably constructed o a plastic e~ctruded material such as polyethylene, teflon, kevlar or other durable material is then guided by the guide wires 13 and 15 past the fracture site 41 into the other porltion 48 of the fractured bone.
The balloon catheter device 10 is formed with a plurality of lumens ll along its lerlgth for guide wire insertion.
~ocation of the lumens 11 are shown in phantom in Figure 2. The guide wires may be removable = from the balloon catheter or permanently incorporated in the catheter. The balloon 16 of the catheter device is inflated to its maximum diameter via the elastic catheter tube 14 with sterile saline solution by means of a syringe 18, associated feed tube 20 and a balloon pressure gauge monitor 22 as shown by respective block diagrams. It is envisioned that the shape of the balloon 16 can be modified in various forms, including smooth, fluted as shown in Figure 3 or ridged outer walls for promoting endosteal blood supply at the site of the balloon insertion. The inflated balloon 16 is held securely in place by the positive pressure applied to the intramedullary walls o~ th~ bone. Once the balloon 16 i8 anchored in place past the fracture site 41, the attached catheter tube 14 can be tightened.
If desired a bone-mineral ~ substitute, bone cement or bioabsorbable bone cement can be applied to the fractured bone ends prior to application of the 21~15~8 compression force. One suitable bone-mineral substitute is a calcium phosphate compound with a sodium phosphate solution. Monocalcium phosphate, monohydrate, triacalcium phosphate and calcium carborlate are dry mixed and a sodium phosphate solution is added to form a paste which is malleable and hardens in about 10 minutes. After implantation the paste harclens and turns into carbonated apatite .
The catheter tensioning device is provided with a calibrated force measurin(g device such as a strain gauge 50 to measure the compression force. The tightening of the catheter 14 with the fixed balloon 16 in place aligns the fracture and compres~es the proximal and distal portions 46 and 48 of the fractured bone together. After alignment and compression of the fracture with the inl L d--l 1 ary balloon compression catheter, the catheter 14 is secured firmly to the bone 46 at it ' s insertion site 44 with a screw, post or peg type of fixation device 30.
Thus, the balloon compression catheter can be incorporated into existing bone fixa~ion technology such as an intramedullary rod, a fixation screw or plate, hip screw or total ~oint arthroplasty that uses a balloon catheter to enhance fixation to the bone. Preferably, the post 30 is hollow with a head 32 and stem 33 which is exteriorly threaded at 34. The stem 33 defines a throughgoing bore 35 with leads into lumen 31 and opens into an arcuate ball seat 36 which is cut into the lumen wall. The bore 35 is threaded to receive a fixation screw 37 which is used to tighten a crimping ball 38 to crimp the catheter tube 14 within the fixation port. The crimping ball 38 can be instructed of metal or plastic. The catheter tube 14 extending through the lumen 31 of the post is thus clamped or affixed to the bone fixation post. The fixation post 30 and catheter 14 can be respectively released and tightened, if necessary, to apply further compression at the f raoture site .
In operation, th~ fixation post, which may be smooth and possibly threaded, fits into the aperture that was cut in the bone for insertion of the balloon catheter.
~he catheter is inserted through the hollow center of the head 33 and lumen 31 of the shaft portion of the fixation post. After the catheter is gulded past the fracture site in the medullary canal of the bone by guide wires, the balloon portion of the catheter is inflated away from the f racture site and in doing so does not , , I ' ~e the e2LI l ?~ l ary periosteal blood supply or the in~l ?~ flry blood supply at the fracture site. The compression force of the catheter allows the fractured fragments of bone to be aligned in close appositlon promoting healing of the fracture similar to the prior art dynamic compression plate device without making an i nc.l ~ n at the fracture site and without ~ 1 q1 n~ the blood supply at the fracture site. The device does not disturb the fracture hematoma which is essential for healing of the fracture. A tensioning device fits over the -head 33 of the f ixation post . At this stage bone 21~1~48 cement or bone-mineral $ubstitute can be applied. The balloon catheter is then tightened with the tF~ns~n1n~
device. This reduces the fracture distance, spplying compression at the fracture site. After the bone i9 aligned and compressed at the fracturc sita, the crimping ball 38, which lies in a separate tunnel or bore 35 within the shaft of the fixation post is tightened with the threaded set screw 37. When tightened against the tube of the catheter, the crimping ball 38 occludes the central lumen of the catheter tube 14 keeping the balloon 16 inflated thus securing the catheter within the shaft of the f ixation post .
After the fracture is healed, or alternatively in some cases af ter the bone cement has set up, the set screw can be released, the balloon deflated and the catheter and fixation post can be easily removed from the bone. If necessary, additional balloon catheters can be similarly positioned in place for fixation. The balloon compression catheter can be used independently for the inl L ci--l lary compression fixation of tubular bones or can be used as a supplement with bioabsorbable bone cement or to metal intramedullary devices to =apply compression across the fracture site.
