WO2020047766A1

WO2020047766A1 - Position marker and delivery system

Info

Publication number: WO2020047766A1
Application number: PCT/CN2018/104114
Authority: WO
Inventors: Dechen FAN
Original assignee: Jmd Innovation Inc.
Priority date: 2018-09-05
Filing date: 2018-09-05
Publication date: 2020-03-12

Abstract

A position marker (120, 120', 220', 320', 420', 520') can have an expandable and degradable marker body that is expandable from a compact state to an expanded state. In the compact state, the marker body defines a first volume and an outer surface (222,422,522) that has a plurality of protrusions (224) in a compacted configuration. In the expanded state, the marker body has a second volume greater than the first volume and the plurality of protrusions (224) are in an extended configuration. The marker body can degrade after expanding to the expanded state.

Description

POSITION MARKER AND DELIVERY SYSTEM

BACKGROUND

Field of the Inventions

The present disclosure relates to devices and methods for the percutaneous delivery and implantation of a position marker. The position marker can be delivered in a compact state to a target location and expanded and degraded in situ.

Description of the Related Art

Position markers are placed within a patient to serve as a target for further surgical intervention or observation. Position markers may be implanted or otherwise introduced into the tissue of a patient. Position markers can be used to identify a subject area of a patient, such as a lesion, a surgical site, or a biopsy site.

A conventional position marker may utilize metals such as titanium alloy. Such conventional position markers may remain within a patient’s body indefinitely and may be difficult to observe in clinical settings.

The foregoing examples of the related art and limitations related therewith are intended to be illustrative and not exclusive. Other limitations of the related art will become apparent to those of skill in the art upon a reading of the specification and a study of the drawings.

SUMMARY

The present disclosure relates to position markers and delivery systems that facilitate delivery of one or more position markers to a target implantation site in a patient. The position markers and the delivery systems can enable a clinician to perform a less invasive implantation procedure, minimizing trauma to the patient. Indeed, some embodiments disclosed herein enable one or more position markers to be introduced into the patient in a compact configuration. Further, a delivery system can introduce the compact position markers into the patient tissue with an introducing lumen. Advantageously, the compact configuration of the position markers can facilitate proper placement of the position markers.

Additionally, in some embodiments, the expansion of the position markers allows for the position markers to be readily identified in situ by increasing the cross-sectional area visible using various imaging techniques. Further, position markers can utilize different materials and shapes to provide feedback using various imaging techniques. Optionally, multiple position markers can be implanted within a patient, wherein each position marker is configured to be individually identifiable. Further, optionally, the expansion of the position markers can allow for the position markers to be retained in a desired location. Additionally, the expansion of the position markers can provide hemostatic pressure against tissue.

Furthermore, in some embodiments, the position marker can degrade in situ. Indeed, by degrading, surgical intervention to remove a position marker can be avoided without the patient permanently retaining the position marker.

Additional features and advantages of the subject technology will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and embodiments hereof as well as the appended drawings.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of illustrative embodiments of the inventions are described below with reference to the drawings. The illustrated embodiments are intended to illustrate, but not to limit, the inventions. The drawings contain the following figures:

Figure 1 shows an implantation site, according to some embodiments.

Figure 2 shows an implantation device and a position marker in a compact state, according to some embodiments.

Figure 3 shows the position marker in a compact state, according to some embodiments.

Figure 4 shows the position marker in an expanded state, according to some embodiments.

Figure 5 shows a position marker with a plurality of protrusions in an expanded state, according to some embodiments.

Figure 6 shows a position marker with a hexagonal cross-sectional shape, according to some embodiments.

Figure 7 shows a position marker with a cubic shape, according to some embodiments.

Figure 8 shows a position marker with a star shape, according to some embodiments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject technology. It should be understood that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.

Further, while the present disclosure sets forth specific details of various embodiments, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting. Furthermore, various applications of such embodiments and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein.

Position markers facilitate identifying a particular area of interest within a patient. Position markers may allow for marking of a particular area in a non-operative setting to allow for further clinical intervention at a later time. Position markers can also be utilized to provide a reliable method to observe a target area over time.

Conventional position markers may be difficult to identify using imaging techniques such as x-rays and ultrasonic imaging. Further, conventional position markers may not be compatible with continuous imaging techniques. Other position markers, such as radionuclide position markers, must be implanted briefly before a surgical procedure due to the short half-life of the position markers. Without reliable position information or continuous imaging information, many procedures may rely on a surgeon’s skill, while running the risk for increased surgical trauma.

The present disclosure describes various aspects of a position marker that can be implanted to an implantation site in a patient. The position marker can comprise an expandable and degradable marker body.

Advantageously, the expandable and degradable marker body can enable a clinician to perform a less invasive implantation procedure, minimizing trauma to the patient. Further, the expandable behavior of the marker body may allow the marker body to be introduced into the patient in a compact configuration. Further, the compact configuration of the position markers can facilitate proper placement of the position markers using a delivery device.

Implanted within a patient, in some embodiments, the expansion of the position markers allows for the position markers to be readily identified in situ by increasing the cross-sectional area visible to various imaging modalities. Optionally, multiple position markers can be implanted within a patient, wherein each position marker is configured to be individually identifiable using various imaging techniques. Further, the expansion of the position markers can allow for the position markers to be retained in a desired location. Additionally, the expansion of the position markers can provide hemostatic pressure against tissue.

