Bone material dispensing device

Abstract

A bone material dispensing device is provided. The bone material dispensing device includes a housing having a proximal end, a distal end, and a longitudinal axis. The proximal end has a first opening and the distal end has a second opening. The first opening and the second opening are configured to slidably receive at least a portion of a plunger. A tubular member is provided that is pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing. The tubular member includes a proximal opening, a distal opening, and a passage disposed therebetween. The proximal opening, the distal opening, and the passage of the tubular member are configured to receive at least the portion of the plunger. The tubular member is movable in a first position to align the proximal opening of the tubular member with the second opening of the housing so as to allow the tubular member to receive at least the portion of the plunger to dispense bone material. A method of implanting bone material using the bone material dispensing device is also provided.

Description

BACKGROUND

[0001] Various devices and methods have been used to apply bone material, such as bone graft, to a surgical site. Bone grafts are important in orthopedic surgery for repairing bone defects caused by injury, disease, wounds, or surgery. To this end, a number of materials have been used or proposed for use in repairing bone defects. The biological, physical, and mechanical properties of the materials are primary factors that influence their suitability and performance in various orthopedic applications.

[0002] Generally, bone tissue regeneration is achieved by filling a bone defect with a bone material, e.g., a bone graft. Over time, the bone graft is resorbed by the host and new bone remodels the bone graft. The bone material can include bone from the patient's own body, synthetic bone material, natural alternative bone material, or combinations thereof.

[0003] To deliver bone material to a bone defect, the bone material is typically mixed with a liquid or therapeutic agent, a powder, a fiber, or a particulate material. Further, the transfer of the bone material to a dispensing device is often accomplished through a rough and chaotic packaging of the bone dispensing device, which can cause undesirable waste and spillage of the bone material. These devices can also increase the risk of contaminating the bone material during the transfer and delivery of the bone material. Additionally, some dispensing devices can cause damage to surrounding tissue of the surgical site during the application of the bone material. Furthermore, the bone material can clog certain dispensing devices due to its consistency and / or due to the design of the dispensing device, and when this occurs, the amount of bone material cannot be effectively controlled.

[0004] Accordingly, it can be desirable to provide a bone material dispensing device that allows for easier loading of bone material that reduces the risk of contaminating the bone material and spillage of the bone material from the dispensing device. It would be beneficial to provide a dispensing device that reduces clogging during the dispensing of the bone material and is also capable of delivering the bone material incrementally to a bone defect in a controlled amount. SUMMARY

[0005] In some embodiments, there is a bone material dispensing device that reduces the risk of contaminating the bone material and spillage of the bone material from the dispensing device, applies the bone material to a bone defect, and the provided devices and methods reduce clogging during the incremental dispensing of the bone material.

[0006] In some embodiments, a bone material dispensing device is provided that includes a housing having a proximal end, a distal end, and a longitudinal axis. The proximal end has a first opening and the distal end has a second opening. The first opening and the second opening are configured to slidably receive at least a portion of a plunger. A tubular member is provided that is pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing. The tubular member includes a proximal opening, a distal opening, and a passageway disposed therebetween. The proximal opening, the distal opening, and the passageway of the tubular member are configured to receive at least the portion of the plunger. The tubular member is movable in a first position to align the proximal opening of the tubular member with the second opening of the housing so as to allow the tubular member to receive at least the portion of the plunger to dispense bone material.

[0007] In some embodiments, a bone material dispensing gun is provided. The bone material dispensing gun includes a housing having a proximal end and a distal end, and a longitudinal axis. The proximal end has a first opening and the distal end has a second opening. The first opening and the second opening are configured to slidably receive at least a portion of a plunger. The housing includes a trigger assembly configured to allow incremental slidable movement of the plunger to dispense bone material. A tubular member is provided that is pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing. The tubular member includes a proximal opening, a distal opening, and a passageway disposed therebetween. The proximal opening, the distal opening, and the passageway of the tubular member are configured to receive at least the portion of the plunger. The tubular member is movable in a first position to align the proximal opening of the tubular member with the second opening of the housing so as to allow the tubular member to receive at least the portion of the plunger to dispense bone material. The tubular member is movable in a second position to misalign the proximal opening of the tubular member with the second opening of the housing so as to prevent the tubular member from receiving at least the portion of the plunger.

[0008] In some embodiments, a method of implanting bone material is provided. The method includes loading a bone material dispensing device with bone material, the bone material dispensing device including a housing having a proximal end, a distal end, and a longitudinal axis, the proximal end having a first opening and the distal end having a second opening, the first opening and the second opening configured to slidably house at least a portion of a plunger, and a tubular member pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing, the tubular member including a proximal opening, a distal opening, and a passageway disposed therebetween, the proximal opening, the distal opening, and the passageway of the tubular member configured to house at least the portion of the plunger, the tubular member movable in a first position to align the proximal opening of the tubular member with the second opening of the housing so as to allow the tubular member to house at least the portion of the plunger to dispense bone material.

[0009] Although a number of embodiments of this application have been described in detail, other modifications and changes specific to the practice of this application are permissible. As will be recognized by those skilled in the art, the innovative concepts described in this application can be modified in various ways without departing from the spirit or scope of the application. Accordingly, inventive concepts are therefore to be considered as limited only by the spirit and scope of the following claims, and not the foregoing description. BRIEF DESCRIPTION OF DRAWINGS

[0010] Other aspects, features, benefits and advantages of embodiments will become apparent from the following detailed description, the accompanying drawings, and the appended claims.

[0011] Figure 1 is a perspective view of a bone material dispensing device in accordance with an aspect of the present application. The bone material dispensing device includes a housing having a proximal end having a first opening, a distal end having a second opening, and a longitudinal axis. The first opening and the second opening are configured to slidably house at least a portion of a plunger. A tubular member is provided that is pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing and configured to house at least the portion of the plunger to dispense bone material.

[0012] Figure 2 is a perspective view of a bone material dispensing device in accordance with an aspect of the present application. The bone material dispensing device includes a housing having a proximal end having a first opening, a distal end having a second opening, and a longitudinal axis. The first opening and the second opening are configured to slidably house at least a portion of a plunger. A tubular member is provided that is pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing and configured to house at least the portion of the plunger to dispense bone material. Figure 1

[0013] Figure 3 is a perspective view of a bone material dispensing device in accordance with an aspect of the present application. The bone material dispensing device includes a housing having a proximal end having a first opening, a distal end having a second opening, and a longitudinal axis. The first opening and the second opening are configured to slidably house at least a portion of a plunger. A tubular member is provided that is pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing and configured to house at least the portion of the plunger to dispense bone material. Figure 1

[0014] ​​Figure 4 is a partial cross-sectional enlarged side view of the bone material dispensing device of Figure 1 , wherein a portion of the housing is removed to illustrate the operation and movement of the bone material dispensing device and plunger.

[0015] Figure 5 is a partial cross-sectional enlarged side view of the bone material dispensing device of Figure 1 , wherein a portion of the housing is removed to illustrate the operation and movement of the bone material dispensing device and plunger.

[0016] Figure 6 is a partial cross-sectional enlarged side view of the bone material dispensing device of Figure 1 , wherein a portion of the housing is removed to illustrate the operation and movement of the bone material dispensing device and plunger.

[0017] Figure 7 is a partial cross-sectional enlarged side view of the bone material dispensing device of Figure 1 , wherein a portion of the housing is removed to illustrate the operation and movement of the bone material dispensing device and plunger.

[0018] Figure 8 is a perspective view of the bone material dispensing device of Figure 1 , showing the tubular member moved in the first position to align the proximal opening of the tubular member with the second opening of the housing so as to allow the tubular member to house at least a portion of the plunger to dispense bone material.

[0019] Figure 9 is a perspective view of the bone material dispensing device of Figure 1 , showing the sleeve and funnel portion engaged.

[0020] Figure 10 is a perspective view of the bone material dispensing device of Figure 1 , wherein the housing includes a locking member for locking the funnel portion to the housing. The sleeve and funnel portion are shown as a cross-sectional view.

[0021] Figure 11 is a perspective view of the bone material dispensing device of Figure 1 and the sleeve including the funnel shown in Figure 9 . In Figure 11 , the end of the sleeve is shown seated with an intervertebral disc for administering bone material. The sleeve and funnel portion are shown as a cross-sectional view.

[0022] Figure 12 is a perspective view of the bone material dispensing device of Figure 9 , engaged with the sleeve including the funnel shown in Figure 1 . In Figure 12In some embodiments, the end of the cannula is shown disposed with an intervertebral disc for administering bone material. The cannula and funnel portion are shown as cross-sectional views.

[0023] Figure 13 is a perspective view of a bone material dispensing device of Figure 9 engaged with a cannula including a funnel shown Figure 1 is a perspective view of a bone material dispensing device of Figure 13 In some embodiments, the end of the cannula is shown disposed with an intervertebral disc and movement of a trigger assembly for administering bone material. The cannula and funnel portion are shown as cross-sectional views.

[0024] Figure 14 is a perspective view of a bone material dispensing device of Figure 9 engaged with a cannula including a funnel shown Figure 1 is a perspective view of a bone material dispensing device of Figure 14 In some embodiments, the end of the cannula is shown disposed with an intervertebral disc and movement of a plunger for administering bone material. The cannula and funnel portion are shown as cross-sectional views.

