US20220280216A1 - Material delivery surgical device - Google Patents
Material delivery surgical device Download PDFInfo
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- US20220280216A1 US20220280216A1 US17/748,843 US202217748843A US2022280216A1 US 20220280216 A1 US20220280216 A1 US 20220280216A1 US 202217748843 A US202217748843 A US 202217748843A US 2022280216 A1 US2022280216 A1 US 2022280216A1
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- delivery tube
- driving rod
- lever
- passageway
- kit
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Definitions
- lever spring 182 may be eliminated in some embodiments and still provide substantially single-handed operation.
- the lever 180 can be moved toward the first position manually. This can be facilitated by including a closed handle (loop) similar to those common on scissors and forceps at the lower end of the lever 180 , through which an operator may place her fingers and by means of which an operator can impart force to the lever 180 in either the direction away from or toward the handle 122 with a single hand.
- a closed handle similar to those common on scissors and forceps at the lower end of the lever 180 , through which an operator may place her fingers and by means of which an operator can impart force to the lever 180 in either the direction away from or toward the handle 122 with a single hand.
- a first ratchet pawl 172 engages the ratchet teeth 162 of the driving rod 160 and a first pawl spring 174 opposes motion of the first ratchet pawl 172 away from the driving rod 160 (downward, in the depicted embodiment, although, it could be in any direction away from the driving rod 160 ).
- a second ratchet pawl 176 is also shown.
- a second pawl spring 178 opposes motion of the second pawl 176 away from the driving rod 160 (downward, in this case, although it could be in any direction away from the driving rod 160 ).
- Movement of the lever 280 away from the handle 222 may be manually forced, or may be the result of a lever spring within the handle 222 that is coupled to the lever pivot.
- the first gripping spring 272 pushes the lever 280 away from the handle 222 .
- the device can include a holding mechanism for resisting proximal motion of the driving rod while resetting the lever after lever activation. Examples of holding mechanisms are described herein.
- the device can have a rotating mechanism for allowing operator rotation of the delivery tube relative to the body. Examples of rotating mechanisms are described herein.
- the device can include a depth indicator for showing the depth to which the delivery tube is inserted by an operator. Examples of a depth indicator are described herein, and an example is shown in FIG. 3 .
- the delivery tube 140 can be filled with flowable material.
- a plug 198 can be secured to the distal end of the delivery tube 140 to block the exit opening of the nozzle 148 while the delivery tube 140 is packed with flowable material.
- the proximal end 144 of the delivery tube 140 can be fitted with a funnel 194 , wherein a funnel sleeve 196 can engage the groove 146 on the proximal end 144 of the delivery tube 140 to secure the funnel 194 to the delivery tube 140 .
Abstract
Medical devices for injecting materials into patients are disclosed. The devices can include a body having a handle and a lever. The devices can also include a delivery tube comprising a passageway along a longitudinal axis and a nozzle with an opening, the delivery tube configured to couple with a distal end of the body. A driving rod can be inserted into the body and extend into the passageway, such that the lever can move the driving rod distally when the lever is actuated toward the handle. Methods of using the material delivery device are also disclosed.
Description
- The present application is a continuation of U.S. application Ser. No. 15/679,916 filed Aug. 17, 2017, which claims priority benefit to U.S. Provisional Application No. 62/376,835 filed Aug. 18, 2016, the disclosures of each of which are incorporated by reference herein in their entireties.
- The present application relates generally to surgical devices, and more particularly to surgical devices for delivering fusion-promoting material to a surgical site.
- The spine is a flexible structure that extends from the base of the skull to the tailbone. The weight of the upper body is transferred through the spine to the hips and the legs. The spine contains a plurality of bones called vertebrae. The vertebrae are hollow and stacked one upon the other, forming a strong hollow column for support. The hollow core of the spine houses and protects the nerves of the spinal cord. Each vertebra is separated from the vertebra above or below by a cushion-like, fibrocartilage called an intervertebral disc. The discs act as shock absorbers, cushioning the spine, and preventing individual bones from contacting each other. In addition, intervertebral discs act as a ligament that holds vertebrae together. Intervertebral discs also work with the facet joint to allow for slight movement of the spine. Together, these structures allow the spine to bend, rotate and twist.
- The spinal structure can become damaged as a result of degeneration, dysfunction, disease and or trauma. More specifically, the spine may exhibit disc collapse, abnormal curvature, asymmetrical disc space collapse, abnormal alignment of the vertebrae and general deformity, which may lead to imbalance and tilt in the vertebrae. This may result in nerve compression, disability and overall instability and pain. If the proper shaping or curvature are not present due to scoliosis, neuromuscular disease, cerebral palsy, or other disorder, it may be necessary to straighten or adjust the spine into a proper curvature with surgery to correct these spinal disorders.
- Some ailments of the spine result in degeneration of the spinal disc in the intervertebral space between adjacent vertebrae. Disc degeneration can cause pain and other complications. Conservative treatment can include non-operative treatment requiring patients to adjust their lifestyles and submit to pain relievers and a level of underlying pain. Operative treatment options include disc removal. This can relieve pain in the short term, but also often increases the risk of long-term problems and can result in motor and sensory deficiencies resulting from the surgery. Disc removal and more generally disc degeneration disease are likely to lead to a need for surgical treatment in subsequent years.
- Another treatment option includes fusion, which is a surgical method wherein two or more vertebrae are joined together (fused) by way of interbody implants, sometimes with bone grafting, to form a single bone. The current standard of care for interbody fusion requires surgical removal of all or a portion of the intervertebral disc. After removal of the intervertebral disc, the interbody implant is implanted in the interspace to correct disc space collapse between adjacent vertebra, resulting in spinal fusion of the adjacent vertebra. In many cases, the fusion is augmented by a process called fixation. Fixation refers to the placement of screws, rods, plates, or cages to stabilize the vertebrae so that fusion can be achieved. The fusion or fixation will minimize or substantially eliminate relative motion between the fixed or fused vertebrae.
- Fusion-promoting material has been shown to provide faster and improved osseointegration of the implant with the native bone and tissue. Oftentimes, fusion-promoting material is placed into and around the interbody implant to expedite and enhance the growth of bone material in the intervertebral space. The fusion-promoting material can be packed into the interbody implant before or after implantation. Additional fusion-promoting material can be packed around the implant to fill voids around the implant at the surgical site.
- An aspect of at least one of the embodiments disclosed herein includes a device for injecting materials into a patient, the device including a body comprising a handle, a lever, a collar and a cavity inside the body. The device can further include a delivery tube comprising a passageway along a longitudinal axis and a nozzle with a lateral opening, the delivery tube configured to releasably couple to the collar at a distal end of the body. A driving rod can be configured to be inserted from a proximal end of the body and extend through the cavity and into the passageway. In some embodiments, the collar is configured to rotate the delivery tube about the longitudinal axis. The lever can be configured to move the driving rod distally toward the delivery tube when the lever is actuated toward the handle.
- An aspect of at least one of the embodiments disclosed herein includes a device for injecting materials into a patient, the device including a body having a handle and a lever. The device can also include a delivery tube with a passageway along a longitudinal axis and a nozzle with an opening, the delivery tube configured to couple with a distal end of the body. A driving rod can be configured to be inserted into the body and extend into the passageway. In some embodiments, the delivery tube is configured to rotate about the longitudinal axis. In some embodiments, the lever is configured to move the driving rod distally when the lever is actuated toward the handle.