Furthermore, in some embodiments, the position marker can degrade in situ. By degrading, surgical intervention to remove a position marker can be avoided without the patient permanently retaining the position marker.

Figure 1 shows an implantation site, according to some embodiments. As illustrated, the implantation site 100 is a representative site of interest within patient tissue 102. Areas of interest within a patient can include, but are not limited to, areas with lesions, surgical sites, and biopsy sites. The representative tissue 102 can include a representative cavity 104. The cavity 104 may be a preexisting cavity or may be formed by displacement by an implanted marker or by other suitable means.

The implantation site 100 within the patient tissue 102 can be identified by a clinician for surgical intervention or further observation. By introducing a positioning marker to the implantation site 100 within the patient tissue, the desired area of surgical intervention can easily be found during the operation or procedure. Similarly, by introducing a positioning marker to the implantation site within the patient tissue, the desired area can be observed at a later time.

Figure 2 shows an implantation device and a position marker in a compact state, according to some embodiments. As illustrated in Figure 2, an implantation device 110 may introduce a position marker 120 in a compact state into the tissue 102 at the implantation site 100.

In the depicted example, the implantation device 110 can be a syringe-style device that can implant the position marker 120 at the desired location. During implantation, the distal end 114 of the introducing lumen 112 can be advanced through the tissue 102 of the patient to be directed to the implantation site 100. As the implantation device 110 is advanced, the distal end 114 of the introducing lumen 112 can displace or separate patient tissue 102. In some embodiments, the distal end 114 can displace portions of the tissue 102 to form at least a portion of the cavity 104. After the clinician locates the distal end 114 of the implantation device 110 near the desired implantation site 100, such as the cavity 104, the implantation device 110 can advance the position marker 120 through the introducing lumen 112 toward the distal end 114 and into the cavity 104. Advantageously, the implantation device 110 allows for the position marker 120 to be implanted at the implantation site 100 in a clinical setting without surgical intervention. Optionally, the position marker 120 can be implanted by other methods, including, but not limited to surgical methods.

As illustrated, the position marker 120 is introduced into the cavity 104 in a compact configuration to facilitate implantation via non-invasive methods such as via the implantation device 110. Advantageously, by introducing the position marker 120 in a compact state, the position marker 120 can be introduced via the introducing lumen 112 with minimal displacement of tissue 102, minimizing trauma to the patient.

Similarly, to further facilitate implantation via non-invasive methods and/or to minimize trauma to the patient, the position marker 120 can have a smooth outer surface in the compact state or configuration. The smooth outer surface of the position marker 120 can allow the position marker 120 to migrate or be more easily pushed or advanced to a desired location within the patient without catching on or getting ensnared with surrounding tissue in a manner that could thereby restrict or inhibit movement to a desired or target location. For example, in some embodiments, the position marker 120 has an outer surface that is smooth enough to migrate within the introducing lumen 112 and to migrate within the cavity 104 without engaging, snagging, or otherwise limiting motion of the marker 120 relative to the surrounding introducing lumen, cavity, or tissue.

As illustrated, in the compact state or configuration, the position marker 120 can have a generally smooth outer surface. In some embodiments, the outer surface of the position marker 120 can be considered generally smooth even if the surface has features that extend from or into an otherwise continuous outer surface of the position marker.

For example, the position marker can comprise a generally rounded (e.g., spherical, ovoid, cylindrical, conical, etc. ) or polygonal (e.g., cuboid, cube, pyramid, polygonal prism, etc. ) solid having features that extend radially outwardly or inwardly relative to an outer surface of the position marker. The position marker can be considered smooth if the features have a height or depth (measured from an adjacent or principal surface of the position marker) that is less than or equal to about 20%of a largest dimension of the position marker in its compact state, less than or equal to about 15%of a largest dimension of the position marker, less than or equal to about 10%of a largest dimension of the position marker, less than or equal to about 8%of a largest dimension of the position marker, less than or equal to about 6%of a largest dimension of the position marker, less than or equal to about 5%of a largest dimension of the position marker, less than or equal to about 4%of a largest dimension of the position marker, less than or equal to about 3%of a largest dimension of the position marker, less than or equal to about 2%of a largest dimension of the position marker, or less than or equal to about 1%of a largest dimension of the position marker.

In some embodiments, the height of a feature or protrusion may be measured from a point at the lowest portion of the outer surface to a highest point, apex, or peak of the feature or protrusion. Alternatively, the height of a feature or protrusions may be measured from a point at the average height of the outer surface to a highest point, apex, or peak of the feature or protrusion. In some embodiments, the height of a feature on a position marker with a generally smooth surface may be less than about 1 millimeter, less than about 500 micrometers, less than about 300 micrometers, less than about 100 micrometers, less than about 50 micrometers, less than about 1 micrometer, less than about 500 nanometers, less than about 300 nanometers, less than about 100 nanometers, or less than about 50 nanometers.

Further, surfaces having feature heights that deviate less than 10%from the average height of the surface over a given area may be considered generally smooth. In comparison, in some embodiments, the outer surface of the position marker in an expanded configuration may have an outer surface having feature heights that deviate more than 10%from the average height of the surface over a given area.