[0025] Figure 15 is a perspective view of a bone material dispensing device of Figure 9 engaged with a cannula and funnel portion shown Figure 1 is a perspective view of a bone material dispensing device of Figure 15 In some embodiments, the end of the cannula is shown disposed with an intervertebral disc and movement of a trigger assembly moves a plunger for administering bone material. The cannula and funnel portion are shown as cross-sectional views.

[0026] Figure 16 is a perspective view of a bone material dispensing device of Figure 9 engaged with a cannula including a funnel shown Figure 1 is a perspective view of a bone material dispensing device of Figure 16 In some embodiments, movement of a passive pawl for ejecting a plunger from the bone material dispensing device is shown. The cannula and funnel portion are shown as cross-sectional views.

[0027] Figure 17 is a perspective view of a folded cannula. The folded cannula includes an upper compartment, a lower compartment, and a fold line. The folded cannula is shown in an unfolded configuration.

[0028] Figure 18 is a perspective view of a folded cannula of Figure 17 The folded cannula is shown in a folded configuration.

[0029] Figure 19 is a perspective view of a folded cannula of Figure 17 loaded into a housing and a tubular member.

[0030] Figure 20 is engaged with a folded cannula of Figure 17 including a funnelFigure 1 A perspective view of the bone material distribution device. Figure 20 The image shows the distal end of the folded cannula positioned within the intervertebral disc, with the funnel partially enclosing the tubular member. In this view, the plunger is not loaded into the device.

[0031] Figure 21 It is with including the funnel Figure 17 Folded sleeve joint Figure 1 A partial cross-sectional perspective view of the bone material distribution device. Figure 21 The image shows an intervertebral disc positioned at the end of a cannula, and movement of the trigger assembly causing a plunger to move for application of bone material.

[0032] Figure 22 It is with including the funnel Figure 17 Folded sleeve joint Figure 1 A partial cross-sectional perspective view of the bone material distribution device. Figure 22 The image shows an intervertebral disc positioned at the end of a cannula, and movement of the trigger assembly causing a plunger to move for application of bone material.

[0033] It should be understood that the accompanying drawings are not drawn to scale. Furthermore, the relationships between objects in the drawings may not be to scale and may actually be inversely related in size. These drawings are intended to aid in understanding and clearly illustrating the structure of each object, and therefore some features may be magnified to illustrate specific structural characteristics. Detailed Implementation

[0034] definition

[0035] Note that, as used in this specification and the appended claims, the singular forms “a,” “an,” and “the” include plural indicators unless explicitly and precisely limited to one indicator.

[0036] The term "allogeneic graft" refers to a tissue graft obtained from a donor of the same species as the recipient but with a different genetic composition, serving as a tissue transplant between two individuals.

[0037] The term "autologous" refers to the body that is derived from or transferred from the same individual, such as an autologous bone marrow graft.

[0038] The term "xenograft" refers to tissue or organ from an individual of one species that is transplanted into or onto an organism of another species, genus or family.

[0039] The term “mammal” refers to organisms derived from the taxonomic category “mammal”, including but not limited to humans; other primates such as chimpanzees, apes, orangutans, and monkeys; rats, mice, cats, dogs, cattle, horses, etc.

[0040] The term "patient" refers to a biological system to which treatment can be administered. A biological system may include, for example, an individual cell, a group of cells (e.g., a cell culture), an organ, or a tissue. Additionally, the term "patient" may refer to an animal, including but not limited to humans.

[0041] The term "bone material" includes natural and / or inorganic materials, such as inorganic ceramics and / or bone substitutes. Bone material may also include natural bone material, such as cortical, cancellous, or corticocancellous bone of autologous, allogeneic, xenogeneic, or genetically modified origin. In some embodiments, bone material may include demineralized bone material, such as substantially demineralized bone material, partially demineralized bone material, or completely demineralized bone material.

[0042] As used herein, “demineralized” refers to any material produced by removing minerals from tissue (e.g., bone tissue). In some embodiments, the demineralized compositions described herein comprise formulations containing less than 5% by weight of calcium, and preferably less than 1% by weight. Partially demineralized bone (e.g., formulations having more than 5% by weight of calcium but containing less than 100% of the original starting amount of calcium) is also considered to be within the scope of this application. In some embodiments, demineralized bone has less than 95% of its original mineral content.

[0043] In some embodiments, the demineralized bone has less than 95% of its original mineral content. In some embodiments, the demineralized bone has less than 95%, 94%, 93%, 92%, 91%, 90%, 89%, 88%, 87%, 86%, 85%, 84%, 83%, 82%, 81%, 80%, 79%, 78%, 77%, 76%, 75%, 74%, 73%, 72%, 71%, 70%, 69%, 68%, 67%, 66%, 65%, 64%, 63%, 62%, 61%, 60%, 59%, 58%, 57%, 56%, 55%, 54%, 5... 3%, 52%, 51%, 50%, 49%, 48%, 47%, 46%, 45%, 44%, 43%, 42%, 41%, 40%, 39%, 38%, 37%, 36%, 35%, 34%, 33%, 32%, 31%, 30%, 29%, 28%, 27%, 26%, 25%, 24%, 23%, 22%, 21%, 20%, 19%, 18%, 17%, 16%, 15%, 14%, 13%, 12%, 11%, 10%, 9%, 8%, 7%, 6%, and / or 5%. In some embodiments, “demineralized” is intended to encompass expressions such as “substantially demineralized,” “shallowly demineralized,” “partially demineralized,” “surface demineralized,” and “completely demineralized.”

[0044] "Partially demineralized material" is intended to encompass "surface demineralized material". "Partially demineralized bone" is intended to refer to a formulation having more than 5% by weight of calcium but containing less than 100% of the original starting amount of calcium. In some embodiments, partially demineralized material comprises 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52% calcium. 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, and / or 99% of the original starting amount of calcium.

[0045] In some embodiments, the demineralized bone may be approximately 1-99% surface demineralized. In some embodiments, the demineralized bone is 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%, 38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%, 53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%, 68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, and / or 99% surface demineralization. In various embodiments, the demineralized bone may be about 15-25% surface demineralized. In some embodiments, the demineralized bone is 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, and / or 25% surface demineralized.

[0046] As used herein, “shallowly demineralized” means bone-derived elements having at least about 90% by weight of their original inorganic mineral content; “partially demineralized” means bone-derived elements having about 8 to about 90% by weight of their original inorganic mineral content; and “fully demineralized” means bone containing less than 8% of its original mineral content.

[0047] As used herein, “demineralized bone matrix” refers to any material produced by removing minerals from bone tissue. In a preferred embodiment, as used herein, the DBM composition comprises a formulation containing less than 5% by weight of calcium, and preferably less than 1% by weight of calcium.

[0048] As used in this article, “biocompatibility” refers to materials that do not induce undesirable long-term effects when administered in vivo.

[0049] As used in this article, "osteoconductivity" refers to the ability of a non-osteoinductive substance to act as a suitable template or material along which bone can grow.

[0050] As used in this article, "osteogenicity" refers to the ability of a drug, material, or implant to enhance or accelerate the growth of new bone tissue through one or more mechanisms such as osteogenic, osteoconduction, and / or osteoinduction.

[0051] As used herein, “osteoinducible” refers to the quality of cells that can recruit from the host and have the potential to stimulate new bone formation. Any material capable of inducing ectopic bone formation in the soft tissues of an animal is considered osteoinducible. For example, most osteoinducible materials induce bone formation in athymic rats when measured according to the method of Edwards et al., “Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model”, Clinical Orthopaedics & Res. 357:219-228, December 1998, which is incorporated herein by reference.

[0052] The terms “upper,” “lower,” “top,” “bottom,” “side,” “proximal,” “farthest,” etc., have been used herein for convenience in describing the invention and its portions as oriented as shown in the accompanying drawings. However, it should be understood that these terms are by no means limited to this disclosure, as the dispensing system described herein can obviously be positioned in different orientations during use.

[0053] The term "removably engageable" includes the engagement of two or more components that can be used or combined into one component by engaging two or more elements with a connecting device, a locking device, or by placing the elements closely together. The two or more elements can be positioned adjacent to each other, and each element includes a contact surface.

[0054] For the purposes of this specification and the appended claims, unless otherwise indicated, all figures expressing the amount of an ingredient, percentage or proportion of materials, reaction conditions, and other numerical values ​​used in this specification and the claims shall be understood to be modified by the term "about" in all cases. Therefore, unless indicated to the contrary, the numerical parameters set forth in the following specification and the appended claims are approximations that may vary depending on the desired characteristics sought to be obtained through the invention. At least, and not at all, the application of the doctrine of equivalence is limited to the scope of the claims, and each numerical parameter shall be interpreted at least according to the number of significant figures reported and by applying ordinary rounding techniques.

[0055] Although numerical ranges and parameters are described herein, the broad scope of this invention is approximate; the numerical values ​​described in the specific examples are reported as precisely as possible. However, any numerical value inherently contains some error, which is necessarily caused by the standard deviation found in its corresponding test measurement. Furthermore, all ranges disclosed herein should be understood to encompass any and all subranges included therein. For example, the range “1 to 10” includes any and all subranges between the minimum value 1 and the maximum value 10 (and includes both the maximum and minimum values), that is, any and all subranges where the minimum value is equal to or greater than 1 and the maximum value is equal to or less than 10, such as 5.5 to 10.

