DEVICE AND METHOD FOR INTRAOSSEOUS DENTAL ANESTHETIZATION

Abstract

An intraosseous tack device is configured to puncture alveolar bone or other human or animal bone at a targeted site of the mouth or body to provide an access point for the delivery of local anesthesia or other medicament. The device includes a tack having a body portion and an elongate member extending from the body portion. The elongate member is formed as a solid structure configured for puncturing targeted bone. The body portion includes an attachment feature enabling attachment to a standard syringe or to a customized handle.

Claims

1. A tack device configured for puncturing bone to provide an access point for intraosseous delivery of a medicament, the device comprising: a body with a proximal end and a distal end, the proximal end including an attachment feature enabling attachment of the body to a syringe or handle; an elongate member attached to the distal end of the body at an attachment point and extending distally therefrom, the elongate member forming a solid structure configured for puncturing targeted bone; and a sleeve covering at least a portion of the elongate member extending distally from the distal end of the body, wherein the body is configured to receive at least a first portion of the sleeve upon proximal movement of the sleeve.

2. The device of claim 1, wherein the elongate member includes a sharpened distal tip.

3. The device of claim 1, wherein the distal tip is beveled along lateral edges of the distal tip.

4. The device of claim 3, wherein the beveled lateral edges of the distal tip include serrations.

5. The device of claim 2, wherein the distal tip is beveled along a front and a back surface of the distal tip.

6. The device of claim 2, wherein the sharpened distal tip is shaped as a spearhead.

7. The device of claim 1, wherein the elongate member has a diameter of about 0.1 mm to about 0.9 mm.

8. The device of claim 1, wherein the attachment feature of the body includes a proximally facing lumen with threads disposed along an interior surface of the lumen.

9. The device of claim 1, wherein the body further comprises one or more grips configured to enhance tactile control of the tack device.

10. The device of claim 1, further comprising a handle having an attachment feature corresponding to the attachment feature of the body and enabling attachment of the body to the handle.

11. The device of claim 10, wherein the handle includes a proximal section and a distal section, the attachment feature of the handle being connected to or extending distally from the distal section, the distal section optionally having a smaller diameter than the proximal section.

12. The device of claim 11, wherein the distal section and the proximal section are rotatable relative to each other.

13. The device of claim 10, wherein the handle includes a plurality of grips configured to enhance tactile control of the handle.

14. The device of claim 10, wherein the handle further comprises an extension disposed between a distal section of the handle and the attachment feature of the handle.

15. The device of claim 1, wherein the sleeve is configured to slide proximally along the elongate member to be received by the body.

16. The device of claim 1, wherein the sleeve is configured to reduce bending or failure of the elongate member at the attachment point.

17. The device of claim 1, wherein the elongate member has a length that extends beyond a distal end of the sleeve a distance of about 1 mm to about 6 mm when the sleeve is in a nested position.

18. A device configured for puncturing bone to provide an access point for intraosseous delivery of a medicament, the device comprising: a tack, the tack including a body with a proximal end and a distal end, the proximal end including an attachment feature, and an elongate member attached to the distal end of the body and extending distally therefrom, the elongate member forming a solid structure configured for puncturing targeted bone; a sleeve covering at least a portion of the elongate member extending distally from the distal end of the body, wherein the body is configured to receive the sleeve; and a handle, the handle including an attachment feature corresponding to the attachment feature of the body and enabling attachment of the body to the handle, and a proximal section and a distal section, the attachment feature extending distally from the distal section, the distal section being rotatable relative to the proximal section.

19. A method of puncturing bone to provide an access point for intraosseous delivery of a medicament, the method comprising: providing a tack device, the tack device including a tack having a body with a proximal end and a distal end, the proximal end including an attachment feature enabling attachment of the body to a syringe or handle, and an elongate member attached to the distal end of the body and extending distally therefrom, the elongate member forming a solid structure configured for puncturing targeted bone, a sleeve covering at least a portion of the elongate member extending distally from the distal end of the body, wherein the body is configured to receive the sleeve, and a handle having an attachment feature corresponding to the attachment feature of the body and enabling attachment of the body to the handle; positioning the elongate member of the tack at a targeted area adjacent to a targeted tooth to be anesthetized; and manipulating the tack device to cause the elongate member of the tack to pass into and through cortical bone at the targeted area.

20. The method of claim 19, wherein manipulating the tack device to cause the elongate member of the tack to pass into and through cortical bone at the targeted area comprises rotating the handle while applying an axial force against the cortical bone at the targeted area such that the elongate member of the tack also rotates and bores through the cortical bone at the targeted area.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0015] To further clarify the above and other advantages and features of the present disclosure, a more particular description will be rendered by reference to specific embodiments illustrated in the appended drawings. It is appreciated that these drawings depict only illustrated and exemplary embodiments of the disclosure and are therefore not to be considered limiting of its scope. Exemplary embodiments of the disclosure will be described with additional specificity and detail through the use of the accompanying drawings in which:

[0016] FIG. 1 illustrates a front view of a human mouth showing the maxillary and mandibular teeth at anterior and posterior regions of the mouth;

[0017] FIG. 2 illustrates a cross-sectional view of a mandibular molar showing intraosseous delivery of anesthesia;

[0018] FIG. 3 illustrates a cross-sectional view of a mandibular molar showing intraligamentary injection of anesthesia;

[0019] FIG. 4 illustrates the mandible from a superior perspective, showing a desired or required orientation of a syringe (this type of syringe sold under the trade name “Ligajet”) during attempted anesthetization of a mandibular molar;

[0020] FIG. 5 illustrates the mandible from a superior perspective, showing a bent-needle syringe device during an attempted anesthetization of a mandibular molar;

[0021] FIG. 6 is an expanded view of the bent-needle syringe device of FIG. 5, showing potential needle bending that may occur during the attempted anesthetization;

[0022] FIG. 7 illustrates an exploded view of an exemplary intraosseous tack device configured for puncturing the cortical plate of a targeted area of the mouth to provide an access point for intraosseous delivery of anesthetic;

