Medical access device

Abstract

A surgical device is provided. The surgical device includes a tubular outer shaft having a longitudinal axis and an angled guide positioned on a first end of the surgical device. The angled guide can be angled relative to the longitudinal axis of the outer shaft. The surgical device includes an elongated inner shaft having a second end and a third end. The inner shaft is detachably connected to the outer shaft and configured to axially translate through the outer shaft. The surgical device includes a pivoting device having at least one joint and an access tool. The at least one joint is pivotably coupled to the third end of the inner shaft and an end of the access tool. The pivoting device can be configured to axially translate through the angled guide to a deployed position.

Description

BACKGROUND

[0001] Spinal disorders, such as degenerative disc disease, herniated discs, osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures can result from factors including trauma, disease, and degenerative conditions resulting from injury and aging. Spinal disorders often result in symptoms including pain, nerve damage, and partial or complete loss of mobility.

[0002] Non-surgical treatments, such as medication, rehabilitation, and exercise therapy can be effective; however, these treatments can not alleviate the symptoms associated with these disorders. Surgical treatment of these spinal disorders can include correction, fusion, fixation, discectomy, laminectomy, and insertion of implantable prosthetics. As part of these surgical treatments, implants, such as intervertebral fusion implant devices, are often used to fuse two adjacent vertebrae. Intervertebral fusion implant devices can be secured to one or both adjacent vertebrae and to the vertebrae by insertion of bone fasteners through respective fastener holes of the implant.

[0003] To secure an implant to a vertebra, a user can use a awl medical device to create a hole in the vertebra or other bone structure to insert a fastener or other medical implant or to gain access or passage through the bone. However, certain conventional awls are substantially linear. Thus, certain linear awls can not be able to access a fastener hole of an implant because the fastener hole can be positioned at an angle that is blocked by other body objects within the patient. Further, for cases where the tip of the awl is angled, the user cannot strike the linear portion of the awl and create a hole at the angle of the awl tip without risking bending or damaging the awl tip, or for other reasons. SUMMARY

[0004] The present disclosure relates generally to medical devices for treating musculoskeletal disorders, and more particularly to medical insertion devices.

[0005] In one or more instances, the disclosed technology relates to a surgical device. In one or more instances, the surgical device includes a tubular outer shaft having a longitudinal axis and an angled guide positioned on a first end of the surgical device. In one or more instances, the angled guide is angled relative to the longitudinal axis of the outer shaft. In one or more instances, the surgical device includes an elongated inner shaft having a second end and a third end. In one or more instances, the inner shaft is detachably coupled to the outer shaft and configured to axially translate through the outer shaft. In one or more instances, the surgical device includes a pivoting device having at least one joint and an access tool. In one or more instances, the at least one joint is pivotably coupled to the third end of the inner shaft and an end of the access tool. In one or more instances, the pivoting device is configured to axially translate through the angled guide to a deployed position.

[0006] In one or more embodiments, the disclosed technology relates to a surgical device. In one or more embodiments, the surgical device includes a tubular outer shaft having a longitudinal axis, wherein an angled guide is positioned on a first end of the surgical device and a housing is positioned on a second end of the surgical device opposite to the first end. In one or more embodiments, the angled guide is angled relative to the longitudinal axis of the outer shaft. In one or more embodiments, the surgical device includes an elongated inner shaft having a third end and a fourth end. In one or more embodiments, the inner shaft is detachably coupled to the outer shaft and configured to translate axially through the outer shaft. In one or more embodiments, the surgical device includes a pivoting device having at least one connector and an access tool. In one or more embodiments, at least one connector is pivotally coupled to the fourth end of the inner shaft and one end of the access tool. In one or more embodiments, the pivoting device is configured to translate axially to an unfolded position via the angled guide. In one or more embodiments, the surgical device includes a knob disposed on the third end of the inner shaft. In one or more embodiments, the surgical device includes at least one pin projecting from the outer surface of the knob. In one or more cases, the surgical device includes at least one track positioned within a housing and configured to guide at least one pin when the knob is axially translated within the housing. In one or more cases, the surgical device includes an external lever having at least one end pivotally coupled to an outer surface of the housing and at least one slot detachably coupled to the pin, thereby securing the inner shaft to the outer shaft.

[0007] In one or more embodiments, the disclosed technology relates to a surgical device. In one or more embodiments, the surgical device includes a tubular outer shaft having a longitudinal axis, wherein an angled guide is positioned on a first end of the surgical device and a housing is positioned on a second end of the surgical device opposite to the first end. In one or more embodiments, the angled guide is angled relative to the longitudinal axis of the outer shaft. In one or more embodiments, the surgical device includes an elongated inner shaft having a third end and a fourth end. In one or more embodiments, the inner shaft is detachably coupled to the outer shaft and configured to translate axially through the outer shaft. In one or more embodiments, the surgical device includes a pivoting device having at least one connector and an access tool. In one or more embodiments, the at least one connector is pivotally coupled to a fourth end of the inner shaft. In one or more embodiments, the pivoting device is configured to translate axially to an unfolded position via the angled guide. In one or more embodiments, the surgical device includes an internal lever pivotally coupled to an outer surface of the housing and having a pin extending laterally from one arm of the internal lever to an opposite arm of the internal lever. In one or more embodiments, a knob includes a slot that detachably engages the pin of the internal lever, thereby securing the inner shaft to the outer shaft.