[0056] Examples of certain embodiments of this disclosure will now be shown in detail with reference to the accompanying drawings. While this disclosure will be described in conjunction with the illustrated embodiments, it should be understood that it is not intended to limit this disclosure to those embodiments. Rather, this disclosure is intended to cover all alternatives, modifications, and equivalents that may be included within the scope of this disclosure as defined by the appended claims.

[0057] The following headings are not intended to limit this disclosure in any way; embodiments under any heading may be used in conjunction with embodiments under any other heading.

[0058] Dispensing device

[0059] like Figures 1-22 As shown, a bone material dispensing device 30 is provided for incrementally applying bone material to a surgical site. The bone material dispensing device may be a bone material dispensing gun, which reduces the risk of contaminating bone material and spilling bone material from the dispensing device and applies bone material to the surgical site (e.g., bone defect) while minimizing damage to surrounding tissues. The bone material dispensing device reduces blockage and allows for incremental dispensing of bone material. The bone material dispensing device is also configured for left- and right-handed use. Surgical sites may include, but are not limited to, injuries, defects, infections, malignancies, or developmental malformations that occur during the course of surgery. Specific bones that can be repaired or replaced with bone material may include, but are not limited to, the ethmoid bone; frontal bone; nasal bone; occipital bone; parietal bone; temporal bone; mandible; maxilla; zygomatic bone; cervical vertebrae; thoracic vertebrae; lumbar vertebrae; sacrum; ribs; sternum; clavicle; scapula; humerus; radius; ulna; carpal bones; metacarpals; phalanges; ilium; ischium; pubis; femur; tibia; fibula; patella; calcaneus; tarsus; and metatarsals. In some embodiments, the bone material delivery device applies bone material to at least a portion of the spinal cord, such as vertebrae or... Figure 11 The vertebra V1 is shown.

[0060] The bone material dispensing device includes a housing 32 having a proximal end 34, a distal end 36, and a longitudinal axis AA disposed therebetween. The proximal end of the housing includes a first opening 38, and the distal end includes a second opening 40. As described herein, the first and second openings are configured to slidably receive at least a portion of a plunger 42.

[0061] like Figure 4 As shown, the first opening has a diameter D1 and the second opening has a diameter D2. D1 and D2 are the same diameter. In some embodiments, D1 and D2 may have different diameters. In some embodiments, diameters D1 and D2 may be from about 2 millimeters (mm) to about 40 mm. The diameter can be from about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm. The first and second openings may be shaped and may be circular, elliptical, rectangular, or square.

[0062] As described herein, the plunger has a proximal end 44 and a distal end 46. As described herein, the plunger is configured to facilitate the distribution / application of bone material to a surgical site. This allows for the controlled and incremental application of bone material to bone defects. In some embodiments, the proximal or distal end of the plunger may include an edge and / or a push plate to facilitate the distribution of bone material. Figure 3 As shown, the diameter D3 of the plunger is smaller than the diameters D1 and D2. In some embodiments, the diameter D3 of the plunger is slightly smaller than the diameters D1 and D2, but allows at least a portion of the plunger to slide within the opening. In some embodiments, the diameter D3 can be from about 2 millimeters (mm) to about 36 mm. The diameter D3 can be from about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34 to about 36 mm. Figure 14 As shown, the plunger may also have a length L1 of about 1 to about 20 inches. In some embodiments, the length L1 of the plunger may be about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 to about 20 inches. As described herein, the plunger length may be less than, greater than or equal to the size of the sleeve. In some embodiments, the plunger may be flexible or rigid.

[0063] The bone material distribution device includes a tubular member 48, which is pivotally connected to the housing and configured to move laterally relative to the longitudinal axis AA of the housing. As described herein, when the tubular member is in a first position, it includes a proximal end 50, a distal end 52, and the longitudinal axis AA disposed therebetween. The tubular member may be conical, and the distal end may be tapered.

[0064] The proximal end of the tubular member includes a proximal opening 54 and the distal end of the tubular member includes a distal opening 56. A channel 58 is disposed therebetween. As described herein, the proximal opening, the distal opening, and the channel of the tubular member are configured to receive at least a portion of the plunger, such that when bone material is placed within the channel, the plunger can be advanced into the channel to dispense or apply bone material. For example, the tubular member can be moved in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least said portion of the plunger (e.g., Figure 3 and 4 (As shown) to distribute bone material. The tubular member can also be moved in a second position such that the proximal opening of the tubular member is misaligned with the second opening of the housing, in order to prevent the tubular member from receiving at least said portion of the plunger.

[0065] As described above, the tubular member is pivotally connected to the housing via a pivot point such as hinge 60. The hinge is transverse relative to the longitudinal axis AA. The hinge facilitates the movement of the tubular member relative to the housing through... Figure 8 Rotate in the directions indicated by arrows A and B. Alternatively, the hinge may be or may include a pivot pin or rod. The tubular member rotates as shown... Figure 8The angle α1, shown as approximately 2 to approximately 180 degrees, pivots towards and away from the housing. In some embodiments, α1 is approximately 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48, 50, 52, 54, 56, 58, 60, 62, 64, 66, 68, 70, 72, 74, 76, 78, 80, 82, 84, 86, 88, 90, 92, 94, 96, 98, 100, 1 02, 104, 106, 108, 110, 112, 114, 116, 118, 120, 122, 124, 126, 128, 130, 132, 134, 136, 138, 140, 142, 144, 146, 148, 150, 152, 154, 156, 158, 160, 162, 164, 166, 168, 170, 172, 174, 176, 178 to approximately 180 degrees. The tubular member can be pivoted to provide sufficient space to load bone material into the tubular member.

[0066] The tubular member is locked to a portion of the distal end of the housing by a latch 62 positioned between the tubular member and the housing. As described above, the latch locks the tubular member in a first position. The latch may be a hook, lever, spring, articulated hook with a notch engaging a ratchet, or a combination thereof. Locking will allow the opening to be aligned (e.g. Figure 10 (As shown) and allows the plunger to slide through the opening. In some embodiments, such as Figure 8 As shown, when the tubular member is rotated open, the hole is misaligned and the plunger cannot slide through the tubular member.

[0067] In some embodiments, the tubular member may be fully detachable and snap-fitted to the housing. In some embodiments, the tubular member may be fully detachable and threaded to the housing. In some embodiments, the tubular member may be pivotally connected to the housing in a manner similar to a breach-loaded shotgun. It should be noted that those skilled in the art can modify the tubular member and its connection to the housing to adjust the design of the bone material dispensing device.

[0068] As described herein, the housing comprises as follows Figure 1The illustrated trigger assembly 64 is configured to allow incrementally slidable movement of the plunger to dispense bone material. The trigger assembly includes a drive handle 66 and a fixed handle 68. The drive handle includes a proximal end 70, a distal end 72, and a longitudinal axis BB disposed therebetween. As described below, the proximal end of the drive handle is configured to pivotally engage with the middle portion of the fixed handle and the proximal end of the drive pawl. Figure 4 As shown, the proximal end of the drive handle includes an extension 74. (As illustrated...) Figure 4 As shown, the extension has an angle α2. The extension may have an angle α2 of about 20 to about 50 degrees. In some embodiments, the extension may have an angle α2 of about 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48 to about 50 degrees. As described below, the extension is configured to engage with the proximal end of the drive pawl.

[0069] The proximal end of the drive handle includes a recess 76 on the distal side of the extension. As described herein, the recess is configured to engage with a pin 78 such that the proximal end of the drive handle is pivotally engaged with the fixed handle.

[0070] like Figure 8 As shown, the surface 80 of the drive handle includes a grip surface 82 and a protrusion 84. The grip surface and the protrusion are configured to engage with the user's hand, allowing the user to effectively control the drive handle. The grip surface may be raised or straight, and the protrusion may be curved or straight. The grip surface may also be roughened to increase the user's control over the drive handle.

[0071] The surface of the drive handle may also define a cut 86. The cut may be elliptical, circular, square, triangular, rectangular, or any other regular or irregular shape. One or more cuts may be formed from the surface of the drive handle, such as one, two, three, four, five, six, or more cuts. The user moves the drive handle in the direction of the fixed handle. The drive handle engages an active claw that causes the plunger to slide longitudinally and incrementally in the direction of the distal end. This allows for incremental dispensing of bone material from the bone material dispensing device.

[0072] The fixed handle includes a proximal end 88, a middle portion 90, a distal end 92, and a longitudinal axis CC disposed between the proximal end and the distal end. The proximal end of the fixed handle includes a first side 94, a second side 96, and a third side 98. The first, second, and third sides are part of the housing. The proximal end of the fixed handle may be integral with the housing, and the first, second, and third sides may be integral or fixed to the fixed handle. Figure 1 and 10 As shown, portions of the first and second sides form part of hinge 60. As described herein and as... Figure 9 As shown, the third side includes a slot 100 configured to engage a portion of a passive pawl.

[0073] The middle portion of the fixed handle is configured to engage with the proximal end of the drive handle. (As described herein and as...) Figure 3 As shown, Figure 3 The recess 102 shown is formed in the middle portion and is configured to interact with, as shown in the figure Figure 5 The pin 78 shown engages such that the proximal end of the drive handle is pivotally engaged with the fixed handle. The drive handle is... Figure 4 and 11 The angle α3, shown as approximately 1 to approximately 60 degrees, pivots toward and away from the fixed handle. In some embodiments, α3 is approximately 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59 to approximately 60 degrees.