[0023] FIG. 8 illustrates the intraosseous tack device of FIG. 7 in an exemplary assembled form;

[0024] FIG. 9 illustrates actuation of the intraosseous tack device of FIGS. 7 and 8;

[0025] FIGS. 10 and 11 illustrate exemplary methods of gripping, positioning, and actuating the intraosseous tack device in order to form an access point for intraosseous delivery of anesthetic near a targeted molar;

[0026] FIG. 12 illustrates an exemplary embodiment of a tack device having a body portion and an elongate member, the tack device being configured for selective attachment to a standard syringe or a handle;

[0027] FIG. 13 illustrates attachment of the tack device of FIG. 12 to a standard syringe;

[0028] FIG. 14 illustrates attachment of the tack device of FIG. 12 to a handle configured to provide enhanced tactile control of the tack device;

[0029] FIG. 15 illustrates use of the tack device of FIG. 12 and manipulation of the handle of FIG. 14 to form an access point for intraosseous delivery of anesthetic near a targeted molar;

[0030] FIG. 16 illustrates a configuration of the tack device of FIG. 12 further including a sleeve;

[0031] FIGS. 17A-17B illustrate another embodiment of a tack device;

[0032] FIGS. 18A-18C illustrate views of various configurations of a tip of the tack device of FIGS. 17A-17B;

[0033] FIGS. 19A-19B illustrate an embodiment of the tack device of FIGS. 17A-17B further including a cap;

[0034] FIG. 20 illustrate an embodiment of an example handle configured for use with the tack device;

[0035] FIG. 21A illustrates attachment of the tack device of FIGS. 17A-17B to a syringe; and

[0036] FIG. 21B illustrates attachment of the tack device of FIGS. 17A-17B to the handle of FIG. 20.

DETAILED DESCRIPTION

Introduction

[0037] FIG. 1 illustrates a front view of a human mouth 10 showing the maxillary (upper) and mandibular (lower) teeth. The mouth 10 includes anterior (front) and posterior (rear) regions. The illustrated Figure roughly shows an anterior maxillary region 12, a posterior maxillary region 14, an anterior mandibular region 16, and a posterior mandibular region 18. Generally, the hard, outer cortical plate of the alveolar bone (the bone that contains the tooth sockets) will be thicker in more posterior regions of the mouth compared to more anterior regions of the mouth and is generally thicker in the mandible than in the maxilla. The posterior mandibular region 18 therefore typically has the thickest cortical plate relative to other regions of the mouth 10.

[0038] For intraosseous administration of anesthesia, the hard, outer cortical plate of the alveolar bone must be punctured to provide an access point to the softer, spongy cancellous bone proximate the tooth roots. Puncturing the cortical plate is more difficult at regions where the cortical plate has greater thickness, and providing a suitable access point can present a serious technical challenge. Because of the associated challenges with these regions, and because of the ability of the described embodiments to overcome these challenges, the following examples are often described in the context of anesthetizing a posteriorly located mandibular tooth (e.g., a mandibular molar). It will be understood, however, that the components and features described herein may also be utilized for providing an access point for administering anesthesia in any other desired region of the mouth, including near maxillary teeth and/or near more anteriorly located teeth. Further, certain embodiments may be utilized outside of the dental/orthodontal field. For example, an intraosseous device as described herein may be used to quickly provide an access site for the intraosseous delivery of a medicament (e.g., anesthetic, epinephrine, or other medical composition) within other bones of a patient (e.g., limb bones such as the tibia).

[0039] FIG. 2 illustrates a cross-section of a mandibular molar 20 within its corresponding tooth socket. The cross-sectional view illustrates the hard, outer cortical plate 24 and the spongy, inner cancellous bone 26. During intraosseous administration of anesthesia, the tip of the needle 50 must be positioned past the cortical plate 24 and within the cancellous bone 26, as shown. FIG. 2 also illustrates the periodontal ligament 22 which is disposed between the tooth 20 and the bone of the socket and which functions to attach the tooth 20 to the socket.

[0040] FIG. 3 illustrates placement of a needle 50 into the periodontal ligament 22 as part of an intraligamentary anesthesia delivery procedure. Although this type of administration can be effective, it is often associated with sharp pain during injection and additional pain following the procedure. In many circumstances, an intraosseous administration route is preferable. However, puncturing the cortical plate to form a suitable access point can be challenging.

[0041] Further, as schematically illustrated in FIG. 4, during anesthetization of a posterior tooth it can be difficult to orient the syringe 52 and needle 50 in a desired position orthogonal to the buccal surface of the mouth 30. The orthogonal position of the syringe 52 and needle 50 shown in FIG. 4 will in practice be difficult to achieve or maintain because a patient's cheeks will push against the syringe 52 and will tend to rotate the syringe 52 away from the orthogonal position, as shown by arrow 64. This can make it difficult to properly orient the needle 50 with respect to the periodontal ligament 22 (when attempting intraligamentary delivery) or with respect to the buccal surface of the gingivae (when attempting intraosseous delivery)

[0042] FIG. 5 illustrates a “bent-needle” syringe configuration that may be utilized in an intraosseous anesthetic procedure. One example of such a device is the commercially available “TuttleNumbNow” device. As shown, the needle 54 is bent to a 90-degree angle relative to the syringe 56 so that the needle 54 may be orthogonally positioned relative to the targeted buccal surface. The device also includes a sheath 58 intended to define the curve formed in the needle 54 during bending and to provide a surface for the user to push against when attempting to puncture the bone. If puncturing is successful, the user may then deliver the local anesthetic by actuating the syringe 56.

