CN113058107B - Anchor type long-acting analgesia pump device implanted in vivo - Google Patents
Anchor type long-acting analgesia pump device implanted in vivo Download PDFInfo
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- CN113058107B CN113058107B CN202110492133.5A CN202110492133A CN113058107B CN 113058107 B CN113058107 B CN 113058107B CN 202110492133 A CN202110492133 A CN 202110492133A CN 113058107 B CN113058107 B CN 113058107B
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/142—Pressure infusion, e.g. using pumps
- A61M5/14244—Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P23/00—Anaesthetics
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M2005/1401—Functional features
- A61M2005/1405—Patient controlled analgesia [PCA]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/04—General characteristics of the apparatus implanted
Abstract
The invention discloses an anchor type long-acting analgesic pump device implanted in a body, which mainly comprises an anchor type drug storage device, wherein the anchor type drug storage device is an integral main drug storage structure; the main body shell is a main composition structure of the anchor type medicine storage device, and the interior of the shell is filled with a semi-fluid slow-release gel liquid medicine; the medicine conveying pipe is fixedly arranged on the surface of one side of the main body shell, and a porous filling net is fixedly arranged inside the conveying pipe. This long-acting analgesia pump device of anchor of internal implantation, this anchor medicine storage device is whole because the volume is less, and is very light, so can directly implant through minimal access surgery to avoid the big operation wound of traditional analgesia transfer pump, reducible 90% surface of a wound, and contain loose network form silver composition in the structure, possess and disinfect, antibacterial function, avoid the postoperative in the internal infection emergence, thereby can make the operation comparatively swift and the follow-up misery that brings little.
Description
Technical Field
The invention relates to the technical field related to medicine-carrying medical instruments, in particular to an anchor type long-acting analgesic pump device implanted in a body.
Background
In order to control pain, patients with advanced cancer pain or patients with severe pain caused by other factors often need to take a large amount of nonsteroidal, weak opioid and strong opioid analgesics and a series of medicines for protecting gastrointestinal tract, promoting digestion and improving body basic conditions, the severe pain can be relieved by taking the analgesics several tens to hundreds times of the conventional treatment dosage every day, the gastrointestinal tract, the central system and the respiratory system are greatly loaded by a large amount of oral analgesics, and the side effects of the oral medicines further lead to frosting of cancer patients suffering from pain, constipation, palpitation, nausea, sleep failure and other comprehensive factors further to the negative of the patients to life, do not want to eat, and even have pessimistic emotion of ending life early, are extremely painful for the patients themselves, and are more distressed for families and friends of the patients, so that in order to relieve the pain, a morphine pump is implanted in the body of the patients through intrathecal drug infusion system implantation for treating the cancer pain, but has some disadvantages:
firstly, morphine pump devices on the market at present have better analgesic effect, more than 300-600mg of morphine is needed for intravenous injection to relieve pain, after the morphine pump is implanted, the dosage of 3-6mg of medicament per day can meet the requirement, but the device has larger volume and complicated electronic components, so that the acceptability in the body of a patient is poor, and the morphine pump device can only be used for patients with severe pain due to late-stage cancer;
secondly, the volume is too large, the morphine pump can not be implanted into a body through a minimally invasive surgery, the morphine pump is implanted through a conventional surgery, the body trauma caused by late-stage cancer patients is large, and postoperative infection and even death are caused due to the fact that the patients are weak, the resistance of the patients is obviously reduced, and the morphine pump has a complex internal structure.
Disclosure of Invention
The invention aims to provide an anchor type long-acting analgesic pump device implanted in a body, which aims to solve the problems that the common morphine pump device proposed by the background technology has larger volume and complicated electronic components, so that the acceptability in the body of a patient is poorer; can not be implanted through minimally invasive surgery, and is very troublesome.
In order to achieve the purpose, the invention provides the following technical scheme: an anchor-type long-acting analgesic pump assembly for implantation in a body, comprising:
the anchor type medicine storage device is of an integral main structure;
the main body shell is a main composition structure of the anchor type medicine storage device, and slow-release gel liquid medicine is filled in the shell;
the conveyer pipe, the conveyer pipe is fixed to be set up main body cover's a side surface, the inside fixed packing net that is provided with of conveyer pipe.