Alternatively, a root mean squared roughness value of the profile of the outer surface of the position marker 120 can provide an overall assessment of the smoothness of the outer surface. In such an assessment, various height values at various locations on the outer surface are each squared and then all of the squared height values summed together. The square root of the resulting sum can provide an overall value corresponding to the overall roughness or surface quality of the outer surface. Therefore, in some embodiments, the root mean squared roughness value of the profile of the outer surface in a compact configuration may be lower than the root mean squared roughness value of the profile in an expanded configuration.

In some embodiments, the outer surface of the position marker 120 can be considered generally smooth if the surface has features that are proportionally smaller than the size of the position marker 120. For example, an outer surface having feature heights that are less than 10%the diameter or other major dimension of the position marker may be considered generally smooth. In comparison, in some embodiments, the outer surface of the position marker 120 in an expanded configuration may have an outer surface having feature heights that are more than 10%the diameter or other major dimension of the position marker.

As illustrated, the compact position marker 120 can have a substantially spherical shape without any corners. Optionally, the compact position marker 120 can have generally polygonal solid, shape. Shapes of the compact position marker 120 can include, but are not limited to, tetrahedron, pyramid, cube, cuboid, prism, triangular prism, octahedron, ellipsoid, cone, and cylinder. Further, although the solid can have sharp corners, the corners can also be rounded to prevent engagement or snagging with the tissue 102 when the marker 120 is being moved in its compact state. However, as discussed herein, when expanded, some embodiments of the marker 120 can preferably engage with surrounding tissue using sharp corners or protrusions that can tend to limit the motion of the marker 120 relative to the tissue.

As described further herein, in some embodiments, a position marker 120 in an expanded state or configuration may have a plurality of protrusions to facilitate engagement with tissue 102. However, as illustrated, in a compact state, the plurality of protrusions may be compressed or otherwise compacted to maintain an overall smooth outer surface. For example, protrusions on the position marker 120 can be generally compressed to minimize the deviation from the average surface height of the outer surface of the position marker 120. Optionally, protrusions on the position marker 120 can be flattened or folded to minimize the deviation from the average surface height of the outer surface of the position marker 120.

Figure 3 shows the position marker in a compact state, according to some embodiments. As illustrated, the position marker 120 can located within the tissue 102 of the patient and may be exposed to the environment within the patient. In some embodiments, the position marker 120 can comprise or otherwise be formed from materials that may react, expand, or otherwise change properties in response to stimulus that may be found or introduced in situ.

In some embodiments, the position marker 120 is formed from a hydrogel material, including, but not limited to polyethylene glycol hydrogel. Optionally, the position marker 120 can be formed from multiple substances, for example as a polymer of several compounds. The materials of the position marker 120 may generally be non-reactive within the patient tissue 102.

Figure 4 shows the position marker in an expanded state, according to some embodiments. As illustrated, the position marker 120′may increase in volume or otherwise expand within the patient. The expansion of the position marker 120′may be a controlled expansion, permitting the position marker 120′to expand to a desired final volume. For example, the position marker 120′can expand up to 10 times the original volume of the position marker 120 in the compact state. In some embodiments, the position marker 120′can expand up to at least about 100 times the original volume of the position marker 120 in the compact state. In some embodiments, the position marker 120′can expand up to at least about 1000 times the original volume of the position marker 120 in the compact state. As illustrated, the position marker 120′can have a generally spherical shape in the expanded state.

In the depicted example, the expansion of the position marker 120′can be initiated by exposure to one or more triggers. Expansion of the position marker 120′may be caused by exposure to water, electrolytes, or other bodily fluids. Optionally, the position marker 120 may be dehydrated in a compact state and may expand as the position marker 120′is rehydrated into the expanded state. In some embodiments, expansion of the position marker 120′may be triggered by changes in environmental conditions, including but not limited to, changes in pH, electrical current, magnetism, light exposure, temperature, ultrasonic frequencies, gravity, and/or pressure. Optionally, expansion of the position marker 120′may be delayed after exposure to one or more triggers.

Advantageously, the expansion of the position marker 120′allows for a clinician to readily locate the position marker 120′using a variety of techniques, including imaging techniques. In some embodiments, the expanded cross-sectional area of the position marker 120′allows for the position marker 120′to be more visible using various imaging techniques, including, but not limited to ultrasound, x-ray, magnetic resonance imaging and continuous imaging techniques. Further, the expanded position marker 120′may be opaque or otherwise distinctly visible to ultrasound, x-ray, magnetic resonance imaging, or continuous imaging techniques.

Optionally, the position marker 120′may include active or reactive components that are responsive to external signals. For example, the position marker 120′may include components that are excited by an external excitation device. External excitation may include specific electrical, magnetic, optical, or acoustic signals, wherein the position marker 120′can provide a signal in response to the received excitation.

Additionally, the expansion of the position marker 120′can permit the position marker 120′to remain or otherwise be retained at the desired implantation site 100. As illustrated, the expanded position marker 120′can expand in size to engage the tissue surface 106 of the tissue 102. In some embodiments, the position marker 120′can expand to fill the space of the cavity 104. As the position marker 120′expands, the position marker 120′can have an interference or friction fit within the tissue 102.

Optionally, the expansion of the position marker 120′can prevent or limit bleeding within the patient. As the position marker 120′expands, the position marker 120′can apply hemostatic pressure to the surrounding tissue 102. However, blood and fluid flow around the expanded position marker 120′may be permitted.