[0043] Such devices have several limitations, however. As shown in FIG. 6, when a force (shown by arrow 60) is directed against the sheath 58, the needle 54 will be contacted against the targeted cortical plate. In some circumstances, it will be difficult to puncture the cortical plate with the needle 54, and the needle 54 may bend or even break before puncturing through the bone, as shown by arrows 62. Bending, breakage or other forms of needle 54 failure often occur at or near the junction of where the needle 54 connects to or attaches to the syringe 52, such as the bend depicted in FIG. 6. Further, the needle 54 must inherently include a hollow inner lumen to enable delivery of the anesthetic. This required structural feature necessarily limits the needle's resistance to bending relative to a solid structure of otherwise similar size, shape, and construction. Moreover, even if puncturing through the cortical plate using a needle is successful, the method carries the risk that the needle will become clogged with portions of the tissue it passes through, preventing delivery of anesthesia to the cancellous bone using the needle once the needle tip has reached the target.

Intraosseous Tack Devices

[0044] FIG. 7 illustrates an exploded view of an exemplary intraosseous device 100, and FIG. 8 illustrates an assembled view of the device 100. The device 100 includes a tack 102, a sleeve 112, and a handle 108. The tack 102 includes a flattened head member 104 and an elongate member 106 extending from the head member 104. Preferably, the elongate member 106 is not a needle and does not have a hollow lumen/interior. Rather, the elongate member 106 is preferably solid (i.e., with a solid cross section).

[0045] A solid elongate member 106 provides several benefits. Compared to a hollow needle of similar size, shape, and construction, the solid elongate member 106 has greater resistance to bending and breakage when an axial force is applied in an attempt to penetrate the alveolar bone. In addition, because the elongate member 106 is solid, problems associated with tissues clogging the lumen of the device are avoided. Rather, the solid elongate member 106 is capable of effectively providing a clean access point through the cortical plate and into the cancellous bone.

[0046] The head member 104 of the tack 102 is shown here with a flattened, circular shape. Other embodiments may include tacks with other shape features. For example, some embodiments may include a tack with a head member that is polygonal (e.g., triangular, square, etc.), rounded, bubble-shaped, cylindrically-shaped, or otherwise shaped. The head member 104 may have a frictional feature or pattern to improve tactile grip during use.

[0047] Regardless of the exact shape of the head member 104, in some embodiments it is preferred that the head member 104 have a diameter that is larger than an inner diameter (i.e., lumen diameter) of the sleeve 112. This prevents the head member 104 from passing into the lumen of the sleeve 112 and defines the positional limit between the tack 102 and the sleeve 112. The head member 104 of the tack 102 may have a diameter that is larger than an inside diameter of the sleeve 112 by a factor of about 1.25 to about 10, or more preferably by a factor of about 1.5 to about 10. Diameter ranges within the foregoing ranges provide effective operability of the device by balancing size constraints for fitting the tack 102 within the sleeve 112 with overall size constraints of the device (which must be usable within the mouth) and with the need to have a tactile, actuatable surface by way of the head member 104.

[0048] As used herein, the “diameter” of a component refers to the longest dimension across the component from one side to the other, whether or not the component is circular or spherical. For example, the “diameter” of a square-shaped component may be measured diagonally from one corner to the opposite corner.

[0049] The elongate member 106 is sized so as to fit within the lumen of the sleeve 112. Preferably, the lumen of the sleeve 112 is sized to receive the elongate member 106 with a tight tolerance to minimize the amount of lateral movement or “play” of the elongate member 106 within the sleeve 112. The illustrated embodiment shows the elongate member 106 with a tapering profile. Alternatively, the cross-sectional diameter of the elongate member 106 may be substantially constant along its length. For example, some embodiments may include a cross-sectional diameter that is substantially constant for most of the length of the elongate member (e.g., 70-99% of its length), but with a distal tip that is tapered or beveled to form a finer/sharper point.

[0050] The size of the elongate member 106 is an important consideration in design of the device 100. For example, an overly large diameter may leave an overly large puncture in the patient's alveolar tissue and may cause undue pain and/or extended healing times. However, an overly small diameter may be unable to effectively puncture the targeted bone. In this regard, for the given puncturing or boring forces required, the solid construction of the elongate member 106 beneficially enables use a smaller diameter as compared to a needle. In presently preferred embodiments, an elongate member 106 having a diameter of about 0.2 mm to about 0.7 mm (e.g., about 0.3 mm, 0.4 mm, 0.5 mm, 0.6 mm) appears to provide effective results for a typical application, with a particularly preferred diameter size ranging from about 0.3 mm to about 0.5 mm (corresponding approximately to needle gauge sizes of 25 to 30). Other particular patient, procedure, or application needs may suggest or require the use of other sizes, however.

[0051] In the illustrated embodiment, the sleeve 112 includes a collapsible portion 114 and a rigid portion 116. As explained in greater detail below, the collapsible portion 114 is configured to collapse and shorten along the longitudinal axis of the sleeve 112 when the sleeve 112 is exposed to an axially-directed compressive force. Typically, this compressive force will be provided by a user's thumb and/or finger. The compressibility of the collapsible portion 114 allows the sleeve 112 to be effectively shortened and allows the elongate member 106 of the tack 102 to translate further through the lumen of the sleeve 112. The rigid portion 116 provides greater axial rigidity and is configured to resist collapsing when exposed to the compressive force.

[0052] As used herein, the proximal or “upper” end of the sleeve refers to the end adjacent to the head member 104 of the tack 102 when the device is assembled. The distal or “lower” end of sleeve refers to the opposite end through which the distal, puncturing end of the elongate member 106 will pass when the device is actuated. The illustrated embodiment positions the collapsible portion 114 adjacent the upper end of the sleeve 112 and the rigid portion adjacent the lower end of the sleeve 112. Other embodiments may reverse the relative positions such that the collapsible portion is adjacent the lower end and the rigid portion is adjacent the upper end. In such an embodiment, the head member of the tack would be adjacent to the rigid portion and the distal end of the elongate member would extend out of and beyond the collapsible portion when the device was actuated.