[0008] The foregoing and other objects, features and advantages of the invention will become apparent from the following more detailed description of exemplary embodiments of the invention as illustrated in the accompanying drawings, in which similar reference numerals generally denote similar parts of the disclosure. Attached Figure Description

[0009] The following figures illustrate specific embodiments of this disclosure and are therefore not intended to limit the scope of this disclosure. The figures are not drawn to scale and are intended for use in conjunction with the explanations in the following detailed description.

[0010] Figure 1A The illustration shows a perspective view of an example medical access device.

[0011] Figure 1B The diagram shows Figure 1A A perspective view of the inner axis of an exemplary medical access device.

[0012] Figure 1C The diagram shows Figure 1A A perspective view of the outer axis of a medical access device.

[0013] Figure 2A The illustration shows a perspective view of the external lever of the medical access device in the retracted position.

[0014] Figure 2B The illustration shows a perspective view of the external lever of the medical access device in the unfolded position.

[0015] Figure 3A The illustration shows a perspective view of another medical access device.

[0016] Figure 3B The diagram shows the location Figure 3A The slot on the knob of the inner shaft of the medical entry device.

[0017] Figure 3C The diagram shows Figure 3A The internal lever of the medical access device.

[0018] Figure 3D The illustration shows a perspective view of the internal lever of a medical access device in the retracted position.

[0019] Figure 3E The illustration shows a perspective view of the internal lever of a medical access device in its unfolded position.

[0020] Figure 4A The diagram shows the retracted position. Figure 1A Medical access devices.

[0021] Figure 4B The diagram shows the unfolded position. Figure 1A Medical access devices.

[0022] Figure 4C The diagram illustrates the use of Figure 1A The extended area for guiding medical entry devices.

[0023] Figure 4D The diagram shows the device in the retracted position for... Figure 1A Replacement guide for medical access devices.

[0024] Figure 4E The diagram shows the unfolded position. Figure 4D Cross-sectional view of the alternative guide.

[0025] Figure 5 The illustration shows a perspective view of a medical implant.

[0026] Figure 6A The diagram illustrates the positioning in the retracted position. Figure 5 Medical implants are medical entry devices.

[0027] Figure 6B The diagram illustrates the positioning of the unfolded position. Figure 5 Medical implants are medical entry devices. Detailed Implementation

[0028] The following discussion omits or only briefly describes certain conventional features associated with medical access devices, features that will be apparent to those skilled in the art. It should be noted that various embodiments are described in detail with reference to the accompanying drawings, wherein similar reference numerals denote similar parts and assemblies throughout the various views. Reference to the various embodiments does not limit the scope of the appended claims. Furthermore, any examples set forth in this specification are intended to be non-limiting and merely illustrate some of the many possible embodiments of the appended claims. Further, the specific features described herein may be used in combination with other described features in every possible combination and arrangement.

[0029] Unless otherwise expressly defined herein, all terms shall be given their broadest possible interpretation, including the meaning implied from the specification and the meaning understood by those skilled in the art and / or defined in dictionaries, papers, etc. It should also be noted that, as used in the specification and appended claims, the singular forms “a / an” and “the” include plural referents unless otherwise stated, and the terms “comprises and / or comprising,” when used in this specification, specify the presence of the stated features, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof.

[0030] Embodiments of this disclosure generally relate to medical devices for treating musculoskeletal disorders, and more specifically, to medical access devices. Embodiments of this disclosure are described below with reference to the accompanying drawings.

[0031] Figure 1A The illustration shows a perspective view of an example medical access device 100. Figure 1B The diagram shows Figure 1A A perspective view of the inner axis 108 of an exemplary medical access device 100. Figure 1C The diagram shows Figure 1A A perspective view of the outer axis 102 of the medical access device 100.

[0032] In one or more cases, the medical access device 100 (hereinafter referred to as "device 100") can be used with, for example, open or micro-open, minimal access and / or minimally invasive techniques (including, for example, percutaneous surgical techniques) to create access holes for fasteners at surgical sites within the body (e.g., a portion of a patient's spine).

[0033] The device 100 includes an outer shaft 102 configured to receive an inner shaft 108. The inner shaft 108 may be positioned within the outer shaft 102 and may be configured to translate along axis L1 through the outer shaft 102.

[0034] The inner shaft 108 may be an elongated rigid member having a solid center disposed between a first end and a second end 123. The elongated rigid member may be a cylindrical shaft. In one or more cases, the inner shaft 108 is an elongated rigid member having a first portion 107 and a second portion 105, wherein the diameter of the first portion 107 is larger than the diameter of the second portion 105. The first portion 107 may be configured to be positioned within the handle 104 of the outer shaft 102. For example, the first portion 107 may include a key portion configured to engage with a key portion formed within the inner surface of the handle 104. For example, the key portion of the first portion 107 may include a flat surface recessed from the diameter of the first portion 107, and the key portion of the handle 104 may be a protrusion having a flat surface projecting from the inner surface of the handle 104 and configured to engage with the key portion of the first portion 107. The first portion 107 may be configured to withstand impacts from objects such as a mallet striking the knob 110 of the inner shaft 108. The smaller diameter of the second portion 105 can be used to provide minimally invasive percutaneous surgical techniques. In one or more other cases, the inner shaft 108 includes a uniform diameter extending from the first end 122 and the second end 123.

