EP-4735069-A1 - SYSTEMS FOR ACCELERATING HYDROLYSIS OF IMPLANTABLE MEDICAL DEVICES

Abstract

Systems for hydrogel hydrolysis as well as methods for hydrogel hydrolysis are disclosed. An example system may include a syringe barrel having a needle connector disposed thereon. A hydrogel hydrolysis material may be disposed in the syringe barrel. The hydrogel hydrolysis material may be configured to be injected into a hydrogel formed in the body of a patient in order to accelerate the hydrolysis of the hydrogel.

Inventors

• CIRKA, HEATHER
• HSU, YEN-HAO
• PLOURDE, Marc
• DELANEY, JR., Joseph Thomas
• PARISI, Cristian

Assignees

• Boston Scientific Scimed, Inc.

Dates

Publication Date

20260506

Application Date

20240626

Claims (15)

1. 1. A system for hydrogel hydrolysis, the system comprising: a syringe barrel having a needle connector disposed thereon; a hydrogel hydrolysis material disposed in the syringe barrel; and wherein the hydrogel hydrolysis material is configured to be injected into a hydrogel formed in the body of a patient in order to accelerate the hydrolysis of the hydrogel.
2. 2. The system of claim 1, wherein the hydrogel hydrolysis material includes a lipase.
3. 3. The system of claim 1, wherein the hydrogel hydrolysis material includes an esterase.
4. 4. The system of any one of claims 1-3, wherein the hydrogel hydrolysis material is configured to hydrolyze ester bonds of triglycerides.
5. 5. The system of any one of claims 1-4, further comprising a complimentary hydrogel-based perirectal spacer system including a needle compatible with the needle connector.
6. 6. A method for accelerating hydrolysis of a hydrogel-based perirectal spacer, the method comprising: delivering the hydrogel-based perirectal spacer into a patient via a delivery syringe system coupled to a needle; disconnecting the delivery syringe system from the needle; attaching a hydrolysis syringe system to the needle, the hydrolysis syringe system including a syringe barrel and a hydrogel hydrolysis material disposed in the syringe barrel; and injecting the hydrogel hydrolysis material into the patient adjacent to the hydrogel-based perirectal spacer in order to accelerate hydrolysis of the hydrogelbased perirectal spacer.
7. 7. The method of claim 6, wherein the hydrogel hydrolysis material includes a lipase.
8. 8. The method of claim 6, wherein the hydrogel hydrolysis material includes an esterase.
9. 9. The method of any one of claims 6-8, wherein the hydrogel hydrolysis material is configured to hydrolyze ester bonds of triglycerides.
10. 10. The method of any one of claims 6-9, further comprising observing the delivering the hydrogel-based perirectal spacer into the patient for a complication prior to injecting the hydrogel hydrolysis material into the patient.
11. 11. The method of claim 10, wherein the complication includes misplacement of the hydrogel-based perirectal spacer.
12. 12. The method of claim 10, wherein the complication includes patient discomfort.
13. 13. The method of any one of claims 6-12, further comprising delivering a replacement hydrogel-based perirectal spacer into the patient.
14. 14. The method of claim 13, further comprising observing the delivering the replacement hydrogel-based perirectal spacer into the patient for a second complication.
15. 15. The method of any one of claims 6-14, wherein injecting the hydrogel hydrolysis material into the patient adjacent to the hydrogel-based perirectal spacer includes injecting the hydrogel hydrolysis material into the hydrogel-based perirectal spacer.

Description

SYSTEMS FOR ACCELERATING HYDROLYSIS OF IMPLANTABLE MEDICAL DEVICES Cross Reference to Related Applications [0001] This application claims the benefit of U.S. Provisional Patent Application Serial No. 63/510,413 filed on June 27, 2023, the disclosure of which is incorporated herein by reference. Technical Field [0002] The present disclosure pertains to medical devices, and methods for manufacturing medical devices. More particularly, the present disclosure pertains to systems for accelerating hydrolysis of implantable medical devices. Background [0003] A wide variety of medical devices have been developed for medical use. These devices are manufactured by any one of a variety of different manufacturing methods and may be used according to any one of a variety of methods. Of the known medical devices and methods, each has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices as well as alternative methods for manufacturing and using medical devices. Brief Summary [0004] This disclosure provides design, material, manufacturing method, and use alternatives for medical devices. A system for hydrogel hydrolysis is disclosed. The system comprises: a syringe barrel having a needle connector disposed thereon; a hydrogel hydrolysis material disposed in the syringe barrel; and wherein the hydrogel hydrolysis material is configured to be injected into a hydrogel formed in the body of a patient in order to accelerate the hydrolysis of the hydrogel. [0005] Alternatively or additionally to any of the embodiments above, the hydrogel hydrolysis material includes a lipase. [0006] Alternatively or additionally to any of the embodiments above, the hydrogel hydrolysis material includes an esterase. [0007] Alternatively or additionally to any of the embodiments above, the hydrogel hydrolysis material is configured to hydrolyze ester bonds of triglycerides. [0008] Alternatively or additionally to any of the embodiments above, further comprising a complimentary hydrogel-based perirectal spacer system including a needle compatible with the needle connector. [0009] A method for accelerating hydrolysis of a hydrogel-based perirectal spacer is disclosed. The method comprises: delivering the hydrogel-based perirectal spacer into a patient via a delivery syringe system coupled to a needle; disconnecting the delivery syringe system from the needle; attaching a hydrolysis syringe system to the needle, the hydrolysis syringe system including a syringe barrel and a hydrogel hydrolysis material disposed in the syringe barrel; and injecting the hydrogel hydrolysis material into the patient adjacent to the hydrogel-based perirectal spacer in order to accelerate hydrolysis of the hydrogel-based perirectal spacer. [0010] Alternatively or additionally to any of the embodiments above, the hydrogel hydrolysis material includes a lipase. [0011] Alternatively or additionally to any of the embodiments above, the hydrogel hydrolysis material includes an esterase. [0012] Alternatively or additionally to any of the embodiments above, the hydrogel hydrolysis material is configured to hydrolyze ester bonds of triglycerides. [0013] Alternatively or additionally to any of the embodiments above, further comprising observing the delivering the hydrogel-based perirectal spacer into the patient for a complication prior to injecting the hydrogel hydrolysis material into the patient. [0014] Alternatively or additionally to any of the embodiments above, the complication includes misplacement of the hydrogel-based perirectal spacer. [0015] Alternatively or additionally to any of the embodiments above, the complication includes patient discomfort. [0016] Alternatively or additionally to any of the embodiments above, further comprising delivering a replacement hydrogel-based perirectal spacer into the patient. [0017] Alternatively or additionally to any of the embodiments above, further comprising observing the delivering the replacement hydrogel-based perirectal spacer into the patient for a second complication. [0018] Alternatively or additionally to any of the embodiments above, further comprising treating the patient with radiation therapy. [0019] Alternatively or additionally to any of the embodiments above, injecting the hydrogel hydrolysis material into the patient adjacent to the hydrogel-based perirectal spacer includes injecting the hydrogel hydrolysis material into the hydrogel-based perirectal spacer. [0020] A system for accelerating hydrolysis of a hydrogel is disclosed. The system comprises: a syringe barrel having a needle connector disposed thereon, the needle connector being compatible with a needle used with a hydrogel-based perirectal spacer system; wherein the hydrogel-based perirectal spacer system is configured to deliver a hydrogel-based perirectal spacer into a patient; a hydrogel hydrolysis material disposed in the syringe barrel; and wherein the hydrogel hydrolysis material is configured to