[0053] The rigid portion 116 of the illustrated sleeve embodiment also includes an attachment feature 120 adapted to enable the handle 108 to couple to the sleeve 112. As shown, the attachment feature 120 may be a groove, notch, or similar structure shaped to engage with a corresponding attachment feature 110 of the handle 108. Other embodiments may additionally or alternatively include other attachment features, such as threaded connections, magnetic connections, clasps, snap-fit connections, and combinations thereof.

[0054] In the illustrated embodiment, the handle 108 is selectively detachable from the sleeve 112. This allows, for example, the handle 108 to be sterilized and reused while the sleeve 112 and tack 102 are disposed of after use on a particular patient. In alternative embodiments, the handle 108 may be permanently coupled to the sleeve 112 as part of an integrated handle/sleeve unit. The handle 108 is shown here as having a plier-like construction with two opposing prongs or members 109 and 111. In other embodiments, the handle 108 may be constructed in an alternative form, such as a simple rod construction, an ergonomic handle construction (see, e.g., FIGS. 14, 15, and 20), a band-shaped construction, or other shape suitable for holding by a user.

[0055] The opposing members 109 and 111 may be biased toward an open position such that there is space between the ends of each member 109 and 111 near the attachment feature 110. For example, the handle 108 may be biased toward the open position shown in FIG. 8. From the position shown in FIG. 8, the device may be actuated to the position shown in FIG. 9 by applying a compressive force to the head member 104 sufficient to overcome the bias in the handle 108 and/or the collapsible portion 114. After the device has been actuated to the position shown in FIG. 9 and the compressive actuating force has been removed, the bias of the handle 108 and/or collapsible portion 114 toward their default positions will cause the device to automatically return to the non-actuated position shown in FIG. 8.

[0056] In some embodiments, the head member 104 of the tack 102 is attached to the sleeve 112. In the illustrated embodiment, for example, a bottom surface of the head member 104 may be attached to the top of the collapsible portion 114 of the sleeve 112. The attachment may be achieved using an adhesive or other suitable attachment means. Attaching the head member 104 to the sleeve 112 can beneficially prevent the tack 102 from detaching and falling away from the sleeve 112. To maintain proper functionality of the device, however, the elongate member 106 should still be longitudinally translatable within the lumen of the sleeve 112.

[0057] In the particular configuration of FIG. 8, the elongate member 106 of the tack 102 has a length that is no longer than the length of the sleeve 112 when the collapsible portion 114 is in an uncollapsed position. This prevents the distal end of the tack 102 from extending beyond the bottom of the sleeve 112. In other words, when the device is assembled and the tack 102 is properly positioned within the sleeve 112, the puncturing end of the elongate member 106 should not be immediately accessible. This prevents accidental sticks since the sharp, puncturing end of the elongate member 106 will only be exposed when a compressive force is properly applied to actuate the device. Other embodiments may include an elongate member that is about the same size as, or is longer than, a sleeve.

[0058] FIG. 9 illustrates actuation of the intraosseous device 100. When a compressive force (as shown by arrow 66) is applied to the head member of the tack 102, the collapsible portion of the sleeve 112 moves to a collapsed position, as shown. This allows the distal end of the tack 102 to pass out of the bottom end of the sleeve 112. In use, the bottom end of the sleeve 112 may be placed against targeted tissue where it is desired to puncture the bone and provide an anesthesia access point. The user then actuates the device by pressing on the head member of the tack 102 to cause the collapsible portion of the sleeve 112 to collapse and to allow the elongate member of the tack 102 to pass out of the sleeve to puncture bone at the targeted position.

[0059] The elongate member 106 preferably has a length such that, when the device is actuated, the elongate member 106 extends beyond the bottom end of the sleeve 112 a distance of about 1 mm to about 6 mm, or more preferably about 2 mm to about 5 mm. In other words, the elongate member 106 preferably has a length that is about 1 mm to about 6 mm, or about 2 mm to about 5 mm greater than a length of the sleeve when the sleeve is in a collapsed position.

[0060] For a typical application, a puncture depth within these ranges provides for an effective access point for administering anesthesia. In particular, the depth should be sufficient to provide good access to the cancellous bone in the targeted area, and should be deep enough to allow the anesthesia to diffuse effectively to surrounding tooth tissue once administered. At the same time, an overly deep penetration can injure more tissue than is needed for effective anesthetization. Lengths within the foregoing ranges therefore balance the need to provide effective penetration with the desire to avoid unnecessary injury risks and unnecessary use of materials. Other particular patient, procedure, or application needs may suggest or require the use of other lengths, however.

[0061] As shown in FIG. 9, the collapsible portion of the sleeve 112 includes a plurality of separable sections 118 configured to separate from one another to allow the collapsible portion to expand radially when compressed. This allows the overall length of the sleeve 112 to shorten, and thus allows the distal end of the tack 102 to pass out of the bottom end of the sleeve 112. As shown, the separable sections 118 may be oriented longitudinally (i.e., substantially parallel with the luminal axis of the sleeve 112). Other embodiments may include one or more separable sections oriented non-longitudinally. Other embodiments may additionally or alternatively include collapsible portions that include springs, accordion tubes, tube with sufficient columnar elasticity, other collapsible and/or resilient mechanisms, and combinations thereof.

[0062] In some embodiments, the collapsible portion 114 is resiliently biased toward the uncollapsed position. For example, when the device is actuated, the collapsible portion 114 is moved to the collapsed position upon application of a sufficient compressive force. When the compressive force is removed, the collapsible portion 114 returns to the uncollapsed position. In use, such a feature allows the exposed, puncturing end of the tack 102 to be drawn back within the sleeve 112 after the puncture has been made. This can beneficially prevent accidental sticks to the patient or user while withdrawing and handling the device following puncture formation.