Preferably, the main body shell is polymer levorotatory polylactic acid PLLA.
Preferably, the delivery pipe is made of a PLLA material and an iron-magnesium-silver alloy thin layer, the filling net in the delivery pipe is made of PLGA, lidocaine hydrochloride and an iron-magnesium-silver alloy metal material, the filling net is in a hollow grid shape, and the proportion of the special alloy of the iron-magnesium-silver alloy material is 7.8%:92%:0.2 percent.
Preferably, the fixed surface of conveyer pipe is provided with square piece, the fixed inside of square piece is provided with first spring, the fixed baffle that is provided with in end of first spring, the fixed surface of baffle is provided with first magnetic block, first magnetic block is about the vertical central line symmetric distribution of side view of baffle, the baffle constitutes elastic construction through first spring and square piece, square piece constitutes sliding construction with the baffle.
Preferably, the fixed electromagnetic coupling controller that is provided with in inside of square piece, second magnetic force piece is installed to electromagnetic coupling controller's output, the fixed inside that sets up at square piece of second magnetic force piece, second magnetic force piece constitutes homopolar repulsion structure with first magnetic force piece, the inside of square piece and body are the preparation of indisputable magnesium silver alloy material and form.
Preferably, the outer surface of the conveying pipe is connected with a connecting rod, the tail end of the connecting rod is connected with a locking gripper, the locking gripper is installed on the outer surface of the conveying pipe, and an anti-falling clamping hook is fixedly arranged on the inner surface of the locking gripper.
Preferably, the connecting rod self constitutes extending structure, the closure tongs and the connecting rod all constitute rotating structure with the conveyer pipe, the closure tongs constitutes rotating structure with the connecting rod.
Preferably, a permeable membrane is fixedly arranged on one side surface of the main body casing, and an accelerator is filled in the main body casing.
Preferably, the permeable membrane is a semipermeable membrane, the semipermeable membrane is provided with a nanometer small hole, the outer surface of the accelerant is attached to the outer surface of the permeable membrane, and the accelerant is osmotic pressure-promoted sustained-release gel liquid medicine.
Preferably, the surface of anti-drop trip is run through by the thorn pole, the fixed surface of thorn pole is connected with the second spring, the fixed inside that sets up at the anti-drop trip of second spring, the anti-drop trip constitutes elastic construction through second spring and thorn pole, thorn pole and anti-drop trip constitute revolution mechanic.
Compared with the prior art, the invention has the beneficial effects that: this long-acting analgesia pump device of anchor formula of implanting in vivo:
1. this anchor formula medicine storage ware is whole because the volume is less, and is very light, so can directly implant through minimal access surgery to avoid big wound, reduce 90% the surface of a wound, thereby can make the operation comparatively swift and the follow-up misery that brings little.
2. The pipeline for conveying the pump medicine is an iridescent anti-drop trip pipe which can quickly unwind the helix, and after being implanted into the body, the helix is quickly unwound to form an infusion channel;
3. the device is simple in structure, can accurately release extremely low dosage of 0.1-0.6 mg by matching with the slow-release medicine phospholipid liquid stored in the anchor type medicine storage device, and is more stable and durable without depending on using redundant dosage;
4. for personalized patients, the remote control can be carried out through the electromagnetic coupling controller, and the medicine amount can be increased or decreased;
5. because the whole material is respectively made of materials such as PLLA, PLGA, iron-magnesium-silver alloy metal and the like, the implant can be slowly degraded into an absorbable object after 3-4 years, and is not required to be taken out after 2 operations, thereby being more convenient.
Drawings
FIG. 1 is a schematic overall front cross-sectional structural view of the present invention;
FIG. 2 is a schematic top view of the present invention;
FIG. 3 is a side cross-sectional structural view of a square block of the present invention;
FIG. 4 is an enlarged schematic view of the structure at A in FIG. 1 according to the present invention.