[0035] The first end 122 of the inner shaft 108 is pivotally coupled to a pivoting device 127. The pivoting device 127 can be used, for example but not limited to, to form an access hole within a segment of a patient's spine or other bone structure. In one or more cases, the access hole can be used to insert a fastener or another medical implant, or to provide access to or through bone. The pivoting device 127 may include at least one connector, such as connector 124, and an access tool 126, wherein the access tool 126, such as a conical tip, is pivotally coupled to an end 128b of connector 124, and the opposite end 128a of connector 124 is pivotally coupled to the first end 122 of the inner shaft 108. For example, in one or more cases, connector 124 may be formed in an "H" shape, such that one end 404 of the access tool 126 is fitted between the ends 128b having a recessed portion of the H-shaped connector 124 and the first end 122 of the inner shaft 108 is fitted between the ends 128a having another recessed portion of the H-shaped connector 124, as shown. Figure 4A and 4B As shown. A pin, such as, but not limited to, a sliding fitting pin, can be inserted through a hole formed on the proximal end of a recessed portion of the end 128b of the H-shaped connector 124 and a hole formed in the end 404 of the entry tool 126, wherein the hole in the recessed portion and the end 404 are aligned with each other. The pin can be welded to each side of the recessed portion, thereby engaging the entry tool 126 to the connector 124. It should be noted that the end 128a of the connector 124 can be engaged to the first end 122 of the inner shaft 108 in the same or similar manner as the end 128b of the connector 124 engaged to the entry tool 126. In one or more other cases, the end 404 of the entry tool 126 can have a “U”-shaped end, wherein the end 128b of the connector 124 is fitted between the U-shaped ends 404 of the entry tool 126. The first end 122 of the inner shaft 108 can also have a “U”-shaped end, wherein the end 128a of the connector 124 is fitted between the U-shaped first ends 122 of the inner shaft 108. When the pivoting device 127 uses more than one connector, each connector can be connected sequentially, with one end of the first connector connected to the first end 122 of the inner shaft 108, and one end of the last connector in the connector chain connected to the end 404 of the entry tool 126. In one or more cases, the connector 124 can rotate 180° about the inner shaft 108. In one or more cases, the entry tool 126 can rotate 180° about the connector 124. In one or more other cases, the range of rotation of the connector 124 can be limited relative to the inner shaft 108. For example, the connector 124 can be limited to rotate 90° about the inner shaft 108. In one or more other cases, the range of rotation of the entry tool 126 can be limited relative to the connector 124. For example, the connector 124 can be limited to rotate 90° about the connector 124.

[0036] In one or more cases, connector 124 may rotate relative to first end 122 within a range of 180 degrees or approximately 180 degrees in direction D. In one or more cases, access tool 126 may rotate relative to connector 124 within a range of 180 degrees or approximately 180 degrees in direction E. In one or more other cases, connector 124 and / or access tool 126 may be restricted to rotation in one direction, for example, rotation to the right or left side of inner shaft 108.

[0037] The second end 123 of the inner shaft 108 can be fixedly connected to the knob 110. In one or more cases, the knob 110 can be fixedly connected to the second end 123 of the inner shaft 108 by fastening the knob 110 to the second end 123 with fasteners such as screws; the knob 110 can be welded to the second end 123, etc. The upper surface 134 of the knob 110 can be a flat surface configured to receive one or more impacts from another object such as a hammer, mallet, or other similar instrument. The knob 110 can transmit the force from the impact to the pivoting device 127 and to another object, such as a vertebra 604, as... Figure 6B As shown. That is, when the pivoting device 127 is inserted into another object at a certain angle, the device 100 can convert the linear force of the impact from the knob 110 into an angular force. The force from the impact can also move the inner shaft 108 through the outer shaft 102. In the fully extended position 403, the upper surface 134 can be raised a distance 130 from the upper surface 132 of the outer casing 116. By raising the upper surface 134 from the upper surface 132 in the fully extended position 403, objects (such as mallets) are prevented from contacting the upper surface 132 and transmitting the impact force to the outer shaft 102.

[0038] Knob 110 may include one or more pins, such as pin 114, which protrude from the outer surface of knob 110. In one or more cases, pin 114 may be positioned at the center of the central axis L2 of knob 110, or it may be positioned off-center from the central axis L2 of knob 110. For cases where the access tool 126 and connector 124 are each configured to rotate within a range of 180 degrees or approximately 180 degrees, pin 114 may be positioned at the center or off-center. In one or more other cases, where rotation of pivoting device 127 is restricted to rotation in one direction, pin 114 may be positioned off-center from the central axis L2 of knob 110. By off-centering pin 114 from the central axis L2, knob 110 can be inserted into the outer housing 116 of outer shaft 102 only in one configuration, thereby preventing the user from improperly installing inner shaft 108 within outer shaft 102.

