CA2341957A1 - Device for targeted, catherized delivery of medications - Google Patents
Device for targeted, catherized delivery of medications Download PDFInfo
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- CA2341957A1 CA2341957A1 CA 2341957 CA2341957A CA2341957A1 CA 2341957 A1 CA2341957 A1 CA 2341957A1 CA 2341957 CA2341957 CA 2341957 CA 2341957 A CA2341957 A CA 2341957A CA 2341957 A1 CA2341957 A1 CA 2341957A1
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- needle
- adapter
- drilling
- perforator
- rotatable
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61C—DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE
- A61C1/00—Dental machines for boring or cutting ; General features of dental machines or apparatus, e.g. hand-piece design
- A61C1/08—Machine parts specially adapted for dentistry
- A61C1/087—Supplying powder or medicines
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- Animal Behavior & Ethology (AREA)
- Oral & Maxillofacial Surgery (AREA)
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- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Anesthesiology (AREA)
- Dentistry (AREA)
- Epidemiology (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Abstract
Apparatus and method for catheterized delivery or infusion of medication and anaesthesia are disclosed. The perforating catheter is first used to perforate the periodontal ligament and/or the cortical plate of bone tissue, and is then left in place and used as a catheter for insertion of a hypodermic needle of smaller gauge to deliver medication or anaesthesia to a target area. The perforator is a beveled needle for drilling into the ligament or bone tissue. For drilling, the device comprises an adaptor which transmits the rotational movement from a dental hand piece or the like to the beveled needle. A cap is also included for protecting the beveled needle during storage of the device. The adaptor may have a rod which extends axially into the beveled needle when the device is assembled for drilling. The rod is used to prevent the debris resulting from drilling from blocking the passage in the beveled needle. As well, the rod reinforces the needle and maintains the alignment between the perforator and the adaptor for improved drilling efficiency. An adapter is disclosed which couples with the catheter once in place easing access to supply medication to difficult to reach areas.
Description
Doc. No. 61-3 CA CIP(4) Patent DEVICE FOR TARGETED, CATHERIZED DELIVERY OF MEDICATIONS
Field of the Invention The present invention provides for a simple method and device for infusing or injecting medication; it is applicable to medical or dental and the like procedures.
More particularly, the invention is directed to catheterized delivery of anesthesia and other to medication. More particularly still, it is directed to catheterized delivery of dental anaesthetic to a targeted nerve and to an apparatus for such delivery.
Background of the Invention There are a variety of methods currently in use for providing local anaesthetic in dentistry. These methods and apparatuses however all have disadvantages, either being difficult for practitioners to perform or painful and unpleasant to the patient.
An example of a method used currently in dentistry is the infiltration method, whereby a local anaesthetic solution is injected into the soft tissue of gingiva. In doing so, the solution eventually passes through the cortical plate affecting the nerve bundle entering the tooth. Disadvantages of this method include the delay of onset of anaesthesia after the injection and, in most cases, ballooning of the injected tissue. As well, there is an extended period of time for recovery of the tissue until return to normal condition.
Another method which is currently used is the regional block method whereby an anaesthetic solution is injected locally in proximity to the nerve trunk as it enters the bone. Disadvantages of this procedure are that it is extremely difficult to locate the nerve trunk, there is discomfort to the patient and a delay for the anaesthetic to take effect. As 3o in the case of the infiltration method, this method necessitates a long recovery period for tissue to return to normal.
Doc. No. 61-3 CA CIP(4) Patent At present, two types of apparatus have been used to perform intra-osseous anaesthesia.
These are surgical burs used to perforate the cortical plate and the villet injectors.
The use of a surgical bur has disadvantages in that burs are expensive and they have to be sterilized between uses or a new bur used each time. In addition, the method is slow, requiring the attached gingiva and periosteum to be anaesthetized before the cortical plate is perforated. The villet injector is an apparatus that serves both as a perforator and injector. It uses specially designed needles rotated by a conventional dental motor. A
to disadvantage of this device is that the needle often becomes clogged with pulverized bone which obstructs the passage in the needle and prevents injection of the anaesthetic solution. It is generally difficult to remove the clogging material from the needle and often the use of a second needle is necessary. Other disadvantages of this method include the initial capital cost of the instrument purchase, and the cost of the needles which are 1 s somewhat expensive. In addition, the design of the instrument makes access to various parts of the mouth difficult and sometimes impossible.
Intra-osseous and targeted injections produce positive, more profound anaesthesia and could be made with less pain than either of the other types according to the present 20 invention.
Targeted anaesthesia has several advantages over prior art nerve block or infiltration methods. There is no feeling of numbness in the tongue, cheek, or lips during or after the injection and there is no after-pain. The anaesthetic is profound and acts immediately 2s alleviating the necessity of waiting for the anaesthetic to take effect as with the nerve block and infiltration methods. Furthermore, as only a few drops of anaesthetic are injected, there is no feeling of faintness or increasing of the pulse rate.
To achieve targeted anaesthesia one must gain access, if intra-osseous, to the cancellous 3o bone by going through the cortical layer; or to the bottom of the tooth, if root-canal targeted anaesthesia is desired. Because of instant anaesthesia and profound pulpal A
Doc. No. 6I-3 CA CIP(4) Patent anaesthesia, there is a much greater control over the region one wishes to anaesthetize, resulting in a much smaller dose of anaesthetic; as well as, of course, other medication, where applicable.
U.S. Pat. No. 4,944,677 (Alexandre) discloses a smooth hollow needle with a beveled point for drilling a hole into the jawbone near the apex of the tooth to be anaesthetized.
Thereafter, the drilling device 13 removed from the jaw, and a hypodermic needle of substantially the same gauge is inserted into the hole and anaesthesia is injected. Thus, there is no cathetized delivery of medication, with the attendant disadvantage that the pre 1 o drilled hole may be difficult to locate when inserting the hypodermic needle.
Over the past 50 years or so devices and processes for intraosseous anesthesia have been developed and refined. However, heretofore, no other inventors have provided a useful, workable convenient and inexpensive solution that affords all of the benefits provided by this invention. For example, none of the prior art devices allow a motorized handpiece to drive a small intraosseous catheter/drill having a rod/drill therein wherein the device can be placed by drilling at high or slower speeds and removed by simple withdrawal by pulling out the catheter. Most of the effort in this field had been directed toward longer term delivery of medication wherein the catheters have had some means of latching into 2o the bone for more permanent placement. Furthermore, the instant invention does not suffer from may of the drawbacks of inserting the needle/drill into the bore being cut by the end tip of the drill, since the outside walls of the needle/drill are of a uniform diameter and non-varying. With the long-felt want of this device, in the past decade in view of the many publications in this field, no such optimal device has been suggested.
In contrast to the prior art, the instant invention provides a dual purpose perforator which includes a needle/sleeve that serves as a relatively high-speed drill bit and which serves as a catheter that is removable by withdrawing it by pulling it out, and not by unscrewing it. The perforator has a substantially uniform outer diameter and has a smooth non-3o threaded outer surface; preferably, the catheter is a larger gauge needle than the removable rod contained within which may also be in the form of a beveled needle for Doc. No. 61-3 CA CIP(4) Patent preventing bone, skin and debris from entering the catheter during entry into the bone. A
hypodermic needle of same gauge as the rod is later placed in the catheter after the rod is removed.
Advantageously, the beveled end of the rod extending beyond the cutting catheter tip assists the cutting of the opening into the bone along with the perforator as they are both rotated by the dental hand piece they are coupled therewith.
To our knowledge, there are no prior art patents of others, which teach the use of a 1o perforator having a hypodermic needle-like cutting tool wherein the outer diameter is uniform allowing both precise cutting of a small hole, and allowing easy removal by simply pulling the device out without unthreading, wherein the perforator has an upper end adapted to be connected to a motorized dental hand piece; wherein the perforator has a rod therein which turns with the perforator needle-like cutting tool assisting in preventing debris from entering the perforator; and wherein the rod is itself a needle-like cutting tool assisting in the cutting of the opening, and wherein means are provided for ensuring that the rod and the cutting needle remain coupled prior to engaging the cutting needle, and wherein the cutting needle and the rod automatically become uncoupled when the cutting needle is engaged in cutting into the bone.
It is the belief of the inventor, that this novel method and combination of elements will eventually change the way in which many dentists infuse medication and local anesthesia.