[0074] As described in this article and as Figures 4-7 As shown, Figure 4 The recess 104 shown is formed in a portion of the second side of the fixed handle and configured to engage with the pin 106, such that the passive pawl can be pivotally engaged with the housing. In some embodiments, the fixed handle and the housing are integral with each other. In some embodiments, the fixed handle and the housing are not integral.

[0075] The trigger assembly of the housing also includes a drive pawl 108 and a passive pawl 110. The drive pawl is configured to engage with a resilient member to facilitate incremental slidable movement of the plunger by the fixed handle and the drive handle, thereby dispensing bone material from the plunger.Figure 5 In the illustrated embodiment, the elastic member, shown as a spring, is concentric with the plunger. When the drive handle moves to the fixed handle, the spring is compressed, and the stored energy propels the plunger longitudinally in increasing order. The drive pawl is positioned at one end of the elastic member, and the other end of the elastic member is biased against the housing and the plunger.

[0076] like Figures 3-7 As shown, the drive pawl includes a first end portion 112 and a second end portion 114. The first end portion of the drive pawl is configured to movably engage with the extension of the drive handle. The first end portion of the drive pawl may have a recessed portion 116 that engages with the extension of the drive handle. Figure 2 As shown, the drive pawl includes a third opening 118 aligned between and located between the first and second openings of the housing. As described herein, the third opening is configured to slidably receive at least a portion of the plunger 42. The third opening may be positioned at the center of the drive pawl.

[0077] like Figure 5 As shown, the third opening has a diameter D4. D4 may be the same diameter as D1 and D2, and the diameter of D4 is larger than the plunger diameter D3. In some embodiments, the diameter of D4 may be different from that of D1 and D2. In some embodiments, the diameter D4 may be from about 6 mm to about 40 mm. The diameter D4 may be from about 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm. The third opening may be shaped and may be circular, elliptical, rectangular, or square.

[0078] The second end of the drive pawl includes a lever 120, the lever being configured to slidably engage with the slot on the third side of the fixed handle. Figure 10 As shown, the lever can be in various shapes, including but not limited to T-shape.

[0079] like Figure 6As shown, the passive pawl includes a first end 122 and a second end 124. The passive pawl is configured to work in conjunction with an elastic member to control the timing of plunger advance during bone material dispensing and the timing of plunger retraction after bone material dispensing or reloading. The passive pawl allows the plunger to be adjusted such that it can be positioned adjacent to bone material, and if more bone material is added to the sleeve or tubular member, the plunger can be adjusted to be placed adjacent to additional bone material. In this way, the bone material dispensing device can easily accommodate various amounts of bone material.

[0080] The first end of the passive pawl can be angled. For example... Figures 4-7 As shown, the second end of the passive pawl includes a recess 126 configured to engage with a pin 106, allowing the passive pawl to be pivotally engaged with the housing. Figure 6 As shown, the passive pawl can pivot at an angle α4 of about 2 to about 45 degrees. In some embodiments, α4 is about 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 45, or about 46 degrees.

[0081] like Figure 2 As shown, the passive pawl includes a fourth opening 128, which is above and aligned with the first and second openings of the housing and the third opening of the drive pawl. As described herein, the fourth opening is configured to slidably receive at least a portion of the plunger 42. The fourth opening may be located at the center of the passive pawl.

[0082] like Figure 4 As shown, the fourth opening has a diameter D5. D5 may be the same diameter as D1, D2, and D4, and its diameter is larger than the plunger diameter D3. In some embodiments, the diameter of D5 may be different from that of D1, D2, and D4. In some embodiments, the diameter D5 may be from about 6 millimeters (mm) to about 40 mm. The diameter D5 may be from about 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm. The fourth opening may be shaped and may be circular, elliptical, rectangular, or square.

[0083] As described herein, the recess 130 is positioned at Figure 1The passive pawl shown is located on its lower side and is configured to engage with the end of the elastic member. The recess can be of various shapes, such as rectangular, circular, elliptical, or square.

[0084] As described herein, the trigger assembly includes a first resilient member, such as a first spring 132, which is configured to engage with the passive pawl. Figure 4 and 5 As shown, the first spring is disposed between the first portion 134 of the housing and the passive pawl. The first spring includes a distal end 136 configured to engage a post 138 positioned on the first portion of the housing and a proximal end 140 disposed within a recess 130 positioned below the passive pawl. The first spring is adjacent to the fourth opening or plunger and may also be concentric with the plunger. When the passive pawl is moved toward the fixed handle, the first spring can be compressed and store energy, which will allow the plunger to be withdrawn or adjusted to allow bone material to be added to the sleeve.

[0085] As described herein, the trigger assembly includes a second resilient member, such as a second spring 142, which is configured to engage with the drive pawl. Figure 4 As shown, the second spring is arranged concentrically with the plunger and positioned between the second portion 144 of the housing and the drive pawl. The second spring includes a distal end 146 that engages with a second opening 40 of the housing and a proximal end 148 that engages with a first opening 38 of the housing. As described herein, at least a portion of the plunger is configured to be slidably received by the second spring.

[0086] In some embodiments, the tubular member is configured to connect with a sleeve (e.g., as shown in the figure). Figure 17 The folding sleeve 150 shown is engaged. The folding sleeve is similar to the collapsible container found and fully described in U.S. Application Serial No. 15 / 581,817, which is the property of the applicant and is fully incorporated herein by reference. Figures 20-22 As shown, the folded cannula is configured to be loaded with bone material and engage the tubular member and / or the plunger to dispense the bone material into the surgical site. The folded cannula includes a proximal end 152 and a distal end 154. The folded cannula is segmented into an upper compartment 156 and a lower compartment 158, and the folded cannula can be folded around a fold line 160 for a folded configuration. Figure 18 ) and foldable configuration ( Figure 17 )move.

[0087] like Figure 5 , 7As shown in Figure 19, the diameter D6 of the folded sleeve is larger than the diameter D7 of the distal opening 56 of the tubular member, so as to allow at least a portion of the folded sleeve to be retained within the tubular member. In some embodiments, the diameter D6 may be from about 2 mm to about 40 mm. The diameter D6 may be from about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm. The folded sleeve may have different diameters throughout the folded sleeve and does not necessarily have a uniform diameter. The diameter D7 is larger than the plunger diameter D3. The diameter D7 may be from about 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36 to about 38 mm.

[0088] In some embodiments, such as Figure 10 and 20 As shown in Figure -22, the folded sleeve engages with a funnel or funnel portion 162, the funnel or funnel portion being configured to removably engage and partially enclose the tubular member. The funnel portion is conically engaged with the distal end of the tubular member. Figure 11 As shown, the funnel portion includes a proximal end 164 and a distal end 166. The proximal end engages with a portion of the housing to allow for... Figure 10 The locking member 168 shown locks the funnel portion to the housing. It should be understood that a cross-sectional view of the sleeve and the funnel portion is shown. The distal end of the funnel portion can have various sizes and can have a length L2, such as 1 to about 20 inches. In some embodiments, the length of the distal end of the funnel portion can be about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 to about 20 inches. In some embodiments, a stop point can be added between the housing and the funnel portion to provide an even more secure engagement between the housing and the funnel portion. In some embodiments, the funnel portion is a separate component or an assembly of the folded sleeve. In some embodiments, the funnel portion is flexible or rigid, or only the funnel portion or one of the plungers is flexible. In operation, in order to load bone material into the bone material dispensing device, the tubular member, as... Figure 8 Rotate in the direction of arrow B shown. Then, as... Figures 19-22 As shown, bone material is loaded into the tubular member, or bone material is loaded into the folded sleeve and the folded sleeve is inserted into the proximal end of the tubular member, such that at least a portion of the folded sleeve is held within the tubular member and at least a portion of the folded sleeve is fed through the distal opening of the tubular member. Then, the tubular member is as follows...Figure 8 Arrow A indicates that the funnel portion moves about hinge 60 in the first position, and the funnel portion engages with the tubular member and / or the combined tubular member and the folded sleeve. Then, as... Figure 10 As shown, the funnel portion is locked to the housing by the locking member. In some embodiments, instead of loading bone material onto the tubular member, bone material can be loaded onto the funnel and then the funnel can be locked to the housing.

[0089] Then, the distal end of the funnel portion is inserted into the surgical site (e.g., as shown in the image). Figure 14 In the vertebra V1 shown. (As shown in the diagram) Figure 11 and 12 As shown, the distal end of the funnel portion can be inserted into the surgical site before or after the funnel portion is locked onto the housing. For example, the funnel portion can first be placed at the surgical site and then locked onto the housing. In the first position, the proximal opening of the tubular member is aligned with the second opening of the housing to allow the tubular member to receive at least a portion of the plunger for dispensing bone material. The plunger is then triggered by the trigger assembly. Figure 14 and 15 The arrow F shown is translated in the direction to the fourth opening of the passive pawl, the first opening of the housing, the third opening of the driving pawl, and the second opening of the housing.

[0090] The drive handle of the trigger assembly is as follows: Figure 3 The drive handle shown is in the Figure 13 and 15 When the drive handle moves toward the fixed handle in the direction indicated by arrow C, it contacts the first end of the drive pawl, and the movement of the drive handle toward the fixed handle causes the drive pawl to... Figure 4 The second spring is compressed in the direction indicated by arrow D, and the instantaneous energy from the compressed second spring allows the plunger to... Figure 4Arrow E indicates the incremental sliding movement. Since the diameter D4 of the third opening of the drive pawl is slightly larger than the diameter D3 of the plunger, and the drive pawl is driven off-axis using the extension 74 of the drive handle, when the drive handle is pressed down on the drive pawl, the drive handle tilts, and the diameter D4 becomes the same as the diameter D3, thereby squeezing the plunger. Any further advancement of the drive handle causes the drive pawl to squeeze the plunger more forcefully and advance the plunger. Once the pressure on the drive handle is released, the second spring pushes the drive pawl upward again, increasing the size of D4, allowing the drive pawl to slide the plunger backward, returning it to the starting position for another push.