In the depicted example, after expanding, the position marker 120′can degrade or dissolve after a desired period of time. For example, the position marker 120′can be made from select materials, such as polyethylene glycol hydrogel which can degrade within 3 to 12 months. Advantageously, by degrading, the position marker 120′does not need to be removed and does not remain in a patient indefinitely.

In some embodiments, the degradation of the position marker 120′can be initiated by exposure to one or more triggers. Degradation of the position marker 120′may be caused by exposure to water, electrolytes, or other bodily fluids. Further, degradation of the position marker 120′may be triggered by changes in environmental conditions, including but not limited to, changes in pH, electrical current, magnetism, light exposure, temperature, ultrasonic frequencies, gravity, and/or pressure. Optionally, degradation of the position marker 120′may be accelerated after exposure to one or more triggers.

Figure 5 shows a position marker with a plurality of protrusions in an expanded state, according to some embodiments. As illustrated, in some embodiments, the position marker 220′can include a plurality of protrusions 224 formed on the outer surface 222, wherein the plurality of protrusions 224 engage the tissue surface 106 of the tissue 102. The engagement of the plurality of protrusions 224 can retain the position marker 220′in the desired location. While the protrusions 224 are shown on spherical position marker 220′, protrusions 224 may be utilized with any embodiment of a position marker including other embodiments described herein.

During in vivo expansion, the plurality of protrusions 224 can extend from the outer surface 222 as the position marker 220′expands. In some embodiments, the protrusions 224 extend from mounds formed in the outer surface 222. Optionally, the protrusions are flattened or folded against the outer surface 222. Protrusions 224 can have generally spike-like shape, a conical shape, a cylindrical shape, or a prismatic shape and may further include concavities and/or convexities. In some embodiments, protrusions 224 can include features that introduce undulations, concavities, and/or convexities into the outer surface 222. Protrusions 224 can vary in height or can have similar heights. Optionally, the protrusions 224 can include some portions with similar heights and other portions varying in height. In some embodiments, the protrusions 224 can be arranged for form patterns, such as rows, columns, or geometric shapes. As may be appreciated, in some embodiments, the configuration of the protrusions 224 may affect the profile of the outer surface of the position marker 220′in the compact configuration.

As the protrusions 224 extend or unfold from the outer surface 222, the overall surface of the position marker 220′is rougher than the compact state, as the protrusions 224 deviate from the average surface height of the outer surface 222 of position marker 220′. In some embodiments, the height of a protrusion 224 may be more than 100 nanometers measured from the lowest point of the outer surface 222 to the highest point, apex, or peak of the protrusion 224. In some embodiments, the height of the protrusion 224 may be more than 100 micrometers.

Further, the outer surface 222 of the position marker 220′may have protrusions 224 that have a height that deviates more than 10%from the average height of the outer surface 222 over a given area. Alternatively, the root mean squared roughness value of the profile of the outer surface 222 including the protrusions 224 may be higher than the root mean squared roughness value of the outer surface of a compact position marker. Further, in some embodiments, the outer surface 222 of the position marker 220′may have protrusions 224 that have a height that is more than 10%of the height of the position marker 220′.

In some embodiments, the protrusions 224 can extend from the position marker 220′in response to exposure to water, electrolytes, or other bodily fluids. Optionally, the protrusions 224 may be dehydrated when retracted and may extend as the protrusions 224 are rehydrated. In some embodiments, expansion of the protrusions 224 may be triggered by changes in environmental conditions, including but not limited to, changes in pH, electrical current, magnetism, light exposure, temperature, ultrasonic frequencies, gravity, and/or pressure. Further, extension of the protrusions 224 may be delayed after exposure to one or more triggers.

Figure 6 shows a position marker with a hexagonal cross-sectional shape, according to some embodiments. As illustrated, the expanded position marker 320′can have a generally hexagonal cross-sectional profile. In the expanded configuration, the corners of the outer surface 322 can engage the tissue surface 106 to retain the position marker 320′in the desired location.

Figure 7 shows a position marker with a cubic shape, according to some embodiments. In the depicted example, the position marker 420′can have a generally cubic shape or a generally rectangular cross-sectional profile. In some embodiments, the position marker 420′can have a generally polygonal cross-section or an overall prism shape. In the expanded configuration, the corners of the outer surface 422 can engage the tissue surface 106 to retain the position marker 420′in the desired location. In some embodiments, for position markers 320′and 420′having polygonal cross-sectional shapes, the corners of the position markers can be compressed or rounded in a compact state.

Figure 8 shows a position marker with a star shape, according to some embodiments. As illustrated the position marker 520′can have a generally star shaped cross sectional profile. In the depicted example, extensions 524 are formed along the outer surface 522. The extensions 524 can engage against the tissue surface 106.

In some embodiments, the overall volume of the position marker 520′may remain constant while extensions 524 extend from the position marker 520′. Therefore, instead of expanding volumetrically, extensions 524 can extend to engage and retain the position marker 520′in the desired location.

Optionally, multiple position markers can be utilized within a single patient to identify multiple positions within a patient. As described, various position markers, such as position markers 120′, 220′, 320′, 420′, and 520′of different cross-sectional shapes can be utilized within a single patient to allow for visual distinction of various positions using various techniques, including imaging techniques previously described. In some embodiments, the material properties of the position markers can be varied, wherein various position markers provide distinguishing visual signals in various imaging technologies, such as ultrasonic imaging, x-rays, magnetic resonance imaging, and continuous imaging techniques.

