Bone material dispensing system with locking member

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 accommodate at least a portion of a plunger. A locking member is provided, which is pivotally connected to an upper surface of the housing and extends adjacent to the upper surface of the housing. The locking member includes a locking surface extending adjacent to the distal end of the housing, and the locking surface is configured to engage a portion of a tubular member, a funnel, or a combination thereof. The locking member is movable in a locked position to lock the portion of the tubular member, the funnel, or the combination thereof with the housing. A bone material dispensing system and a method for implanting bone material using the bone material dispensing system are also provided.

Description

Background Art

[0001] Various devices and methods have been used to apply bone materials (such as bone grafts) to surgical sites. Bone grafts are very important in orthopedic procedures to repair bone defects caused by injury, disease, wounds or surgery. To this end, many materials have been used or proposed for repairing bone defects. The biological, physical and mechanical properties of materials are the main factors affecting their suitability and performance in various orthopedic applications.

[0002] Conventionally, bone tissue regeneration is achieved by filling bone defects with bone material (e.g., bone grafts). Over time, the bone material is absorbed 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 replacement bone material, or a combination thereof.

[0003] In order to deliver bone material to bone defect, bone material is usually mixed with liquid or therapeutic agent, powder, fiber or granular material. Further, the transfer of bone material to dispensing device is usually completed by the rough and chaotic packaging of bone dispensing device, which may cause undesirable waste and overflow of bone material. During the transfer and delivery of bone material, these devices may also increase the risk of contaminating bone material. In addition, some dispensing devices may damage the surrounding tissues of the surgical site during the application of bone material. In addition, bone material may block some dispensing devices due to its consistency and / or due to the design of dispensing device, and the amount of bone material can not be effectively controlled when this occurs.

[0004] It would therefore be desirable to provide a bone material dispensing system that includes a reusable bone material dispensing device that allows for easier loading of bone material, which reduces the risk of bone material contamination and spillage from the dispensing device. It would be useful for the bone material dispensing system to include a bone material dispensing tray that holds the bone material on the surface of the tray when the tray is engaged with the device so that a user can easily load the device and / or cannula with bone material. It would also be beneficial to provide a dispensing device that reduces clogging during dispensing of bone material and is also capable of incrementally delivering bone material to a bone defect in controlled amounts. Summary of the invention

[0005] In some embodiments, a bone material dispensing system is provided that reduces the risk of bone material contamination and spillage from a reusable dispensing device that applies the bone material to a bone defect, and the device and method reduce clogging during incremental dispensing of bone material. The bone material dispensing system includes a tray for loading bone material into a bone material dispensing device and / or a cannula.

[0006] In some embodiments, 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 accommodate at least a portion of a plunger. A locking member is provided, the locking member being pivotally connected to an upper surface of the housing and extending adjacent to the upper surface of the housing. The locking member includes a locking surface extending adjacent to the distal end of the housing, the locking surface being configured to engage a portion of a tubular member, a funnel, or a combination thereof. The locking member can be moved in a locked position to lock the portion of the tubular member, the funnel, or the combination thereof with the housing.

[0007] In some embodiments, a bone material dispensing system is provided. The bone material dispensing system includes a bone material dispensing gun, which 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 accommodate at least a portion of a plunger. The bone material dispensing gun includes a locking member, which is pivotally connected to the upper surface of the housing and extends adjacent to the upper surface of the housing. The locking member includes a locking surface extending adjacent to the distal end of the housing. The locking member can be moved in a locked position to lock the tubular member, the funnel or the portion thereof with the housing. The bone material dispensing system includes a tray that can be engaged with the bone material dispensing gun to load bone material to the bone material dispensing gun.

[0008] In some embodiments, a method of implanting a bone material is provided. The method includes loading bone material from a tray into a bone material dispensing gun, the bone material dispensing gun 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 being configured to slidably accommodate at least a portion of a plunger; and a locking member pivotally connected to an upper surface of the housing and extending adjacent to the upper surface from the housing, the locking member including a locking surface extending adjacent to the distal end of the housing, the locking surface being configured to engage a portion of a tubular member, a funnel, or a combination thereof, the locking member being movable in a locking position such as a downward position to lock the portion of the tubular member, the funnel, or the combination thereof to the housing, the tubular member being movable in a first position to align the proximal opening of the tubular member or the proximal opening of the tubular member and the funnel with the second opening of the housing so as to allow the tubular member or the tubular member and the funnel to accommodate at least the portion of the plunger to dispense the bone material.

[0009] Although multiple embodiments are disclosed, other embodiments of the present disclosure will be apparent to those skilled in the art from the following detailed description. It will be apparent that the present disclosure can be modified in various obvious aspects, all without departing from the spirit and scope of the present disclosure. Therefore, the detailed description should be regarded as illustrative in nature and not restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

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

[0011] Figure 1 1 is a perspective view of a bone material dispensing system according to one aspect of the present application. The bone material dispensing system includes a bone material dispensing device, a plunger, a funnel, a folding sleeve and a tray. The tray can be engaged with the bone material dispensing device to load the bone material into the bone material dispensing device.

[0012] Figure 2is a perspective view of a bone material dispensing device according to one aspect of the present application. The bone material dispensing device includes a housing having a proximal end, a distal end, and a longitudinal axis, the proximal end having a first opening, the distal end having a second opening. The first opening and the second opening are configured to slidably accommodate at least a portion of a plunger. The bone material dispensing device includes a locking member pivotally connected to an upper surface of the housing and extending transversely above the upper surface from at least the proximal end of the housing to the distal end. The locking member includes a distal end configured to engage a portion of a tubular member, a funnel, or a combination thereof.

[0013] Figure 3 yes Figure 1 An end view of a bone material dispensing device partially in phantom form, wherein the tubular member is shown in phantom.

[0014] Figure 4 yes Figure 1 An end view of a bone material dispensing device partially in phantom form, wherein the tubular member is shown in phantom.

[0015] Figure 5 yes Figure 2 A perspective view of a bone material dispensing device of FIG. The funnel and folding sleeve are shown separated from the device.

[0016] Figure 6 yes Figure 2 An enlarged perspective view of a portion of a bone material dispensing device having a housing showing a locking member in a released position, showing second and third biasing members and a plunger.

[0017] Figure 7 yes Figure 2 An enlarged perspective view of a portion of a bone material dispensing device having a housing showing a locking member in a locked position, showing second and third biasing members and a plunger.

[0018] Figure 8 yes Figure 1 A perspective view of a bone material dispensing system of FIG. 1 , wherein a bone material dispensing device is engaged with a tray to load bone material into the bone material dispensing device. The funnel is not shown in this figure.

[0019] Fig. 9 yes Figure 1 A bottom view of a bone material dispensing system of FIG. 1 , wherein a bone material dispensing device is engaged with a tray to load bone material into the bone material dispensing device. The funnel and folding sleeve are not shown in this figure.

[0020] Fig.10 yes Figure 1A top view of a bone material dispensing system of FIG. 1 , wherein a bone material dispensing device is engaged with a tray to load bone material into the bone material dispensing device. The funnel is not shown in this figure.

[0021] Fig.11 yes Figure 2 A perspective view of a bone material dispensing device. The end of the funnel is shown adjacent to the intervertebral disc for applying bone material.

[0022] It should be understood that the drawings are not drawn to scale. Further, the relationships between objects in the drawings may not be to scale and may actually have inverse relationships with respect to size. These drawings are intended to aid understanding and clarity of the structure of each of the objects shown, and therefore, some features may be exaggerated in order to illustrate specific features of a structure. DETAILED DESCRIPTION

[0023] definition

[0024] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless expressly and unequivocally limited to one referent.

[0025] The term "allogeneic graft" refers to a tissue graft obtained from a donor of the same species as the recipient but of a different genetic makeup, as a transplant of tissue between two people.

[0026] The term "autologous" refers to derived from or transferred from the body of the same individual, such as an autologous bone marrow transplant.

[0027] The term "xenograft" refers to a tissue or organ from an individual of one species that is transplanted into or onto an organism of another species, genus, or family.

[0028] The term "mammal" refers to organisms from the class "Mammalia" of the classification system, including but not limited to humans; other primates (such as chimpanzees, apes, gorillas and monkeys); rats, mice, cats, dogs, cows, horses, etc.

[0029] The term "patient" refers to a biological system to which a treatment can be administered. A biological system can include, for example, an individual cell, a group of cells (e.g., a cell culture), an organ, or a tissue. Additionally, the term "patient" can refer to an animal, including but not limited to a human.

[0030] The term "bone material" includes natural and / or inorganic materials, such as inorganic ceramics and / or bone substitute materials. Bone material can also include natural bone material, such as cortical, cancellous or cortical-cancellous bone of autologous, allogeneic, xenogeneic or transgenic origin. In some embodiments, bone material can include demineralized bone material, such as substantially demineralized bone material, partially demineralized bone material or completely demineralized bone material.

