EP4676364A1 - A distal humerus fracture repair assembly - Google Patents

A distal humerus fracture repair assembly

Info

Publication number
EP4676364A1
EP4676364A1 EP24766608.4A EP24766608A EP4676364A1 EP 4676364 A1 EP4676364 A1 EP 4676364A1 EP 24766608 A EP24766608 A EP 24766608A EP 4676364 A1 EP4676364 A1 EP 4676364A1
Authority
EP
European Patent Office
Prior art keywords
implant
plate
assembly
humerus
hole
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP24766608.4A
Other languages
German (de)
French (fr)
Inventor
Ritesh Arjunkumar Rathi
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP4676364A1 publication Critical patent/EP4676364A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary devices, e.g. pins or nails
    • A61B17/7233Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/04Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/80Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
    • A61B17/8061Cortical plates, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates specially adapted for particular bones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/56Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/68Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
    • A61B17/72Intramedullary devices, e.g. pins or nails
    • A61B17/7233Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone
    • A61B17/725Intramedullary devices, e.g. pins or nails with special means of locking the nail to the bone with locking pins or screws of special form

Definitions

  • the present invention relates to mechanisms and implants for fixing distal humerus fractures.
  • the humerus is the largest bone of the upper half of a human body.
  • the proximal end of the humerus is joined to the shoulder socket, while the distal head of the humerus allows connection of the radius and the ulna thereto.
  • Distal humerus fractures have a bimodal distribution. Therefore, even if the humerus is strong enough to take on a strong force of a trauma or a fall, if fractured, it will take a few months for recovery. Although rare, but a distal humerus fracture can happen in either youngsters or old people, either of which would require surgery for repairing the bone.
  • the fracture In case of the younger population, the fracture is associated with high energy injury, whereas in case of the older age group the fracture is due to low energy injury secondary to weaker bones (osteoporosis). High energy injuries generally lead to multi-fragmentary fractures while low energy injuries result in simple two- part fractures.
  • the humerus fractures are identified based on the shape or pattern of the fracture line as transverse fracture, spiral fracture, buckle fracture, oblique fracture, segmental fracture, impacted fracture, comminuted fracture, or hairline fracture, or how they occur as stress fracture or avulsion fracture.
  • An object of the present disclosure is to provide a distal humerus fracture repair assembly.
  • Another object of the present disclosure is to provide a distal humerus fracture repair assembly which addresses issues such as multi-fragmentary fracture fragments and weak humerus bone.
  • Yet another object of the present disclosure is to provide a distal humerus fracture repair assembly which helps in eliminating misalignment of fragments of the fracture while it is being healed.
  • the present disclosure envisages a distal humerus fracture repair assembly.
  • the assembly comprises an implant configured to be received in fracture fragments of the distal head of the humerus.
  • the implant has a plurality of holes configured thereon in different operative planes.
  • a first plate is configured to be attached to the medial ridge of the humerus.
  • the first plate is further configured to be attached to the implant.
  • the first plate has a set of first apertures, at least one second aperture(s), and a third aperture configured thereon.
  • a second plate is configured to be attached to the lateral ridge of the humerus.
  • the second plate is further configured to be attached to the implant.
  • the second plate has a set of fourth apertures, at least one fifth aperture(s), and a sixth aperture configured thereon.
  • a set of eighth fasteners is configured to facilitate attachment of the implant in the distal head of the humerus or a part thereof.
  • the fasteners are configured to be received in the holes of the implant and the apertures of the plates to enable fixation of distal humerus fracture.
  • Figure 1A illustrates an anterior view of the assembly, of the present disclosure, implemented in the distal head of the humerus
  • Figure ID illustrates a distal view of the assembly, respectively
  • Figure 2A illustrates an anterior view of the implant
  • Figure 2B illustrates a proximal view of the implant
  • Figure 3A illustrates the humerus bone in its intact form
  • Figure 3B illustrates an anterior view of the distal head of the humerus bone (in its intact form);
  • Figure 3B illustrates a posterior view of the distal head of the humerus bone (also in its intact form);
  • Figure 4A through Figure 4D illustrate an anterior view, a medial view, a posterior view and a lateral view of a two-part fracture of the distal head of the humerus bone, respectively;
  • Figure 5A through Figure 7F illustrate a first embodiment showing the sequence for joining the implant and plates to the distal head of the humerus
  • Figure 8A illustrates an anterior view of a multi-part fracture of the distal head of the humerus bone (10), showing the different fragments of the bone;
  • Figure 8B illustrates a distal view of the fragmented bone of Figure 8A
  • Figure 8C illustrates a posterior view of the fragmented bone of Figure 8A
  • Figure 9 A through Figure 11G illustrate a second embodiment showing the sequence for joining the implant and plates to the distal head of the humerus.
  • Figure 12 illustrates an isometric view of an end cap.
  • Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
  • a distal humerus fracture repair assembly (100) of the present disclosure will now be described in detail with reference to Figure 1A through Figure 12.
  • the distal humerus fracture repair assembly (100) (hereinafter referred to as ‘the assembly (100)’) is configured to enable fixation of the fractured fragments of the distal head (15) of the humerus bone (10) with the humerus bone (10).
  • Figure 1A illustrates an anterior view of the assembly (100) implemented in the distal head (15) of the humerus (10).
  • Figure IB illustrates a medial view of the assembly (100).
  • Figure 1C illustrates a posterior view, and Figure ID illustrates a distal view of the assembly (100), respectively.