In the figure: 1. an anchor type medicine storage device; 2. a main body housing; 3. slowly releasing the gel liquid medicine; 4. a delivery pipe; 5. filling a net; 6. a square block; 7. a first spring; 8. a baffle plate; 9. a first magnetic block; 10. an electromagnetic coupling controller; 11. a second magnetic block; 12. a connecting rod; 13. locking the gripper; 14. an anti-falling hook; 15. membrane penetration; 16. an accelerator; 17. pricking a rod; 18. a second spring.
The specific implementation mode is as follows:
the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention. It should be apparent that the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments, which can be obtained by a person skilled in the art without making any creative effort based on the embodiments in the present invention, belong to the protection scope of the present invention.
Referring to fig. 1-4, the present invention provides a technical solution: an anchor-type long-acting analgesic pump device for implantation in a body, comprising:
the anchor type medicine storage device 1 is of an integral main structure;
the main body shell 2 is a main composition structure of the anchor type medicine storage device 1, and the slow-release gel liquid medicine 3 is filled in the shell 2;
the conveying pipe 4 is fixedly arranged on one side surface of the main body shell 2, and the filling net 5 is fixedly arranged inside the conveying pipe 4.
The main body shell 2 is made of polymer levorotatory polylactic acid PLLA material, is degradable material, and is convenient to slowly drop in vivo.
The conveying pipe 4 is made of a PLLA material and an iron-magnesium-silver alloy thin layer, the filling net 5 inside the conveying pipe 4 is made of PLGA, lidocaine hydrochloride and an iron-magnesium-silver alloy metal material, and the filling net 5 is in a hollow grid shape, because the conveying pipe 4 and the filling net 5 are hollow grid passages made of PLLA, PLGA, lidocaine hydrochloride and an iron-magnesium-silver alloy metal grid, the space grid is made of PLGA and iron-magnesium-silver alloy is degradable, the PLLA and the PLGA can be completely degraded into carbon dioxide, water and the like in vivo after 4 years, secondary taking out is not needed, and the proportion of special alloy of the iron-magnesium-silver alloy material is 7.8%:92%:0.2 percent, the iron-magnesium-silver alloy material is a material which can be gradually degraded in vivo, can completely disappear after 4 years, iron can generate magnetic force to be conveniently sucked, and the silver material can prevent infection.
The outer fixed surface of conveyer pipe 4 is provided with square piece 6, the inside fixed first spring 7 that is provided with of square piece 6, the end fixed baffle 8 that is provided with of first spring 7, the outer fixed surface of baffle 8 is provided with first magnetic force piece 9, first magnetic force piece 9 is around the longitudinal center line symmetric distribution of side view of baffle 8, baffle 8 constitutes elastic construction through first spring 7 and square piece 6, square piece 6 constitutes sliding construction with baffle 8, and when baffle 8 received the elastic force of first spring 7, baffle 8 can slide and slightly separate to conveyer pipe 4, the volume of restriction release, release medicine touches the hand passageway and contains PLGA and the compound porous loose net passageway of lidocaine, along with PLGA degradation, lidocaine also can slow, stably release to the nerve sheath in, morphine, lidocaine analgesia in coordination, the effect is very good.
An electromagnetic coupling controller 10 is fixedly arranged inside the square block 6, a second magnetic block 11 is installed at the output end of the electromagnetic coupling controller 10, the second magnetic block 11 is fixedly arranged inside the square block 6, the second magnetic block 11 and the first magnetic block 9 form a homopolar repulsion structure, the inside and the body of the square block 6 are made of iron magnesium silver alloy materials, in the process that the remote control chip drives the electromagnetic coupling controller 10 to start, the electromagnetic coupling controller 10 conducts electricity to the second magnetic block 11, so that the second magnetic block 11 generates repulsion force, the second magnetic block 11 repels the first magnetic block 9, the first magnetic block 9 drives the baffle plate 8 to expand outwards, the space of the conveying pipe 4 is opened to release medicine more, the conveying amount of the conveying pipe 4 can be increased at the moment, the individualized patient can adapt to active intervention and adjustment, and the whole internal structure of the square block 6 is made of iron magnesium silver alloy materials, and the iron magnesium silver alloy materials can be gradually dissolved after several years.
