WO2018159865A1 - Needle-free solution-injecting device and needle-free solution-injecting method using same - Google Patents

Abstract

The present invention provides a needle-free solution-injecting device which can inject a solution into a living body without use of a needle. The needle-free solution-injecting device of the present invention comprises: a body; a solution holding member which holds a solution and is disposed on one side of the body while being exposed so as to come into contact with the skin of a living body; a heat lamp which emits light to heat the solution holding member and is disposed opposite the solution holding member in the body; a power supply disposed in the body to supply power to the heat lamp; and a control unit disposed in the body and electrically connected to the power supply and the heat lamp to control the same, wherein the solution holding member is heated by the heat lamp, and thus the solution is injected into the living body through the skin in contact with the solution holding member.

Description

Needle-free solution injection device and needle-free solution injection method using the same

The technical idea of the present invention relates to a solution injection in vivo, and relates to a needleless solution injection device and a needleless solution injection method using the same.

Daily insulin secretion in healthy people consists of extra insulin secretion from the pancreas in response to increased blood glucose, such as basal insulin secretion and basal metabolism. Diabetes is divided into type 1 diabetes in which no insulin is formed from the pancreas and type 2 diabetes in which insulin does not function properly. Recent studies have shown that diabetes has a high prevalence regardless of age, gender, and ethnicity, and the incidence has also increased steadily.

A countermeasure against diabetes is to control insulin concentration in the blood to reduce hyperglycemia to normal levels of blood sugar. To date, a common method for insulin control is insulin injection by injection. Insulin injection for long term action stimulates insulin basal secretion. Insulin injection for short-term action, for example 30 minutes before food intake, will increase the insulin concentration in the blood to counteract hyperglycemia after food intake. However, the infusion of insulin for short-term action is as frequent as three to four times a day, and patients are uncomfortable with it. This type of injection uses needles, which can cause mechanical trauma, pain, infection, and psychological discomfort in diabetics, and also cause allergic reactions due to high concentrations of insulin medication at the injection site, or hypoglycemia ( risk of hypoglycaemia may occur.

Insulin infusions, which are widely used for diabetic response, offer many advantages, but patients still feel the discomfort and pain associated with several daily administrations by needle injection. In response, there is a need for the development of insulin infusion methods that do not use a needle. Insulin injection method that does not use a needle developed so far is to inject insulin into the oral cavity or inhaled through the nose. Alternatively, pancreas transplantation is also actively developed as a method for diabetes. However, these methods do not yet provide sufficient effect and are not widely used. One proposed method of needleless insulin injection is jet injection, which allows liquid flow to the subcutaneous layer at high speed to allow insulin solution to diffuse through the skin, but this method requires expensive and complex devices, and In principle, not much different.

Therefore, there is a need for new methods for providing convenience and safe effects on insulin injection for diabetics, and in particular, research on needleless solution injection that can inject a solution into a living body without using a needle.

[Preceding technical literature]

[Non-Patent Documents]

Watkins, P.J. ABC of Diabetes. 5th ed. London: Blackwell Publishing. 2003.

Holt, T .; Kumar, S. ABC of diabetes. 6th ed. Oxford: Wiley-Blackwell. 2010.

Owens, D. R .; Nat Rev Drug Discov., 2002, 1, 529.

Brook, C. G .; Dattani, M.T. Handbook of Clinical Pediatric Endocrinology. 2nd ed. Wiley Blackwel. 2012.

The technical problem of the present invention is to provide a needle-free solution injection device capable of injecting a solution into a living body without using a needle.

The technical problem of the present invention is to provide a needleless solution injection method that can inject a solution into a living body without using a needle.

However, these problems are exemplary, and the technical idea of the present invention is not limited thereto.

Needleless solution injection device according to the technical idea of the present invention for achieving the above technical problem, the body; A solution receiving member exposed to contact the skin of the living body on one side of the body and accommodating a solution; A heating lamp which emits light to heat the solution receiving member and is positioned in the body opposite the solution receiving member; A power source located in the body and supplying power to the heating lamp; And a control unit positioned in the body and electrically connected to and controlling the power supply and the heating lamp, wherein the solution receiving member is heated by the heating lamp so that the solution contacts the solution receiving member. It is injected into the living body through.

In some embodiments of the present invention, the solution may be injected into the living body according to a temperature gradient generated between the solution receiving member and the skin heated by the heating lamp.

In some embodiments of the invention, the solution may comprise insulin.

The solution receiving member may have a porous structure including pores, and the solution may be accommodated in the pores.

In some embodiments of the present invention, the solution receiving member may include TiNi.

