Source: https://patents.google.com/patent/WO2016057090A1/en
Timestamp: 2018-10-20 11:51:19
Document Index: 217781104

Matched Legal Cases: ['art.\n7', 'art.\n8', 'art.\n10', 'art.\n11', 'art.\n16', 'art.\n18']

WO2016057090A1 - Implantable bone marrow access apparatus - Google Patents
WO2016057090A1
WO2016057090A1 PCT/US2015/036407 US2015036407W WO2016057090A1 WO 2016057090 A1 WO2016057090 A1 WO 2016057090A1 US 2015036407 W US2015036407 W US 2015036407W WO 2016057090 A1 WO2016057090 A1 WO 2016057090A1
PCT/US2015/036407
Bone marrow access apparatus includes a bone attachment part attachable to bone, a tubular conduit part attached to the bone attachment part defining a conduit communicating with a hollow interior of the bone attachment part, a port attached to the conduit part. The port defines a hollow interior communicating with the conduit defined by the conduit part. One or more optional flow control components are in a passage defined by the interior of the bone attachment member, the conduit of the conduit part and the interior of the port and operatively restrict inflow or outflow. A localization part is on the port and enables the port to be located through skin. In use, a sampling device is inserted through skin overlying the port, through the passage defined by the apparatus, through the flow control component(s), and into the marrow space. Marrow is captured and then the sampling device is removed.
An object of one or more embodiments of the present invention is to provide a bone marrow access apparatus and method that allow repeated sampling of bone marrow at multiple timepoints without the need for repeated bone punctures through the bone cortex (the outer portion of the bone that has nerves which make punctures painful). The subcutaneous location of the device may reduce infection from repeated sampling. A bone marrow access apparatus in accordance with the invention includes a bone attachment part or member adapted to be attached to bone and having a hollow interior, a tubular conduit part or member attached to the bone attachment member and defining a conduit communicating with the interior of the bone attachment member, and a port attached to the conduit member. The port includes a housing defining a hollow interior communicating with the conduit defined by the tubular member. The interior of the bone attachment member, the conduit of the tubular member and the hollow interior of the housing of the port define a passage in which a flow control component is arranged. A localization part or member is on or integrated into the port and configured to enable the port to be located through skin that covers the port and allows alignment of the needle with the channel through the device from the exterior.
The bone attachment member, tubular conduit member and localization member may be parts in the sense that they are all formed on a common, unitary structure along with the port. This one- piece structure provides the functionality of the various members. Alternatively, different combinations of the parts may be formed on the same component.
When the port incudes a palpable structure as the localization member, in the biopsy stage before inserting the sampling device, the port can be located by feeling along the skin for the palpable structure on the port. Different techniques would be used for other localization members, for example magnetic localization. Localization of the port enables alignment of the needle exterior to the patient with the conduit within the device.
FIG. 11 shows a another embodiment of bone marrow access apparatus in accordance with the invention; FIG. 12 shows yet another embodiment of bone marrow access apparatus in accordance with the invention;
Alternatively, different bone marrow access apparatus 10 may be formed, each with a different length conduit member 14. The surgeon then selects the appropriate sized apparatus 10 depending on the patient' s physical dimensions.
The localization member facilitates alignment of the external sampling needle or biopsy instrument with the passage defined by the interior of the bone attachment member 12, the conduit of the tubular conduit member 14 and the hollow interior of the housing of the port 16. This alignment allows for easy sampling and retrieval of bone marrow from the bone to which the bone attachment member 12 is attached. As shown in FIG. 3, the port 16 is directly above the bone attachment member 12, providing a minimum length of the conduit member 14 for the specific patient. However, the port 16 is not required to be directly above the bone attachment member 12.
Once the bone attachment member 12 is fully inserted, the conduit member 14 is attached to the housing 18 (if it is not pre-attached to the housing 18, which is equally viable possibility). The conduit member 14 is then shortened or cut to fit the patient, i.e., provide the appropriate length between the bone attachment member 12 and the expected site of the port 16 below the patient' s skin 36. This distance may be the same as the distance between the bone attachment member 12 and the patient' s skin 12. The port may be superficial and palpable while the bone is deeper to the skin.
Installation of the apparatus 10 is now complete. The incision site is then covered by the patient' s skin 36, with the localization member in a position below and preferably adjacent the skin to enable its easy location when needed for a sampling procedure.