[0063] FIGS. 10 and 11 schematically show exemplary uses of the intraosseous device 100. As shown, a user may grip the handle 108 and position the device near the targeted tissue to be punctured. Unlike a typical syringe, the handle 108 does not need to be orthogonal to the buccal surface 32, and may beneficially be aligned with the buccal surface 32 for easier access to posterior regions of the mouth 30. The sleeve 112 and tack 102 are positioned such that the luminal axis is orthogonal to the buccal surface 32. Typically, prior to puncture of the soft tissue and bone at the targeted site, the user administers topical and local anesthetic. For example, the user may first apply a topical anesthetic to the outer surface of the gingival tissue at and near the targeted site, and then may use a syringe to apply an amount of local anesthetic within the gingival tissue before proceeding with the intraosseous technique.

[0064] As described above, the user contacts the bottom surface of the sleeve 112 against the gingivae near the targeted tooth/teeth to be numbed (typically between two teeth), and then presses the tack 102 to push it through the sleeve 112, puncture the cortical plate, and provide an access point for delivering anesthesia. As shown, the device may be held in any desirable or preferred manner, such as with a thumb-actuating grip (FIG. 10) or a finger-actuating grip (FIG. 11). Following formation of the access point, the local anesthesia may be easily delivered using standard syringe and needle components. The needle may be bent to an angle for easier positioning at the access point, if desired. Because an access point has already been formed, the problems associated with using a needle to puncture bone (e.g., breakage, clogging) are avoided.

[0065] Because of the manual manner in which the device is actuated, it also beneficially provides effective tactile feedback to the user. In contrast, a user may accidentally reach and damage tooth roots when using a mechanized mechanism such as a mechanized drill. When using the disclosed device, the user is able to receive tactile feedback indicating how the procedure is advancing. For example, a user will typically be able to feel resistance as the tack is pressed against the cortical bone and will feel the “give” as it passes the cortical bone and enters the cancellous bone. Further if the tack happens to approach a root during penetration, the user will be able to feel the contact and will thus know to limit further penetration.

[0066] The illustrated device may be constructed using a variety of different suitable materials, such as medical-grade polymers, metals, and/or ceramics. In one embodiment, the sleeve 112 is constructed of a polymer and the tack 102 and handle 108 are constructed of stainless steel. Other suitable material combinations may be utilized, however.

[0067] FIGS. 12 through 16 illustrate various aspects of another embodiment of a tack 202 that may be utilized to puncture the cortical plate of a targeted region of the mouth to provide an access point for intraosseous delivery of an anesthetic and/or other medicament. The tack 202 includes a body 204 and an elongate member 206 extending from the body 204. The tack 202 and its associated components illustrated in FIGS. 12 through 16 and described in more detail below may share certain features with the tack 102 and its associated components. For example, portions of the above description related to the solidity, shape, length, and/or diameter of the elongate member 106 may also be applied to the elongate member 206, and portions of the above description related to the sleeve 112 may be applied to the sleeve 212 (see FIG. 16). Accordingly, the absence of specific details regarding some aspect of the tack 202 or its associated components should not be interpreted as necessarily requiring that it is therefore different from tack 102 in that particular aspect.

[0068] The body 204 of the illustrated tack 202 includes an attachment feature 224 disposed at the proximal end of the body 204 (i.e., the end opposite the elongate member 206) and configured to enable attachment of the tack 202 to a syringe, handle, or other such tool. The attachment feature 224 typically includes threads disposed on the inside of the body 204 (not shown) to allow a threaded connection with matching threads of the syringe or handle. However, the attachment feature 224 may additionally or alternatively include friction or snap-fit features, magnetic couplers, and/or clasps, for example, configured to engage with a corresponding attachment feature of the syringe or handle to which it is intended to be attached.

[0069] The body 204 of the illustrated tack 202 also includes one or more grips 222 configured to enhance tactile control of the tack 202 when manipulated by the user. The grips 222 may include one or more flanges, grooves, ridges, dents, high-friction sections (e.g., rubber or other elastomer), or other shapes or components configured to enhance friction and/or the ability to grip and maneuver the tack 202. These features beneficially provide ease of use when the user is attaching/detaching the tack 202 to a syringe or handle, or otherwise using the tack 202.

[0070] The tack 202 is typically constructed as a disposable unit. For example, the body 204 may be made from a biocompatible but often disposed polymer materials such as polycarbonate, polypropylene, polyethylene, other such polymers, and combinations thereof. The elongate member 206 will typically be formed of stainless steel or other such biocompatible metal capable of withstanding forces needed to puncture the cortical plate. Unlike standard syringe needles, the elongate member 206 has a solid construction without a hollow inner lumen extending therethrough. As with other tack embodiments described herein, the solid construction provides necessary structural integrity and reduces the risk of bending or breaking during penetration of the cortical plate.

[0071] FIG. 13 illustrates an example of how the tack 202 may be attached to a syringe 52. The attachment feature 224 of the tack 202 and a corresponding attachment feature 68 of the syringe 52 engage with one another to form a connection (e.g., a threaded connection). Although a syringe 52 is not needed for use of the tack 202, the ability to selectively attach the tack 202 to a standard syringe 52 is beneficial because such syringes will already likely be present and ready for use during the procedure along with other standard armamentarium, and it will therefore be easy for a dentist or other user to quickly attach the tack 202 to the syringe 52 in the same manner as attaching a standard needle tip to the syringe 52.

[0072] FIG. 14 illustrates an example of how the tack 202 may be attached to a handle 208 designed for use with the tack 202. Although the tack 202 may be readily attached to a standard syringe 52 as in FIG. 13, and although this may be easy and suitable in some circumstances, the use of a syringe 52 may not be optimal for all applications. For example, because a syringe is not designed for transmitting the kinds of forces sometimes necessary to puncture the cortical plate, it may not be suitable for less experienced users and/or situations where the cortical plate is particularly difficult to puncture. The handle 208 includes design features better tailored to use of the tack 202 for puncturing the cortical plate of a patient.