Illustration of Subject Technology as Clauses

Various examples of aspects of the disclosure are described as numbered clauses (1, 2, 3, etc. ) for convenience. These are provided as examples, and do not limit the subject technology. Identifications of the figures and reference numbers are provided below merely as examples and for illustrative purposes, and the clauses are not limited by those identifications.

Clause 1. A position marker comprising an expandable and degradable marker body, the marker body expandable from a compact state to an expanded state, wherein in the compact state the marker body defines a first volume and an outer surface with a first surface roughness, and in the expanded state the marker body comprises a second volume greater than the first volume and the outer surface comprises a plurality of protrusions extending radially outward, forming a second surface roughness, wherein the second surface roughness is greater than the first surface roughness and the marker body degrades after expanding to the expanded state.

Clause 2. The position marker of Clause 1, wherein the plurality of protrusions are compressed in the compact state.

Clause 3. The position marker of any preceding Clause, wherein the plurality of protrusions are flattened in the compact state.

Clause 4. The position marker of any preceding Clause, wherein the second volume is at least 10 times greater than the first volume.

Clause 5. The position marker of any preceding Clause, wherein the second volume is at least 100 times greater than the first volume.

Clause 6. The position marker of any preceding Clause, wherein the second volume is at least 1000 times greater than the first volume.

Clause 7. The position marker of any preceding Clause, wherein the marker body is expandable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 8. The position marker of any preceding Clause, wherein the marker body degrades within 3 to 12 months.

Clause 9. The position marker of any preceding Clause, wherein the marker body is degradable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 10. The position marker of any preceding Clause, wherein the marker body is ultrasonically opaque.

Clause 11. The position marker of any preceding Clause, wherein the marker body is opaque to radiation.

Clause 12. The position marker of any preceding Clause, wherein the marker body is opaque to magnetic resonance imaging.

Clause 13. The position marker of any preceding Clause, wherein the marker body comprises a hydrogel.

Clause 14. The position marker of Clause 13, wherein the hydrogel comprises a polyethylene glycol hydrogel.

Clause 15. The position marker of any preceding Clause, wherein the expandable and degradable material comprises a first material and a second material.

Clause 16. The position marker of any preceding Clause, wherein the expandable and degradable material comprises a non-reactive material.

Clause 17. The position marker of any preceding Clause, further comprising an excitation component.

Clause 18. The position marker of any preceding Clause, wherein the marker body comprises a hexagonal cross-section in the expanded state.

Clause 19. The position marker of any preceding Clause, wherein the marker body comprises a star cross-section in the expanded state.

Clause 20. The position marker of any preceding Clause, wherein the marker body comprises a rectangular cross-section in the expanded state.

Clause 21. The position marker of any preceding Clause, wherein the marker body comprises a substantially spherical shape in the compact state.

Clause 22. The position marker of any preceding Clause, wherein the marker body comprises a polygonal prism shape in the compact state.

Clause 23. A position marker comprising an expandable and degradable marker body, the marker body expandable from a compact state to an expanded state, wherein in the compact state the marker body defines a first volume and an outer surface comprising a plurality of protrusions in a compacted configuration, and in the expanded state the marker body comprises a second volume greater than the first volume, wherein the plurality of protrusions are in an extended configuration and the marker body degrades after expanding to the expanded state.

Clause 24. The position marker of Clause 23, wherein the plurality of protrusions are compressed in the compact state.

Clause 25. The position marker of Clause 23 or 24, wherein the plurality of protrusions are flattened in the compact state.

Clause 26. The position marker of Clause 23–25, wherein the second volume is at least 10 times greater than the first volume.

Clause 27. The position marker of Clause 23–26, wherein the second volume is at least 100 times greater than the first volume.

Clause 28. The position marker of Clause 23–27, wherein the second volume is at least 1000 times greater than the first volume.

Clause 29. The position marker of Clause 23–28, wherein the marker body is expandable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 30. The position marker of Clause 23–29, wherein the marker body degrades within 3 to 12 months.

Clause 31. The position marker of Clause 23–30, wherein the marker body is degradable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 32. The position marker of Clause 23–31, wherein the marker body is ultrasonically opaque.

Clause 33. The position marker of Clause 23–32, wherein the marker body is opaque to radiation.

Clause 34. The position marker of Clause 23–33, wherein the marker body is opaque to magnetic resonance imaging.

Clause 35. The position marker of Clause 23–34, wherein the marker body comprises a hydrogel.

Clause 36. The position marker of Clause 35, wherein the hydrogel comprises a polyethylene glycol hydrogel.

Clause 37. The position marker of Clause 23–36, wherein the expandable and degradable material comprises a first material and a second material.

Clause 38. The position marker of Clause 23–37, wherein the expandable and degradable material comprises a non-reactive material.

Clause 39. The position marker of Clause 23–38, further comprising an excitation component.

Clause 40. The position marker of Clause 23–39, wherein the marker body comprises a hexagonal cross-section in the expanded state.

Clause 41. The position marker of Clause 23–40, wherein the marker body comprises a star cross-section in the expanded state.

Clause 42. The position marker of Clause 23–41, wherein the marker body comprises a rectangular cross-section in the expanded state.