- The passageway of the delivery tube can be configured to be filled with fusion-promoting material. In some embodiments, the opening in the nozzle is a lateral opening. In some embodiments, the nozzle has an angled inner surface.
- One or more of the delivery tube and driving rod can be at least partially flexible. The driving rod can have a plurality of ratchet teeth that are engaged by an advancement mechanism coupled to the lever. The device can further include a gripping element coupled to the lever that is configured to grab the driving rod when the lever is actuated. In some embodiments, the delivery tube and driving rod are disposable. The driving rod can be configured to move unidirectionally in the distal direction. In some embodiments, the driving rod includes at least one channel configured to align with at least one tab on the body. The delivery tube can further include indications representing the depth of insertion of the delivery tube into a patient.
- An aspect of at least one of the embodiments disclosed herein includes a kit for injecting materials into a patient, the kit including a delivery tube with a passageway along a longitudinal axis with an opening at both ends of the passageway. A funnel can be configured to couple with an end of the delivery tube and a plug can be configured to block one of the openings of the delivery tube. The kit can include a ramrod with a shaft that is configured to fit in the passageway of the delivery tube.
- The kit can further include a body with a handle and a lever. A driving rod can be configured to be inserted into the body and extend through the body. In some embodiments, the delivery tube is configured to releasably couple to a distal end of the body and be rotatable about the longitudinal axis while coupled to the body. In some embodiments, the lever is configured to move the driving rod distally into the passageway of the delivery tube when the lever is actuated toward the handle.
- The body can further include a collar configured to rotate the delivery tube about the longitudinal axis. In some embodiments, one or more of the delivery tube and driving rod are at least partially flexible. In some embodiments, the delivery tube and driving rod are disposable.
- At least one of the openings in the delivery tube can be a lateral opening. The passageway of the delivery tube can be configured to be filled with fusion-promoting material. The ramrod can be configured to push the fusion-promoting material through the funnel into the passageway. In some embodiments, at least a portion of the ramrod is flexible. In some embodiments, the funnel has a bent funnel stem.
- An aspect of at least one of the embodiments disclosed herein includes a method of injecting materials into a patient. The method can include coupling a delivery tube on a distal portion of a body, wherein the delivery tube is filled with fusion-promoting material. The method can include inserting a driving rod into the body, wherein the driving rod is configured to fit in the delivery tube. A nozzle of the delivery tube can be placed in the patient, the nozzle having an exit opening. In some embodiments, the method includes manipulating a collar to rotate the delivery tube and direct the exit opening in a desired direction. A lever can be actuated to advance the driving rod distally and push the fusion-promoting material out of the exit opening.
- In some embodiments, the delivery tube can be filled with fusion-promoting material prior to coupling with the body. The steps of filling of the delivery tube can include coupling a plug over the exit opening of the nozzle. A funnel can be coupled on an end of the delivery tube. The funnel is filled with fusion-promoting material and the fusion-promoting material can be pushed into the delivery tube with a ramrod.
- In some embodiments, the method further includes the step of disposing of the delivery tube and the driving rod after injection of the fusion-promoting material.
- These and other features, aspects and advantages of the described embodiments are described with reference to drawings of certain embodiments, which are intended to illustrate, but not to limit. It is to be understood that the attached drawings are for the purpose of illustrating concepts of the described embodiments and may not be to scale.
-
FIG. 1 is a side view of a device for delivering material, in accordance with an embodiment of the present invention. -
FIG. 2 is a rear perspective view of the device ofFIG. 1 . -
FIG. 3 is a perspective view of a delivery tube of the device ofFIG. 1 . -
FIG. 4 is a perspective view of a body and a driving rod of the device ofFIG. 1 . -
FIG. 5 is a close-up side section view of a portion of the body, delivery tube and driving rod of the device ofFIG. 1 . -
FIG. 6 is a perspective view of the driving rod ofFIG. 1 . -
FIG. 7 is a close-up rear perspective view of the driving rod and body ofFIG. 1 . -
FIG. 8 is a side section view of the body ofFIG. 1 illustrating the advancement mechanism. -
FIG. 9 is another side section view of the body ofFIG. 1 with the trigger actuated. -
FIG. 10 is a side section view of a body, in accordance with another embodiment of the present invention. -
FIG. 11 is a perspective view of a delivery tube and a ramrod, in accordance with an embodiment of the present invention. -
FIG. 12 is a perspective view of a delivery tube, a funnel and a ramrod, in accordance with an embodiment of the present invention. -
FIG. 13 is a perspective view of a delivery tube, a funnel, a plug and a ramrod, in accordance with an embodiment of the present invention. -
FIG. 14 is a perspective view of a delivery tube, a funnel, a plug and a ramrod, in accordance with another embodiment of the present invention. -
FIG. 15 is a close-up side section view of the delivery tube and the funnel ofFIG. 14 . - Disclosed herein is a device to aid in the delivery and placement of flowable material to a surgical site such as an intervertebral space. The flowable material can include fusion-promoting material, such as Demineralized Bone Matrix (DBM), allograft, and other bone graft material. In some situations, the flowable material includes medications, saline, water, other fluids, and the like. Although the device is described herein in connection with a spinal surgical procedure, the device can be used in other surgical procedures where delivery of flowable material is desired.
- The device, or tool, allows a surgeon to more easily access the surgical site from outside the incision and deliver the fusion-promoting material. In some embodiments, the device allows a surgeon to control the flow rate and dispensing direction of the fusion-promoting material. Additionally disclosed is a device that permits substantially single-handed operation. Such a device frees up an operator's other hand to perform other functions during surgery. In some embodiments, the device can have one or more disposable components that are discarded after use to minimize the potential for cross-contamination and infection. By providing one or more of the preceding advantages, the device described herein improves the ease and speed with which disc replacement, spinal fusion surgery, or other surgery can be completed.
- The device will be further described with reference to the drawings, which are intended to be illustrative of certain embodiments of the device, but are not intended to limit the scope of the device. One of skill in the art will recognize that other embodiments of the invention are possible within the scope of the disclosure and no disclaimer of such additional embodiments is intended by referring to the illustrative examples.