[0031] As used herein, "demineralization" refers to any material produced by removing mineral material from a tissue (e.g., bone tissue). In certain embodiments, the demineralized compositions described herein include preparations containing less than 5% by weight calcium and preferably less than 1% by weight calcium. Partially demineralized bone (e.g., a preparation having greater than 5% by weight calcium but containing less than 100% of the original starting amount of calcium) is also considered within the scope of the present application. In certain embodiments, demineralized bone has less than 95% of its original mineral content.

[0032] 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%, 53% of its original content. %, 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 "substantially demineralized", "shallowly demineralized", "partially demineralized", "surface demineralized" and "completely demineralized".

[0033] "Partially demineralized" is intended to encompass "surface demineralized." "Partially demineralized bone" is intended to refer to preparations having greater than 5% calcium by weight but containing less than 100% of the original starting amount of calcium. In some embodiments, partially demineralized bone 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%, 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%, 99%, 100%, 101%, 102%, 103%, 104%, 105%, 106%, 107%, 108%, 109%, 110%, 111%, %, 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.

[0034] In some embodiments, the demineralized bone can be about 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%, 99%, 100%, 101%, 102%, 103%, 104%, 105%, 106%, 107%, 108%, 109%, 110%, 111 In various embodiments, the demineralized bone may be about 15-25% demineralized. In some embodiments, the demineralized bone is 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, and / or 25% surface demineralized.

[0035] As used herein, "shallowly demineralized" refers to bone-derived elements having at least about 90% by weight of its original inorganic mineral content, the expression "partially demineralized" as used herein refers to bone-derived elements having from about 8% to about 90% by weight of its original inorganic mineral content, and the expression "completely demineralized" as used herein refers to bone containing less than 8% of its original mineral content.

[0036] Demineralized bone matrix as used herein refers to any material produced by the removal of minerals from bone tissue. In preferred embodiments, the DBM compositions used herein comprise formulations containing less than 5% calcium and preferably less than 1% calcium by weight.

[0037] As used herein, "biocompatible" refers to a material that does not cause undesirable long-term effects when administered in vivo.

[0038] As used herein, the term "osteoconductive" refers to the ability of a non-osteoinductive substance to serve as a suitable template or substance along which bone can grow.

[0039] As used herein, "osteogenetic" refers to the ability of an agent, material, or implant to enhance or accelerate the growth of new bone tissue through one or more mechanisms such as osteogenesis, osteoconduction, and / or osteoinduction.

[0040] As used herein, "osteoinduction" refers to the quality of being able to recruit cells with the potential to stimulate new bone formation from a host. Any material that can induce ectopic bone formation in the soft tissue of an animal is considered osteoinductive. For example, most osteoinductive materials induce bone formation in athymic rats when measured according to the following method: Edwards et al., "Osteoinduction of Human Demineralized Bone: Characterization in a Rat Model", Clinical Orthopaedics & Rel. Res., 357: 219-228, December 1998, which is incorporated herein by reference.

[0041] The terms "upper", "lower", "top", "bottom", "side", "proximal", "distal", etc. are used herein for convenience only to describe the present invention and its parts as oriented as shown in the figures. However, it should be understood that these terms are in no way limiting to the present disclosure, as the dispensing systems described herein can obviously be positioned in different orientations when in use.

[0042] The term "removably engageable" includes the engagement of two or more components that can be used or combined into one component by engagement of 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.

[0043] For the purpose of this specification and the appended claims, unless otherwise indicated, all numerals expressing the amount of ingredients, percentages or ratios of materials, reaction conditions and other numerical values ​​used in this specification and the claims should be understood to be modified by the term "about" in all cases. Therefore, unless otherwise indicated, the numerical parameters set forth in the following specification and the appended claims are approximate values ​​that may vary in the desired properties that are attempted to be obtained by the present invention. At a minimum, and without attempting to limit the scope of the application of the doctrine of equivalents to the claims, each numerical parameter should at least be interpreted according to the number of reported significant digits and by applying general rounding techniques.

[0044] Although the numerical ranges and parameters describing the broad scope of the invention herein are approximate; the numerical values ​​described in the specific examples are reported as accurately as possible. However, any numerical value inherently contains certain errors that are necessarily caused by the standard deviation found in its corresponding test measurements. In addition, all ranges disclosed herein are understood to encompass any and all subranges contained therein. For example, the range "1 to 10" includes any and all subranges between (and including) a minimum value of 1 and a maximum value of 10, that is, any and all subranges having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10, such as 5.5 to 10.

[0045] Reference will now be made in detail to certain embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. Although the present disclosure will be described in conjunction with the illustrated embodiments, it should be understood that they are not intended to limit the present disclosure to those embodiments. On the contrary, the present disclosure is intended to cover all alternatives, modifications and equivalents that may be included in the present disclosure as defined by the appended claims.

[0046] The following headings are not meant to limit the disclosure in any way; embodiments under any heading may be used in combination with embodiments under any other heading.

[0047] Distribution system

[0048] like Figure 1-11 As shown, a bone material dispensing system 20 is provided that includes a reusable bone material dispensing device 22 that allows for easier loading of bone material, thereby reducing the risk of bone material contamination and spillage from the bone material dispensing device. The system also provides a bone material dispensing tray 24 that holds the bone material on the surface of the tray, while the tray holds the device in place, so that a user can easily load the device with bone material as described herein.

[0049] The reusable bone material dispensing device applies bone material to the surgical site in incremental amounts. The bone material dispensing device can be a bone material dispensing gun that reduces the risk of bone material contamination and overflow from the dispensing device and applies bone material to the surgical site (e.g., a bone defect) while reducing damage to surrounding tissue. The bone material dispensing device reduces blockage and allows incremental distribution of bone material. The bone material dispensing device is also configured for left-handed and right-handed use. The surgical site may include, but is not limited to, an injury, a defect caused during the surgical procedure, an infection, a malignant tumor, or a developmental deformity. Specific bones that may be repaired or replaced with bone material may include, but are not limited to, the ethmoid; frontal; nasal; occipital; parietal; temporal; mandible; maxilla; zygomatic; cervical; thoracic; lumbar; sacrum; ribs; sternum; clavicle; scapula; humerus; radius; ulna; carpals; metacarpals; phalanges; ilium; ischium; pubis; femur; tibia; fibula; patella; calcaneus; tarsals and metatarsals. In some embodiments, the bone material dispensing device administers bone material to at least a portion of the spinal cord, such as vertebra V1 or vertebra L2. Fig.11 shown.

[0050] The bone material dispensing device comprises a housing 25 having a proximal end 26, a distal end 28 and a longitudinal axis AA disposed therebetween. Figure 2 The proximal end of the housing includes a first opening 30, and the distal end includes a second opening 32, as shown. Figure 6 As described herein, the first opening and the second opening are configured to slidably receive at least a portion of the plunger 34 .

[0051] like Figure 7 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 can have different diameters. In some embodiments, the diameters D1 and D2 can be about 2 millimeters (mm) to about 40 mm. The diameter can be 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 opening and the second opening can be shaped and can be circular, oval, rectangular or square.

[0052] As described herein, the plunger has a proximal end 36, a distal end 38 and a body 40 disposed therebetween. As described herein, the plunger is configured to assist in distributing / applying bone material to the surgical site. This allows the bone material to be applied to the bone defect in a controlled and incremental manner. The proximal end of the plunger includes a stopper 42, which is configured to prevent the plunger from completely passing through the first and second openings of the housing when the plunger is translated in the direction of the distal end of the housing. In some embodiments, the stopper can be spherical and have a diameter greater than diameters D1 and D2. In some embodiments, the distal end of the plunger can include a tip 44 with various geometries and sizes, which are customized for various sizes of sleeves as described herein and / or various viscosities of bone material as described herein. In some embodiments, the tip of the plunger can be square, rectangular, circular, plug-shaped or disc-shaped.

[0053] The tip may have a diameter D3, and the body may have a diameter D4, such as Figure 5 As shown. In some embodiments, diameter D3 is greater than diameter D4. In some embodiments, diameters D3 and D4 are the same size. Diameter D4 of the body of the plunger is smaller than diameters D1 and D2, and diameter D3 can be greater than, equal to, or less than diameters D1 and D2. In some embodiments, diameter D4 of the body of the plunger is slightly smaller than diameters D1 and D2, but allows at least a portion of the plunger to slide within the opening. In some embodiments, diameters D3 and D4 can be from about 2 millimeters (mm) to about 36 mm. Diameters D3 and D4 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. The plunger can also have a determined length L1 of about 1 inch to about 20 inches, such as Figure 5 In some embodiments, the length L1 of the plunger 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. As described herein, the plunger length can be less than, greater than, or equal to the size of the cannula. In some embodiments, the plunger can be flexible or rigid.

[0054] The bone material dispensing device includes a locking member 46. The locking member is configured to lock a portion of a tubular member and / or a funnel as described herein to a housing of the bone material dispensing device. The locking member is pivotally connected to an upper surface 48 of the housing and extends adjacent to the upper surface of the housing, such as Figure 2 , 6and 7. The locking member includes a proximal end 50 configured to engage with a biasing member as described herein and a distal end 52 configured to engage with a portion of a tubular member and / or a funnel as described herein, and an intermediate portion 54 disposed therebetween, the intermediate portion being configured to pivotally engage with a portion of an upper surface of the housing.