To aid in the insertion of the biopsy needle into the passage 14A defined by the conduit member 14, an interior surface of the housing 28 may be provided with threads 42, and a trocar 44 provided with complementary threads 46, see FIG. 4. The trocar 44 is initially inserted through the patient' s skin 36 and into the valve 32 until its threads 46 engage threads 42. The trocar 44 is then rotated to attach it to the port 16. Thereafter, the biopsy needle is inserted through the trocar 44 directly into the passage 14A defined by the conduit member 14.
FIGS. 5-10 relate to an embodiment of a bone marrow access apparatus 50 that does not include a tubular conduit member or sheath. Bone marrow access apparatus 50 includes an access port 52 that is supra-osseous, i.e., formed on the bone 38. To install such an access port 52, the access port 52 may be threaded down a rod 54 that extends into the marrow space 40 of the bone 38 (FIG. 5) until it reaches a position in which flanges 56 of a housing 58 of the access port 52 rest against the bone 38 (FIG. 6). This threading may be achieved using a screwdriver when the upper surface of the access port 52 including a portion of the flanges 56 is provided with screwdriver fittings (see FIG. 5). The flanges 56 thus define, in part, a tool engagement surface to enable installation of the housing 58 on the bone 38 by the tool.
A channel 72 is situated below the valve 66 and extends through the access port 52. If access port 54 is used as a replacement for port 16 (in the embodiment of FIGS. 1-3 described above) or with an internal conduit 104(in the embodiment of FIGS. 11 and 12 described below), then the channel 72 would communicate with the passage 14A defined by the conduit member 14 or the passage defined by the internal conduit 104.
The channel 70 and/or channel 72 may each be funneled to direct the external needle, forceps or sampling device to the orifice 62 of the access port 54, or entrance of the passage 14A defined by the conduit member 14 or entrance of the passage defined by the internal conduit.
FIG. 11 shows an embodiment of a bone marrow access apparatus 100 in accordance with the invention with an access port 102 at a proximal end external to the patient and a conduit 104 having a proximal end 106 connected to the access port 102 and a distal end 108. The distal end 108 of the conduit 104 includes multiple side holes 110 adapted to be positioned within the marrow space 40 of the patient' s bone 38. Conduit 104 is designed to penetrate the bone 38 with a portion or all of the distal end 108 inside of the bone 38 and a remaining portion, if any, outside of the bone 38.
The conduit 104 also includes an internal retention (Malecot retention) device 116 that retains the conduit 104 in place in connection with the bone 114. The retention device 116 may be situated proximally to the side holes 110, but on that portion of the distal end 108 that will be secured in the marrow space 40 of the bone 38. Other retaining structure that fixes a tube in connection with the body known to those skilled in the art may be used to retain the conduit 104 in connection with the bone 114. For example, the conduit 104 may be configured as a catheter and may have a Malecot winged formation within the marrow space 112 or a pigtail to help secure it within the intramedullary space or retention barbs to avoid inadvertent dislodgment.
The distal end 108 of the conduit 104 lying within the bone 114 may be a catheter with multiple holes for aspiration, e.g., like side holes 110. The conduit 104 may also include an end hole 118 for biopsy forceps penetration.
In use, the conduit 104 would be installed into the patient through an opening in the bone 38 such that the distal end 18 is in the marrow space 40 and the proximal end 106 of the conduit 104 is outside of the patient, i.e., above their skin 36. The access port 102 may then be fixed to the patient' s skin 36, i.e., by tape. When it is desired to sample bone marrow, the access port 102 is opened. Opening of the access port 102 may entail penetrating an elastomer diaphragm, valve and/or covering (not shown in this embodiment) using a needle or forceps for aspiration or biopsy. For example, a sampling device may be inserted through the internal channel in the housing of the access port 102 and then into the conduit 104 to the distal end 18 thereof and through one of the side holes 110 to contact and remove a marrow sample. The sampling device is then removed from the conduit 104 outside of the access port 102, and the access port 102 is then automatically or manually closed. This sampling procedure may be repeated. Also, a syringe may be attached to the port end that may allow direct aspiration.
In the embodiments described above, the conduit 104 extends from the access port 102, 12, into the marrow space 40 of the bone 38. Conduit 104 may also be used with the embodiments of FIGS. 5-10, i.e., attached to the end of the access portions 52, 74, 90. In this case, the conduit 104 may have dimensions that correspond to the thickness of the cortex (bone 38) for the embodiment shown in FIGS. 5-10 wherein the access port 42, 64, 80 is on the bone 38, i.e., there is conduit outside of the bone 38, only in the marrow space 40. However, for the embodiments shown in FIGS. 11 and 12, the conduit 104 would extend several centimeters to the external location for the embodiment shown in FIG. 11, or extend several centimeters to the subcutaneous location for the embodiment shown in FIG. 12.