The outer surface of the delivery pipe 4 is connected with a connecting rod 12, the tail end of the connecting rod 12 is connected with a locking hand grip 13, the locking hand grip 13 is installed on the outer surface of the delivery pipe 4, an anti-falling clamping hook 14 is fixedly arranged on the inner surface of the locking hand grip 13, the connecting rod 12 forms a telescopic structure, the locking hand grip 13 and the connecting rod 12 form a rotary structure together with the delivery pipe 4, the locking hand grip 13 and the connecting rod 12 are made of PLLA, the PLLA is normally contracted and stored, and is expanded when being implanted into a body with water, and cannot fall off from the nerve sheath after being unfolded and expanded, the PLLA is folded before being inserted into the nerve sheath, the PLLA is automatically opened after being inserted into the nerve sheath, the locking hand grip 13 is released, the needle is prevented from falling off through an anti-falling clamping hook 14 barb, the locking hand grip 13 is pushed after the connecting rod 12 is expanded, the locking hand grip 13 is driven to rotate to be inserted into the nerve sheath, when a patient moves, the common needle is easy to bring about to be clamped to replace a fixed needle in the nerve sheath, and the needle easily falls off, and is automatically formed.
One side fixed surface of main body housing 2 is provided with and passes through membrane 15, the inside packing of main body housing 2 has promoter 16, it is the pellicle to pass through membrane 15, and seted up the nanometer aperture on the pellicle, promoter 16's surface and the surface of passing through membrane 15 are laminated mutually, promoter 16 is the promotion liquid of osmotic pressure, there is membrane 15 one side of anchor formula medicine storage ware 1, through the nanometer aperture, body fluid passes through inside the aperture gets into main body housing 2, 16 reactions with the promoter of osmotic pressure promotion liquid, produce osmotic pressure, slowly promote morphine gel release to the right side.
At present, the existing foreign intrathecal drug infusion system implantation (namely morphine pump) is introduced to treat severe late cancer pain and various chronic intractable pain, the technology is to implant an intelligent drug (morphine) infusion pump into subcutaneous or deep part of abdomen, directly infuse analgesic drugs such as morphine, lidocaine and the like into subarachnoid cavity through a catheter, and use a slow release substrate, an osmotic drug release and a dose adjusting switch to be associated with an in vitro program control system, so that a patient can actively adjust the infusion speed at any time according to the pain sensation degree of the patient, and the aim of relieving and eliminating pain is achieved.
1. The drug delivery gel channel composition structure is as follows:
| raw and auxiliary materials | Dosage of prescription | Prescription effect |
| Morphine hydrochloride | 260mg | Anesthetic agent |
| PLLA (MW: 10-15 ten thousand) | 1756.8mg | Degradable shell |
| Sucrose isobutyrate (SAIB) | 38.4mg | Sustained release gel compositions |
| Lidocaine hydrochloride | 110.3mg | Anesthetic agent |
| PLGA75:25 (MW: 3-5 ten thousand) | 85.6mg | Porous lattice component |
| Iron-magnesium-silver alloy | 864.1mg | Degradable component |
| Hydrogenated soybean phospholipid HSPC | 8.9mg | Sustained release gel components in drug depots |
| Cross-linked sodium hyaluronate (high degree of polymerization) | 2.25mg | Sustained release gel components in drug depots |
| N-methyl pyrrolidone | 48.33mg | Sustained release gel components in drug depots |
| Ethanol | 33mg | Sustained release gel components in drug depots |
| Propylene glycol | 58mg | Sustained release gel components in drug depots |
| PEO | 3.8mg | Osmotic pressure promoting agent |
| HPMC(K100M) | 0.86mg | Osmotic pressure promoting agent |
2. The device and the formula and the manufacturing process of the medicine gel are as follows:
(1) Preparing a sustained-release gel medicament: dissolving morphine hydrochloride, SAIB and PLGA and N-methyl pyrrolidone, phospholipid and cross-linked sodium hyaluronate (high polymerization degree) in the formula amount in an organic solvent of ethanol, propylene glycol and NMP, and stirring at normal temperature until the components are dissolved to obtain the sustained-release gel drug matrix;