  • the assembly (100) comprises an implant (110) configured to be received in fracture fragments of the distal head (15) of the humerus (10).
  • the implant (110) is configured to address various issues like multi-fragmentary fracture fragments and weak humerus bone (10) of the fractured humerus.
  • the implant (110) is an intramedullary implant (110) which serve as a scaffold for reconstruction.
  • the implant (110) has a plurality of holes configured thereon in different operative planes.
  • the assembly (100) further comprises a first plate (150) and a second plate (190).
  • the first plate (150) is configured to be attached to the medial ridge of the humerus (10).
  • the first plate (150) is further configured to be attached to the implant (110).
  • the first plate (150) has a configuration complementary to the medial ridge of the humerus (10), and has a set of first apertures, at least one second aperture(s), and a third aperture configured thereon.
  • the second plate (190) is configured to be attached to the lateral ridge of the humerus (10).
  • the second plate (190) is further configured to be attached to the implant (110).
  • the second plate (190) has a configuration complementary to the lateral ridge of the humerus (10), and has a set of fourth apertures, at least one fifth aperture(s), and a sixth aperture configured thereon.
  • the assembly (100) additionally comprises a plurality of fasteners configured to be inserted in the holes of the implant (110) and the apertures of the plates to enable fixation of the distal humerus fracture.
  • the fasteners are selectively inserted in the implant (110) and the plates, as per the type of the fracture.
  • the plurality of fasteners includes a set of first fasteners (210) configured to facilitate attachment of the first plate (150) with the medial ridge of the humerus (10), at least one second fastener (215) configured to facilitate attachment of the first plate (150) with the implant (110), a third fastener (220) configured to facilitate attachment of the first plate (150) with the implant (110), a set of fourth fasteners (225) configured to facilitate attachment of the second plate (190) with the lateral ridge of the humerus (10), at least one fifth fastener (230) configured to be received in the holes to facilitate attachment of the second plate (190) with the implant (110), at least one sixth fastener (235) configured to facilitate attachment of the second plate (190) with the implant (110), and a set of seventh fasteners (240) and a set of eighth fasteners (245) configured to facilitate attachment of the implant (110) in the distal head (15) of the humerus (10) or a part thereof.
  • Figure 2A illustrates an anterior view of the implant (110).
  • Figure 2B illustrates a proximal view of the implant (HO)implant.
  • the implant (110) is defined by a cylindrical body.
  • the body has a first hole (112) configured on operative central region of the body at an axis parallel to an operative vertical axis.
  • a pair of second holes (115) is configured on the body at an axis perpendicular to an operative horizontal axis.
  • a pair of third holes (120) is configured on the body at a first predetermined angle.
  • a fourth hole (125) is configured on the body at a second predetermined angle.
  • At least one fifth hole (130) is configured on the body at a third predetermined angle.
  • a sixth hole (135) is configured on an operative first end of the body parallel to an operative longitudinal axis.
  • a seventh hole (140) is configured on the body at a fourth predetermined angle.
  • An eighth hole (145) is configured on an operative first end of the body parallel to an operative longitudinal axis.
  • the holes are threaded holes configured to allow the screws to have better purchase in metal and takes weaker bone (10) out of equation.
  • the body of the implant (110) includes a plurality of suturing holes (148) configured at predetermined locations on the body.
  • the suturing hole are configured on different planes on the body.
  • the suturing holes (148) are configured to allow passage of sutures therethrough for repairing soft tissues or small bony and/or cartilaginous fragments around the distal head (15) of the humerus bone (10).
  • the suturing holes (148) are also configured to allow passage of sutures therethrough to fix small fracture fragments that cannot be otherwise fixed with the help of screws.
  • the set of first fasteners (210) is configured to be received in the set of first apertures to facilitate attachment of the first plate (150) with the medial ridge of the humerus (10).
  • the second fastener (215) is configured to be received in the second aperture of the first plate (150) and the fifth hole (130) of the implant (110) to facilitate attachment of the first plate (150) with the implant (110).
  • the third fastener (220) is configured to be received in the third aperture of the first plate (150) and the sixth hole (135) of the implant (110) to lockably secure the implant (110) to the first plate (150) in the operative longitudinal axis.
  • the set of fourth fasteners (225) is configured to be received in the set of fourth apertures to facilitate attachment of the second plate (190) with the lateral ridge of the humerus (10).
  • the fifth fastener (230) is configured to be received in the fifth aperture of the second plate (190) and the seventh hole (140) of the implant (110) to facilitate attachment of the second plate (190) with the implant (110).
  • the sixth fastener (235) is configured to be received in the sixth aperture of the second plate (190) and the eighth hole (145) of the implant (110) to lockably secure the implant (110) with the second plate (190) in the operative longitudinal axis.
  • the assembly (100) includes a jig (not shown in figures) configured to secure the fragments together. More specifically, the jig is configured to provide a support to the bottom portion of the distal head (15), thereby helping in a faster rate of fixation of the fragmented distal head (15) with the humerus bone (10). In an embodiment, the jig has a slot configured thereon.
  • the assembly (100) includes a ninth fastener configured to be received in the first hole (112) and the slot to facilitate attachment of the jig with the implant (HO).
  • the set of seventh fasteners (240) is configured to be received in the second holes (115) of the implant (110).
  • a set of eighth fasteners (245) is configured to be received in the third holes (120) and the fourth hole (125) of the implant (110) to facilitate attachment of the implant (110) with the humerus (10).