[0055] As described herein, the locking member can be moved in a locked position (such as a downward position) to lock a portion of the tubular member, funnel, or a combination thereof with the shell, and the locking member can be moved in an unlocked position (such as an upward position) for unlocking a portion of the tubular member, funnel, or a combination thereof with the shell.

[0056] The proximal end of the locking member includes an outer surface 56, which in some embodiments includes a gripping surface 58 that provides a grip for a user when the user pushes down on the proximal end of the locking member during use. The inner surface 60 of the locking member defines a post 62 disposed at the proximal end, the post being configured to engage with a first end 66 of a first resilient member (e.g., a first spring 64), such as Figure 2 and 7 A portion of the upper surface of the proximal end of the housing includes a recess 68 configured to engage with the second end 70 of the first spring. The post and recess are configured to engage with the first spring.

[0057] The middle portion of the locking member includes a pivot point 72 that engages the upper surface of the housing. The pivot point includes an opening 74, a pin 76, and an opening 78 formed by a portion of the upper surface of the housing, such as Figure 6 and 7 As shown. The pin is configured to be disposed within openings 74 and 78. In some embodiments, the pivot point pivots at an angle α1 of about 1 degree to about 30 degrees. In some embodiments, the pivot point pivots at an angle α1 of about 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 to about 30 degrees.

[0058] The distal end of the locking member includes a locking surface, such as a flange 80 extending adjacent the distal end of the housing. The flange locks a portion of the tubular member, funnel, or combination thereof to the housing of the bone material dispensing device. Figure 6 As shown, the flange may include an inner surface that is grooved 82 to facilitate engagement with a portion of the tubular member and / or the funnel.

[0059] like Figure 7As shown by arrow BB in FIG. , the flange at the distal end of the locking member moves in a downward position to lock a portion of the tubular member, funnel, or combination thereof with the housing. When the flange is in the downward position, the proximal end is positioned in an upward direction, as shown by arrow CC. In this configuration, the first spring is partially compressed by stored energy, which applies a constant force to the support 62 and the recess 68. When the user pushes the proximal end of the locking member in a downward direction (as shown by arrow EE), the flange moves in an upward position (as shown by arrow EE). Figure 6 When the locking member moves in the downward position again, the first spring is further compressed and energy is stored for use.

[0060] The bone material dispensing device comprises a tubular member 84 pivotably connected to the housing and configured to move radially relative to the longitudinal axis AA of the housing. Figure 2-4 As shown, the tubular member includes a proximal end 86, a distal end 88, and as described herein, when the tubular member is in the first position, the longitudinal axis AA is disposed between the proximal and distal ends. The tubular member can be conical, and the distal end can be tapered.

[0061] The proximal end of the tubular member includes a proximal opening 90, and the distal end of the tubular member includes a distal opening 92. A passage 94 is disposed therebetween. The proximal opening, distal opening, and passage of the tubular member are configured to accommodate at least a portion of the plunger so that when bone material is disposed in the passage, the plunger can be advanced into the passage to dispense or administer the bone material as described herein. 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 accommodate at least a portion of the plunger (e.g., Figure 4 The tubular member can also be moved in the second position to misalign the proximal opening of the tubular member with the second opening of the housing to prevent the tubular member from accommodating at least a portion of the plunger (as shown). Figure 3 shown).

[0062] As described above, the tubular member is pivotally connected to the housing by a pivot point such as hinge 96. The hinge is transverse to the longitudinal axis AA. The hinge facilitates rotation of the tubular member relative to the housing in the directions indicated by arrows FF and GG, as shown in FIG. Figure 3 and 4 The hinge may alternatively be or may include a pivot pin or rod. The tubular member pivots toward and away from the housing at an angle α2 of about 2 degrees to about 320 degrees, as shown. Figure 4In some embodiments, α2 is about 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, 97, 98, 99, 100, 101, 102, 103, 104, 105, 106, 107, 108, 109, 110, 111, 112, 113, 114, 115 6, 98, 100, 102, 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, 1 72, 174, 176, 178, 180, 182, 184, 186, 188, 190, 192, 194, 196, 198, 200, 202, 204, 206, 208, 210, 212, 214, 216, 218, 220, 222, 224, 226, 228, 230, 232, 234, 236, 238, 240, 242, 244, 246 , 248, 250, 252, 254, 256, 258, 260, 262, 264, 266, 268, 270, 272, 274, 276, 278, 280, 282, 284, 286, 288, 290, 292, 294, 296, 298, 300, 302, 304, 306, 308, 310, 312, 314, 316, 318 to about 320 degrees. The tubular member can be pivoted so that sufficient space is provided for the tubular member to be loaded with bone material.

[0063] The tubular member is locked to a portion of the distal end of the housing by a catch 97 and / or a flange of a locking member. The catch is positioned on a portion of the distal end of the housing. As described above, the catch locks the tubular member in the first position. The catch can be a clip, lever, spring, or hinged clip that engages with a notch, protrusion, wall, or combination thereof of the ratchet. Locking will allow the opening to align (e.g., Figure 4 In some embodiments, when the tubular member is rotated open, the holes are misaligned and the plunger cannot slide through the tubular member, such as Figure 4 shown.

[0064] In some embodiments, the tubular member can be fully removable and snap-connected to the housing. In some embodiments, the tubular member can be fully removable and connected to the housing by screw-on thread. In some embodiments, the tubular member can be pivotally connected to the housing in a manner similar to a breach loaded shot-gun. It should be noted that one of ordinary skill in the art can modify the tubular member and its connection to the housing to adjust the design of the bone material dispensing device.

[0065] like Figure 2 As shown, the housing includes a trigger assembly 98 configured to allow incremental slidable movement of the plunger to dispense bone material as described herein. The trigger assembly includes a drive handle 100 and a fixed handle 102. The drive handle includes a proximal end 104, a distal end 106, and a longitudinal axis HH disposed therebetween. As described below, the proximal end of the drive handle is configured to pivotally engage with the intermediate portion of the fixed handle and the proximal end of the drive pawl. As described below, Figure 2 and 4 As shown, the proximal end of the drive handle includes a cavity 108. As described herein, the cavity is configured to movably engage a portion of the drive pawl.

[0066] The proximal end of the drive handle transverse to the cavity includes a recess 110. The recess is configured to engage with a pin 112 so that the proximal end of the drive handle can pivotally engage with a portion of the drive pawl, as described herein. Figure 2 As shown, the proximal end of the drive handle distal to the recess 110 includes a recess 114. The recess is configured to engage with a pin 116 so that the proximal end of the drive handle is movably engaged with a portion of the housing. The housing includes a recess 118 configured to engage with the pin 116.

[0067] The surface of the drive handle includes a gripping surface 119. The gripping surface is configured to engage with the user's hand so that the user can effectively control the drive handle. The gripping surface can be convex, curved or straight. The gripping surface can also be roughened to increase the user's control over the drive handle.

[0068] The user moves the drive handle in the direction of the fixed handle. The drive handle engages with an active pawl, which slides the plunger longitudinally and incrementally in the direction of the distal end. This allows bone material to be dispensed incrementally from the bone material dispensing device.

[0069] The fixed handle includes a proximal end 120, a distal end 122, a middle portion 124, and a longitudinal axis II disposed between the proximal end and the distal end. The proximal end of the fixed handle includes a first side 126, a second side 128, and a third side 130, such as Figure 6 and 9 The first side, the second side, and the third side are part of the housing. The proximal end of the fixed handle can be integral with the housing, and the first side, the second side, and the third side can be integral or fixed to the fixed handle. The middle portion of the fixed handle can be integral with the housing, and the middle portion can be inserted into the cavity of the drive handle. The second side includes a slot 132 that is configured to engage with a portion of a passive pawl, as described herein and Figure 4 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.

[0070] The intermediate portion of the fixed handle is configured to engage with the proximal end of the drive handle. Figure 2 As shown, the drive handle pivots toward and away from the fixed handle at an angle α3 of about 1 degree to about 60 degrees. In some embodiments, α3 is about 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 about 60 degrees.

[0071] The fixed handle defines one or more cutouts 134, such as Figure 7 The cutouts may be oval, circular, square, triangular, rectangular or any other regular or irregular shape. One or more cutouts, such as 1, 2, 3, 4, 5, 6 or more cutouts may be formed from the surface of the fixed handle.

[0072] The trigger assembly of the housing further includes a drive pawl 136 and a passive pawl 138, as shown in FIG. Figure 6 and 7 The drive pawl is configured to work in conjunction with the resilient member to assist in the fixation of the handle and the drive handle as the plunger is incrementally slidably moved so that the plunger dispenses bone material. Figure 6 In the illustrated embodiment, the resilient member, shown as a spring, is concentric with the plunger. As the drive handle moves toward the fixed handle, the pawl 136 engages the plunger 34 and pushes the plunger longitudinally in an incremental manner while compressing the spring. The drive pawl is disposed at one end of the resilient member, and the other end of the resilient member is biased against the housing and the plunger. Upon release of the drive handle, the energy stored in the spring returns the drive handle and the pawl longitudinally to their original positions.