Unlike the prior art catheters the catheter drill of the instant invention will not bind or increase its resistance against the drilling hand piece as it is drilling into the bone. The uniform outer diameter allows the drill/needle to cut without binding and acting as a self tapping hollow screw.
3o In addition to this novel way of performing dentistry, there is preferred embodiment of this invention which facilitates use of the device in more difficult to access areas of a A
Doc. No. 6I-3 CA CIP(4) Patent patient's mouth, for example, when it is required to access molars in the back of the mouth. In order to reach these otherwise difficult to reach areas with medication, after the catheter drill resides in its targeted area, an adapter for injecting fluid at a right angle to the longitudinal axis of the catheter drill is provided.
Furthermore, this adapter can be used or embodiments thereof are provided which obviate the use of a syringe equipped with a hypodermic needle.
Advantageously, this invention provides an adapter for coupling with the interosseous Io catheter drill that allows fluid to be injected without having to locate the tip of a hypodermic needle into the catheter, which can be difficult.
A very important aspect of this invention is the provision of a mating coupling between the blocking rod hub and the drilling catheter hub which ensures that the hub of the drilling needle does not accidentally de-couple from the hub or end of the drilling shaft prior to use as a drill. For example without this mating coupling simply holding the unit by the shaft end may result in the drilling needle falling out of engagement with the shaft portion and falling on the floor and becoming contaminated.
2o SUMMARY OF THE INVENTION
The present invention endeavours to mitigate the problems and disadvantages of delivering dental anaesthetic encountered with the prior art methods and devices.
The present invention provides a perforator having a central passage, which perforator then remains in place as a catheter for allowing a hypodermic needle to be inserted through the passage to deliver the desired medication. The preferred apparatus is provided with means for obstructing the entry of debris in the perforator's passage.
3o In accordance with the invention, there is provided a device for perforating the periodontal ligaments, cortical plate or small bones, and the like and for injecting Doc. No. 6I-3 CA CIP(4) Patent substances at a predetermined site, comprising:
perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole for directing a hypodermic needle to the predetermined site; and an adapter for coupling to an end of the perforator and for latching a latching-type powered dental handpiece thereto and for transmitting rotational movement from the powered dental handpeice to said perforator, the perforator having a drilling needle extending from an end thereof, the drilling needle having a uniform outer diameter and a smooth non-varying outer surface allowing removal once inserted into the periodontal ligaments, cortical plate or small 1 o bones and the like by withdrawing the needle by pulling backwards along a line defined by a longitudinal axis of the inserted drilling needle; the adapter for coupling with the perforator in a locking engagement such that rotational motion imparted to the adapter, rotates the perforator when the adapter is coupled with the perforator, the adapter having an upper end having a driving shank extending along a rotational axis for removably engaging the powered dental hand tool, the adapter having a rod sized to be accommodated within the perforator and sized to fit into a passage in said drilling needle at a lower end thereof; and, means for ensuring that the adapter and the perforator together to prevent their separation after they have been coupled, prior to use; and for allowing their easy separation after the catheter has been drilled and inserted into bone.
According to another aspect of the present invention, there is provided a device for perforating the periodontal ligaments, cortical plate of small bones, and the like, for injecting substances at a predetermined site, comprising:
a perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole perforated for directing a hypodermic needle to said predetermined site; an adaptor for latching in a latching-type powered dental handpiece for transmitting rotational movement to said perforator, the adapter having a rod at an end thereof sized to be disposed within the perforator inner passage; and, 3o means for ensuring the perforator and rod remain coupled together when perforator and the adapter are coupled, prior to use, such that a force of at least fl is required to separate Doc. No. 61-3 CA CIP(4) Patent them and for ensuring that the perforator and the rod can be easily separated after the perforated has perforated and entered into bone of a patient such that their separation only requires a force f2 or less, where, fl>f2.
The catheterized intra-osseous delivery system of the present invention comprises a perforator with a beveled drilling needle that is used as a drill and a catheter. The needle is attached at one end to a plastic or metal body.
For drilling, the body is attached to a matching adaptor provided with a driving shank 1o which is rotated by a conventional contra angle or straight dental hand piece. Then, the perforator is used as a catheter, whereby a hypodermic needle is inserted through the drilling needle without losing access to the already perforated bone.
In the preferred form of the invention the apparatus is disposable. Before disposal, the perforator receives a cap over the needle for protection against accidental contamination of environment.
The present invention also provides a method of medical treatment, comprising the steps of: inserting a catheter, at a point in the gingival sulcus between outer tooth surface and 2o marginal gingiva, or through gingiva and cortical plate, to a predetermined depth; and injecting medication or anaesthesia through said catheter.
Advantageously, the system of the present invention provide users with a more secure and less painful method and device for direct access for injecting medication to a target area into the cortical plate of the bone.
In addition, the system facilitates and adds a level of security previously unavailable for the anaesthetic in that it has a sure and immediate effect.
3o Another advantage of this system is that it provides benefits to the dentists by facilitating the use of a low cost, disposable device.
Field of the Invention The present invention provides for a simple method and device for infusing or injecting medication; it is applicable to medical or dental and the like procedures.
More particularly, the invention is directed to catheterized delivery of anesthesia and other to medication. More particularly still, it is directed to catheterized delivery of dental anaesthetic to a targeted nerve and to an apparatus for such delivery.
Background of the Invention There are a variety of methods currently in use for providing local anaesthetic in dentistry. These methods and apparatuses however all have disadvantages, either being difficult for practitioners to perform or painful and unpleasant to the patient.
An example of a method used currently in dentistry is the infiltration method, whereby a local anaesthetic solution is injected into the soft tissue of gingiva. In doing so, the solution eventually passes through the cortical plate affecting the nerve bundle entering the tooth. Disadvantages of this method include the delay of onset of anaesthesia after the injection and, in most cases, ballooning of the injected tissue. As well, there is an extended period of time for recovery of the tissue until return to normal condition.
Another method which is currently used is the regional block method whereby an anaesthetic solution is injected locally in proximity to the nerve trunk as it enters the bone. Disadvantages of this procedure are that it is extremely difficult to locate the nerve trunk, there is discomfort to the patient and a delay for the anaesthetic to take effect. As 3o in the case of the infiltration method, this method necessitates a long recovery period for tissue to return to normal.
Doc. No. 61-3 CA CIP(4) Patent At present, two types of apparatus have been used to perform intra-osseous anaesthesia.
These are surgical burs used to perforate the cortical plate and the villet injectors.
The use of a surgical bur has disadvantages in that burs are expensive and they have to be sterilized between uses or a new bur used each time. In addition, the method is slow, requiring the attached gingiva and periosteum to be anaesthetized before the cortical plate is perforated. The villet injector is an apparatus that serves both as a perforator and injector. It uses specially designed needles rotated by a conventional dental motor. A
to disadvantage of this device is that the needle often becomes clogged with pulverized bone which obstructs the passage in the needle and prevents injection of the anaesthetic solution. It is generally difficult to remove the clogging material from the needle and often the use of a second needle is necessary. Other disadvantages of this method include the initial capital cost of the instrument purchase, and the cost of the needles which are 1 s somewhat expensive. In addition, the design of the instrument makes access to various parts of the mouth difficult and sometimes impossible.
Intra-osseous and targeted injections produce positive, more profound anaesthesia and could be made with less pain than either of the other types according to the present 20 invention.
Targeted anaesthesia has several advantages over prior art nerve block or infiltration methods. There is no feeling of numbness in the tongue, cheek, or lips during or after the injection and there is no after-pain. The anaesthetic is profound and acts immediately 2s alleviating the necessity of waiting for the anaesthetic to take effect as with the nerve block and infiltration methods. Furthermore, as only a few drops of anaesthetic are injected, there is no feeling of faintness or increasing of the pulse rate.
To achieve targeted anaesthesia one must gain access, if intra-osseous, to the cancellous 3o bone by going through the cortical layer; or to the bottom of the tooth, if root-canal targeted anaesthesia is desired. Because of instant anaesthesia and profound pulpal A
Doc. No. 6I-3 CA CIP(4) Patent anaesthesia, there is a much greater control over the region one wishes to anaesthetize, resulting in a much smaller dose of anaesthetic; as well as, of course, other medication, where applicable.
U.S. Pat. No. 4,944,677 (Alexandre) discloses a smooth hollow needle with a beveled point for drilling a hole into the jawbone near the apex of the tooth to be anaesthetized.