[0091] The movement of the drive handle toward the fixed handle causes the first spring to be compressed by the passive pawl against a first portion of the housing. The drive handle is released, and the drive handle is... Figure 16 The arrow G indicates the direction of movement. Then, the proximal end of the passive pawl moves as shown by... Figure 7 The downward direction indicated by arrow H in the diagram is pushed to compress the first spring again, causing the first spring to contain instantaneous energy, allowing the user to... Figure 7 and 16 The plunger retracts in the proximal direction as indicated by arrow I. The forward and retraction of the plunger can be controlled by the passive pawl and the first spring. For example, the passive pawl presses against the plunger, preventing it from retracting when the drive pawl returns to its initial position. Furthermore, because the passive pawl pivots and is spring-loaded via the first spring, it allows the plunger to move through the fourth opening.

[0092] Once the bone material dispensing device has completed dispensing the bone material, the tubular member can also, as... Figure 8 and Figures 11-12 The tubular member is moved in the second position shown so that the proximal opening of the tubular member is misaligned with the second opening of the housing, in order to prevent the tubular member from receiving at least a portion of the plunger.

[0093] In some embodiments, the bone material delivery device may be used in conjunction with products found and fully described in: U.S. Application Serial Nos. 15 / 340,770 and 15 / 818,395; and U.S. Publications Nos. 2017 / 0216051, 2018 / 0078385, 2017 / 0216045, 2018 / 0071113, and 2016 / 0100955, all of which are the property of the applicant and are incorporated herein by reference in their entirety. In some embodiments, various orthopedic implants may be used in conjunction with the bone material delivery device.

[0094] In some embodiments, the folding sleeve may be made of shape-memory polymers and / or alloys to allow the folding sleeve to move from a non-folding configuration to a folding configuration without the need for a locking mechanism. Shape-memory polymers include, but are not limited to, polyethers, polyacrylates, polyamides, polysiloxanes, polyurethanes, polyetheramides, polyurethane / urea, polyether esters, polynorbornene, crosslinked polymers (such as crosslinked polyethylene and crosslinked poly(cyclooctene)), inorganic-organic hybrid polymers, and copolymers (such as urethane / butadiene copolymers and styrene-butadiene copolymers). Shape-memory alloys include, but are not limited to, TiNi, CuZnAl, and FeNiAl alloys. In some embodiments, the folding sleeve may be manufactured by injection molding of plastic materials, including rigid, surgical-grade plastics and / or metallic materials.

[0095] In some embodiments, components of the bone material delivery device may be made of materials such as polyurethane, polyurea, polyether (amide), PEBA, thermoplastic elastomers, olefins, copolyesters and styrene-based thermoplastic elastomers, steel, aluminum, stainless steel, titanium, nickel-titanium, metal alloys with high non-ferrous metal content and low iron content, carbon fiber, glass fiber, plastics, ceramics, or combinations thereof. The folded cannula, funnel portion, plunger, or tubular member may optionally include one or more tapered regions. In various embodiments, these components may be blunt, beveled, diamond-shaped, spherical tips, cannula needle tips, etc. These components may also have tip styles that are crucial for accurate patient treatment, depending on the surgical site. Examples of tip styles include, for example, Trephine, Cournand, Veress, Huber, Seldinger, Chiba, Francine, Bias, Crawford, deflected tips, Hustead, Lancet, or Tuohey. In some embodiments, the bone material dispensing device may be made of a material that allows the bone material dispensing device to be reused, or alternatively, of a material that allows for single-use.

[0096] In some embodiments, the shape of the folded sleeve can be selected for a specific application. Such shapes and configurations may include, for example, the basic shape of a folded sleeve (e.g., a tubular sleeve).

[0097] method

[0098] A method for implanting bone material is provided. The method includes loading bone material into a bone material dispensing device (e.g., a gun), the bone material dispensing device comprising: a housing having a proximal end, a distal end, and a longitudinal axis, the proximal end having a first opening and the distal end having a second opening, the first and second openings being configured to slidably receive at least a portion of a plunger; and a tubular member pivotally connected to the housing and configured to be laterally movable relative to the longitudinal axis of the housing, the tubular member including a proximal opening, a distal opening, and a channel disposed therebetween, the proximal opening, the distal opening, and the channel of the tubular member being configured to receive at least said portion of the plunger, the tubular member being movable in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least said portion of the plunger for dispensing bone material.

[0099] In some embodiments, moving the tubular member in a second position such that the proximal opening of the tubular member is misaligned with the second opening of the housing prevents the tubular member from receiving at least a portion of the plunger.

[0100] When the drive handle pivots, the drive pawl moves a predetermined amount. The volume of the cylinder can be calculated by multiplying the translation distance X by the diameter of the funnel portion or sleeve. The bone material dispensing device can be adjusted to dispense a predetermined amount of bone material with each pivot of the drive handle. In some embodiments, the predetermined amount of bone material dispensed from the bone material dispensing device can be from about 0.25 cc to about 1 cc or from about 0.25 ounces (oz) to about 1 oz.

[0101] In some embodiments, bone material may be dispensed in a quantitative, controlled, and predetermined amount from about 0.25 cc to about 1 cc. Bone material may be dispensed in a quantitative, controlled, and predetermined amount from about 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95 to about 1 cc. In some embodiments, bone material may be dispensed in a quantitative, controlled, and predetermined amount from about 0.25 oz to about 1 oz. Bone material can be quantitatively, controlledly, and predeterminedly allocated in amounts of about 0.25, 0.30, 0.35, 0.40, 0.45, 0.50, 0.55, 0.60, 0.65, 0.70, 0.75, 0.80, 0.85, 0.90, 0.95 to about 1 oz.

[0102] Bone material can be mixed with liquid materials and optionally therapeutic agents until the desired consistency of the bone material (e.g., putty, mud, etc.) is achieved. The bone material can be mixed with a suitable diluent and then loaded. The folded sleeve may have sufficient space to allow mixing of the bone material and a volume of diluent. In some embodiments, the diluent comprises dextrose, other sugars (including but not limited to sucrose, fructose, glucose, lactated Ringer's solution), polyols (including but not limited to mannitol, xylitol, sorbitol, maltitol, lactitol), polysaccharides (including but not limited to natural or pregelatinized starch, maltodextrin, cyclodextrin), inorganic compounds (including but not limited to dihydrate or anhydrous dicalcium phosphate or tricalcium phosphate), cellulose derivatives (including but not limited to microcrystalline cellulose, lactose monohydrate or anhydrous lactose), and mixtures thereof (e.g., dicalcium phosphate dihydrate, mannitol, pregelatinized corn starch, microcrystalline cellulose, and mixtures thereof), water, and / or NaCl (saline solution). In some embodiments, the saline solution is 0.90% saline or 0.45% saline. In some embodiments, other delivery media may be used, such as D5W (5% glucose solution), D5NS (5% glucose solution and physiological saline), and D5W / 1 / 2NS (D5W and 1 / 2 physiological saline), blood, mesenchymal stem cells, etc.

[0103] In various embodiments, a kit is provided that includes a bone material dispensing device. The kit may include additional components, including the bone material dispensing device, which contains bone material and other components for applying the bone material (e.g., a wiping cloth, needle, syringe, other mixing device, etc.). The kit may contain the bone material dispensing device in a first compartment. A second compartment may contain the bone material. A third compartment may contain a tray for loading the bone material into the bone material dispensing device. In some embodiments, the shape of the tray may be selected for a particular application. Such shapes and configurations may include, for example, the basic shape of a tray (e.g., a square box). The tray is similar to the tray found and fully described in U.S. Application Serial No. 15 / 581,817, which is the property of the applicant and is fully incorporated herein by reference.

[0104] The fourth compartment may contain vials that hold the carrier and any other instruments required for delivery. The fifth compartment may contain gloves, curtains, wound dressings, and other procedural supplies to maintain sterility during the implantation process, as well as instructions, which may include diagrams showing how to apply the bone material after mixing. The sixth compartment may contain needles, additional devices, and / or sutures. Each tool may be individually packaged in a sterilized plastic pouch. The seventh compartment may contain reagents for radiographic imaging. The kit's cap may contain diagrams of the dispensing / application procedure, and a transparent plastic cap may be placed over the compartments to maintain sterility.

[0105] In various embodiments, during the terminal sterilization step of final packaging, one or more components of the bone material dispensing device are sterilized by radiation. Compared to processes that require individual sterilization of product components and assembly of the final package in a sterile environment, such as aseptic processes, terminal sterilization of the product provides better assurance of sterility.

[0106] In various embodiments, gamma radiation is used in the terminal sterilization step, involving the utilization of the ionizing energy of gamma rays from gamma rays deeply penetrating into the bone material dispensing device. Gamma rays efficiently kill microorganisms, leaving no residue, and do not possess sufficient energy to confer radioactivity onto the device. Gamma rays can be used when the device is in packaging, and gamma sterilization does not require high pressure or vacuum conditions, thus avoiding stress on packaging seals and other components. Furthermore, gamma radiation eliminates the need for permeable packaging materials.