(2) Adding penetration pressure promoters HPMC (K100M), PEO and the like into the leftmost side of the anchor type medicine storage device 1, sealing the end by a cellulose acetate permeable membrane, and opening holes;
(3) Storing the prepared sustained-release gel drug matrix in the anchor type drug storage device 1 made of PLLA, wherein the outer layer is coated with an iron-magnesium-silver alloy thin layer;
(4) The shell of the drug delivery pipe 4 is made of PLLA material (the thickness of the shell is 30-45 um), and the outer diameter is 1.22mm;
(5) Uniformly mixing lidocaine hydrochloride with the prescription amount, residual PLGA, iron-magnesium-silver alloy (the alloy is metal particle powder with the diameter of about 10-15 um) and the like with a proper amount of ethyl acetate to obtain a colloidal substance, and filling the colloidal substance into a drug delivery pipe 4 made of PLLA; (ii) a
(6) After the drug delivery tube 4 prepared in the step (5) is dried in vacuum at low temperature for 48 hours (minus 10 ℃), a loose and porous drug release channel with a metal support is obtained. The principle is as follows: drugs such as morphine and the like in the anchor type storage 1 are input into the nerve sheath through the drug delivery pipe 4 under the pressure of the osmotic pressure promoter 16, and meanwhile, lidocaine hydrochloride in the drug release channel slowly enters the nerve sheath along with morphine along with the gradual degradation of the degradable PLGA, so that the compound synergistic analgesic effect is achieved;
(7) The tip fixing device of the drug delivery pipe 4 is inserted into the nerve sheath, the anti-falling clamping hook 14 is automatically opened to form an agnail to prevent the pipeline from falling off, and the colloidal drug in the drug bag is gradually absorbed into the nerve sheath through the permeation and siphon effects of the porous pipeline, so that the anesthesia effect can be achieved;
(8) An anchor type medicine storage bag made of polymer materials can be provided with 1-6 medicine releasing ports which are linked with 1-6 sustained-release gel medicine conveying pipes 4 to control the anesthesia function of 1-6 main pain nerve sheaths;
(9) The device is packaged by medical plastic packaging material, and sterilized by gamma ray for standby;
(10) The device can be gradually and completely degraded after being implanted in a body for 4 years without taking out and burning or treating medical materials.
(11) According to the above process, examples 1 and comparative examples 1, 2, 3 and 4 with different formulations were prepared to confirm the difference of the effect of the formulations with different ratios on in vitro dissolution and in vivo release.
3. In vitro and in vivo evaluation means:
(1) The test conditions are as follows:
the release rate in vivo was simulated by the SOTAX flow cell method, and the release rate of the device implanted in vivo was preliminarily estimated by elution of both drugs with a flow-through solution. The experimental conditions were:
release temperature: the solution was poured into a 22.6mm reagent reservoir at 52. + -. 2 ℃ at a flow rate of 22ml/min and phosphate at pH = 9.0. The opening of the fixed gripper is connected into a release pool of the flow cell and sealed, and the semi-permeable membrane end of the anchor type medicine storage device is soaked in acetate buffer solution with the pH value of 4.5 so as to provide medicine release pressure. At the beginning of the experiment: sampling for 12h, 24h, 3d, 4d, 5d, 6d and 12d to detect the release concentrations of the two anesthetics, calculating according to Arrhenius thermodynamic equation, and simulating the in vivo release drug amount of 0.5, 1, 3, 4, 5, 6 and 12 months at 37 +/-2 ℃ in organism tissues after the device is implanted into animals or human bodies to carry out preliminary drug release rate prejudgment.
The detection means is an LC-MS method, 0.025ml of sample is taken in the flow cell each time, the concentration of morphine hydrochloride and lidocaine hydrochloride is detected after technical treatment, the correlation coefficient of a standard curve is determined above 99% each time, and the results all accord with methodology standards.