In some embodiments of the present invention, the solution receiving member may have a thickness through which the light is transmitted such that the light emitted by the heat lamp directly heats the skin.

In some embodiments of the present invention, the solution receiving member has a porosity of 65% to 75% and a pore size distribution of 40 μm to 900 μm, and may have an average pore size of 130 μm to 170 μm.

In some embodiments of the present invention, the solution receiving member may have a detachable structure detachable from the body.

In some embodiments of the present invention, the heating lamp may include an infrared light emitting diode.

In some embodiments of the invention, the heating temperature by the heating lamp may range from 20 ℃ to 45 ℃.

In some embodiments of the present invention, the power source may include a primary battery or a secondary battery.

In some embodiments of the present invention, the needleless solution injection device may be worn on the ankle or patched.

In accordance with an aspect of the present invention, there is provided a needleless solution injection method comprising: placing a solution receiving member containing a solution in contact with skin of a living body; Heating the solution receiving member using a heating lamp; And heating the solution receiving member by the heating lamp so that the solution is injected into the living body through the skin in contact with the solution receiving member.

The needleless solution injection device according to the technical concept of the present invention may use the solution receiving member including the porous TiNi-based alloy, so that the porous TiNi-based alloy may function as high density materials containing insulin solutions. In addition, by irradiating the solution receiving member with infrared rays, it is possible to promote the directional diffusion of insulin from the solution receiving member into the skin of the living body.

As a result of clinical experiments with the needleless solution infusion device according to the technical idea of the present invention to 42 insulin patients, it was found that the insulin control of the patients was effectively performed, and the skin irritation or lesions caused by the device were found. Was not generated, and safety in use was also confirmed. Therefore, it can be seen that the needle-free solution injection device according to the technical idea of the present invention has a prospect as a new technology for supplying insulin or liquid medicine without using a needle in a living body. In addition, the needleless injection device according to the technical concept of the present invention can provide an easy and simple use method, it can be used as an outpatient treatment or home treatment.

The effects of the present invention described above have been described by way of example, and the scope of the present invention is not limited by these effects.

1 is a schematic diagram showing a needleless solution injection device according to an embodiment of the present invention.

2 is a flowchart illustrating a needleless solution injection method according to an embodiment of the present invention.

3 is a photograph showing a solution receiving member included in the needleless solution injection device of FIG. 1 according to an embodiment of the present invention.

Figure 4 is a schematic diagram showing a hand ankle wearable needleless injection device according to an embodiment of the present invention.

Figure 5 is a graph showing the temperature change with time when the needle-free solution injection device according to an embodiment of the present invention.

Figure 6 is a schematic diagram showing a patch-type needleless solution injection device according to an embodiment of the present invention.

Figure 7 is a graph showing the change in blood sugar according to the blood sugar of patients wearing a needleless solution injection device according to an embodiment of the present invention.

Figure 8 is a graph showing the change in blood sugar according to the blood sugar of the patient M wearing a needleless solution injection device according to an embodiment of the present invention.

Figure 9 is a graph showing the blood sugar changes according to the blood sugar of the patient E wearing a needleless solution injection device according to an embodiment of the present invention.

Hereinafter, exemplary embodiments of the present invention will be described in detail with reference to the accompanying drawings. Embodiments of the present invention are provided to more fully explain the technical idea of the present invention to those skilled in the art, and the following embodiments may be modified in many different forms, and The scope of the technical idea is not limited to the following examples. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the inventive concept to those skilled in the art. Like numbers refer to like elements all the time. Furthermore, various elements and regions in the drawings are schematically drawn. Therefore, the technical idea of the present invention is not limited by the relative size or the distance drawn in the accompanying drawings.

The technical idea of the present invention relates to the in vivo injection of insulin without the use of needles to counteract diabetes. In addition, the technical idea of the present invention is not limited to insulin, and may include an apparatus and a method for injecting a solution such as a medicament without using a needle into a living body.

Needleless insulin infusion is an area of active research, as the patient may feel convenient and comfortable during insulin infusion. One method of needleless insulin injection is based on the diffusion of insulin solution through the skin. Diffusion of a liquid, such as an insulin solution, occurs through a large surface area of the contact site and is generally the width of the skin of tens of square centimeters and may not cause wounds by injection. However, the main obstacle during injection is the stratum corneum, which has low permeability to large molecules such as insulin composed of more than 6000 atoms. Thus, various physical methods have been applied, such as sonication, laser radiation, and electrical and radio frequency treatment, to form passages or micropores within such stratum corneum. On the other hand, to facilitate the diffusion of insulin, a method has been proposed in which insulin molecules are packaged in liposome capsules to increase permeability.

1 is a schematic diagram showing a needleless solution injection device 100 according to an embodiment of the present invention.