Thereafter, the drilling device 13 removed from the jaw, and a hypodermic needle of substantially the same gauge is inserted into the hole and anaesthesia is injected. Thus, there is no cathetized delivery of medication, with the attendant disadvantage that the pre 1 o drilled hole may be difficult to locate when inserting the hypodermic needle.
Over the past 50 years or so devices and processes for intraosseous anesthesia have been developed and refined. However, heretofore, no other inventors have provided a useful, workable convenient and inexpensive solution that affords all of the benefits provided by this invention. For example, none of the prior art devices allow a motorized handpiece to drive a small intraosseous catheter/drill having a rod/drill therein wherein the device can be placed by drilling at high or slower speeds and removed by simple withdrawal by pulling out the catheter. Most of the effort in this field had been directed toward longer term delivery of medication wherein the catheters have had some means of latching into 2o the bone for more permanent placement. Furthermore, the instant invention does not suffer from may of the drawbacks of inserting the needle/drill into the bore being cut by the end tip of the drill, since the outside walls of the needle/drill are of a uniform diameter and non-varying. With the long-felt want of this device, in the past decade in view of the many publications in this field, no such optimal device has been suggested.
In contrast to the prior art, the instant invention provides a dual purpose perforator which includes a needle/sleeve that serves as a relatively high-speed drill bit and which serves as a catheter that is removable by withdrawing it by pulling it out, and not by unscrewing it. The perforator has a substantially uniform outer diameter and has a smooth non-3o threaded outer surface; preferably, the catheter is a larger gauge needle than the removable rod contained within which may also be in the form of a beveled needle for Doc. No. 61-3 CA CIP(4) Patent preventing bone, skin and debris from entering the catheter during entry into the bone. A
hypodermic needle of same gauge as the rod is later placed in the catheter after the rod is removed.
Advantageously, the beveled end of the rod extending beyond the cutting catheter tip assists the cutting of the opening into the bone along with the perforator as they are both rotated by the dental hand piece they are coupled therewith.
To our knowledge, there are no prior art patents of others, which teach the use of a 1o perforator having a hypodermic needle-like cutting tool wherein the outer diameter is uniform allowing both precise cutting of a small hole, and allowing easy removal by simply pulling the device out without unthreading, wherein the perforator has an upper end adapted to be connected to a motorized dental hand piece; wherein the perforator has a rod therein which turns with the perforator needle-like cutting tool assisting in preventing debris from entering the perforator; and wherein the rod is itself a needle-like cutting tool assisting in the cutting of the opening, and wherein means are provided for ensuring that the rod and the cutting needle remain coupled prior to engaging the cutting needle, and wherein the cutting needle and the rod automatically become uncoupled when the cutting needle is engaged in cutting into the bone.
It is the belief of the inventor, that this novel method and combination of elements will eventually change the way in which many dentists infuse medication and local anesthesia.
Unlike the prior art catheters the catheter drill of the instant invention will not bind or increase its resistance against the drilling hand piece as it is drilling into the bone. The uniform outer diameter allows the drill/needle to cut without binding and acting as a self tapping hollow screw.
3o In addition to this novel way of performing dentistry, there is preferred embodiment of this invention which facilitates use of the device in more difficult to access areas of a A
Doc. No. 6I-3 CA CIP(4) Patent patient's mouth, for example, when it is required to access molars in the back of the mouth. In order to reach these otherwise difficult to reach areas with medication, after the catheter drill resides in its targeted area, an adapter for injecting fluid at a right angle to the longitudinal axis of the catheter drill is provided.
Furthermore, this adapter can be used or embodiments thereof are provided which obviate the use of a syringe equipped with a hypodermic needle.
Advantageously, this invention provides an adapter for coupling with the interosseous Io catheter drill that allows fluid to be injected without having to locate the tip of a hypodermic needle into the catheter, which can be difficult.
A very important aspect of this invention is the provision of a mating coupling between the blocking rod hub and the drilling catheter hub which ensures that the hub of the drilling needle does not accidentally de-couple from the hub or end of the drilling shaft prior to use as a drill. For example without this mating coupling simply holding the unit by the shaft end may result in the drilling needle falling out of engagement with the shaft portion and falling on the floor and becoming contaminated.
2o SUMMARY OF THE INVENTION
The present invention endeavours to mitigate the problems and disadvantages of delivering dental anaesthetic encountered with the prior art methods and devices.
The present invention provides a perforator having a central passage, which perforator then remains in place as a catheter for allowing a hypodermic needle to be inserted through the passage to deliver the desired medication. The preferred apparatus is provided with means for obstructing the entry of debris in the perforator's passage.
3o In accordance with the invention, there is provided a device for perforating the periodontal ligaments, cortical plate or small bones, and the like and for injecting Doc. No. 6I-3 CA CIP(4) Patent substances at a predetermined site, comprising:
perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole for directing a hypodermic needle to the predetermined site; and an adapter for coupling to an end of the perforator and for latching a latching-type powered dental handpiece thereto and for transmitting rotational movement from the powered dental handpeice to said perforator, the perforator having a drilling needle extending from an end thereof, the drilling needle having a uniform outer diameter and a smooth non-varying outer surface allowing removal once inserted into the periodontal ligaments, cortical plate or small 1 o bones and the like by withdrawing the needle by pulling backwards along a line defined by a longitudinal axis of the inserted drilling needle; the adapter for coupling with the perforator in a locking engagement such that rotational motion imparted to the adapter, rotates the perforator when the adapter is coupled with the perforator, the adapter having an upper end having a driving shank extending along a rotational axis for removably engaging the powered dental hand tool, the adapter having a rod sized to be accommodated within the perforator and sized to fit into a passage in said drilling needle at a lower end thereof; and, means for ensuring that the adapter and the perforator together to prevent their separation after they have been coupled, prior to use; and for allowing their easy separation after the catheter has been drilled and inserted into bone.
According to another aspect of the present invention, there is provided a device for perforating the periodontal ligaments, cortical plate of small bones, and the like, for injecting substances at a predetermined site, comprising:
a perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole perforated for directing a hypodermic needle to said predetermined site; an adaptor for latching in a latching-type powered dental handpiece for transmitting rotational movement to said perforator, the adapter having a rod at an end thereof sized to be disposed within the perforator inner passage; and, 3o means for ensuring the perforator and rod remain coupled together when perforator and the adapter are coupled, prior to use, such that a force of at least fl is required to separate Doc. No. 61-3 CA CIP(4) Patent them and for ensuring that the perforator and the rod can be easily separated after the perforated has perforated and entered into bone of a patient such that their separation only requires a force f2 or less, where, fl>f2.
The catheterized intra-osseous delivery system of the present invention comprises a perforator with a beveled drilling needle that is used as a drill and a catheter. The needle is attached at one end to a plastic or metal body.
For drilling, the body is attached to a matching adaptor provided with a driving shank 1o which is rotated by a conventional contra angle or straight dental hand piece. Then, the perforator is used as a catheter, whereby a hypodermic needle is inserted through the drilling needle without losing access to the already perforated bone.
In the preferred form of the invention the apparatus is disposable. Before disposal, the perforator receives a cap over the needle for protection against accidental contamination of environment.
The present invention also provides a method of medical treatment, comprising the steps of: inserting a catheter, at a point in the gingival sulcus between outer tooth surface and 2o marginal gingiva, or through gingiva and cortical plate, to a predetermined depth; and injecting medication or anaesthesia through said catheter.
Advantageously, the system of the present invention provide users with a more secure and less painful method and device for direct access for injecting medication to a target area into the cortical plate of the bone.
In addition, the system facilitates and adds a level of security previously unavailable for the anaesthetic in that it has a sure and immediate effect.
3o Another advantage of this system is that it provides benefits to the dentists by facilitating the use of a low cost, disposable device.
Doc. No. 61-3 CA CIP(4) Patent Still another advantage of this invention is that the risk of contamination is lower than with the current devices. This is because the device is disposable and because the risk of the dental equipment used with the device of the invention becoming contaminated is low.