  • the first predetermined angle at which the third holes (120) are configured ranges between 25°-35°
  • the second predetermined angle at which the fourth hole (125) is configured ranges between 40°-50°.
  • the third predetermined angle at which the fifth hole (130) is configured ranges between 40°-50°.
  • the fourth predetermined angle at which the seventh hole (140) is configured ranges between 40°-50°. In yet another embodiment, the angle at which the holes are configured, and their dimensions are dependent on the anatomy of the patient.
  • the fasteners are cannulated screws.
  • the cannulated screw is defined by a hollow shaft having a plurality of cutting teeth configured on an operative end thereof. The teeth are configured to cut through the bone (10) when the screw is inserted in the bone (10).
  • these screws are inserted using a target device which makes insertion procedure technically easier and avoids complications associated with free hand technique such as screws in the joint.
  • the fasteners are non-cannulated screws.
  • the assembly (100) includes at least one end cap(s) (250) (as shown in Figure 12) configured to be received in the sixth hole (220) and/or the eighth hole (235).
  • the end cap(s) (250) is configured to allow the passage of at least one suture therethrough to help repair soft tissues.
  • the length of the implant (110) ranges between 40 mm to 110mm. In another embodiment, the diameter of the implant (110) ranges between 4mm to 12mm. In yet another embodiment, the size and the dimensions of the implant (110) are dependent on the anatomy of the patient.
  • the assembly (100) helps in alignment of the fragments of the fractured distal head (15) of the humerus (10), thereby eliminating any probability of malunion or even nonunion of the fragments.
  • Figure 3A through Figure 3C illustrate the humerus bone (10) in its intact form, and the anterior and posterior view of the distal head (15) of the humerus bone (10) (also in its intact form).
  • Figure 4A through Figure 4D illustrate an anterior view, a medial view, a posterior view and a lateral view of a two-part fracture of the distal head (15) of the humerus bone (10).
  • Figure 5A illustrates a first step of fixing the fragment (20) with the humerus (10), wherein the implant (110) is inserted in the fragment (20).
  • the implant (110) is inserted in the fragment (20) from the lateral side, specifically, in the center of the condyle (as shown in Figure 6B), and remains implanted as shown in Figures 5B and 5C.
  • the second step includes abutting the first plate (150) on the medial ridge of the humerus (10), as shown in Figure 6A.
  • the third fastener (220) is inserted through the third aperture of the first plate (150) into the sixth hole (135) of the implant (110).
  • the second fastener (215) is then inserted through the second aperture of the first plate (150) into the fifth hole (130) of the fixation plate, as shown in Figure 6C. Thereafter, a first fastener (210) of the set of first fasteners (210) is inserted in a first aperture of the set of first apertures of the first plate (150), as shown in Figure 6D.
  • the first plate (150) is attached to the humerus (10), the fragment (20) of the humerus (10) and the implant (110).
  • the third step includes abutting the second plate (190) on the lateral ridge of the humerus (10), as shown in Figure 7A.
  • Figure 7B illustrates insertion of the fifth fastener (230) into the seventh hole (140) of the implant (110) through the fifth aperture of the second plate (190).
  • Figure 7C illustrates insertion of the sixth fastener (235) into the eighth hole (145) of the implant (110) through the sixth aperture of the second plate (190).
  • the set of fourth fasteners (225) are inserted in the fourth apertures of the second plate (190), one by one, as shown in Figures 7D and 7E.
  • the rest of the first fasteners (210) are then inserted in the first apertures as shown in Figure 7F.
  • the second plate (190) is attached to the humerus (10), the fragment (20) of the humerus (10) and the implant (110).
  • the number of the fasteners to be inserted would range from one to three or even more depending on the anatomy of the bone (10) and the severity of the fracture. Further, the sequence of performing the steps could vary as per the requirement and the skill of the surgeon.
  • Figure 8A through Figure 8C illustrate an anterior view, a distal view and a posterior view of a multi-part fracture of the distal head (15) of the humerus bone (10), showing the different fragments (20, 30, 40, 50, 60) of the bone (10).
  • a first fragment (20) is arranged on the bone (10) as shown in Figure 9 A.
  • a first end of the implant (110) is inserted in the first part, as shown in Figure 9B.
  • the first plate (150) is then abutted on the medial ridge of the humerus (10), as shown in Figure 9C.
  • the third fastener (220) is inserted in the sixth hole (135) of the implant (110) through the third aperture of the locking plate.
  • the second fastener (215) is inserted in the fifth hole (130) of the implant (110) through the second aperture of the locking plate; while a first fastener of the set of first fasteners (210) is received in a first aperture of the set of first apertures, of the first plate (150), as shown in Figure 9F.
  • a second fragment (30) and a third fragment (40) is then joined to the implant (110), as shown in Figure 10A. These fragments (30, 40) are fastened to the implant (110) with the help of a seventh fastener which is configured to be received in a second hole of the implant (110), as shown in Figure 10B and Figure 10C.
  • a fourth fragment (50) is joined to the implant (110), as shown in Figure 10D, and then fastened to the implant (110) with the help of the eighth fasteners (245) configured to be received in the third holes (120) and the fourth hole (125) of the implant (110), as shown in Figures 10E and 10F.
  • the fifth fragment (60) is first arranged on to the distal head (15) of the humerus (10) and to the fourth fragment as shown in Figure 11 A.
  • the second plate (190) is then abutted on the fifth fragment as shown in Figure 1 IB, and the fifth fastener (230) is passed through the fifth aperture of the second plate (190) and is received in the seventh hole (140) of the implant (110), as shown in Figure 11C.