[0073] The attachment feature 224 of the tack 202 is configured to engage with a corresponding attachment feature 210 of the handle 208 to allow connection (e.g., threaded connection) of the two components. As shown, the handle 208 may include a proximal section 228 and a distal section 230 extending distally from the proximal section 228. The attachment feature 210 then extends further distally from the distal section 230. An optional extension 232 may be disposed between the distal section 230 and the attachment feature 210 to provide distance between the distal section 230 and the attachment feature 210 where desired. In some embodiments, the extension 232 has an adjustable length (e.g., via telescoping construction, interchangeable pieces of different sizes, sliding within the handle, etc.) such that the user can adjust and customize its length according to particular user preferences and/or application needs.

[0074] In the illustrated embodiment, the distal section 230 has a smaller diameter than the proximal section 228. This allows an ergonomic grip of the handle 208, with the fingers and thumb allowed to be somewhat closer together, for finer movement control, while gripping the handle 208 at the distal section 230 while providing greater size at the proximal section 228 for better lodging in the palm of the hand. Other embodiments may omit this size difference and instead have a substantially constant diameter across the proximal section 228 and distal section 230. Further, while the illustrated embodiment shows a discrete change in diameter between the proximal section 228 and the distal section 230, other embodiments include a gradual transition or taper from one diameter to another.

[0075] The handle 208 may also include a plurality of grips 226 configured to enhance tactile control of the handle 208 when manipulated by the user. The grips 226 may include one or more flanges, grooves, ridges, dents, high-friction sections (e.g., rubber or other elastomer), or other shapes or components configured to enhance friction and/or the ability to grip and maneuver the handle 208 during use. Grips 226 may be provided at the proximal section 228, distal section 230, or both.

[0076] FIG. 15, for example, illustrates one use of the handle 208 and tack 202 to puncture the cortical plate at the buccal surface 32 of a targeted region of the mouth 30. As the user grips the handle 208 and applies forward/distal force to push the tack 202 through the cortical plate, the handle 208 provides good grip and control of the device. The handle 208 also allows the user to apply a slight rotating motion (as indicated by arrows 70) to the tack 202 while applying forward/distal pressure to aid in puncturing the cortical plate and accessing the underlying cancellous bone.

[0077] FIG. 16 illustrates an embodiment of the tack 202 further comprising a sleeve 212. As with sleeve 112, at least a portion of sleeve 212 may be collapsible. The collapsible portion 214 is configured to collapse and shorten along the longitudinal length of the sleeve 212 when the sleeve 212 is exposed to an axially-directed compressive force. The sleeve 212 may also include a rigid portion 216 configured to resist collapsing when exposed to the compressive force. The sleeve 212 may be attached at one end to the body 204 of the tack 202, while the other end extends over at least a portion of the elongate member 206 but is not attached to the elongate member 206 to allow the elongate member 206 to maintain longitudinal position while the sleeve 212 collapses.

[0078] The sleeve 212 may be biased toward the uncollapsed position. The relative lengths of the elongate member 206 and the sleeve 212 are preferably arranged so that the sleeve 212 covers the distal tip of the elongate member 206 when in the uncollapsed position (e.g., to prevent accidental sticks), but allows the elongate member 206 to extend beyond the sleeve 212 by a distance of about 1 mm to about 6 mm, or more preferably about 2 mm to about 5 mm when the sleeve is collapsed.

[0079] FIGS. 17A through 21B illustrate various aspects of another embodiment of a tack 302 that may be utilized to puncture the cortical plate of a targeted region of the mouth to provide an access point for intraosseous delivery of an anesthetic and/or other medicament. The tack 302 includes a body 304, a sleeve 312 and an elongate member 306 extending from and through the body 304. The tack 302 and its associated components illustrated in FIGS. 17A through 21B, and described in more detail below, may share certain features with the tacks 102, 202 previously described and their associated components. For example, portions of the above description related to the solidity, shape, length, and/or diameter of the elongate members 106, 206 may also be applied to the elongate member 306, and portions of the above description related to the sleeves 112, 212 may be applied to the sleeve 312. Accordingly, the absence of specific details regarding some aspect of the tack 302 or its associated components should not be interpreted as necessarily requiring that it is therefore different from tacks 102, 202 in that particular aspect.

[0080] The body 304 of the illustrated tack 302 includes an attachment feature 324 disposed at the proximal end of the body 304 (i.e., the end opposite the elongate member 306) and configured to enable attachment of the tack 302 to a syringe, handle, or other such tool. The attachment feature 324 typically includes threads disposed on the inside of the body 304 (not shown) to allow a threaded connection with matching threads of the syringe or handle. However, the attachment feature 324 may additionally or alternatively include friction or snap-fit features, magnetic couplers, and/or clasps, for example, configured to engage with a corresponding attachment feature of the syringe or handle to which it is intended to be attached.

[0081] The elongate member 306 is illustrated as extending both distally beyond the body 305 and proximally beyond the attachment feature 306. In some embodiments, the elongate member 306 may only extend distally beyond the body 304 and not extend proximally beyond the attachment feature 324. In some embodiments, for example, the elongate member 306 may terminate in alignment with, or just distal to, the attachment feature 324.

[0082] The body 304 of the illustrated tack 302 may also include one or more grips 322 configured to enhance tactile control of the tack 302 when manipulated by the user. The grips 322 may include one or more flanges, grooves, ridges, dents, high-friction sections (e.g., rubber or other elastomer), or other shapes or components configured to enhance friction and/or the ability to grip and maneuver the tack 302. These features beneficially provide ease of use when the user is attaching/detaching the tack 302 to a syringe or handle, or otherwise using the tack 302.

[0083] The tack 302 is typically constructed as a disposable unit. For example, the body 304 may be made from a biocompatible but often disposed polymer materials such as polycarbonate, polypropylene, polyethylene, other such polymers, and combinations thereof. The elongate member 306 will typically be formed of stainless steel or other such biocompatible metal capable of withstanding forces needed to puncture the cortical plate. Unlike standard syringe needles, the elongate member 306 has a solid construction without a hollow inner lumen extending therethrough. As with other tack embodiments described herein, the solid construction provides necessary structural integrity and reduces the risk of bending or breaking during penetration of the cortical plate.