[0073] like Figure 4As shown, the drive pawl includes a first end 140 and a second end 142. The first end of the drive pawl is configured to be movably engaged within the cavity of the drive handle. The recess 110 and the recess 144 disposed within the first end of the drive pawl engage with the pin 112 so that the proximal end of the drive handle can be pivotally engaged with the first end of the drive pawl. The drive pawl includes a third opening 146 that is aligned with the first opening and the second opening of the housing and between the first opening and the second opening, as shown in FIG. Figure 3 and 4 As described herein, the third opening is configured to slidably receive at least a portion of the plunger. The third opening can be positioned in the center of the drive pawl.

[0074] like Figure 7 As shown, the third opening has a diameter D5. The diameter of D5 can be the same as D1 and D2, and the diameter of D5 is greater than the plunger diameter D4. In some embodiments, D5 can have a diameter different from D1 and D2. In some embodiments, diameter D5 can be about 6 millimeters (mm) to about 40mm. Diameter D5 can be about 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40mm. The third opening can be shaped and can be circular, oval, rectangular or square.

[0075] The passive pawl includes a first end 148 and a second end 150. Figure 6 and 7 As shown. The first end is configured to engage with the narrow slot 132. The passive pawl is configured to work with the elastic member to control when to advance the plunger during dispensing bone material and when to retract the plunger after dispensing or reloading bone material. The passive pawl allows the plunger to be adjusted so that the plunger can be positioned adjacent to the bone material, and if more bone material is added to the sleeve or tubular member, the plunger can be adjusted to place it adjacent to the additional bone material. In this way, the bone material dispensing device can easily accommodate various amounts of bone material.

[0076] like Figure 7 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.

[0077] The passive pawl includes a fourth opening 152 above the first and second openings of the housing and aligned with the first and second openings and the third opening of the driving pawl. Figure 6 and 7As described herein, the fourth opening is configured to slidably receive at least a portion of the plunger. The fourth opening can be positioned in the center of the passive pawl.

[0078] like Figure 7 As shown, the fourth opening has a diameter D6. The diameter of D6 can be the same as D1, D2 and D5, and the diameter is greater than the plunger diameter D4. In some embodiments, D6 can have a diameter different from D1, D2 and D5. In some embodiments, diameter D6 can be about 6 millimeters (mm) to about 40mm. Diameter D6 can be about 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40mm. The fourth opening can be shaped and can be circular, oval, rectangular or square.

[0079] like Figure 2 As shown, the trigger assembly includes a second elastic member, such as a second spring 154, which is configured to engage with a portion of the passive pawl and the plunger. The second spring is disposed on a portion of the plunger and is located between the second side 128 of the fixed handle and the passive pawl, such as Figure 2 and 6 The second spring includes a proximal end 156 configured to engage the bottom side of the passive pawl and a distal end 158 that engages the second side 128 of the fixed handle and the first opening 30 of the housing. The second spring is concentric with the fourth opening of the passive pawl and concentric with the plunger. When the passive pawl is moved toward the fixed handle, the second 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.

[0080] The trigger assembly includes a third resilient member, such as a third spring 160, which is configured to engage with a drive pawl as described herein. The third spring is disposed concentrically with the plunger and disposed between a portion of the distal end of the housing and the drive pawl, such as Figure 6 and 7 The third spring includes a proximal end 162 that engages the distal surface of the drive pawl and a distal end 164 that engages the second opening 32 of the housing. As described herein, at least a portion of the plunger is configured to be slidably received by the third spring.

[0081] In some embodiments, the tubular member is configured to engage with a sleeve (e.g., folded sleeve 165), such as Figure 1 and 515 / 581,817, which is owned by the applicant and fully incorporated herein by reference. The folding sleeve is configured to be loaded with bone material and engage with a tubular member, a funnel and / or a plunger to dispense the bone material into a surgical site. The folding sleeve includes a proximal end 166 and a distal end 168. The folding sleeve is divided into an upper compartment 170 and a lower compartment 172, and the folding sleeve can be moved about a fold line 174 in a folded configuration and an unfolded configuration.

[0082] The diameter D7 of the folded sleeve is smaller than the diameter D8 of the distal opening 92 of the tubular member so as to allow at least a portion of the folded sleeve to be retained within the tubular member, such as Figure 3 and 5 As shown. In some embodiments, diameter D7 can be about 2 millimeters (mm) to about 40 mm. Diameter D7 can be 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 folding sleeve can have different diameters throughout the folding sleeve and does not have to have a uniform diameter. Diameter D8 has a diameter larger than plunger diameter D4. Diameter D8 can be about 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm.

[0083] In some embodiments, the proximal end of the folded sleeve can have a variety of geometric shapes and sizes. In some embodiments, the proximal end of the folded sleeve can be square, rectangular, circular, plug-shaped, or disc-shaped. The proximal end geometry of the folded sleeve can have a diameter D9 that is greater than diameters D7 and D8, so that the proximal end geometry cannot pass through the distal opening 92 of the tubular member. In some embodiments, the diameter D9 can be about 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38 to about 40 mm.

[0084] In some embodiments, the folded sleeve is engaged with a funnel 176 that is configured to removably engage and partially enclose the tubular member, such as Figure 2 , 6 , 7 and 11. The proximal portion 178 of the funnel is conically engaged with the distal end of the tubular member. As described above, the proximal end engages with the locking member to lock the funnel to the housing. Figure 5 As shown, the funnel portion includes a distal end 180. In some embodiments, the distal end of the funnel has a tip geometry (eg, a concave tip geometry) to help apply bone material to the surgical site. The distal end of the funnel can have a variety of sizes.

[0085] The funnel has a length L2, such as about 1 inch to about 20 inches. In some embodiments, the length of the funnel 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, the funnel is flexible or rigid, or only one of the funnel or the plunger is flexible.

[0086] The bone material dispensing system comprises a tray 24, which is as described above and Figure 1 and 8 -10. The tray is configured to load bone material into the bone material dispensing device and / or the folding sleeve. The tray is also configured to engage the bone material dispensing device and / or the folding sleeve to load the bone material. The tray includes a proximal end 182 and a distal end 184. A first side 186 is disposed at the proximal end of the tray, and a second side 188 is disposed at the distal end of the tray. The tray includes a third side 190 disposed transversely relative to the first side and the second side, and a fourth side 192 disposed transversely relative to the first side and the second side and parallel to the third side.

[0087] The third side of the tray is configured to engage with a bone material dispensing device, as described herein. Figure 8 As shown, a slot such as a first slot 194 is defined from a portion of the third side and the second side. The first slot is configured to accommodate a tubular member, and a first recess 196 is defined from a portion of the second side to engage with a portion of the distal end of the tubular member so that the tubular member rests or docks in the first slot. Fig. 9 As shown, the lower surface 198 of the tray defines a first shoulder 200 configured to engage a portion of the plunger. When the tubular member of the bone material dispensing device is docked in the first slot, a portion of the plunger is positioned on the first shoulder.

[0088] like Fig.10 As shown, the tray includes an upper surface 202, which defines a first groove or a first channel 204. The first groove or the first channel is configured to accommodate a folding sleeve. The folding sleeve can be placed in the first groove or the first channel and loaded with bone material. Once the folding sleeve is loaded, it can be inserted into the tubular member of the bone distribution device, or it can be inserted into the tubular member and the funnel.

[0089] like Fig.10As shown, a second slot 206 is defined from a portion of the fourth side and the first side. As described herein, the second slot can also be configured to accommodate a tubular member and / or a container for storing bone material. A second recess 208 is defined from a portion of the first side to engage with a portion of the distal end of the tubular member so that the tubular member rests or docks within the second slot. Fig. 9 As shown, the lower surface 198 of the tray defines a second shoulder 210, which is configured to engage a portion of the plunger. When the tubular member of the bone material dispensing device is docked in the second slot, a portion of the plunger is positioned on the second shoulder. Fig.10 As shown, the upper surface 202 of the tray defines a second groove or second channel 212. The second groove or second channel is configured to receive a folding sleeve. It is noted that the system may include one or more folding sleeves.

[0090] The upper surface of the tray includes a mixing surface 214. In some embodiments, the mixing surface is defined by the upper surface and is located at the center of the upper surface of the tray, such as Figure 8 and 10 As shown. The mixing surface is configured for the user and is used to mix the bone material and other components (e.g., therapeutic agents, diluents, blood, cells, etc.) together. The mixing surface can have a bowl-shaped configuration to allow mixing of solid and liquid components of the bone material. It will be appreciated by those of ordinary skill in the art that the bone material can be in the form of powder, particles, paste, putty, liquid and / or gel. In order to mix the components and / or distribute the bone material, in some embodiments, the bone material distribution system can include a spatula.