Clause 43. The position marker of Clause 23–42, wherein the marker body comprises a substantially spherical shape in the compact state.

Clause 44. The position marker of Clause 23–43, wherein the marker body comprises a polygonal prism shape in the compact state.

Clause 45. A position marker comprising a degradable marker body, the marker body configurable from a dehydrated state to a hydrated state, wherein in the dehydrated state the marker body defines an outer surface comprising a plurality of protrusions in a compacted configuration, and in the hydrated state the marker body the plurality of protrusions are in an extended configuration and the marker body degrades after reaching the hydrated state.

Clause 46. The position marker of Clause 45, wherein the plurality of protrusions are compressed in the dehydrated state.

Clause 47. The position marker of Clause 45 or 46, wherein the plurality of protrusions are flattened in the hydrated state.

Clause 48. The position marker of Clause 45–47, wherein the marker body is expandable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 49. The position marker of Clause 45–48, wherein the marker body degrades within 3 to 12 months.

Clause 50. The position marker of Clause 45–49, wherein the marker body is degradable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 51. The position marker of Clause 45–50, wherein the marker body is ultrasonically opaque.

Clause 52. The position marker of Clause 45–51, wherein the marker body is opaque to radiation.

Clause 53. The position marker of Clause 45–52, wherein the marker body is opaque to magnetic resonance imaging.

Clause 54. The position marker of Clause 45–53, wherein the marker body comprises a hydrogel.

Clause 55. The position marker of Clause 54, wherein the hydrogel comprises a polyethylene glycol hydrogel.

Clause 56. The position marker of Clause 45–55, wherein the degradable marker body comprises a first material and a second material.

Clause 57. The position marker of Clause 45–56, wherein the degradable marker body comprises a non-reactive material.

Clause 58. The position marker of Clause 45–57, further comprising an excitation component.

Clause 59. The position marker of Clause 45–58, wherein the marker body comprises a hexagonal cross-section in the hydrated state.

Clause 60. The position marker of Clause 45–59, wherein the marker body comprises a star cross-section in the hydrated state.

Clause 61. The position marker of Clause 45–60, wherein the marker body comprises a rectangular cross-section in the hydrated state.

Clause 62. The position marker of Clause 45–61, wherein the marker body comprises a substantially spherical shape in the dehydrated state.

Clause 63. The position marker of Clause 45–62, wherein the marker body comprises a polygonal prism shape in the dehydrated state.

Clause 64. A position marker comprising an expandable and degradable marker body, the marker body expandable from a compact state to an expanded state, wherein in the compact state the marker body comprises a round-cornered or substantially spherical first profile and in the expanded state the marker body comprises one or more corners or protrusions that extend radially outward beyond the first profile to provide a second profile for engaging surrounding tissue.

Clause 65. The position marker of Clause 64, wherein the marker body is expandable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 66. The position marker of Clause 64 or 65, wherein the marker body degrades within 3 to 12 months.

Clause 67. The position marker of Clause 64–66, wherein the marker body is degradable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 68. The position marker of Clause 64–67, wherein the marker body is ultrasonically opaque.

Clause 69. The position marker of Clause 64–68, wherein the marker body is opaque to radiation.

Clause 70. The position marker of Clause 64–69, wherein the marker body is opaque to magnetic resonance imaging.

Clause 71. The position marker of Clause 64–70, wherein the marker body comprises a hydrogel.

Clause 72. The position marker of Clause 71, wherein the hydrogel comprises a polyethylene glycol hydrogel.

Clause 73. The position marker of Clause 64–72, wherein the expandable and degradable material comprises a first material and a second material.

Clause 74. The position marker of Clause 64–73, wherein the expandable and degradable material comprises a non-reactive material.

Clause 75. The position marker of Clause 64–74, further comprising an excitation component.

Clause 76. The position marker of Clause 64–75, wherein the marker body comprises a hexagonal cross-section in the expanded state.

Clause 77. The position marker of Clause 64–76, wherein the marker body comprises a star cross-section in the expanded state.

Clause 78. The position marker of Clause 64–77, wherein the marker body comprises a rectangular cross-section in the expanded state.

Clause 79. The position marker of Clause 64–78, wherein the marker body comprises a substantially spherical shape in the compact state.

Clause 80. The position marker of Clause 64–79, wherein the marker body comprises a polygonal prism shape in the compact state.

Clause 81. A position marker delivery system, comprising: an implantation device comprising an introducing lumen; and a first position marker comprising: an expandable and degradable marker body, the marker body expandable from a compact state to an expanded state, wherein in the compact state the marker body defines a first volume and an outer surface with a first surface roughness, and in the expanded state the marker body comprises a second volume greater than the first volume and the outer surface comprises a plurality of protrusions extending radially outward, forming a second surface roughness, wherein the second surface roughness is greater than the first surface roughness and the marker body degrades after expanding to the expanded state.

Clause 82. The position marker delivery system of Clause 81, wherein the plurality of protrusions are compressed in the compact state.

Clause 83. The position marker delivery system of Clause 81 or 82, wherein the plurality of protrusions are flattened in the compact state.

Clause 84. The position marker delivery system of Clause 81–83, wherein the second volume is at least 10 times greater than the first volume.

Clause 85. The position marker delivery system of Clause 81–84, wherein the second volume is at least 100 times greater than the first volume.