[0084] Additionally, and/or alternatively, a distal tip 307 of the elongate member 306 may be configured as a “spearhead” shape, examples of which are shown in FIGS. 18A-18C. FIGS. 18A and 18B are top views of the distal tip 307 showing embodiments of the shape of the distal tip 307. FIG. 18C is a side view of the distal tip 307 depicted in FIG. 18B. In other words, the viewing plane in FIG. 18C is aligned with a lateral edge of the distal tip 307, where the distal tip 307 (and thus the front and/or back surfaces 309) have been rotated 90° from the views in FIGS. 18A-18B. The distal tip 307 of the elongate member 306 may be beveled and/or sharpened along lateral surfaces or faces 313. Additionally, and/or alternatively, the distal tip 307 of the elongate member 306 may be beveled and/or sharpened along front and back surfaces or faces 309 of the distal tip 307.

[0085] In some embodiments, the front and back surfaces 309 include additional three-dimensional beveling and/or contouring along one or more surfaces such as the front and/or back surfaces 309. In some embodiments, as illustrated, the widest part of the distal tip 307 is wider than the diameter of more proximal sections of the elongate member 306. In other embodiments, the distal tip 307 essentially matches the diameter of the more proximal sections of the elongate member 306 and then tapers to a narrower point distally therefrom.

[0086] The lateral surfaces or edges 313 of the spearhead and the most distal tip of the spearhead may be sharp. In some embodiments, the lateral surfaces or edges 313 of the spearhead tip may have small serrations. Beneficially, the beveled lateral surfaces and/or beveled front and back surfaces that produces the spearhead shape of the tip enables boring of a hole through the cortical plate of a targeted region of the mouth through rotation of the device to enable or assist in reaching the targeted cancellous tissue, rather than (only) forcing the tip through the cortical plate.

[0087] FIGS. 17A-B illustrate the tack 302 comprising a sleeve 312. FIG. 17A illustrates the sleeve 312 is an extended position and FIG. 17B illustrates the sleeve 312 in a nested position. The elongate member 306 is sized to fit within the lumen of the sleeve 312. Preferably, the lumen of the sleeve 312 is sized to receive the elongate member 306 with a snug tolerance to minimize the amount of lateral movement or “play” of the elongate member 306 within the sleeve 312. The tolerance is not so tight as to prevent a sliding motion, as the sleeve 312 is configured to slide over and cover at least a portion of the elongate member 306. In some embodiments, the sleeve 312 is sized to cover an entire length of the elongate member 306.

[0088] The body 304 is configured to receive the sleeve 312 when a compressive force is applied. When compressive forces are applied to the elongate member 306 and the sleeve 312, the sleeve 312 will slide proximally along the elongate member 306 and into the body 304 (see FIG. 17B). The sleeve 312 supports the elongate member 306 where the elongate member 306 contacts and/or attaches to the body 304. Generally, the elongate member 306 is prone to failure at that point when an axially oriented force is applied. That is, the elongate member 306 may bend or snap at the point where it contacts and/or attaches to the body 304 (see, for example, FIG. 6). The sleeve 312 provides extra support at the contact and/or attachment point (when received by the body 304), to prevent failure of the elongate member 306 when an axially oriented force is applied. In some embodiments, at least a portion of the sleeve remains or extends distally from the body 304 to provide the extra support to the elongate member 306.

[0089] The elongate member 306 preferably has a length such that, when the device is used, the elongate member 306 extends beyond a distal end (i.e., where the sleeve 312 and elongate member 306 join the body 304) of the sleeve 312 a distance of about 1 mm to about 6 mm, or more preferably about 2 mm to about 5 mm. In other words, the elongate member 306 preferably has a length that is about 1 mm to about 6 mm, or about 2 mm to about 5 mm greater than a length of the sleeve 312 when the sleeve 312 is received by the body 304.

[0090] For a typical application, achieving a depth within these ranges provides for an effective access point for administering anesthesia. In particular, the depth should be sufficient to provide good access to the cancellous bone in the targeted area, and should be deep enough to allow the anesthesia to diffuse effectively to surrounding tooth tissue once administered. At the same time, an overly deep penetration can injure more tissue than is needed for effective anesthetization. Lengths within the foregoing ranges therefore balance the need to provide effective penetration with the desire to avoid unnecessary injury risks and unnecessary use of materials. Other particular patient, procedure, or application needs may suggest or require the use of other lengths, however.

[0091] FIGS. 19A-B illustrate an embodiment of the tack 302 with a cap 311. The cap 311 is configured to fit over the tack 302 and protect the tack 302 when not in use. As shown in FIG. 19B, the cap 311 has a distal part 314 and a proximal part 316, where the proximal part 316 may be configured to engage with a syringe, handle or other tool. For example, the proximal part 316 may be configured for a threaded attachment. The distal part 314 is removably engaged with the proximal part 316 and simply needs to be pulled away from the proximal part 316 to expose the tack 302.

[0092] FIG. 20 illustrates an embodiment of a handle for use with an interosseous tack of the present disclosure. FIG. 21A illustrates an example of how the tack 302 may be attached to a handle 308 designed for use with the tack 302. Although the tack 302 may be readily attached to a standard syringe 52 as in FIG. 21B, and although this may be easy and suitable in some circumstances, the use of a syringe 52 may not be optimal for all applications. For example, because a syringe is not designed for transmitting the kinds of forces sometimes necessary to puncture the cortical plate, it may not be suitable for less experienced users and/or situations where the cortical plate is particularly difficult to puncture. The handle 308 includes design features better tailored to use of the tack 302 for puncturing and/or boring through the cortical plate of a patient.