The in~l - ' 1 lary balloon compression catheter is designed spec~f1r;~11y to apply a ~ ive force at the fracture site, to align the fractured bone and promote healing of the fracture.
21~1 ~48 Osteogenesis is p~omoted by compression across a fracture site and the in~ l ary baLloon o~ alOn catheter facilitates this in an inl,l -~11ll 1 ary fashion.
In the foregoing description, the invention has been described with reference to a particular preferred embodiment, although it is to be understood that specif ic details shown are merely i:Llustrative, and the invention may be carried out in other ways without departing f rom the true spirlt and scope of the following claims:
Claims (21)
- Claim 1. An assembly for setting a fractured bone comprising a balloon catheter with tubing, said balloon catheter defining an inflation section which inflates when said balloon catheter is pressurized and at least one throughgoing lumen, a guide wire mounted in said lumen, said inflation section being inflated in a fractured bone portion to fixedly engage said bone segment and anchor means mounted in another fractured bone portion distal from said fractured bone portion, said anchor means being secured to said catheter tubing to hold said balloon catheter in a tensioned condition which provides compression on the fracture site of fractured bone portions.
- Claim 2. The assembly of Claim 1 including a calibrated force measuring device secured to said tubing to measure the compression force on said balloon catheter.
- Claim 3. The assembly of Claim 1 including a pressure monitoring means connected to said balloon catheter to measure the pressure of the inflated balloon of said balloon catheter.
- Claim 4. An assembly for setting fractured bones comprising a balloon catheter with a tubing having an inner lumen and an inflatable balloon with fluted sides secured to said tubing at the distal end thereof, said balloon with fluted sides being in fluid communication with the lumen of said tubing, a guide wire mounted to said balloon and means separate from said balloon catheter adapted to be mounted in a portion of said fractured bone distal from said balloon with fluted sides to receive said tubing and hold said balloon catheter when said balloon with fluted sides is inflated in a fixed stressed condition to provide compression on the fracture site of fractured bone portions.
- Claim 5. The assembly of Claim 4 wherein said catheter is flexible and reinforced.
- Claim 6. The assembly of Claim 4 wherein said catheter tubing is elastic and constructed of teflon.
- Claim 7. An assembly for setting fractured bones comprising a balloon catheter with a tubing having an inner lumen and an inflatable balloon secured to said tubing at the distal end thereof, said balloon being in fluid communication with the lumen of said tubing, a guide wire mounted to said balloon and means separate from said balloon catheter adapted to be mounted in a portion of said fractured bone distal from said balloon to receive said tubing and hold said balloon catheter when said balloon is inflated in a fixed stressed condition to provide compression on the fracture side of fractured bone portions and a fluid discharge means connected to said balloon catheter and communicating with said tubing lumen to allow fluid discharge from said fluid discharge means into said tubing lumen to inflate the balloon of said balloon catheter.
- Claim 8. The assembly of Claim 7 including a pressure monitoring means connected to said balloon catheter and communicating with said tubing lumen to measure the pressure of the inflated balloon of said catheter.
- Claim 9. The assembly of Claim 7 wherein said catheter tubing is flexible and reinforced.
- Claim 10. The assembly of Claim 7 wherein said catheter tubing is elastic and constructed of teflon.
- Claim 11. The assembly of Claim 7 wherein said means adapted to be mounted in a portion of said fractured bone is a hollow post member with external screw threads.
- Claim 12. The assembly of Claim 11 wherein said hollow post member adapted to be mounted in a portion of said fractured bone includes set screw means moveably mounted therein.
- Claim 13. The assembly of Claim 12 wherein said set screw means comprises a ball seat defined by said hollow post, a throughgoing channel formed in said hollow post member leading into said ball seat, a ball seated in said ball seat and a set screw moveably mounted in said throughgoing channel adapted to engage and move said ball.
- Claim 14. The assembly of Claim 7 wherein said balloon has fluted sides.
- Claim 15. The assembly of Claim 7 wherein said fluid is a saline solution.
- Claim 16. An assembly for setting a fractured bone by holding the fractured bone portions together under a compression force across the fracture site comprising a balloon catheter with a tubing having an inner lumen and an inflatable balloon secured to said tubing and being in fluid communication with the lumen of said tubing, said balloon catheter being sized to move within the medullary cavity of the bone, a guide wire mounted to said balloon and mounting means adapted to be mounted in a portion of said fractured bone distal from said balloon, said mounting means selectively engaging said tubing and holding said tubing in a fixed stressed condition to provide compression on the fracture site of fractured bone portions after said balloon has been inflated inside one of said bone portions, and means connected to said tubing allowing the inflation of said balloon with fluid.
- Claim 17. The assembly of Claim 16 wherein said mounting means comprises a post member with a throughgoing lumen and set screw means threadably mounted to said post member and extending into said lumen.