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features of the invention will become more apparent from the following 1o description of the preferred embodiments, in which reference is made to the appended drawings, wherein:
FIG. 1 illustrates an exploded view of the device showing the component parts and their inter-relationship;
FIG. 2A illustrates the device assembled for drilling;
FIG. 2B Illustrated a longitudinal cross-section through the device illustrated in FIG. 2A, taken along line A--A of FIG. 2A;
FIG. 3 shows a detailed view of the area marked on FIG. 2B;
FIG. 3B shows a detailed view of the rod-needle inserted in the perforator cutting/drilling-needle inserted in a different orientation than in FIG. 3;
FIG. 4 is a cross-sectional view of the body of the perforator taken along lines B--B of FIG. 2;
FIG. 5 is a cross-sectional view of the adaptor body;
FIG. 6 is a cross-sectional view of the cap;
BRIEF DESCRIPTION OF THE DRAWINGS
These and other features of the invention will become more apparent from the following 1o description of the preferred embodiments, in which reference is made to the appended drawings, wherein:
FIG. 1 illustrates an exploded view of the device showing the component parts and their inter-relationship;
FIG. 2A illustrates the device assembled for drilling;
FIG. 2B Illustrated a longitudinal cross-section through the device illustrated in FIG. 2A, taken along line A--A of FIG. 2A;
FIG. 3 shows a detailed view of the area marked on FIG. 2B;
FIG. 3B shows a detailed view of the rod-needle inserted in the perforator cutting/drilling-needle inserted in a different orientation than in FIG. 3;
FIG. 4 is a cross-sectional view of the body of the perforator taken along lines B--B of FIG. 2;
FIG. 5 is a cross-sectional view of the adaptor body;
FIG. 6 is a cross-sectional view of the cap;
Doc. No. 61-3 CA CIP(4) Patent FIGS. 7A-7C illustrate the method according to the invention, FIG. 7A shows the device drilling, in the bone tissue; FIG. 7B shows the perforator inserted into the bone tissue and the adaptor de-coupled; and FIG. 7C shows the perforator inserted into the bone tissue as a catheter and a hypodermic needle set for delivering an injection;
FIG. 8 illustrates another embodiment of the invention;
FIG. 9 illustrates an alternative method of delivery medication to treat a root-canal nerve;
FIGS. 10a and l Ob illustrate a preferred embodiment of the invention wherein means are provided for ensuring that the adapter and hub remain coupled prior to use and insertion into bone;
FIGs. 11 a and 11 b is a perspective views illustrating an alternative embodiment to that of FIGs. 10a and lOb wherein a cut-away section is provided in the adapter for receiving a mating locking protrusion for ensuring that the adapter and hub remain coupled prior to use and insertion into bone;
2o Fig. 11 c is a perspective view illustrating a more simple embodiment wherein a protrusion on the adapter is used to ensure that the adapter and hub remain coupled prior to use and insertion into bone;
Fig. 12 is a sectional elevation of the same catheter assembly; and, Fig. 13 is a plane view of an additional, optional component of the assembly.
Fig. 14 is a cross sectional view of an alternative preferred embodiment of a catheter wherein the hollow needle protrudes both ends of the hub;
FIG. 8 illustrates another embodiment of the invention;
FIG. 9 illustrates an alternative method of delivery medication to treat a root-canal nerve;
FIGS. 10a and l Ob illustrate a preferred embodiment of the invention wherein means are provided for ensuring that the adapter and hub remain coupled prior to use and insertion into bone;
FIGs. 11 a and 11 b is a perspective views illustrating an alternative embodiment to that of FIGs. 10a and lOb wherein a cut-away section is provided in the adapter for receiving a mating locking protrusion for ensuring that the adapter and hub remain coupled prior to use and insertion into bone;
2o Fig. 11 c is a perspective view illustrating a more simple embodiment wherein a protrusion on the adapter is used to ensure that the adapter and hub remain coupled prior to use and insertion into bone;
Fig. 12 is a sectional elevation of the same catheter assembly; and, Fig. 13 is a plane view of an additional, optional component of the assembly.
Fig. 14 is a cross sectional view of an alternative preferred embodiment of a catheter wherein the hollow needle protrudes both ends of the hub;
Doc. No. 6I-3 CA CIP(4) Patent Fig. 1 S is a cross-sectional view of an adapter coupled in locked sealing engagement with the catheter shown in Fig. 14; and, Fig. 16 is an alternative embodiment of the adapter having a syringe at one end.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 illustrates an exploded view of the device showing the component parts and their 1o inter-relationship. The device comprises a perforator 1, an adaptor 3 and a cap 5.
The perforator 1 has a beveled drilling needle 7 which is used both as a drill and a catheter. Needle 7 is beveled at both ends, as better shown on FIG. 2B. The first end 9 is formed as a drilling tip in that it has cutting teeth along the edge, as shown in FIG. 3. The 1 s second end 11 is beveled for receiving and directing the needle of a hypodermic syringe and for easy coupling with the adaptor 3, as will be seen later.
A flange 13 is fixed on the needle about the second end 11, so that the needle passes along the geometrical axis of the flange 13. The flange 13 is manufactured or moulded of 2o a plastic or other material, and it has a generally cylindrical outer shape. This shape is preferred as the flange 13 rotates together with the needle 7 for drilling.
Variations of the shape illustrated in the attached drawings may also be contemplated.
The flange 13 is adapted for receiving cap 5 at one end and for coupling with the adaptor 25 3 at the other end. As an example, a collar 15 may be provided on the flange 13 so that the cap 5 holds over the collar 15 when pressed. The cap 5 is needed to protect and cover the tip 9 of the needle 7 before use and when the device is disposed o~
For ease of manipulation the internal diameter of the cap 5 and the external diameter of 3o the collar 15 should be as large as is reasonable and preferably between 10 to 20 times greater than the diameter of the needle 7. Another advantage of the collar 15 is that it Io Doc. No. 61-3 CA CIP(4) Patent provides a stop to limit the depths of penetration of the needle 7 (the depth of penetration of the needle 7 is, therefore, termed the drilling length, as opposed to the remaining length of the needle 7, which is termed the attachment length). The flange 13 is shaped to form an inner axial shaft 17 projecting from the centre of the collar 15, and a female connector 19 for coupling with a corresponding male connector provided in the adaptor 3.
The coupling between the perforator and the adaptor is illustrated on FIGS.
2B, 4 and 5.
FIG. 2B shows a longitudinal section of a female connector 19 provided in the flange 13 and a male connector 21 provided in the adaptor 3. FIG. 4 illustrates a cross-section of an to exemplary female connector 19, while FIG. 5 shows a cross-section of the corresponding male connector 21. The male connector is provided with radial ribs 23, extending towards the centre but not meeting to leave room for the central shaft 17, while corresponding grooves 25 are provided in the female connector, alternating with islands 20.
The female connector is also formed with a clearance ring 22 for accommodating the thickness of the body 29 of the adaptor.
The tubular shaft 17 forms a reinforced passage for drilling needle 7. The shaft also provides enough contact surface between the drilling needle and the body to ensure that these two parts rotate together during drilling. As could be seen on FIG. 2B, end 11 of the 2o needle is beveled and extends a little over the shaft 17, but there is a clearance between the tip of end 11 and the male connector when the device is assembled for drilling.
When rotated, the drilling needle 7 and the adapter hub become unlocked however remain coupled so that the adapter hub engages and drives the cutting needle which penetrates in the bone tissue through gingiva or ligament and drills a hole with the cutting tip 9. The perforator 1 may remain in place as a catheter, with the drilling needle inserted into the bone. Then, a hypodermic needle may be introduced through the passage of drilling needle 7 to inject a medicament directly into the bone. Therefore, the drilling needle 7 is selected to have a wide enough passage for allowing a hypodermic needle 3o with a smaller gauge to be inserted through needle 7.
Doc. No. 61-3 CA CIP(4) Patent The adaptor 3 has several important functions. Firstly, the adaptor conveys the rotational movement from a dental hand piece or the like to the perforator. As well, the adaptor is provided with means for blocking bone debris for entering into the syringe passage and also aligns and reinforces the needle 7 during drilling. In the preferred embodiment of this invention is it important that the adapter be coupled with the dental hand tool which dives the adapter about its longitudinal axis. It is also important that the adapter conveys its rotational movement from the dental hand piece to the perforator 3. By providing this novel arrangement, after the perforator is inserted into the bone, where it is to remain, all that is required is that the adapter with the dental handpiece be removed from the to perforator. Hence the order of dental hand piece driving the adapter including the rod 27 which in turn drives the perforator and its drilling needle is important in the preferred embodiment.