Referring to FIG. 1, the needleless solution injection device 100 includes a body 110, a solution receiving member 120, a heating lamp 130, a power supply 140, and a controller 150.

The body 110 may accommodate the solution accommodating member 120, the heating lamp 130, the power supply 140, and the controller 150 therein. The body 110 may be made of metal, ceramic, or polymer.

The solution receiving member 120 may be exposed and positioned to contact the skin of the living body on one side of the body 110. The solution receiving member 120 may have a detachable structure detachable from the body 110. The detachable structure may be made in various ways such as an adhesive method using an adhesive, a fitting method fitted into a groove formed in the body, a binding method binding to a binding element formed in the body, and the like.

The solution receiving member 120 may have a thickness through which the light is transmitted so that the light emitted from the heating lamp 130 directly heats the skin of the living body. The solution receiving member 120 may have a thickness of, for example, about 0.2 mm to about 1 mm.

The solution receiving member 120 may have a structure capable of accommodating a solution, for example, may have a porous structure including pores. The solution may be accommodated in the pores formed in the solution receiving member 120. In addition, the solution receiving member 120 may have a pore size of, for example, about 10 μm to about 900 μm, such as about 40 μm to about 500 μm. However, the thickness and pore size of the solution receiving member 120 is exemplary, and the technical spirit of the present invention is not limited thereto.

The solution receiving member 120 may include, for example, porous TiNi. However, the material constituting the solution accommodating member 120 is exemplary, and a case including all kinds of materials capable of forming a porous structure is also included in the inventive concept. The solution receiving member 120 may be used repeatedly by refilling the insulin solution. The solution receiving member 120 will be described in detail below with reference to FIG. 3.

The heating lamp 130 may emit light to heat the solution accommodating member 120, and may be positioned in the body 110 to face the solution accommodating member 120. The heat lamp 130 may emit light for heating the solution receiving member 120, and may emit infrared light having a wavelength in a range of about 880 nm to about 1200 nm, for example. The heating lamp 130 may include various light sources and may include, for example, a light emitting diode (LED). The heating lamp 130 may include, for example, an infrared light emitting diode. Light emitting diodes for such infrared radiation preferably provide small size and high light emission. Infrared emission can be easily controlled by selecting the level of current required for power of the light emitting diodes. Such current control may be performed by the controller 150 described below.

The solution receiving member 120 may be heated by the heating lamp 130 to inject the solution into the living body through the skin in contact with the solution receiving member 120. The heating temperature by the heating lamp 130 may be a range of temperatures in a range that does not damage the skin of the living body, for example, may be a temperature of about 20 ℃ to about 45 ℃ range.

The solution may include various liquids for infusion into a living body, and may be, for example, bioequivalent liquids such as saline or glucose, drugs such as antibiotics, hormones such as insulin, and the like. The present invention has been exemplarily described in the case where insulin is used as the solution, but the technical idea of the present invention is not limited thereto.

The power source 140 may be located in the body 110 and may be electrically connected to the heating lamp 130 to supply power. The power source 140 may have a structure connected to an external power source or may have a battery structure separated from the outside. The power source 140 may include a primary battery that is replaced, for example, a battery, or may include a rechargeable secondary battery. The power source 140 may be, for example, a lithium ion battery or a lithium polymer battery.

The controller 150 may be located in the body 110 and may be electrically connected to and control the heating lamp 130 and the power source 140. The controller 150 may control the power of the power source 140 supplied to the heating lamp 130 to control the heating temperature by the heating lamp 130 in a predetermined range, for example, in the range of about 20 ° C. to about 45 ° C. Can be. The controller 150 may be configured to include a temperature measuring element 152 for measuring the temperature inside the body 110 and a power control element 154 for controlling the power supplied from the power source 140 to the heating lamp 130. Can be. In FIG. 1, the controller 150 is illustrated as being located at one side of the power supply 140, but this is exemplary and the present invention is not limited thereto. The controller 150 may be used in the needleless solution injection device 100. May be located at the location. The controller 150 may be provided in various forms such as an integrated circuit.

2 is a flowchart illustrating a needleless solution injection method S100 according to an embodiment of the present invention.

Referring to Figure 2, the needle-free solution injection method (S100), the step of placing a solution receiving member containing a solution to contact the skin of the living body (S110); Heating the solution receiving member using a heating lamp (S120); And the solution receiving member is heated by the heating lamp, and the solution is injected into the living body through the skin in contact with the solution receiving member (S130). The needleless solution injection method S100 may be performed using the needleless solution injection device 100 described above with reference to FIG. 1, or may be performed using another device.