-
FIGS. 1-3 illustrate various external views of an embodiment of thedevice 100.FIG. 1 is a side view of thedevice 100 illustrating abody 120, adelivery tube 140 in mechanical communication with thebody 120, and a drivingrod 160 extending through at least a portion of thebody 120 and into thedelivery tube 140.FIG. 2 is a perspective view of thedevice 100. Thebody 100 can include ahandle 122 and a mechanism configured to advance the drivingrod 160. In the illustrated embodiment, the mechanism is alever 180 attached to thehandle 122 that can be actuated to move the drivingrod 160. In some embodiments, thebody 120 does not enclose the drivingrod 160 and the drivingrod 160 is external to, but in communication with, thebody 120. - As used herein, the distal direction of the
device 100 is defined as being toward thedelivery tube 140 side and the proximal direction is defined as being toward the drivingrod 160 side. The bottom of thedevice 100 is the side with thehandle 122 and the top of thedevice 100 is the side opposite thehandle 122. - With continued reference to
FIGS. 1-2 , thelever 180 is in mechanical communication with the drivingrod 160. Movement of thelever 180 toward thehandle 122 can urge the drivingrod 160 to advance in the distal direction relative to thebody 120. The advancement mechanism may operate in any of a plurality of different ways. For example, in the illustrated embodiment the advancement mechanism is a ratcheting drive mechanism within thebody 120. The ratcheting drive mechanism can use ratchet teeth to engage the drivingrod 160 and advance the drivingrod 160 distally when thelever 180 is moved toward thehandle 122, as described in further detail below. - The
delivery tube 140 can be releasably attached to the distal end of thebody 120.FIG. 3 illustrates an embodiment of thedelivery tube 140. Thedelivery tube 140 is an elongate component with apassageway 142 extending along thelongitudinal axis 154 of thedelivery tube 140. Thepassageway 142 can transport material from theproximal end 144 to thenozzle 146 where the material is discharged to the surgical site. - The
proximal end 144 of thedelivery tube 140 can be configured to couple with the distal end of thebody 120. In the embodiments illustrated inFIGS. 3-4 , thedelivery tube 140 includes ahex portion 148 and thebody 120 includes anaperture 126 with a complementary hex shape to accept thedelivery tube 140. When thedelivery tube 140 is inserted into theaperture 126, a locking mechanism can secure thedelivery tube 140 to thebody 120 to prevent thedelivery tube 140 from uncoupling from theaperture 126. The locking mechanism can have any of a plurality of different functional locking designs. - In the illustrated embodiment, the
delivery tube 140 has agroove 146, and thebody 120 has a slidingsleeve 128 that is configured to engage with thegroove 146 on thedelivery tube 140 to secure the two components together. With reference toFIGS. 3-5 , thegroove 146 is an area of thedelivery tube 140 with a reduced diameter. The slidingsleeve 128 includes a cutout that can be aligned with theaperture 126 of thebody 120 to form an unobstructed passage. Thedelivery tube 140 can be inserted into theaperture 126 when the cutout of the slidingsleeve 128 is aligned with theaperture 126. The slidingsleeve 128 can then be moved so that aprotrusion 130 in the slidingsleeve 128 engages with thegroove 146 of thedelivery tube 140 to hold thedelivery tube 140 on thebody 120. Thedelivery tube 140 is prevented from moving longitudinally and decoupling from thebody 120. In some embodiments, the slidingsleeve 128 is a push button mechanism that can be actuated from the outer surface of thebody 120. The slidingsleeve 128 can be normally biased in the engage position, such as with aspring 130. When the button is depressed, the slidingsleeve 128 can be in the release position, wherein the protrusion in the slidingsleeve 128 does not obstruct theaperture 126. Thedelivery tube 140 can be decoupled from thebody 120 when the button is depressed. - The distal end of the
delivery tube 140 includes anozzle 148 with an opening to discharge the flowable material. The opening at thenozzle 148 is in fluid communication with an opening at theproximal end 144 of thedelivery tube 140 through thepassageway 142. In the embodiment illustrated inFIG. 3 , thenozzle 148 has an opening that discharges laterally at an angle from the longitudinal axis of the delivery tube; i.e., in a sideways direction from the longitudinal axis. The lateral opening of thenozzle 148 can allow the user to place thedelivery tube 140 adjacent a surgical site and discharge the flowable material to efficiently fill in the cavity and help disperse the material throughout the implant site. In some embodiments, thenozzle 148 has an angled inner surface to deflect the flowable material out the lateral opening. Theangled nozzle 148 can be particularly useful to reach the space behind an implanted device. The inner surface can have an angle of approximately 30, 45 or 60 degrees from the longitudinal direction. In some embodiments, the angle of the inner surface is at least approximately 15 degrees and/or less than or equal to approximately 90 degrees. - With continued reference to
FIG. 3 , thedelivery tube 140 can have an anti-rotation feature, such as aknob 150 near theproximal end 144. Theknob 150 can have a hexagonal shape and is configured to fit in a complementary cavity of theaperture 126. The hexagonal shaped coupling allows thedelivery tube 140 to be secured to thebody 120 in 60 degree increments so that the nozzle orientation can be turned in several directions. In some embodiments, theknob 150 can have other shapes, such as triangular, square, octagonal, star, oval or any other non-circular shape. The orientation of the nozzle can be rotated in any increments depending on the shape of the knob and aperture, such as 15 degrees, 30 degrees, 45 degrees, 90 degrees, 120 degrees or 180 degrees. In some embodiments, the orientation of the nozzle is adjustable in increments from at least approximately 1 degree and/or less than or equal to approximately 180 degrees. - In some embodiments, the orientation of the nozzle can be adjusted without removing and reinserting the
delivery tube 140 in a different orientation. Theaperture 126 andknob 150 can have any of a plurality of different rotational mechanisms. For example, the illustrated embodiment shows thebody 120 with arotatable collar 134. Thecollar 134 includes theaperture 126 that is configured to couple with theknob 150. Thecollar 134 can be rotated, which in turn rotates thedelivery tube 140 about itslongitudinal axis 154 to orient the nozzle in the desired direction. In the illustrated embodiment, thecollar 134 has aplunger 136 with a ball that is configured to engage detents on thebody 120. The detents can be arranged in a circular configuration. The number and spacing between detents can be determined depending on the desired rotational orientations for the nozzle. As the number of detents increases, thedelivery tube 140 can be set to finer increments of rotational orientations. - Other rotational mechanisms are also envisaged for the
device 100. For example, theknob 150 can have a ball plunger and theaperture 126 can have detents around the inner perimeter where the ball protrusion can engage in order to hold thedelivery tube 140 in discreet rotational orientations. In another example, thecollar 134 can have a plurality of teeth and thebody 120 can have a tab that engages the teeth to rotationally lock the collar. The tab can be released by depressing a button to release the tab from the teeth. In some embodiments, the rotational orientation ofcollar 134 is infinitely adjustable and can be rotated to any angle, such as a collar with a friction locking mechanism that clamps on the collar to secure it in position. - In some embodiments, the
delivery tube 140 is rigid. Thedelivery tube 140 may not bend or only have minimal bending so that thenozzle 148 can be pushed to the surgical site through obstacles. In other embodiments, thedelivery tube 140 is flexible and can bend along itslongitudinal axis 154 to help route thedelivery tube 140 around obstacles in the patient's anatomy to the surgical site. In embodiments with a flexible delivery tube, thedelivery tube 140 is preferably sufficiently rigid so that thepassageway 142 does not collapse or kink. - The
delivery tube 140, or portions thereof, can be made of any of a variety of materials known in the art, including but not limited to a polymer such as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), polyethylene, fluoropolymer, hydrogel, or elastomer; a ceramic such as zirconia, alumina, or silicon nitride; a metal such as titanium, titanium alloy, cobalt chromium or stainless steel; or any combination of the above materials. Thedelivery tube 140 can be made of multiple materials in combination. For example, the proximal portion can be made of a metal and the nozzle can be made of a polymer. Thedelivery tube 140 is preferably made of a biocompatible material. - With continued reference to