[0091] In operation, to load the bone material dispensing device with bone material, the bone material dispensing device is docked or attached to the tray as described above. Figure 3 As shown, the tubular member is rotated in the direction of arrow FF. The tubular member is then loaded with bone material, or the folding sleeve is loaded with bone material and inserted into the proximal end of the tubular member so that at least a portion of the folding sleeve is retained within the tubular member and at least a portion of the folding sleeve is fed through the distal opening of the tubular member. The tubular member is then moved about hinge 96 in the first position, as shown. Figure 4 As shown by the arrow GG in FIG. , the funnel is engaged with the tubular member and / or the combined tubular member and the folded sleeve. Figure 7 As shown, when the user places the locking member in the locking position or in the downward position, as shown by arrow BB, the funnel is then locked to the housing by the locking member. In certain embodiments, instead of the tubular member being loaded with bone material, the funnel can be loaded with bone material and then locked to the housing.

[0092] The distal end of the funnel is then inserted into the surgical site, such as vertebra V1, as Fig.11The distal end of the funnel can be inserted into the surgical site before or after the funnel is locked to the housing. For example, the funnel can be placed at the surgical site first and then locked to 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 to dispense bone material. The plunger is then released by the trigger assembly. Fig.11 The vehicle moves in a direction of arrow JJ shown in the figure, enters 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.

[0093] When the drive handle is Fig.11 The drive handle of the trigger assembly moves the drive pawl when it moves toward the fixed handle in the direction indicated by the arrow KK in FIG. The movement of the drive handle toward the fixed handle causes the drive pawl to compress the third spring in the direction indicated by the arrow JJ. The incremental slidable movement of the plunger is determined by the incremental movement of the drive handle toward the fixed handle. Since the diameter D5 of the third opening of the drive pawl is slightly larger than the diameter D4 of the plunger, and the drive pawl is moved away from the axis by the drive handle, when the drive handle is pressed downward, the drive pawl tilts and the diameter D5 becomes the same size as the diameter D4, thereby clamping the plunger. Any further advancement of the drive handle causes the drive pawl to clamp the plunger harder and advance the plunger. After the pressure on the drive handle is released, the third spring pushes the drive pawl upward again, thereby increasing the size of D5 so that the drive pawl slides back to the plunger, returning it to its initial position for another push.

[0094] The movement of the drive handle toward the fixed handle also causes the second spring to be compressed by the passive pawl against the second side of the housing. Fig.11 Then, Fig.11 As shown by the arrow LL in FIG. 1 , the second end of the passive pawl is pushed in the downward direction to compress the second spring again, so that the second spring contains transient energy, so that the user can retract the plunger in the proximal direction, as shown in FIG. Fig.11 As shown by the arrow MM. The advancement and retraction of the plunger can be controlled by the passive pawl and the second spring. For example, the passive pawl clamps the plunger, thereby preventing the plunger from retracting when the driving pawl returns to its initial position. Further, since the passive pawl pivots and is spring-loaded via the second spring, the passive pawl allows the plunger to move through the fourth opening.

[0095] Once the bone material dispensing device has completed dispensing of bone material and the plunger is fully retracted into the housing, the tubular member may also be moved to a second position (eg, Figure 3 FF in the figure), so that the proximal opening of the tubular member is misaligned with the second opening of the housing, thereby preventing the tubular member from accommodating at least a portion of the plunger.

[0096] In some embodiments, the funnel is configured to be unlocked / released from the bone material dispensing device by the user in vivo. The unlocking / releasing of the funnel in vivo allows the user to remove the folded sleeve while loading a new folded sleeve into the tubular member using a tray. The funnel can then be locked / reattached to the bone material dispensing device without having to remove the funnel from the patient. It is beneficial to reduce potential trauma or damage to soft tissues (especially nerves) during funnel placement. The unlocking / releasing of the funnel in vivo also reduces the number of steps required in the surgical procedure.

[0097] In some embodiments, the bone material dispensing device can be used in conjunction with the products found and fully described in U.S. Application Serial Nos. 15 / 340,770 and 15 / 818,395; and U.S. Publication Nos. 2017 / 0216051, 2018 / 0078385, 2017 / 0216045, 2018 / 0071113, and 2016 / 0100955, all of which are owned by the applicant and are fully incorporated herein by reference. In some embodiments, various orthopedic implants can be used in conjunction with the bone material dispensing device.

[0098] In some embodiments, the folding sleeve can be made of memory shape polymers and / or alloys to allow the folding sleeve to move from an unfolded configuration to a folded configuration without the need for a locking mechanism. Memory shape polymers include, but are not limited to, polyethers, polyacrylates, polyamides, polysiloxanes, polyurethanes, polyetheramides, polyurethane / ureas, polyetheresters, polynorbornenes, cross-linked polymers (such as cross-linked polyethylene and cross-linked poly(cyclooctene)), inorganic-organic hybrid polymers, and copolymers, such as urethane / butadiene copolymers, styrene-butadiene copolymers. Memory shape alloys include, but are not limited to, TiNi, CuZnAl, and FeNiAl alloys. In some embodiments, the folding sleeve can be manufactured by injection molding of plastic materials including, but not limited to, rigid, surgical grade plastics and / or metallic materials.

[0099] In some embodiments, the components of the bone material distribution system can be made of materials such as polyurethane, polyurea, polyether (amide), PEBA, thermoplastic elastomer olefin, copolyester and styrene thermoplastic elastomer, steel, aluminum, stainless steel, titanium, nitinol, metal alloys with high non-ferrous metal content and low relative proportion of iron, carbon fiber, fiberglass, plastic, ceramic or its combination. The folded sleeve, funnel portion, plunger or tubular member can optionally include one or more tapered areas. In various embodiments, these components can be blunt, beveled, diamond vertices, spherical tips, the tip of the trocar, etc. Depending on the surgical site, these components can also have a tip style that is crucial for accurately treating patients. 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 distribution device and tray can be made of materials that allow the bone material distribution device to be reusable, or alternatively made of materials that allow single use.

[0100] In some embodiments, the shape of the folded sleeve can be selected for a specific application. Such shapes and configurations can include, for example, the basic shape of a folded sleeve (e.g., a tubular sleeve).

[0101] method

[0102] A method for implanting bone material is provided. The method includes loading bone material from a tray into a bone material dispensing gun, the bone material dispensing gun 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 being configured to slidably receive at least a portion of a plunger; and a locking member pivotally connected to an upper surface of the housing and extending adjacent to the upper surface from the housing, the locking member including a locking surface extending adjacent to the distal end of the housing, the locking surface being configured to engage a portion of a tubular member, a funnel, or a combination thereof, the locking member being movable in a locking position such as a downward position to lock the portion of the tubular member, the funnel, or the combination thereof to the housing, the tubular member being movable in a first position to align the proximal opening of the tubular member or the proximal opening of the tubular member and the funnel with the second opening of the housing so as to allow the tubular member or the tubular member and the funnel to receive at least the portion of the plunger to dispense the bone material.

[0103] In some embodiments, loading the bone material into the bone material dispensing gun via the tray includes: engaging the tubular member with a slot of the tray; engaging a portion of the plunger with a shoulder defined by a lower surface of the tray; and adding the bone material to an upper surface of the tray so that the bone material can be loaded into the tubular member and / or cannula.

[0104] When the drive handle is pivoted, the drive pawl moves a limited amount. If the translation distance X is multiplied by the diameter of the funnel portion or sleeve, the volume of the cylinder can be calculated. The bone material dispensing device can be adjusted to dispense a predetermined amount of bone material when the drive handle is pivoted each time. In certain embodiments, the predetermined amount of bone material dispensed from the bone material dispensing device can be about 0.25cc to about 1cc or about 0.25 ounces (oz) to about 1oz.

[0105] In some embodiments, bone material can be dispensed in a quantifiable, controlled, and predetermined amount of about 0.25 cc to about 1 cc. Bone material can be dispensed in a quantifiable, controlled, and predetermined amount 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 cc. In some embodiments, bone material can be dispensed in a quantifiable, controlled, and predetermined amount of about 0.25 ounce to about 1 ounce. The bone material may be dispensed in metered, controlled and predetermined 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 ounce.

[0106] Bone material can be mixed with liquid material and optional therapeutic agent until the desired bone material consistency (e.g., putty, paste, etc.) is obtained. Bone material can be mixed with a suitable diluent and then loaded. The folded sleeve can have enough space to allow the bone material and a certain volume of diluent to be mixed. In certain 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), mineral compounds (including but not limited to dihydrated or anhydrous dicalcium phosphate or tricalcium), cellulose derivatives (including but not limited to microcrystalline cellulose), its monohydrate or anhydrous lactose and mixtures thereof, such as dihydrated dicalcium phosphate, mannitol, pregelatinized corn starch, microcrystalline cellulose and mixtures thereof, water and / or NaCl (saline). In certain embodiments, saline is 0.90% saline or 0.45% saline. In some embodiments, other delivery vehicles may be used, for example, D5W (glucose in 5% water), D5NS (glucose in 5% water and saline), and D5W / 1 / 2NS (D5W and 1 / 2 saline), blood, mesenchymal stem cells, etc.