The solution receiving member 120 of FIG. 1 may include various porous materials. As one example that can be applied to the solution receiving member 120, the porous TiNi-based material is proposed.

The porous TiNi-based material may be formed using powder metallurgy technology and selfpropagating high temperature synthesis (SHS) technology in combustion mode. The development of this self-transfer high temperature synthesis technology can provide porous new biomaterials with complex structure and high permeability for cell cell tissue engineering and clinical applications. Self-transferring high temperature synthesis techniques are described, introducing liquid phases to facilitate the kinetics of mass transfer and thus dissolving solids. An exothermic reaction of Ni and Ti occurs from one side of the filled filler, and thus thermal expansion proceeds and heat is transferred through the filler in a self-sustaining manner. In the present invention, the porous TiNi-based alloy can be produced by a self-transferring high temperature synthesis method using the following powders. The powder may use Ti-PTM or PTOM and Ni-PNK-10T2 or PNK-1L5 as a Russian trade name or Russian classification. It may be carried out at an initial self-transfer high temperature synthesis temperature in the range of 400 ° C. to 500 ° C. under argon gas atmosphere. At this time, the effect of process variables such as the behavior of combustion wave propagation, phase formation and starting powders on the pore structure, firing temperature and preheating schedule can be considered. The success of such self-transfer high temperature synthesis may depend largely on the shape of the canister that accepts the fill. In the present invention, a quartz cylinder sleeve having an inner diameter of 55 mm and closed at one end was used. Depending on the factors described above, the formed porous body may have different surface conditions of minimum pore size, maximum pore size, pore size distribution and pore wall surface topology of pore walls, phases, and chemical structures.

3 is a photograph showing a solution receiving member 120 included in the needleless solution injection device 100 of FIG. 1, according to an embodiment of the present invention.

Referring to FIG. 3, a TiNi-based material is shown as an example of a solution accommodating member. In FIG. 3, (a) is an external photograph of the solution accommodating member, and (b) is a scanning electron micrograph of the solution accommodating member.

The macroscopic structure of the formed porous TiNi-based material represents a 3D pore cluster, the morphology of which is common for highly porous materials obtained through eutectic reactions. It can be seen that the TiNi-based material includes large open pores and connected pores, thus having a high specific surface. The formed TiNi-based material has a porosity of, for example, about 65% to about 75%, and a pore size distribution, for example, having a disordered porous structure having about 40 μm to about 900 μm, and the average pore size is, for example, For example about 130 μm to about 170 μm, for example about 150 μm. Such porous TiNi-based materials can maintain a liquid medium such as insulin solution in the porous space.

From the study of the interaction of these TiNi-based materials with various biological fluids, these TiNi-based materials can be applied as effective and capacitive medical materials.

The conductive physical and mechanical properties of these TiNi-based alloys, the possibility of forming porous structures due to high levels of heat transfer and low thermal conductivity, have been found to contain materials that effectively enable the inclusion of insulin to supply insulin without the use of needles in vivo. Can provide. For example, having a porosity of about 60% to about 70%, more than half the volume of the full dose can be filled with insulin solution. The development of these devices relies on a light source of infrared radiation to control the diffusion of the solution.

The diffusion process from the porous TiNi base depends on many factors, such as viscosity, specific gravity, density, TiNi permeability, pore size, pore length, surface area in contact with the external environment, and temperature of the porous body. The dependence between the rate of change of the fluid volume of the TiNi porous structure and the basic parameters of solution diffusion is expressed by Equation 1 below. :

[Equation 1]

In Equation 1, ΔQ is the liquid diffusion rate from the porous TiNi-based material; k is the diffusion coefficient; ΔT is the temperature gradient of the porous material; μ is the liquid viscosity; ρ is the liquid density; V ₀ is the initial volume of liquid in the porous material; S is the contact area between the surface pores of the sample and the cell tissues; Δh is the height of the liquid in the porous material; L is the average length of pores; P is porosity; And g is gravity acceleration. In Equation 1, ΔT representing the temperature gradient can be changed using infrared rays, and also varies depending on the amount of power and the wavelength of the infrared rays, and the diffusion rate of the solution can be adjusted by these variables.

In vivo injection of a liquid, such as insulin, is analyzed to occur due to the effects of capillary action and infrared radiation by pores configured in the solution receiving member, whereby the liquid contained in the pores can be injected into the cellular tissue of the living body. In other words, thermal diffusion is a major physical factor that stimulates the diffusion of insulin solution into the subcutaneous layer of a patient. That is, the skin may swell as the solution receiving member is heated and the skin to be contacted is heated, thereby facilitating the diffusion of the insulin solution into the cellular tissue.