FIG. 3 , thedelivery tube 140 can haveindications 152 along the length of the tube. Theindications 152 can be markings that display the position from the distal tip of thedelivery tube 140 to inform the user of the depth of insertion into the patient's body. In some embodiments, theindications 152 include distance measurements, such as in inches, millimeters, centimeters, and the like. In some embodiments, theindications 152 show relative depth, such as with different colored indications, lines of increasing thickness, increasing sequential numbers, or any of a plurality of other indications that show increasing depth. Theindications 152 can be placed along the entire length of thedelivery tube 140 or only a portion of the length of thedelivery tube 140. - In the embodiment illustrated in
FIG. 6 , the drivingrod 160 is an elongate member having alongitudinal axis 164 and asurface 166 with a plurality ofratchet teeth 162 on at least a portion of thesurface 166. The drivingrod 160 is configured to insert into ahole 124 disposed on the proximal end of thebody 120. In other embodiments, the drivingrod 160 is inserted from a distal end of thebody 120, or from the top side of thebody 120, or any other side of the body that provides access into the body. The drivingrod 160 can extend through thebody 120 and the drivingrod 160 can be advanced in the distal direction by an advancement mechanism. The advancement mechanism can be in mechanical communication with theratchet teeth 162 to move the drivingrod 160. The drivingrod 160 is configured to fit into thepassageway 142 of thedelivery tube 140 to push the flowable material out thenozzle 146 of thedelivery tube 140. -
FIG. 7 illustrates an embodiment of the proximal end of thebody 120 with thehole 124 through which the drivingrod 160 is inserted. Thehole 124 can have a shape and size that matches and/or is complementary to the shape and size of the drivingrod 160. The drivingrod 160 can be inserted into thehole 124 with theratchet teeth 162 facing downward (i.e. toward the handle) to engage with the advancement mechanism. In some embodiments, the rotational orientation of the drivingrod 160 when inserting into thehole 124 is set by aligning an indicator (e.g., a line marking) on the drivingrod 160 with a second indicator on thebody 120. - The driving
rod 160 andhole 124 can be configured so that the drivingrod 160 can only be inserted in one or more desired rotational configurations. In some embodiments, thehole 124 has at least onetab 138 and the drivingrod 160 has acomplementary channel 168 for inserting the drivingrod 160 in the desired orientation into thehole 124. The drivingrod 160 can be inserted into thehole 124 only when thetab 138 is aligned with thechannel 168 to ensure that the drivingrod 160 is in the desired orientation. In the embodiment illustrated inFIG. 7 , thehole 124 has twotabs 138 and the drivingrod 160 has twochannels 168. Thetabs 138 in the illustrated embodiment are not 180 degrees apart such that the drivingrod 160 can be inserted into thehole 124 in only one orientation. In a different example, the hole can have two tabs that are 180 degrees apart and the driving rod can have twochannels 180 degrees apart so that the driving rod can be inserted in either of two orientations. In another example, the hole can have one tab and the driving rod can have a plurality of channels, such as six channels equally distanced around the driving rod, so that the driving rod can be inserted in six different orientations that are 60 degrees apart. In embodiments where the driving rod can be inserted in more than one orientation, the driving rod can have ratchet teeth on several surfaces so that the ratchet teeth can engage the advancement mechanism in all the different orientations. - In some embodiments, the driving
rod 160 is locked rotationally so that the drivingrod 160 cannot rotate once it is inserted in thebody 120. For example, thetab 138 andchannel 168 engagement discussed above can prevent the drivingrod 160 from rotating in thehole 124. The rotationally locked configuration can help prevent disengagement of the advancement mechanism. For example, as discussed herein, the drivingrod 160 can have ratchetteeth 162 that face downward in order to engage with ratchet pawls. The rotationally locked configuration can ensure that theratchet teeth 162 stay engaged with the ratchet pawls during operation of the device. -
FIG. 8 is a cutaway side view of an embodiment of thedevice 100 showing theinternal cavity 127 of thebody 120. In thecavity 127, theratchet teeth 162 of the drivingrod 160 can engage with anadvancement mechanism 170 of thebody 120. Further shown is afirst ratchet pawl 172 and afirst pawl spring 174 which work together with thelever 180,lever spring 182 andlever pivot 184 to drive the drivingrod 160 distally when thelever 180 is moved toward the handle 122 (i.e. toward a second position from a first position, shown by the double-headed arrow ofFIG. 8 ). When an operator grips thehandle 122 and thelever 180 in one hand and pulls thelever 180 proximally toward thehandle 122, thelever 180 moves thefirst ratchet pawl 172 distally by pivoting about thelever pivot 184. Since thefirst ratchet pawl 172 is engaged against theratchet teeth 162 of the drivingrod 160, the distal motion of theratchet pawl 172 drives the drivingrod 160 distally. Also depicted in this view are asecond ratchet pawl 176 and asecond pawl spring 178. Thesecond ratchet spring 178 allows thesecond ratchet pawl 176 to move away from the drivingrod 160 as eachangled ratchet tooth 162 advances distally. Once eachtooth 162 passes thesecond pawl 176, thepawl spring 178 pushes thesecond pawl 176 back toward the drivingrod 160, to engage thenext ratchet tooth 162 along the drivingrod 160. Thus thesecond ratchet pawl 176 allows distal motion of the drivingrod 160 and prevents proximal motion of the drivingrod 160. As thelever 180 is pulled again or farther toward thehandle 122, further distal motion is imparted to the drivingrod 160. - Thus, the
second ratchet pawl 176 and thesecond pawl spring 178 cooperate to restrict or oppose proximal motion of the drivingrod 160 as thelever 180 is reset away from thehandle 122. In the illustrated embodiment, thelever 180 has aspring 182 that biases thelever 180 toward the first position. Once the operator releases the force on thelever 180, thelever spring 182 can move thelever 180 away from thehandle 122 toward its original position. As this occurs, thefirst ratchet pawl 172 andfirst pawl spring 174, coupled to thelever 180, are also returned toward their original positions prior to the operator pulling thelever 180 proximally. This occurs with no distal or proximal motion of the drivingrod 160 since thefirst pawl spring 174 allows thefirst ratchet pawl 172 to move away and toward the drivingrod 160 along theratchet teeth 162 of therod 160 as thefirst ratchet pawl 172 moves along theteeth 162 proximally. Thesecond ratchet pawl 176, engaged against theratchet teeth 162, opposes proximal motion of therod 160 during this action. In embodiments where a gripping or other type of driving mechanism is used, thesecond ratcheting pawl 176 andspring 178 may be used to provide similar restricted proximal motion where the drivingrod 160 comprises someratchet teeth 162 on at least a portion of therod 160 which can cooperate with thesecond ratchet pawl 176 andspring 178. - It is to be understood that the
lever spring 182 may be eliminated in some embodiments and still provide substantially single-handed operation. In such cases, thelever 180 can be moved toward the first position manually. This can be facilitated by including a closed handle (loop) similar to those common on scissors and forceps at the lower end of thelever 180, through which an operator may place her fingers and by means of which an operator can impart force to thelever 180 in either the direction away from or toward thehandle 122 with a single hand. - In another embodiment, the device comprises a holding means wherein a second ratchet pawl and second ratchet spring are not present. The holding means instead may comprise, for example, a pneumatic grip, a hook, a latch, a grabbing device, the gripping mechanism described further herein, manually holding the driving rod in its distal position, or another mechanical means of restricting proximal motion.
- In other embodiments, the device comprises a driving means comprising a first ratchet pawl and a spring that engages a thread which winds around the driving rod. Ratchet teeth may be unnecessary in this embodiment. The lever may instead drive the driving rod distally by engaging the threads in the same ratcheting manner described herein, and retraction may be achieved by rotating the driving rod such that the rod moves proximally with the ratchet pawls engaged against the threads of the driving rod.