  • the sixth fastener (235) is passed through the sixth aperture and is received in the eighth hole (145) of the implant (110).
  • a fourth fastener (225) is received in a fourth aperture of the second plate (190).
  • the rest of the first fasteners (210) and the fourth fasteners (225) are inserted into the first apertures of the first plate (150) and the fourth apertures of the second plate (190), respectively, as shown in Figures HF and 11G.
  • first plate (150) and the second plate (190) are attached to the humerus (10) and the implant (110) to help fix the fractured distal head (15) of the humerus (10).
  • the number of the fasteners to be inserted would range from one to three or even more depending on the anatomy of the bone (10) and the severity of the fracture. Further, the sequence of performing the steps could vary as per the requirement and the skill of the surgeon.

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Abstract

The present disclosure relates to mechanisms for fixing distal humerus fractures The present disclosure envisages a distal humerus fracture repair assembly (100) which comprises an implant (110) configured to be received in fracture fragments. The implant (110) has a plurality of holes configured thereon. The assembly (100) further comprises a first plate (150) and a second plate (190), both having a plurality of apertures configured thereon. The first plate (150) is configured to be attached to the medial ridge of the humerus (10). The second plate (190) is configured to be attached to the lateral ridge of the humerus (10). The second plate (190) is further configured to be attached to the implant (110). A plurality of fasteners is configured to be inserted in the holes of the implant (110) and the apertures of the plates to enable fixation of the distal humerus fracture.

Description

A DISTAL HUMERUS FRACTURE REPAIR ASSEMBLY
FIELD
The present invention relates to mechanisms and implants for fixing distal humerus fractures.
BACKGROUND
The background information herein below relates to the present disclosure but is not necessarily prior art.
The humerus is the largest bone of the upper half of a human body. The proximal end of the humerus is joined to the shoulder socket, while the distal head of the humerus allows connection of the radius and the ulna thereto. Distal humerus fractures have a bimodal distribution. Therefore, even if the humerus is strong enough to take on a strong force of a trauma or a fall, if fractured, it will take a few months for recovery. Although rare, but a distal humerus fracture can happen in either youngsters or old people, either of which would require surgery for repairing the bone. In case of the younger population, the fracture is associated with high energy injury, whereas in case of the older age group the fracture is due to low energy injury secondary to weaker bones (osteoporosis). High energy injuries generally lead to multi-fragmentary fractures while low energy injuries result in simple two- part fractures. The humerus fractures are identified based on the shape or pattern of the fracture line as transverse fracture, spiral fracture, buckle fracture, oblique fracture, segmental fracture, impacted fracture, comminuted fracture, or hairline fracture, or how they occur as stress fracture or avulsion fracture.
While dealing with fractures of the humerus bone, early mobilization is highly desirable to restore the elbow function. One of the prerequisites for early mobilization is a strong surgical fixation. To achieve stable surgical fixation, both high and low energy injuries pose different challenges to a surgeon. The fixation of multi-fragmentary fracture is like solving the jig saw puzzle, which need a stable platform/scaffold for reconstruction. On the other hand, low energy fractures do not offer strong purchase of the screws due to osteoporosis. Further, sub- optimal fracture fixation needs additional support from outside such as a splint which further delays mobilization and thereby compromises the elbow function. Therefore, there is felt a need for an assembly which helps in fixing the distal humerus fracture and alleviates the aforementioned drawbacks.
OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
An object of the present disclosure is to provide a distal humerus fracture repair assembly.
Another object of the present disclosure is to provide a distal humerus fracture repair assembly which addresses issues such as multi-fragmentary fracture fragments and weak humerus bone.
Yet another object of the present disclosure is to provide a distal humerus fracture repair assembly which helps in eliminating misalignment of fragments of the fracture while it is being healed.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.
SUMMARY
The present disclosure envisages a distal humerus fracture repair assembly. The assembly comprises an implant configured to be received in fracture fragments of the distal head of the humerus. The implant has a plurality of holes configured thereon in different operative planes. A first plate is configured to be attached to the medial ridge of the humerus. The first plate is further configured to be attached to the implant. The first plate has a set of first apertures, at least one second aperture(s), and a third aperture configured thereon. A second plate is configured to be attached to the lateral ridge of the humerus. The second plate is further configured to be attached to the implant. The second plate has a set of fourth apertures, at least one fifth aperture(s), and a sixth aperture configured thereon. A set of first fasteners is configured to facilitate attachment of the first plate with the medial ridge of the humerus. At least one second fastener is configured to facilitate attachment of the first plate with the implant. A third fastener is configured to facilitate attachment of the first plate with the implant. A set of fourth fasteners configured to facilitate attachment of the second plate with the lateral ridge of the humerus. At least one fifth fastener is configured to be received in the holes to facilitate attachment of the second plate with the implant. At least one sixth fastener is configured to facilitate attachment of the second plate with the implant. A set of seventh fasteners is configured to facilitate attachment of the implant in the distal head of the humerus or a part thereof. A set of eighth fasteners is configured to facilitate attachment of the implant in the distal head of the humerus or a part thereof. The fasteners are configured to be received in the holes of the implant and the apertures of the plates to enable fixation of distal humerus fracture.
BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING
A distal humerus fracture repair assembly of the present disclosure will now be described with the help of the accompanying drawing, in which:
Figure 1A illustrates an anterior view of the assembly, of the present disclosure, implemented in the distal head of the humerus;
Figure IB illustrates a medial view of the assembly;
Figure 1C illustrates a posterior view; and
Figure ID illustrates a distal view of the assembly, respectively;
Figure 2A illustrates an anterior view of the implant;
Figure 2B illustrates a proximal view of the implant;
Figure 3A illustrates the humerus bone in its intact form;
Figure 3B illustrates an anterior view of the distal head of the humerus bone (in its intact form);
Figure 3B illustrates a posterior view of the distal head of the humerus bone (also in its intact form);
Figure 4A through Figure 4D illustrate an anterior view, a medial view, a posterior view and a lateral view of a two-part fracture of the distal head of the humerus bone, respectively;
Figure 5A through Figure 7F illustrate a first embodiment showing the sequence for joining the implant and plates to the distal head of the humerus;
Figure 8A illustrates an anterior view of a multi-part fracture of the distal head of the humerus bone (10), showing the different fragments of the bone;
Figure 8B illustrates a distal view of the fragmented bone of Figure 8A; Figure 8C illustrates a posterior view of the fragmented bone of Figure 8A;
Figure 9 A through Figure 11G illustrate a second embodiment showing the sequence for joining the implant and plates to the distal head of the humerus; and
Figure 12 illustrates an isometric view of an end cap.
LIST OF REFERENCE NUMERALS
10 humerus bone
12 proximal end of the bone
15 distal head of the bone
20, 30, 40, 50, 60 fragment of the distal head of the bone
100 distal humerus fracture repair assembly
110 implant
112 first hole
115 second hole
120 third hole
125 fourth hole
130 fifth hole
135 sixth hole
140 seventh hole
145 eighth hole
148 suturing hole
150 first plate
190 second plate
210 first fastener
215 second fastener
220 third fastener 225 fourth fastener
230 fifth fastener
235 sixth fastener
240 seventh fastener
245 eighth fastener
250 end cap
DETAILED DESCRIPTION
Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms “a”, “an” and “the” may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms “comprises”, “comprising”, “including”, “includes” and “having” are open-ended transitional phrases and therefore specify the presence of stated features, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, elements, components, and/or groups thereof.
Embodiments, of the present disclosure, will now be described with reference to the accompanying drawing.
A distal humerus fracture repair assembly (100) of the present disclosure will now be described in detail with reference to Figure 1A through Figure 12.
The distal humerus fracture repair assembly (100) (hereinafter referred to as ‘the assembly (100)’) is configured to enable fixation of the fractured fragments of the distal head (15) of the humerus bone (10) with the humerus bone (10). Figure 1A illustrates an anterior view of the assembly (100) implemented in the distal head (15) of the humerus (10). Figure IB illustrates a medial view of the assembly (100). Figure 1C illustrates a posterior view, and Figure ID illustrates a distal view of the assembly (100), respectively.
The assembly (100) comprises an implant (110) configured to be received in fracture fragments of the distal head (15) of the humerus (10). The implant (110) is configured to address various issues like multi-fragmentary fracture fragments and weak humerus bone (10) of the fractured humerus. The implant (110) is an intramedullary implant (110) which serve as a scaffold for reconstruction. The implant (110) has a plurality of holes configured thereon in different operative planes. The assembly (100) further comprises a first plate (150) and a second plate (190). The first plate (150) is configured to be attached to the medial ridge of the humerus (10). The first plate (150) is further configured to be attached to the implant (110). The first plate (150) has a configuration complementary to the medial ridge of the humerus (10), and has a set of first apertures, at least one second aperture(s), and a third aperture configured thereon. The second plate (190) is configured to be attached to the lateral ridge of the humerus (10). The second plate (190) is further configured to be attached to the implant (110). The second plate (190) has a configuration complementary to the lateral ridge of the humerus (10), and has a set of fourth apertures, at least one fifth aperture(s), and a sixth aperture configured thereon.
The assembly (100) additionally comprises a plurality of fasteners configured to be inserted in the holes of the implant (110) and the apertures of the plates to enable fixation of the distal humerus fracture. Typically, the fasteners are selectively inserted in the implant (110) and the plates, as per the type of the fracture. The plurality of fasteners includes a set of first fasteners (210) configured to facilitate attachment of the first plate (150) with the medial ridge of the humerus (10), at least one second fastener (215) configured to facilitate attachment of the first plate (150) with the implant (110), a third fastener (220) configured to facilitate attachment of the first plate (150) with the implant (110), a set of fourth fasteners (225) configured to facilitate attachment of the second plate (190) with the lateral ridge of the humerus (10), at least one fifth fastener (230) configured to be received in the holes to facilitate attachment of the second plate (190) with the implant (110), at least one sixth fastener (235) configured to facilitate attachment of the second plate (190) with the implant (110), and a set of seventh fasteners (240) and a set of eighth fasteners (245) configured to facilitate attachment of the implant (110) in the distal head (15) of the humerus (10) or a part thereof.
Figure 2A illustrates an anterior view of the implant (110). Figure 2B illustrates a proximal view of the implant (HO)implant.
As shown in Figure 2 A and Figure 2B, the implant (110) is defined by a cylindrical body.
The body has a first hole (112) configured on operative central region of the body at an axis parallel to an operative vertical axis. A pair of second holes (115) is configured on the body at an axis perpendicular to an operative horizontal axis. A pair of third holes (120) is configured on the body at a first predetermined angle. A fourth hole (125) is configured on the body at a second predetermined angle. At least one fifth hole (130) is configured on the body at a third predetermined angle. A sixth hole (135) is configured on an operative first end of the body parallel to an operative longitudinal axis. A seventh hole (140) is configured on the body at a fourth predetermined angle. An eighth hole (145) is configured on an operative first end of the body parallel to an operative longitudinal axis.