Clause 86. The position marker delivery system of Clause 81–85, wherein the second volume is at least 1000 times greater than the first volume.

Clause 87. The position marker delivery system of Clause 81–86, wherein the marker body is expandable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 88. The position marker delivery system of Clause 81–87, wherein the marker body degrades within 3 to 12 months.

Clause 89. The position marker delivery system of Clause 81–88, wherein the marker body is degradable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 90. The position marker delivery system of Clause 81–89, wherein the marker body is ultrasonically opaque.

Clause 91. The position marker delivery system of Clause 81–90, wherein the marker body is opaque to radiation.

Clause 92. The position marker delivery system of Clause 81–91, wherein the marker body is opaque to magnetic resonance imaging.

Clause 93. The position marker delivery system of Clause 81–92, wherein the marker body comprises a hydrogel.

Clause 94. The position marker delivery system of Clause 93, wherein the hydrogel comprises a polyethylene glycol hydrogel.

Clause 95. The position marker delivery system of Clause 81–94, wherein the expandable and degradable material comprises a first material and a second material.

Clause 96. The position marker delivery system of Clause 81–95, wherein the expandable and degradable material comprises a non-reactive material.

Clause 97. The position marker delivery system of Clause 81–96, further comprising an excitation component.

Clause 98. The position marker delivery system of Clause 81–97, wherein the marker body comprises a hexagonal cross-section in the expanded state.

Clause 99. The position marker delivery system of Clause 81–98, wherein the marker body comprises a star cross-section in the expanded state.

Clause 100. The position marker delivery system of Clause 81–99, wherein the marker body comprises a rectangular cross-section in the expanded state.

Clause 101. The position marker delivery system of Clause 81–100, wherein the marker body comprises a substantially spherical shape in the compact state.

Clause 102. The position marker delivery system of Clause 81–101, wherein the marker body comprises a polygonal prism shape in the compact state.

Clause 103. The position marker delivery system of Clause 81–102, comprising a second position marker, wherein an identifying characteristic of the second position marker is different from the first position marker.

Clause 104. The position marker delivery system of Clause 103, wherein the identifying characteristic comprises an opacity characteristic.

Clause 105. The position marker delivery system of Clause 104, wherein the identifying characteristic comprises a cross-sectional characteristic.

Clause 106. A method to mark a target position within a patient, the method comprising: identifying the target position within the patient; introducing a distal end of a implantation device to the target position; advancing a first position marker through an introducing lumen to the target position, wherein the first position marker is in a compact state; expanding the first position marker to an expanded state, wherein an outer surface of the first position marker comprises a plurality of protrusions extending radially outward; engaging the plurality of protrusions of the first position marker with patient tissue at the target position; and degrading the first position marker from the expanded state.

Clause 107. The method of Clause 106, further comprising hemostatically engaging the patient tissue in the expanded state.

Clause 108. The method of Clause 106 or 107, wherein the plurality of protrusions are compressed in the compact state.

Clause 109. The method of Clause 106–108, wherein the plurality of protrusions are flattened in the compact state.

Clause 110. The method of Clause 106–109, further comprising advancing a second position marker through the introducing lumen to a second target position, wherein an identifying characteristic of the second position marker is different from the first position marker.

Clause 111. The method of Clause 110, wherein the identifying characteristic comprises an opacity characteristic.

Clause 112. The method of Clause 110, wherein the identifying characteristic comprises a cross-sectional characteristic.

Clause 113. The method of Clause 106–112, further comprising expanding the first position marker the expanded state of at least 10 times a volume of the compact state.

Clause 114. The method of Clause 106–113, further comprising expanding the first position marker the expanded state of at least 100 times a volume of the compact state.

Clause 115. The method of Clause 106–114, further comprising expanding the first position marker the expanded state of at least 1000 times a volume of the compact state.

Clause 116. The method of Clause 106–115, further comprising expanding the first position marker in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 117. The method of Clause 106–116, further comprising degrading the first position marker within 3 to 12 months.

Clause 118. The method of Clause 106–117, further comprising degrading the first position marker in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.

Clause 119. The method of Clause 106–118, wherein the first position marker is ultrasonically opaque.

Clause 120. The method of Clause 106–119, wherein the first position marker is opaque to radiation.

Clause 121. The method of Clause 106–120, wherein the first position marker is opaque to magnetic resonance imaging.

Clause 122. The method of Clause 106–121, wherein the first position marker comprises a hydrogel.

Clause 123. The method of Clause 122, wherein the hydrogel comprises a polyethylene glycol hydrogel.

Clause 124. The method of Clause 106–123, wherein the first position marker comprises a first material and a second material.

Clause 125. The method of Clause 106–124, wherein the first position marker comprises a non-reactive material.

Clause 126. The method of Clause 106–125, further comprising transmitting a signal from the first position marker in response to an excitation signal.

Clause 127. The method of Clause 106–126, wherein the first position marker comprises a hexagonal cross-section in the expanded state.

Clause 128. The method of Clause 106–127, wherein the first position marker comprises a star cross-section in the expanded state.

Clause 129. The method of Clause 106–128, wherein the first position marker comprises a rectangular cross-section in the expanded state.

Clause 130. The method of Clause 106–129, wherein the first position marker comprises a substantially spherical shape in the compact state.