- In other embodiments, the device comprises a driving mechanism comprising for example, a pneumatic grip, a hook, a latch, a grabbing device, the gripping mechanism (described further below), an element adapted and configured for manually pushing the driving rod distally, or another mechanical means of moving the driving rod distally to push the flowable material through the delivery tube. These and similar embodiments will be apparent to the person skilled in the art upon consideration of alternative embodiments described herein.
- As illustrated in the embodiment of
FIG. 8 , in operation afirst ratchet pawl 172 engages theratchet teeth 162 of the drivingrod 160 and afirst pawl spring 174 opposes motion of thefirst ratchet pawl 172 away from the driving rod 160 (downward, in the depicted embodiment, although, it could be in any direction away from the driving rod 160). Also shown is asecond ratchet pawl 176. Asecond pawl spring 178 opposes motion of thesecond pawl 176 away from the driving rod 160 (downward, in this case, although it could be in any direction away from the driving rod 160). Further depicted is thelever pivot 184 about which thelever 180 pivots to drive the drivingrod 160 distally by engaging and moving theratchet teeth 162 distally when thelever 180 is moved toward thehandle 122. Also depicted is thelever spring 182, which opposeslever 180 movement toward thehandle 122, and which is capable of moving thelever 180 away from thehandle 122 when thelever 180 is released. -
FIG. 9 is a cutaway side view of an embodiment of thedevice 100 showing thecavity 127 of thebody 120. In the illustrated embodiment, theratchet teeth 162 are engaged by theadvancement mechanism 170, wherein thelever 180 is in a second position toward thehandle 122. Theadvancement mechanism 170, thefirst ratchet pawl 172, and the drivingrod 160 are shown as they appear when thelever 180 is moved toward thehandle 122. As can be seen, movement of thelever 180 toward thehandle 122 causes thefirst ratchet pawl 172, and the drivingrod 160 to move distally, through engagement of theratchet pawl 172 with theratchet teeth 162 of the drivingrod 160. - In some embodiments, the
device 100 is adapted for single-handed use. It is to be understood in regards to the phrase “single-handed,” the functions of holding the device in place and advancing the drivingrod 160 may, in most instances, be performed with a single hand. However, it is also noted that in some cases, depending upon operator preference and the vagaries of patient physiology, two hands may be used, e.g. to impart greater force to thelever 180, without departing from the spirit and scope of the disclosure. The phrase “single-handed” thus distinguishes embodiments of the present device over other fluid delivery devices in which the device is held in place with one hand and the material is delivered by pushing, twisting or striking an injection arm. In preferred embodiments, the device of the present disclosure also permits the operator to hold the device in place and impart force for insertion with a single hand. In addition to the aforementioned advantages, single-handed use is amenable to less invasive surgery than two-handed use. - In some embodiments, the
ratchet teeth 162 extend along the driving rod 160 a length sufficient to allow the drivingrod 160 to advance to thenozzle 148 of thedelivery tube 140. For example, theratchet teeth 162 can extend along the length of the drivingrod 160 for between about 6 and about 10 inches, for about 8 inches, for about 12 inches, for about 16 inches, for at least 3 inches, or for the entire length of the rod. In referring to the ratchet teeth length along the rod, “about” refers to variations of 0.5 inches to 1 inch, or of 1 inch to 2 inches. - In some embodiments, the device is configured so that the driving
rod 160 can only be advanced in the one direction. For example, theadvancement mechanism 170 may be configured to move the drivingrod 160 distally but not proximally. Moving the drivingrod 160 only in the distal direction can help prevent contamination of thebody 120, which can be difficult to clean and sterilize, particularly the internal mechanisms of thebody 120. Also, in procedures where more than onedelivery tube 140 and/or drivingrod 160 are used, thebody 120 can be interchangeably used with several delivery tubes and driving rods without cross-contamination of materials. - Some embodiments of the device are adapted and configured to allow retraction of the driving rod in the proximal direction. This may be achieved in any of a plurality of different ways. In some embodiments, the surface of the driving
rod 160 comprises an area that is substantially free of ratchet teeth on a contiguous longitudinal surface of the driving rod, and the drivingrod 160 is movable proximally relative to thebody 120 upon rotation of the drivingrod 160 about itslongitudinal axis 164 such that theratchet pawls ratchet teeth 162 and are instead in contact with the contiguous longitudinal surface that is free ofratchet teeth 162. In some embodiments, theratchet teeth 162 disengage from first andsecond ratchet pawls rod 160 about itslongitudinal axis 164. In some embodiments, the drivingrod 160 comprises a proximal end having a handle to rotate the driving rod. - Although this retraction is preferably carried out by the operator holding the
handle 122 in one hand and turning the drivingrod 160 with the other, this action is not to be interpreted as derogating in any way single-handed operation of thedevice 100, as single-handed operation generally refers to simultaneously holding thehandle 122 and imparting drive force to thelever 180 with a single hand, and that only in most cases. As the drivingrod 160 may be easily disengaged from theratchet pawls axis 164, it is considered that the present disclosure provides for easy and fast retraction of the drivingrod 160. - In other embodiments, the driving rod may comprise a threading around the driving rod instead of ratchet teeth, wherein the
ratchet pawls rod 160 can be retracted by turning the drivingrod 160 about thelongitudinal axis 164 to unscrew the threads. Other embodiments may comprise combinations of threads, ratchet teeth, and/or a substantially smooth area along the driving rod surface, and a combination of ratcheting and gripping elements to provide the controlled distal and proximal movement of the driving rod. - If needed or desired, retraction of the driving
rod 160 using the features and methods described herein may also allow return or suction of the flowable material. When the drivingrod 160 is moved in the proximal direction in thepassageway 142 of thedelivery tube 140, the vacuum created by the retracted drivingrod 160 can cause the flowable material to be sucked back into thedelivery tube 140. This feature can be used to collect excess flowable material that was dispensed, collect flowable material for repositioning, or collect other fluids in the surgical site for disposal. For example, blood in the surgical site can be collected in thedelivery tube 140 by retracting the drivingrod 160 to suck up the blood. -
FIG. 10 is a cutaway side view illustrating a non-ratcheting embodiment of adevice 200. Thedevice 200 can have abody 220 with aninternal cavity 227 housing twogripping elements gripping element 270 is adapted and configured to grip and push the drivingrod 260 distally when thelever 280 is moved toward thehandle 222. The secondgripping element 274 allows distal movement of the drivingrod 260, but opposes proximal motion of the drivingrod 260 when thelever 280 is released and allowed to move away from thehandle 222, for example, to its original resting (first) position. The firstgripping element 270 also releases its grip on the drivingrod 260 when thelever 280 is moved away from thehandle 222, for example, to its original resting position. The firstgripping spring 272 moves the firstgripping element 270 proximally when thelever 280 is released. The firstgripping element 270 is adapted and configured to only grip the drivingrod 260 upon distal motion of the drivingrod 260. Similarly, the secondgripping element 274 is adapted and configured to only grip the drivingrod 260 upon proximal motion of the drivingrod 260. - With continued reference to
FIG. 10 , the firstgripping spring 272 can bias the firstgripping element 270 in the proximal direction. When an operator moves thelever 280 toward thehandle 222, thelever 280 can push the lower part of the firstgripping element 270 distally, which tilts the firstgripping element 270. The tilt can enable the firstgripping element 270 to grip the drivingrod 260 and move it distally. When thelever 280 moves away from thehandle 222, the firstgripping element 270 moves proximally to return to its proximal-most position. The force from the firstgripping spring 272 can make the firstgripping element 270 less tilted to enable the firstgripping element 270 to slide over the drivingrod 260 without gripping the rod. Movement of thelever 280 away from thehandle 222 may be manually forced, or may be the result of a lever spring within thehandle 222 that is coupled to the lever pivot. In some embodiments, the firstgripping spring 272 pushes thelever 280 away from thehandle 222. - A second
gripping element 274 is normally biased in a tilted position by a secondgripping spring 276. When the drivingrod 260 moves in the distal direction, the secondgripping element 274 becomes less tilted and allows the drivingrod 260 to slide through the secondgripping element 274. However, the secondgripping element 274 grips the drivingrod 260 and prevents the drivingrod 260 from moving proximally when the firstgripping element 270 is moved proximally. A grippingrelease lever 278 can be actuated to make the secondgripping element 274 less tilted, which releases the secondgripping element 274 and allows the drivingrod 260 to be retracted. - In some embodiments of the device comprises a gripping element and a ratcheting drive mechanism as described previously. Some embodiments comprise other means for moving the driving rod distally. Other mechanical mechanisms may be capable of allowing unidirectional movement, along with having a release mechanism for reversing such unidirectional movement.