In another embodiment, the holes are threaded holes configured to allow the screws to have better purchase in metal and takes weaker bone (10) out of equation.
In another embodiment, the body of the implant (110) includes a plurality of suturing holes (148) configured at predetermined locations on the body. In an embodiment, the suturing hole are configured on different planes on the body. The suturing holes (148) are configured to allow passage of sutures therethrough for repairing soft tissues or small bony and/or cartilaginous fragments around the distal head (15) of the humerus bone (10). The suturing holes (148) are also configured to allow passage of sutures therethrough to fix small fracture fragments that cannot be otherwise fixed with the help of screws.
In another embodiment, the set of first fasteners (210) is configured to be received in the set of first apertures to facilitate attachment of the first plate (150) with the medial ridge of the humerus (10). In another embodiment, the second fastener (215) is configured to be received in the second aperture of the first plate (150) and the fifth hole (130) of the implant (110) to facilitate attachment of the first plate (150) with the implant (110). In yet another embodiment, the third fastener (220) is configured to be received in the third aperture of the first plate (150) and the sixth hole (135) of the implant (110) to lockably secure the implant (110) to the first plate (150) in the operative longitudinal axis. In one embodiment, the set of fourth fasteners (225) is configured to be received in the set of fourth apertures to facilitate attachment of the second plate (190) with the lateral ridge of the humerus (10). In another embodiment, the fifth fastener (230) is configured to be received in the fifth aperture of the second plate (190) and the seventh hole (140) of the implant (110) to facilitate attachment of the second plate (190) with the implant (110). In still another embodiment, the sixth fastener (235) is configured to be received in the sixth aperture of the second plate (190) and the eighth hole (145) of the implant (110) to lockably secure the implant (110) with the second plate (190) in the operative longitudinal axis.
In an embodiment, the assembly (100) includes a jig (not shown in figures) configured to secure the fragments together. More specifically, the jig is configured to provide a support to the bottom portion of the distal head (15), thereby helping in a faster rate of fixation of the fragmented distal head (15) with the humerus bone (10). In an embodiment, the jig has a slot configured thereon.
In another embodiment, the assembly (100) includes a ninth fastener configured to be received in the first hole (112) and the slot to facilitate attachment of the jig with the implant (HO).
In an embodiment, the set of seventh fasteners (240) is configured to be received in the second holes (115) of the implant (110). In another embodiment, a set of eighth fasteners (245) is configured to be received in the third holes (120) and the fourth hole (125) of the implant (110) to facilitate attachment of the implant (110) with the humerus (10).
In one embodiment, the first predetermined angle at which the third holes (120) are configured ranges between 25°-35°
In an embodiment, the second predetermined angle at which the fourth hole (125) is configured ranges between 40°-50°.
In an embodiment, the third predetermined angle at which the fifth hole (130) is configured ranges between 40°-50°.
In an embodiment, the fourth predetermined angle at which the seventh hole (140) is configured ranges between 40°-50°. In yet another embodiment, the angle at which the holes are configured, and their dimensions are dependent on the anatomy of the patient. In an embodiment, the fasteners are cannulated screws. The cannulated screw is defined by a hollow shaft having a plurality of cutting teeth configured on an operative end thereof. The teeth are configured to cut through the bone (10) when the screw is inserted in the bone (10).
In another embodiment, these screws are inserted using a target device which makes insertion procedure technically easier and avoids complications associated with free hand technique such as screws in the joint.
In an embodiment, the fasteners are non-cannulated screws.
In another embodiment, the assembly (100) includes at least one end cap(s) (250) (as shown in Figure 12) configured to be received in the sixth hole (220) and/or the eighth hole (235). The end cap(s) (250) is configured to allow the passage of at least one suture therethrough to help repair soft tissues.
In an embodiment, the length of the implant (110) ranges between 40 mm to 110mm. In another embodiment, the diameter of the implant (110) ranges between 4mm to 12mm. In yet another embodiment, the size and the dimensions of the implant (110) are dependent on the anatomy of the patient.
The assembly (100) helps in alignment of the fragments of the fractured distal head (15) of the humerus (10), thereby eliminating any probability of malunion or even nonunion of the fragments.
A first exemplary embodiment of the usage of the assembly (100) for a simple two-part fracture will now be explained in detail as follows:
Figure 3A through Figure 3C illustrate the humerus bone (10) in its intact form, and the anterior and posterior view of the distal head (15) of the humerus bone (10) (also in its intact form).
Figure 4A through Figure 4D illustrate an anterior view, a medial view, a posterior view and a lateral view of a two-part fracture of the distal head (15) of the humerus bone (10).
Figure 5A illustrates a first step of fixing the fragment (20) with the humerus (10), wherein the implant (110) is inserted in the fragment (20). The implant (110) is inserted in the fragment (20) from the lateral side, specifically, in the center of the condyle (as shown in Figure 6B), and remains implanted as shown in Figures 5B and 5C. The second step includes abutting the first plate (150) on the medial ridge of the humerus (10), as shown in Figure 6A. As shown in Figure 6B, the third fastener (220) is inserted through the third aperture of the first plate (150) into the sixth hole (135) of the implant (110). The second fastener (215) is then inserted through the second aperture of the first plate (150) into the fifth hole (130) of the fixation plate, as shown in Figure 6C. Thereafter, a first fastener (210) of the set of first fasteners (210) is inserted in a first aperture of the set of first apertures of the first plate (150), as shown in Figure 6D. Thus, the first plate (150) is attached to the humerus (10), the fragment (20) of the humerus (10) and the implant (110).