[0107] In various embodiments, electron beam (e-beam) radiation can be used to sterilize one or more components of the bone material delivery device. Electron beam radiation includes forms of ionizing energy, which are typically characterized by low penetration and high dose rates. Electron beam radiation is similar to gamma treatment because it alters various chemical and molecular bonds upon contact, including those of the reproductive cells of microorganisms. The resulting beam for electron beam sterilization is a concentrated, high-charge electron stream generated by the acceleration and conversion of electricity.

[0108] Other methods may also be used to sterilize bone material dispensing devices, including, but not limited to, gas sterilization or steam sterilization using ethylene oxide.

[0109] The bone material delivery device can be used to treat a variety of conditions, including osteoporosis, fracture repair or healing, dental procedures with clinical benefit in increasing bone formation in the jaw, repair of craniofacial bone defects induced by trauma or congenital defects (such as cleft palate / lip), and many other musculoskeletal conditions with insufficient natural bone growth, as will be apparent to those skilled in the art. Bone material can be applied to treat open fractures and fractures at high risk of nonunion, as well as subjects with spinal conditions, including those requiring spinal fusion (e.g., anterior lumbar interbody fusion, posterior lumbar fusion, and cervical fusion) or those with degenerative disc disease or arthritis affecting the lumbar and cervical spine.

[0110] Bone materials

[0111] In some embodiments, the bone material may be demineralized bone material. Demineralized bone material may include demineralized bone, powder, fragments, microparticles, debris, fibers, or other shapes having irregular or random geometry. These may comprise, for example, substantially demineralized, partially demineralized, or fully demineralized cortical and cancellous bone. These also include surface demineralization, wherein the surface of the bone structure is substantially demineralized, partially demineralized, or fully demineralized, while the body of the bone structure is fully mineralized. The configuration of the bone material may be obtained by milling, grinding, cutting, or machining the entire bone, as described, for example, in U.S. Patent No. 5,899,939. The entire disclosure is incorporated herein by reference.

[0112] In some embodiments, the bone material may include elongated demineralized bone fibers, wherein the ratio of the average length to the average thickness of the elongated demineralized bone fibers, or the aspect ratio, is from about 50:1 to about 1000:1. In general appearance, the elongated demineralized bone fibers may be round, spherical, microparticles, elongated, powder, fragments, fibers, cylinders, threads, narrow strips, sheets, or combinations thereof. In some embodiments, the bone material comprises elongated demineralized bone fibers and fragments. In some embodiments, the bone material comprises fully demineralized fibers and surface-demineralized fragments. In some embodiments, the fiber-to-fragment or powder ratio is about 5, 10, 15, 20, 25, 30, 35, 40, or 45 fibers to about 30, 35, 40, 45, 50, 55, 60, 65, or 70 fragments.

[0113] In some embodiments, the bone material comprises demineralized bone matrix fibers and demineralized bone matrix fragments in a ratio of 30:60. In some embodiments, the bone material comprises demineralized bone matrix fibers and demineralized bone matrix fragments in a fiber-to-fragment ratio of 25:75 to about 75:25.

[0114] In some embodiments, the bone material may be an inorganic material, such as inorganic ceramics and / or bone substitutes. Exemplary inorganic materials or bone substitutes include, but are not limited to, aragonite, carboapatite, calcite, clear calcite, amorphous calcium carbonate, spherulite, calcium oxalate, calcium oxalate hydrous, struvite, urate, ferrihydrite, fine-grained apatite, monohydrate calcite, magnetite, goethite, dentin, calcium carbonate, calcium sulfate, calcium phosphosilicate, sodium phosphate, calcium aluminate, calcium phosphate, hydroxyapatite, α-tricalcium phosphate, dicalcium phosphate, β-tricalcium phosphate, tetracalcium phosphate, amorphous calcium phosphate, octacalcium phosphate, and bioglas. TM Fluoroapatite, chlorapatite, magnesium-substituted tricalcium phosphate, carbonate hydroxyapatite, substituted forms of hydroxyapatite (e.g., bone-derived hydroxyapatite can be substituted with other ions (such as fluorine, chlorine, magnesium, sodium, potassium, etc.)) or combinations or derivatives thereof.

[0115] In some embodiments, the bone material may include mineral particles comprising tricalcium phosphate and hydroxyapatite in a ratio of about 80:20 to about 90:10. In some embodiments, the mineral particles comprise tricalcium phosphate and hydroxyapatite in a ratio of about 70:30 to about 95:5. In some embodiments, the mineral particles comprise tricalcium phosphate and hydroxyapatite in a ratio of about 85:15.

[0116] In some embodiments, when mixing bone material, the bone material can be inoculated together with harvested osteocytes and / or bone tissue (e.g., cortical bone, autologous bone, allogeneic bone, and / or xenogeneic bone).

[0117] In some embodiments, the bone material may be mixed with one or more therapeutic agents (e.g., anti-inflammatory agents, analgesics, bone-inducing growth factors, antimicrobial agents, or combinations thereof). The bone inducer comprises one or more members of the bone morphogenetic protein (“BMP”) family. BMPs are a class of proteins believed to have bone-inducing or growth-promoting activity in endogenous bone tissue or to function as procollagen precursors. Known members of the BMP family include, but are not limited to, BMP-1, BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14 (GDF-5), BMP-15, BMP-16, BMP-17, BMP-18, and their polynucleotides or polypeptides, as well as mature polypeptides or polynucleotides encoding them.

[0118] BMPs used as bone inducers include one or more of the following: BMP-1; BMP-2; BMP-3; BMP-4; BMP-5; BMP-6; BMP-7; BMP-8; BMP-9; BMP-10; BMP-11; BMP-12; BMP-13; BMP-15; BMP-16; BMP-17; or BMP-18; and any combination of one or more of these BMPs, comprising a full-length BMP or a fragment thereof or a combination thereof, or a polypeptide or polynucleotide as a polypeptide fragment encoding all of said BMPs. Isolated BMP bone inducers can be administered as polynucleotides, polypeptides, full-length proteins, or combinations thereof.

[0119] In fact, the bone-inducing factor is recombinant human bone morphogenetic protein (rhBMP) because it is available in unlimited quantities and does not transmit infectious diseases. In some embodiments, the bone morphogenetic protein is rhBMP-2, rhBMP-4, rhBMP-7, or a heterodimer thereof. Recombinant BMP-2 can be used at a concentration of about 0.4 mg / mL to about 10.0 mg / mL, preferably about 1.5 mg / mL.

[0120] Bone material may contain one or more members from the TGF-β superfamily or a mixture of said members. For example, the matrix may contain AMH, ARTN, GDF1, GDF10, GDF11, GDF15, GDF2, GDF3, GDF3A, GDF5, GDF6, GDF7, GDF8, GDF9, GDNF, INHA, INHBA, INHBB, INHBC, INHBE, LEFTY1, LEFTY2, MSTN, NODAL, NRTN, PSPN, TGFB1, TGFB2, TGFB3, FGF, basic FGF, VEGF, insulin-like growth factor, EGF, PDGF, nerve growth factor, or combinations thereof.

[0121] Bone materials may contain or be mixed with therapeutic agents, said therapeutic agents including, but not limited to, IL-1 inhibitors (such as...). (anakinra, the IL-1 inhibitor being a recombinant non-glycosylated form of human interleukin-1 receptor antagonist (IL-1Ra)) or AMG 108 (a monoclonal antibody that blocks the action of IL-1). Bone materials may contain or be mixed with therapeutic agents, said therapeutic agents comprising antagonists or inhibitors of excitatory amino acids (such as glutamate and aspartate), glutamate binding to NMDA receptors, AMPA receptors, and / or phycocyanin receptors. Bone materials may contain or be mixed with therapeutic agents to reduce inflammation, said therapeutic agents comprising, but not limited to, interleukin-1 receptor antagonists, thalidomide (a TNF-α release inhibitor), thalidomide analogs (reducing macrophage TNF-α production), quinapril (an angiotensin II inhibitor that upregulates TNF-α), interferons such as IL-11 (which regulates TNF-α receptor expression), or aurora tricarboxylic acid (which inhibits TNF-α).

[0122] Bone materials may contain or be mixed with therapeutic agents, including but not limited to analgesics. Examples of analgesics include, but are not limited to, acetaminophen, tramadol, lidocaine, bupivacaine, ropivacaine, opioid analgesics such as buprenorphine, butorphanol, dextromoramide, dezocine, dextropropoxyphene, diamorphine, fentanyl, alfentanil, sufentanil, hydrocodone, hydromorphone, ketobemidone, levomethadyl, and levorphanol. l), meperidine, methadone, morphine, nalbuphine, opium, oxycodone, papaveretum, pentazocine, pethidine, phenoperidine, pitiramide, dextropropoxyphene, remifentanil, sufentanil, tilidine, tramadol, codeine, dihydrocodeine, meptazinol, dezocine, eptazocine, flupirtine, or combinations thereof.