(2) And (3) test results:
results of the assay-Table 1 (simulated 0.5 month after implantation)
Results of the assay-Table 2 (simulated implantation 1 month)
Results of the assay-Table 3 (simulated 3 months after implantation)
Results of the assay-Table 4 (4 months after simulated implantation)
Results of the assay-Table 5 (simulated 5 months after implantation)
Results of the assay-Table 6 (simulated implantation 6 months)
Results of the measurements-Table 7 (simulated 12 months after implantation)
(3) And (4) test conclusion:
the concentration levels of morphine hydrochloride and lidocaine hydrochloride in different prescriptions in the flow cell simulation test are detected, and obvious differences appear. The following reasons were analyzed:
the working principle is as follows: when the anchor type long-acting analgesia pump device implanted in vivo is used, according to the picture 1, the picture 2 and the picture 3, after the whole is installed, the whole anchor type medicine storage device 1 is firstly implanted into the human body through a minimally invasive surgery, the locking gripper 13 is hung on the nerve tip, at the moment, the connecting rod 12 is expanded by liquid to push the locking gripper 13 to rotate, so that the anti-falling hook 14 on the locking gripper 13 is penetrated into the nerve tip, in the penetrating process, the outer wall of the nerve tip extrudes the thorn rod 17, so that the thorn rod 17 rotationally extrudes the second spring 18 to retract into the anti-falling hook 14, the anti-falling hook 14 can be completely penetrated into the nerve tip, until the anti-falling hook 14 enters the nerve tip, the second spring 18 can push the thorn rod 17 to rotate out the anti-falling hook 14, a barb is formed through the thorn rod 17, so that the nerve tip can be firmly grasped, at this time, the permeable membrane 15 on the main body shell 2 can allow body fluid to penetrate through the nano-pores to enter and react with the osmotic pressure promoter 16, so that the pressure pushes the morphine sustained-release gel liquid medicine 3 rightwards, the sustained-release gel liquid medicine 3 is discharged into the nerve tip together through the locking gripper 13 through the delivery pipe 4 and the filling net 5, and an analgesic effect is achieved, meanwhile, the second magnetic block 11 can be started by the electromagnetic coupling controller 10 on the square block 6 of the patient, so that the second magnetic block 11 generates repulsive force for the first magnetic block 9, the first magnetic block 9 drives the baffle 8 on the first spring 7 to slide outwards, meanwhile, the opening range of the delivery pipe 4 is expanded, the sustained-release gel liquid medicine 3 can enter the nerve tip through the locking gripper 13 in an incremental manner, and the overall practicability is increased.
Although the present invention has been described in detail with reference to the foregoing embodiments, it will be apparent to those skilled in the art that various changes, modifications, equivalents, and improvements may be made without departing from the spirit and scope of the invention.
Claims (7)
1. An anchor-type long-acting analgesic pump assembly for implantation in a body, comprising: the anchor type medicine storage device (1), the anchor type medicine storage device (1) is an integral main structure;
the main body shell (2) is a main composition structure of the anchor type medicine storage device (1), and the slow-release gel liquid medicine (3) is filled in the main body shell (2);
the conveying pipe (4) is fixedly arranged on the surface of one side of the main body shell (2), a filling net (5) is fixedly arranged inside the conveying pipe (4), and the filling net (5) is loose network-shaped alloy;
a square block (6) is fixedly arranged on the outer surface of the conveying pipe (4), a first spring (7) is fixedly arranged inside the square block (6), a baffle plate (8) is fixedly arranged at the tail end of the first spring (7), a first magnetic block (9) is fixedly arranged on the outer surface of the baffle plate (8), the first magnetic blocks (9) are symmetrically distributed about the longitudinal center line of the side view surface of the baffle plate (8), the baffle plate (8) and the square block (6) form an elastic structure through the first spring (7), and the square block (6) and the baffle plate (8) form a sliding structure;
an electromagnetic coupling controller (10) is fixedly arranged inside the square block (6), a second magnetic block (11) is installed at the output end of the electromagnetic coupling controller (10), the second magnetic block (11) is fixedly arranged inside the square block (6), the second magnetic block (11) and the first magnetic block (9) form a homopolar repulsion structure, and the inside of the square block (6) and the body of the square block are both made of iron-magnesium-silver alloy materials;
the outer surface of the conveying pipe (4) is connected with a connecting rod (12), the tail end of the connecting rod (12) is connected with a locking gripper (13), the locking gripper (13) is installed on the outer surface of the conveying pipe (4), and an anti-falling clamping hook (14) is fixedly arranged on the inner surface of the locking gripper (13).