- In some embodiments, the
delivery tube 140 is preloaded with flowable material prior to being mounted to thebody 120. The flowable material can be viscous and it may be difficult to pack the material into thepassageway 142 of thedelivery tube 140. Preloading thedelivery tube 140 while it is disconnected from thebody 120 can make the packing of the flowable material easier and faster. As illustrated inFIG. 11 , aramrod 190 can be used to pack the flowable material into thedelivery tube 140. Theramrod 190 can have anelongate shaft 192 that is configured to slide within thepassageway 142 of thedelivery tube 140. For example, thepassageway 142 can have a circular cross-sectional shape and theramrod 190 can have a cylindrically shaped shaft, wherein thepassageway 142 and theramrod 190 are substantially the same diameter. In other embodiments, the passageway can have a cross-sectional shape that is square, star, polygon, oval, or any other shape. Theramrod 190 has a shaft with a shape that is complementary to the shape of the passageway. - The flowable material can be inserted in the
passageway 142 of thedelivery tube 140 and theramrod 190 can be used to push and compact the flowable material in thepassageway 142. As discussed previously, the cross-section of theshaft 192 of theramrod 190 is preferably substantially the same size and shape as the cross-section of thepassageway 142 to effectively and efficiently move the flowable material through thepassageway 142 without leakage around theshaft 192. Afunnel 194 can be used to help insert the flowable material into thepassageway 142, as illustrated inFIG. 12 . Thefunnel 194 can couple to theproximal end 144 of thedelivery tube 140 such that the inside of the funnel is in fluid communication with thepassageway 142. - The
funnel 194 can be coupled to thedelivery tube 140 through any of a plurality of different releasable connections, such as for example a compression fitting, interference coupling, threaded connection, or any other functional coupler. In some embodiments, thefunnel 194 has afunnel sleeve 196 that is configured to engage with thegroove 146 on thedelivery tube 140 to secure the two components together. As discussed above, thegroove 146 is an area of thedelivery tube 140 with a reduced diameter. Thefunnel sleeve 196 includes a cutout that can be aligned with the drain tube of thefunnel 194 to form an unobstructed passage. Thefunnel 194 can be coupled over thedelivery tube 140 when the cutout of thefunnel sleeve 196 is aligned with the drain tube. Thefunnel sleeve 196 can then be moved so that a protrusion in thefunnel sleeve 196 engages with thegroove 146 of thedelivery tube 140 to hold thefunnel 194 on thedelivery tube 140, similar to described above for the connection between thebody 120 and thedelivery tube 140. In some embodiments, thefunnel sleeve 196 is a push button mechanism that can be actuated from the outer surface of thefunnel 194. Thefunnel sleeve 196 can be normally biased in the engage position, such as with a spring. When the button is depressed, thefunnel sleeve 196 can be in the release position, wherein the protrusion in thefunnel sleeve 196 does not obstruct the drain tube. Thefunnel 194 can be decoupled from thedelivery tube 140 when the button is depressed. - With reference to
FIG. 13 , aplug 198 can be placed over thenozzle 148 of thedelivery tube 140 to prevent the flowable material from unintentionally exiting out thenozzle 148 as thedelivery tube 140 is filled from theproximal end 144. In some embodiments, theplug 198 has a cavity, which accepts thenozzle 148 to block the exit opening of thenozzle 148. Theplug 198 can be coupled to thedelivery tube 140 through any of a plurality of different releasable connections, such as for example a compression fitting, interference coupling, threaded connection, or any other functional coupler. In the illustrated embodiment, theplug 198 includes setscrews that are fastened against thenozzle 148 to fix theplug 198 onto thedelivery tube 140. Theramrod 190 can be used to pack the flowable material in thedelivery tube 140 in preparation for dispensing in the surgical site. Thedelivery tube 140 can be packed either with or without theplug 198 attached to the distal end. - As illustrated in
FIG. 14 , afunnel 294 can be coupled to a distal end of thedelivery tube 240 through any of a plurality of different releasable connections, such as for example a compression fitting, interference coupling, threaded connection, or any other functional coupler. Coupling thefunnel 294 on the distal end of thedelivery tube 240 can help to reach and fill the distal portion of thedelivery tube 240 with flowable material, particularly when the flowable material is viscous. In some embodiments, aplug 298 is placed over the proximal end of thedelivery tube 240 to prevent the flowable material from unintentionally exiting out the proximal end as thedelivery tube 140 is filled from the distal end. Theplug 298 can have a cavity that accepts the proximal end of thedelivery tube 240 to block the opening of the passageway. Theplug 298 can be coupled to thedelivery tube 240 through any of a plurality of different releasable connections, such as for example a compression fitting, interference coupling, threaded connection, or any other functional coupler. In some embodiments, theplug 298 includes setscrews that are fastened against thedelivery tube 240. In other embodiments, theplug 298 has protrusions on the inner surface that fits into a groove on a surface of thedelivery tube 140. - The
funnel 294 can fit over thenozzle 248 and is configured to direct the flowable material into the opening in thenozzle 248. In the illustrated embodiment ofFIG. 15 , thefunnel stem 296 has a bent shape. The angle of the bend can generally coincide with the angled inner surface of the nozzle, as discussed above. As illustrated inFIG. 15 , a first portion of thefunnel stem 296 is configured to fit over the distal portion of thedelivery tube 240. A second portion of thefunnel stem 296 is configured to direct flowable material into the opening in thenozzle 248. - The
ramrod 290 can be used to push the flowable material into the passageway of thedelivery tube 240 before dispensing in the surgical site. Theshaft 292 of theramrod 290 can be sized and shaped to have generally the same dimensions as the passageway. Theramrod 290 can push the flowable material down thefunnel 294 through the second portion of thefunnel stem 296 and into thenozzle 248. In some embodiments, at least a portion of theramrod 290 can be flexible and/or compressible so that theramrod 290 can conform to the contours of the bend in thefunnel stem 296 as theramrod 290 pushes the flowable material into thedelivery tube 240. For example, theshaft 292 can be made of a rubber material and be flexible enough to bend in thefunnel stem 296, but still provide sufficient rigidity to force the flowable material into thedelivery tube 240. - In some embodiments, the device comprises a body, a delivery tube with a passageway in fluid communication with the body, an advancement mechanism for driving a rod distally into the passageway, and a lever to move the advancement mechanism. The advancement mechanism can comprise a gripping mechanism for gripping the driving rod while the lever drives the driving rod distally relative to the body. An example of a gripping mechanism is illustrated in
FIG. 10 . In some embodiments, the advancement mechanism comprises ratcheting teeth for incrementally ratcheting the driving rod distally as the lever is pulled proximally relative to the handle. Examples of a ratcheting mechanism are described herein and shown inFIGS. 8 and 9 . The device can include a holding mechanism for resisting proximal motion of the driving rod while resetting the lever after lever activation. Examples of holding mechanisms are described herein. The device can have a rotating mechanism for allowing operator rotation of the delivery tube relative to the body. Examples of rotating mechanisms are described herein. The device can include a depth indicator for showing the depth to which the delivery tube is inserted by an operator. Examples of a depth indicator are described herein, and an example is shown inFIG. 3 . - In a method of preparing a