[0123] Bone materials may contain or be mixed with therapeutic agents, including, but not limited to, anti-inflammatory agents. Examples of anti-inflammatory agents include, but are not limited to, clonidine, sulindac, sulfasalazine, naproxen, diclofenac, indomethacin, ibuprofen, flurbiprofen, ketoprofen, aclofenac, aloxrin, aproxen, aspirin, diflunisal, fenoprofen, mefenamic acid, naproxen, phenylbutazone, piroxicam, meloxicam, salicylamide, and salicylic acid. deoxysulindac, tenoxicam, ketoralac, clonidine, flufenisal, salsalate, triethanolamine salicylate, aminopyrine, antipyrine, oxyphenbutazone, azapril, cintazone, flufenamic acid, clonixeril, clonixin, meclofenamic acid, flunixin, colchicine, demecolcine, allopurinol, oxypurinol, benzyldamine hydrochloride hydrochloride, dimefadane, indoxole, intrazole, mimbane hydrochlorideparanylene hydrochloride, tetrydamine, benzindopyrine hydrochloride, fluprofen, ibufenac, naproxol, fenbufen, cinchophen, diflumidone sodium, fenamole, flutiazin, metazamide, letimide hydrochloride, nexeridine hydrochloride, octazamide, molinazole, neocinchophen, nimazole, proxazole citrate citrate, tesicam, tesimide, tolmetin, triflumidate, fenamates (mefenamic acid, meclofenamic acid), nabumetone, celecoxib, etodolac, nimesulide, apazone, gold, tepoxalin; dithiocarbamate or combinations thereof.

[0124] Anti-inflammatory agents also include steroids, such as 21-acetoxypregnenolone, alclometasone, algestone, amcinonide, beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol, clobetasone, clocortolone, cloprednol, corticosterone, cortisone, cortivazol, deflazacort, desonide, deoximetasone, dexamethasone, and dexamethasone (21-acetic acid dexamethasone). 21-acetate, dexamethasone 21-phosphate di-Na salt, diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort, flucloronide, flumethasone, flunisolide, fluocinolone acetonide, fluocinonide, fluocortin butyl, fluocortolone, fluorometholone, fluperolone acetate, fluprednideneacetate, fluprednisolone, flurandrenolide, fluticasone propionate propionate, formocortal, halcinonide, halobetasolPropionate, halometasone, halopredone acetate, hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone, medrysone, meprednisone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylamino-acetate, prednisolone sodium phosphate Prednisone, prednisolone valerate, prednylidene, rimexolone, tixocortol, triamcinolone, triamcinolone acetonide, triamcinolone benetonide, triamcinolone hexacetonide, or combinations thereof.

[0125] Bone materials may contain or be mixed with therapeutic agents, including but not limited to statins. Examples of useful statins include, but are not limited to, atorvastatin, simvastatin, pravastatin, cerivastatin, mevastatin (see U.S. Patent No. 3,883,140, ​​the entire disclosure of which is incorporated herein by reference), velostatin (also known as synvinolin; see U.S. Patent Nos. 4,448,784 and 4,450,171, the entire disclosure of which is incorporated herein by reference), fluvastatin, lovastatin, rosuvastatin, and fluindostatin (Sandoz). XU-62-320), dalvastain (EP application publication number 738510A2, the entire disclosure of which is incorporated herein by reference), pravastatin, pitavastatin, or pharmaceutically acceptable salts thereof, or combinations thereof. In various embodiments, statins may include a mixture of (+)R and (-)-S enantiomers of statins. In various embodiments, statins may include a 1:1 racemic mixture of statins.

[0126] In some embodiments, the bone material may contain an antimicrobial agent. In some embodiments, the antimicrobial agent may contain one or more of triclosan (also known as 2,4,4'-trichloro-2'-hydroxydiphenyl ether, chlorhexidine, and its salts), including chlorhexidine acetate, chlorhexidine gluconate, chlorhexidine hydrochloride, and chlorhexidine sulfate; silver and its salts (including silver acetate, silver benzoate, silver carbonate, silver citrate, silver iodate, silver iodide, silver lactate, silver laurate, silver nitrate, silver oxide, silver palmitate, silver protein, and silver sulfadiazine); polymyxin; and tetracycline. e) Aminoglycosides (such as tobramycin and gentamicin), rifampicin, bacitracin, neomycin, chloramphenicol, miconazole, quinolones (such as oxolinicacid, norfloxacin, nalidixic acid, pefloxacin, enoxacin, and ciprofloxacin), penicillins (such as oxacillin and piperacillin), nonoxynol 9, fusidic acid, cephalosporins, or combinations thereof.

[0127] Examples of antimicrobial agents include, but are not limited to: acetosulfonone sodium; alamecin; alexidine; amdinocillin; amdinocillin pivoxil; amicycline; amifloxacin; amifloxacin mesylate; amikacin; amikacin sulfate; aminosalicylic acid; aminosalicylate sodium; amoxicillin; ampomycin; ampicillin; ampicillin sodium; apalcillin sodium; and other antimicrobial agents. sodium); apramycin; aspartocin; astromicin sulfate; avilamycin; avoparcin; azithromycin; azlocillin; azlocillin sodium; bacampicillin hydrochloride; bacitracin; methylenedisalicylate; bacitracin zinc; bambermycins; benzoylpas calcium; berythromycin B; betamethasone sulfate; biapenem; biniramycin; biphenamine hydrochloride; bispyrithione magnesium sulfate Magsulfex; Butikacin; Butirosin sulfate; Capreomycin sulfate; Carbadox; Carbenicillin disodium;Carbenicillin indanyl sodium; carbenicillin phenyl sodium; carbenicillin potassium; carumonam sodium; cefaclor; cefadroxil; cefamandole; cefamandole nafate; cefamandole sodium; cefaparole; cefatrizine; cefazaflur sodium; cefazolin; cefazolin sodium; cefabuperazone; cefdinir; cefepime; cefepime hydrochloride hydrochloride; cefetecol; cefixime; cefixime hydrochloride; cefmetazole; cefmetazole sodium; cefonicid monosodium; cefonicid sodium; cefoperazone sodium; ceforanide; cefotaxime sodium; cefotetan; cefotetan disodium; cefotiam hydrochloride; cefoxitin; cefoxitin sodium; cefpimizole; cefpimizole sodium sodium); cefpiramide; cefpiramide sodium; cefpirome sulfate; cefpodoxime proxetil; cefprozil; cefroxadine; cefsulodin sodium; ceftazidime; ceftibuten;Cefazolin sodium; Ceftriaxone sodium; Cefuroxime; Cefuroxime axetil; Cefuroxime pivoxetil; Cefuroxime sodium; Cefacloride sodium; Cefacloride sodium; Cefacloride sodium; Cefacloride sodium; Cefacloride hydrochloride; Cefacloride sodium ... acetylchloramphenicol; chloramphenicol; chloramphenicol palmitate; chloramphenicol pantothenate complex; sodium chloramphenicol succinate; chlorhexidine phosphanilate; chloroxylenol; chlortetracycline bisulfate; chlortetracycline hydrochloride; cinoxacin; ciprofloxacin; ciprofloxacin hydrochloride; cirolemycin; clarithromycin; clinafxacin hydrochloride; clindamycin; clindamycin hydrochloride clindamycin palmitate hydrochloride; clindamycin phosphate; clofazimine; cloxacillinbenzathine;Cloxacillin sodium; chlorhexidine, clooxyquin; colistimethate sodium; colistin sulfate; comermycin; comermycin sodium; cyclacillin; cycloserine; dalfopristin; dapsone; daptomycin; demeclocycline; demeclocycline hydrochloride; demecycline; denofungin; diaveridine; dicloxacillin; dicloxacillin sodium; dihydrostreptomycin sulfate sulfate); dipyrithione; dithromycin; doxycycline; doxycycline calcium; doxycycline fosfatex; doxycycline hyclate; droxacin sodium; enoxacin; epipicillin; epitetracycline hydrochloride; erythromycin; erythromycin acistrate; erythromycin estolate; erythromycin ethylsuccinate; erythromycin gluceptate; erythromycin lactobionate; erythromycin propionate. propionate; erythromycin stearate; ethambutol hydrochloride; ethionamide; fleroxacin;Floxacillin; Fludalanine; Flumequine; Fosfomycin; Fosfomycin tromethamine; Fumoxicillin; Furazolium chloride; Furazolium tartrate; Fusidate sodium; Fusidic acid; Ganciclovir and Ganciclovir sodium; Gentamicin sulfate; Gloximonam; Gramicidin; Haloprogin; Hetacillin; Hetacillin potassium Potassium); Hexedine; Ibafloxacin; Imipenem; Isoconazole; Isepamicin; Isoniazid; Josamycin; Kanamycin sulfate; Kitasamycin; Levofurantadone; Levopropylcillin potassium; Lexithromycin; Lincomycin; Lincomycin hydrochloride; Lomefloxacin; Lomefloxacin hydrochloride; Lomefloxacin mesylate mesylate); loracarbef; mafenide; meclocycline; meclocycline sulfosalicylate; megalomicin potassium phosphate; mequidox; meropenem; methacycline; methacycline hydrochloride;Methenamine; Methenamine hippurate; Methenamine mandelate; Methicillin sodium; Metioprim; Metronidazole hydrochloride; Metronidazole phosphate; Mezlocillin; Mezlocillin sodium; Minocycline; Minocycline hydrochloride; Mirincamycin hydrochloride; Monensin; Monensin sodiumr; Nafcillin sodium; Nalidixate sodium sodium); nalidixic acid; natainycin; nebramycin; neomycin palmitate; neomycin sulfate; neomycin undecylenate; netilmicin sulfate sulfate); neutral mycin; nifuiradene; nifuraldezone; nifuratel; nifuratrone; nifurdazil; nifurimide; nifiupirinol; nifurquinazol; nifurthiazole; nitrocycline; nitrofurantoin; nitromide; norfloxacin; novobiocin sodium; ofloxacin; onnetoprim; oxacillin and oxacillin sodium; oximonam; oximonam sodium); oxopropyl acid; oxytetracycline;Oxytetracycline calcium; oxytetracycline hydrochloride; paldimycin; parachlorophenol; paucomycin; pefloxacin; pefloxacin mesylate; penamecillin; penicillins, such as penicillin G benzathine, penicillin G potassium, procaine penicillin G, penicillin G sodium, penicillin V, benzathine penicillin V, hymexazol V, and penicillin V potassium; pentizidone sodium; phenyl aminosalicylate; piperacillin sodium; pirbenicillin sodium; piridicillin sodium; pirlimycin hydrochloride. hydrochloride; pivampicillin hydrochloride; pivampicillin pamoate; pivampicillin probenate; polymyxin B sulfate; porfiromycin; propikacin; pyrazinamide; pyrithione zinc; quindecamine acetate acetate); quinupristin; racephenicol; ramoplanin; ranimycin; relomycin; repromicin; rifabutin; rifametane; rifamexil; rifamide; rifampin; rifapentine; rifaximin; rolitetracycline; rolitetracycline nitrate; rosaramicin; rosaramicin butyrate;Rosaramicin propionate; Rosaramicin sodium phosphate; Rosaramicin stearate; Rosoxacin; Roxarsone; Roxithromycin; Sancycline; Sanfetrine sodium; Sarmoxicillin; Sarpicillin; Scopafungin; Sisomicin; Sisomicin sulfate; Sparfloxacin; Spectinomycin hydrochloride; Spiramycin; Stalimycin hydrochloride; Steffimycin; Streptomycin sulfate sulfate); streptonicozid; sulfabenz; sulfabenzamide; sulfacetamide; sulfacetamide sodium; sulfacytine; sulfadiazine; sulfadiazine sodium sodium); sulfadoxine; sulfalene; sulfamerazine; sulfameter; sulfamethazine; sulfamethizole; sulfamethoxazole; sulfamonomethoxine; sulfamoxole; zinc sulfanilatezinc; sulfanitran; sulfasalazine; sulfasomizole; sulfathiazole; sulfazamet; sulfisoxazole; sulfisoxazole acetyl.Sulfamethoxazole diolamine; sulfomyxin; sulopenem; sultamricillin; suncillin sodium; talampicillin hydrochloride; teicoplanin; temafloxacin hydrochloride; temocillin; tetracycline; tetracycline hydrochloride; tetracycline phosphate complex; tetroxoprim; thiamphenicol; thiphencillin potassium; ticarcillin cresyl sodium; ticarcillin sodium Disodium; ticarcillin monosodium; ticlatone; tiodonium chloride; tobramycin; tobramycin sulfate; tosufloxacin; trimethoprim; trimethoprim sulfate; trisulfapyrimidines; troleandomycin; trospectomycin sulfate; tyrothricin; vancomycin; vancomycin hydrochloride; virginiamycin; zorbamycin; or combinations thereof.

