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EP-4736926-A1 - DEVICE FOR DELIVERING OBJECTS INTO A SUBJECT

EP4736926A1EP 4736926 A1EP4736926 A1EP 4736926A1EP-4736926-A1

Abstract

Embodiments pertain to a device (2000) configured to transport objects (500) from outside a subject's body to at least one site of interest internal to a subject's body for delivering the objects at the at least one site of interest. The device comprises a device body (1000) having a device distal portion (1200) and a device proximal portion (1100). The device proximal portion includes a receptacle (1110) configured to receive the objects. The receptacle may be reversibly configurable from a closed configuration for securely holding the objects, to an open configuration for releasing the objects from the receptacle to the at least one site. The objects to be released can include, for example, hydrogel-particles, hydrogel-based particles, and/or nanoparticles, optionally encapsulated by hydrogel.

Inventors

  • LANDERS, Fabian Christopher
  • SALVADOR, Pané
  • BRADLEY, James Nelson
  • RISS, Silas

Assignees

  • Landers, Fabian Christopher
  • Pané, Salvador
  • Nelson, Bradley James

Dates

Publication Date
20260506
Application Date
20241105

Claims (15)

  1. A device configured to transport objects from outside a subject's body to at least one site of interest internal to a subject's body for delivering the objects at the at least one site of interest, the device comprising: a device body comprising a device distal portion and a device proximal portion; the device proximal portion comprising a receptacle configured to receive the objects; wherein the receptacle is reversibly configurable from a closed configuration for securely holding the objects, to an open configuration for releasing the objects from the receptacle to the at least one site; wherein the objects include hydrogel-particles, hydrogel-based particles, and/or nanoparticles, optionally encapsulated by hydrogel; and wherein the receptacle is configured to securely hold the particles for transport to and delivery at the at least one site of interest without damaging the structural integrity of most or all of the particles.
  2. The device of claim 1, wherein the receptacle is made of material having a hardness and/or rigidity that allows to securely hold and release the hydrogel particles without damaging the structural integrity of most or all of the hydrogel particles to be released.
  3. The device of claim 1 and/or claim 2, wherein the receptacle is made of material having a hardness and/or rigidity that allows to securely hold and release the hydrogel particles without adversely affecting the therapeutic effectiveness of the objects released to the at least one site of interest.
  4. The device of any one or more of the preceding claims, wherein the receptacle comprises a cover configurable from a closed configuration for retaining the objects in the receptacle, to an open configuration for releasing at least some of the objects for delivery to the at least one site of interest.
  5. The device of any one or more of the preceding claims, wherein the receptacle comprises a plurality of prongs which are selectively expandable from the closed configuration for holding the objects to the open configuration for releasing at least some of the objects to the at least one site of interest wherein, optionally, in the open configuration, the prongs are expanded or distanced away from each other.
  6. The device of any one or more of the preceding claims, wherein the receptacle is configurable from the open to the closed configuration.
  7. The device of any one or more of the claims 5 and/or 6, wherein the prongs and/or the catheter are configured such to remain undamaged during retraction into catheter, and/or wherein the prongs and/or the catheter are configured such to remain undamaged during retraction back into catheter.
  8. The device of any one or more of the claims 4 to 7, wherein at least one prong of the plurality of prongs has a width that is at least 5 wider than a thickness of the prong, or wherein at least one prong of the plurality of prongs has a width that is at least 10 times wider than a thickness of the same prong.
  9. The device of any one or more of the preceding claims, having a generally longitudinal axis.
  10. The device of any one or more of the preceding claims, wherein the device body is slidably receivable by a delivery catheter having a distal catheter end and a proximal catheter end, the proximal catheter end having a proximal catheter opening through which the receptacle can be pushed, to allow the receptacle to assume the open configuration for releasing of the at least one object to the site.
  11. The device of any one or more of the preceding claims, wherein the receptacle is configured to automatically assume the open configuration when being pushed out of the proximal catheter opening.
  12. The device of any one or more of the claims 5 to 10, wherein the prongs and/or cover are configured to automatically assume the expanded or open configuration when being pushed out of the proximal catheter opening.
  13. The device of any one or more of the preceding claims, comprising a handle for allowing controllably opening of the receptacle for releasing the at least one object, wherein, optionally, the handle can be actuated to cause the receptacle to slide out of the catheter opening.
  14. The device of any one or more of the preceding claims, wherein the receptacle has superelastic characteristics.
  15. The device of any one or more of the claims 9 to 14, wherein the delivery catheter is an off-the-shelve delivery catheter.