delivery tube 140 for use on adevice 100, thedelivery tube 140 can be filled with flowable material. Aplug 198 can be secured to the distal end of thedelivery tube 140 to block the exit opening of thenozzle 148 while thedelivery tube 140 is packed with flowable material. Theproximal end 144 of thedelivery tube 140 can be fitted with afunnel 194, wherein afunnel sleeve 196 can engage thegroove 146 on theproximal end 144 of thedelivery tube 140 to secure thefunnel 194 to thedelivery tube 140. - Flowable material can be placed in the
funnel 194 and directed through the bottom of the funnel into thepassageway 142 of thedelivery tube 140. In some embodiments, aramrod 190 is used to push the flowable material into thepassageway 142. Theramrod 190 can be used to move the flowable material toward the distal end of thedelivery tube 140, and to compress the flowable material when desired. In some embodiments, theplug 198 has a vent, or the vent can be an opening disposed between theplug 198 andnozzle 148, so that air inside thedelivery tube 140 can be expelled as the flowable material is placed in thepassageway 142. The venting of the air can help to relieve pressure that may otherwise build up in thepassageway 142, which can lead to resistance in inserting the flowable material. - After a desired amount of flowable material is placed in the
delivery tube 140, thefunnel 194 and/or plug 198 can be removed from thedelivery tube 140 in preparation for attachment to thebody 120. As discussed above, thedelivery tube 140 can be attached to thebody 120 in a plurality of orientations wherein thenozzle 148 is directed in one of several directions. As illustrated inFIGS. 3 and 4 , theknob 150 of thedelivery tube 140 can be coupled with theaperture 126 of thebody 120 in various rotational orientations about itslongitudinal axis 154. In the illustrated embodiment, theknob 150 has a hexagonal shape such that thedelivery tube 140 can be inserted in six rotational orientations that are 60 degrees apart. In other embodiments, the delivery tube and aperture are configured to be coupled in increments of 5 degrees, 15 degrees, 30 degrees, 45 degrees, 60 degrees, 90 degrees, etc., or infinite adjustability. The user can select the orientation of thedelivery tube 140 that places the exit opening of thenozzle 148 in the desired direction, while allowing easy operation of thelever 180 without obstruction from the patient's anatomy or other instruments. - The driving
rod 160 can be inserted into thehole 124 and into thecavity 127 of thebody 120. The drivingrod 160 is positioned so that the at least onechannel 168 is aligned with the at least onetab 138 in thehole 124. The alignment of thetab 138 andchannel 168 can position theratchet teeth 162 of the drivingrod 160 in the correct orientation to engage theadvancement mechanism 170 in thecavity 127. The drivingrod 160 can be pushed distally until theratchet teeth 162 engage theadvancement mechanism 170. In some embodiments, the drivingrod 160 is pushed through thecavity 127 and into thepassageway 142 of thedelivery tube 140 until the distal end of the drivingrod 160 is near the flowable material in thedelivery tube 140. Thelongitudinal axis 164 of the drivingrod 160 is substantially aligned with thelongitudinal axis 154 of thedelivery tube 140 as the drivingrod 160 is advanced through thepassageway 142 of thedelivery tube 140. - In some embodiments, a method of using the
device 100 comprises inserting thedelivery tube 140 into the surgical site. Thedelivery tube 140 can be inserted with the exit opening in thenozzle 148 directed in the desired direction for dispensing. In some embodiments, thedelivery tube 140 hasindications 152 that are used to realize the depth of thenozzle 148 from the patient's skin tissue. Theindications 152 can measure the actual distance from thenozzle 148 along thedelivery tube 140, or may indicate relative distances. In some embodiments, the delivery tube has a mark to show the direction of the exit opening on thenozzle 148 in case visualization of thenozzle 148 is obstructed. The user can then dispense the flowable material by actuating thelever 180 to move the drivingrod 160 and push the flowable material out through the exit opening of thenozzle 148. - In some embodiments, a method for using the device comprises the step of applying a force to the
lever 180 to move thelever 180 toward the second position. In some embodiments thebody 120 comprises ahandle 122 and alever spring 182 coupled to thelever 180 and thehandle 122, wherein thelever spring 182 opposes proximal movement of thelever 180 relative to thehandle 122, and wherein the step of ratcheting further comprises the steps of releasing the force on thelever 180 and allowing thelever spring 182 to move thelever 180 toward the first position. - A method of using the device can comprise activating the
advancement mechanism 170 wherein the activating comprises the step of ratcheting the drivingrod 160 distally. The drivingrod 160 can comprise alongitudinal axis 164 and asurface 166 with a plurality ofangled ratchet teeth 162 on at least a portion of thesurface 166. In such embodiments, theadvancement mechanism 170 is coupled to alever 180 capable of movement between a first position and a second position and mounted to thebody 120 by alever pivot 184. The advancement mechanism may further comprise afirst ratchet pawl 172 coupled to thelever 180 and adapted to engage theratchet teeth 162. Thefirst ratchet pawl 172 may move the drivingrod 160 distally relative to thebody 120 as described herein. The drive mechanism may further comprise asecond ratchet pawl 176 adapted to engage theratchet teeth 162 and oppose proximal motion of the drivingrod 160 relative to thebody 120 as described herein. - A method of using the device can comprise gripping the driving
rod 260 and moving the drivingrod 260 distally. As described herein, thedevice 200 can havegripping elements rod 260. In some embodiments, the method comprises the step of applying a force to thelever 280 to move thelever 280 toward the second position. Moving thelever 280 toward the second position engages the firstgripping element 270 to move the firstgripping element 270 distally. The firstgripping element 270 grips the drivingrod 260 to move the drivingrod 260 distally. In some embodiments, the method further comprises the steps of releasing the force on thelever 280 and allowing the firstgripping spring 272 to move the firstgripping element 270 proximally, which moves thelever 280 toward the first position. The secondgripping element 274 grips the drivingrod 260 to prevent the drivingrod 260 from moving proximally as the firstgripping element 270 moves proximally. - In some embodiments, a method of using the
device 100 comprises rotating thedelivery tube 140 before, during and/or after thedevice 100 is inserted to the surgical site. As described herein, thedevice 100 can have acollar 134 that can be rotated, which causes rotation of thedelivery tube 140 about itslongitudinal axis 154. Rotating thecollar 134 changes the direction of the exit opening of thenozzle 148. In some situations, the user can rotate thecollar 134 to affect the direction of thenozzle 148 during surgery and efficiently distribute the flowable material out of thenozzle 148 around the surgical site. For example, when inserting the delivery tube into the surgical site, a user can rotate thecollar 134 so that the other parts of thedevice 100, such as thebody 120, handle 122, andlever 180, are accessible and are not impeded by the patient's anatomy or other equipment. In another example, once thedelivery tube 140 is inserted into the surgical site, thecollar 134 can be rotated to redirect the exit opening in the nozzle and spread the discharge of the flowable material to more effectively fill in areas around implants, bones, and tissue. - In some embodiments, a method of using the device comprises bending the delivery tube. As discussed above, the delivery tube can be made of a flexible material and the user can bend the delivery tube to avoid obstacles and reach the surgical site. The delivery tube can be pliable and bend during the insertion of the delivery tube, or the delivery tube can be bent before inserting into the surgical site. In embodiments where the delivery tube is bent before insertion, the delivery tube can retain its bent shape until the user straightens the delivery tube. The driving rod can also be flexible so that when the driving rod is advanced into the bent delivery tube, the driving rod can bend to match the shape of the bent delivery tube.