[0107] In various embodiments, a kind of kit that comprises bone material distribution system is provided.Described kit can comprise other parts together with bone material distribution device, comprise bone material, tray and other other components (for example, wipes, needles, syringes, other mixing devices, etc.) for applying bone material.Kit can comprise the bone material distribution device in the first compartment.The second compartment can comprise bone material.The third compartment can comprise the tray for loading bone material to the bone material distribution device.In certain embodiments, the shape of tray can be selected for specific application.Such shape and configuration can comprise the basic shape (for example, square box, etc.) of tray for example.Tray can comprise additional features, as found and fully described tray and feature in U.S. application serial number 15 / 581,817, described application is owned by applicant and fully incorporated herein by reference.

[0108] The fourth compartment may include a container for holding bone material and / or a vial for holding any other apparatus required for delivery. The third compartment may include gloves, drapes, wound dressings and other surgical supplies for keeping the implant process sterile, and instructions, which may include a chart showing how to apply bone material after mixing. The sixth compartment may include a spatula, a needle, additional devices and / or sutures. Each tool may be packaged in a sterilized plastic pouch, respectively. The seventh compartment may include a medicament for radiographic imaging. The lid of the kit may include a diagram of the distribution / use procedure, and a transparent plastic cover may be placed on the compartment to keep sterile.

[0109] In various embodiments, one or more components of the bone material dispensing system are sterilized by radiation in a final sterilization step in the final packaging. Final sterilization of the product provides a higher assurance of sterility than processes that require sterilizing individual product components separately and assembling the final packaging in a sterile environment, such as an aseptic process.

[0110] In various embodiments, gamma radiation is used in the terminal sterilization step, which involves using the ionizing energy from gamma radiation to penetrate deeply into the bone material dispensing device. Gamma radiation kills microorganisms efficiently, leaves no residue, and does not have enough energy to make the device radioactive. Gamma radiation can be used while the device is in packaging, and gamma sterilization does not require high pressure or vacuum conditions, so the package seal and other components are not subjected to stress. In addition, gamma radiation eliminates the need for permeable packaging materials.

[0111] In various embodiments, one or more components of the bone material dispensing device may be sterilized using electron beam (e-beam) radiation. E-beam radiation includes a form of ionizing energy characterized by low penetration and high dose rate. E-beam irradiation is similar to gamma treatment in that it alters various chemical and molecular bonds on contact, including the germ cells of microorganisms. The beam produced for e-beam sterilization is a concentrated, large stream of charged electrons produced by electrical acceleration and conversion.

[0112] Other methods may also be used to sterilize the bone material dispensing system, including but not limited to gas sterilization, such as ethylene oxide, or steam sterilization.

[0113] The bone material dispensing system can be used to treat a variety of conditions, including osteoporosis, fracture repair or healing, dental procedures for which increased bone formation in the jaw is of clinical benefit, repair of craniofacial bone defects caused by trauma or congenital defects, such as cleft palate / lip, and many other musculoskeletal disorders in which congenital bone growth is insufficient, as will be apparent to one of ordinary skill in the art. The bone material can be administered to treat open fractures and fractures at high risk of nonunion in subjects with spinal disorders, including subjects requiring spinal fusion (e.g., anterior lumbar interbody fusion, posterior lumbar spinal fusion, and cervical fusion) or subjects with degenerative disc disease or arthritis affecting the lumbar and cervical spine.

[0114] Bone material

[0115] In certain embodiments, bone material can be demineralized bone material.In certain embodiments, demineralized bone material can include demineralized bone, powder, fragment, particulate, debris, fiber or other shapes with irregular or random geometry.These can comprise cortex and cancellous bone that for example is demineralized, partially demineralized or demineralized completely.These also comprise surface demineralization, wherein the surface of bone construct is demineralized, partially demineralized or demineralized completely basically, and the main body of bone construct is fully mineralized.The configuration of bone material can obtain by milling, shaving, cutting or processing whole bone, as described in U.S. Patent No. 5,899,939.The whole disclosure is incorporated into the present disclosure by reference.

[0116] In certain embodiments, bone material can comprise elongated demineralized bone fiber, and described elongated demineralized bone fiber has the average length to average thickness ratio or aspect ratio of about 50:1 to about 1000:1.In general appearance, elongated demineralized bone fiber can be circular, spherical, particulate, elongated, powder, fragment, fiber, cylinder, line, narrow strip, thin slice or its combination.In certain embodiments, bone material comprises elongated demineralized bone fiber and fragment.In certain embodiments, bone material comprises the fiber of complete demineralization and the fragment of surface demineralization.In certain embodiments, the ratio of fiber to fragment or powder is about 5,10,15,20,25,30,35,40 or 45 fiber and about 30,35,40,45,50,55,60,65 or 70 fragment.

[0117] 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, wherein the ratio of fibers to fragments is 25:75 to about 75:25.

[0118] In some embodiments, the bone material can be an inorganic material, such as an inorganic ceramic and / or a bone substitute material. Exemplary inorganic materials or bone substitute materials include, but are not limited to, aragonite, feldspar, calcite, brushite, amorphous calcium carbonate, vaterite, keystone, charophyte, struvite, urate, ferrihydrite, cristobalite, diaspore, 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, BIOGLASS TM Fluorapatite, chlorapatite, magnesium-substituted tricalcium phosphate, carbonate hydroxyapatite, substituted forms of hydroxyapatite (e.g., hydroxyapatite derived from bone can be substituted with other ions, such as fluoride, chloride, magnesium, sodium, potassium, etc.), or combinations or derivatives thereof.

[0119] In some embodiments, the bone material may include mineral particles that include tricalcium phosphate and hydroxyapatite in a ratio of about 80:20 to about 90:10. In some embodiments, the mineral particles may include tricalcium phosphate and hydroxyapatite in a ratio of about 70:30 to about 95:5. In some embodiments, the mineral particles may include tricalcium phosphate and hydroxyapatite in a ratio of about 85:15.

[0120] In some embodiments, when the bone material is mixed, it can be seeded together with harvested bone cells and / or bone tissue (eg, cortical bone, autologous bone, allogeneic bone, and / or xenogeneic bone).

[0121] In certain embodiments, bone material can be mixed with one or more therapeutic agents (e.g., anti-inflammatory agents, analgesics, osteoinductive growth factors, antimicrobial agents or combinations thereof). Osteoinductive agents include one or more members of bone morphogenetic protein ("BMP") family. BMP is a class of proteins that are considered to have osteoinductive or growth-promoting activity on endogenous bone tissue, or act as a procollagen precursor. 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 polynucleotides or polypeptides thereof, and mature polypeptides or polynucleotides encoding them.

[0122] BMPs used as osteoinductive agents 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, including full-length BMPs or fragments thereof, or combinations thereof, or polypeptides or polynucleotides encoding polypeptide fragments of all of the BMPs. The isolated BMP osteoinductive agents can be administered as polynucleotides, polypeptides, full-length proteins, or combinations thereof.

[0123] In fact, the osteoinductive factor is a recombinant human bone morphogenetic protein (rhBMP) because they can be supplied indefinitely and do not spread infectious diseases. In certain 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.

[0124] The bone material can include or be mixed with one or more members from the TGF-β superfamily. For example, the matrix can include 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 a combination thereof.

[0125] The bone material may contain or be mixed with a therapeutic agent, including but not limited to an IL-1 inhibitor, such as (anakinra, which is a recombinant non-glycosylated form of human interleukin-1 receptor antagonist (IL-1Ra), or AMG108, which is a monoclonal antibody that blocks the action of IL-1. The bone material may contain or be mixed with a therapeutic agent, the therapeutic agent comprising excitatory amino acids, such as glutamate and aspartate, antagonists or inhibitors of glutamate binding to NMDA receptors, AMPA receptors and / or alginate receptors. The bone material may contain or be mixed with a therapeutic agent for reducing inflammation, the therapeutic agent including but not limited to interleukin-1 receptor antagonists, thalidomide (TNF-α release inhibitor), thalidomide analogs (which reduce TNF-α produced by macrophages), quinapril (an inhibitor of angiotensin II, which upregulates TNF-α), interferons, such as IL-11 (which regulates TNF-α receptor expression) or golden tricarboxylic acid (which inhibits TNF-α).

[0126] The bone material may contain or be mixed with a therapeutic agent, including but not limited to an analgesic. Examples of analgesics include but are not limited to acetaminophen, tramadol, lidocaine, bupivacaine, ropivacaine, narcotic analgesics such as buprenorphine, butorphanol, dextromorphamide, dezocine, dextropropoxyphene, diacetylmorphine, fentanyl, alfentanil, sufentanil, hydrocodone, hydromorphone, ketobemidone, levomethadone, pethidine, methadone, morphine, nalbuphine, opium, oxycodone, opium alkali, pentozocin, pethidine, phenperidine, pirithramide, dextropropoxyphene, remifentanil, sufentanil, tilidine, tramadol, codeine, dihydrocodeine, meptazocine, dezocine, eptazocine, flupirtine, or a combination thereof.