The adaptor includes a rod 27, a body 29 and a shank 31.
Body 29 includes male connector 21 which is formed, as indicated above, with longitudinal ribs 23 which couple with grooves 25 of the female connector 19 for driving needle 7. The shank 31 extends along the axis of the adaptor and is formed with a joint 33 for attachment with a contra-angle or straight hand piece. The shank 31 has a groove 35 2o and a cut-out 37 to fix the shank in place in the known manner.
Generally, the shank transmits to the needle 7 the rotational movement from the hand piece.
The shank 31 also acts as a barrier for contamination, at it is generally thought that bacteria is reluctant to change direction, and there are a plurality of 90° angles between the tip 9 of drilling needle 7 and the joint 33.
3o The rod 27 has the diameter and length selected in accordance with the size of needle 7.
The rod 27 is fixed in the geometrical centre of body 29 so as to readily penetrate into the Doc. No. 61-3 CA CIP(4) Patent hollow passage of the needle, when the device is assembled for drilling. When the rod 27 is inserted within the needle passage, it advances through the length of the needle up to the beveled end, as shown on FIGS. 2A and 3 and 3B in dotted lines. In this way, the debris from drilling cannot penetrate to block the needle passage. In addition, the rod gives additional rigidity, strength and alignment to needle 7 during drilling.
The rod also Advances through the a portion of the shank as is illustrated in FIG. 2B in dotted lines.
Furthermore, the rod which can itself be in the form of a needle similar to the hypodermic needle for delivery of medication, wherein the rod end is sharp and pointed, to assist in the drilling process. By using standard hypodermic needle tubing for the rod, the cost of 1 o the device can be minimized while gaining the benefit of the cutting tip.
In manufacture, the cutting tip of the drilling needle 7 and the rod can be cut at the same time to a desired length.
FIG. 8 illustrates an alternative embodiment of the present invention. In this variant, body 13 is provided with an internal thread while body 29 is provided with a matching external thread. By threading one to the other and using the central rod 27 to align the two bodies together, the perforator could be driven by the hand piece in a similar manner as in the variant disclosed above. Of course, the thread is going in an opposite direction to the direction of rotation of the device for avoiding disconnection of the two bodies.
An alternative method of targeted delivery is shown in FIGS. 9 and 10. The perforator 7 is inserted at a point 30 between teeth, parallel to the tooth 31 in treatment, and penetrates through gingival sulcus 32 and ligament 33 to a depth near the entry of the nerve, artery and vein bundle 34 through the bone 35 and into the tooth-root canal 36. This method of targeted delivery, say, of anaesthesia is suitable, where perforating vertical to the tooth through gingiva and cortical bone is not convenient or possible; as in the case of rear molars.
There are a variety of ways that this invention can be devised but the end result is to 3o perform catheterized intra-osseous delivery system.
Doc. No. 61-3 CA CIP(4) Patent The device of this invention operates as follows:
After the device is removed from its sterile package the adapter end being inserted into the catheter end, the two parts are securely coupled by the unlockable coupling a site for the injection is selected by the practitioner.
The gingiva over the injection side is disinfected and topically anaesthetized. A small amount of anaesthetic solution is injected until blanching of the tissue, and this will anaesthetize the gingiva and the periosteum. The following operations are illustrated in FIGS. 7A, 7B and 7C, and FIGS. 9 and 10.
to As can be seen in FIG. 7A, the beveled end 9 of the needle 7 is placed against the gingiva and shank 31 is attached with joint 33 to a contra angle or to a straight dental hand piece.
The adaptor and perforator are coupled in a locked engagement for drilling.
The perforator should be held perpendicular to the cortical plate, or if not possible or convenient, it should be held vertical and parallel to the long axis of the tooth as shown in FIG. 9, having been inserted between teeth as shown in FIG. 10. The perforator is then operated in small bursts of rotation from the hand piece until resistance is no longer felt, as is well known to dentists. As the rotational motion is imparted from the adapter to the perforator, the relative position of the adapter hub and mating perforator hub is varied 2o such that the rotating adapter rotates the perforator; notwithstanding, this varied relative position allows the two to be separated when the adapter is drawn backward away from the drilling target facilitating easy removal of the rod.
Next, the adaptor 3 is removed; although the adapter can be easily removed from the engagement with perforator 1 it may be preferred to apply pressure to the body 13 with the fingers thus keeping the needle 7 in the perforated cortical plate. This is shown in FIG. 7B.
The presence of the needle 7 in the cortical plate, or down the side of the tooth as in FIG.
9, allows an injection to be made without complicated manoeuvres to find the perforation in the case of floating gingiva or the free or marginal gingiva. FIG. 7C
illustrates the next Doc. No. 61-3 CA CIP(4) Patent step, namely how the injection needle is inserted through the perforator 1 for delivering the anaesthetic solution required.
The last step is to remove the perforator 1 from the cortical plate and reinstall the cover cap 5 over the needle 7, then insert the adaptor to the perforator making the unit complete and disposable. The cap 5 provides a means whereby the apparatus may be removed from the dental hand piece without any risk of the user being in contact with body fluids which will be present on the needle after use.
to In summary, this invention provides particular advantages not suggested in prior art devices. The provision of an adapter piece having a rod at a lower end, a shaft at an upper end for coupling with a motorized dental handpeice, and an intermediate hub disposed between the rod and the shaft wherein the hub has means for locking with a catheter having a drilling needle provides numerous advantages. The drilling needle has a uniform ~ 5 outer diameter and can be withdrawn by simply pulling it out. The adapter is designed to prevent the drilling needle from becoming blocked during drilling and is designed to turn the drilling needle when powered by the handpeice. More importantly, when the catheter has drilled the hole in the bone, the adapter can be removed with the handtool leaving the catheter in place.
Numerous other embodiments can be envisaged without departing from the spirit and scope of the invention. For example, the end of the rod can be provided with a cutting tip assisting the cutting needle in drilling the hole. Furthermore, the rod itself can be a square rod for engaging a complementary recess in the catheter opening. This embodiment would allow the device to function even if the rod was partially extracted during the drilling of the hole as any portion of the square rod could be used to drive the cutting needle.
Turning now to Figs. 10a, and lOb an adapter is shown having means 130 and 131 3o respectively for ensuring that the adapter 31 and hub 13 are engaged so that they do not separate prior to use and become separable after the hub is drilled into the soft bone. Fig.
Doc. No. 61-3 CA CIP(4) Patent l Ob shows the hub 13 having a cut away portion 131 which mates with an abutment 130 on the adapter. The edge 135 shown in Fig. 10a indicates that the two parts are locked.
Driving the adapter and engaging the hub into the drilling or cutting position unlocks the latch at 135 allowing separation when the adapter is withdrawn after inserting the hub.
Figs. 11 a and 11 b illustrate alternative embodiments wherein the adapter and hub having a cut-away region and male mating portion in the hub which fits into the cut-away region in the adapter to lock therewith prior to drilling, preventing the inadvertent separation of the two pieces. The drilling action or rotation automatically allows the two pieces to be to separated.
Yet alternatively shown in Fig. 1 lc, an abutment 56 on the outside wall of the hub can be provided to fit into a complementary recess on the inside wall of the adapter (not shown) covering the abutment, so as to couple the two parts into engagement until drilling occurs; the rotational movement of the adapter on the hub then breaks the coupling and allow the adapter to engage an engaging portion of the hub driving its cutting needle to cut into the soft bone.
2o The abutment and complementary recess is just one of many embodiments for means for ensuring the perforator and rod remain coupled together when perforator and the adapter are coupled, prior to use. The design is such that a force of at least f, is required to separate them and for ensuring that the perforator and the rod can be easily separated after the perforated has perforated and entered into bone of a patient such that their separation only requires a force f2 or less, where, fi>f2. Essentially it should be easy to separate the perforator hub from the adapter after the cutting needle is in place in the bone.
Although the device described heretofore and shown in the figures is performs 3o satisfactorily, and locating and disposing the drill into the bone at a desired location is relatively simple, it would be advantageous to provide easier access to the catheter once Doc. No. 61-3 CA CIP(4) Patent in place about the molars and teeth in general at the back of a patient's mouth. Locating the opening at the top of the hub, i.e. the opening of the drilling needle with the hypodermic needle can be an onerous task. It would be preferred to connect a sleeve or tube to the top of the drilling needle so that a medication supply could be provided s thereto.