2. An implanted anchor-type long-acting analgesic pump device of claim 1 wherein: the main body shell (2) is composed of polymer levorotatory polylactic acid (PLLA).
3. An implanted anchor-type long-acting analgesic pump device of claim 1 wherein: the outer shell of the conveying pipe (4) is made of a polymer left-handed polylactic acid (PLLA) material and an iron-magnesium-silver alloy thin layer, the filling net (5) inside the conveying pipe (4) is made of a glycolic acid copolymer (PLGA), lidocaine hydrochloride and an iron-magnesium-silver alloy metal material, and the filling net (5) is in a hollow grid shape.
4. An implanted anchor-type long-acting analgesic pump device of claim 1 wherein: the connecting rod (12) forms a telescopic structure, the locking hand grab (13) and the connecting rod (12) form a rotating structure together with the conveying pipe (4), and the locking hand grab (13) and the connecting rod (12) form a rotating structure.
5. An implanted anchor-type long-acting analgesic pump device of claim 1 wherein: a permeable membrane (15) is fixedly arranged on the surface of one side of the main body shell (2), and an accelerant (16) is filled in the main body shell (2).
6. An implanted anchor-type long-acting analgesic pump device of claim 5 wherein: permeate membrane (15) and be the pellicle, and seted up the nanometer aperture on the pellicle, the surface of promoter (16) is laminated mutually with the surface of permeating membrane (15), promoter (16) promotes the sustained-release gel liquid medicine for osmotic pressure.
7. An anchor-type long-acting analgesic pump apparatus implanted in a body as claimed in claim 1 wherein: the surface of anti-drop trip (14) is run through by thorn pole (17), the fixed surface of thorn pole (17) is connected with second spring (18), second spring (18) are fixed to be set up in the inside of anti-drop trip (14), anti-drop trip (14) constitute elastic construction through second spring (18) and thorn pole (17), thorn pole (17) constitute rotating-structure with anti-drop trip (14).
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| CN204379974U (en) * | 2015-01-06 | 2015-06-10 | 北京国械堂科技发展有限责任公司 | A kind of subcutaneous implantation doser |
| RU2015108901A (en) * | 2012-08-15 | 2016-10-10 | Пфм Медикал Аг | IMPLANTED DEVICE FOR USE IN THE BODY OF A HUMAN AND / OR ANIMAL FOR REPLACEMENT OF THE VALVE OF THE BODY |
| CN209270606U (en) * | 2018-02-02 | 2019-08-20 | 南方医科大学南方医院 | Orthopaedics implantable drug delivery system |
| CN110478568A (en) * | 2019-08-23 | 2019-11-22 | 黄太满 | A kind of analgesia continuous infusion epidural target is to port and its application method |
| CN111278478A (en) * | 2017-10-27 | 2020-06-12 | 美敦力公司 | Kit for anchoring an implantable medical device |
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2021
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|---|---|---|---|---|
| RU2015108901A (en) * | 2012-08-15 | 2016-10-10 | Пфм Медикал Аг | IMPLANTED DEVICE FOR USE IN THE BODY OF A HUMAN AND / OR ANIMAL FOR REPLACEMENT OF THE VALVE OF THE BODY |
| CN204379974U (en) * | 2015-01-06 | 2015-06-10 | 北京国械堂科技发展有限责任公司 | A kind of subcutaneous implantation doser |
| CN111278478A (en) * | 2017-10-27 | 2020-06-12 | 美敦力公司 | Kit for anchoring an implantable medical device |
| CN209270606U (en) * | 2018-02-02 | 2019-08-20 | 南方医科大学南方医院 | Orthopaedics implantable drug delivery system |
| CN110478568A (en) * | 2019-08-23 | 2019-11-22 | 黄太满 | A kind of analgesia continuous infusion epidural target is to port and its application method |
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