Clause 131. The method of Clause 106–130, wherein the first position marker comprises a polygonal prism shape in the compact state.

Further Considerations

In some embodiments, any of the clauses herein may depend from any one of the independent clauses or any one of the dependent clauses. In some embodiments, any of the clauses (e.g., dependent or independent clauses) may be combined with any other one or more clauses (e.g., dependent or independent clauses) . In some embodiments, a claim may include some or all of the words (e.g., steps, operations, means or components) recited in a clause, a sentence, a phrase or a paragraph. In some embodiments, a claim may include some or all of the words recited in one or more clauses, sentences, phrases or paragraphs. In some embodiments, some of the words in each of the clauses, sentences, phrases or paragraphs may be removed. In some embodiments, additional words or elements may be added to a clause, a sentence, a phrase or a paragraph. In some embodiments, the subject technology may be implemented without utilizing some of the components, elements, functions or operations described herein. In some embodiments, the subject technology may be implemented utilizing additional components, elements, functions or operations.

The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.

There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.

It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.

As used herein, the term “distal” can denote a location or direction that is away from a point of interest. Additionally, the term “proximal” can denote a location or direction that is closer to a point of interest.

As used herein, the phrase “at least one of” preceding a series of items, with the term “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item) . The phrase “at least one of” does not require selection of at least one of each item listed; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.

Terms such as “top, ” “bottom, ” “front, ” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

Furthermore, to the extent that the term “include, ” “have, ” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.

The word “exemplary” is used herein to mean “serving as an example, instance, or illustration. ” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.

A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more. ” Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term “some” refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.

Although the detailed description contains many specifics, these should not be construed as limiting the scope of the subject technology but merely as illustrating different examples and aspects of the subject technology. It should be appreciated that the scope of the subject technology includes other embodiments not discussed in detail above. Various other modifications, changes and variations may be made in the arrangement, operation and details of the method and apparatus of the subject technology disclosed herein without departing from the scope of the present disclosure. Unless otherwise expressed, reference to an element in the singular is not intended to mean “one and only one” unless explicitly stated, but rather is meant to mean “one or more. ” In addition, it is not necessary for a device or method to address every problem that is solvable (or possess every advantage that is achievable) by different embodiments of the disclosure in order to be encompassed within the scope of the disclosure. The use herein of “can” and derivatives thereof shall be understood in the sense of “possibly” or “optionally” as opposed to an affirmative capability.

Claims

A position marker comprising an expandable and degradable marker body, the marker body expandable from a compact state to an expanded state, wherein in the compact state the marker body defines a first volume and an outer surface with a first surface roughness, and in the expanded state the marker body comprises a second volume greater than the first volume and the outer surface comprises a plurality of protrusions extending radially outward, forming a second surface roughness, wherein the second surface roughness is greater than the first surface roughness and the marker body degrades after expanding to the expanded state.
The position marker of Claim 1, wherein the marker body is expandable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.
The position marker of Claim 1, wherein the marker body is degradable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.
The position marker of Claim 1, wherein the marker body is ultrasonically opaque.
The position marker of Claim 1, wherein the marker body is opaque to radiation.
The position marker of Claim 1, wherein the marker body is opaque to magnetic resonance imaging.
The position marker of Claim 1, wherein the marker body comprises a hydrogel.
The position marker of Claim 1, wherein the expandable and degradable material comprises a first material and a second material.
The position marker of Claim 1, wherein the marker body comprises a hexagonal cross-section in the expanded state.
The position marker of Claim 1, wherein the marker body comprises a star cross-section in the expanded state.
The position marker of Claim 1, wherein the marker body comprises a rectangular cross-section in the expanded state.
The position marker of Claim 1, wherein the marker body comprises a substantially spherical shape in the compact state.
The position marker of Claim 1, wherein the marker body comprises a polygonal prism shape in the compact state.
A position marker delivery system, comprising:

an implantation device comprising an introducing lumen; and

a first position marker comprising:

an expandable and degradable marker body, the marker body expandable from a compact state to an expanded state, wherein in the compact state the marker body defines a first volume and an outer surface with a first surface roughness, and in the expanded state the marker body comprises a second volume greater than the first volume and the outer surface comprises a plurality of protrusions extending radially outward, forming a second surface roughness, wherein the second surface roughness is greater than the first surface roughness and the marker body degrades after expanding to the expanded state.
The position marker delivery system of Claim 14, comprising a second position marker, wherein an identifying characteristic of the second position marker is different from the first position marker.
The position marker delivery system of Claim 15, wherein the identifying characteristic comprises an opacity characteristic.
The position marker delivery system of Claim 15, wherein the identifying characteristic comprises a cross-sectional characteristic.
A position marker comprising an expandable and degradable marker body, the marker body expandable from a compact state to an expanded state, wherein in the compact state the marker body defines a first volume and an outer surface comprising a plurality of protrusions in a compacted configuration, and in the expanded state the marker body comprises a second volume greater than the first volume, wherein the plurality of protrusions are in an extended configuration and the marker body degrades after expanding to the expanded state.
The position marker of Claim 18, wherein the plurality of protrusions are compressed in the compact state.
The position marker of Claim 18, wherein the marker body is expandable in response to exposure to water, electrolytes, a bodily fluid, a change in pH, electricity, magnetism, light, a change in temperature, ultrasonic waves, or a change in pressure.