[0039] The outer shaft 102 can be an elongated rigid member having a hollow center disposed between a first end 125 and a second end 129. An angled guide 106 can be disposed on the first end 125 of the outer shaft 102 opposite to the second end 129. The angled guide 106 can accommodate the pivoting device 127 and provide a protective cover for the pivoting device. When the pivoting device 127 is moved from... Figure 4A The retraction position 401 shown is moved to the position as indicated. Figure 4B In the deployed position 403 shown, the angled guide 106 can provide an angled path in direction G, and vice versa. In one or more cases, the angled guide 106 can be at an angle between 0 and 90 degrees relative to the central axis L3 of the outer shaft 102, preferably between 20 and 70 degrees, and more preferably at 45 degrees or about 45 degrees. In one or more other cases, the angled guide 106 can be angled to correspond to the angle of the receiver 501 of the medical implant 500.

[0040] In one or more cases, the angled guide 106 includes a guide extension region configured to provide rotational space for the pivoting device 127, particularly the connector 124, when the pivoting device 127 moves from the retracted position 401 to the extended position 403, and vice versa. In one or more cases, the guide extension region 402 may be a removed portion of the angled guide 106, such as... Figure 4A and 4B As shown in the diagram. The guide extension region 402 can be an opening that exposes the inner shaft 108 to the external environment. At the guide extension region 402, the pivoting device 127 can extend beyond the inclined path of the angled guide 106, as shown in the diagram. Figure 4B As shown, the pivoting device 127 is allowed to rotate within the angled guide 106. In one or more other cases, the guide extension region 412 may be a closed, rigid protrusion formed by the outer shaft 102, such as... Figure 4C As shown. In the guide extension region 412, the inner shaft 108 may not be exposed to the external environment. The guide extension region 412 may protrude inward from the angled guide 106, such that the guide extension region 412 is tilted relative to the central axis L3 of the outer shaft 102 at an angle different from that of the angled guide 106.

[0041] In one or more cases, the angled guide 106 may include a nested end 406 configured to be positioned within the medical implant 500, such as, but not limited to, [examples not specified]. Figure 5The illustrated interbody fusion implant device. The medical implant 500 may include one or more fastener holes, such as a receiver 501, configured to receive a portion of an angled guide 106 and fasteners therein for securing the medical implant 500 to, for example, a patient's vertebra. The receiver 501 may include one or more notches, each sized to match the diameter of a corresponding nesting portion of the nesting end 406. For example, the nesting end 406 may include a first nesting portion 407a and a second nesting portion 407b. In one or more cases, the first nesting portion 407a may include a proximal end 409 of the angled guide 106 and a tapered portion 411 of the angled guide 106. The proximal end 409 may be a rigid tubular member integrally formed with the outer shaft 102. The tapered portion 411 may be formed as a tapered shape that gradually tapers from the outer shaft 102 to the proximal end 409 of the first nesting portion 407a. The tapered portion 411 facilitates translation of the pivoting device 127 between the retracted position 401 and the deployed position 403. In one or more other cases, the first nesting portion 407a may include only the proximal end 409, in which case the proximal end 409 may have the same diameter as the outer shaft 102 and a diameter larger than the diameter of the second nesting portion 407b. The second nesting portion 407b includes a proximal end 415 and a tapered portion 413. The proximal end 415 may be a rigid tubular member integrally formed with the outer shaft 102. The tapered portion 413 may be formed as a tapered shape that gradually tapers from the proximal end 409 to the proximal end 415 of the second nesting portion 407b. The tapered portion 413 facilitates translation of the pivoting device 127 between the retracted position 401 and the deployed position 403. The receiver 501 of the medical implant 500 may include, for example, a first recess 502 and a second recess 504. The first recess 502 may have a diameter that matches the first nested portion 407a, and the second recess 504 may have a diameter that matches the second nested portion 407b. If the nested end 406 is located within the receiver 501, the first nested portion 407a may be located within the first recess 502, and the second nested portion 407b may be located within the second recess 504.

[0042] In one or more other cases, device 100 includes a straight guide 107, such as Figure 4D and 4E As shown, and with Figures 4A-4CThe angled guide 106 shown is the opposite. It should be noted that the straight guide 107 includes one or more of the same or similar features as the angled guide 106. These features are indicated by the same reference numerals. Therefore, a description of such features will not be repeated. Furthermore, in the case where the device 100 utilizes the straight guide 107, the inner shaft 108 may include an access tool 426, such as a conical tip, rigidly coupled to the proximal end 422 of the inner shaft 108. The access tool 426 can be used, for example, but not limited to, to form an access hole within a segment of the patient's spine or other bone structure. Note that the medical access device 300 may also use the straight guide 107 instead of the angled guide 106.