Any of the bone marrow access apparatus disclosed above enables repeated bone marrow access throughout a patient's therapy. Use of the bone marrow apparatus 10 is described above. For the bone marrow apparatus described in FIGS. 5-12, each access involves simply finding the access port, whether attached to the bone 24 (FIGS. 5-10), above the skin (FIG. 11), or beneath the skin (FIG. 12), and puncturing the diaphragm and/or valve associated with the access port. The diaphragm and/or valve may be designed to self-seal to enable repeated punctures, which feature is known to those skilled in the art of medical devices. A bone marrow biopsy needle can be used to take biopsy samples or a simple needle may be used for aspirations.
With respect to the embodiments shown in FIGS. 11 and 12, a bone marrow aspiration or biopsy method in accordance with the invention includes inserting a distal end 108 of the conduit 104 into the marrow space 40 in bone 38 through an opening of a bone penetration site of the bone 38. A proximal end 106 of the conduit 104 is coupled to the access port 102, 122 and includes a penetrable valve and/or an elastomer diaphragm. The distal end 108 of the conduit 104 is retained in the marrow space 40, e.g., by the internal retention device 116. The access port 102, 112 is retained at least partly exterior of the bone 38, e.g., exterior of the skin 36 (FIG. 11), or subcutaneously (FIG. 12). Then, at a plurality of spaced apart times while the distal end 108 of the conduit 104 is retained in the marrow space 112 and the access port 102, 112 is retained exterior of the bone 38, bone marrow is acquired by accessing the access port 102, 112 each time. The conduit 104 is not removed between the bone marrow acquisition procedures.
The aspiration or biopsy method for the bone marrow access apparatus including access ports 52, 74, 90 is slightly different when they do not include the conduit 104 and are attached directly to the bone 38. For access port 74, the bone 38 is aligned at the bone penetration site 82, the opening 80 is formed at the bone penetration site 82, and the access port 74 is mounted to the bone 38 with the channels 70, 72 aligning at least partly with the opening 80 at the bone penetration site 82 by fixing it to the bone 38 using the securing members 88 (FIG. 9). For access port 90, the bone 38 is aligned at the bone penetration site 82, the opening 80 is formed at the bone penetration site 82 and the access port 90 is wedged into the opening 80 (FIG. 10).
Similarly, various embodiments of the kit may include whatever tools and accessories are needed to accomplish implantation of a bone marrow access apparatus, tissue acquisition via the bone marrow access apparatus, and removal of the bone marrow access apparatus. For example, the trocar 44 shown in FIG. 4 may be used whenever guidance of a biopsy needle into an access port, conduit member, sheath or internal conduit is needed. These tools may be used in a method for installing any of the embodiments of the bone marrow access apparatus described above. In a basic embodiment of the method, an opening into the marrow space 40 of the bone 38 is formed at a bone penetration site and the distal end 108 of the conduit 104 is inserted into the marrow space 40 through the formed opening at the bone penetration site. The distal end 108 is retained in the narrow space 40. The proximal end 106 of the conduit 104 that is coupled to the access port 102, 112 is retained at least partly exterior of the bone, e.g., exterior of the skin 36 (FIG. 11), or subcutaneously (FIG. 12). Other installation methods may also be used to install the bone marrow access apparatus described above.
a bone attachment part adapted to be attached to bone, said bone attachment member having a hollow interior;
a tubular conduit part attached to said bone attachment part and defining a conduit communicating with said interior of said bone attachment part;
a port attached to said conduit part, said port including a housing defining a hollow interior communicating with said conduit defined by said conduit part, said interior of said bone attachment part, said conduit of said conduit part and said hollow interior of said housing of said port defining a passage;
a flow control component arranged in said passage; and
a localization part on or integrated into said port and configured to enable said port to be located through skin that covers said port.
2. The apparatus of claim 1 , wherein said localization part comprises palpable structure on a surface of said housing of said port.
4. The apparatus of claim 1, wherein said flow control component is a valve.
5. The apparatus of claim 1, wherein said flow control component is a diaphragm.
6. The apparatus of claim 1, wherein said flow control component is arranged in said bone attachment part.
7. The apparatus of claim 1, wherein said flow control component is arranged in said conduit of said tubular part.
8. The apparatus of claim 1, wherein said flow control component is arranged in said housing of said port.
9. The apparatus of claim 1, wherein said conduit part is permanently fixed to said bone attachment part.
10. The apparatus of claim 1, wherein said port includes an attachment structure to enable said port to be attached to said conduit part.