The three major factors for effective infusion, ie diffusion, of insulin into the body are the temperature gradient of the contact area between insulin and the skin, the heating of the skin in contact, and the direct effect on the skin's inner layer by infrared radiation. These three factors can induce the diffusion of insulin through the skin and can exhibit an excellent antidiabetic effect.

Referring to the first element, the temperature gradient of the contact area between insulin and the skin, a temperature gradient occurs in the insulin solution contained in the pores in the solution receiving member as heat (or infrared) is provided by the heating lamp. This temperature gradient can be activated by radiating heat provided at the pore walls and intersections. As the living body self-controls heat movement from the surface of the solution receiving member in contact with the skin of the living body by the blood flow, heating due to partial absorption of infrared radiation by the surface of the solution receiving member may produce the required temperature gradient. have. That is, a temperature gradient occurs because the solution receiving member becomes a high temperature region and the skin of the living body becomes a low temperature region, and thus a driving force for moving insulin from the solution receiving member, which is a high temperature region, to the skin of the living body, which is a low temperature region, is generated. Can be. The driving force of this temperature gradient causes insulin to move into the skin of the living body, and the mobility of this insulin can be specified by the presence of an excess pressure distributed in the contact surface area between the solution receiving member and the skin of the living body. Can be. Importantly, the "slightly increased temperature" of the solution receiving member containing insulin may be sufficient for activation to diffuse and deliver insulin to tissues in the skin of the living body in contact. The time dependence of thermodynamics during operation of the needleless fluid injector clearly indicates the meaning of "slightly increased temperature," which is the difference between the temperature of the skin of the living body, eg, the wrist and the temperature of the needleless fluid injector. Is a term to consider.

Referring to the second element, the heating of the skin of the living body in contact, it can be made as the solution receiving member is placed in contact with or adjacent to the skin is heated by infrared rays of the heating lamp. In addition, since the insulin filled in the solution receiving member contacts the skin of the living body, the temperature of the skin can be increased, thereby swelling the skin, and can also increase the permeability of internal cellular tissues. Since insulin diffuses from the solution receiving member to the cell tissue inside the skin of the living body, a concentration gradient is generated across the solution receiving member, and then the wetting of the solution receiving member and the capillary phenomenon of the solution receiving member Insulin may continue to be replenished from internal pores. The rate at which insulin is removed from the solution receiving member may be determined by the liquid concentration at the surface and the inner interface of the skin and the absorbency of the skin. In addition, as contemplated in some studies, insulin absorption may be further promoted by heating insulin to locally heat the skin.

Referring to the direct effect on the inner skin layer by the third element, infrared light, for example, infrared light having a wavelength of about 920 nm can be transmitted into the cell tissue to a depth of about 3 mm to about 4 mm in the skin. For example, infrared light having a wavelength in the range of about 880 nm to about 1200 nm has a strong thermal effect and is located in the skin, mucous membranes, or cornea and in the hypothalamus and spinal cord of the central nervous system. (spinal cord) can release the heat receptor. The light can penetrate up to about 2 cm to about 4 cm deep of living cell tissue. The transmission depth of this infrared light may depend on the wavelength, moisture of the skin, blood supply, pigmentation level, and personal factors. As such, signals from activated thermoreceptors are input to a thermoregulatory center located in the hypothalamus or spinal cord, and consequently thermoregulation responses may indicate an enlargement of the blood vessels of the skin, a local increase in blood volume and an increase in sweat. . Neural reflexes can occur as a result of infrared light on the reflective areas of skin parts directly related to internal organs. For example, it may indicate the formation of bioactive substances such as bradykinin and kallidin, which play an important role in the humoral regulation of local and systemic circulation. The bradykinin has a strong vasodilation effect and can be observed locally and systemically. Appropriate amounts of infrared light can increase the regeneration process and also provide the effects of metabolism enhancement, cell proliferation, and enzymatic potentiation. Such infrared radiation can rapidly accelerate the liquid migration from the solution receiving member, which is a porous TiNi-based material, to cellular tissues in the skin. Heat flow onto the wet skin surface can form a temperature gradient in the boundary layer. Subsequently, when infrared radiation passes through the internal pores of the solution receiving member to reach the skin, vasodilation occurs, and insulin diffusion may be accelerated into adjacent cell tissues.

Figure 4 is a schematic diagram showing a hand ankle wearable needleless injection device 100 according to an embodiment of the present invention.

Referring to Figure 4, (a) shows the appearance of the ankle wearable needleless injection device, (b) shows an example of wearing the ankle wearable needleless injection device. Needle-free solution injection device according to the technical idea of the present invention can be applied to the thinnest skin area for easy injection of insulin, for example, elbow or wrist, ankle and the like.