[0043] The outer shaft 102 may include a handle 104 disposed on or near a second end 129 of the outer shaft 102. The handle 104 may provide a user with an ergonomic grip to hold the device 100. A housing 116 may be attached to the second end 129 of the outer shaft 102. In one or more cases, the housing 116 is manufactured together with the outer shaft 102 to form an integral part. In one or more other cases, the housing 116 is coupled to the outer shaft 102 by welding or threading a portion of the housing 116 to a portion of the outer shaft 102. The housing 116 may be configured to receive at least a portion of a knob 110 therein, such that the knob 110 is movable in directions A and B. The housing 116 may include one or more pin rails 118 configured to receive a pin 114 and guide the pin 114 when the knob 110 moves in directions A and / or B. The pin rail 118 may be a recess within the wall of the housing 116. In the case where the knob 110 uses multiple pins, the housing 116 includes an equal number of pin rails, each pin rail being positioned to receive a pin protruding from the knob 110.

[0044] An external lever 112 can be pivotally coupled to the outer surface of a housing 116. The external lever 112 can be formed in a "U" or "V" shape, having two connecting ends 133 disposed at each end of the external lever 112 and connected to a central portion 137 of the external lever 112. The central portion 137 of the external lever 112 can be a rigid body, wherein a curved portion of the body surrounds the housing 116 to form two arms 147 extending toward the two connecting ends 133 on either side of the housing. The housing 116 includes a channel 149 disposed at a bottom end 139 of the housing 116, wherein the channel 149 includes a hole extending laterally through the housing 116. The two connecting ends 133 can be located at each end of the channel 149 and are coupled to the channel 149 by inserting a pin 131 passing through the two connecting ends and the channel 149. The external lever 112 can be configured to rotate in directions C and I about the position where the two connecting ends 133 are coupled to the channel 149.

[0045] The external lever 112 can be spring-loaded by at least one spring 141 so as to return the device 100 to the retracted position 401 after the device 100 has been moved to the deployed position 403. Figure 2A As shown. A portion of the spring 141 may be positioned within a recessed region 143 located on the underside of the arm 147, and another portion of the spring 141 may be positioned within a recessed region 145 on the bottom side 139 of the housing 116.

[0046] The outer lever 112 may include a slot 120 located on the arm 147 of the outer lever 112. The outer lever 112 may include a slot 120 for each pin 144 protruding from the knob 110. The surface 135 of the outer lever 112 above the position of the slot 120 may taper towards the middle portion 137 of the outer lever 112. The slot 120 may be formed in an "L" shape. A receiving portion 120b is the vertical pin track portion of the slot 120, and a locking portion 120a is the horizontal pin track portion of the slot 120. The receiving portion 120b is configured to receive the pin 114 when the knob 110 is inserted into the housing 116 and allow the knob 110 to exit the housing 116. The locking portion 120a is configured to prevent the knob 110 from fully exiting the housing 116. In the retracted position 401, the pin 114 may be positioned within the locking portion 120a, and the locking portion 120a may be aligned with the pin track 118. In the deployment positioning 403, pin 114 can be positioned within receiving portion 120b, and receiving portion 120b can be aligned with pin track 118.

[0047] Figure 2A A perspective view of the external lever 112 of the device 100 in the retracted position 401 is shown. Figure 2B A perspective view of the external lever 112 of the device 100 in the unfolded position 403 is shown.

[0048] When knob 110 is inserted into housing 116 in direction A, pin 114 can contact and smoothly move through the tapered surface 135 of outer lever 112, thereby forcing outer lever 112 downward in direction C. As pin 114 slides past surface 135, outer lever 112 moves downward in direction C, and pin 114 moves in direction A into receiving portion 120b of slot 120 and into pin track 118. As pin 114 moves further downward into pin track 118, pin 114 moves into locking portion 120a, so that pin 114 moves below upper surface 151 of locking portion 120a, thereby locking knob 110 into housing 116. Spring 141 can bias outer lever 112 upward to retracted position 401. When the outer lever 112 moves upward, the bottom surface 152 of the slot 120 contacts the pin 114 in direction B, thereby forcing the inner shaft 102 upward into the retracted position 401 via the pin 114 connected to the knob 110.

[0049] During procedures such as fusion surgery, the user can position the implant 500 between two vertebrae, such as vertebrae 602 and 604. After positioning the implant 500, the user can insert the device 100 into the patient in a retracted position 401. For example, the user can insert the device 100 into the patient's area, from the front to the side, and more preferably, the anterolateral portion. The user can position the device 100 such that the pivoting device 127 is angled to enter the top portion 604a (e.g., endplate) of the vertebra (e.g., vertebra 604), as... Figure 6A As shown. The user can position the nested end 406 of the angled guide 106 into the receiver 501 of the implant 500, as... Figure 6A As shown. The user can strike the upper surface 134 of the knob 110 with an object such as a mallet. As the knob 110 is struck, it moves in direction A, thereby moving the inner shaft 108 and the pivoting device 127 to the unfolded position 403, as shown. Figure 6B As shown. In the deployed position 403, the entry tool 126 of the pivot device 127, such as a cone tip, pierces the vertebra 604, thereby forming an entry hole in the vertebra 604. In one or more cases, the entry tool 126 may be an elongated rod with a tip at the insertion end 414 of the entry tool 126. The spring 141 may bias the external lever 112, thereby biasing the internal shaft 102 upwards to the retracted position 401 via the pin 114 connected to the knob 110, so that the entry tool 126 is not located within the vertebra 604. The user can remove the device 100 from the patient, and the implant 500 can be secured to the vertebra 604 by inserting fasteners into the holes in the receiver 501 and the vertebra 604. It should be noted that the receiver 501 may be positioned within the implant 500 such that an entry hole may be formed in the vertebra 602 in the same or similar manner as the entry hole formed in the vertebra 604.