[0093] The attachment feature 324 of the tack 302 is configured to engage with a corresponding attachment feature 310 of the handle 308 to allow connection (e.g., threaded connection or friction fit) of the two components. As shown, the handle 308 may include a proximal section 328 and a distal section 330 extending distally from the proximal section 328. The attachment feature 310 then extends further distally from the distal section 330. An optional extension 332 may be disposed between the distal section 330 and the attachment feature 310 to provide distance between the distal section 330 and the attachment feature 310 where desired. In some embodiments, the extension 332 has an adjustable length (e.g., via telescoping construction, interchangeable pieces of different sizes, sliding within the handle, etc.) such that the user can adjust and customize its length according to particular user preferences and/or application needs.

[0094] In some embodiments, the distal section 330 is configured to twist or spin independently of the proximal section 328. A rotational force applied to the distal section 330 would cause the tack 302, when attached to the handle 308, to be correspondingly rotated. When a rotational force is applied to the distal section 330, the proximal section 328 does not rotate, but stays static. This decoupling of a twisting motion beneficially maintains the ergonomic shape and feel of the handle 308 in the grip of a practitioner, while allowing the distal section 330 and the tack 302 to twist.

[0095] Beneficially, rotating the tack 302 against the cortical plate of a targeted region of the mouth helps the tack 302 to bore through the cortical plate. Boring through the cortical plate provides an access point for delivery of medicament or local anesthetic. Boring through the cortical plate rather than attempting to puncture the cortical plate without rotation also enables a practitioner to better identify when the soft, spongy bone has been reached as the practitioner will be able to feel a difference in resistance without overly driving the tack into the targeted cancellous bone. Such tactile differences may be ignored or missed, especially with less experienced users, when applying a direct puncturing force without a rotational component.

[0096] Boring through the cortical plate also takes less time than puncturing or forcing the tack 302 through the cortical plate. For example, a hole may be bored through the cortical plate in about 15 seconds, or about 10 seconds or less. This substantially speeds up the time for delivery of anesthesia, in turn speeding up the time for dental procedures. Further, by ensuring the practitioner has bored through to the soft, spongy cancellous bone, the right amount of local anesthesia may be applied to more quickly diffuse through the vasculature of the mouth to provide the intended anesthetic effects. In some embodiments, the numbing sensation is felt after about 2 minutes, or after about 1.5 minutes after local delivery of anesthesia.

[0097] A method of using the interosseous tack and/or boring through bone is also disclosed. The method of boring through bone to provide an access point for intraosseous delivery of a medicament may include providing a tack device, the tack device including a tack having a body with a proximal end and a distal end, the proximal end including an attachment feature enabling attachment of the body to a syringe or handle, and an elongate member attached to the distal end of the body and extending distally therefrom, the elongate member forming a solid structure with a spearhead tip that enables boring through targeted bone, and a handle having an attachment feature corresponding to the attachment feature of the body and enabling attachment of the body to the handle.

[0098] The method may also include positioning the elongate member of the tack at a targeted area adjacent to a targeted tooth to be anesthetized; and manipulating the tack device to cause the elongate member of the tack to pass into and through cortical bone at the targeted area. In some embodiments, manipulating the tack device includes twisting the handle and, thereby, twisting the tack. Twisting the tack against the bone will cause the elongate member of the tack to bore through the bone, providing an access point for intraosseous delivery of a medicament. A most distal tip of the elongate member of the tack may be spearhead shaped, with two beveled and sharp edges enabling boring through the bone. The rotational/twisting motion may be combined with an axially directed force to assist in puncturing the cortical plate.

[0099] As described above, the user contacts the bottom surface of the sleeve 312 against the gingivae near the targeted tooth/teeth to be numbed (typically between two teeth), and then presses slightly inward. This causes the sleeve 312 to slide proximally towards and into the body 304. In this position, as described above, the sleeve 312 provides additional protection against bending or failure of the tack 302 at the point where failure is most common. The user may then twist the handle 308 to bore through the cortical plate and provide an access point for delivering anesthesia. Following formation of the access point, the local anesthesia may be easily delivered using standard syringe and needle components. The needle may be bent to an angle for easier positioning at the access point, if desired. Because an access point has already been formed, the problems associated with using a needle to puncture bone (e.g., breakage, clogging) are avoided.

[0100] Because of the manual manner in which the device is actuated, it also beneficially provides effective tactile feedback to the user. In contrast, a user may accidentally reach and damage tooth roots when using a mechanized mechanism such as a mechanized drill. When using the disclosed device, the user is able to receive tactile feedback indicating how the procedure is advancing. For example, a user will typically be able to feel resistance as the tack is pressed against the cortical bone and will feel the “give” as it passes the cortical bone and enters the cancellous bone. Further if the tack happens to approach a root during penetration, the user will be able to feel the contact and will thus know to limit further penetration.

CONCLUSION

[0101] It should be understood that for any given element of component of a described embodiment, any of the possible alternatives listed for that element or component may generally be used individually or in combination with one another, unless implicitly or explicitly stated otherwise. It will also be appreciated that embodiments described herein may include properties, features (e.g., ingredients, components, members, elements, parts, and/or portions) described in other embodiments described herein. Accordingly, the various features of a given embodiment can be combined with and/or incorporated into other embodiments of the present disclosure. Thus, disclosure of certain features relative to a specific embodiment of the present disclosure should not be construed as limiting application or inclusion of said features to the specific embodiment. Rather, it will be appreciated that other embodiments can also include such features.

[0102] In addition, unless otherwise indicated, numbers expressing quantities, constituents, distances, or other measurements used in the specification and claims are to be understood as optionally being modified by the term “about” or its synonyms. When the terms “about,” “approximately,” “substantially,” “essentially,” or the like are used in conjunction with a stated amount, value, or condition, it may be taken to mean an amount, value or condition that deviates by less than 20%, less than 10%, less than 5%, or less than 1% of the stated amount, value, or condition. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques.

[0103] Any headings and subheadings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. It will also be noted that, as used in this specification and the appended claims, the singular forms “a,” “an” and “the” do not exclude plural referents unless the context clearly dictates otherwise. Thus, for example, an embodiment referencing a singular referent (e.g., “widget”) may also include two or more such referents.