The size of the ankle wearing needle-free solution injection device 100 is 45mm x 30mm x 16mm. The power source 140 installed therein (see FIG. 1) may use a lithium secondary battery of 840 mA and 5V. The size of the ankle wearing needleless solution injection device 100 may be determined by the average wrist size of the patient to be worn and the size of the lithium secondary battery. The total weight of the ankle worn needleless solution injection device 100 of Figure 4 is 51 g.

On one side of the ankle wearable needleless injection device 100, the power button 160, LED indicator 170, and a mini USB port 180 for charging is installed. In addition, the wrist ankle wearable needle injection device 100 may further include a strap 190 of a material such as leather that can be attached to the wrist or ankle.

The solution receiving member 120 is exposed to contact the skin of the patient to be worn. The solution receiving member 120 uses the above-described porous TiNi-based material. The porous TiNi-based material may be formed by cutting electric discharge wire, and in this example, has a size of 45 mm x 30 mm x 0.7 mm. The solution receiving member 120 may contain an insulin solution.

The heating lamp 130 emits infrared light having a wavelength of 920 nm and may have a power consumption of 120 mW. The heating lamp 130 may use, for example, "Kingbrig" type L-53SF6C LEDs, and install six of them.

Hereinafter, a description will be given of the operation method of the hand ankle wearable needleless injection device.

The ankle wearable needleless injection device has the advantage that the patient can simply use it. The operating principle of the needleless solution injection device is by the heat flow which heats the solution accommodating member by providing electrical energy of the power supply 140 (see FIG. 1) to the heating lamp 130 (see FIG. 1). First, the lithium secondary battery is fully charged as a power source. Install a solution receiving member fully filled with insulin. The solution receiving member may have a housing groove. The ankle wearable needleless injection device is then placed on the wrist or ankle and secured using the strap. Then, the power button 160 is turned on to operate the ankle wearable needleless injection solution.

Figure 5 is a graph showing the temperature change with time when the needle-free solution injection device according to an embodiment of the present invention.

Referring to Figure 5, it increases from about 20 ° C at the start of operation and reaches and maintains about 45 ° C after about 4 minutes to about 5 minutes. Upon reaching about 45 ° C., insulin infusion may begin into the body of the patient wearing it.

Figure 6 is a schematic diagram showing a patch-type needleless solution injection device according to an embodiment of the present invention.

Referring to FIG. 6, the patch-type needleless solution injection device further includes an adhesive member 195 covering the needleless solution injection device 100 described above. The adhesive member 195 may include various materials adhered to the skin of the living body. In FIG. 6, the adhesive member 195 is illustrated to cover the needleless solution injector 100 as a whole. However, this is illustrative and the technical spirit of the present invention is not limited thereto. It may include various ways in which the adhesive member 195 is provided at a fixed level.

Experimental Example

In the following, in order to verify the efficiency of the needleless solution injection device of the present invention, a clinically applied experimental example will be described.

The experimental example was applied to 42 diabetic patients. The experiment was performed in compliance with the Helsinki Declaration, approved by the Council of Ethics of the Siberian State Medical University, and agreed to all patients prior to performance. Patients with various early hyperglycemic levels participated.

Criteria for participation in the experiment were (1) ages 18 to 80 years, (2) type 1 diabetes or type 2 diabetes, (3) LDL-cholesterol levels in the range of 130 mg / dl to 190 mg / dl, ( 4) body mass index in the range of 25 kg / m ² to 30 kg / m ² , (5) Triglycerides in the range 150 mg / dl to 400 mg / dl, and (6) fasting up to 125 mg / dl Fasting plasma glucose levels.

Criteria for eliminating experiments include: (1) cancer patients, (2) taking irregular or unstable drugs that may interfere with fat or sugar metabolism, and (3) taking drugs for chronic gastrointestinal disorders and treatment. (4) patients with thyroid, liver, kidney, or muscle, (5) allergic or rejective responses to insulin, and (6) medical surgical conditions that may have irregular effects on this experiment. If it is.

Personal data, history, and medical history of each subject were questioned at the start. Patients were asked to continue their usual food intake and work activities prior to the experiment, and to stop previous blood glucose reduction treatments, such as administering insulin or drugs. Anthropometric parameters, hemodynamic parameters and biochemical parameters were collected at the start. Hemodynamic parameters were collected by measuring orthostatic and clinostatic systolic and diastolic blood pressure. In addition, orthostatic and cryostet wrist blood pressure and heart frequency were measured. The blood glucose of these patients was measured using an Accu-Chek Active glucose meter with 393 and 436 test strips.