[0050] To remove the inner shaft 108 from the outer shaft 102, the user can rotate the outer lever 112 in direction C to the fully extended position 403, aligning the receiving portion 120b of the slot 120 with the pin rail 118. In the fully extended position 403, the user can grasp the knob 110 and pull it in direction B until the inner shaft 108 is removed from the outer shaft 102.

[0051] Figure 3A The illustration shows a perspective view of another medical access device 300 (hereinafter referred to as "device 300"). Figure 3B The diagram shows the location Figure 3A The slot 312 on the knob 302 of the inner shaft 304 of the device 300. Figure 3C The diagram shows Figure 3AThe internal lever 306 of the device 300. Figure 3D The illustration shows a perspective view of the internal lever 306 of the device 300 in the retracted position 401. Figure 3E The figure shows a perspective view of the internal lever 306 of the device in the unfolded position 403. It should be noted that device 300 includes one or more features that are the same as or similar to those of device 100. These features are indicated by the same reference numerals. Therefore, a description of such features will not be repeated.

[0052] In one or more cases, the device 300 can be used with, for example, open or micro-open, minimally invasive and / or minimally invasive techniques (including, for example, percutaneous surgical techniques) to create an access hole for the fastener at a surgical site within the body (e.g., a portion of a patient's spine).

[0053] The device 300 includes an outer shaft 102 configured to receive an inner shaft 304. The inner shaft 304 may be positioned within the outer shaft 102 and may be configured to translate along axis L1 through the outer shaft 102. The inner shaft 304 may have one or more features that are the same as or similar to those of the inner shaft 108. Additionally, the inner shaft 304 may include a keyed edge 310 configured to interlock with a pin 308 extending laterally through an inner lever 306. The keyed edge 310 may be a flat surface extending along axis L1, while the remaining surfaces of the inner shaft 304 are formed in a cylindrical shape. For example, the outer periphery of the inner shaft 304 may be formed in a "D" shape, wherein the keyed edge 310 is the flat portion of the D-shaped periphery. By aligning the keyed edge 310 with the pin 308 of the inner lever 306, the keyed edge 310 can be used to orient the inner shaft 304 for proper insertion into the outer shaft 102. In one or more cases, the key edge 310 may extend along the axis L1 of the first portion 107 of the inner shaft 304, covering the entire length of the first portion 107. In one or more other cases, the key edge 310 may extend along at least a portion of the axis L1 of the first portion 107.

[0054] The second end 323 of the inner shaft 304 can be fixedly connected to the knob 302. In one or more cases, the second end 323 of the inner shaft 304 can be fixedly connected to the knob 302 in the same or similar manner as the second end 123 of the inner shaft 108 is fixedly connected to the knob 110. Therefore, the description of such features will not be repeated.

[0055] The upper surface 134 of the knob 302 may be a flat surface configured to receive one or more impacts from another object, such as a hammer, mallet, or other similar instrument. The knob 302 can transmit the force from the impacts to the pivoting device 127 and to another object, such as a vertebra 604. Figure 6BAs shown. That is, when the pivoting device 127 is inserted into another object at a certain angle, the device 300 can convert the linear force of the impact from the knob 302 into an angular force. The force from the impact can also move the inner shaft 304 through the outer shaft 102. In the fully extended position 403, the upper surface 134 can be raised a distance 130 from the upper surface 132 of the outer casing 314, as... Figure 3E As shown. By raising the upper surface 134 from the upper surface 132 in the fully extended position 403, objects (such as mallets) are prevented from contacting the upper surface 132 and from transmitting the impact force to the outer shaft 102.

[0056] The knob 302 may include a slot 312 configured to receive a pin 308 positioned on an inner lever 306. The slot 312 may include a vertical track 312a engaging with a diagonal track 312b. In one or more cases, the slot 312 may engage with a keyed edge 310 such that the flat surface of the keyed edge 310 is aligned with the flat surface of the vertical track 312a. The vertical track 312a may be positioned on the same side of the inner shaft 304 as the keyed edge 310. The diagonal track 312b may engage with the top of the vertical track 312a and may be angled downwards away from the keyed edge 310.

[0057] The outer housing 314 can be attached to the second end 129 of the outer shaft 102. The outer housing 314 can be attached to the outer shaft 102 in the same or similar manner as attaching the outer housing 116 to the outer shaft 102. Therefore, a further description of such features will not be repeated. The outer housing 314 is configured to house at least a portion of the knob 302, such that the knob 302 is movable in directions F and H. The outer housing 314 may include at least two tracks, such as tracks 322a and 322b, which allow the internal lever 306 to translate through the outer housing 314. To accommodate the two tracks, a portion of the outer housing 314 may be divided into four walls, with three walls defining one track. For example, track 322a may be defined by walls 314a, 314d, and 314b, and track 322b may be defined by walls 314c, 314b, and 314d. The arm of the internal lever 306 can move within the tracks. For example, arm 147a of the internal lever 306 can move within track 322a, and arm 147b of the internal lever 306 can move within track 322b.