Turning now to Figs. 14 and 15, the catheter assembly comprises a hollow drilling needle or catheter 140, having a lower pointed end 141 a and an upper pointed end 141 b, preferably of stainless steel; the lower end 141 a is designed to cut as it rotates and the non-drilling upper pointed end serves to puncture a rubber membrane 152 of an adapter 1 o 151. As in previous embodiments, a rod 143 and upper housing 145 are adapted to fit over and within the drilling needle 140. The adapter 151 has lockable clips 154a and 154b for locking into engagement with the recesses 146 within the hub 148. The adapter conveniently serves as an extension that extends the length and the size and angle of the access port of the catheter when in place so that inserting the hypodermic needle 158 15 containing medication becomes much simpler. Of course the body of the adapter 1 S 1 can be rigid. In another embodiment not shown a flexible adapter is provided.
The adapter shown in Fig. 15 is used as an extension passage, for extending the length and orientation of the catheter. However, the adapter shown in Fig. 16 serves as both an 2o extension of the catheter and as a syringe, obviating the requirement to provide a hypodermic needle.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
FIG. 1 illustrates an exploded view of the device showing the component parts and their 1o inter-relationship. The device comprises a perforator 1, an adaptor 3 and a cap 5.
The perforator 1 has a beveled drilling needle 7 which is used both as a drill and a catheter. Needle 7 is beveled at both ends, as better shown on FIG. 2B. The first end 9 is formed as a drilling tip in that it has cutting teeth along the edge, as shown in FIG. 3. The 1 s second end 11 is beveled for receiving and directing the needle of a hypodermic syringe and for easy coupling with the adaptor 3, as will be seen later.
A flange 13 is fixed on the needle about the second end 11, so that the needle passes along the geometrical axis of the flange 13. The flange 13 is manufactured or moulded of 2o a plastic or other material, and it has a generally cylindrical outer shape. This shape is preferred as the flange 13 rotates together with the needle 7 for drilling.
Variations of the shape illustrated in the attached drawings may also be contemplated.
The flange 13 is adapted for receiving cap 5 at one end and for coupling with the adaptor 25 3 at the other end. As an example, a collar 15 may be provided on the flange 13 so that the cap 5 holds over the collar 15 when pressed. The cap 5 is needed to protect and cover the tip 9 of the needle 7 before use and when the device is disposed o~
For ease of manipulation the internal diameter of the cap 5 and the external diameter of 3o the collar 15 should be as large as is reasonable and preferably between 10 to 20 times greater than the diameter of the needle 7. Another advantage of the collar 15 is that it Io Doc. No. 61-3 CA CIP(4) Patent provides a stop to limit the depths of penetration of the needle 7 (the depth of penetration of the needle 7 is, therefore, termed the drilling length, as opposed to the remaining length of the needle 7, which is termed the attachment length). The flange 13 is shaped to form an inner axial shaft 17 projecting from the centre of the collar 15, and a female connector 19 for coupling with a corresponding male connector provided in the adaptor 3.
The coupling between the perforator and the adaptor is illustrated on FIGS.
2B, 4 and 5.
FIG. 2B shows a longitudinal section of a female connector 19 provided in the flange 13 and a male connector 21 provided in the adaptor 3. FIG. 4 illustrates a cross-section of an to exemplary female connector 19, while FIG. 5 shows a cross-section of the corresponding male connector 21. The male connector is provided with radial ribs 23, extending towards the centre but not meeting to leave room for the central shaft 17, while corresponding grooves 25 are provided in the female connector, alternating with islands 20.
The female connector is also formed with a clearance ring 22 for accommodating the thickness of the body 29 of the adaptor.
The tubular shaft 17 forms a reinforced passage for drilling needle 7. The shaft also provides enough contact surface between the drilling needle and the body to ensure that these two parts rotate together during drilling. As could be seen on FIG. 2B, end 11 of the 2o needle is beveled and extends a little over the shaft 17, but there is a clearance between the tip of end 11 and the male connector when the device is assembled for drilling.
When rotated, the drilling needle 7 and the adapter hub become unlocked however remain coupled so that the adapter hub engages and drives the cutting needle which penetrates in the bone tissue through gingiva or ligament and drills a hole with the cutting tip 9. The perforator 1 may remain in place as a catheter, with the drilling needle inserted into the bone. Then, a hypodermic needle may be introduced through the passage of drilling needle 7 to inject a medicament directly into the bone. Therefore, the drilling needle 7 is selected to have a wide enough passage for allowing a hypodermic needle 3o with a smaller gauge to be inserted through needle 7.
Doc. No. 61-3 CA CIP(4) Patent The adaptor 3 has several important functions. Firstly, the adaptor conveys the rotational movement from a dental hand piece or the like to the perforator. As well, the adaptor is provided with means for blocking bone debris for entering into the syringe passage and also aligns and reinforces the needle 7 during drilling. In the preferred embodiment of this invention is it important that the adapter be coupled with the dental hand tool which dives the adapter about its longitudinal axis. It is also important that the adapter conveys its rotational movement from the dental hand piece to the perforator 3. By providing this novel arrangement, after the perforator is inserted into the bone, where it is to remain, all that is required is that the adapter with the dental handpiece be removed from the to perforator. Hence the order of dental hand piece driving the adapter including the rod 27 which in turn drives the perforator and its drilling needle is important in the preferred embodiment.
The adaptor includes a rod 27, a body 29 and a shank 31.
Body 29 includes male connector 21 which is formed, as indicated above, with longitudinal ribs 23 which couple with grooves 25 of the female connector 19 for driving needle 7. The shank 31 extends along the axis of the adaptor and is formed with a joint 33 for attachment with a contra-angle or straight hand piece. The shank 31 has a groove 35 2o and a cut-out 37 to fix the shank in place in the known manner.
Generally, the shank transmits to the needle 7 the rotational movement from the hand piece.
The shank 31 also acts as a barrier for contamination, at it is generally thought that bacteria is reluctant to change direction, and there are a plurality of 90° angles between the tip 9 of drilling needle 7 and the joint 33.
3o The rod 27 has the diameter and length selected in accordance with the size of needle 7.
The rod 27 is fixed in the geometrical centre of body 29 so as to readily penetrate into the Doc. No. 61-3 CA CIP(4) Patent hollow passage of the needle, when the device is assembled for drilling. When the rod 27 is inserted within the needle passage, it advances through the length of the needle up to the beveled end, as shown on FIGS. 2A and 3 and 3B in dotted lines. In this way, the debris from drilling cannot penetrate to block the needle passage. In addition, the rod gives additional rigidity, strength and alignment to needle 7 during drilling.
The rod also Advances through the a portion of the shank as is illustrated in FIG. 2B in dotted lines.
Furthermore, the rod which can itself be in the form of a needle similar to the hypodermic needle for delivery of medication, wherein the rod end is sharp and pointed, to assist in the drilling process. By using standard hypodermic needle tubing for the rod, the cost of 1 o the device can be minimized while gaining the benefit of the cutting tip.
In manufacture, the cutting tip of the drilling needle 7 and the rod can be cut at the same time to a desired length.
FIG. 8 illustrates an alternative embodiment of the present invention. In this variant, body 13 is provided with an internal thread while body 29 is provided with a matching external thread. By threading one to the other and using the central rod 27 to align the two bodies together, the perforator could be driven by the hand piece in a similar manner as in the variant disclosed above. Of course, the thread is going in an opposite direction to the direction of rotation of the device for avoiding disconnection of the two bodies.
An alternative method of targeted delivery is shown in FIGS. 9 and 10. The perforator 7 is inserted at a point 30 between teeth, parallel to the tooth 31 in treatment, and penetrates through gingival sulcus 32 and ligament 33 to a depth near the entry of the nerve, artery and vein bundle 34 through the bone 35 and into the tooth-root canal 36. This method of targeted delivery, say, of anaesthesia is suitable, where perforating vertical to the tooth through gingiva and cortical bone is not convenient or possible; as in the case of rear molars.
There are a variety of ways that this invention can be devised but the end result is to 3o perform catheterized intra-osseous delivery system.
Doc. No. 61-3 CA CIP(4) Patent The device of this invention operates as follows:
After the device is removed from its sterile package the adapter end being inserted into the catheter end, the two parts are securely coupled by the unlockable coupling a site for the injection is selected by the practitioner.