- Once the flowable material is delivered to the surgical site, the
device 100 can be removed from the patient. Thedelivery tube 140 can be released from thebody 120. In some embodiments, thedelivery tube 140 is released by pushing the button to actuate the slidingsleeve 128. In other embodiments, the delivery tube is released by other uncoupling methods depending on the design, such as by unscrewing a threaded connection. - The driving rod can be removed by continuing to actuate the ratcheting mechanism or gripping mechanism until the driving rod is moved distally entirely through the body and exiting out the distal end of the body. In some embodiments, the driving rod can be removed by pulling out the driving rod manually, either in the distal or proximal direction. In some embodiments, the ratcheting mechanism or gripping mechanism can be disengaged so that the driving rod can be removed freely. For example, in some embodiments the driving rod can be rotated about its longitudinal axis such that a smooth surface of the driving rod contacts the ratcheting mechanism and the driving rod can be removed without obstruction from the ratchet teeth.
- In some embodiments, the delivery tube and driving rod can be disposable and discarded after use. The delivery tube and driving rod may contact the patient and the flowable material during use and can be discarded for sterile purposes while the body and other parts of the device can be reused after sterilization. In other embodiments, the delivery tube and driving rod can be cleaned and sterilized for reuse. In some embodiments, the delivery tube can be prefilled with flowable material and then delivered to the user. A variety of kits can be produced that include a prefilled delivery tube and a complementary sized/shaped driving rod. Kits having different volumes for the delivery tube, different flowable materials, and/or different lengths and diameters of the delivery tube can be made available.
- Although certain embodiments, features, and examples have been described herein, it will be understood by those skilled in the art that many aspects of the methods and devices illustrated and described in the present disclosure may be differently combined and/or modified to form still further embodiments. For example, any one component of the device illustrated and described above can be used alone or with other components without departing from the spirit of the present disclosure. Additionally, it will be recognized that the methods described herein may be practiced in different sequences, and/or with additional devices as desired. Such alternative embodiments and/or uses of the methods and devices described above and obvious modifications and equivalents thereof are intended to be included within the scope of the present disclosure. Thus, it is intended that the scope of the present disclosure should not be limited by the particular embodiments described above, but should be determined only by a fair reading of the claims that follow.
Claims (22)
1. A device for injecting materials into a patient, the device comprising:
a body comprising a handle, a lever, a collar and a cavity inside the body;
a delivery tube comprising a passageway along a longitudinal axis and a nozzle with a lateral opening, the delivery tube configured to releasably couple to the collar at a distal end of the body; and
a driving rod configured to be inserted from a proximal end of the body and extend through the cavity and into the passageway;
wherein the collar is configured to rotate the delivery tube about the longitudinal axis; and
wherein the lever is configured to move the driving rod distally toward the delivery tube when the lever is actuated toward the handle.
2. A device for injecting materials into a patient, the device comprising:
a body comprising a handle and a lever;
a delivery tube comprising a passageway along a longitudinal axis and a nozzle with an opening, the delivery tube configured to couple with a distal end of the body; and
a driving rod configured to be inserted into the body and extend into the passageway;
wherein the delivery tube is configured to rotate about the longitudinal axis; and
wherein the lever is configured to move the driving rod distally when the lever is actuated toward the handle.
3. The device of claim 2 , wherein the passageway of the delivery tube is configured to be filled with fusion-promoting material.
4. The device of claim 2 , wherein the opening in the nozzle is a lateral opening.
5. The device of claim 2 , wherein one or more of the delivery tube and driving rod are at least partially flexible.
6. The device of claim 2 , wherein the driving rod comprises a plurality of ratchet teeth that are engaged by an advancement mechanism coupled to the lever.
7. The device of claim 2 , further comprising a gripping element coupled to the lever that is configured to grab the driving rod when the lever is actuated.
8. The device of claim 2 , wherein the delivery tube and driving rod are disposable.
9. The device of claim 2 , wherein the driving rod is configured to move unidirectionally in the distal direction.
10. The device of claim 2 , wherein the nozzle comprises an angled inner surface.
11. The device of claim 2 , wherein the driving rod comprises at least one channel configured to align with at least one tab on the body.
12. The device of claim 2 , wherein the delivery tube further comprises indications representing the depth of insertion of the delivery tube into a patient.
13. A kit for injecting materials into a patient, the kit comprising:
a delivery tube comprising a passageway along a longitudinal axis with an opening at both ends of the passageway;
a funnel configured to couple with an end of the delivery tube;
a plug configured to block one of the openings of the delivery tube; and
a ramrod comprising a shaft that is configured to fit in the passageway of the delivery tube.
14. The kit of claim 13 , the kit further comprising:
a body comprising a handle and a lever; and
a driving rod configured to be inserted into the body and extend through the body;
wherein the delivery tube is configured to releasably couple to a distal end of the body and be rotatable about the longitudinal axis while coupled to the body; and
wherein the lever is configured to move the driving rod distally into the passageway of the delivery tube when the lever is actuated toward the handle.
15. The kit of claim 14 , wherein the body further comprises a collar configured to rotate the delivery tube about the longitudinal axis.
16. The kit of claim 14 , wherein one or more of the delivery tube and driving rod are at least partially flexible.
17. The kit of claim 14 , wherein the delivery tube and driving rod are disposable.
18. The kit of claim 13 , wherein at least one of the openings in the delivery tube is a lateral opening.
19. The kit of claim 13 , wherein the passageway of the delivery tube is configured to be filled with fusion-promoting material.
20. The kit of claim 19 , wherein the ramrod is configured to push the fusion-promoting material through the funnel into the passageway.
21. The kit of claim 13 , wherein at least a portion of the ramrod is flexible.
22. The kit of claim 13 , wherein the funnel comprises a bent funnel stem.
Priority Applications (1)
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US17/748,843 US20220280216A1 (en) | 2016-08-18 | 2022-05-19 | Material delivery surgical device |
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US201662376835P | 2016-08-18 | 2016-08-18 | |
US15/679,916 US11364062B2 (en) | 2016-08-18 | 2017-08-17 | Material delivery surgical device |
US17/748,843 US20220280216A1 (en) | 2016-08-18 | 2022-05-19 | Material delivery surgical device |
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US20230255789A1 (en) * | 2022-02-14 | 2023-08-17 | Warsaw Orthopedic, Inc. | Graft Delivery Device with Accurate Dispensing |
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US11364062B2 (en) | 2022-06-21 |
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