- Claim 18. The assembly of Claim 17 wherein said set screw means comprises a ball seat defined by said post member communicating with said lumen, a throughgoing channel cut in said post member leading into said ball seat, a ball seated in said ball seat and extending into said lumen and a set screw moveably mounted in said throughgoing channel adapted to engage and move said ball into said lumen.
- Claim 19. A method of setting a fractured bone by compression comprising the steps of:
a) cutting an aperture into one portion of the fractured bone away from the site of the fracture allowing communication with the medullary canal of the bone;
b) inserting a balloon catheter device through the aperture cut in the bone into the medullar cavity of the bone;
c) guiding the balloon catheter device past the fracture site into another portion of the fractured bone;
d) inflating the balloon of the balloon catheter device to its maximum diameter so that the balloon catheter device is held securely in place by the positive pressure of the balloon applied to the intramedullary walls of the bone; and e) tightening the attached catheter with the fixed balloon in place to align the fracture and compress the proximal and distal portions of the fractured bone together. - Claim 20. A method of setting a fractured bone by compression comprising the steps of:
a) cutting an aperture into one portion of the fractured bone away from the site of the fracture allowing communication with the medullary canal of the bone;
b) inserting a balloon catheter device and catheter guide wire means through the aperture cut in the bone into the medullar cavity of the bone;
c) transporting the balloon catheter in the medullary canal of the bone past the fracture site by use of the catheter guide wire means to a point distal from the fracture site;
d) inflating the balloon of the balloon catheter device to its maximum diameter co that the balloon catheter device is held securely in place by the positive pressure of the balloon applied to the intramedullary walls of the bone; and e) tensioning the attached catheter with the fixed balloon in place by securing the catheter under tension to holding means to align the fracture and compress the proximal and distal portions of the fractured bone together. - Claim 21. A method of setting a fractured bone by compression as claimed in Claim 20 including the step of:
f) applying bone cement material to at least one fracture site of the bone.
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/130,434 US5480400A (en) | 1993-10-01 | 1993-10-01 | Method and device for internal fixation of bone fractures |
US08/153,030 US5423850A (en) | 1993-10-01 | 1993-11-17 | Balloon compressor for internal fixation of bone fractures |
US08/464,294 US5658310A (en) | 1993-10-01 | 1995-06-05 | Balloon compressor for internal fixation of bone fractures |
CA002151548A CA2151548A1 (en) | 1993-10-01 | 1995-06-12 | Improved balloon catheter for internal fixation of bone fractures |
AU21666/95A AU2166695A (en) | 1993-10-01 | 1995-06-12 | Improved balloon catheter for internal fixation of bone fractures |
EP95304043A EP0748615A1 (en) | 1993-10-01 | 1995-06-12 | Balloon compressor for internal fixation of bone fractures |
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/130,434 US5480400A (en) | 1993-10-01 | 1993-10-01 | Method and device for internal fixation of bone fractures |
US08/153,030 US5423850A (en) | 1993-10-01 | 1993-11-17 | Balloon compressor for internal fixation of bone fractures |
CA002151548A CA2151548A1 (en) | 1993-10-01 | 1995-06-12 | Improved balloon catheter for internal fixation of bone fractures |
AU21666/95A AU2166695A (en) | 1993-10-01 | 1995-06-12 | Improved balloon catheter for internal fixation of bone fractures |
EP95304043A EP0748615A1 (en) | 1993-10-01 | 1995-06-12 | Balloon compressor for internal fixation of bone fractures |
Publications (1)
Publication Number | Publication Date |
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CA2151548A1 true CA2151548A1 (en) | 1996-12-13 |
Family
ID=27506672
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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CA002151548A Abandoned CA2151548A1 (en) | 1993-10-01 | 1995-06-12 | Improved balloon catheter for internal fixation of bone fractures |
Country Status (3)
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US (2) | US5423850A (en) |
EP (1) | EP0748615A1 (en) |
CA (1) | CA2151548A1 (en) |
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EP3813696A4 (en) | 2018-06-27 | 2022-04-13 | IlluminOss Medical, Inc. | Systems and methods for bone stabilization and fixation |
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-
1993
- 1993-11-17 US US08/153,030 patent/US5423850A/en not_active Expired - Lifetime
-
1995
- 1995-06-05 US US08/464,294 patent/US5658310A/en not_active Expired - Lifetime
- 1995-06-12 CA CA002151548A patent/CA2151548A1/en not_active Abandoned
- 1995-06-12 EP EP95304043A patent/EP0748615A1/en not_active Ceased
Also Published As
Publication number | Publication date |
---|---|
EP0748615A1 (en) | 1996-12-18 |
US5423850A (en) | 1995-06-13 |
US5658310A (en) | 1997-08-19 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
FZDE | Discontinued |