The gingiva over the injection side is disinfected and topically anaesthetized. A small amount of anaesthetic solution is injected until blanching of the tissue, and this will anaesthetize the gingiva and the periosteum. The following operations are illustrated in FIGS. 7A, 7B and 7C, and FIGS. 9 and 10.
to As can be seen in FIG. 7A, the beveled end 9 of the needle 7 is placed against the gingiva and shank 31 is attached with joint 33 to a contra angle or to a straight dental hand piece.
The adaptor and perforator are coupled in a locked engagement for drilling.
The perforator should be held perpendicular to the cortical plate, or if not possible or convenient, it should be held vertical and parallel to the long axis of the tooth as shown in FIG. 9, having been inserted between teeth as shown in FIG. 10. The perforator is then operated in small bursts of rotation from the hand piece until resistance is no longer felt, as is well known to dentists. As the rotational motion is imparted from the adapter to the perforator, the relative position of the adapter hub and mating perforator hub is varied 2o such that the rotating adapter rotates the perforator; notwithstanding, this varied relative position allows the two to be separated when the adapter is drawn backward away from the drilling target facilitating easy removal of the rod.
Next, the adaptor 3 is removed; although the adapter can be easily removed from the engagement with perforator 1 it may be preferred to apply pressure to the body 13 with the fingers thus keeping the needle 7 in the perforated cortical plate. This is shown in FIG. 7B.
The presence of the needle 7 in the cortical plate, or down the side of the tooth as in FIG.
9, allows an injection to be made without complicated manoeuvres to find the perforation in the case of floating gingiva or the free or marginal gingiva. FIG. 7C
illustrates the next Doc. No. 61-3 CA CIP(4) Patent step, namely how the injection needle is inserted through the perforator 1 for delivering the anaesthetic solution required.
The last step is to remove the perforator 1 from the cortical plate and reinstall the cover cap 5 over the needle 7, then insert the adaptor to the perforator making the unit complete and disposable. The cap 5 provides a means whereby the apparatus may be removed from the dental hand piece without any risk of the user being in contact with body fluids which will be present on the needle after use.
to In summary, this invention provides particular advantages not suggested in prior art devices. The provision of an adapter piece having a rod at a lower end, a shaft at an upper end for coupling with a motorized dental handpeice, and an intermediate hub disposed between the rod and the shaft wherein the hub has means for locking with a catheter having a drilling needle provides numerous advantages. The drilling needle has a uniform ~ 5 outer diameter and can be withdrawn by simply pulling it out. The adapter is designed to prevent the drilling needle from becoming blocked during drilling and is designed to turn the drilling needle when powered by the handpeice. More importantly, when the catheter has drilled the hole in the bone, the adapter can be removed with the handtool leaving the catheter in place.
Numerous other embodiments can be envisaged without departing from the spirit and scope of the invention. For example, the end of the rod can be provided with a cutting tip assisting the cutting needle in drilling the hole. Furthermore, the rod itself can be a square rod for engaging a complementary recess in the catheter opening. This embodiment would allow the device to function even if the rod was partially extracted during the drilling of the hole as any portion of the square rod could be used to drive the cutting needle.
Turning now to Figs. 10a, and lOb an adapter is shown having means 130 and 131 3o respectively for ensuring that the adapter 31 and hub 13 are engaged so that they do not separate prior to use and become separable after the hub is drilled into the soft bone. Fig.
Doc. No. 61-3 CA CIP(4) Patent l Ob shows the hub 13 having a cut away portion 131 which mates with an abutment 130 on the adapter. The edge 135 shown in Fig. 10a indicates that the two parts are locked.
Driving the adapter and engaging the hub into the drilling or cutting position unlocks the latch at 135 allowing separation when the adapter is withdrawn after inserting the hub.
Figs. 11 a and 11 b illustrate alternative embodiments wherein the adapter and hub having a cut-away region and male mating portion in the hub which fits into the cut-away region in the adapter to lock therewith prior to drilling, preventing the inadvertent separation of the two pieces. The drilling action or rotation automatically allows the two pieces to be to separated.
Yet alternatively shown in Fig. 1 lc, an abutment 56 on the outside wall of the hub can be provided to fit into a complementary recess on the inside wall of the adapter (not shown) covering the abutment, so as to couple the two parts into engagement until drilling occurs; the rotational movement of the adapter on the hub then breaks the coupling and allow the adapter to engage an engaging portion of the hub driving its cutting needle to cut into the soft bone.
2o The abutment and complementary recess is just one of many embodiments for means for ensuring the perforator and rod remain coupled together when perforator and the adapter are coupled, prior to use. The design is such that a force of at least f, is required to separate them and for ensuring that the perforator and the rod can be easily separated after the perforated has perforated and entered into bone of a patient such that their separation only requires a force f2 or less, where, fi>f2. Essentially it should be easy to separate the perforator hub from the adapter after the cutting needle is in place in the bone.
Although the device described heretofore and shown in the figures is performs 3o satisfactorily, and locating and disposing the drill into the bone at a desired location is relatively simple, it would be advantageous to provide easier access to the catheter once Doc. No. 61-3 CA CIP(4) Patent in place about the molars and teeth in general at the back of a patient's mouth. Locating the opening at the top of the hub, i.e. the opening of the drilling needle with the hypodermic needle can be an onerous task. It would be preferred to connect a sleeve or tube to the top of the drilling needle so that a medication supply could be provided s thereto.
Turning now to Figs. 14 and 15, the catheter assembly comprises a hollow drilling needle or catheter 140, having a lower pointed end 141 a and an upper pointed end 141 b, preferably of stainless steel; the lower end 141 a is designed to cut as it rotates and the non-drilling upper pointed end serves to puncture a rubber membrane 152 of an adapter 1 o 151. As in previous embodiments, a rod 143 and upper housing 145 are adapted to fit over and within the drilling needle 140. The adapter 151 has lockable clips 154a and 154b for locking into engagement with the recesses 146 within the hub 148. The adapter conveniently serves as an extension that extends the length and the size and angle of the access port of the catheter when in place so that inserting the hypodermic needle 158 15 containing medication becomes much simpler. Of course the body of the adapter 1 S 1 can be rigid. In another embodiment not shown a flexible adapter is provided.
The adapter shown in Fig. 15 is used as an extension passage, for extending the length and orientation of the catheter. However, the adapter shown in Fig. 16 serves as both an 2o extension of the catheter and as a syringe, obviating the requirement to provide a hypodermic needle.
Claims (17)
1. A device for perforating the periodontal ligaments, cortical plate or small bones, and the like and for injecting substances at a predetermined site, comprising:
a perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole for directing a hypodermic needle to the predetermined site; and, an adapter for coupling to an end of the perforator for coupling with a powered dental handpiece thereto and for transmitting rotational movement from the powered dental handpiece to said perforator, the perforator having a drilling needle extending from an end thereof, the drilling needle having a uniform outer diameter and a smooth non-varying outer surface allowing removal once inserted into the periodontal ligaments, cortical plate or small bones and the like by withdrawing the needle by pulling backwards along a line defined by a longitudinal axis of the inserted drilling needle;
the adapter for coupling with the perforator in a locking engagement such that rotational motion imparted to the adapter, rotates the perforator when the adapter is coupled with the perforator, the adapter having an upper end having a driving shank extending along a rotational axis for removably engaging the powered dental hand tool, the adapter having a rod sized to be accommodated within the perforator and sized to fit into a passage in said drilling needle at a lower end thereof; and, means for ensuring that the adapter and the perforator are coupled in engagement together to prevent their separation after they have been coupled, prior to use; and for allowing their easy separation after the catheter has been drilled and inserted into bone.
a perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole for directing a hypodermic needle to the predetermined site; and, an adapter for coupling to an end of the perforator for coupling with a powered dental handpiece thereto and for transmitting rotational movement from the powered dental handpiece to said perforator, the perforator having a drilling needle extending from an end thereof, the drilling needle having a uniform outer diameter and a smooth non-varying outer surface allowing removal once inserted into the periodontal ligaments, cortical plate or small bones and the like by withdrawing the needle by pulling backwards along a line defined by a longitudinal axis of the inserted drilling needle;
the adapter for coupling with the perforator in a locking engagement such that rotational motion imparted to the adapter, rotates the perforator when the adapter is coupled with the perforator, the adapter having an upper end having a driving shank extending along a rotational axis for removably engaging the powered dental hand tool, the adapter having a rod sized to be accommodated within the perforator and sized to fit into a passage in said drilling needle at a lower end thereof; and, means for ensuring that the adapter and the perforator are coupled in engagement together to prevent their separation after they have been coupled, prior to use; and for allowing their easy separation after the catheter has been drilled and inserted into bone.