[0127] The bone material may contain or be mixed with a therapeutic agent, including but not limited to an anti-inflammatory agent. Examples of anti-inflammatory agents include, but are not limited to, clonidine, sulindac, sulfasalazine, naroxyn, diclofenac, indomethacin, ibuprofen, flurbiprofen, ketoprofen, aclofenac, aloprin, aproxen, aspirin, diflunisal, fenoprofen, mefenamic acid, naproxen, phenylbutazone, piroxicam, meloxicam, salicylamide, salicylic acid, desoxysulbutic acid, tenoxicam, ketoralac, clonidine, flufenal, salicylsalicylic acid, triethanolamine salicylate, aminopyrine, antipyrine, oxyphenylbutazone, apazone, cinpentazone, flufenamic acid, cloniserine, clonixin, meclofenamic acid, flunixin, colchicine, colchicine, fentanyl, allopurinol, oxypurinol, benzyl hydrochloride, dimethofenadine, bismethoxazole, indole, methyl yohenane hydrochloride, hydroquinone hydrochloride, tetrahydromethindole, benzindole purine hydrochloride, fluprofen, ibufenac, naproxol, fenbufen, cinchophen, diflumizone sodium, fenamox, flutiazine, metazamide, ethamidine hydrochloride, nesiridine hydrochloride, octamidine, miconazole (molinazole), neocinchophen, nimazole, prosazine citrate, texicam, tesimide, tolmetin, trifluprofen, fenamic acid esters (mefenamic acid, meclofenamic acid), nabumetone, celecoxib, etodolac, nimesulide, azapropazone, gold, tepoxalin; dithiocarbamate or a combination thereof.

[0128] Anti-inflammatory agents also include steroids such as 21-acetoxypregnenolone, alclomethasone, dihydroxyprogesterone, amcinonide, beclomethasone, betamethasone, budesonide, cloprednisone, clobetasol, clobetasone, clocortolone, clopredniol, corticosterone, cortisone, cortivazole, deflazacort, hydroxyprednisolone, desoximetasone, dexamethasone, dexamethasone 21-acetate, dexamethasone 21-dinadium, diflorasone, diflucortolone, difluprednate, glycyrrhetinic acid, fluzacort, fluclorazepate, flumethasone, flunisolide, fluocinolone acetate, fluocinolone acetate, fluocinolone butyl, fluocortolone ... Milon, methylfluanilide acetate, fluprednididine acetate, fluprednisolone, flurandrenolide, fluticasone propionate, formocortal, halcinonide, halobetasol propionate, halometasone, bromofluanilide acetate, hydrocortisone, hydrocortisone, loteprednol, maprednione, medrysone, methylprednisone, methylprednisolone, methylprednisolone, mometasone furoate, paramethasone, prednicarbate, prednisolone, prednisolone 25-diethylaminoacetate, prednisolone sodium phosphate, prednisone, prednisolone valerate, prednididine, dimethoate, tixocortolone, triamcinolone, triamcinolone acetonide, triamcinolone acetonide benzyl, triamcinolone acetonide hexyl, or a combination thereof.

[0129] The bone material may contain or be mixed with a therapeutic agent, including but not limited to a statin. Examples of useful statins include but are not limited to atorvastatin, simvastatin, pravastatin, cerivastatin, mevastatin (see U.S. Pat. No. 3,883,140, ​​the entire disclosure of which is incorporated herein by reference), vilvastatin (also known as synvinolin; see U.S. Pat. Nos. 4,448,784 and 4,450,171, all of which are incorporated herein by reference), fluvastatin, lovastatin, rosuvastatin and fluvastatin (Sandoz XU-62-320), dalvastatin (EP Application Publication No. 738510A2, the entire disclosure of which is incorporated herein by reference), eptastatin, pitavastatin or a pharmaceutically acceptable salt thereof or a combination thereof. In various embodiments, the statin may include a mixture of (+) R and (-)-S enantiomers of the statin. In various embodiments, the statin may include a 1:1 racemic mixture of the statin.

[0130] In some embodiments, the bone material may include an antimicrobial agent. In some embodiments, the antimicrobial agent may include one or more of the following: 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; tetracycline; aminoglycosides, such as tobramycin and gentamicin; rifampicin; bacitracin; neomycin; chloramphenicol); miconazole; quinolones, such as oxolinic acid, norfloxacin, nalidixic acid, pefloxacin, enoxacin and ciprofloxacin; penicillins, such as oxacillin and piperacillin; nonoxynol 9; fusidic acid; cephalosporins or a combination thereof.

[0131] Examples of antibacterial agents include, by way of illustration and not limitation, escipasone; sodium sulfadiazine; aletomycin; alexitin; amicillin; pivomecillin; amicycline; amlofloxacin; amlofloxacin mesylate; amikacin; amikacin sulfate; aminosalicylic acid; sodium aminosalicylate; amoxicillin; amphotericin; ampicillin; ampicillin sodium; apacillin sodium; apramycin; aspartic acid; astamicin sulfate; benomycin; avopacin; azithromycin; azlocillin; azlocillin sodium; bacampicillin hydrochloride; bacitracin; bacitracin salicylate; bacitracin zinc; calcium benzoate; erythromycin B; betamycin sulfate; bleomycin sulfate; biapenem; binimycin; benzylpenicillin hydrochloride; bispyribacin; butikacin; bupropion sulfate ; Capreomycin sulfate; Carbadox; Carbenicillin sodium; Carbenicillin sodium; Carbenicillin potassium; Carumonam sodium; Ampicillin; Cefoperazone; Cefdrol; Cefmandole sodium; Cefmandole sodium; Cefoperazone; Ceftriaxone; Cefuroxime sodium; Cefazolin; Cefazolin sodium; Cefbuperazine; Cefuroxime sodium; Cefuroxime; Cefdrin; Cefepime; Cefoperazone hydrochloride Cefuroxime; Cefotecol; Cefixime; Cefmenoxime hydrochloride; Cefmetazole; Cefmetazole sodium; Cefonicid sodium; Cefonicid sodium; Cefuroxime; Cefuroxime sodium; Cefuroxime; Cefuroxime sodium; Cefuroxime; Cefuroxime sodium; Cefuroxime; Cefuroxime sodium; Cefuroxime; Cefuroxime sodium; Cefuroxime; Cefuroxime sodium; Cefuroxime; Cefuroxime sodium; Cefuroxime; Cefuroxime proxetil; Cefuroxime Cefuroxime; Cefuroxime; Cefsulodin sodium; Ceftazidime; Ceftibuten; Cefuroxime sodium; Ceftriaxone sodium; Cefuroxime; Cefuroxime axetil; Cefuroxime axetil; Cefuroxime axetil sodium; Cefuroxime sodium; Cephalexin; Cefalexin hydrochloride; Cefuroxime; Cefuroxime sodium; Cefuroxime sodium; Cephalosporin; Cefuroxime hydrochloride; Cefadroxil; Cefotaxime; Cephalosporin sodium; Cephapirin sodium; Cefadroxil; Cetuximab; Chloramphenicol; Chloramphenicol; Chloramphenicol palmitate; Chloramphenicol pantothenate; Chloramphenicol sodium succinate; Chlorhexidine phosphatidate; Chloroxylenol; Chlortetracycline hydrogen sulfate; Chlortetracycline hydrochloride; Cinofloxacin; Ciprofloxacin; Ciprofloxacin hydrochloride; Ciromycin; Clarithromycin; Clinfloxacin hydrochloride; Clindamycin; Clindamycin hydrochloride; Clindamycin palmitate; Clindamycin phosphate; Clofazimine ; benzathine cloxacillin; cloxacillin sodium; chlorhexidine cloquinol; polymyxin E sodium mesylate; anti-antibiotic sulfate; kumamycin; kumamycin sodium cyclopentyl penicillin; cycloserine; dalfopristin; dapsone; daptomycin; demeclocycline hydrochloride; demeclocycline; dinomycin; diaminoveratridine; dicloxacillin; dicloxacillin sodium; dihydrostreptomycin sulfate; dithiothioate; dirithromycin; doxycycline; doxycycline calcium; doxycycline phosphate complex; doxycycline hydrochloride; oxofuranolate sodium; enoxacin; epicillin; epitetracycline hydrochloride; erythromycin; erythromycin acetate stearate; erythromycin estolate; erythromycin ethylsuccinate; erythromycin glucoheptonate; erythromycin lactobionate; erythromycin propionate; erythromycin stearate; ethambutol hydrochloride; ethionamide;Fleroxacin; Flucloxacillin; Fludeuterated Alanine; Flumequine; Fosfomycin; Fosfomycin Tromethamine; Furoxithrin; Furazolium Chloride; Furazolium Tartrate; Sodium Fusidate; Fusidic Acid; Ganciclovir and Ganciclovir Sodium; Gentomycin Sulfate; Gromonam; Gramicidin; Haloprogin; Hetacillin; Ampicillin Potassium Ketal; Hexidine; Ibafloxacin; Imipenem; Isoconazole; Ipamimicin; Isoniazid; Josamycin; Kanamycin Sulfate; Beilimycin; Levofurantazone; Levophenoxypropyl Penicillin Potassium; Lexithromycin; Lincomycin; Lincomycin Hydrochloride; Lomefloxacin; Lomefloxacin Hydrochloride; Lomefloxacin Mesylate; Locarbef; Sulfamyron; Meclocycline; Meclocycline Sulfosalicylate; Megamycin Potassium Hydrogen Phosphate; Mequindox; Meropenem South; methenomycin; methenomycin hydrochloride; methenamine; methenamine hippurate; methenamine mandelate; methicillin; metronidazole hydrochloride; mezlocillin; mezlocillin sodium; minocycline; minocycline hydrochloride; milincomycin hydrochloride; monensin; monensin sodium; nafcillin sodium; nalidixic acid sodium; nalidixic acid; natamycin; neomycin; neomycin palmitate; neomycin sulfate; neomycin undecylenate; netilmicin sulfate; neutramycin; nifuiradene; nifuradene; nifuratel; nifuron; nifurdazide; nifuramide; nifiupirinol; nifuquinazole; nifurthiazole; nitrocycline; furazolidone; nitroamide; norfloxacin ; Neobiocin sodium; Ofloxacin; Onnetoprim; Penicillin benzylpenicillin and penicillin sodium benzylpenicillin; Oximemonam; Oximemonam sodium; Oxolinic acid; Oxytetracycline; Oxytetracycline calcium; Oxytetracycline hydrochloride; Padilamycin; Parachlorophenol; Paclomycin; Pefloxacin; Pefloxacin mesylate; Penacillin; Penicillins such as benzathine penicillin G, penicillin G potassium, procaine penicillin G, penicillin G sodium, penicillin V, benzathine penicillin V, penicillin V hydralazine and penicillin V potassium; Pentoclax sodium; Pyrimethamine; Piperacillin sodium; Piricillin sodium; Pyrimethamine hydrochloride; Pyrimethamine hydrochloride; Pyrimethamine pamoate; Pyrimethamine penicillin probamate; Polymyxin B sulfate; Methyl Mitomycin; Pupikacin; Pyrazinamide; Zinc pyrithione; Quinicamine acetate; Quinupristin; Racemic thiamphenicol; Ramoplanin; Ranilomycin; Rilomycin; Replicin; Rifabutin; Riformestane; Rifaxil; Rifaamide; Rifampicin; Rifapentine; Rifaximin; Hydropytetracyline; Rosalicycline nitrate; Rosomycin; Rosomycin butyrate; Rosomycin propionate; Rosomycin sodium phosphate; Rosomycin stearate; Rosoxacin; Nitrophenylarsonic acid; Roxithromycin; Sanfepenem sodium; Samoxillin; Sapicillin; Hydroxymycin; Sisomicin; Sisomicin sodium; Sparfloxacin; Spectinomycin hydrochloride; Spiramycin; Distamycin hydrochloride; Stolymycin; Streptomycin sulfate; Streptomycin isoniazid; Sulfadiazine; Sulfadibenzoyl; Sulfacetamide;Sulfadiazine sodium; Sulfadiazine; Sulfadiazine sodium; Sulfadoxine; Sulfadiaz ... Ning; temafloxacin hydrochloride; temocillin; tetracycline; tetracycline hydrochloride; tetracycline phosphate complex salt; tetraoxoprene; thiamphenicol; tifencillin potassium; carboxytopenicillin sodium cresylate; ticarcillin sodium; ticarcillin monosodium; ticarcillinone; chlortetracycline chloride; tobramycin; tobramycin sulfate; tosufloxacin; trimethoprim; co-trimoxazole; triple sulfadiazine; troleandomycin; spectinomycin; gramicidin; vancomycin; vancomycin hydrochloride; vilgamycin; larithromycin; or a combination thereof. ;