11. A bone marrow apparatus installation method, comprising:
attaching a bone attachment part to the bone in a position in which a hollow interior of the bone attachment part is in flow communication with a marrow space in the bone, one end region of a tubular conduit part being attached to a housing of the bone attachment part, the conduit part defining a conduit in flow communication with the hollow interior of the bone attachment part, a port being attached to an opposite end region of the conduit part, the port including a housing defining a hollow interior communicating with the conduit defined by the sheath, the port including a localization part configured to enable the port to be located through skin that covers said port; and then
12. The method of claim 11, further comprising changing the height or length of the conduit part from an initial height to a length dependent on the distance between the bone attachment part and the patient's skin.
13. The method of claim 11, further comprising changing the height or length of the port from an initial height to a length dependent on the distance between the bone attachment part and the patient' s skin.
14. The method of claim 11, wherein the step of attaching the bone attachment part to the bone comprises fixing the bone attachment part into the bone.
15. A method for performing a bone marrow biopsy, comprising:
attaching a bone attachment part to bone of a patient in a position in which a hollow interior of the bone attachment part is in flow communication with a marrow space in the bone, one end region of a tubular conduit part being attached to a housing of the bone attachment part, the conduit part defining a conduit in flow communication with the hollow interior of the bone attachment part that communicates with the bone marrow, a port being attached to an opposite end region of the conduit part, the port including a hollow interior communicating with the conduit defined by the conduit part and a localization part configured to enable the port to be located through skin that covers the port; and then
covering the port with skin of the patient with the localization part in a position under the skin of the patient;
in each of at least one specimen sampling stage,
inserting a sampling device through the skin above the port, through the hollow interior of the port, into the conduit defined by the conduit part, through the flow control component and through the hollow interior of the bone attachment part into the marrow space;
capturing marrow or tissue from the marrow space using the sampling device; and then removing the sampling device from the marrow space through the port, the conduit part and the bone attachment part.
16. The method of claim 15, further comprising, in the sampling stage before inserting the sampling device, inserting a trocar through the skin above the port, and through the hollow interior of the port until the trocar engages with the port, the trocar defining a guide for the insertion of the sampling device.
17. The method of claim 15, further comprising, in the sampling stage before inserting the sampling device, locating the port by interacting with the localization part.
18. A bone marrow access apparatus, comprising:
an access port including an interior passage and attachment means to attach said access port to a bone, said access port being configured to be attached to the bone to cause said interior passage to define part of a conduit leading to a marrow space in the bone;
a flow control component in said interior passage; and
a localization part on or integrated into said access port and configured to enable said access port to be located through skin covers said access port,
whereby a bone marrow sampling instrument is insertable through said flow control component, and through said interior passage into the marrow space when said interior passage defines part of the conduit leading to the marrow space in the bone.
19. The apparatus of claim 18, wherein said access port comprises:
a housing defining an internal channel extending through an interior of said housing, said attachment means being arranged on said housing, said flow control component being arranged in said housing; and
a covering connected to said housing and defining an internal channel aligning with said internal channel of said housing, said internal channel of said covering and said housing defining said interior passage of said access port.
20. The apparatus of claim 19, wherein said internal channel of said covering having a funnel shape to guide the sampling device into said interior passage of said access port.
PCT/US2015/036407 2014-10-09 2015-06-18 Implantable bone marrow access apparatus WO2016057090A1 (en)
US201462062105 true 2014-10-09 2014-10-09
US62/062,105 2014-10-09
US15024522 US9770425B2 (en) 2014-10-09 2015-06-18 Implantable bone marrow access apparatus
WO2016057090A1 true true WO2016057090A1 (en) 2016-04-14
US (3) US9770425B2 (en)
WO2018067525A1 (en) * 2016-10-05 2018-04-12 Aperture Medical Technology Llc Bone marrow access apparatus and system including same
WO1997022624A3 (en) * 1995-12-16 1997-08-28 Beiersdorf Ag Cosmetic preparations containing vertebrate proteins and having antibacterial, antimycotical and antiviral action
US9301736B2 (en) * 2009-04-30 2016-04-05 Joseph G. Rusnak Fine needle biopsy with adaptor
US20170035396A1 (en) 2017-02-09 application
US20170079943A1 (en) 2017-03-23 application
US20160101079A1 (en) 2016-04-14 application
US9770425B2 (en) 2017-09-26 grant
Ref document number: 15024522
Ref document number: 15848853