Description

BACKGROUND Over the last century, the development of therapeutics such as chemotherapies, antibiotics, T-cell therapies, vaccinations, and cell and gene therapies has revolutionized medicine, significantly improving patient outcomes across a wide range of diseases. However, a critical trade-off must be made when administering therapeutic agents: the dose must be high enough to achieve a therapeutic effect but low enough to minimize side effects. This balance, known as the therapeutic window, defines the safe and effective dose range. Currently, most drugs are administered systemically, for example intravenously, resulting in a significant proportion of the drug failing to reach the target site. This inefficiency leads to off-target effects and severely restricts the therapeutic window. As a consequence, severe side effects accompany many treatments, and several promising drug candidates are rejected during clinical trials due to severe adverse effects. Limited targeting also inhibits many promising complex drugs, such as cell and gene therapies, which cannot be delivered to their target sites in adequate concentrations. The description above is presented as a general overview of related art in this field and should not be construed as an admission that any of the information it contains constitutes prior art against the present patent application. BRIEF DESCRIPTION OF THE FIGURES The figures illustrate generally, by way of example, but not by way of limitation, various embodiments discussed in the present document. For simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity of presentation. Furthermore, reference numerals may be repeated among the figures to indicate corresponding or analogous elements. References to previously presented elements are implied without necessarily further citing the drawing or description in which they appear. The figures are listed below. Figure 1 is a schematic illustration of a device comprising a receptacle in a retracted configuration, according to some embodiments.Figure 2 is a schematic illustration of the device in the expanded configuration, according to some embodiments.Figure 3 is a schematic illustration of a manufacturing process of the device, according to some embodiment.Figure 4 is a schematic illustration device prototypes (S1-S4) that may be obtained using different mold shapes, respectively, according to some embodiments.Figure 5A shows a matrix of mold types S1-S4 and various cutting structures employed for obtaining Prototypes 1 using material PU 80A, according to some embodiments.Figure 5B shows a matrix of mold types S1-S4 and various cutting structures employed for obtaining Prototypes 1 using material PU 80B, according to some embodiments.Figures 6A and 6B show Prototypes made of PU30A, with three digits and S3 and S4 molds, according to some embodiments.Figure 7 shows high-density polyethylene (HDPE) medical tubes where a surgical scalpel was used to cut the individual digits, according to some embodiments.Figure 8 shows a prototype made of a Polyether ether ketone (PEEK) tube, according to some embodiments.Figure 9A-9Cshowing a connector employed for connecting between a guidewire and the device, according to some embodiments.Figure 10 shows an image of release of a polymeric capsule in a Silicone Model, according to some embodiments.Figures 11A and 11B show a handle configured to controllably block and unblock passage of the device through a catheter, according to some embodiments. DESCRIPTION Embodiments of the invention to a device configured to delivery drugs to a patient site of interest internal to a subject (e.g., a human and/or animal subject). In some embodiments, the device may be configured to transport objects (also: payload) from outside a subject's body to a site of interest internal to a subject's body for delivering the objects to and releasing the objects at the site of interest. In some examples, the site of interest may be a treatment or target site. In some other examples, the objects may be transported from the site of interest to the target site by the flow of bodily fluid (e.g., blood stream) and/or other kinetic energy imparted on the objects released at the site of interest. The site of interest may include, for example, an intravenous, intraarterial, epidural, and/or intracranial (e.g., intrathecal, subarachonoate) space. Objects deliverable by the device may include, for example, hydrogel-particles, hydrogel-based particles, and/or nanoparticles, optionally encapsulated by hydrogel, and/or microrobots for targeted therapies. Such microrobots may have a microrobotic (e.g., hydrogel-based) capsule configured for acting, for example, in mammalian vessels, cerebral spine, or subarachonoate space to act as an untethered end-effector. In some examples, such microrobo