[0132] The antimicrobial agent in the bone material can be an antiviral agent that can be mixed with the bone material. The antiviral agent can include but is not limited to adenosine, acyclovir, famciclovir, valacyclovir, ganciclovir, valganciclovir, nucleoside analog reverse transcriptase inhibitors (such as AZT (zidovudine), ddI (didanosine), ddC (zalcitabine), d4T (stavudine) and 3TC (lamivudine)), nevirapine, delavirdine, protease inhibitors (such as saquinavir, ritonavir, indinavir and nelfinavir), ribavirin, amantadine), rimantadine, neuraminidase inhibitors (such as zanamivir and oseltamivir), praconaril, cidofovir, foscarnet and / or interferon.

[0133] Although the present invention has been described with reference to embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the present 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 opening and the second opening being configured to slidably receive at least a portion of a plunger; and a locking member pivotally connected to and extending adjacent to an upper surface of the housing, the locking member including a locking surface extending adjacent to the distal end of the housing, the locking surface being configured to engage a portion of a tubular member, a funnel, or a combination thereof, the locking member being movable in a locked position to lock the portion of the tubular member, the funnel, or a combination thereof with the housing, wherein the tubular member comprises a proximal opening, a distal opening, and a passage disposed therebetween, the proximal opening, the distal opening, and the passage of the tubular member being configured to receive at least the portion of the plunger, and wherein the tubular member is capable of moving 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 accommodate at least the portion of the plunger to dispense bone material, and wherein the tubular member is capable of moving 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 accommodating at least the portion of the plunger.

2. The bone material dispensing device according to claim 1, wherein the locking member is movable in a downward position and an upward position, the downward position being the locking position, and the upward position being an unlocking position for unlocking the tubular member, the funnel or the portion of the combination thereof from the housing.

3. A bone material distribution device according to claim 1, wherein the locking member includes an inner surface, the inner surface includes a support at the proximal end, and a portion of the upper surface of the proximal end of the shell includes a recess, and the support and the recess are configured to engage with the first elastic member.

4. The bone material dispensing device of claim 1, wherein the locking member includes a middle portion including a pivot point that engages the upper surface of the housing.

5. The bone material dispensing device of claim 1, wherein a distal end of the locking member includes the locking surface, the locking surface comprising a flange.

6. The bone material dispensing device of claim 1, wherein the tubular member and / or the funnel is configured to engage a cannula.

7. The bone material dispensing device of claim 6, wherein the sleeve comprises a folded sleeve.

8. The bone material dispensing device of claim 7, wherein the diameter of the folded sleeve is smaller than the diameter of the distal opening of the tubular member so as to allow at least a portion of the folded sleeve to be retained within the tubular member.

9. The bone material distribution device of claim 6, wherein (i) the funnel is configured to partially enclose the tubular member; or (ii) the funnel includes a distal end having a tip geometry, the distal end tip geometry of the funnel being concave.

10. 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.

11. A bone material dispensing device according to claim 10, wherein the trigger assembly includes a driving handle, a fixed handle, a driving pawl, a passive pawl, a second elastic member disposed between the first portion of the shell and the passive pawl, and a third elastic member, the third elastic member being concentric with the plunger and the second elastic member and disposed between the second portion of the shell and the driving pawl, the driving handle being configured to contact the driving pawl when the driving handle moves toward the fixed handle, wherein movement of the driving handle toward the fixed handle causes the driving pawl to engage the plunger and compress the third elastic member, and allows the plunger to perform incremental slidable movement.

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

13. The bone material dispensing device of claim 1, wherein the plunger includes a proximal end and a distal end, the proximal end including a stop.

14. A bone material dispensing system, comprising a bone material dispensing gun and a tray, wherein the bone material dispensing gun comprises: 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 being configured to slidably receive at least a portion of a plunger; and a locking member pivotally connected to and extending adjacent to an upper surface of the housing, the locking member including a locking surface extending adjacent to the distal end of the housing, the locking member being movable in a locked position to lock a portion of a tubular member, a funnel, or a combination thereof with the housing, the tray being engageable with the bone material dispensing gun to load the bone material dispensing gun with bone material, wherein the tubular member comprises a proximal opening, a distal opening, and a passage disposed therebetween, the proximal opening, the distal opening, and the passage of the tubular member being configured to receive at least the portion of the plunger, and wherein the tubular member is capable of moving 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 accommodate at least the portion of the plunger to dispense bone material, and wherein the tubular member is capable of moving 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 accommodating at least the portion of the plunger.

15. The bone material dispensing system of claim 14, wherein the tray is engageable with distal ends of the tubular member and the plunger.

16. The bone material dispensing system of claim 15, wherein the tray comprises: a slot configured to receive the tubular member; a shoulder on a lower surface of the tray, the shoulder configured to receive a portion of the plunger; an upper surface configured to distribute the bone material; and a recess defined from the upper surface, the recess configured to receive a sleeve.

Images