[0128] Antimicrobial agents in bone materials can be antiviral agents that can be mixed with bone materials. Antiviral agents may include, but are not limited to, vidarabine, acyclovir, famciclovir, valacyclovir, gancyclovir, valganciclovir, nucleoside analog reverse transcriptase inhibitors (e.g., AZT (zidovudine), ddI (didanosine), ddC (zalcitabine), d4T (stavudine), and 3TC (lamivudine)), nevirapine (nev... Inhibitors include irapine, delavirdine, protease inhibitors (e.g., saquinavir, ritonavir, indinavir, and nelfinavir), ribavirin, amantadine, rimantadine, neuraminidase inhibitors (e.g., zanamivir and oseltamivir), pleconaril, cidofovir, foscarnet, and / or interferon.

[0129] Although the invention has been described with respect to embodiments, those skilled in the art will recognize that changes in form and detail may be made without departing from the spirit and scope of this disclosure.

Claims

1. A bone material dispensing device comprising: a housing having a proximal end, a distal end, and a longitudinal axis, the proximal end having a first opening and the distal end having a second opening, the first and second openings configured to slidably receive at least a portion of a plunger; and a tubular member pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing, the tubular member including a proximal opening, a distal opening, and a passageway disposed therebetween for dispensing bone material, the proximal opening, the distal opening, and the passageway of the tubular member configured to receive at least the portion of the plunger, wherein the tubular member is pivotably connected to the housing through a pivot point disposed laterally relative to the longitudinal axis, the tubular member being pivoted such that sufficient space is provided to load the tubular member with bone material, wherein the tubular member is configured to move laterally relative to the longitudinal axis of the housing through the pivot point such that the tubular member can be moved in a first position to align the proximal opening of the tubular member with the second opening of the housing to allow the tubular member to receive at least the portion of the plunger to dispense bone material, wherein the tubular member is configured to engage a sleeve, and wherein the sleeve includes a funnel portion configured to partially enclose the tubular member, and the tubular member can be moved in a second position to misalign the proximal opening of the tubular member with the second opening of the housing to prevent the tubular member from receiving at least the portion of the plunger, thereby allowing the tubular member to be loaded with bone material.

2. The bone material dispensing device of claim 1, wherein the tubular member is locked with the housing through a detent in the housing.

3. The bone material dispensing device of claim 1, wherein the sleeve comprises a folding sleeve.

4. The bone material dispensing device of claim 3, wherein the folding sleeve includes an upper compartment, a lower compartment, and a fold line, and the folding sleeve is movable about the fold line in a folded configuration and an unfolded configuration.

5. The bone material dispensing device of claim 3, wherein a diameter of the folding sleeve is greater than a diameter of the distal opening of the tubular member to allow at least a portion of the folding sleeve to be retained within the tubular member.

6. The bone material dispensing device of claim 1, wherein the housing includes a locking member for locking the funnel portion to the housing.

7. The bone material dispensing device of claim 1, wherein the housing includes a trigger assembly configured to allow incremental slidable movement of the plunger to dispense bone material.

8. The bone material dispensing device of claim 7, wherein the trigger assembly comprises a drive handle, a fixed handle, a drive pawl, a passive pawl, a first resilient member disposed between a first portion of the housing and the passive pawl, and a second resilient member concentric with the plunger and disposed between a second portion of the housing and the drive pawl, the drive handle configured to contact the drive pawl when the drive handle is moved toward the fixed handle, wherein movement of the drive handle toward the fixed handle causes the drive pawl to compress the second resilient member and allow incremental slidable movement of the plunger.

9. The bone material dispensing device of claim 8, wherein (i) the first resilient member is adjacent to the plunger; or (ii) the first resilient member is concentric with the plunger.

10. The bone material dispensing device of claim 8, wherein a distal end of the first resilient biasing member is disposed about a post positioned on the housing and a proximal end of the first resilient biasing member is disposed within a recess positioned within the passive pawl.

11. The bone material dispensing device of claim 8, wherein movement of the drive handle toward the fixed handle causes the first resilient member to be compressed by the passive pawl against the first portion of the housing.

12. A bone material dispensing gun comprising: a housing having a proximal end, a distal end, and a longitudinal axis, the proximal end having a first opening and the distal end having a second opening, the first and second openings configured to slidably house at least a portion of a plunger, and the housing including a trigger assembly configured to allow incremental slidable movement of the plunger to dispense bone material; and a tubular member pivotably connected to the housing and configured to move laterally relative to the longitudinal axis of the housing, the tubular member being pivoted such that sufficient space is provided to load the tubular member with bone material, the tubular member including a proximal opening, a distal opening, and a passageway disposed therebetween for dispensing bone material, the proximal opening, the distal opening, and the passageway of the tubular member configured to house at least the portion of the plunger, wherein the tubular member is pivotably connected to the housing by a pivot point disposed laterally relative to the longitudinal axis, wherein the tubular member is configured to move laterally relative to the longitudinal axis of the housing by the pivot point such that the tubular member can be moved in a first position to align the proximal opening of the tubular member with the second opening of the housing in order to allow the tubular member to house at least the portion of the plunger to dispense bone material, and the tubular member can be moved in a second position to misalign the proximal opening of the tubular member with the second opening of the housing in order to prevent the tubular member from housing at least the portion of the plunger, thereby allowing the tubular member to be loaded with bone material, wherein (i) the tubular member is locked with the housing by a detent in the housing; or (ii) the tubular member is configured to engage a folding sleeve, the folding sleeve comprising an upper compartment, a lower compartment, and a fold line, and the folding sleeve is movable about the fold line in a folded configuration and an unfolded configuration, and wherein (i) a diameter of the folding sleeve is greater than a diameter of the distal opening of the tubular member so as to allow at least a portion of the folding sleeve to be held within the tubular member; (ii) the folding sleeve comprises a funnel portion configured to partially enclose the tubular member; or (iii) the housing comprises a locking member for locking the funnel portion to the housing.

13. The bone material dispensing gun of claim 12, wherein the trigger assembly comprises a drive handle, a fixed handle, a drive pawl, a passive pawl, a first resilient member disposed between a first portion of the housing and the passive pawl, and a second resilient member concentric with the plunger and disposed between a second portion of the housing and the drive pawl, the drive handle configured to contact the drive pawl when the drive handle is moved toward the fixed handle, wherein movement of the drive handle toward the fixed handle causes the drive pawl to compress the second resilient member and allow incremental slidable movement of the plunger.

Images