After attaching the needleless injection device to the wrists of the patients, blood glucose was measured after the initial time point (referred to as 0 minutes), after 30 minutes, and after 60 minutes. For reference, in the needleless injection device, 10 units of short acting insulin (two insulin Actrapid® HM and Rinosulin® NPH) were injected into the solution receiving member on the surface of the device and uniformly distributed. The measured blood glucose data was interpreted using Statistical 5.0 for Windows.

Table 1 is a table showing the blood sugar changes according to the blood glucose of the patients wearing a needleless solution injection device according to an embodiment of the present invention. The unit of numerical values stated is mmol / L.

Patient number	0 min	30 minutes	60 minutes	Patient number	0 min	30 minutes	60 minutes
One	17.3	12.8	9.9	22	14.7	10.9	7.7
2	19.6	11.7	9.2	23	15.6	11.0	7.4
3	16.7	12.6	9.1	24	18.2	13.2	8.5
4	18.6	11.2	8.8	25	17.9	12.6	7.6
5	16.1	10.6	7.9	26	14.7	10.9	7.7
6	16.3	11.0	8.7	27	17.5	12.5	8.4
7	17.4	10.8	8.6	28	14.8	8.4	6.6
8	15.2	9.5	7.2	29	18.1	13.2	8.9
9	16.2	11.9	8.0	30	16.0	11.1	7.3
10	19.4	13.9	9.5	31	17.7	12.5	7.8
11	15.2	10.5	6.9	32	15.9	9.4	6.5
12	18.1	12.3	7.6	33	18.4	12.9	8.7
13	16.4	11.6	7.4	34	20.8	14.7	9.9
14	15.5	10.2	6.3	35	18.3	12.2	7.3
15	17.7	12.0	8.8	36	14.9	9.8	6.8
16	19.8	14.9	10.4	37	19.1	14.1	10.2
17	14.7	8.6	6.7	38	17.5	12.0	7.4
18	17.5	13.1	8.4	39	15.7	11.5	7.1
19	14.3	10.7	7.9	40	18.3	13.4	8.4
20	18.0	14.6	9.5	41	15.8	10.2	6.5
21	16.4	12.8	8.6	42	17.2	12.8	7.9

Figure 7 is a graph showing the change in blood sugar according to the blood sugar of patients wearing a needleless solution injection device according to an embodiment of the present invention. 7 is a graph created by statistically processing the results shown in Table 1. FIG.

Referring to Table 1 and FIG. 7, the average blood glucose was about 17.11 mmol / L after 0 minutes, about 11.92 mmol / L after 30 minutes, and about 8.16 mmol / L after 60 minutes. During 30 minutes after wearing, blood glucose was relatively sharply decreased, and thereafter, the decrease in blood glucose gradually changed, indicating a tendency to continue to decrease. After about 120 minutes, it can be confirmed that a stable state of blood sugar is reached. The average decrease in blood glucose was about 56%, and no side effects were found in all patients. Thus, the significant effect of blood glucose reduction is analyzed to occur in the range from 30 minutes to 120 minutes after wearing.

Clinical case # 1

Patient M: age 70 years old; Case number # A1016; Type 2 diabetes; Require insulin; Indicates severe decompensation; And diabetic limb syndrome with a trophic ulcer in the fourth toe of the left foot; And Siofor 850-b.i.d., NovoMix 20U-16U as baseline treatment. A needleless injector was applied to patient E.

Figure 8 is a graph showing the change in blood sugar according to the blood sugar of the patient M wearing a needleless solution injection device according to an embodiment of the present invention.

Referring to FIG. 8, the blood glucose of patient M was about 17.3 mmol / L after 0 minutes, about 12.8 mmol / L after 30 minutes, and about 9.9 mmol / L after 60 minutes. After blood glucose normalized, general and local treatment continued, and the onset dystrophy ulcer was treated, and upon discharge, patient M's blood glucose level was about 5.3 mmol / L, reaching normal levels.

Clinical case # 2

Patient E: age 53 years; Case number # A1263; Diabetes diagnosed 6 years ago during defined determination of blood glucose levels by thirst, polyuria, and family history; And patients have been treated with various combinations of metformin and sulfonylurea over the long term. A needleless injector was applied to patient E.

Figure 9 is a graph showing the blood sugar changes according to the blood sugar of the patient E wearing a needleless solution injection device according to an embodiment of the present invention.

Referring to FIG. 9, the blood glucose of patient E was about 19.6 mmol / L after 0 minutes, about 11.7 mmol / L after 30 minutes, and about 9.2 mmol / L after 60 minutes. Positive results such as a gradual reduction in blood glucose and associated side effects with the device of Patient E were clearly observed. It was then decided to continue the selected treatment for glycemic control. The blood glucose level of patient E was about 6.5 mmol / L, reaching normal level.