[0058] An internal lever 306 can be pivotally connected to the outer surface of the housing 314. The internal lever 306 can be formed in a "U" shape, having two connecting ends 133 disposed at each end of arms 147a and 147b of the internal lever 306. Arms 147a and 147b can be connected via a middle portion 337 of the internal lever 306. The middle portion 337 of the internal lever 306 can be a rigid body, wherein a curved portion of the body winds around the wall 314b of the housing 314 to form the two arms 147a and 147b. The housing 314 includes a channel 349 disposed at its bottom end 139, wherein the channel 349 includes a hole extending laterally through the housing 314. The two connecting ends 133 can be located at each end of the channel 349 and are connected to the channel 349 by inserting a pin 131 through the two connecting ends 133 and the channel 349. The internal lever 306 can be configured to rotate in directions C and I about the position where the two connecting ends 133 are connected to the channel 349. The internal lever 306 includes a pin 308, one end of which is attached to arm 147a and the opposite end of which is attached to arm 147b. The pin 308 can be configured to move within the slot 312. In one or more cases, the internal lever 306 can be spring-loaded in the same or similar manner as the spring-loaded external lever 112 to return the device 300 to the retracted position 401. Therefore, a further description of such features will not be repeated.

[0059] To initially insert the inner shaft 304 into the outer shaft 102, the inner shaft 304 is positioned within the outer shaft 102. As the inner shaft 304 slides into the outer shaft 102 in the F direction, the pin 308 of the inner lever 306 enters the vertical track 312a of the slot 312. When the pin 308 reaches the top 312c of the vertical track 312a, the spring 141 biases the inner lever 306 upward and into the diagonal track 312b, thereby locking the inner shaft 304 to the outer shaft 102 and preventing the inner shaft 304 from completely disengaging from the outer shaft 102. When locked to the outer shaft 102, the device 300 can move between a retracted position 401 and an extended position 403. To move the device 300 to the extended position 403, the knob 302 moves in the F direction. During this movement, the pin 308 can slide upward within the diagonal track 312b and then downward into the vertical track 312a. When the device 300 moves from the extended position 403 to the retracted position 401, the pin 308 contacts a portion of the slot 312, and the biasing force of the spring 141 pushes the knob 302 upward in the H direction and into the retracted position 401. To remove the inner shaft 108 from the outer shaft 102, the user moves the device 300 to the fully extended position 403, grasps the inner lever 306 downward in the C direction, and while grasping a portion of the knob 302, removes the knob 302 in the H direction until the inner shaft 304 is removed from the outer shaft 102.

[0060] In one or more embodiments, the devices 100 and 300 and implant 500 of this disclosure can be used to treat spinal conditions such as degenerative disc disease, herniated disc, osteoporosis, vertebral lordosis, spinal stenosis, scoliosis and other curvature abnormalities, kyphosis, tumors, and fractures. In one or more embodiments, the devices 100 and 300 and implant 500 of this disclosure can be used with other spinal or skeletal applications, including those related to diagnosis and treatment. In one or more embodiments, the devices 100 and 300 and implant 500 of this disclosure can be used for surgical treatment of patients in a prone or supine position, and / or for various surgical approaches to the spine, including anterior, posterior, posterior midline, direct lateral, posterolateral, and / or anterolateral approaches, as well as in other body regions. The devices 100 and 300 and implant 500 of this disclosure can be used in conjunction with surgeries for treating the lumbar, cervical, thoracic, sacral, and pelvic regions of the spine. The system disclosed herein can also be used on animals, bone models, and other non-biological substrates, for example, during training, testing, and demonstration. Devices 100 and 300 can be assembled for surgical procedures, disassembled post-operatively for cleaning, sterilization, and maintenance purposes, and reassembled for another surgical procedure. In one or more other embodiments, devices 100 and 300 can be used to create access ports for other types of orthopedic surgeries, such as, but not limited to, foot, ankle, shoulder, elbow, and / or hand surgeries.