The third step includes abutting the second plate (190) on the lateral ridge of the humerus (10), as shown in Figure 7A. Figure 7B illustrates insertion of the fifth fastener (230) into the seventh hole (140) of the implant (110) through the fifth aperture of the second plate (190). Figure 7C illustrates insertion of the sixth fastener (235) into the eighth hole (145) of the implant (110) through the sixth aperture of the second plate (190). Thereafter, the set of fourth fasteners (225) are inserted in the fourth apertures of the second plate (190), one by one, as shown in Figures 7D and 7E. The rest of the first fasteners (210) are then inserted in the first apertures as shown in Figure 7F. Thus, the second plate (190) is attached to the humerus (10), the fragment (20) of the humerus (10) and the implant (110).
The number of the fasteners to be inserted would range from one to three or even more depending on the anatomy of the bone (10) and the severity of the fracture. Further, the sequence of performing the steps could vary as per the requirement and the skill of the surgeon.
A second exemplary embodiment of the usage of the assembly (100) for a complex multi-part fracture will now be explained in detail as follows:
Figure 8A through Figure 8C illustrate an anterior view, a distal view and a posterior view of a multi-part fracture of the distal head (15) of the humerus bone (10), showing the different fragments (20, 30, 40, 50, 60) of the bone (10).
To facilitate the fixation of the fragment, a first fragment (20) is arranged on the bone (10) as shown in Figure 9 A. A first end of the implant (110) is inserted in the first part, as shown in Figure 9B. The first plate (150) is then abutted on the medial ridge of the humerus (10), as shown in Figure 9C. As shown in Figure 9D, the third fastener (220) is inserted in the sixth hole (135) of the implant (110) through the third aperture of the locking plate. Thereafter, as shown in Figure 9E, the second fastener (215) is inserted in the fifth hole (130) of the implant (110) through the second aperture of the locking plate; while a first fastener of the set of first fasteners (210) is received in a first aperture of the set of first apertures, of the first plate (150), as shown in Figure 9F.
A second fragment (30) and a third fragment (40) is then joined to the implant (110), as shown in Figure 10A. These fragments (30, 40) are fastened to the implant (110) with the help of a seventh fastener which is configured to be received in a second hole of the implant (110), as shown in Figure 10B and Figure 10C. A fourth fragment (50) is joined to the implant (110), as shown in Figure 10D, and then fastened to the implant (110) with the help of the eighth fasteners (245) configured to be received in the third holes (120) and the fourth hole (125) of the implant (110), as shown in Figures 10E and 10F. For joining the fifth fragment (60) to the humerus (10), the fifth fragment (60) is first arranged on to the distal head (15) of the humerus (10) and to the fourth fragment as shown in Figure 11 A. The second plate (190) is then abutted on the fifth fragment as shown in Figure 1 IB, and the fifth fastener (230) is passed through the fifth aperture of the second plate (190) and is received in the seventh hole (140) of the implant (110), as shown in Figure 11C. Thereafter, as shown in Figure 1 ID, the sixth fastener (235) is passed through the sixth aperture and is received in the eighth hole (145) of the implant (110). Further, as shown in Figure HE, a fourth fastener (225) is received in a fourth aperture of the second plate (190). The rest of the first fasteners (210) and the fourth fasteners (225) are inserted into the first apertures of the first plate (150) and the fourth apertures of the second plate (190), respectively, as shown in Figures HF and 11G.
Thus, the first plate (150) and the second plate (190) are attached to the humerus (10) and the implant (110) to help fix the fractured distal head (15) of the humerus (10).
The number of the fasteners to be inserted would range from one to three or even more depending on the anatomy of the bone (10) and the severity of the fracture. Further, the sequence of performing the steps could vary as per the requirement and the skill of the surgeon.
The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.
TECHNICAL ADVANCEMENTS
The present disclosure described hereinabove has several technical advantages including, but not limited to, the realization of a distal humerus fracture repair assembly which:
• addresses issues such as multi-fragmentary fracture fragments and weak humerus bone; and
• helps in eliminating misalignment of fragments of the fracture while it is being healed.
The foregoing disclosure has been described with reference to the accompanying embodiments which do not limit the scope and ambit of the disclosure. The description provided is purely by way of example and illustration.
The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
The foregoing description of the specific embodiments so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein. Any discussion of materials, implants, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.