It can be seen that the clinical cases clearly demonstrate the efficiency of the needleless device for the implementation and efficiency of the administration of insulin through the transdermal. Therefore, it is considered that the medical effect of the needleless solution injection device and method according to the present invention is verified. In addition, the needleless solution injection device and method according to the technical concept of the present invention can be extended for bioinfusion into other drugs, and thus can be widely applied to medical practice.

conclusion

Needle-free solution injection device and method according to the technical idea of the present invention is the main purpose of the treatment of diabetes, specifically to reduce hyperglycemia to normal blood sugar. To date, insulin injection has been proposed to supply insulin in vivo or stimulate natural insulin secretion from the body, and various methods of insulin injection have been proposed. Insulin injection for long-term action is to stimulate basal secretion of insulin, and insulin injection for short-term action, such as 30 minutes before food intake, is to further increase insulin levels in the blood to correspond to hyperglycemia after food intake.

Needle-free solution injection device and method according to the technical concept of the present invention is to accelerate the in vivo injection and absorption of insulin by locally heating the skin corresponding to the insulin injection portion without using a needle, the existing research The results were reviewed. Using the needleless injection device and method according to the technical concept of the present invention, 42 insulin patients were clinically verified the efficiency of insulin supply. Specifically, by locally heating the skin by a needleless device, it was effective for infusion and absorption of insulin without increasing the risk of hypoglycemia. This local skin heating can cause the loop to close and increase the overall insulin supply. It is also analyzed that increasing the temperature of the skin at the infusion site does not cause other side effects in the patient and is therefore sufficient to increase the infusion of insulin. In addition, it can be seen that the needleless injection device and method according to the technical concept of the present invention do not cause skin irritation or lesions and are safe to use.

Needle-free solution injection device and method according to the technical idea of the present invention can alleviate or eliminate the usual constraints on the treatment of diabetes in everyday life for patients. In addition, the needleless injection device and method according to the technical concept of the present invention shows that there is a prospect as a new technology for supplying insulin and liquid medicine. Thus, the use of infrared and porous permeable self-transfer high temperature synthetic TiNi alloys may provide an opportunity to develop new needleless solution injection devices and methods. In the future, the importance and function of individual factors, such as food composition and time of administration for diabetics, may be proposed for future research.

The technical spirit of the present invention described above is not limited to the above-described embodiment and the accompanying drawings, and various substitutions, modifications, and changes can be made without departing from the technical spirit of the present invention. It will be apparent to those of ordinary skill in the art.

Claims (13)

1. Body;

   A solution receiving member exposed to contact the skin of the living body on one side of the body and accommodating a solution;

   A heating lamp which emits light to heat the solution receiving member and is positioned in the body opposite the solution receiving member;

   A power source located in the body and supplying power to the heating lamp; And

   A control unit located in the body and electrically connected to and controlling the power supply and the heating lamp;

   Including,

   And the solution receiving member is heated by the heating lamp so that the solution is injected into the living body through the skin in contact with the solution receiving member.
2. The method of claim 1,

   And the solution is injected into the living body in accordance with a temperature gradient generated between the solution receiving member and the skin heated by the heating lamp.
3. The method of claim 1,

   The needleless injection device of claim 1, wherein the solution comprises insulin.
4. The method of claim 1,

   And the solution receiving member has a porous structure including pores, and the solution is accommodated in the pores.
5. The method of claim 1,

   And the solution receiving member comprises TiNi.
6. The method of claim 1,

   And the solution containing member has a thickness through which the light is transmitted such that light emitted by the heat lamp directly heats the skin.
7. The method of claim 1,

   And the solution receiving member has a porosity of 65% to 75% and a pore size distribution of 40 μm to 900 μm and an average pore size of 130 μm to 170 μm.
8. The method of claim 1,

   And the solution receiving member has a detachable structure detachable from the body.
9. The method of claim 1,

   And the heating lamp comprises an infrared light emitting diode.
10. The method of claim 1,

    The needleless solution injection device, wherein the heating temperature by the heating lamp ranges from 20 ℃ to 45 ℃.
11. The method of claim 1,

    The power supply comprises a primary battery or a secondary battery, needle-free injection device.
12. The method of claim 1,

    The needleless solution injecting device is an ankle wearable or patch type, needleless solution injecting device.
13. Positioning a solution receiving member containing the solution in contact with the skin of the living body;

    Heating the solution receiving member using a heating lamp; And

    The solution receiving member is heated by the heating lamp so that the solution is injected into the living body through the skin in contact with the solution receiving member;

    Including, needle-free solution injection method.

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