[0061] Components of devices 100 and 300 and implant 500 may be manufactured from bio-acceptable materials suitable for medical applications, including metals, plastics, synthetic polymers, ceramics, bone materials, and / or composites thereof. For example, components of devices 100 and 300 may be manufactured individually or collectively from materials such as: stainless steel alloys, aluminum, commercially pure titanium, titanium alloys, grade 5 titanium, superelastic titanium alloys, cobalt-chromium alloys, stainless steel alloys, and superelastic metal alloys (e.g., nickel-titanium, superelastic-plastic metals, such as GUM METAL® manufactured by Toyota Material Incorporated in Japan). In another instance, implant 500 may be made, individually or collectively, from the following materials: thermoplastics, such as polyaryletherketone (PAEK), including polyetheretherketone (PEEK), polyetherketoneketone (PEKK), and polyetherketone (PEK), carbon-PEEK composites, PEEK-BaSO4 polymer rubber, polyethylene terephthalate (PET), fabrics, silicone resins, polyurethanes, silicone-polyurethane copolymers, polymer rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigid materials, elastomers, rubbers, thermoplastic elastomers, thermosetting elastomers, elastomer composites, and rigid polymers including polyphenylene, polyamides, polyimides, polyetherimides, and polyethylene glycol. The materials include alkenes, epoxy resins, bone materials, including autologous, allogeneic, xenograft, or transgenic cortical and / or cortical cancellous bone, as well as tissue growth or differentiation factors, partially resorbable materials such as metal and calcium-based ceramic composites, composites of PEEK and calcium-based ceramics, composites of PEEK and resorbable polymers, fully resorbable materials such as calcium-based ceramics like calcium phosphate, tricalcium phosphate (TCP), hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymers such as polyaetide, polyglycolic acid, polytyrosine carbonate, polycaprolactone, and combinations thereof. Various components of devices 100 and 300 and implant 500 may have material composites including the above materials to achieve various desired properties such as strength, stiffness, elasticity, compliance, biomechanical properties, durability, and radiolucency or imaging preference. The components of devices 100 and 300 and implant 500 may be made individually or collectively of heterogeneous materials, such as combinations of two or more of the materials described above. The components of devices 100 and 300 and implant 500 may be integrally formed, integrally connected, or include fastening elements and / or instruments as described herein.

[0062] As used in this article, the term “approximately” for numerical values ​​refers to the value being used or a value within plus or minus 10% of the value of the number being used.

[0063] It should be understood that various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as examples of various embodiments. Other modifications within the scope and spirit of the appended claims will be contemplated by those skilled in the art.

Claims

1. A surgical device comprising: a tubular outer shaft having a longitudinal axis, wherein an angled guide is positioned on a first end of the surgical device and a housing is positioned on a second end of the surgical device opposite the first end, the angled guide being angled relative to the longitudinal axis of the outer shaft; an elongated inner shaft having a third end and a fourth end, the inner shaft being detachably coupled to the outer shaft and configured to axially translate through the outer shaft; a pivoting device having at least one joint and an access tool, wherein the at least one joint is pivotably coupled to the fourth end of the inner shaft and an end of the access tool, and wherein the pivoting device is configured to axially translate through the angled guide to a deployed position; a knob disposed at the third end of the inner shaft; at least one pin protruding from an outer surface of the knob; at least one track positioned within the housing and configured to guide the at least one pin as the knob axially translates within the housing; and an external lever having at least one end pivotably coupled to an outer surface of the housing and at least one slot detachably coupled to the pin, thereby securing the inner shaft to the outer shaft.

2. The surgical device of claim 1, wherein the knob is configured to receive an impact from an object and move the pivoting device from a retracted position to a deployed position.

3. The surgical device of claim 1, wherein the surgical device is configured to convert a linear force resulting from an impact to the third end of the inner shaft into an angular force as the pivoting device axially translates through the angled guide.

4. The surgical device of claim 1, wherein the access tool is a awl configured to pierce a portion of a bone.

5. The surgical device of claim 1, wherein a nesting end of the angled guide is nested and configured to fit within a fastening hole of an implant, the fastening hole having a shape corresponding to the nesting end of the angled guide.

6. The surgical device of claim 5, wherein a first portion of the nesting end comprises a tubular shape having a first diameter and a second portion of the nesting end comprises a tubular shape having a second diameter less than the first diameter.

7. A surgical device comprising: a tubular outer shaft having a longitudinal axis, wherein an angled guide is positioned on a first end of the surgical device and a housing is positioned on a second end of the surgical device opposite the first end, the angled guide being angled relative to the longitudinal axis of the outer shaft; an elongated inner shaft having a third end and a fourth end, the inner shaft being detachably coupled to the outer shaft and configured to axially translate through the outer shaft; a pivoting device having at least one joint and an access tool, wherein the at least one joint is pivotably coupled to the fourth end of the inner shaft and an end of the access tool, and wherein the pivoting device is configured to axially translate through the angled guide to a deployed position; and a knob disposed at the third end of the inner shaft; ​ ​ an inner lever pivotably coupled to an outer surface of the housing and having a pin extending laterally from one arm of the inner lever to an opposite arm of the inner lever, wherein the knob includes a slot that detachably couples the pin of the inner lever, thereby securing the inner shaft to the outer shaft.

8. The surgical device of claim 7, wherein the knob is configured to receive an impact from an object and move the pivoting device from a retracted position to a deployed position.

9. The surgical device of claim 7, wherein the surgical device is configured to convert a linear force resulting from an impact to the third end of the inner shaft into an angular force when the pivoting device is axially translated through the angled guide.

10. The surgical device of claim 7, wherein a nested end of the angled guide is nested and configured to fit within a fastening hole of an implant, the fastening hole having a shape corresponding to the nested end of the angled guide.

11. The surgical device of claim 10, wherein a first portion of the nested end includes a tubular shape having a first diameter and a second portion of the nested end includes a tubular shape having a second diameter that is less than the first diameter.

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