The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher/lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary. While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

CLAIMS:
1. A distal humerus fracture repair assembly (100) comprising:
• an implant (110) configured to be received in fracture fragments of the distal head (15) of the humerus (10), said implant (110) having a plurality of holes configured thereon in different operative planes;
• a first plate (150) configured to be attached to the medial ridge of the humerus (10), said first plate (150) further configured to be attached to said implant (110), said first plate (150) having a set of first apertures, at least one second aperture(s), and a third aperture configured thereon;
• a second plate (190) configured to be attached to the lateral ridge of the humerus (10), said second plate (190) further configured to be attached to said implant (110), said second plate (190) having a set of fourth apertures, at least one fifth aperture(s), and a sixth aperture configured thereon;
• a set of first fasteners (210) configured to facilitate attachment of said first plate (150) with the medial ridge of the humerus (10);
• at least one second fastener (215) configured to facilitate attachment of said first plate (150) with said implant (110);
• a third fastener (220) configured to facilitate attachment of said first plate (150) with said implant (110);
• a set of fourth fasteners (225) configured to facilitate attachment of said second plate (190) with the lateral ridge of the humerus (10);
• at least one fifth fastener (230) configured to be received in said holes to facilitate attachment of said second plate (190) with said implant (110);
• at least one sixth fastener (235) configured to facilitate attachment of said second plate (190) with said implant (110);
• a set of seventh fasteners (240) configured to facilitate attachment of said implant (110) in the distal head (15) of the humerus (10) or a part thereof; and
• a set of eighth fasteners (245) configured to facilitate attachment of said implant (110) in the distal head (15) of the humerus or a part thereof; wherein said fasteners are configured to be received in said holes of said implant (110) and said apertures of said plates (150, 190) to enable fixation of distal humerus fracture.
2. The assembly (100) as claimed in claim 1, wherein said implant (110) is defined by a cylindrical body having: o a first hole (112) configured on operative central region of said body at an axis parallel to an operative vertical axis; o a pair of second holes (115) configured on said body at an axis perpendicular to an operative horizontal axis; o a pair of third holes (120) configured on said body at a first predetermined angle; o a fourth hole (125) configured on said body at a second predetermined angle; o at least one fifth hole (130) configured on said body at a third predetermined angle; o a sixth hole (135) configured on an operative first end of said body parallel to an operative longitudinal axis; o a seventh hole (140) configured on said body at a fourth predetermined angle; and o an eighth hole (145) configured on an operative first end of said body parallel to an operative longitudinal axis.
3. The assembly (100) as claimed in claim 2, wherein said body of said implant (110) includes a plurality of suturing holes (148) configured at predetermined locations on said body.
4. The assembly (100) as claimed in claiml, wherein said set of first fasteners (210) is configured to be received in said set of first apertures to facilitate attachment of said first plate (150) with the medial ridge of the humerus (10).
5. The assembly (100) as claimed in claim 2, wherein said second fastener (215) is configured to be received in said second aperture of said first plate (150) and said fifth hole (130) of said implant (110) to facilitate attachment of said first plate (150) with said implant (110).
6. The assembly (100) as claimed in claim 2, wherein said third fastener (220) is configured to be received in said third aperture of said first plate (150) and said sixth hole (135) of said implant (110) to lockably secure said implant (110) to said first plate (150) in said operative longitudinal axis.
7. The assembly (100) as claimed in claim 1, wherein said set of fourth fasteners (225) is configured to be received in said set of fourth apertures to facilitate attachment of said second plate (190) with the lateral ridge of the humerus (10).
8. The assembly (100) as claimed in claim 2, wherein said fifth fastener (230) is configured to be received in said fifth aperture of said second plate (190) and said seventh hole (140) of said implant (110) to facilitate attachment of said second plate (190) with said implant (110).
9. The assembly (100) as claimed in claim 2, wherein said sixth fastener (235) is configured to be received in said sixth aperture of said second plate (190) and said eighth hole (145) of said implant (110) to lockably secure said implant (110) with said second plate (190) in said operative longitudinal axis.
10. The assembly (100) as claimed in claim 1, which includes a jig configured to secure said fragments together, said jig having a slot configured thereon.
11. The assembly (100) as claimed in claim 10, which includes a ninth fastener configured to be received in said first hole (112) and said slot to facilitate attachment of said jig with said implant (110).
12. The assembly (100) as claimed in claim 2, wherein said set of seventh fasteners (240) is configured to be received in said second holes (115) of said implant (110) to facilitate attachment of said implant (110) with the humerus (10).
13. The assembly (100) as claimed in claim 2, wherein said set of eighth fasteners (245) are configured to be received in each of said third holes (120) and said fourth hole (125) of said implant (110) to facilitate attachment of said implant (110) with the humerus (10).
14. The assembly (100) as claimed in claim 2, wherein said first predetermined angle ranges between 25°-35°.
15. The assembly (100) as claimed in claim 2, wherein said second predetermined angle ranges between 40°-50°.
16. The assembly (100) as claimed in claim 2, wherein said third predetermined angle ranges between 40°-50°.
17. The assembly (100) as claimed in claim 2, wherein said fourth predetermined angle ranges between 40°-50°.
18. The assembly (100) as claimed in claim 1, wherein said fasteners are cannulated screws.
19. The assembly (100) as claimed in claim 1, wherein said fasteners are non-cannulated screws.
20. The assembly (100) as claimed in claim 2, which includes at least one end cap(s) (250) configured to be received in said sixth hole (220) and/or said eighth hole (235), said end cap(s) (250) configured to allow passage of a suture therethrough.
21. The assembly (100) as claimed in claim 1, wherein the length of said implant (110) ranges between 40mm to 110mm.
22. The assembly (100) as claimed in claim 1, wherein the diameter of said implant (110) ranges between 4mm to 12mm.
EP24766608.4A 2023-03-08 2024-03-07 A distal humerus fracture repair assembly Pending EP4676364A1 (en)

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RO127162B1 (en) * 2010-08-12 2016-08-30 Eduard Mitroi Modular implant for fixing fractures of the lower end of the humerus
US20120330313A1 (en) * 2010-12-03 2012-12-27 Grady John F Intramedullary nail technology
US9861402B2 (en) * 2012-03-08 2018-01-09 Trimed, Incorporated System and method for treating a fractured bone

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