2. A device for perforating the periodontal ligaments, cortical plate of small bones, and the like, for injecting substances at a predetermined site, comprising:
a perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole perforated for directing a hypodermic needle to said predetermined site; an adaptor for latching in a latching-type powered dental handpiece for transmitting rotational movement to said perforator, the adapter having a rod at an end thereof sized to be disposed within the perforator inner passage; and, means for ensuring the perforator and rod remain coupled together when perforator and the adapter are coupled, prior to use, such that a force of at least f1 is required to separate them and for ensuring that the perforator and the rod can be easily separated after the perforated has perforated and entered into bone of a patient such that their separation only requires a force f2 or less, where, f1>f2.
a perforator for drilling a hole into the ligament, bone or tissue, wherein said perforator is provided with an inner passage to form a catheter adapted to remain in the hole perforated for directing a hypodermic needle to said predetermined site; an adaptor for latching in a latching-type powered dental handpiece for transmitting rotational movement to said perforator, the adapter having a rod at an end thereof sized to be disposed within the perforator inner passage; and, means for ensuring the perforator and rod remain coupled together when perforator and the adapter are coupled, prior to use, such that a force of at least f1 is required to separate them and for ensuring that the perforator and the rod can be easily separated after the perforated has perforated and entered into bone of a patient such that their separation only requires a force f2 or less, where, f1>f2.
3. A rotatable drilling device for use in injecting medication, said rotatable drilling device comprising:
a rotatable hollow drill bit, wherein the rotatable hollow drill bit includes a catheter huh and a needle extending upwardly and downwardly from opposite ends of the catheter hub, wherein the needle has a sharpened tip at an upper end for puncturing a membrane of a medication supply, and having a sharpened tip at a lower end thereof wherein the rotatable hollow drill bit has a bore extending through the hub and needle, and wherein an upper end of the needle has an opening through which medication can be introduced into the bore.
a rotatable hollow drill bit, wherein the rotatable hollow drill bit includes a catheter huh and a needle extending upwardly and downwardly from opposite ends of the catheter hub, wherein the needle has a sharpened tip at an upper end for puncturing a membrane of a medication supply, and having a sharpened tip at a lower end thereof wherein the rotatable hollow drill bit has a bore extending through the hub and needle, and wherein an upper end of the needle has an opening through which medication can be introduced into the bore.
4. A rotatable drilling device as defined in claim 3, wherein the sharpened tip at the upper end and the sharpened tip a the lower end have pointed ends;
5. A rotatable drilling device as defined in claim 3, wherein the needle extending upwardly and the needle extending downwardly are two needles coupled to serve as a conduit for carrying the medication to a lower end.
6. A rotatable drilling device as defined in claim 3, wherein the needle extending upwardly and downwardly are ends of a same needle.
7. A rotatable drilling device as defined in claim 2 further comprising:
an adapter having a rod at a lower end for removable insertion in the bore of the rotatable hollow drill bit, wherein the rod when inserted into the bore extends into the bore of the rotatable hollow drill bit toward the tip of the needle, the rod and the hollow drill bit being coupled together in locked engagement when the rod is inserted into the bore of the rotatable hollow drill bit, the adapter having an end adapted to couple the rod to hand piece for rotation therewith.
4. A device as defined in 3, wherein the rod has a cutting end for cutting simultaneously with the drilling needle.
7. A rotatable drilling device as defined in claim 2 further comprising:
an adapter having a rod at a lower end for removable insertion in the bore of the rotatable hollow drill bit, wherein the rod when inserted into the bore extends into the bore of the rotatable hollow drill bit toward the tip of the needle, the rod and the hollow drill bit being coupled together in locked engagement when the rod is inserted into the bore of the rotatable hollow drill bit, the adapter having an end adapted to couple the rod to hand piece for rotation therewith.
4. A device as defined in 3, wherein the rod has a cutting end for cutting simultaneously with the drilling needle.
7. A device as defined in claim 2 wherein the rod is a drilling needle having a smaller diameter than the hollow drill bit on the perforator.
8. A rotatable drilling device for use in injecting medication, said rotatable drilling device comprising:
a rotatable hollow drill bit adapted for mounting in a a drill, wherein the rotatable hollow drill bit includes a hub and a needle extending outwardly from both ends of the hub, wherein the needle has a sharpened tip at one end extending downwardly, wherein the rotatable hollow drill bit has a bore extending through the hub and needle, and wherein an end of the needle extending upwardly from the hub has an opening through which medication can be introduced into the bore, wherein the hub further includes an adapter means for coupling the hub to the drill for rotation therewith; and a rod removably inserted in the bore of the rotatable hollow drill bit, wherein the rod extends through the bore of the rotatable hollow drill bit toward the tip of the needle.
a rotatable hollow drill bit adapted for mounting in a a drill, wherein the rotatable hollow drill bit includes a hub and a needle extending outwardly from both ends of the hub, wherein the needle has a sharpened tip at one end extending downwardly, wherein the rotatable hollow drill bit has a bore extending through the hub and needle, and wherein an end of the needle extending upwardly from the hub has an opening through which medication can be introduced into the bore, wherein the hub further includes an adapter means for coupling the hub to the drill for rotation therewith; and a rod removably inserted in the bore of the rotatable hollow drill bit, wherein the rod extends through the bore of the rotatable hollow drill bit toward the tip of the needle.
9. A rotatable drilling device as defined in claim 8 wherein an end of the needle extending upwardly is sharp at its end for piercing through a membrane for receiving medication destined for the end of the needle extending downwardly.
10. A rotatable drilling device as defined in claim 9, further comprising and adapter for coupling to and sealing with the needle extending upwardly from the hub for easing access to supply medication to difficult to reach areas.
11. A rotatable drilling device as defined in claim 10, further comprising and adapter for coupling to and sealing with the needle at its sharp end extending upwardly from the hub.
12. A rotatable drilling device as defined in claim 11, wherein the adapter for coupling to and sealing with the needle further comprises means for latching with the hub to remain fixedly connected with the hub in a latched position.
13. A rotatable drilling device as defined in claim 12 wherein the adapter is a longitudinal member forming a substantially L-shaped device when coupled with the hub in a latched position.
14. A rotatable drilling device as defined in claim 11, wherein the adapter has one of a membrane for receiving and pierceable by a hypodermic needle and a plunger for forcing medication into the needle.
15. A rotatable drilling device as defined in claim 11, further comprising and adapter for providing a conduit for delivering medication to the drilling needle from a direction other than along an axis of the drilling needle, the adapter for providing a sealing coupling with the end of the needle extending upwardly.
16. A rotatable device as defined in claim 14 further comprising means for locking the adapter for providing a conduit into engagement with the hub.
17. An adapter for delivery of medication to difficult to reach areas and for use with a rotatable drilling catheter having a substantially hollow drilling needle at one end, an upper hollow puncturing end and a hub therebetween, the adapter comprising means for coupling into locking engagement with the hub to fixedly seal the adapter with the puncturing end once the drilling catheter is in situ in a target location, the adapter for delivery of medication to the hollow drilling needle for delivery to a patient, the adapter having one of means for delivery of the medication and means for sealing with medication delivery device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2341957 CA2341957A1 (en) | 2001-03-23 | 2001-03-23 | Device for targeted, catherized delivery of medications |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CA 2341957 CA2341957A1 (en) | 2001-03-23 | 2001-03-23 | Device for targeted, catherized delivery of medications |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA2341957A1 true CA2341957A1 (en) | 2002-09-23 |
Family
ID=4168680
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA 2341957 Abandoned CA2341957A1 (en) | 2001-03-23 | 2001-03-23 | Device for targeted, catherized delivery of medications |
Country Status (1)
| Country | Link |
|---|---|
| CA (1) | CA2341957A1 (en) |
-
2001
- 2001-03-23 CA CA 2341957 patent/CA2341957A1/en not_active Abandoned
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| Date | Code | Title | Description |
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| EEER | Examination request | ||
| FZDE | Dead |